Fluoride: The Ultimate Cluster-Flux And the Players Involved A Compilation of Documents and Articles Relating to Fluoride This collection is dedicated to those who wrote the original works and made them available on the internet. I have spent countless hours searching for information on fluoride and it is my wish, by assembling these works, to enable others to save time looking and make available more time for them to ‘do’. If you are sickened and appalled by the approved use of fluoride in food, beverage and other consumer products then I ask that you spread this knowledge on to others and contact your local representatives in the hopes that one day fluoride will be more strictly regulated or, banned altogether. These documents are listed in roughly the order I found them. It would be nearly impossible to group them in some kind of order since they are all linked together – a cluster-flux of monumental proportions. I would like to thank (or curse) Christopher Bryson whose excellent book, The Fluoride Deception, opened my eyes to fluoride and started me on this journey of uncovering the truth. For more information on fluoride, I would recommend the Fluoride Action Network (FAN) http://www.fluoridealert.org/ as a good place to start. NOTICE In accordance with Title 17 U.S.C., section 107, some material on this web site is provided without permission from the copyright owner, only for purposes of criticism, comment, news reporting, teaching, scholarship and research under the "fair use" provisions of federal copyright laws. These materials may not be distributed further, except for "fair use" non-profit educational purposes, without permission of the copyright owner. COPYRIGHT 2005 Mothering Magazine http://www.accessmylibrary.com/coms2/summary_0286-19173790_ITM John Ruby was angry. So outraged, in fact, that the associate professor of pediatric dentistry from the University of Alabama at Birmingham found himself hanging a provocative poster on the general bulletin board at the American Academy of Pediatric Dentistry's annual meeting in May 2003. The poster disappeared, and when Ruby put up another, he was told by the executive director of AAPD to take it down or be thrown out of the conference. The poster featured the familiar Coca-Cola logo in a black circle with a thick diagonal line across it, Ghostbusters style. Across the top Ruby had written "Coca-Cola, Nutritional Trash" and had provided information about the high sugar content of the soda and its high acidity, which can rot teeth. (1) Ruby was protesting the $1 million grant from Coca-Cola that AAPD, the nation's leading pediatric dental association, had accepted in March 2003. (2) Along with many other dentists, Ruby was concerned about the spectacular jump in soda intake among children and adolescents that has occurred over the past five decades. Since 1950, per-capita soda consumption in children has increased by a factor of nearly five. (3) Many doctors believe this rise in soda consumption is contributing to the rapid increase in obesity and type 2 diabetes that has been observed in American children over the past two decades. (4) Recent research suggests that soda consumption is also contributing to high blood pressure in adolescents, especially teenagers of color. (5) Dentists, of course, are concerned about soft drinks and cavities, or caries. (6) We first met Dr. Ruby when our group, the Campaign for a Commercial-Free Childhood, was collecting signatures from dentists for a letter asking AAPD to return the grant from CocaCola. In our letter to AAPD, we noted that it was difficult "to imagine a research funder less appropriate for AAPD than Coca-Cola, the world's most popular brand of soda." (7) We went on to say that the AAPD-Coca-Cola partnership sends a message to the American public that soda drinks are not harmful; if they were, surely pediatric dentists wouldn't team up with Coke. We wondered if this message did not fly in the face of recent policy statements by the American Dental Association (ADA) and AAPD itself recommending that soda intake be limited, because drinking sugared beverages, as AAPD put it, "contributes to the initiation and progression of dental caries." (8,9) In short, we believed AAPD was selling out. Despite its protests to the contrary--AAPD insisted it was not endorsing any of Coca-Cola's products--the fact remained that Coke could use the grant to counter claims that it did not care about children's health. AAPD knew Coke was likely to do this when it signed on. But still, we were curious: Did the rest of the dental world share our opinion? Dental Group Is Under Fire For Coke Deal By MARIAN BURROS Published: March 4, 2003 New York Times In one of the more unlikely industry-health partnerships, a soft drink company will give about $1 million to an organization dedicated to the health of children's teeth to promote health education and research. The charitable arm of the American Academy of Pediatric Dentistry has signed an agreement with the Coca-Cola Foundation, and Coke will distribute the academy's education messages. The academy would not say how that would be done. Coca-Cola would not comment. ''There is such an important message our organization is trying to get to the public and Coke has an exceptional reach to consumers and the opportunity is there to help us reach them,'' Dr. David Curtis, president of the academy, said. But Dr. Michael Biermann, a member of the academy and of the board of trustees of the American Dental Association, said the deal ''leaves the implication that there is something shady going on.'' He said: ''It just doesn't look right and I just don't like the association with any commercial product like that casting a shadow on our industry.'' Dr. Jonathan Shenkin, a second-year resident at the department of pediatric dentistry at the University of Iowa, is also concerned about the partnership. ''Such an arrangement presents a clear conflict of interest,'' he said. Some academic pediatric dentists who were asked for comment said they had been told by their universities that they could not speak about the partnership arrangement. Others fear retribution from the academy. Generally, pediatric dentists in private practice who were willing to talk appeared to be torn by conflict about the arrangement. They say they can see the value in having the money to educate parents and children about oral hygiene, but they worry about appearances. ''Really it's a hot potato and I'm not sure what side of the fence I fall on,'' said Dr. John Willis, who practices in South Portland, Me., and who, along with the Maine Dental Association, is backing the state's legislative effort to get soft drinks out of the schools. Whether consumption of soft drinks causes cavities is still a matter of dispute. From 1977 to 1996, consumption of soft drinks among 12-to 19-year-old boys who drank soda increased to 28 ounces a day from 16; among girls, it rose to 21 ounces a day from 15. A study published last October in General Dentistry, written by Dr. Shenkin and three of his professors, concludes: ''This increase in soft-drink consumption has been paralleled by increasing rates of obesity in children and reports of rampant tooth decay.'' The soft drink association vigorously disagrees, and in a recent letter to a reporter said, ''A growing body of scientific evidence shows that soft drinks do not cause obesity, dental cavities or any other health problems.'' Some dentists do not think that soft drinks are any more of a problem than other sweets but children consume larger quantities of sodas than other cavity-producing foods. Dr. Willis said: ''I do think there is something wrong with sugar in the soft drinks and some have three acids in them, and I think we know scientifically that the frequency of sugar and acid insults play a key role in cavity activity. We have kids drinking a six-pack or two a day, and that's poor health.'' In a letter to the academy, Dr. Michael Jacobson, executive director of the Center for Science in the Public Interest, a health-based advocacy group, said: ''Though the A.A.P.D. may contend that a deal would not represent an endorsement of Coca-Cola's soft drinks, many people will see that as a difference without a distinction. Furthermore, you can bet that Coca-Cola will ballyhoo to the skies its close relationship with the A.A.P.D., hoping to gain 'innocence by association' with a hitherto credible health professional organization.'' ADA wiki http://en.wikipedia.org/wiki/American_Dental_Association The American Dental Association (ADA) is an American professional association established in 1859 and has more than 152,000 members. Based in Chicago, the ADA is the world's largest and oldest national dental association and promotes good oral health to the public while representing the dental profession. The ADA publishes a monthly journal of dental related articles named the Journal of the American Dental Association. The ADA was founded August 1859, at Niagara Falls, New York, by twenty-six dentists who represented various dental societies in the United States. Today, the ADA has more than 152,000 members, 55 constituent (state-territorial) and 545 component (local) dental societies. It is the largest and oldest national dental association in the world. The Association has more than 400 employees at its headquarters in Chicago and its office in Washington, D.C. The Paffenbarger Research Center (PRC), located on the campus of the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland, is an agency of the American Dental Association Foundation (ADAF) and a Department of the Division of Science. PRC scientists conduct basic and applied studies in clinical research, dental chemistry, polymer chemistry and cariology. The ADA established rigorous guidelines for testing and advertising of dental products and the first ADA Seal of Acceptance was awarded in 1931. Today, about 350 manufacturers participate in the voluntary program and more than 1300 products have received the Seal of Acceptance. The Board of Trustees, the administrative body of the Association, is composed of the President, the President-elect, two Vice Presidents and 17 trustees from each of the 17 trustee districts in the United States. The Treasurer and Executive Director serve as ex officio members. The House of Delegates, the legislative body of the Association, is composed of 460 delegates representing 53 constituent societies, five federal dental services and the American Student Dental Association. The House meets once a year during the Association's annual session. The Association's 11 councils serve as policy recommending agencies. Each council is assigned to study issues relating to its special area of interest and to make recommendations on those matters to the Board of Trustees and the House of Delegates. The Association's official publication is The Journal of the American Dental Association. Other publications include the ADA News and the ADA Guide to Dental Therapeutics. The Commission on Dental Accreditation, which operates under the auspices of the ADA, is recognized by the U.S. Department of Education as the national accrediting body for dental, advanced dental and allied dental education programs in the United States. The ADA formally recognizes 9 specialty areas of dental practice: dental public health, endodontics, oral and maxillofacial pathology, oral and maxillofacial surgery, orthodontics and dentofacial orthopedics, pediatric dentistry, periodontics, prosthodontics, and oral and maxillofacial radiology. The ADA library has an extensive collection of dental literature with approximately 33,000 books and 17,500 bound journal volumes. The ADA library also subscribes to more than 600 journal titles. The ADA Foundation is the charitable arm of the Association. The Foundation provides grants for dental research, education, scholarships, access to care and charitable assistance programs such as relief grants to dentists and their dependents who are unable to support themselves due to injury, a medical condition or advanced age; and grants to those who are victims of disasters. [edit] Advocacy The ADA is a vociferous promoter of water fluoridation.[1] The ADA has purchased internet websites with names that mimic those of prominent websites that do not favor fluoridation. The ADA redirects visitors from the websites flouridation.com fluoridealert.com and fluoridealert.net to their own pro-fluoridation pages. The domain names of these websites are intentional misspellings of advocacy websites fluoridation.com and fluoridealert.org that do not favor fluoridation.[2][3] In November of 2006, the ADA began recommending to parents that infants from 0 through 12 months of age have their formula prepared with water that is fluoride-free or contains low levels of fluoride to reduce the risk of fluorosis.[4] [edit] Significant events • • 1840: First dental college, the Baltimore College of Dental Surgery; American Society of Dental Surgeons is established. 1845: American Society of Dental Surgeons ask members to sign a mandatory pledge promising not to use amalgam fillings. • • • • • • • • • • • • • • • • • • • • • • • 1856: American Society of Dental Surgeons, because of its stance against dental amalgam, is disbanded in 1856 due to loss of membership. 1859: Twenty-six dentists meet in Niagara Falls, New York to form a professional society. 1860: First ADA constitution and bylaws are adopted. 1897: ADA merges with the Southern Dental Association to form the National Dental Association (NDA). 1908: NDA publishes the first patient dental education pamphlet. 1913: NDA adopts a new constitution and bylaws, establishing the House of Delegates and Board of Trustees. 1913: The Journal of the National Dental Association is first published under the title, Bulletin of the National Dental Association 1922: NDA is renamed the American Dental Association (ADA). 1928: ADA affiliates with the NBS; National Board of Dental Examiners is established. 1930: Council of Dental Therapeutics established to oversee the evaluation of dental products. The Council establishes the ADA's Seal Program. 1931: First ADA Seal of Approval awarded; ADA headquarters located on north side of Chicago. 1936: ADA Council on Dental Education is formed. 1948: The National Institute of Dental Research (NIDR) is established (since renamed the NIDCR (National Institute of Dental and Craniofacial Research)). 1950: ADA works with Congress to proclaim February 6 as National Children's Dental Health Day; ADA endorses fluoridation. 1964: ADA produces the first color television Public Service Announcement by a non-profit health agency; ADA establishes the ADA Health Foundation, a501 (c)(3) non-profit organization for the purpose of engaging in dental health research and educational programs. 1970: ADA News is first published. 1978: Council on Dental Practice established. 1979: The Commission on Dental Accreditation established. 1987: ADA Commission on the Young Professional is formed (later becomes the Committee on the New Dentist). 1991: First woman ADA president, Dr. Geraldine Morrow. 1995: ADA Web site, ADA ONLINE, created (later becomes ADA.org) 2002: First minority ADA president, Dr. Eugene Sekiguchi. 2003: First “Give Kids a Smile” day held as part of National Children’s Dental Health Month. New York Times article: http://www.nytimes.com/2005/12/13/science/13narw.html?pagewanted=3 The investigators zeroed in on the riddle with sophisticated instruments at the Paffenbarger Research Center of the National Institute of Standards and Technology, a federal organization in Gaithersburg, Md. The American Dental Association finances the research center. NIST wiki: http://en.wikipedia.org/wiki/National_Institute_of_Standards_and_Technology The National Institute of Standards and Technology (NIST), known between 1901 and 1988 as the National Bureau of Standards (NBS), is a measurement standards laboratory which is a non-regulatory agency of the United States Department of Commerce. The institute's mission is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve quality of life. NIST had an operating budget for fiscal year 2007 (October 1, 2006-September 30, 2007) of about $843.3 million.[1] NIST employs about 2,900 scientists, engineers, technicians, and support and administrative personnel. About 1,800 NIST associates (guest researchers and engineers from American companies and foreign nations) complement the staff. In addition, NIST partners with 1,400 manufacturing specialists and staff at nearly 350 affiliated centers around the country. NIST's headquarters are in Gaithersburg, Maryland. It also has laboratories in Boulder, Colorado. NIST has four major programs through which it helps U.S. industry: the NIST Laboratories (physics, information technology, chemical science and technology, electronics and electrical engineering, materials science and engineering, manufacturing engineering, and building and fire research); the Hollings Manufacturing Extension Partnership (HMEP), a nationwide network of centers to assist small manufacturers; the Advanced Technology Program (ATP), a grant program where NIST and industry partners cost share the early-stage development of innovative but high-risk technologies; and the Malcolm Baldrige National Quality Award program, the nation's highest award for performance and business excellence. NIST's Boulder laboratories are best known for NIST-F1, one of the world's two most accurate atomic clocks. (The other is in Paris, France). NIST-F1 serves as the source of the nation's official time. From its precise measurement of the natural resonance frequency of cesium—which is used to define the second —NIST broadcasts time signals via longwave radio station WWVB at Fort Collins, Colorado, and shortwave radio stations WWV and WWVH, located at Fort Collins, Colorado and Kekaha, Hawaii, respectively. NIST manages some of the world’s most specialized measurement facilities—including a cost effective NIST Center for Neutron Research (NCNR) user facility where cutting edge research is done on new and improved materials, advanced fuel cells, and biotechnology. The SURF III Synchrotron Ultraviolet Radiation Facility is the world's senior dedicated source of synchrotron radiation, in continuous operation since 1961. SURF III now serves as the US primary national standard for source-based radiometry throughout the generalized optical spectrum: from infrared through extreme ultraviolet. NIST's Advanced Measurement Laboratory (AML) is among the most technically advanced research facilities of its kind in the world. The AML offers American researchers opportunities to make the most sensitive and reliable measurements. This is important as new technologies become more complex and smaller. Based in the AML is the Center for Nanoscale Science and Technology (CNST). The CNST's prime objective is to lay the technical groundwork necessary to translate nanotechnology’s many anticipated offerings into practical realities—manufacturable, market-ready products. To accomplish this goal, the center leverages and combines the diverse knowledge and capabilities of NIST, industry, academia, and other government agencies to support all phases of nanotechnology development. The CNST features a Nanofabrication (Nanofab) Facility. CNST's “clean room” is equipped with an array of state-of-the-art tools for making, testing, and characterizing prototype nanoscale devices and materials. These instruments will be available to collaborators and outside users through a proposal process. As part of its mission, NIST supplies industry, academia, government and other users with over 1,300 Standard Reference Materials (SRMs) of the highest quality and metrological value. These artifacts are certified as having specific characteristics or component content, making them valuable as calibration standards for measuring equipment and procedures, quality control benchmarks for industrial processes, and experimental control samples for all kinds of laboratories. For example, NIST SRMs for the food manufacturing sector include: • • • • • • • • • Typical diet (SRM 1548a, $624) Non-fat milk powder (SRM 1549, $318, 100 g) Oyster tissue (SRM 1566b, $540, 25 g) Wheat flour (SRM 1567a, $418, 80 g) Rice flour (SRM 1568a, $390, 80 g) Bovine liver (SRM 1577b, $261, 50 g) Tomato leaves (SRM 1573A, $332, 50 g) Natural water (SRM 1640, $198, 250 mL) Peanut butter (SRM 2387, $501, three 6 oz (170 g) jars) NIST has 7 standing committees: • • • • • Technical Guidelines Development Committee (TGDC) Advisory Committee on Earthquake Hazards Reduction (ACEHR) National Construction Safety Team Advisory Committee (NCST Advisory Committee) Information Security and Privacy Advisory Board (ISPAB) Visiting Committee on Advanced Technology (VCAT) • • Baldrige National Quality Program Board of Overseers (BNQP Board of Overseers) Manufacturing Extension Partnership National Advisory Board (MEPNAB) NIST is currently developing government-wide identification card standards for federal employees and contractors to prevent unauthorized persons from gaining access to government buildings and computer systems. In 2002 the National Construction Safety Team Act mandated NIST to conduct an investigation into the collapse of the World Trade Center, as well as the 47-story 7 World Trade Center. The investigation covered three aspects, including a technical building and fire safety investigation to study the factors contributing to the probable cause of the collapses of the WTC Towers (WTC 1 and 2) and WTC 7. NIST also established a research and development program to provide the technical basis for improved building and fire codes, standards, and practices, and a dissemination and technical assistance program to engage leaders of the construction and building community in implementing proposed changes to practices, standards and codes. NIST also is providing practical guidance and tools to better prepare facility owners, contractors, architects, engineers, emergency responders, and regulatory authorities to respond to future disasters. The investigation portion of the response plan is scheduled to be completed in 2008 with the release of the final report on 7 World Trade Center. The final report on the WTC Towers – including 30 recommendations for improving building and occupant safety – was released on October 26, 2005.[2] NIST works in conjunction with the Technical Guidelines Development Committee of the Election Assistance Commission to develop the Voluntary Voting System Guidelines for voting machines and other election technology. Further information: certification of voting machines Three researchers at NIST have been awarded Nobel Prizes for their work in physics, William D. Phillips in 1997, Eric A. Cornell in 2001 and John L. Hall in 2005. Other notable people who have worked at NIST include • • • • • • • • • • • • Milton Abramowitz James S. Albus Ferdinand Brickwedde Lyman James Briggs John W. Cahn William Coblentz Keith Codling Ronald Colle Philip J. Davis Hugh L. Dryden Ugo Fano Charlotte Froese Fischer • • • • • • • • • • • • Douglas Hartree Magnus Hestenes Cornelius Lanczos Theodore Madey Wilfrid Mann William Meggers Frank W. J. Olver Ward Plummer Jacob Rabinow Charlotte Moore Sitterly Irene Stegun Bill Stone The director of NIST is a Presidential appointment and confirmed by the Senate. Thirteen persons have held the position (in addition to three acting directors who served temporarily). They are: • • • • • • • • • • • • • • • • Samuel W. Stratton, 1901-1922 George K. Burgess, 1923-1932 Lyman J. Briggs, 1932-1945 Edward U. Condon, 1945-1951 Allen V. Astin, 1951-1969 Lewis M. Branscomb, 1969-1972 Richard W. Roberts, 1973-1975 Ernest Ambler, 1975-1989 John W. Lyons, 1990-1993 Arati Prabhakar, 1993-1997 Raymond G. Kammer, 1997-2000 Karen Brown (acting director), 2000-2001 Arden L. Bement Jr., 2001-2004 Hratch Semerjian (acting director), 2004-2005 William Jeffrey, 2005-2007 James Turner (acting director), 2007-Present ADA website: http://www.ada.org/prof/resources/pubs/adanews/adanewsarticle.asp?articleid=742 Honolulu's city council votes to ban fluoridation Bill could affect 80-90 percent of Hawaii's population Posted Feb. 20, 2004 Honolulu — A bill to ban fluoridation of the water supply here passed the Honolulu City Council Jan. 28 by a vote of 7-2. Disguised as a “pure water” bill, the ban prohibits “any product, substance or chemical... for the purpose of treating or affecting the physical or mental functions of the body or any person” from being added to the city's water supply. “They snuck up on us on this one,” says Dr. Norman Chun, legislative chair of the Hawaii Dental Association. “It stayed under the radar for several months. Although it was supposedly introduced last October, we didn't know about it until 10 days before the vote, and neither did any of the other pro-fluoridation groups that we work with who also monitor this type of activity. We knew right away the vote would go against fluoridation because there are a greater number of antis on the city council than in the state legislature.” The bill is now on the mayor's desk, notes Dr. Chun, “and we are pulling out all stops to get it vetoed. We have a few more days to work on this.” Dr. Chun urges dentists to be watchful for this type of legislation being introduced at their own city and county government levels. “The antifluoridationists didn't have success at the state level,” said Dr. Kim Lawler, president of the Hawaii Dental Association, “but by targeting Honolulu, they've still affected 80 to 90 percent of Hawaii's population.” In New Hampshire, for example, a similar antifluoridation bill remains in committee and “it doesn't look like it's going to come out,” says Dr. Alphonse Homicz, president-elect of the New Hampshire Dental Society. New Hampshire House Bill 1209 would prohibit any substance from being added to a public drinking water supply that “is intended to treat people and not water, or to fulfill a health claim,” unless the added substance has been approved by the U.S. Food and Drug Administration for safety and effectiveness for all ages, health conditions and levels of water consumption. Thanks to information received from the ADA, Dr. Homicz stresses, New Hampshire dentists were able to testify against the bill, educating legislators about the fact that the FDA does not have jurisdiction over water fluoridation chemicals. “We went in with strong data from the ADA and successfully argued against the substance of the legislation.” In a recent letter to the mayor of Honolulu, the ADA provided clarification on the regulation of fluoride chemicals. Proposals requiring the U.S. Food and Drug Administration to approve chemicals used in fluoridation are targeted at the wrong jurisdiction. The FDA does not, and will not in the foreseeable future, have jurisdiction over water fluoridation chemicals. The only way this could happen would be through an act of Congress. To help insure the public's safety, the American Water Works Association and the American National Standards Institute set standards for all chemicals used in the water treatment plant, including fluoride chemicals. The National Sanitation Foundation also sets standards and does product certification for products used in the water industry, including fluoride chemicals. This type of bill has been introduced in five other state legislatures since 2000 — California, Hawaii, Oregon, Utah and Washington — but all failed to pass. So, Dr. Chun warns, antifluoridationists are quietly introducing so-called “pure water” bills at the city council or county level. Better known as the Fluoride Product Quality Control Act, these bills would require all fluoride compounds used in water fluoridation to be approved by the U.S. Food and Drug Administration. Another city-level fluoridation challenge in Watsonville, Calif., still awaits final resolution. For more information regarding fluoride and fluoridation visit the ADA's Fluoride and Fluoridation Web page. ** National Sanitation Foundation – NSF http://en.wikipedia.org/wiki/NSF_International Board of Directors • • • • • • • Charles Depew (Chairman of the Board)- GlaxoSmithKline, Vice President, Worldwide Regulatory Affairs Mary Jane England - Regis College, President, Cleary University, Board of Trustees Nina McClelland - NSF International, President 1980-1994, previously Gelman Sciences Kevan Lawlor - NSF International, President 2003-present; Cleary University, Board of Trustees Brenda L. Jones - Arbortext (now PTC), Vice President Leslie L. Loomans - Detroit Edison, Retired Dennis Mangino - NSF International, President 1995-2003, previously Weirton Steel ** ANI board of directors: http://publicaa.ansi.org/sites/apdl/Documents/About%20ANSI/Governance/ANS I_Board_Directors-2008.pdf.pdf Sharon K Stanford, Chair, ADA ** American Waterworks Association: http://en.wikipedia.org/wiki/American_Water_Works_Association Drinking water standard development In May 1985, the United States Environmental Protection Agency entered into a cooperative agreement with a consortium led by NSF International to develop voluntary third-party consensus standards and a certification program for all direct and indirect drinking water additives. Other members of the consortium include AWWA. The consortium is responsible for the cooperative effort of manufacturers, regulators, product users and other interested parties that develop and maintain the NSF standards. ** http://www.ingentaconnect.com/content/wef/wefproc/2004/00002004/00000011/art0000 9 Abstract: There is no shortage of challenges facing today's water and wastewater utilities. The demand to increase efficiency and productivity comes from many factions, including elected and appointed officials, management and ratepayers. The workforce and customer base are changing as a result of an aging population, different attitudes and perceptions, and dramatic shifts in demographics. New and more stringent regulations are requiring more resources, demands for greater monitoring and innovative solutions. The infrastructure that utilities operate and maintain is aging and will require a greater level of investment than in the past. With all of these challenges, customers still expect safe water, effective wastewater treatment, and rates that hold steady and remain relatively inexpensive compared to other vital commodities. Over the last ten years, waterborne disease outbreaks in the United States and Canada have challenged the confidence of the public to the extent that new laws have been enacted and additional ones proposed requiring accreditation of water service providers. Confidence questions have, in part, spurred bottled water sales and achieving customer satisfaction is more challenging than ever. At the same time, the International Organization of Standardization (ISO) is developing new standards specific to water and wastewater utility operations. The combination of these events may suggest the beginnings of a trend toward more certification or accreditation of utilities. Utility continuous improvement programs are crucial to meet growing demands for demonstrable accountability. Document Type: Research article DOI: 10.2175/193864704784136216 http://www.ingentaconnect.com/content/wef/wefproc;jsessionid=5bu0qs27c9pa6.alice Summary: The ADA does not answer to the FDA. It is under the jurisdiction of the AWWA, ANSI and the NSI. The Paffenbarger Research Center of the National Institute of Standards and Technology, a federal organization in Gaithersburg, Md. is financed by the ADA. American Dental Association Constitution and Bylaws Revised to January 1, 2008 Contents Constitution of American Dental Association.......................................... 3 Amendments, Article VIII ............................................................ 5 Annual Session, Article VI ........................................................... 4 Government, Article IV................................................................ 4 Name, Article I ............................................................................ 3 Object, Article II .......................................................................... 3 Officers, Article V........................................................................ 4 Organization, Article III ............................................................... 3 Principles of Ethics and Code of Professional Conduct, Article VII................................................................... 5 Bylaws of American Dental Association ................................................. 6 Alliance of the American Dental Association, Chapter XVIII ...........................................................................77 Amendments, Chapter XXI .........................................................78 American Dental Association Foundation, Chapter XIII..............................................................................68 Appointive Officer, Chapter IX ...................................................49 Board of Trustees, Chapter VII....................................................37 Commissions, Chapter XIV.........................................................69 Component Societies, Chapter III ................................................23 Conflict of Interest, Chapter VI ...................................................36 Constituent Societies, Chapter II .................................................18 Construction, Chapter XX ...........................................................78 Councils, Chapter X ....................................................................50 Elective Officers, Chapter VIII....................................................45 Finances, Chapter XVII...............................................................76 House of Delegates, Chapter V....................................................26 Indemnification, Chapter XIX .....................................................77 Membership, Chapter I................................................................. 6 Principles of Ethics and Code of Professional Conduct and Judicial Procedure, Chapter XII ………………….……… ……63 Publications, Chapter XVI...........................................................75 Scientific Session, Chapter XV....................................................75 Special Committees, Chapter XI..................................................63 Trustee Districts, Chapter IV .......................................................24 Articles of Incorporation of American Dental Association……..……….79 Constitution • • • • • • • • • • • • • • • • • • • • • • • • • • ARTICLE I • NAME 1 2 3 The name of this organization shall be the American Dental Association, hereinafter referred to as “the Association” or “this Association.” ARTICLE II • OBJECT 4 5 6 The object of this Association shall be to encourage the improvement of the health of the public and to promote the art and science of dentistry. ARTICLE III • ORGANIZATION 6 7 8 9 10 11 12 13 14 15 16 Section 10. INCORPORATION: This Association is a non-profit corporation organized under the laws of the State of Illinois. If this corporation shall be dissolved at any time, no part of its funds or property shall be distributed to, or among, its members but, after payment of all indebtedness of the corporation, its surplus funds and properties shall be used for dental education and dental research in such manner as the then governing body of the Association may determine. 17 18 19 20 21 Section 20. HEADQUARTERS OFFICE: The registered office of this Association shall be known as the Headquarters Office and shall be located in the City of Chicago, County of Cook, State of Illinois. 22 23 24 25 Section 30. BRANCH OFFICES: Branch offices of this Association may be established in any city of the United States by a majority vote of the House of Delegates. 26 27 28 29 Section 40. MEMBERSHIP: The membership of this Association shall consist of dentists and other persons whose qualifications and classifications shall be as established in Chapter I of the Bylaws. 30 31 Section 50. CONSTITUENT SOCIETIES: Constituent societies of this Association shall be Constitution Bylaws 3 32 33 34 those dental societies or dental associations chartered as such in conformity with Chapter II of the Bylaws. 35 36 37 38 39 40 Section 60. COMPONENT SOCIETIES: Component societies of this Association shall be those dental societies or dental associations organized as such in conformity with Chapter III of the Bylaws of this Association and in conformity with the bylaws of their respective constituent societies. 41 42 43 44 Section 70. TRUSTEE DISTRICTS: The constituent societies of the Association and the federal dental services shall be grouped into seventeen (17) trustee districts, as provided in Chapter IV of the Bylaws. ARTICLE IV • GOVERNMENT 45 46 47 48 49 Section 10. LEGISLATIVE BODY: The legislative and governing body of this Association shall be a House of Delegates which may be referred to as “the House” or “this House,” as provided in Chapter V of the Bylaws. 50 51 52 53 54 Section 20. ADMINISTRATIVE BODY: The administrative body of this Association shall be a Board of Trustees, which may be referred to as “the Board” or “this Board” as provided in Chapter VII of the Bylaws. ARTICLE V • OFFICERS 55 56 57 58 59 60 61 Section 10. ELECTIVE OFFICERS: The elective officers of this Association shall be a President, a President-elect, a First Vice President, a Second Vice President, a Treasurer and a Speaker of the House of Delegates, each of whom shall be elected by the House of Delegates as provided in Chapter VIII of the Bylaws. 62 63 64 65 66 Section 20. APPOINTIVE OFFICER: The appointive officer of this Association shall be an Executive Director who shall be appointed by the Board of Trustees as provided in Chapter IX of the Bylaws. ARTICLE VI • ANNUAL SESSION 67 68 69 The annual session of this Association shall be conducted in accordance with Chapters V and XV of the Bylaws. 4 7 Constitution Bylaws ARTICLE VII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT 70 71 72 73 74 75 The Principles of Ethics and Code of Professional Conduct of this Association and the codes of ethics of the constituent and component societies which are not in conflict with the Principles of Ethics and Code of Professional Conduct of this Association, shall govern the professional conduct of all members. ARTICLE VIII • AMENDMENTS 76 77 78 79 80 81 82 83 84 85 This Constitution may be amended by a two-thirds (2/3) affirmative vote of the delegates present and voting, provided that the proposed amendments have been presented in writing at any previous session of the House of Delegates. This Constitution may also be amended at any session of the House of Delegates by a unanimous vote, provided the proposed amendments have been presented in writing at a previous meeting of such session. Constitution Bylaws 5 8 Bylaws • • • • • • • • • • • • • • • • • • • • • • • • • • 86 87 CHAPTER I • MEMBERSHIP Section 10. CLASSIFICATION: The members of this Association shall be classified as follows: 88 89 90 91 92 93 94 95 96 Active Members Life Members Retired Members Nonpracticing Dentist Members Student Members Honorary Members Provisional Members Associate Members Affiliate Members 97 98 Section 20. QUALIFICATIONS, PRIVILEGES, DUES AND SPECIAL ASSESSMENTS: 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 A. ACTIVE MEMBER. a. QUALIFICATIONS. An active member shall be a dentist who is licensed to practice dentistry (or medicine provided the physician has a D.D.S. or D.M.D. or equivalent dental degree) in a state or other jurisdiction of the United States and shall be a member in good standing of this Association as that is defined in these Bylaws. In addition, a dentist shall be a member in good standing of this Association’s constituent and component societies, unless: (1) the dentist is in the exclusive employ of, or is serving on active duty in, one of the federal dental services. A dentist is considered to be in the exclusive employ of one of the federal dental services when the dentist is under contract to provide dental services to the beneficiaries of the federal agency on a full-time basis and does not engage in private practice within the jurisdiction of a constituent or component society; (2) the dentist is practicing in a country other than the United States and consequently is ineligible for membership in a constituent or component society; or (3) the dentist is working as a dental school faculty member, dental administrator or consultant within the territorial jurisdiction of a constituent society and is ineligible for active 6 Bylaws CHAPTER I • MEMBERSHIP 127 128 129 membership in the constituent or component society because the dentist is not licensed in the territorial jurisdiction of that constituent. 130 131 132 133 134 135 136 Explanatory Notes: The term “other jurisdiction of the United States” as used in this Constitution and Bylaws shall mean the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands and the territories of the United States Virgin Islands, Guam and American Samoa. 137 138 139 140 141 The term “federal dental services” as used in this Constitution and Bylaws shall mean the dental departments of the Air Force, the Army, the Navy, the Public Health Service, the department of Veterans Affairs and other federal agencies. 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 The term “direct member” as used in this Constitution and Bylaws shall mean a member in good standing who pursuant to Chapter I of these Bylaws does not hold membership in any constituent society of this Association. b. PRIVILEGES. (1) An active member in good standing shall receive annually a membership card and The Journal of the American Dental Association, the subscription price of which shall be included in the annual dues. An active member shall be entitled to attend any scientific session of this Association and receive such other services as are provided by the Association. (2) An active member in good standing shall be eligible for election as a delegate or alternate delegate to the House of Delegates and for election or appointment to any office or agency of this Association, except as otherwise provided in these Bylaws. (3) An active member under a disciplinary sentence of suspension shall not be privileged to hold office, either elective or appointive, including delegate and alternate delegate, in such member’s component and constituent societies and this Association, or to vote or otherwise participate in the selection of officials of such member’s component and constituent societies and this Association. c. DUES AND SPECIAL ASSESSMENTS. Beginning January 1, 2006, and each year thereafter, the dues of active members shall be the amount established annually by the House of Delegates in accordance with the procedure set forth in Chapter V, Section 130Ad of these Bylaws. In addition to their annual dues, active members shall pay any special assessments levied by the House of Delegates, due January 1 of each year. However, any dentist, who satisfies the eligibility requirements for active membership and any of the Bylaws 7 CHAPTER I • MEMBERSHIP following conditions shall be entitled to pay the reduced active member dues and any special assessment stated under such satisfied condition so long as that dentist maintains continuous membership, subject to the further reductions permitted under the provisions of Chapter I, Section 20Ad of these Bylaws: (1) Dentists, when awarded a D.D.S. or D.M.D. degree, shall be exempt from the payment of active member dues and any special assessment for the remaining period of that year and the following first full calendar year. Dentists shall pay twenty-five percent (25%) of active member dues and special assessment for the second full calendar year following the year in which the degree was awarded, fifty percent (50%) of active member dues and special assessment in the third year, seventyfive percent (75%) of active member dues and special assessment in the fourth year and one hundred percent (100%) in the fifth year and thereafter. Eligibility for this benefit shall be conditioned on maintenance of continuous membership or payment of reduced dues and special assessment(s) for the years not previously paid, at the rates current during the missing year(s). (2) The dentist who is engaged full-time in (a) an advanced training course of not less than one (1) academic year’s duration in an accredited school or a residency program in areas neither recognized by this Association nor accredited by the Commission on Dental Accreditation or (b) a residency program or advanced education program in areas recognized by this Association and in a program accredited by the Commission on Dental Accreditation shall pay thirty dollars ($30.00) due on January 1 of each year until December 31 following completion of such program. For the dentist who enters such a course or program while eligible for the dues reduction program set forth in the foregoing condition (1), the applicable reduced dues rate shall be tolled until completion of that program. Upon completing the program, the dentist shall pay dues and any special assessments for active members at the reduced dues rate where the dentist left off in the progression under condition (1). Eligibility for this benefit shall be conditioned on maintenance of continuous membership or payment of postgraduate student dues and active member dues and special assessment(s) for years not previously paid, at the rates current during the missing years. The dentist who is engaged full-time in (a) an advanced training course of not less than one (1) academic year’s duration in an accredited school or residency program in areas neither recognized by this Association nor accredited by the Commission on Dental Accreditation or (b) a residency program or 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 8 Bylaws CHAPTER I • MEMBERSHIP 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 advanced education program in areas recognized by this Association and in a program accredited by the Commission on Dental Accreditation shall be exempt from the payment of any active member special assessment then in effect through December 31 following completion of such course or program. (3) A graduate of a non-accredited dental school who has recently been licensed to practice dentistry in a jurisdiction in which there is a constituent dental society of the American Dental Association shall be exempt from payment of active member dues and any special assessment for the remaining period of the year in which the license was issued and the following first full calendar year. The newly licensed graduate of a non-accredited school shall pay twenty-five percent (25%) of active member dues and any special assessment the second calendar year following the year in which the license was obtained, fifty percent (50%) of active member dues and any special assessment in the third year, seventy-five percent (75%) of active member dues and any special assessment in the fourth year and one hundred (100%) in the fifth year and thereafter. (4) A licensed dentist who has never been an active member of this Association and is ineligible for dues reduction as a new graduate under this Section of the Bylaws, shall pay fifty percent (50%) of active member dues and any special assessment in the first year of membership, and shall pay one hundred percent (100%) of active member dues and any special assessment in the second year and each year thereafter. (5) The Board of Trustees may authorize limited dues reduction, up to fifty percent (50%) of active member dues and any special assessments for the purposes of promoting active membership in target U.S. markets through marketing campaigns recommended by the Council on Membership. This reduction of active member dues and any special assessments shall be on a one-time only basis for these members. d. ACTIVE MEMBERS SELECTED AFTER JULY 1 AND OCTOBER 1. Those members selected to active membership in this Association after July 1, except for those whose membership has lapsed for failure to pay the current year’s dues and/or special assessments, shall pay one half (1/2) of the current year’s dues and one half (1/2) of any active member special assessment then in effect, and those selected after October 1, shall be exempt from the payment of the current year’s dues and any active member special assessment then in effect on a one-time only basis. Bylaws 9 CHAPTER I • MEMBERSHIP 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 B. LIFE MEMBER. a. QUALIFICATIONS. A life member shall be a member in good standing of this Association who (1) has been an active and/or retired member in good standing of this Association for thirty (30) consecutive years or a total of forty (40) years of active and/or retired membership or has been a member of the National Dental Association for twenty-five (25) years and subsequently held at least ten (10) years of membership in the American Dental Association; (2) has attained the age of sixty-five (65) years in the previous calendar year; and (3) has submitted an affidavit attesting to the qualifications for this category through said component and constituent societies, if such exist. A dentist who immigrated to the United States may receive credit for up to twenty-five (25) consecutive or total years of membership in a foreign dental association in order to qualify for the respective requirements for life membership. Years of student membership shall not be counted as active membership for purposes of establishing eligibility for life membership unless the dentist was an active member in good standing prior to becoming a student member. The Association will give notification to members who are eligible for life membership. Life membership shall be effective the calendar year following the year in which the requirements are fulfilled. Maintenance of membership in good standing in the member’s constituent and component societies, if such exist, shall be a requisite for continuance of life membership in this Association. b. PRIVILEGES. A life member in good standing of this Association shall receive annually a membership card. A life member shall be entitled to all the privileges of an active member, except that a retired life member shall not receive The Journal of the American Dental Association except by subscription. A life member under a disciplinary sentence of suspension shall not be privileged to hold office, either elective or appointive, including delegate and alternate delegate, in such member’s component and constituent societies and this Association, or to vote or otherwise participate in the selection of officials of such member’s component and constituent societies and this Association. c. DUES AND SPECIAL ASSESSMENTS. (1) ACTIVE LIFE MEMBERS. Regardless of a member’s previous classification of membership, the dues of life members who have not fulfilled the qualifications of retired membership pursuant to Chapter I, Section 20C of these Bylaws with regard to income related to dentistry shall be fifty percent (50%) of the dues of active members, due January 1 of each year. In addition to their annual dues, active 10 Bylaws CHAPTER I • MEMBERSHIP 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 life members shall pay fifty percent (50%) of any active member special assessment levied by the House of Delegates, due January 1 of each year. (2) RETIRED LIFE MEMBERS. Life members who have fulfilled the qualifications of Chapter I, Section 20C of these Bylaws with regard to income related to dentistry shall be exempt from payment of dues and any special assessment levied by the House of Delegates. (3) ACCEPTANCE OF BACK DUES AND SPECIAL ASSESSMENTS. For the purpose of establishing continuity of active membership to qualify for life membership, back dues and special assessments, except as otherwise provided in these Bylaws, shall be accepted for not more than the three (3) years of delinquency prior to the date of application for such payment. The rate of such dues and/or special assessments, except as otherwise provided in these Bylaws, shall be in accordance with Chapter I, Section 40 of these Bylaws. For the purpose of establishing continuity of active membership in order to qualify for life membership, an active member, who had been such when entering upon active duty in one of the federal dental services but who, during such federal dental service, interrupted the continuity of active membership because of failure to pay dues and/or special assessments and who, within one year after separation from such military or equivalent duty, resumed active membership, may pay back dues and special assessments for any missing period of active membership at the rate of dues and/or special assessments current during the missing years of membership. 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 C. RETIRED MEMBER. a. QUALIFICATIONS. A retired member shall be an active member in good standing of this Association who is now a retired member of a constituent society, if such exists, and is no longer earning income from the performance of any dentally related activity, and has submitted an affidavit attesting to qualifications for this category through said component and constituent society, if such exist. Maintenance of active or retired membership in good standing in the member’s component society and retired membership in good standing in the member’s constituent, if such exist, entitling such member to all the privileges of an active member, shall be requisite for entitlement to and continuance of retired membership in this Association. b. PRIVILEGES. A retired member in good standing shall receive annually a membership card. A retired member shall be entitled to all the privileges of an active member. Bylaws 11 CHAPTER I • MEMBERSHIP 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 A retired member under a disciplinary sentence of suspension shall not be privileged to hold office, either elective or appointive, including delegate and alternate delegate, in such member’s component and constituent societies and this Association, or to vote or otherwise participate in the selection of officials of such member’s component and constituent societies and this Association. c. DUES AND SPECIAL ASSESSMENTS. The dues of retired members shall be twenty-five percent (25%) of the dues of active members, due January 1 of each year. In addition to their annual dues, retired members shall pay twenty-five percent (25%) of any active member special assessment levied by the House of Delegates, due January 1 of each year. 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 D. NONPRACTICING DENTIST MEMBER. a. QUALIFICATIONS. A nonpracticing dentist member shall be a dentist who is ineligible for any other classification of membership and: (1) has a dental degree from any country; (2) resides in the United States or its territories; (3) does not hold a dental license in the United States nor has a revoked U.S. dental license; (4) is not delivering patient care as a dentist for remuneration; and (5) is a member in good standing of this Association, and the Association’s constituent and component societies, if such exists. b. PRIVILEGES. (1) A nonpracticing dentist member in good standing shall receive annually a membership card and The Journal Of The American Dental Association, the subscription price of which shall be included in the annual dues. A nonpracticing dentist member shall be entitled to attend any scientific session of this Association and receive such other services as are authorized by the Association. (2) A nonpracticing dentist member in good standing shall be eligible for election to any council. (3) A nonpracticing dentist member shall also be eligible for appointment as an additional member to any council, provided the council requests such additional nonpracticing membership representation and the Board of Trustees approves the council’s request. Such members shall be appointed by the Board of Trustees. The tenure of an additional council member shall be one (1) term of four (4) years. (4) A nonpracticing dentist member under a disciplinary sentence of suspension shall not be privileged to serve as a member of any council. c. DUES AND SPECIAL ASSESSMENTS. The 12 Bylaws CHAPTER I • MEMBERSHIP 457 458 459 460 461 462 463 dues of nonpracticing dentists shall be fifty percent (50%) of the dues of active members, due January 1 of each year. In addition to their annual dues, nonpracticing dentists shall pay fifty percent (50%) of any active member special assessment levied by the House of Delegates, due January 1 of each year. 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 E. STUDENT MEMBER. a. QUALIFICATIONS. A student member shall be a predoctoral student of a dental school accredited by the Commission on Dental Accreditation of this Association, a predoctoral student of a dental school listed in the World Directory of Dental Schools compiled by the FDI World Federation or a dentist eligible for membership in this Association who is engaged full time in an advanced training course of not less than one academic year’s duration in an accredited school or residency program. b. PRIVILEGES. A student member in good standing of this Association shall receive annually a membership card and The Journal of the American Dental Association, the subscription price of which shall be included in the annual dues. A student member shall be entitled to attend any scientific session of this Association. A student member under a disciplinary sentence of suspension shall not be privileged to serve as the American Student Dental Association’s delegate or alternate delegate in this Association’s House of Delegates. c. DUES AND SPECIAL ASSESSMENTS. (1) PREDOCTORAL STUDENT MEMBERS: The dues of predoctoral student members shall be five dollars ($5.00) due January 1 of each year. Such student members shall be exempt from the payment of any special assessment levied by the House of Delegates. (2) POSTDOCTORAL STUDENTS AND RESIDENTS: The dues of dentists who are student members pursuant to Chapter I, Section 20E shall be thirty dollars ($30.00) due January 1 of each year. Such student members shall be exempt from the payment of any special assessment levied by the House of Delegates. (3) Student membership terminates on December 31 after graduation or after completion of a residency or graduate work. 505 506 507 508 509 510 511 F. HONORARY MEMBER. a. QUALIFICATIONS. An individual who has made outstanding contributions to the advancement of the art and science of dentistry, upon election by the Board of Trustees, shall be classified as an honorary member of this Association. b. PRIVILEGES. An honorary member shall Bylaws 13 CHAPTER I • MEMBERSHIP 512 513 514 515 516 517 518 519 520 receive a membership card and The Journal of the American Dental Association. An honorary member shall be entitled to attend any scientific session of this Association and receive such other services as are authorized by the Board of Trustees. c. DUES AND SPECIAL ASSESSMENTS. Honorary members shall be exempt from payment of dues and any special assessment levied by the House of Delegates. 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 G. PROVISIONAL MEMBER. a. QUALIFICATIONS. A provisional member shall be a dentist who: (1) has received a D.D.S. or D.M.D. degree from a dental school accredited by the Commission on Dental Accreditation of the American Dental Association or shall be a graduate of an unaccredited dental school who has recently been licensed to practice dentistry in a jurisdiction in which there is a constituent dental society; (2) has not established a place of practice; and (3) shall have applied for provisional membership within 12 months of graduation or licensure. Provisional membership shall terminate December 31 of the second full calendar year following the year in which the degree was awarded. b. PRIVILEGES. A provisional member in good standing shall be entitled to all the privileges of an active member except that, notwithstanding anything in these Bylaws to the contrary, a provisional member shall have no right to appeal from a denial of active membership in the Association. A provisional member under a disciplinary sentence of suspension shall not be privileged to hold office, either elective or appointive, including delegate and alternate delegate, in such member’s component and constituent societies and this Association, or to vote or otherwise participate in the selection of officials of such member’s component and constituent societies and this Association. c. DUES AND SPECIAL ASSESSMENTS. The dues and/or special assessments of provisional members shall be the same as the dues and/or special assessments of active members. 557 558 559 560 561 562 563 564 H. ASSOCIATE MEMBER. a. QUALIFICATIONS. An associate member shall be a person ineligible for any other type of membership in this Association, who contributes to the advancement of the objectives of this Association, is employed in dental-related education or research, does not hold a dental license in the United States, and has applied to and been 14 Bylaws CHAPTER I • MEMBERSHIP 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 approved by the Board of Trustees.* b. PRIVILEGES. An associate member in good standing shall receive annually a membership card and The Journal of the American Dental Association, the subscription price of which shall be included in the annual dues. An associate member shall be entitled to attend any scientific session of this Association and receive such other services as are authorized by the Board of Trustees. c. DUES AND SPECIAL ASSESSMENTS. The dues of associate members shall be twenty-five percent (25%) of the dues of active members, due January 1 of each year. In addition to their annual dues, associate members shall pay twenty-five percent (25%) of any active member special assessment levied by the House of Delegates, due January 1 of each year. 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610 I. AFFILIATE MEMBER. a. QUALIFICATIONS. An affiliate member shall be a dentist who is ineligible for any other classification of membership and: (1) is practicing in a country other than the United States; (2) has been classified as an affiliate member upon application to and approval by the Board of Trustees; and (3) is a member in good standing of this Association. b. PRIVILEGES. An affiliate member in good standing shall receive annually a membership card, have access to the members-only content areas of ADA.org, be entitled to attend any scientific session of this Association, purchase items through the ADA Catalog at the member rate and receive such other services as are authorized by the Board of Trustees. c. DUES AND SPECIAL ASSESSMENTS. The dues of affiliate members shall be twelve dollars ($12.00) for those members practicing in least developed and low income countries eligible for special fee criteria as established by the Fédération Dentaire Internationale and seventy-five dollars ($75.00) for other such members, due January 1 of each year. Affiliate members shall be exempt from the payment of any special assessment levied by the House of Delegates. * Individuals who are classified as associate members of this Association prior to the 1996 annual session of the House of Delegates but who are not employed full-time in dentally-related education or research by an accredited institution of higher education, may maintain their associate membership so long as other eligibility requirements are met and current dues and special assessments are paid. Bylaws 15 CHAPTER I • MEMBERSHIP 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 Section 30. DEFINITION OF “IN GOOD STANDING”. A member of this Association whose dues and special assessments for the current year have been paid shall be in good standing; provided, however, that a member, to remain in good standing may be required under the bylaws of the member’s constituent or component society, to meet standards of continuing education, pay special assessments, cooperate with peer review bodies or committees on ethics, or attend, if a newly admitted active member, a stated number of membership meetings between the date of admission and the completion of the first calendar year of active membership. If under a disciplinary sentence of suspension, such member shall be designated as a “member in good standing temporarily under suspension” until the member’s disciplinary sentence has terminated. The requirement of paying current dues does not apply to retired life, honorary and those members of this Association who pursuant to Section 50 of this Chapter have been granted dues waivers for the purpose of determining their good standing. The requirement of paying special assessments does not apply to retired life, honorary, affiliate, student and those members of this Association who pursuant to Section 50 of this Chapter have been granted special assessment waivers for purposes of determining their good standing. 639 640 Section 40. LAPSE OF MEMBERSHIP AND REINSTATEMENT. 641 642 643 644 645 646 647 648 A. LAPSE OF MEMBERSHIP. Any member whose dues and special assessments have not been paid by March 31 of the current year shall cease to be a member of this Association. Further, an associate member who terminates employment in dental-related education or research shall cease to be an associate member of this Association December 31 of that calendar year. 649 650 651 652 653 654 655 656 B. REINSTATEMENT. Reinstatement of active, life, retired, nonpracticing dentist, student or affiliate membership may be secured on payment of appropriate dues and special assessments of this Association by any former member and on compliance by any former member with the pertinent bylaws and regulations of the constituent and component societies involved and this Association. 657 658 659 660 661 662 663 664 Section 50. DUES OR SPECIAL ASSESSMENT RELATED ISSUES. A. PAYMENT DATE AND INSTALLMENT PAYMENTS. Dues and special assessments of all members are payable January 1 of each year, except for active and active life members who may participate in an installment payment plan. Such plan shall be sponsored by the members’ respective 16 Bylaws CHAPTER I • MEMBERSHIP 665 666 667 668 669 670 671 672 673 674 675 676 677 678 constituent or component dental societies, or by this Association if the active or active life members are in the exclusive employ of, or are serving on active duty in, one of the federal dental services. The plan shall require monthly installment payments that conclude with the current dues and special assessment amount fully paid by June 30. Transactional costs may be imposed, prorated to this Association and the constituent or component dental society. The installment plan shall provide for the expeditious transfer of member dues and special assessments to this Association and the applicable constituent or component dental society, if such exists, as soon as commercially feasible. 679 680 681 682 683 684 685 686 687 688 689 690 691 B. FINANCIAL HARDSHIP WAIVERS. Those members who have suffered a significant financial hardship that prohibits them from payment of their full dues and/or special assessments may be excused from the payment of fifty percent (50%), seventy-five percent (75%) or all of the current year’s dues and/or special assessment(s) as determined by their constituent and component dental societies. The constituent and component society secretaries shall certify the reason for the waiver, and the constituent and component societies shall provide the same proportionate waiver of their dues as that provided by this Association.* 692 693 694 695 696 697 698 699 700 701 C. WAIVERS FOR ACTIVE MEMBERS TEMPORARILY ACTIVATED TO FEDERAL SERVICE. An active member in good standing who pursuant to Chapter I of these Bylaws holds membership in a constituent and component society and is temporarily called to active duty with a federal dental service on a non-career basis shall be exempt from the payment of dues to this Association during such military duty, but not to exceed a period of three years. 702 703 704 D. WAIVERS FOR ACTIVE MEMBERS WORKING FOR A CHARITABLE ORGANIZATION. An active member who is * Members with disabilities who were granted dues and special assessment disability waivers prior to the 2007 House of Delegates may continue to receive such waivers provided they are unable to practice dentistry within the definition of these Bylaws and they submit through the member’s component and constituent societies, if such exist, to this Association, a medical certificate attesting to the disability and a certificate from said component and constituent societies, if such exist, attesting to the disability, upon request of the Association, during the exemption period. Bylaws 17 CHAPTER I • MEMBERSHIP CHAPTER I • MEMBERSHIP CHAPTER II • CONSTITUENT SOCIETIES 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 serving the profession by working full-time for a charitable organization and is receiving neither income nor a salary for such charitable service other than a subsistence amount which approximates a cost of living allowance shall be exempt from the payment of dues and any special assessment then in effect through December 31 following completion of such service provided that such charitable service is being performed continuously for not less than one (1) year and provided further that such member does not supplement such subsistence income by the performance of services as a member of the faculty of a dental or dental auxiliary school, as a dental administrator or consultant, or as a practitioner of any activity for which a license to practice dentistry or dental hygiene is required. 721 722 723 724 725 726 727 E. CALCULATING PERCENTAGE DUES OR SPECIAL ASSESSMENTS. In establishing the dollar rate of dues or special assessments in this chapter expressed as a percentage of active member dues or special assessments, computations resulting in fractions of a dollar shall be rounded up to the next whole dollar. 728 729 730 731 732 733 734 735 736 737 738 739 740 741 742 Section 60. INTERIM SERVICES FOR APPLICANTS. A dentist who has submitted a complete application for active membership in this Association and the appropriate constituent and component societies, if such exist, may on a onetime, interim basis: receive complimentary copies of the Journal of the American Dental Association and the ADA News, have access to the ADA.org memberonly content areas and purchase items at a member rate through the ADA Catalog. Such interim services shall terminate when the membership application has been processed or within six (6) months of the application submission, whichever is sooner. Applicants shall have no right of appeal from a denial of membership in the Association. CHAPTER II • CONSTITUENT SOCIETIES 743 744 745 746 747 748 749 750 751 752 Section 10. ORGANIZATION: A constituent society may be organized and chartered, subject to the approval of the House of Delegates, upon application of at least one hundred (100) dentists, practicing in any state or other jurisdiction of the United States who are active, life or retired members of the Association in good standing. No such society shall be chartered in any state or other jurisdiction of the United States in which a constituent society is already chartered by this Association. 753 754 755 Section 20. NAME: A constituent society shall take its name from the state or other jurisdiction of the United States. 18 Bylaws CHAPTER II • CONSTITUENT SOCIETIES 756 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 Section 30. POWERS AND DUTIES: A. A constituent society shall have the power to select its active, life, and retired members as active members of this Association within the limits of Section 40 of this Chapter. B. It shall have the power to organize its members into component societies within the limits imposed by Chapter III, Section 10 of these Bylaws. C. It shall have the power to provide for its financial support and to establish bylaws, rules and regulations to govern its members provided such bylaws, rules and regulations do not conflict with, or limit, these Bylaws. D. It shall have the power to discipline any of its members subject to the provisions in Chapter XII, Section 20 of these Bylaws. E. It shall be its duty to collect membership dues and special assessments for this Association in conformity with Chapter I, Section 20, of these Bylaws. F. It shall have the power to establish committees, councils and commissions of the constituent society; to designate their power and duties; and to adopt reasonable eligibility requirements for service thereon. 781 782 783 784 785 786 787 788 789 790 791 792 793 794 795 796 797 798 799 Section 40. MEMBERSHIP: A. The active, life, and retired membership of each constituent society, except as otherwise provided in these Bylaws, shall consist solely of dentists practicing within the territorial jurisdiction of the constituent society; dentists retired from active practice; dentists engaged in activities furthering the object of this Association; dentists serving on the faculty of a dental school or receiving compensation as a dental administrator or consultant within the jurisdiction of the constituent society but are licensed in another jurisdiction; and dentists in a federal dental service (provided that the federal dentist is either licensed in or serving within the confines of the constituent society’s jurisdiction), provided that such dentists are active, life or retired members in good standing of a component of the constituent (except for the federal dentists), if such exists, and this Association. 800 801 802 803 804 Explanatory Note: A dentist who has retired from active practice or who is engaged in activities furthering the object of this Association shall be considered to be practicing dentistry within the meaning of this section. 805 806 807 808 809 B. REMOVAL FROM ONE JURISDICTION TO ANOTHER. A member who has changed the location of the member’s practice from the jurisdiction of one constituent society to that of another constituent society may maintain active membership in the Bylaws 19 CHAPTER II • CONSTITUENT SOCIETIES 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828 829 830 831 832 833 834 835 836 837 838 839 840 841 constituent society in which membership is being held for the calendar year following that of the member’s removal from the jurisdiction of such society. The same privilege shall apply to a member who is separated from a federal dental service and who enters practice in an area under the jurisdiction of a constituent society or a member who is retired from a federal dental service and who is serving on a faculty of a dental school, or is receiving compensation as a dental administrator or consultant, or is engaged in any activity in the area under the jurisdiction of a constituent society for which a license to practice dentistry or dental hygiene is required by the state or other jurisdiction of the United States wherein the activity is conducted. A dentist who retires from active practice and establishes residence in an area outside of the jurisdiction of the constituent society in which the dentist holds membership shall be permitted to continue membership in such constituent society for the period of retirement. A member who is unsuccessful in transferring membership from one constituent society to another shall be entitled to a hearing (by either the component or constituent society), on the decision denying the member’s application for transfer of membership and to appeal to the constituent society to which transfer is sought, if applicable, and thereafter to the Council on Ethics, Bylaws and Judicial Affairs of this Association in accordance with the procedures in Chapter XII, Section 20C and D of these Bylaws even though a disciplinary penalty is not involved. 842 843 844 845 C. PRIVILEGES. An active, life, or retired member in good standing shall enjoy all privileges of constituent society membership except as otherwise provided by these Bylaws. 846 847 848 849 850 851 852 853 854 855 856 857 858 859 860 861 862 863 864 D. MULTIPLE JURISDICTIONS. A member may hold membership in more than one constituent society with the consent of the constituent society involved. A member is required to maintain active membership in the constituent society, if accepted therein, in whose jurisdiction the member maintains or practices dentistry at a secondary or “branch” office. In order to meet the requirement of tripartite membership, a member must also maintain active membership in one component society of each constituent society into which the member is accepted, if such exist. If such a member is accused of unethical conduct and disciplinary proceedings are brought, then those proceedings shall be instituted in the component or constituent society where the alleged unethical conduct occurred. A disciplinary ruling affecting membership in one constituent society shall affect membership in both societies and in the Association. A member shall have the right of appeal as provided 20 Bylaws CHAPTER II • CONSTITUENT SOCIETIES 865 866 867 868 in Chapter XII of the Bylaws. Such member shall pay dues in this Association only through the constituent society in whose jurisdiction the member conducts the major part of the member’s practice. 869 870 871 Section 50. OFFICERS: The officers of a constituent society shall be president, secretary, treasurer and such others as may be prescribed in its bylaws. 872 873 874 Section 60. SESSIONS: A constituent society shall hold a business session at least once each calendar year. 875 876 877 878 879 880 881 Section 70. CONSTITUTION AND BYLAWS: Each constituent society shall adopt and maintain a constitution and bylaws which shall not be in conflict with, or limit, the Constitution and Bylaws of this Association and shall file a copy thereof and any changes which may be made thereafter, with the Executive Director of this Association. 882 883 884 885 886 887 888 Section 80. “PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT”: The Principles of Ethics and Code of Professional Conduct of this Association and the code of ethics adopted by the constituent society shall be the code of ethics of that constituent society for governing the professional conduct of its members. 889 890 891 892 893 894 895 896 897 898 Section 90. RIGHT OF HEARING AND APPEAL: Disputes arising between constituent societies or between a constituent society and one or more of its component societies may be referred to the Council on Ethics, Bylaws and Judicial Affairs of this Association for hearing and decision as provided in Chapter X, Section 120Gd in accordance with the procedure of Chapter XII, Section 20C and D of these Bylaws even though a disciplinary penalty is not involved. 899 900 901 902 903 904 905 906 907 908 909 910 911 912 913 914 915 916 917 Section 100. PRIVILEGE OF REPRESENTATION: Each constituent society shall be entitled to two (2) delegates in the House of Delegates, except that one (1) delegate shall be allocated to the Virgin Islands Dental Association. The Air Force Dental Corps, the Army Dental Corps, the Navy Dental Corps, the Public Health Service and the Department of Veterans Affairs shall each be entitled to two delegates, one of which shall be elected by the respective service, without regard to the number of members. The remaining number of delegates shall be allocated as provided in Chapter V, Sections 10C and 10D. Each constituent society and each federal dental service may select from among its active, life and retired members the same number of alternate delegates as delegates and shall designate the alternate delegate who shall replace an absent delegate. Bylaws 21 CHAPTER II • CONSTITUENT SOCIETIES 918 919 920 921 922 923 924 925 926 927 928 929 930 931 932 933 934 935 936 937 938 939 940 941 942 943 944 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 969 970 Section 110. CHARTERED CONSTITUENT SOCIETIES: The Executive Director of the Association is authorized to issue a charter to each constituent society denoting its name and territorial jurisdiction. The following societies are chartered as constituent societies of this Association: Alabama Dental Association Alaska Dental Society Arizona State Dental Association Arkansas State Dental Association California Dental Association Colorado Dental Association Connecticut State Dental Association, The Delaware State Dental Society District of Columbia Dental Society, The Florida Dental Association Georgia Dental Association Hawaii Dental Association Idaho State Dental Association Illinois State Dental Society Indiana Dental Association Iowa Dental Association Kansas Dental Association Kentucky Dental Association Louisiana Dental Association, The Maine Dental Association Maryland State Dental Association Massachusetts Dental Society Michigan Dental Association Minnesota Dental Association Mississippi Dental Association, The Missouri Dental Association Montana Dental Association Nebraska Dental Association, The Nevada Dental Association New Hampshire Dental Society New Jersey Dental Association New Mexico Dental Association New York State Dental Association North Carolina Dental Society, The North Dakota Dental Association Ohio Dental Association Oklahoma Dental Association Oregon Dental Association Pennsylvania Dental Association Puerto Rico, Colegio de Cirujanos Dentistas de Rhode Island Dental Association South Carolina Dental Association South Dakota Dental Association Tennessee Dental Association Texas Dental Association Utah Dental Association Vermont State Dental Society 22 Bylaws CHAPTER II • CONSTITUENT SOCIETIES CHAPTER III • COMPONENT SOCIETIES 971 972 973 974 975 976 Virgin Islands Dental Association Virginia Dental Association Washington State Dental Association West Virginia Dental Association Wisconsin Dental Association Wyoming Dental Association CHAPTER III • COMPONENT SOCIETIES 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 Section 10. ORGANIZATION: Component societies may be organized in conformity with a plan approved by the constituent society of which they shall be recognized entities provided, however, that the active, life or retired members of each component society shall consist of dentists who are members in good standing of their respective constituent societies and of this Association. The plan adopted by the constituent society may or may not limit active membership in a component society to dentists who reside or practice within the geographic area of that component society. Each component society shall adopt and maintain a constitution and bylaws, which shall not be in conflict with, or limit, the Constitution and Bylaws of this Association or that of its constituent society, and shall file a copy thereof and any changes which may be made thereafter with the Executive Director of this Association. 995 Section 20. POWER AND DUTIES: 996 997 998 999 A. A component society shall have the power to select its active, life, and retired members as active members of the constituent society in accordance with Chapter II, Section 40, of these Bylaws. 1000 1001 1002 1003 1004 1005 1006 1007 B. It shall have the power to provide for its financial support, to establish bylaws, rules and regulations, not in conflict with, or limiting, the Constitution and Bylaws of this Association or that of its constituent society and to adopt a code of ethics not in conflict with the Principles of Ethics and Code of Professional Conduct of this Association or code of ethics of its constituent society. 1008 1009 1010 C. It shall have the power to discipline any of its members subject to the provisions in Chapter XII, Section 20 of these Bylaws. 1011 1012 1013 1014 1015 D. It shall have the power to establish committees, councils and commissions of the component society; to designate their powers and duties; and to adopt reasonable eligibility requirements for service thereon. 1016 1017 1018 1019 1020 Section 30. PRIVILEGES OF MEMBERSHIP: An active, life, or retired member in good standing shall have the opportunity of enjoying all privileges of component society membership except as otherwise provided by these Bylaws. Bylaws 23 CHAPTER III • COMPONENT SOCIETIES CHAPTER IV • TRUSTEE DISTRICTS 1021 1022 Section 40. TRANSFER FROM ONE COMPONENT TO ANOTHER: 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 1034 1035 1036 1037 1038 1039 1040 1041 1042 1043 1044 1045 1046 A member who has changed residence or location of practice within the jurisdiction of a constituent society so that the member no longer fulfills the membership requirements of the component society of which he or she is a member may maintain active membership in that component society for the calendar year following such change of residence or practice location. A member who is required to transfer membership from one component society to another and whose application for transfer of membership is denied shall be entitled to a hearing (by either the component or constituent society), on the decision denying the member’s application for transfer of membership and to appeal to the member’s constituent society, if applicable, and the Council on Ethics, Bylaws and Judicial Affairs of this Association in accordance with the procedures in Chapter XII, Section 20C and D of these Bylaws even though a disciplinary penalty is not involved. A component society which receives an application for transfer of membership from a dentist who has moved from the jurisdiction of another constituent society is governed by Chapter II, Section 40B of these Bylaws. CHAPTER IV • TRUSTEE DISTRICTS 1047 1048 1049 Section 10. ORGANIZATION: The constituent societies and the federal dental services shall be organized into seventeen (17) trustee districts. 1050 1051 1052 1053 Section 20. PURPOSE: The purpose of establishing trustee districts is to provide representation of the members of the constituent societies and the federal dental services on the Board of Trustees. 1054 1055 Section 30. COMPOSITION: The trustee districts are numbered and composed as follows: 1056 1057 1058 1059 1060 1061 1062 DISTRICT 1 Connecticut State Dental Association, The Maine Dental Association Massachusetts Dental Society New Hampshire Dental Society Rhode Island Dental Association Vermont State Dental Society 1063 1064 DISTRICT 2 New York State Dental Association 1065 1066 DISTRICT 3 Pennsylvania Dental Association 1067 1068 DISTRICT 4 Air Force Dental Corps 24 Bylaws CHAPTER IV • TRUSTEE DISTRICTS 1069 1070 1071 1072 1073 1074 1075 1076 1077 1078 Army Dental Corps Delaware State Dental Society District of Columbia Dental Society, The Maryland State Dental Association Navy Dental Corps New Jersey Dental Association Public Health Service Puerto Rico, Colegio de Cirujanos Dentistas de Veterans Affairs Virgin Islands Dental Association 1079 1080 1081 1082 DISTRICT 5* Alabama Dental Association Georgia Dental Association Mississippi Dental Association, The 1083 1084 1085 1086 1087 DISTRICT 6 Kentucky Dental Association Missouri Dental Association Tennessee Dental Association West Virginia Dental Association 1088 1089 1090 DISTRICT 7 Indiana Dental Association Ohio Dental Association 1091 1092 DISTRICT 8 Illinois State Dental Society 1093 1094 1095 DISTRICT 9 Michigan Dental Association Wisconsin Dental Association 1096 1097 1098 1099 1100 1101 DISTRICT 10 Iowa Dental Association Minnesota Dental Association Nebraska Dental Association, The North Dakota Dental Association South Dakota Dental Association 1102 1103 1104 1105 1106 1107 DISTRICT 11 Alaska Dental Society Idaho State Dental Association Montana Dental Association Oregon Dental Association Washington State Dental Association 1108 1109 1110 1111 1112 DISTRICT 12 Arkansas State Dental Association Kansas Dental Association Louisiana Dental Association, The Oklahoma Dental Association 1113 1114 DISTRICT 13 California Dental Association 1115 1116 1117 1118 DISTRICT 14 Arizona State Dental Association Colorado Dental Association Hawaii Dental Association Bylaws 25 CHAPTER IV • TRUSTEE DISTRICTS CHAPTER V • HOUSE OF DELEGATES 1119 1120 1121 1122 Nevada Dental Association New Mexico Dental Association Utah Dental Association Wyoming Dental Association 1123 1124 DISTRICT 15 Texas Dental Association 1125 1126 1127 1128 DISTRICT 16 North Carolina Dental Society, The South Carolina Dental Association Virginia Dental Association 1129 1130 DISTRICT 17 Florida Dental Association * CHAPTER V • HOUSE OF DELEGATES 1131 Section 10. COMPOSITION. 1132 1133 1134 1135 1136 1137 1138 1139 1140 1141 1142 1143 A. VOTING MEMBERS. The House of Delegates shall be limited to four hundred sixty (460) voting members for the two years 2004 to 2005 inclusive. Thereafter, the number of voting members shall be determined by the methodologies set forth in Section 10C of this Chapter. It shall be composed of the officially certified delegates of the constituent dental societies, two (2) officially certified delegates from each of the five (5) federal dental services and five (5) student members of the American Student Dental Association who are officially certified delegates from the American Student Dental Association. 1144 1145 1146 1147 1148 1149 1150 B. EX OFFICIO MEMBERS. The elective and appointive officers and trustees of this Association shall be ex officio members of the House of Delegates without the power to vote. They shall not serve as delegates. Past presidents of this Association shall be ex officio members of the House of Delegates without the power to vote unless designated as delegates. 1151 1152 C. REPRESENTATIONAL REQUIREMENTS AND GOALS. Each constituent society shall be entitled to * In order to establish the required pattern of four, four, four and five members respectively retiring from councils and commissions each year, members of councils and commissions from the new 5th and 17th districts who are in office at the time this footnote becomes effective shall finish their terms in accordance with their scheduled term completion dates. Councils and commissions that have incumbent members from the new 5th district shall add a new member from the 17th district to a full four-year term. Councils and commissions that have incumbent members from the new 17th district shall add a new member from the new 5th district to a full four-year term. 26 Bylaws CHAPTER OF DISTRICTS DELEGATES CHAPTER V IV••HOUSE TRUSTEE CHAPTER V • HOUSE OF DELEGATES 1153 1154 1155 1156 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 1167 1168 1169 1170 1171 1172 1173 1174 1175 1176 1177 1178 1179 1180 1181 1182 1183 1184 1185 1186 1187 two (2) delegates, except that one (1) delegate shall be allocated to the Virgin Islands Dental Association. The Air Force Dental Corps, the Army Dental Corps, the Navy Dental Corps, the Public Health Service and the Department of Veteran Affairs shall each be entitled to two (2) delegates, one of which shall be elected by the respective service, without regard to the number of members. For the two years 2004-2005 inclusive, the remaining number of delegates shall be allocated to the constituent societies, through their trustee districts based on the representational goals that each trustee district's representation in the House of Delegates shall vary by no more or less than 0.3% from its active, life or retired membership share in this Association, based on the Association's December 31, 2002 membership records, and that no district or constituent shall lose a delegate from its 2003 allocation. Thereafter, to allow for changes in the delegate allocation due to membership fluctuations, the Board of Trustees shall use this variance method of district delegate allocation (a variance of no more than 0.3% of its active, life and retired membership share in the Association) at subsequent intervals of three (3) years, with the first such review occurring for the 2006 House of Delegates. Such reviews shall be based on the Association's year-end membership records for the calendar year preceding the review period in question. No district shall lose a delegate unless their membership numbers are at least one percent less than their membership numbers of the prior three years. Any changes deemed necessary shall be presented to the House of Delegates in the form of a Bylaws' amendment to Section 10D of this Chapter. 1188 1189 1190 D. DELEGATE ALLOCATION. Based on the representational requirements and goals set forth in Section 10C, the delegates are allocated as follows: 1191 1192 1193 1194 1195 1196 1197 1198 1199 DISTRICT 1 Connecticut State Dental Association, The, 7 delegates Maine Dental Association, 3 delegates Massachusetts Dental Society, 13 delegates New Hampshire Dental Society, 3 delegates Rhode Island Dental Association, 3 delegates Vermont State Dental Society, 2 delegates District Total: 31 delegates 1200 1201 1202 DISTRICT 2 New York State Dental Association, 41 delegates District Total: 41 delegates 1203 1204 1205 DISTRICT 3 Pennsylvania Dental Association, 18 delegates District Total: 18 delegates Bylaws 27 CHAPTER V • HOUSE OF DELEGATES 1206 1207 1208 1209 1210 1211 1212 1213 1214 1215 1216 1217 1218 1219 1220 DISTRICT 4 Air Force Dental Corps, 2 delegates Army Dental Corps, 2 delegates Delaware State Dental Society, 2 delegates District of Columbia Dental Society, The, 2 delegates Maryland State Dental Association, 7 delegates Navy Dental Corps, 2 delegates New Jersey Dental Association, 12 delegates Public Health Service, 2 delegates Puerto Rico, Colegio de Cirujanos Dentistas de, 2 delegates Veterans Affairs, 2 delegates Virgin Islands Dental Association, 1 delegate District Total: 36 delegates 1221 1222 1223 1224 1225 DISTRICT 5 Alabama Dental Association, 5 delegates Georgia Dental Association, 9 delegates Mississippi Dental Association, The, 3 delegates District Total: 17 delegates 1226 1227 1228 1229 1230 1231 DISTRICT 6 Kentucky Dental Association, 6 delegates Missouri Dental Association, 7 delegates Tennessee Dental Association, 7 delegates West Virginia Dental Association, 3 delegates District Total: 23 delegates 1232 1233 1234 1235 DISTRICT 7 Indiana Dental Association, 9 delegates Ohio Dental Association, 16 delegates District Total: 25 delegates 1236 1237 1238 DISTRICT 8 Illinois State Dental Society, 19 delegates District Total: 19 delegates 1239 1240 1241 1242 DISTRICT 9 Michigan Dental Association, 17 delegates Wisconsin Dental Association, 9 delegates District Total: 26 delegates 1243 1244 1245 1246 1247 1248 1249 DISTRICT 10 Iowa Dental Association, 5 delegates Minnesota Dental Association, 9 delegates Nebraska Dental Association, The, 3 delegates North Dakota Dental Association, 2 delegates South Dakota Dental Association, 2 delegates District Total: 21 delegates 1250 1251 1252 1253 1254 1255 1256 DISTRICT 11 Alaska Dental Society, 2 delegates Idaho State Dental Association, 3 delegates Montana Dental Association, 2 delegates Oregon Dental Association, 6 delegates Washington State Dental Association, 10 delegates District Total: 23 delegates 28 Bylaws CHAPTER V • HOUSE OF DELEGATES 1257 1258 1259 1260 1261 1262 DISTRICT 12 Arkansas State Dental Association, 4 delegates Kansas Dental Association, 4 delegates Louisiana Dental Association, The, 6 delegates Oklahoma Dental Association, 5 delegates District Total: 19 delegates 1263 1264 1265 DISTRICT 13 California Dental Association, 63 delegates District Total: 63 delegates 1266 1267 1268 1269 1270 1271 1272 1273 1274 DISTRICT 14 Arizona State Dental Association, 6 delegates Colorado Dental Association, 8 delegates Hawaii Dental Association, 3 delegates Nevada Dental Association, 3 delegates New Mexico Dental Association, 3 delegates Utah Dental Association, 4 delegates Wyoming Dental Association, 2 delegates District Total: 29 delegates 1275 1276 1277 DISTRICT 15 Texas Dental Association, 23 delegates District Total: 23 delegates 1278 1279 1280 1281 1282 DISTRICT 16 North Carolina Dental Society, The, 9 delegates South Carolina Dental Association, 5 delegates Virginia Dental Association, 10 delegates District Total: 24 delegates 1283 1284 1285 DISTRICT 17 Florida Dental Association, 21 delegates District Total: 21 delegates 1286 1287 AMERICAN STUDENT DENTAL ASSOCIATION, 5 delegates 1288 1289 1290 1291 1292 1293 1294 E. ALTERNATE DELEGATES. Each constituent dental society and each federal dental service may select from among its active, life and retired members the same number of alternate delegates as delegates. The American Student Dental Association may select from among its active members the same number of alternate delegates as delegates. 1295 1296 1297 1298 1299 1300 1301 1302 F. SELECTION OF AMERICAN STUDENT DENTAL ASSOCIATION DELEGATES AND ALTERNATE DELEGATES. The American Student Dental Association shall select its five (5) delegates from its even numbered regions in even numbered years, and the odd numbered regions in odd numbered years, with their alternate delegates selected from the opposite groups of regions. 1303 1304 1305 1306 Section 20. ELECTION OF DELEGATES AND ALTERNATE DELEGATES: The officially certified delegates and the alternate delegates of each constituent society shall be elected by one or more of Bylaws 29 CHAPTER V • HOUSE OF DELEGATES 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 the following methods: 1. By the membership at large of that constituent society 2. By the constituent society’s governing legislative body 3. By a component with respect to the delegates representing that component Each federal dental service and the American Student Dental Association may establish its own method for selecting delegates. 1317 1318 1319 1320 1321 1322 1323 1324 1325 1326 1327 1328 1329 1330 1331 1332 1333 1334 1335 1336 Section 30. CERTIFICATION OF DELEGATES AND ALTERNATE DELEGATES: The executive director or equivalent chief executive officer of each constituent society, the ranking administrative officer of each federal dental service, and the secretary of the American Student Dental Association shall file with the Executive Director of this Association, at least sixty (60) days prior to the first day of the annual session of the House of Delegates, the names of the delegates and alternate delegates designated by the society, service or association. The Executive Director of this Association shall provide each delegate and alternate delegate with credentials which shall be presented to the Committee on Credentials, Rules and Order of the House of Delegates. In the event of a contest over the credentials of any delegate or alternate delegate, the Committee on Credentials, Rules and Order shall hold a hearing and report its findings and recommendations to the House of Delegates for final action. 1337 Section 40. POWERS: 1338 1339 A. The House of Delegates shall be the supreme authoritative body of this Association. 1340 B. It shall possess the legislative powers. 1341 1342 C. It shall determine the policies which shall govern this Association in all of its activities. 1343 1344 D. It shall have the power to enact, amend and repeal the Constitution and Bylaws. 1345 1346 1347 1348 E. It shall have the power to adopt and amend the Principles of Ethics and Code of Professional Conduct for governing the professional conduct of the members. 1349 1350 1351 1352 1353 1354 1355 1356 1357 1358 F. It shall have the power to grant, amend, suspend or revoke charters of constituent societies. It shall also have the power by a two-thirds (2/3) affirmative vote of the delegates present and voting to suspend the representation of a constituent society in the House of Delegates upon a determination by the House that the bylaws of the constituent society violate the Constitution or Bylaws of this Association providing, however, such suspension shall not be in effect until the House of Delegates has voted that the constituent 30 Bylaws CHAPTER V • HOUSE OF DELEGATES 1359 1360 1361 society is in violation and has one year after notification of the specific violation in which to correct its constitution or bylaws. 1362 1363 G. It shall have the power to create special committees of the Association. 1364 1365 H. It shall have the power to establish branch offices of the Association. 1366 1367 1368 I. It shall have the power to approve all memorials, resolutions or opinions issued in the name of the American Dental Association. 1369 1370 Section 50. DUTIES: It shall be the duty of the House of Delegates: 1371 A. To elect the elective officers. 1372 B. To elect the members of the Board of Trustees. 1373 1374 1375 C. To elect the members of the councils and commissions except as otherwise provided by these Bylaws. 1376 1377 D. To receive and act upon reports of the committees of the House of Delegates. 1378 1379 E. To adopt an annual budget and establish the dues of active members for the following year. 1380 1381 1382 1383 F. To serve as the court of appeal from decisions of the Council on Ethics, Bylaws and Judicial Affairs except those decisions involving discipline of members. 1384 1385 1386 1387 1388 1389 1390 1391 1392 1393 1394 1395 1396 1397 1398 1399 1400 1401 1402 1403 Section 60. TRANSFER OF POWERS AND DUTIES OF THE HOUSE OF DELEGATES: The powers and duties of the House of Delegates, except the power to amend, enact and repeal the Constitution and Bylaws, and the duty of electing the elective officers and the members of the Board of Trustees, may be transferred to the Board of Trustees of this Association in time of extraordinary emergency. The existence of a time of extraordinary emergency may be determined by unanimous consent of the members of the Board of Trustees present and voting at a regular or special session. Such extraordinary emergency may also be determined by mail vote of the last House of Delegates on recommendation of at least four (4) of the elective officers. A mail vote to be valid shall consist of ballots received from not less than one-fourth (1/4) of the members of the last House of Delegates. A majority of the votes cast within thirty (30) days after the mailing of the ballot shall decide the vote. 1404 1405 Section 70. ANNUAL SESSION: The House of Delegates shall meet annually. 1406 1407 Section 80. SPECIAL SESSIONS: A special session of the House of Delegates shall be called by the Bylaws 31 CHAPTER V • HOUSE OF DELEGATES 1408 1409 1410 1411 1412 1413 1414 1415 1416 1417 1418 1419 President on a three-fourths (3/4) affirmative vote of the members of the Board of Trustees or on written request of delegates representing at least one-third (1/3) of the constituent societies and not less than one-fifth (1/5) of the number of officially certified delegates of the last House of Delegates. The time and place of a special session shall be determined by the President, provided the time selected shall be not more than forty-five (45) days after the request was received. The business of a special session shall be limited to that stated in the official call except by unanimous consent. 1420 Section 90. OFFICIAL CALL: 1421 1422 1423 1424 1425 1426 1427 1428 A. ANNUAL SESSION. The Executive Director of the Association shall cause to be published in The Journal of the American Dental Association an official notice of the time and place of each annual session, and shall send to each member of the House of Delegates an official notice of the time and place of the annual session at least thirty (30) days before the opening of such session. 1429 1430 1431 1432 1433 1434 1435 B. SPECIAL SESSION. The Executive Director of the Association shall send an official notice of the time and place of each special session and a statement of the business to be considered to every officially certified delegate and alternate delegate of the last House, not less than fifteen (15) days before the opening of such session. 1436 1437 1438 1439 1440 1441 Section 100. QUORUM: One-fourth (1/4) of the voting members of the House of Delegates, representing at least one-fourth (1/4) of the constituent societies and federal dental services, shall constitute a quorum for the transaction of business at any meeting. 1442 Section 110. OFFICERS: 1443 1444 1445 1446 1447 1448 1449 1450 1451 A. SPEAKER AND SECRETARY. The officers of the House shall be the Speaker of the House of Delegates and the Secretary of the House of Delegates. The Executive Director of this Association shall serve as Secretary of the House of Delegates. In the absence of the Speaker the office shall be filled by the President. In the absence of the Secretary of the House of Delegates the Speaker shall appoint a Secretary of the House of Delegates pro tem. 1452 1453 1454 1455 1456 1457 1458 1459 B. DUTIES. a. SPEAKER. The Speaker shall preside at all meetings of the House of Delegates and, in accordance with Chapter V, Section 140Bb, determine the order of business for all meetings subject to the approval of the House of Delegates, appoint tellers to assist in determining the result of any action taken by vote and perform such other 32 Bylaws CHAPTER V • HOUSE OF DELEGATES 1460 1461 1462 1463 1464 1465 1466 1467 1468 1469 1470 1471 1472 1473 1474 1475 1476 1477 duties as custom and parliamentary procedure require. The decision of the Speaker shall be final unless an appeal from such decision shall be made by a member of the House, in which case final decision shall be by majority vote. In addition, following adjournment of the Standing Committee on Constitution and Bylaws, the Speaker and the Chair of the Council on Ethics, Bylaws and Judicial Affairs shall be responsible for reviewing and either approving or redrafting any new resolutions or changes to resolutions that propose amendments to the Constitution and Bylaws, in accordance with Chapter V, Section 140Ab. b. SECRETARY. The Secretary of the House of Delegates shall serve as the recording officer of the House and the custodian of its records, and shall cause a record of the proceedings of the House to be published as the official transactions of the House. 1478 1479 1480 1481 Section 120. ORDER OF BUSINESS: The order of business shall be that order of business adopted by the House of Delegates in conformity with Chapter V, Section 110Ba and Chapter V, Section 140Bb. 1482 Section 130. RULES OF ORDER: 1483 1484 1485 1486 1487 1488 1489 1490 1491 1492 1493 1494 1495 1496 1497 1498 1499 1500 1501 1502 1503 1504 1505 1506 1507 1508 1509 1510 1511 1512 1513 A. STANDING RULES AND REPORTS. a. REPORTS. All reports of elective officers, councils and committees, except supplemental reports, shall be sent to each delegate and alternate delegate at least fourteen (14) days in advance of the opening of the annual session. All supplemental reports shall be distributed to each delegate before such report is considered by the House of Delegates. b. APPROPRIATION OF FUNDS. Any resolution proposing an appropriation of funds, except those relating to the annual budget, shall be referred to the Board of Trustees for a report at the same session on the availability of funds for the purpose specified. c. APPROVAL OF ANNUAL BUDGET. The proposed annual budget shall be submitted by the Board of Trustees to the members of the House of Delegates at least fourteen (14) days prior to the opening meeting of the annual session, shall be referred to a special reference committee on budget for hearings at the annual session and then shall be considered for approval as a special order of business at the second meeting of the House of Delegates. In the event the budget as submitted is not approved, all recommendations for changes shall be referred to the Board of Trustees to prepare and present a revised budget. This procedure shall be repeated until a budget for the ensuing fiscal year shall be adopted. d. APPROVAL OF THE DUES OF ACTIVE MEMBERS. The dues of active members of this Association shall be established by the House of Bylaws 33 CHAPTER V • HOUSE OF DELEGATES 1514 1515 1516 1517 1518 1519 1520 1521 1522 1523 1524 1525 1526 1527 1528 1529 1530 1531 1532 1533 1534 1535 1536 1537 1538 1539 1540 1541 1542 1543 1544 1545 1546 1547 1548 1549 1550 1551 1552 Delegates as the last item of business at each annual session. The resolution to establish the dues of active members for the following year shall be proposed at each annual session by the Board of Trustees in conformity with Chapter VII, Section 100F of these Bylaws, may be amended to any amount and/or reconsidered by the House of Delegates until a resolution establishing the dues of active members is adopted by a two-thirds (2/3) affirmative vote of the delegates present and votin g. e. INTRODUCTION OF NEW BUSINESS. No new business shall be introduced into the House of Delegates less than 15 days prior to the opening of the annual session, unless submitted by a Trustee District. No new business shall be introduced into the House of Delegates at the last meeting of a session except when such new business is submitted by a Trustee District and is permitted to be introduced by a two-thirds (2/3) affirmative vote of the delegates present and voting. The motion introducing such new business shall not be debatable. Approval of such new business shall require a majority vote except new business introduced at the last meeting of a session that would require a bylaw amendment cannot be adopted at such last meeting. Reference committee recommendations shall not be deemed new business. f. RESOLUTIONS. A resolution becomes the property of the American Dental Association when submitted to the ADA House of Delegates for consideration. If adopted by the House of Delegates, this Association shall be the sole owner of the resolution which shall constitute “work made for hire” under copyright laws. This Association shall have the exclusive right to seek copyright registration for the resolution and to secure copyrights and retain ownership of such copyrights in its own name. 1553 1554 1555 1556 1557 1558 B. ADDITIONAL RULES. The rules contained in the current edition of The Standard Code of Parliamentary Procedure by Alice Sturgis shall govern the deliberations of the House of Delegates in all cases in which they are applicable and not in conflict with the standing rules or these Bylaws. 1559 1560 Section 140. COMMITTEES: The committees of the House of Delegates shall be: 1561 1562 1563 1564 1565 1566 1567 A. COMMITTEE ON CONSTITUTION AND BYLAWS. a. COMPOSITION. The Committee shall consist of not more than eight (8) nor less than six (6) members of the Council on Ethics, Bylaws and Judicial Affairs of this Association appointed by the President in consultation with the Speaker of the 34 Bylaws CHAPTER V • HOUSE OF DELEGATES 1568 1569 1570 1571 1572 1573 1574 1575 1576 1577 1578 1579 1580 1581 1582 1583 1584 1585 1586 1587 1588 House of Delegates and the Council Chair. b. DUTIES: Prior to the first meeting of each new session of the House of Delegates, the Committee shall review all resolutions proposing amendments to the Constitution and Bylaws and shall either approve the text of the amendment as written or shall redraft the resolution to accomplish the intent of the maker in the form currently used by the House of Delegates. The Committee shall file a report of its findings and actions at the first meeting of the House of Delegates and then shall adjourn. Thereafter until the House of Delegates adjourns sine die, the Speaker of the House and the Chair of the Council on Ethics, Bylaws and Judicial Affairs shall be responsible for reviewing any new resolutions or changes to resolutions that propose amendments to the Constitution and Bylaws, and they shall either approve the text of the amendment as written or shall redraft the resolution to accomplish the intent of the maker in the form currently used by the House of Delegates. 1589 1590 1591 1592 1593 1594 1595 1596 1597 1598 1599 1600 1601 1602 1603 1604 1605 1606 1607 B. COMMITTEE ON CREDENTIALS, RULES AND ORDER. a. COMPOSITION. The Committee, consisting of nine (9) members from the officially certified delegates and alternate delegates, shall be appointed by the President at least sixty (60) days in advance of each session. b. DUTIES. It shall be the duty of the Committee (1) to record and report the roll call of the House of Delegates at each meeting; (2) to conduct a hearing on any contest regarding the certification of a delegate or alternate delegate and to report its recommendations to the House of Delegates; (3) to prepare a report, in consultation with the Speaker and Secretary of the House of Delegates, on matters relating to the order of business and special rules of order; (4) to consider all matters referred to it and report its recommendations to the House of Delegates. 1608 1609 1610 1611 1612 1613 1614 1615 1616 1617 1618 C. RESOLUTIONS COMMITTEE. a. COMPOSITION. The Resolutions Committee shall consist of the Speaker and the Secretary of the House of Delegates and the chairs of the reference committees authorized by Subsection D of this Chapter. b. DUTIES. The duties of the Resolutions Committee shall be to examine resolutions after action by the reference committees and arrange a sequence for House action based upon the importance of the resolutions’ subject matter. 1619 1620 1621 D. REFERENCE COMMITTEES. a. COMPOSITION. Reference committees, consisting of nine (9) members from the officially Bylaws 35 CHAPTER V • HOUSE OF DELEGATES CHAPTER VI • CONFLICT OF INTEREST 1622 1623 1624 1625 1626 1627 1628 certified delegates and alternate delegates, shall be appointed by the President at least sixty (60) days in advance of each annual session. b. DUTIES. It shall be the duty of a reference committee to consider reports referred to it, to conduct open hearings and to report its recommendations to the House of Delegates. 1629 1630 1631 1632 1633 E. SPECIAL COMMITTEES. The Speaker, with the consent of the House of Delegates, shall appoint special committees to perform duties not otherwise assigned by these Bylaws, to serve until adjournment sine die of the session at which they were appointed. 1634 1635 1636 1637 1638 1639 1640 1641 1642 1643 1644 1645 1646 1647 1648 1649 1650 1651 1652 1653 1654 Section 150. ELECTION PROCEDURE: Elective officers, members of the Board of Trustees and members of councils and committees shall be elected by the House of Delegates except as otherwise provided in these Bylaws. Voting shall be by ballot, except that when there is only one candidate for an office, council or committee, such candidate may be declared elected by the Speaker. The Secretary shall provide facilities for voting. The polls shall be open for at least one and one-half (1-1/2) hours. a. When one is to be elected, and more than one has been nominated, the majority of the ballots cast shall elect. In the event no candidate receives a majority of the votes cast on the first ballot, the two (2) candidates receiving the greatest number of votes shall be balloted upon again. b. When more than one is to be elected, and the nominees exceed the number to be elected, the votes cast shall be non-cumulative, and the candidates receiving the greatest number of votes shall be elected. CHAPTER VI • CONFLICT OF INTEREST 1655 1656 1657 1658 1659 1660 1661 1662 1663 1664 1665 1666 1667 1668 1669 1670 1671 1672 1673 It is the policy of this Association that individuals who serve in elective, appointive or employed offices or positions do so in a representative or fiduciary capacity that requires loyalty to the Association. At all times while serving in such offices or positions, these individuals shall further the interests of the Association as a whole. In addition, they shall avoid: a. placing themselves in a position where personal or professional interests may conflict with their duty to this Association. b. using information learned through such office or position for personal gain or advantage. c. obtaining by a third party an improper gain or advantage. As a condition for selection, each nominee, candidate and applicant shall complete a conflict of interest statement as prescribed by the Board of Trustees, disclosing any situation which might be 36 Bylaws CHAPTER VI • CONFLICT OF INTEREST CHAPTER VII • BOARD OF TRUSTEES 1674 1675 1676 1677 1678 1679 1680 1681 1682 1683 1684 1685 1686 1687 1688 1689 1690 1691 1692 1693 1694 1695 1696 1697 1698 1699 construed as placing the individual in a position of having an interest that may conflict with his or her duty to the Association. Candidates for offices of President-elect, Second Vice President, Treasurer, Speaker of the House, nominees for office of trustee, and nominees to councils and commissions shall file such statements with the Secretary of the House of Delegates to be made available to the delegates prior to election. As a condition of appointment, consultants, advisers and staff of Councils, Commissions and Special Committees, and each person nominated or seeking such positions, shall file conflict of interest statements with the executive director of this Association. While serving in any elective, appointive or employed office or position, the individual shall comply with the conflict of interest policy applicable to his or her office or position, shall complete and file a conflict of interest statement for each year of service, and shall promptly report any situation in which a potential conflict of interest may arise. The Board of Trustees shall approve any additional compliance activities that will implement the requirements of this chapter. The Board of Trustees shall render a final judgment on what constitutes a conflict of interest. CHAPTER VII • BOARD OF TRUSTEES 1700 1701 1702 1703 1704 1705 1706 1707 1708 1709 Section 10. COMPOSITION: The Board of Trustees shall consist of one (1) trustee from each of the seventeen (17) trustee districts. Such seventeen (17) trustees, the President-elect and the two Vice Presidents shall constitute the voting membership of the Board of Trustees. In addition, the President, the Treasurer and the Executive Director of the Association, except as otherwise provided in the Bylaws shall be ex officio members of the Board without the right to vote. 1710 1711 1712 1713 1714 1715 1716 1717 1718 1719 Section 20. QUALIFICATIONS: A trustee must be an active, life or retired member, in good standing, of this Association and an active, life, or retired member of one of the constituent societies of the trustee district which the trustee is elected to represent. Should the status of any trustee change in regard to the preceding qualifications during the trustee’s term of office, that office shall be declared vacant by the President and the President shall fill such vacancy as provided in Chapter VII, Section 80, of these Bylaws. 1720 1721 1722 1723 Section 30. TERM OF OFFICE: The term of office of a trustee shall be four (4) years. The tenure of a trustee shall be limited to one (1) term of four (4) years. Bylaws 37 CHAPTER VII • BOARD OF TRUSTEES 1724 1725 1726 1727 1728 1729 1730 1731 1732 1733 1734 1735 1736 1737 1738 1739 1740 Section 40. NOMINATION: A. SINGLE CONSTITUENT DISTRICT. In trustee districts consisting of a single constituent dental society, the trustee nomination procedures shall be determined by an elective process established by the constituent dental society which shall produce a single nominee for trustee. Until such time as the Speaker declares the nominee elected pursuant to Paragraph A of Section 50 of this Chapter, the nomination may be reconsidered by the duly constituted caucus of the trustee district during the appropriate annual session, provided that at no time shall more than one nominee be presented by the trustee district for election. The House of Delegates may vote to reject any such nominee and thereby compel the trustee district caucus to select a different nominee. 1741 1742 1743 1744 1745 1746 1747 1748 1749 1750 1751 1752 1753 1754 1755 1756 1757 1758 1759 1760 1761 1762 1763 1764 1765 1766 1767 1768 1769 1770 B. MULTIPLE CONSTITUENT DISTRICTS. In multiple constituent districts, the delegates from the constituent societies of the trustee district in which the term of the trustee is to terminate, shall hold a caucus to select a nominee or nominees for the office of trustee. Such caucus shall be called by the trustee whose term is about to expire, or by the trustee’s designee. The notice of the time and place of such caucus shall be reported to the Secretary of the House. At the caucus the delegates shall nominate one (1) or two (2) candidates for the office of trustee, whose name or names shall be presented to the House of Delegates in accordance with the following rules. An action taken at a duly constituted caucus of the trustee district to nominate or select a trustee may be reconsidered at a later caucus during the appropriate annual session. a. A person receiving the unanimous vote of the delegates present and voting at the caucus shall be the only nominee presented by the district. b. In the event that one (1) candidate receives a majority vote, one (1) or more of the delegates voting in the minority may select another nominee and the names of both nominees shall be presented to the House of Delegates as the nominees of that district. c. The number of votes received by each nominee in the caucus shall be reported to the House of Delegates. 1771 1772 1773 1774 1775 1776 1777 C. NOMINATING PROCEDURE. Candidates for the office of trustee shall be nominated from the floor of the House of Delegates by a simple declaratory statement, which may be followed by an acceptance speech not to exceed four (4) minutes by the candidate from the podium, according to the protocol established by the Speaker of the House of Delegates. 38 Bylaws CHAPTER VII • BOARD OF TRUSTEES 1778 Seconding a nomination is not permitted. 1779 1780 1781 Section 50. ELECTION: The trustee shall be elected by the House of Delegates according to the following rules: 1782 1783 1784 A. If there is only one (1) nominee from a trustee district, the Speaker shall declare such nominee elected. 1785 1786 1787 1788 1789 1790 1791 1792 1793 1794 B. If there are two (2) nominees from a trustee district, the election shall be by ballot in accordance with Chapter V, Section 150. The nominee receiving the larger number of votes cast shall be declared elected. The method of election set forth in this paragraph shall not be used for any trustee district consisting of a single constituent dental society. A trustee district consisting of a single constituent dental society may present a single nominee to be elected pursuant to Paragraph A of this Section. 1795 1796 1797 Section 60. INSTALLATION: The trustee shall be installed by the President or by the President’s designee. 1798 1799 1800 1801 1802 1803 1804 1805 1806 1807 1808 1809 Section 70. REMOVAL FOR CAUSE: The House of Delegates may remove a trustee for cause in accordance with procedures established by the House of Delegates, which procedures shall provide for notice of the charges and an opportunity for the accused to be heard in his or her defense. A twothirds (2/3) affirmative vote of the delegates present and voting is required to remove a trustee from office. If the House of Delegates elects to remove the trustee, that action shall create a vacancy on the Board of Trustees which shall be filled in accordance with Chapter VII, Section 80. 1810 1811 1812 1813 1814 1815 1816 1817 1818 1819 1820 1821 1822 1823 1824 1825 1826 1827 1828 1829 1830 Section 80. VACANCY: In the event of a vacancy in the office of trustee, an active, life or retired member may be appointed by the President to fill the unexpired term of the vacancy. The appointment shall be made by the President with the advice and consent of the former trustee’s district. A trustee district may file rules with the Association’s Executive Director setting forth how its nominee shall be chosen. In the event an appointment to fill the vacancy has not been made by the time of the next meeting of the House of Delegates following the occurrence of the vacancy, then a successor trustee shall be elected for the remainder of the unexpired term by the House of Delegates pursuant to the provisions of Chapter VII, Sections 40 and 50 of these Bylaws. If the term of the vacated trustee position has less than fifty percent (50%) of a full four-year term remaining at the time the successor trustee is appointed or elected, the successor trustee shall be eligible for election to a new, consecutive four-year term. If fifty percent (50%) or more of the vacated term remains to be Bylaws 39 CHAPTER VII • BOARD OF TRUSTEES 1831 1832 1833 served at the time of the appointment or election, the successor trustee shall not be eligible for another term. 1834 1835 1836 1837 1838 1839 1840 1841 1842 1843 1844 1845 1846 1847 1848 1849 Section 90. POWERS: A. The Board of Trustees shall be the managing body of the Association, vested with full power to conduct all business of the Association, subject to the laws of the State of Illinois, the Articles of Incorporation, the Constitution and Bylaws and the mandates of the House of Delegates. The power of the Board of Trustees to act as the managing body of the Association shall not be construed as limiting the power of the House of Delegates to establish policy with respect to the governance of this Association in all its activities, except for areas expressly reserved in these Bylaws as powers and/or duties of the Board of Trustees, as the same may be amended by the House of Delegates from time to time in accordance with these Bylaws. 1850 1851 1852 B. It shall have the power to establish rules and regulations not inconsistent with these Bylaws to govern its organization and procedure. 1853 1854 1855 C. It shall have the power to direct the President to call a special session of the House of Delegates as provided in Chapter V, Section 80, of the Bylaws. 1856 1857 1858 1859 D. It shall have full discretionary power to cause to be published in, or to be omitted from, any official publication of the Association any article in whole or in part. 1860 1861 1862 1863 1864 1865 1866 E. It shall have the power to establish ad interim policies when the House of Delegates is not in session and when such policies are essential to the management of the Association provided, however, that all such policies must be presented for review and consideration by the House of Delegates at its next session. 1867 1868 1869 F. It shall have the power to remove a council member for cause in accordance with procedures established by the Board of Trustees in its Rules. 1870 G. It shall have the power to elect honorary members. 1871 1872 1873 1874 H. It shall have the power to appoint its members to committees that shall have the power to perform any duty that the Board of Trustees may lawfully delegate. 1875 1876 1877 1878 1879 1880 1881 I. It shall have the interim power to supervise, monitor and guide the activities of all councils and special committees in order to ensure the fulfillment of initiatives and directives assigned to each council or special committee by the House of Delegates or Board of Trustees subject to the requirement that all interim actions of the Board must be approved by the 40 Bylaws CHAPTER VII • BOARD OF TRUSTEES 1882 House of Delegates. 1883 1884 1885 1886 1887 1888 1889 1890 1891 1892 1893 J. In accordance with the laws of the State of Illinois, it shall have the power to transact its business by unanimous consent via mail ballot, including electronic mail; to authorize the councils, commissions and committees of this Association to transact their business by mail ballot; and to establish rules and procedures for itself and for councils, commissions and committees of this Association to govern the use of ballots circulated and returned by U.S. mail, overnight courier, facsimile transmission or electronic mail. 1894 1895 1896 1897 1898 1899 1900 1901 K. It shall have the power to appoint agents and/or other representatives for the purpose of supervising, managing and otherwise conducting business under its direction and in accordance with these Bylaws and the laws of the State of Illinois. No such appointment shall relieve the Board of Trustees of its fiduciary duties as the managing body of the Association as provided in these Bylaws. 1902 1903 Section 100. DUTIES: It shall be the duty of the Board of Trustees: 1904 1905 1906 1907 A. To provide for the purchase, sale, mortgage, maintenance and supervision of the Headquarters Office and all other property or offices owned or operated by this Association. 1908 1909 B. To appoint the Executive Director of the Association. 1910 1911 1912 1913 C. To determine the date and place for convening each annual session and provide for the management and general arrangements for each annual session as provided in Chapter XV, Section 30. 1914 1915 1916 D. To cause to be bonded by a surety company the Treasurer, the Executive Director and employees of the Association entrusted with Association funds. 1917 1918 1919 1920 1921 1922 E. To provide guidelines and directives to govern the Treasurer’s custody, investment and disbursement of Association funds and other property as provided in Chapter VIII, Section 90F, of these Bylaws; and to cause all accounts of the Association to be audited by a certified public accountant at least once a year. 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 F. To prepare a budget for carrying on the activities of the Association for each ensuing fiscal year, and present for action by each House of Delegates a resolution setting forth the proposed dues of active members for the following year. Notice of such a resolution shall be sent by a certifiable method of delivery to each constituent society not less than ninety (90) days before such session to permit prompt, adequate notice by each constituent society to its delegates and alternate delegates to the House of Bylaws 41 CHAPTER VII • BOARD OF TRUSTEES 1933 1934 1935 1936 Delegates of this Association, and shall be announced to the general membership in an official publication of the Association at least sixty (60) days in advance of the annual session. 1937 1938 1939 1940 1941 1942 1943 1944 G. To establish rules to govern its procedures in serving as the nominating committee for the office of Treasurer, and as provided in Chapter VIII of these Bylaws, to submit in printed form the name(s) and curriculum vitae of the Board’s nominee(s) to the House of Delegates in the first mailing to the House in the year that the incumbent Treasurer’s term is about to end. 1945 1946 1947 1948 H. To submit to the House of Delegates at the opening meeting of the annual session, in printed form, nominations for membership to the councils, except as otherwise provided in these Bylaws. 1949 1950 1951 1952 1953 I. To appoint annually the chair of each council, except as otherwise provided in these Bylaws, and to act upon council, commission, and bureau nominations for consultants and advisers except as otherwise provided in these Bylaws. 1954 1955 1956 1957 1958 J. To provide interim guidance and supervision to all councils and special committees in order to ensure the fulfillment of initiatives and directives assigned to each council or special committee by the House of Delegates or Board of Trustees. 1959 1960 1961 1962 K. To review the reports of councils and special committees of the Association and to make recommendations concerning such reports to the House of Delegates. 1963 1964 1965 1966 L. To act upon applications for active membership from applicants practicing in dependencies of the United States in which no constituent society exists or in federal dental services. 1967 1968 1969 M. To submit an annual report to the House of Delegates of its activities and those of the Treasurer and Executive Director. 1970 1971 1972 N. To review the delegate allocations to the House of Delegates as provided in Chapter V, Section 10C, of these Bylaws. 1973 O. To elect associate members. 1974 1975 1976 P. To establish other funds as divisions of the General Fund in accordance with the provisions of Chapter XVII, Section 30. 1977 1978 1979 Q. To appoint special committees of the Association in accordance with Chapter XI, Section 10 of these Bylaws. 1980 1981 R. To perform such other duties as are prescribed by these Bylaws. 42 Bylaws CHAPTER VII • BOARD OF TRUSTEES 1982 1983 1984 1985 1986 1987 1988 S. To establish such administrative agencies of this Association as may be necessary to implement the Association’s programs, to assign the duties of such agencies through the Executive Director of the Association under whose jurisdiction each shall operate, and to require reports of such agencies through the same channels. 1989 Section 110. SESSIONS: 1990 1991 1992 1993 1994 A. REGULAR SESSIONS. The Board of Trustees shall hold a minimum of three regular sessions each year. The number of actual regular meetings to be held in excess of three for the ensuing year shall be determined in advance by the Board of Trustees. 1995 1996 1997 1998 1999 B. SPECIAL SESSIONS. Special sessions of the Board of Trustees may be called at any time either by the President or at the request of five voting members of the Board, provided notice is given to each member in advance of the session. 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 C. PLACE OF MEETINGS: Regular or special meetings may be held in a single geographic location within or outside the state of Illinois or from multiple remote locations through the use of a conference telephone or other communications equipment by means of which all members can communicate with each other; provided, however, special meetings held through the use of a conference telephone or other communications equipment may be called by the President or at the request of five voting members of the Board of Trustees for matters of the Association requiring immediate attention. Such meetings shall be conducted in accordance with rules and procedures established by the Board of Trustees. 2014 2015 2016 Section 120. QUORUM: A majority of the voting members of the Board of Trustees shall constitute a quorum. 2017 Section 130. OFFICERS: 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 A. CHAIR AND SECRETARY. The officers of the Board of Trustees shall be the President of the Association who shall be the Chair, and the Executive Director of the Association who shall be the Secretary. In the absence of the President, the office of Chair shall be filled by the President-elect and, in his or her absence, by the First or Second Vice President in that order and, in their absence, a voting member of the Board shall be elected Chair pro tem. In the absence of the Secretary, the Chair shall appoint a Secretary pro tem. 2030 2031 2032 2033 B. DUTIES. a. CHAIR. The Chair shall preside at all meetings of the Board of Trustees. The Chair shall cast the deciding vote in case of a tie. Bylaws 43 CHAPTER VII • BOARD OF TRUSTEES 2034 2035 2036 2037 2038 b. SECRETARY. The Secretary shall serve as the recording officer of the Board of Trustees and as the custodian of its records. The Secretary shall cause a factual record of the proceedings to be published as the official transactions of the Board. 2039 2040 2041 2042 2043 2044 2045 2046 2047 2048 2049 2050 2051 2052 2053 2054 2055 2056 2057 2058 2059 2060 2061 2062 2063 2064 2065 2066 2067 2068 2069 2070 2071 2072 2073 2074 2075 2076 2077 2078 2079 2080 2081 2082 2083 2084 2085 2086 2087 2088 Section 140. COMMITTEES: The Board of Trustees shall have a standing Committee on the New Dentist. The Committee shall consist of one (1) member from each trustee district who are active members selected by the Board of Trustees and confirmed by the House of Delegates. Members of the Committee shall have received their D.D.S. or D.M.D. degree less than ten (10) years before the time of selection. The chair of the Committee shall be appointed annually by the Board of Trustees. Members of the Committee shall serve one (1) term of four (4) years and shall not be eligible for appointment to a council or commission for a period of two (2) years after completing service on the Committee. However, the Board of Trustees shall stagger the terms of the members of the Committee in a manner so four (4) members will complete their terms each year, except every fourth year when five (5) members shall complete their terms. The Board of Trustees shall have the power to remove a Committee member for cause in accordance with procedures established by the Board in its Rules. In the event of any vacancy on the Committee, the Board of Trustees shall select a member of this Association possessing the same qualifications as established by these Bylaws for the previous member, to fill such vacancy for the remainder of the unexpired term. If the term of the vacated Committee position has less than fifty percent (50%) of a full four-year term remaining at the time the successor member is selected, the successor member shall be eligible for selection to a new, consecutive four-year term. If fifty percent (50%) or more of the vacated term remains to be served at the time of selection, the successor member shall not be eligible for another term. The Committee’s work shall be assigned by the Board of Trustees, and reports and proposals formulated by the Committee shall be referred to the Board for decision and action. The duties of the Committee shall be: a. To provide the Board of Trustees with expertise on issues affecting new dentists less than ten years following graduation from dental school. b. To advocate to the Board of Trustees and other agencies of this Association the perspectives of the new dentist in the development of policies, programs, benefits and services of the Association. c. To identify the needs and concerns of new graduate dentists and make recommendations for 44 Bylaws CHAPTER VII • BOARD OF TRUSTEES CHAPTER VIII • ELECTIVE OFFICERS 2089 2090 2091 2092 2093 2094 2095 2096 2097 2098 2099 any programs to assist with their transition to practice. d. To stimulate the increased involvement and active participation of new dentists in organized dentistry. e. To serve as ex officio members, without the power to vote, of councils and commissions of this Association on issues affecting new dentists; these appointments will be recommended by the Committee and assigned by the Board of Trustees. f. To enhance communications with constituent and component new/young dentist networks. CHAPTER VIII • ELECTIVE OFFICERS 2100 2101 2102 2103 2104 Section 10. TITLE: The elective officers of this Association shall be President, President-elect, First Vice President, Second Vice President, Treasurer and Speaker of the House of Delegates, as provided in Article V of the Constitution. 2105 2106 2107 2108 2109 2110 2111 2112 Section 20. ELIGIBILITY: Only an active, life or retired member, in good standing, of this Association shall be eligible to serve as an elective officer. Trustees and elective officers may not apply for the office of Treasurer while serving in any of those offices, except that the Treasurer may apply for a second term pursuant to Chapter VIII, Section 50 of these Bylaws. 2113 Section 30. NOMINATIONS: 2114 2115 2116 2117 2118 2119 2120 2121 2122 2123 2124 A. Nominations for the offices of President-elect, Second Vice President and Speaker of the House shall be made in accordance with the order of business. Candidates for these elective offices shall be nominated from the floor of the House of Delegates by a simple declaratory statement, which may be followed by an acceptance speech not to exceed four (4) minutes by the candidate from the podium, according to the protocol established by the Speaker of the House of Delegates. Seconding a nomination is not permitted. 2125 2126 2127 2128 2129 2130 2131 2132 2133 2134 2135 2136 2137 2138 2139 B. Nominations for the office of Treasurer shall be made in accordance with the order of business. If there is only one (1) eligible candidate for the office of Treasurer, the Board of Trustees shall nominate that individual from the floor of the House of Delegates by a simple declaratory statement, which may be followed by an acceptance speech not to exceed four (4) minutes by the candidate from the podium, according to the protocol established by the Speaker of the House of Delegates. If there are two (2) or more eligible candidates for the office of Treasurer, the Board of Trustees shall nominate at least two (2) and not more than three (3) candidates from the floor of the House of Delegates by a simple declaratory statement for each nominee, which may Bylaws 45 CHAPTER VIII • ELECTIVE OFFICERS 2140 2141 2142 2143 2144 be followed by an acceptance speech not to exceed four (4) minutes by the candidate from the podium, according to the protocol established by the Speaker of the House of Delegates. Seconding a nomination is not permitted. 2145 2146 Section 40. ELECTIONS: The elective officers shall be elected in accordance with Chapter V, Section 150. 2147 2148 2149 2150 2151 2152 2153 2154 2155 2156 Section 50. TERM OF OFFICE: The President, President-elect, First Vice President, Second Vice President and Speaker of the House of Delegates shall serve for a term of one (1) year, except as otherwise provided in this chapter of the Bylaws, or until their successors are elected and installed. The term of office of the Treasurer shall be three (3) years, or until a successor is elected and installed. The Treasurer shall be limited to two (2) consecutive terms of three (3) years each. 2157 2158 2159 2160 2161 2162 2163 2164 Section 60. INSTALLATION: The elective officers shall be installed at the last meeting of the annual session of the House of Delegates. The Presidentelect shall be installed as President at the next annual session of the House following election. The Second Vice President shall be installed as First Vice President at the next annual session of the House following election. 2165 2166 2167 2168 2169 2170 2171 2172 2173 2174 2175 Section 70. REMOVAL FOR CAUSE: The House of Delegates may remove an elective officer for cause in accordance with procedures established by the House of Delegates, which shall include notice of the charges and an opportunity for the accused to be heard in his or her defense. A two-thirds (2/3) affirmative vote of the delegates present and voting is required to remove an elective officer from office. If the House of Delegates elects to remove the elective officer, that action shall create a vacancy which shall be filled in accordance with Chapter VIII, Section 80. 2176 Section 80. VACANCIES: 2177 2178 2179 2180 2181 2182 2183 2184 2185 2186 2187 2188 2189 2190 2191 A. VACANCY OF ELECTIVE OFFICE: In the event the office of President becomes vacant, the Presidentelect shall become President for the unexpired portion of the term. In the event the office of President becomes vacant for the second time in the same term or at a time when the office of President-elect is also vacant, the First Vice President shall become President for the unexpired portion of the term. In the event the office of First Vice President becomes vacant, the Second Vice President shall become the First Vice President for the unexpired portion of the term. A vacancy in the office of the Second Vice President shall be filled by a majority vote of the Board of Trustees. In the event of a vacancy in the office of Speaker of the House of Delegates, the 46 Bylaws CHAPTER VIII • ELECTIVE OFFICERS 2192 2193 2194 2195 2196 2197 2198 2199 2200 2201 2202 2203 2204 2205 2206 2207 2208 2209 2210 2211 President, with approval of the Board of Trustees, shall appoint a Speaker pro tem. In the event the office of President-elect becomes vacant by reason other than the President-elect succeeding to the office of the President earlier than the next annual session, the office of President for the ensuing year shall be filled at the next annual session of the House of Delegates in the same manner as that provided for the nomination and election of elective officers, except that the ballot shall read “President for the Ensuing Year.” A vacancy in the office of Treasurer shall be filled by a majority vote of the Board of Trustees until the process of inviting applications, screening and nominating candidates and electing a new Treasurer has been completed by the Board of Trustees and the House of Delegates. The Treasurer pro tem shall be eligible for election to a new consecutive three (3) year term. The newly elected Treasurer shall be limited to two (2) consecutive terms of three (3) years each. 2212 2213 2214 2215 2216 2217 2218 2219 2220 2221 2222 2223 2224 2225 2226 2227 2228 B. TEMPORARY INCAPACITY OF THE PRESIDENT: Whenever the President notifies the Board of Trustees that he or she is unable to discharge the duties of the office of President due to temporary incapacity, the President-elect shall assume the duties of the office of President, as Acting President, until the President notifies the Board of Trustees that he or she is prepared to resume the duties of the office of President. Whenever the voting members of the Board of Trustees of this Association determine by majority vote that the President is unable to discharge the duties of his or her office due to temporary incapacity, the President-elect shall assume the duties of the office of President, as Acting President, until the President satisfies the voting members of the Board of Trustees that he or she is prepared to resume the duties of the office of President. 2229 Section 90. DUTIES: 2230 2231 2232 2233 2234 2235 2236 2237 2238 2239 2240 2241 2242 2243 2244 2245 A. PRESIDENT. It shall be the duty of the President: a. To serve as the primary official representative of this Association in its contacts with governmental, civic, business and professional organizations for the purpose of advancing the objectives and policies of this Association. b. To serve as Chair and ex officio member of the Board of Trustees and to perform such duties as are provided in Chapters V and VII of these Bylaws. c. To call special sessions of the House of Delegates and the Board of Trustees as provided in Chapters V and VII of these Bylaws. d. To appoint the members of all committees of the House of Delegates except as otherwise provided in these Bylaws. e. To fill vacancies in the office of trustee as Bylaws 47 CHAPTER VIII • ELECTIVE OFFICERS 2246 2247 2248 2249 2250 2251 2252 provided in Chapter VII, Section 80, of these Bylaws and to fill other vacancies in accordance with these Bylaws. f. To submit an annual report to the House of Delegates. g. To perform such other duties as may be provided in these Bylaws. 2253 2254 2255 2256 2257 2258 2259 2260 2261 2262 2263 2264 2265 B. PRESIDENT-ELECT. It shall be the duty of the President-elect: a. To assist the President as requested. b. To serve as an ex officio member of the House of Delegates without the right to vote. c. To serve as an ex officio member of the Board of Trustees. d. To succeed to the office of President at the next annual session of the House of Delegates following election as President-elect. e. To succeed immediately to the office of President in the event of vacancy not only for the unexpired term but also for the succeeding year. 2266 2267 2268 2269 2270 2271 2272 2273 2274 C. FIRST VICE PRESIDENT. It shall be the duty of the First Vice President: a. To assist the President as requested. b. To serve as an ex officio member of the House of Delegates without the right to vote. c. To serve as an ex officio member of the Board of Trustees. d. To succeed to the office of President, as provided in this chapter of the Bylaws. 2275 2276 2277 2278 2279 2280 2281 2282 2283 2284 2285 2286 2287 D. SECOND VICE PRESIDENT. It shall be the duty of the Second Vice President: a. To assist the President as requested. b. To serve as an ex officio member of the House of Delegates without the right to vote. c. To serve as an ex officio member of the Board of Trustees. d. To succeed to the office of First Vice President at the next annual session of the House of Delegates following election as Second Vice President. e. To succeed immediately to the office of First Vice President in the event of vacancy not only for the unexpired term but also for the succeeding term. 2288 2289 2290 2291 2292 2293 E. SPEAKER OF THE HOUSE OF DELEGATES. The Speaker shall preside at the meetings of the House of Delegates and shall perform such duties as custom and parliamentary procedure require. The Speaker shall not be a member of the Board of Trustees. 2294 2295 2296 2297 2298 F. TREASURER. It shall be the duty of the Treasurer: a. To serve as custodian of all monies, securities and deeds belonging to the Association which may come into the Treasurer’s possession. 48 Bylaws CHAPTER VIII • ELECTIVE OFFICERS CHAPTER IX • APPOINTIVE OFFICER 2299 2300 2301 2302 2303 2304 2305 2306 2307 2308 2309 2310 2311 2312 2313 2314 2315 2316 b. To hold, invest and disburse all monies, securities and deeds, subject to the direction of the Board of Trustees. c. To design a budgetary process in concert with the Board of Trustees. d. To oversee Association finances and budget development. e. To serve as the principal resource person for the budget reference committee in the House of Delegates and to help interpret the Association’s finances for the membership. f. To review all financial information and data and report on financial matters to the Board of Trustees on a quarterly basis. g. To review travel reimbursement for the elective officers, trustees and Executive Director. h. To perform such other duties as may be provided in these Bylaws. CHAPTER IX • APPOINTIVE OFFICER 2317 2318 2319 Section 10. TITLE: The appointive officer of this Association shall be an Executive Director, as provided in Article V of the Constitution. 2320 2321 2322 2323 2324 Section 20. APPOINTMENTS: While any active, life or retired member in good standing may be appointed to the office of Executive Director, the Board of Trustees may appoint a qualified individual who is not eligible for membership in this Association. 2325 2326 2327 2328 2329 2330 Section 30. TERM OF OFFICE AND SALARY: The Board of Trustees shall determine the salary, if any, and the tenure of the Executive Director, which shall not exceed three (3) years. The completion of the full term of any appointment shall be at the discretion of the Board of Trustees. 2331 2332 2333 2334 2335 2336 2337 2338 2339 2340 2341 2342 2343 2344 2345 2346 2347 2348 2349 Section 40. DUTIES: The Executive Director shall be the principal agent of the Board of Trustees and elective officers. As agent and under the direction of the Board of Trustees and elective officers, the Executive Director shall be the chief operating officer of this Association and all its branches. In this capacity, the Executive Director shall (a) preserve and protect the Constitution and Bylaws and the standing rules of this Association; (b) facilitate the activities of the officers and trustees of this Association in carrying out their respective administrative responsibilities under these Bylaws; (c) engage the staff of this Association and direct and coordinate their activities; (d) provide leadership in the formulation and recommendation of new policies to the Board of Trustees and elective officers; (e) oversee the management of Association policies that have been adopted by the Board of Trustees and/or the House of Delegates; (f) assist the Board of Bylaws 49 CHAPTER IX • APPOINTIVE OFFICER CHAPTER X • COUNCILS 2350 2351 2352 2353 2354 2355 2356 2357 2358 2359 2360 2361 2362 2363 2364 Trustees in supervising, monitoring and providing guidance to all Association councils, commissions and committees in regard to their administrative functions and specific assignments, and to systematize the preparation of their reports, and to encourage the exchange of information concerning mutual interests and issues between councils, committees and commissions; (g) maintain effective internal and external relationships through frequent and comprehensive communication with all officers and trustees of this Association, the leadership of related dental organizations, and representatives from other leading public and private organizations that interact with this Association; and (h) perform such other duties as are prescribed by these Bylaws. CHAPTER X • COUNCILS 2365 2366 Section 10. NAME: The councils of this Association shall be: 2367 2368 2369 2370 2371 2372 2373 2374 2375 2376 2377 2378 2379 Council on Access, Prevention and Interprofessional Relations Council on ADA Sessions Council on Communications Council on Dental Benefit Programs Council on Dental Education and Licensure Council on Dental Practice Council on Ethics, Bylaws and Judicial Affairs Council on Government Affairs Council on Members Insurance and Retirement Programs Council on Membership Council on Scientific Affairs 2380 2381 Section 20. MEMBERS, SELECTIONS, NOMINATIONS AND ELECTIONS: 2382 2383 2384 2385 2386 2387 2388 2389 2390 2391 2392 2393 2394 2395 2396 A. The composition of the councils of this Association shall be as follows: In addition, a council may request an additional member who shall be a nonpracticing dentist member appointed in accordance with Chapter I, Section 20Db of these Bylaws. Council on Access, Prevention and Interprofessional Relations shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. In addition, there shall be one (1) member who is a physician and one (1) member who is a health care facility administrator nominated by the Board of Trustees. 2397 2398 2399 Council on ADA Sessions shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four 50 Bylaws CHAPTER X • COUNCILS 2400 2401 2402 2403 2404 2405 2406 2407 (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. In addition, the General Chair of the Local Arrangements Committee for the current year and the General Chair-elect for the succeeding year shall serve as ex officio members with the right to vote and shall not be eligible to serve as Council Chair. 2408 2409 2410 2411 2412 2413 Council on Communications shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. 2414 2415 2416 2417 2418 2419 Council on Dental Benefit Programs shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. 2420 2421 2422 2423 2424 2425 2426 2427 2428 2429 2430 2431 2432 2433 2434 2435 2436 2437 2438 2439 2440 2441 2442 2443 2444 2445 2446 2447 2448 2449 2450 2451 2452 2453 Council on Dental Education and Licensure shall be composed of sixteen (16) members selected as follows: a. Nominations and Selection. (1) Eight (8) members shall be nominated by the Board of Trustees on a rotational system by trustee district from the active, life or retired members of this Association, no one of whom shall be a fulltime member of a faculty of a school of dentistry or a member of a state board of dental examiners or jurisdictional dental licensing agency. A person shall be considered to be a full-time member of a faculty if he or she works for the school of dentistry more than two (2) days or sixteen (16) hours per week. (2) Four (4) members who are active, life or retired members of this Association shall be selected by the American Association of Dental Examiners from the active membership of that body, no one of whom shall be a member of a faculty of a school of dentistry. (3) Four (4) members who are active, life or retired members of this Association shall be selected by the American Dental Education Association from its active membership. These members shall hold positions of professorial rank in dental schools accredited by the Commission on Dental Accreditation and shall not be members of any state board of dental examiners or jurisdictional dental licensing agency. b. Election. The eight (8) members of the Council on Dental Education and Licensure nominated by the Board of Trustees shall be elected by the House of Delegates from nominees selected in accordance Bylaws 51 CHAPTER X • COUNCILS 2454 2455 2456 2457 2458 2459 2460 2461 2462 with this section. c. Committees. The Council on Dental Education and Licensure shall establish a standing Committee on Dental Education and Educational Measurements and a standing Committee on Licensure, each consisting of eight (8) members selected by the Council. The Council may establish additional committees when they are deemed essential to carry out the duties of this Council. 2463 2464 2465 2466 2467 2468 Council on Dental Practice shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. 2469 2470 2471 2472 2473 2474 Council on Ethics, Bylaws and Judicial Affairs shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. 2475 2476 2477 2478 2479 2480 2481 2482 2483 2484 2485 2486 2487 2488 2489 2490 2491 Council on Government Affairs shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. In addition, the chair of the political action committee shall be an ex officio member of the Council without the power to vote. Consideration shall be given to a candidate’s experience in the military or other federal dental services. Members of the Council shall not be in the full-time employ of the federal government. Individuals called to active duty from the military reserves or national guard forces, providing such active duty has not been requested by the individual, shall not be considered to be in the full-time employ of the federal government. 2492 2493 2494 2495 2496 2497 2498 Council on Members Insurance and Retirement Programs shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. 2499 2500 2501 2502 2503 2504 Council on Membership shall be composed of one (1) member from each trustee district whose terms of office shall be staggered in such a manner that four (4) members will complete their terms each year except every fourth year when five (5) members shall complete their terms. 2505 2506 Council on Scientific Affairs shall be composed of sixteen (16) members who shall be selected from 52 Bylaws CHAPTER X • COUNCILS 2507 2508 2509 nominations open to all trustee districts, and the current recipient of the Gold Medal Award for Excellence in Dental Research. 2510 2511 2512 2513 2514 2515 2516 2517 2518 2519 2520 2521 2522 B. Nominations for all councils shall be made by the Board of Trustees except as otherwise provided in these Bylaws. The Board of Trustees shall adhere to the systems of nominations provided in Chapter X, Section 20A of these Bylaws*. The House of Delegates may make additional nominations pursuant to the systems for council nominations provided in Chapter X, Section 20A of these Bylaws. The elective and appointive officers and the trustees of this Association shall not serve as members of councils. Members of councils shall be elected by the House of Delegates in accordance with Chapter V, Section 150 except as otherwise provided in these Bylaws. 2523 2524 2525 2526 2527 2528 2529 2530 2531 2532 2533 2534 2535 2536 C. REMOVAL FOR CAUSE. The Board of Trustees may remove a council member for cause in accordance with procedures established by the Board of Trustees, which procedures shall provide for notice of the charges, including allegations of the conduct purported to constitute each violation, and a decision in writing which shall specify the findings of fact which substantiate any and all of the charges, and that prior to issuance of the decision of the Board of Trustees, no council member shall be excused from attending any meeting of a council unless there is an opportunity to be heard or compelling reasons exist which are specified in writing by the Board of Trustees. 2537 Section 30. ELIGIBILITY: 2538 2539 2540 2541 A. All members of councils must be active, life, retired or nonpracticing dentist members in good standing of this Association except as otherwise provided in these Bylaws. 2542 2543 B. No member of a council may serve concurrently as a member of another council or commission. * In order to establish the required pattern of four, four, four and five members respectively retiring from councils and commissions each year, members of councils and commissions from the new 5th and 17th districts who are in office at the time this footnote becomes effective shall finish their terms in accordance with their scheduled term completion dates. Councils and commissions that have incumbent members from the new 5th district shall add a new member from the 17th district to a full four-year term. Councils and commissions that have incumbent members from the new 17th district shall add a new member from the new 5th district to a full four-year term. Bylaws 53 CHAPTER X • COUNCILS 2544 2545 2546 2547 2548 2549 C. A member of the Council on Dental Education and Licensure who was selected by the American Association of Dental Examiners and who is no longer an active member of the American Association of Dental Examiners, may continue as a member of the Council for the balance of that member’s term. 2550 2551 2552 2553 2554 2555 2556 D. When a member of the Council on Dental Education and Licensure who was selected by the American Dental Education Association, shall cease to be a member of the faculty of a member school of that Association, such membership on either council shall terminate, and the President of the Association shall declare the position vacant. 2557 2558 2559 2560 2561 2562 E. To be eligible to serve on the Council on Scientific Affairs, the current recipient of the Gold Medal Award for Excellence in Dental Research shall be an active, life, retired or nonpracticing dentist* member in good standing of this Association if the current recipient qualifies for such membership. 2563 2564 2565 2566 2567 2568 2569 Section 40. CHAIRS: One member of each council shall be appointed annually by the Board of Trustees to serve as chair with exception of the Council on Dental Education and Licensure. The Chair of the Council on Dental Education and Licensure shall be appointed from nominations submitted by the Council. 2570 2571 Section 50. CONSULTANTS, ADVISERS AND STAFF: 2572 2573 2574 2575 2576 A. CONSULTANTS AND ADVISERS. Each council shall have the authority to nominate consultants and advisers in conformity with rules and regulations established by the Board of Trustees except as otherwise provided in these Bylaws. 2577 2578 2579 B. STAFF. The Executive Director shall employ the staff of councils, in the event they are employees, and shall select the titles for council staff positions. 2580 2581 2582 2583 2584 2585 2586 2587 2588 Section 60. TERM OF OFFICE: The term of office of members of councils shall be four (4) years except as otherwise provided in these Bylaws. The tenure of a member of a council shall be limited to one (1) term of four (4) years except as otherwise provided in these Bylaws. A member shall not be eligible for appointment to another council or commission for a period of two (2) years after completing a previous council appointment. The physician and the health * The eligibility requirement for nonpracticing dentist membership shall take effect upon completion of the 2006 Gold Medal Award for Excellence in Dental Research recipient’s term on the Council on Scientific Affairs. 54 Bylaws CHAPTER X • COUNCILS 2589 2590 2591 2592 2593 2594 2595 2596 2597 2598 care facility administrator, nominated by the Board of Trustees for membership on the Council on Access, Prevention and Interprofessional Relations, shall be elected for a one (1) year term; however, such member shall not be limited as to the number of consecutive one (1) year terms that he or she may serve. The current recipient of the Gold Medal Award for Excellence in Dental Research shall serve on the Council on Scientific Affairs until the award is bestowed on the next honoree. 2599 2600 2601 2602 2603 2604 2605 2606 2607 2608 2609 2610 2611 2612 2613 2614 2615 2616 2617 2618 2619 2620 2621 2622 2623 Section 70. VACANCY: In the event of a vacancy in the membership of any council, the President shall appoint a member of the Association possessing the same qualifications as established by these Bylaws for the previous member, to fill such vacancy until a successor is elected by the next House of Delegates for the remainder of the unexpired term. In the event such vacancy involves the chair of the council, the President shall have the power to appoint an ad interim chair. In the event it is the current recipient of the Gold Medal Award for Excellence in Dental Research who cannot serve on the Council on Scientific Affairs, the President, in consultation with the Board of Trustees, shall have the power to appoint a prominent research scientist who shall serve until the award is bestowed on the next honoree. If the term of the vacated council position has less than fifty percent (50%) of a full four-year term remaining at the time the successor member is appointed or elected, the successor member shall be eligible for election to a new, consecutive four-year term. If fifty percent (50%) or more of the vacated term remains to be served at the time of the appointment or election, the successor member shall not be eligible for another term. 2624 2625 2626 2627 2628 2629 2630 2631 2632 2633 2634 2635 Section 80. MEETINGS OF COUNCILS. Each council shall hold at least one regular meeting annually, provided that funds are available in the budget for that purpose and unless otherwise directed by the Board of Trustees. Meetings may be held in the Headquarters Building, the Washington Office or from multiple remote locations through the use of a conference telephone or other communications equipment by means of which all members can communicate with each other. Such meetings shall be conducted in accordance with rules and procedures established by the Board of Trustees. 2636 2637 2638 Section 90. QUORUM: Except as otherwise provided in these Bylaws, a majority of the members of any council shall constitute a quorum. 2639 2640 2641 2642 Section 100. PRIVILEGE OF THE FLOOR: Chairs and members of councils who are not members of the House of Delegates shall have the right to participate in the debate on their respective reports but shall not Bylaws 55 CHAPTER X • COUNCILS 2643 have the right to vote. 2644 Section 110. ANNUAL REPORT AND BUDGET: 2645 2646 2647 2648 A. ANNUAL REPORT. Each council shall submit, through the Executive Director, an annual report to the House of Delegates and a copy thereof to the Board of Trustees. 2649 2650 2651 2652 B. PROPOSED BUDGET. Each council shall submit to the Board of Trustees, through the Executive Director, a proposed itemized budget for the ensuing fiscal year. 2653 Section 120. DUTIES: 2654 2655 2656 2657 2658 2659 2660 2661 2662 2663 2664 2665 2666 2667 2668 2669 2670 2671 2672 2673 2674 2675 2676 2677 2678 2679 2680 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2691 2692 2693 2694 2695 A. COUNCIL ON ACCESS, PREVENTION AND INTERPROFESSIONAL RELATIONS. The duties of the Council shall be: a. To foster improvement in the health of the public in matters of access to care, prevention of disease and interprofessional relations by appropriate programs. b. To recommend policies and formulate programs relating to community oral health, including access to care, oral health planning, dental health personnel resources, preventive dentistry, fluoridation and nutrition issues. c. To evaluate for the Association trends in dental public health and access to care that enhance oral health on a community level, including public/private partnerships, tobacco use prevention, volunteerism, oral cancer prevention and community caries prevention. d. To assist constituent and component societies, public health agencies and others in the management and coordination of local resources or programs for access to care, preventive dentistry and other community health programs. e. To promote the Association’s position and maintain liaison with oral health agencies and special interest organizations regarding access to care, community oral health and dental health personnel issues. f. To serve as liaison for the Association with The Joint Commission and with corporate members of The Joint Commission and other national health care organizations. g. To recommend policy on issues pertaining to the relationship of dentistry to medicine, including interdisciplinary patient management, dentistphysician relations, the oral health needs of medically compromised patients and the role of physical evaluation and medical risk management in dental practice. h. To conduct activities to improve the health outcomes of patients requiring cooperative dentalmedical management. i. To conduct activities to increase patient access to 56 Bylaws CHAPTER X • COUNCILS 2696 2697 2698 2699 2700 2701 2702 2703 2704 2705 2706 2707 2708 2709 2710 2711 2712 2713 dental care, including assessing public and private dental access programs and advising other Association agencies charged with recommending policy and legislation on access to care. j. To conduct activities to increase access to the benefits of cooperative dental-medical management in hospitals, ambulatory care centers, long-term care facilities and other interdisciplinary health care settings. k. To foster dentistry’s role in the hospital, including active medical staff membership and clinical privileges. l. To advise other Association agencies charged with communications, scientific, legislative and legal activities related to community oral health including tobacco use prevention, dental health personnel resources, preventive dentistry, fluoridation and nutrition issues. 2714 2715 2716 2717 2718 2719 2720 2721 B. COUNCIL ON ADA SESSIONS. The duties of the Council shall be: a. To have responsibility for conducting the annual session of this Association, except the House of Delegates, subject to approval by the Board of Trustees as provided in these Bylaws. b. To plan and coordinate other Association sessions or regional meetings. 2722 2723 2724 2725 2726 2727 2728 2729 2730 2731 2732 2733 2734 2735 2736 2737 2738 2739 2740 2741 2742 2743 2744 2745 C. COUNCIL ON COMMUNICATIONS. The duties of the Council shall be: a. To identify, recommend, and maintain an external strategic communications plan for the Association to facilitate other work throughout and on behalf of the Association. b. To advise the Association on the external image and brand implications of Association plans, programs, services and activities. c. To provide counsel to the Association on the priority and allocation of externally focused communication resources, to advise on their implications, and to identify the areas where the greatest strategic communications impact can be achieved. d. To identify, recommend, articulate and maintain strategies for significant external communications campaigns across the Association. e. To serve as a strategic communications resource to other Association agencies on communications to the profession. f. To create, implement, monitor and update an ongoing communication support strategy for the constituent and component dental societies. 2746 2747 2748 2749 D. COUNCIL ON DENTAL BENEFIT PROGRAMS. The duties of the Council shall be: a. To formulate and recommend policies relating to the planning, administration and financing of dental Bylaws 57 CHAPTER X • COUNCILS 2750 2751 2752 2753 2754 2755 2756 2757 2758 2759 2760 2761 2762 2763 2764 2765 2766 2767 2768 2769 2770 2771 2772 benefit programs. b. To study, evaluate and disseminate information on the planning, administration and financing of dental benefit programs. c. To assist the constituent societies and other agencies in developing programs for the planning, administration and financing of dental benefit programs. d. To provide assistance, guidance and support to constituent and component societies in the development and management of professional review systems. e. To encourage the inclusion of dental benefits in health benefit plans and to promote dental benefit plans in accordance with Association policy. f. To conduct activities and formulate and recommend policies concerning the assessment and improvement of the quality of dental care relating to dental benefit plans. g. To formulate procedural and diagnostic codes in conjunction with national dental organizations and the dental benefits industry that dentists can use to report patient care on dental benefit claim forms. 2773 2774 2775 2776 2777 2778 2779 2780 2781 2782 2783 2784 2785 2786 2787 2788 2789 2790 2791 2792 2793 2794 2795 2796 2797 2798 2799 2800 2801 2802 E. COUNCIL ON DENTAL EDUCATION AND LICENSURE. The duties of the Council shall be: a. To act as the agency of the Association in matters related to the evaluation and accreditation of all dental educational, dental auxiliary educational and associated subjects. b. To study and make recommendations including the formulation and recommendation of policy on: (1) Dental education and dental auxiliary education. (2) The recognition of dental specialties. (3) The recognition of categories of dental auxiliaries. (4) The approval or disapproval of national certifying boards for special areas of dental practice and for dental auxiliaries. (5) The educational and administrative standards of the certifying boards for special areas of dental practice and for dental auxiliaries. (6) Associated subjects that affect all dental, dental auxiliary and related education. (7) Dental licensure and dental auxiliary credentialing. c. To act on behalf of this Association in maintaining effective liaison with certifying boards and related agencies for special areas of dental practice and for dental auxiliaries. d. To monitor and disseminate information on continuing dental education and to encourage the provision of and participation in continuing dental education. 2803 2804 F. COUNCIL ON DENTAL PRACTICE. The duties of the Council shall be: 58 Bylaws CHAPTER X • COUNCILS 2805 2806 2807 2808 2809 2810 2811 2812 2813 2814 2815 2816 2817 2818 2819 2820 2821 2822 2823 2824 2825 2826 2827 2828 2829 2830 2831 2832 2833 2834 2835 2836 2837 2838 2839 2840 a. To formulate and recommend policies relating to dental practice. b. To study, evaluate and disseminate information concerning various forms of business organization of a dental practice, economic factors related to dental practice, practice management techniques, auxiliary utilization and dental laboratory services to the end that dentists may continue to improve services to the public. c. To develop educational and other programs to assist dentists in improved practice management, including practice marketing materials and continuing education seminars, and to assist constituent and component societies and other dental organizations in the development of such programs so that dentists may continue to improve the delivery of their services to the public. d. To encourage and develop satisfactory relations with the various organizations representing the dental laboratory industry and craft. e. To formulate programs for establishing and maintaining the greatest efficiency, quality and service of the dental laboratory industry and craft in their relation to the dental profession. f. To encourage and develop satisfactory relations with the various organizations representing dental auxiliaries. g. To gather, formulate and disseminate information related to auxiliary utilization, management and employment practices. h. To serve in a consultative capacity to those educational and promotional activities directed to the public and the profession and to assess their impact on dental practice. i. To provide assistance, education and information on issues related to dentists’ well being. 2841 2842 2843 2844 2845 2846 2847 2848 2849 2850 2851 2852 2853 2854 2855 2856 2857 2858 2859 G. COUNCIL ON ETHICS, BYLAWS AND JUDICIAL AFFAIRS. The duties of the Council shall be: a. To consider proposals for amending the Principles of Ethics and Code of Professional Conduct. b. To provide advisory opinions regarding the interpretation of the Principles of Ethics and Code of Professional Conduct. c. To consider appeals from members of the Association, or from component societies subject to the requirements of Chapter XII, Section 20 of these Bylaws. d. To hold hearings and render decisions in disputes arising between constituent societies or between constituent and component societies. e. To discipline any of the direct members of this Association in accordance with the requirements and procedures of Chapter XII of these Bylaws, using Bylaws 59 CHAPTER X • COUNCILS 2860 2861 2862 2863 2864 2865 2866 2867 2868 2869 2870 2871 2872 2873 2874 2875 2876 2877 2878 2879 2880 2881 2882 2883 2884 2885 2886 2887 2888 2889 2890 2891 2892 2893 2894 2895 2896 2897 2898 hearing panels composed of not less than three (3) of its elected members selected by the Council chair. The Council may adopt procedures governing the discipline of direct members of this Association consistent with Chapter XII of these Bylaws, which may include the use of an investigating committee or individual to investigate any complaint made against such member and report findings to the hearing panel concerning whether charges should issue. f. To review the articles of the Constitution and Bylaws in order to keep them consistent with the Association’s program. g. To recommend editorial changes in the Bylaws to improve their consistency, clarity and style. h. Notwithstanding paragraph g of this subsection, the Council shall have the authority to make corrections in punctuation, grammar, spelling, name changes, gender references, and similar editorial corrections in the Bylaws which do not alter its context or meaning. Such corrections shall be made only by a unanimous vote of the Council members present and voting. i. To review the rules and bylaws of all commissions of the Association in order to keep such rules and bylaws consistent with the Constitution and Bylaws of this Association. j. To act as the Standing Committee on Constitution and Bylaws of the House of Delegates, with the composition of such committee to be determined in accordance with Chapter V, Section 140A of these Bylaws, and to conduct other business it deems necessary. k. To provide guidance and advice on ethical and professional issues to constituent and component societies. l. To formulate and disseminate materials related to ethical and professional conduct in the practice and promotion of dentistry. 2899 2900 2901 2902 2903 2904 2905 2906 2907 2908 2909 2910 2911 2912 2913 2914 H. COUNCIL ON GOVERNMENT AFFAIRS. The duties of the Council shall be: a. To encourage the improvement of the health of the public and to promote the art and science of dentistry in matters of legislation and regulations by appropriate activities. b. To formulate and recommend policies related to legislative and regulatory issues and to governmental agency programs. c. To formulate proposed legislation, approved by the Board of Trustees, that may be submitted to Congress and which will promote the art and science of dentistry in accordance with Association policies. d. To disseminate information which will assist the constituent and component societies involving legislation and regulation affecting the dental health 60 Bylaws CHAPTER X • COUNCILS 2915 2916 2917 2918 2919 2920 2921 2922 2923 2924 2925 2926 2927 2928 2929 2930 2931 2932 2933 2934 2935 2936 2937 2938 2939 2940 2941 of the public. e. To serve and assist the American Dental Association as a liaison with agencies of the federal government. f. To advise other Association agencies charged with developing, recommending and/or implementing legislative policies adopted by the House of Delegates. g. To serve as liaison for the American Dental Association with those agencies of the federal government which employ dental personnel in direct dental care delivery programs and the dentists in those services. h. To recommend programs and policies which will ensure that eligible beneficiaries of federal dental service programs have access to quality dental care. i. To recommend programs and policies which promote an efficient and effective dental care delivery system within the federal dental services. j. To assist in the development of dental workforce requirements and appropriate mobilization programs in times of emergency. k. To formulate and recommend policies which are designed to advance the professional status of federally employed dentists. l. To monitor dental training programs conducted by the federal dental services. 2942 2943 2944 2945 2946 2947 2948 2949 2950 2951 2952 2953 2954 2955 2956 2957 I. COUNCIL ON MEMBERS INSURANCE AND RETIREMENT PROGRAMS. The duties of the Council shall be: a. To evaluate on a continuing basis all Association sponsored insurance programs. b. To examine and evaluate other insurance programs that might be of benefit to the membership. c. To advise and recommend courses of action on insurance programs. d. To assist constituent societies in matters related to insurance programs. e. To serve as Trustees for the American Dental Association Members Retirement Program.∗ f. To advise and recommend courses of action on retirement programs.** 2958 2959 2960 2961 2962 2963 2964 2965 J. COUNCIL ON MEMBERSHIP. Except as otherwise provided in these Bylaws, the duties of the Council shall be: a. To formulate and recommend policies related to membership recruitment and retention and other related issues. b. To identify and monitor trends and issues that affect membership recruitment and retention, ∗ This duty shall expire April 30, 2008. ** This duty shall commence April 30, 2008. Bylaws 61 CHAPTER X • COUNCILS 2966 2967 2968 2969 2970 2971 2972 2973 2974 2975 2976 2977 particularly among under-represented segments, and to encourage membership involvement throughout organized dentistry. c. To support, monitor and encourage membership activities of constituent and component dental societies and to enhance cooperation and communication on tripartite recruitment and retention efforts. d. To recommend, monitor and support the development of membership benefits and services that respond to identified needs of members. e. To act as an advocate for membership benefits. 2978 2979 2980 2981 2982 2983 2984 2985 2986 2987 2988 2989 2990 2991 2992 2993 2994 2995 2996 2997 2998 2999 3000 3001 3002 3003 3004 3005 3006 3007 3008 3009 3010 3011 3012 3013 3014 3015 3016 3017 3018 K. COUNCIL ON SCIENTIFIC AFFAIRS. The duties of the Council shall be: a. To develop and promote an annual research agenda with appropriate means for funding. b. To identify emergent issues and areas of research that require response from the research community. c. To report results on the latest scientific developments to practicing dentists. d. To evaluate and issue statements to the profession regarding the efficacy of concepts, procedures and techniques for use in the treatment of patients. e. To guide, assist and act as liaison to the American Dental Association Foundation and serve as its peer review body. f. To represent the Association on scientific and research matters and maintain liaison with related regulatory, research and professional organizations. g. To encourage the development and improvement of materials, instruments and equipment for use in dental practice, and to coordinate development of national and international standardization programs. h. To determine the safety and effectiveness of, and disseminate information on, materials, instruments and equipment that are offered to the public or the profession and further critically evaluate statements of efficacy and advertising claims. i. To study, evaluate and disseminate information with regard to the proper use of dental therapeutic agents, their adjuncts and dental cosmetic agents that are offered to the public or the profession. j. To award the American Dental Association Seal to dental products that meet the Association’s requirements for acceptance. k. To promote efforts to develop dental research workforce and to involve students in dental research. l. To study, evaluate and disseminate information on those aspects of the dental practice environment related to the health of the public, dentists and dental auxiliaries. m. To serve as the primary resource for scientific inquiries from the public and the profession. 62 Bylaws CHAPTER XI • SPECIAL COMMITTEES CHAPTER XII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT AND JUDICIAL PROCEDURE CHAPTER XI • SPECIAL COMMITTEES 3019 3020 3021 3022 3023 3024 3025 3026 3027 3028 3029 3030 3031 3032 3033 3034 3035 3036 3037 3038 Section 10. APPOINTMENT AND TERM. Special committees of this Association may be created at any session of the House of Delegates or, when the House is not in session, by the Board of Trustees, for the purpose of performing duties not otherwise assigned by these Bylaws. Duties otherwise assigned by these Bylaws solely to one (1) council, commission or other agency should be assigned to that council, commission or other agency with the necessary funding to accomplish the task. If duties are assigned to a special committee that are assigned under these Bylaws to more than one (1) council, commission or other agency, members of the relevant councils, commissions or other agencies shall be appointed to serve on the special committee. Such special committees may serve until adjournment sine die of the next annual session of the House of Delegates. The authority for appointing the members of a special committee and their number shall be set forth in the resolution creating such committee. 3039 3040 3041 3042 3043 Section 20. PRIVILEGE OF THE FLOOR: Chairs and members of special committees who are not members of the House of Delegates shall have the right to participate in the debate on their respective reports but shall not have the right to vote. CHAPTER XII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT AND JUDICIAL PROCEDURE 3044 3045 3046 3047 3048 3049 3050 3051 3052 Section 10. PROFESSIONAL CONDUCT OF MEMBERS: The professional conduct of a member of this Association shall be governed by the Principles of Ethics and Code of Professional Conduct of this Association and by the codes of ethics of the constituent and component societies within whose jurisdiction the member practices, or conducts or participates in other professional dental activities. 3053 Section 20. DISCIPLINE OF MEMBERS: 3054 3055 3056 3057 3058 3059 3060 3061 3062 3063 A. CONDUCT SUBJECT TO DISCIPLINE. A member may be disciplined for (1) having been found guilty of a felony, (2) having been found guilty of violating the dental practice act of a state or other jurisdiction of the United States, (3) having been discharged or dismissed from practicing dentistry with one of the federal dental services under dishonorable circumstances, or (4) violating the Bylaws, the Principles of Ethics and Code of Professional Conduct, or the bylaws or code of ethics Bylaws 63 CHAPTER XII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT AND JUDICIAL PROCEDURE 3064 3065 3066 3067 3068 3069 3070 3071 of the constituent or component society of which the accused is a member. For a member of a constituent society, disciplinary proceedings may be instituted by either the member’s component or constituent society. Disciplinary proceedings against a direct member of this Association may be instituted by the Council on Ethics, Bylaws and Judicial Affairs of this Association. 3072 3073 3074 3075 3076 3077 3078 3079 3080 3081 3082 3083 3084 3085 3086 3087 3088 3089 3090 3091 3092 3093 3094 3095 3096 3097 3098 3099 3100 3101 3102 3103 3104 3105 3106 3107 3108 3109 3110 3111 3112 3113 3114 3115 B. DISCIPLINARY PENALTIES. A member may be placed under a sentence of censure or suspension or may be expelled from membership for any of the offenses enumerated in Section 20A of this Chapter. Censure is a disciplinary sentence expressing in writing severe criticism or disapproval of a particular type of conduct or act. Suspension, subject to Chapter I, Section 30 of these Bylaws, means all membership privileges except continued entitlement to coverages under insurance programs are lost during the suspension period. Suspension shall be unconditional and for a specified period at the termination of which full membership privileges are automatically restored. A subsequent violation shall require a new disciplinary procedure before additional discipline may be imposed. Expulsion is an absolute discipline and may not be imposed conditionally except as otherwise provided herein. Probation, to be imposed for a specified period and without loss of privileges, may be administratively and conditionally imposed when circumstances warrant in lieu of a suspended disciplinary penalty. Probation shall be conditioned on good behavior. Additional reasonable conditions may be set forth in the decision for the continuation of probation. In the event that the conditions for probation are found by the society which preferred charges to have been violated, after a hearing on the probation violation charges in accordance with Chapter XII, Section 20C, the original disciplinary penalty shall be automatically reinstated; except that when circumstances warrant the original disciplinary penalty may be reduced to a lesser penalty. There shall be no right of appeal from a finding that the conditions of probation have been violated. After all appeals are exhausted or after the time for filing an appeal has expired, a sentence of censure, suspension or expulsion meted out to any member, including those instances when the disciplined member has been placed on probation, shall be promulgated by such member’s component and constituent societies, if such exist, and this Association. 3116 3117 C. DISCIPLINARY PROCEEDINGS. Before a disciplinary penalty is invoked against a member, the 64 Bylaws CHAPTER XII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT AND JUDICIAL PROCEDURE 3118 3119 3120 3121 3122 3123 3124 3125 3126 3127 3128 3129 3130 3131 3132 3133 3134 3135 3136 3137 3138 3139 3140 3141 3142 3143 3144 3145 3146 3147 3148 3149 3150 3151 3152 3153 3154 3155 3156 3157 3158 3159 3160 following procedures shall be followed by the agency preferring charges: a. HEARING. The accused member shall be entitled to a hearing at which the accused shall be given the opportunity to present a defense to all charges brought against the accused. The agency preferring charges shall permit the accused member to be represented by legal counsel. b. NOTICE. The accused member shall be notified in writing of charges brought against the accused and of the time and place of the hearing, such notice to be sent by certified—return receipt requested letter addressed to the accused’s last known address and mailed not less than twenty-one (21) days prior to the date set for the hearing. An accused member, upon request, shall be granted one postponement for a period not to exceed thirty (30) days. c. CHARGES. The written charges shall include an officially certified copy of the alleged conviction or determination of guilt, or a specification of the bylaw or ethical provisions alleged to have been violated, as the case may be, and a description of the conduct alleged to constitute each violation. d. DECISION. Every decision which shall result in censure, suspension or expulsion or in probation shall be reduced to writing and shall specify the charges made against the member, the facts which substantiate any or all of the charges, the verdict rendered, the penalty imposed or when appropriate the suspended penalty imposed and the conditions for probation, and a notice shall be mailed to the accused member informing the accused of the right to appeal. Within ten (10) days of the date on which the decision is rendered a copy thereof shall be sent by certified—return receipt requested mail to the last known address of each of the following parties: the accused member; the secretary of the component society of which the accused is a member, if applicable; the secretary of the constituent society of which the accused is a member, if applicable; the Chair of the Council on Ethics, Bylaws and Judicial Affairs of this Association and the Executive Director of this Association. 3161 3162 3163 3164 3165 3166 3167 3168 3169 3170 3171 3172 D. APPEALS. The accused member under sentence of censure, suspension or expulsion shall have the right to appeal from a decision of the accused’s component society to the accused’s constituent society by filing an appeal in affidavit form with the secretary of the constituent society. Such an accused member, or the component society concerned, shall have the right to appeal from a decision of the constituent society to the Council on Ethics, Bylaws and Judicial Affairs of this Association by filing an appeal in affidavit form with the Chair of the Council on Ethics, Bylaws and Judicial Affairs. Where the Bylaws 65 CHAPTER XII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT AND JUDICIAL PROCEDURE 3173 3174 3175 3176 3177 3178 3179 3180 3181 3182 3183 3184 3185 3186 3187 3188 3189 3190 3191 3192 3193 3194 3195 3196 3197 3198 3199 3200 3201 3202 3203 3204 3205 3206 3207 3208 3209 3210 3211 3212 3213 3214 3215 3216 3217 3218 3219 3220 3221 3222 3223 3224 3225 3226 3227 3228 accused is a direct member of this Association, the accused member shall have the right of appeal from a disciplinary decision of a hearing panel of the Council on Ethics, Bylaws and Judicial Affairs to the Council by filing an appeal in affidavit form with the Chair of the Council on Ethics, Bylaws and Judicial Affairs. Members of the hearing panel shall not have the right to vote on the Council’s decision on such an appeal. An appeal from any decision shall not be valid unless notice of appeal is filed within thirty (30) days and the supporting brief, if one is to be presented, is filed within sixty (60) days after such decision has been rendered. A reply brief, if one is to be presented, shall be filed within ninety (90) days after such decision is rendered. A rejoinder brief, if one is to be presented, shall be filed within one hundred five (105) days after such decision is rendered. After all briefs have been filed, a minimum of forty-five (45) days shall elapse before the hearing date. Omission of briefs will not alter the briefing schedule or hearing date unless otherwise agreed to by the parties and the chair of the appropriate appellate agency. No decision shall become final while an appeal there from is pending or until the thirty (30) day period for filing notice of appeal has elapsed. In the event of a sentence of expulsion and no notice of appeal is received within the thirty (30) day period, the constituent society shall notify all parties of the failure of the accused member to file an appeal. The sentence of expulsion shall take effect on the date the parties are notified. The component and constituent societies shall each determine what portion of their current dues and their special assessments, if any, shall be returned to the expelled member. Dues and special assessments paid to this Association shall not be refundable in the event of expulsion. The following procedure shall be used in processing appeals: a. HEARINGS ON APPEAL. The accused member or the society (or societies) concerned shall be entitled to a hearing on an appeal, provided that such appeal is taken in accordance with, and satisfies the requirements of, Section 20D of this Chapter. The appellate agency hearing the appeal shall permit the accused member to be represented by legal counsel. A party need not appear for the appeal to be heard by an appellate agency. b. NOTICE. The appellate agency receiving an appeal shall notify the society (or societies) concerned, or where applicable the hearing panel of the Council on Ethics, Bylaws and Judicial Affairs, and the accused member of the time and place of the hearing, such notice to be sent by certified— return receipt requested letter to the last known address of the parties to the appeal and mailed not less than thirty (30) days prior to the date set for the 66 Bylaws CHAPTER XII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT AND JUDICIAL PROCEDURE 3229 3230 3231 3232 3233 3234 3235 3236 3237 3238 3239 3240 3241 3242 3243 3244 3245 3246 3247 3248 3249 3250 3251 3252 3253 3254 3255 3256 3257 3258 3259 3260 3261 3262 3263 3264 3265 3266 3267 3268 3269 3270 3271 3272 3273 3274 3275 3276 3277 3278 3279 3280 3281 3282 3283 3284 hearing. Granting of continuances shall be at the option of the agency hearing the appeal. c. PREHEARING MATTERS. Prehearing requests shall be granted at the discretion of the appellate agency. In appeals to this Association’s Council on Ethics, Bylaws and Judicial Affairs, the Council chair has the authority to rule on motions from the parties for continuances and other prehearing procedural matters with advice from legal counsel of this Association. The Council chair may consult with the Council before rendering prehearing decisions. d. BRIEFS. Every party to an appeal shall be entitled to submit a brief in support of the party’s position. The briefs of the parties shall be submitted to the secretary of the constituent society or the Chair of the Council on Ethics, Bylaws and Judicial Affairs of this Association, as the case may be, and to the opposing party(ies) in accordance with the prescribed briefing schedule. The party initiating the appeal may choose to rely on the record and/or on an oral presentation and not file a brief. e. RECORD OF DISCIPLINARY PROCEEDINGS. Upon notice of an appeal the agency which preferred charges shall furnish to the appellate agency which has received the appeal and to the accused member a transcript of, or an officially certified copy of the minutes of the hearing accorded the accused member. The transcript or minutes shall be accompanied by certified copies of any affidavits or other documents submitted as evidence to support the charges against the accused member or submitted by the accused member as part of the accused’s defense. Where the agency preferring the charges does not provide for transcription of the hearing, the accused member, at the accused’s own expense, shall be entitled to arrange for the services of a court reporter to transcribe the hearing. f. APPEALS JURISDICTION. The agency to which a decision has been appealed shall be required to review the decision appealed from to determine whether the evidence before the society or agency which preferred charges against the accused member supports that decision or warrants the penalty imposed. The appellate agency shall not be required to consider additional evidence unless there is a clear showing that either party to the appeal will be unreasonably harmed by failure to consider the additional evidence. The parties to an appeal are the accused member and the society or agency which preferred charges. In appeals to the Council on Ethics, Bylaws and Judicial Affairs of this Association, the society which heard the first appeal may, at its option, participate in the appeal. g. DECISION ON APPEALS. Every decision on Bylaws 67 CHAPTER XII • PRINCIPLES OF ETHICS AND CODE OF PROFESSIONAL CONDUCT AND JUDICIAL PROCEDURE CHAPTER XIII • AMERICAN DENTAL ASSOCIATION FOUNDATION 3285 3286 3287 3288 3289 3290 3291 3292 3293 3294 3295 3296 3297 3298 3299 3300 3301 3302 3303 3304 3305 3306 3307 3308 3309 3310 3311 3312 3313 3314 3315 3316 3317 appeal shall be reduced to writing and shall state clearly the conclusion of the appellate agency and the reasons for reaching that conclusion. The appellate agency shall have the discretion (1) to uphold the decision of the agency which preferred charges against the accused member; (2) to reverse the decision of the agency which preferred charges and thereby exonerate the accused member; (3) to deny an appeal which fails to satisfy the requirements of Section 20D of this Chapter; (4) to refer the case back to the agency which preferred charges for new proceedings, if the rights of the accused member under all applicable bylaws were not accorded the accused; (5) to remand the case back to the agency which preferred charges for further proceedings when the appellate record is insufficient in the opinion of the appellate agency to enable it to render a decision; or (6) to uphold the decision of the agency which preferred charges against the accused member and reduce the penalty imposed. Within thirty (30) days of the date on which a decision on appeal is rendered, a copy thereof shall be sent by certified—return receipt requested mail to the last known address of each of the following parties: the accused member, the secretary of the component society of which the accused is a member, if applicable, the secretary of the constituent society of which the accused is a member, if applicable, the Chair of the Council on Ethics, Bylaws and Judicial Affairs of this Association and the Executive Director of this Association. 3318 3319 3320 3321 E. NON-COMPLIANCE. In the event of a failure of technical conformance to the procedural requirements of Chapter XII, the agency hearing the appeal shall determine the effect of non-conformance. CHAPTER XIII • AMERICAN DENTAL ASSOCIATION FOUNDATION 3322 3323 3324 3325 3326 3327 Section 10. AGENCIES AND PERSONNEL: The Research Institute and the Paffenbarger Research Center at the National Institute of Standards and Technology will be agencies of the American Dental Association Foundation and the personnel of these agencies shall be employees of the Foundation. 3328 3329 3330 3331 3332 Section 20. FINANCIAL SUPPORT: The Association shall annually furnish sufficient financial support, as an addition to generated non-Association funding, to assure the continued viability of the Foundation’s research activities. 68 Bylaws CHAPTER XIII • AMERICAN DENTAL ASSOCIATION FOUNDATION CHAPTER XIV • COMMISSIONS 3333 Section 30. DUTIES: 3334 3335 3336 3337 3338 3339 3340 3341 A. The Foundation, through its agencies, the Research Institute and the Paffenbarger Research Center at the National Institute of Standards and Technology shall: a. Conduct basic and applied research for the utilization in and development of oral health. b. Conduct training programs in research disciplines that relate to the basic and applied problems of oral health. 3342 3343 3344 3345 3346 3347 3348 B. In addition, the Foundation shall submit, either through or in cooperation with the Council on Scientific Affairs, an annual report to the House of Delegates, interim reports on request to the Board of Trustees, and an annual budget to the Board of Trustees for such financial support allocations as the Board may deem necessary. 3349 3350 3351 3352 3353 3354 3355 C. In addition, the Foundation’s Administrative/ Charitable group shall submit, through the ADA Board of Trustees acting as the Member, an annual report to the House of Delegates, interim reports on request to the Member, and an annual budget to the Board of Trustees for such financial support allocations as the Board may deem necessary. 3356 3357 3358 3359 D. The Foundation also may perform such other charitable and research functions as permitted under its articles of incorporation and bylaws and the laws of the State of Illinois. CHAPTER XIV • COMMISSIONS 3360 3361 3362 3363 Section 10. NAME: The commissions of this Association shall be: Commission on Dental Accreditation Joint Commission on National Dental Examinations 3364 3365 3366 3367 3368 3369 3370 3371 3372 3373 3374 3375 3376 3377 3378 3379 3380 3381 Section 20. MEMBERS, SELECTIONS, NOMINATIONS AND ELECTIONS: A. COMMISSION ON DENTAL ACCREDITATION. The number of members and the method of selection of the members of the Commission on Dental Accreditation shall be governed by the Rules of the Commission on Dental Accreditation and these Bylaws. Twelve (12) of the members of the Commission on Dental Accreditation shall be selected as follows: (1) Four (4) members shall be selected from nominations open to all trustee districts from the active, life or retired members of this Association, no one of whom shall be a faculty member working for a school of dentistry more than one day per week or a member of a state board of dental examiners or jurisdictional dental licensing agency. These members shall be nominated by the Board of Bylaws 69 CHAPTER XIV • COMMISSIONS 3382 3383 3384 3385 3386 3387 3388 3389 3390 3391 3392 3393 3394 3395 3396 3397 Trustees and elected by the House of Delegates. (2) Four (4) members who are active, life or retired members of this Association shall be selected by the American Association of Dental Examiners from the active membership of that body, no one of whom shall be a member of a faculty of a school of dentistry. (3) Four (4) members who are active, life or retired members of this Association shall be selected by the American Dental Education Association from its active membership. These members shall hold positions of professorial rank in dental schools accredited by the Commission on Dental Accreditation and shall not be members of any state board of dental examiners or jurisdictional dental licensing agency. 3398 3399 3400 3401 3402 3403 3404 3405 3406 3407 3408 3409 3410 3411 3412 3413 3414 3415 3416 3417 3418 3419 3420 3421 3422 3423 3424 3425 3426 3427 3428 3429 3430 3431 3432 3433 3434 B. JOINT COMMISSION ON NATIONAL DENTAL EXAMINATIONS. The Joint Commission on National Dental Examinations shall be composed of fifteen (15) members selected as follows: a. Three (3) members shall be nominated by the Board of Trustees from the active, life or retired members of this Association and additional nominations may be made by the House of Delegates but no one of such nominees shall be a member of a faculty of a school of dentistry or a member of a state board of dental examiners or jurisdictional dental licensing agency. The House of Delegates shall elect the three (3) members from those nominated by the Board of Trustees and the House of Delegates. b. Six (6) members who are active, life or retired members of this Association shall be selected by the American Association of Dental Examiners from the active membership of that body, no one of whom shall be a member of a faculty of a dental school. c. Three (3) members who are active, life or retired members of this Association shall be selected by the American Dental Education Association from its active membership. These members shall hold positions of professorial rank in the dental schools accredited by this Association and shall not be members of any state board of dental examiners or jurisdictional dental licensing agency. d. One (1) member who is a dental hygienist shall be selected by the American Dental Hygienists’ Association. e. One (1) member who is a public representative shall be selected by the Joint Commission on National Dental Examinations. f. One (1) member who is a dental student shall be selected annually by the American Student Dental Association. 3435 3436 Section 30. REMOVAL FOR CAUSE: The Board of Trustees may remove a commission member for 70 Bylaws CHAPTER XIV • COMMISSIONS 3449 cause in accordance with procedures established by the Board of Trustees, which procedures shall provide for notice of the charges, including allegations of the conduct purported to constitute each violation, and a decision in writing which shall specify the findings of fact which substantiate any and all of the charges, and that prior to issuance of the decision of the Board of Trustees, no commission member shall be excused from attending any meeting of a commission unless there is an opportunity to be heard or compelling reasons exist which are specified in writing by the Board of Trustees. Section 40. ELIGIBILITY: 3450 3451 3452 3453 A. All members of commissions who are dentists must be active, life or retired members in good standing of this Association except as otherwise provided in these Bylaws. 3454 3455 3456 3457 3458 3459 B. A member of the Joint Commission on National Dental Examinations, who was selected by the American Association of Dental Examiners and who is no longer an active member of that Association, may continue as a member of the Commission for the balance of that member’s term. 3460 3461 3462 3463 3464 3465 3466 3467 C. When a member of the Joint Commission on National Dental Examinations, who was selected by the American Dental Education Association, shall cease to be a member of the faculty of a member school of that Association, such membership on the Commission shall terminate, and the President of the American Dental Association shall declare the position vacant. 3468 3469 3470 D. No member of a commission may serve concurrently as a member of a council or another commission. 3471 3472 3473 E. CHAIRS. The Commissions of this Association shall elect their own chairs who shall be active, life or retired members of this Association. 3474 3475 Section 50. CONSULTANTS, ADVISERS AND STAFF: 3476 3477 3478 3479 3480 3481 3482 3483 3484 3485 3486 3487 3488 A. CONSULTANTS AND ADVISERS. Each commission shall have the authority to nominate consultants and advisers in conformity with rules and regulations established by the Board of Trustees except as otherwise provided in these Bylaws. The Joint Commission on National Dental Examinations also shall select consultants to serve on the Commission’s test construction committees. The Commission on Dental Accreditation shall have the power to appoint consultants to assist in developing requirements and guidelines for the conducting of accreditation evaluations, including site visitations, of predoctoral, advanced dental educational, and dental 3437 3438 3439 3440 3441 3442 3443 3444 3445 3446 3447 3448 Bylaws 71 CHAPTER XIV • COMMISSIONS 3489 auxiliary educational programs. 3490 3491 3492 3493 B. STAFF. The Executive Director shall employ the staff of Commissions, in the event they are employees, and shall select the titles for commission staff positions. 3494 3495 3496 3497 3498 3499 3500 3501 3502 3503 3504 3505 3506 3507 3508 3509 3510 3511 3512 3513 3514 3515 3516 3517 Section 60. TERM OF OFFICE: The term of office of members of the commissions shall be four (4) years except that (a) the term of office of members of the Commission on Dental Accreditation selected pursuant to the Rules of the Commission on Dental Accreditation shall be governed by those Rules and (b) the term of office of the dental student selected by the American Student Dental Association for membership on the Joint Commission on National Dental Examinations shall be one (1) year. The tenure of a member of a commission shall be limited to one (1) term of four (4) years except that (a) the consecutive tenure of members of the Commission on Dental Accreditation selected pursuant to the Rules of the Commission on Dental Accreditation shall be governed by those Rules and (b) tenure in office of the dental student selected by the American Student Dental Association for membership on the Joint Commission on National Dental Examinations shall be one (1) term. As of 1990, a member shall not be eligible for appointment to another commission or council for a period of two (2) years after completing a previous commission appointment. 3518 3519 3520 Section 70. VACANCY: In the event of a vacancy in the office of a commissioner, the following procedure shall be followed: 3521 3522 3523 3524 3525 3526 3527 3528 3529 A. In the event the member of a commission, whose office is vacant, is or was a member of and was appointed or elected by this Association, the President of this Association shall appoint a member of this Association possessing the same qualifications as established by these Bylaws for the previous member, to fill such vacancy until a successor is elected by the next House of Delegates of this Association for the remainder of the unexpired term. 3530 3531 3532 3533 3534 3535 B. In the event the member of a commission whose office is vacant was selected by an organization other than this Association, such other organization shall appoint a successor possessing the same qualifications as those possessed by the previous member of the commission. 3536 3537 3538 3539 C. In the event such vacancy involves the chair of the commission, the President of this Association shall have the power to appoint an ad interim chair, except as otherwise provided in these Bylaws. 3540 D. If the term of the vacated commission position has 72 Bylaws CHAPTER XIV • COMMISSIONS 3541 3542 3543 3544 3545 3546 3547 3548 less than fifty percent (50%) of a full four-year term remaining at the time the successor member is appointed or elected, the successor member shall be eligible for election to a new, consecutive four-year term. If fifty percent (50%) or more of the vacated term remains to be served at the time of the appointment or election, the successor member shall not be eligible for another term. 3549 3550 3551 3552 3553 3554 3555 3556 3557 3558 3559 3560 Section 80. MEETINGS OF COMMISSIONS. Each commission shall hold at least one regular meeting annually, provided that funds are available in the budget for that purpose and unless otherwise directed by the Board of Trustees. Meetings may be held at the Headquarters Building, the Washington Office or from multiple remote locations through the use of a conference telephone or other communications equipment by means of which all members can communicate with each other. Such meetings shall be conducted in accordance with rules and procedures established by the Board of Trustees. 3561 3562 3573 3574 3575 3576 Section 90. QUORUM: A majority of the members of any commission shall constitute a quorum. Section 100. PRIVILEGE OF THE FLOOR: Chairs and members of the commissions who are not members of the House of Delegates shall have the right to participate in the debate on their respective reports but shall not have the right to vote. Section 110. ANNUAL REPORT AND BUDGET: A. ANNUAL REPORT. Each commission shall submit, through the Executive Director, an annual report to the House of Delegates and a copy thereof to the Board of Trustees. B. PROPOSED BUDGET. Each commission shall submit to the Board of Trustees, through the Executive Director, a proposed itemized budget for the ensuing fiscal year. 3577 3578 3579 3580 3581 3582 3583 3584 3585 3586 3587 3588 3589 3590 3591 3592 Section 120. POWER TO ADOPT RULES: Any commission of this Association shall have the power to adopt rules for such commission and amendments thereto, provided such rules and amendments thereto do not conflict with or limit the Constitution and Bylaws of this Association. Rules and amendments thereto, adopted by any commission of this Association, shall not be effective until submitted in writing to and approved by majority vote of the House of Delegates of this Association, except the Joint Commission on National Dental Examinations shall have such bylaws and amendments thereto as the House of Delegates of this Association may adopt by majority vote for the conduct of the purposes and management of the Joint Commission on National Dental Examinations. 3563 3564 3565 3566 3567 3568 3569 3570 3571 3572 Bylaws 73 CHAPTER XIV • COMMISSIONS 3594 3595 3596 3597 3598 3599 3600 3601 3602 3603 3604 3605 3606 3607 3608 3609 3610 3611 3612 3613 3614 3615 3616 Section 130. DUTIES: A. COMMISSION ON DENTAL ACCREDITATION. The duties of the Commission on Dental Accreditation shall be: a. To formulate and adopt requirements and guidelines for the accreditation of dental educational and dental auxiliary educational programs. b. To accredit dental educational and dental auxiliary educational programs. c. To provide a means for appeal from an adverse decision of the accrediting body of the Commission to a separate and distinct body of the Commission whose membership shall be totally different from that of the accrediting body of the Commission. d. To submit an annual report to the House of Delegates of this Association and interim reports, on request, and the Commission’s annual budget to the Board of Trustees of the Association. e. To submit the Commission’s articles of incorporation and rules and amendments thereto to this Association’s House of Delegates for approval by majority vote either through or in cooperation with the Council on Dental Education and Licensure. 3617 3618 3619 3620 3621 3622 3623 3624 3625 3626 3627 3628 3629 3630 3631 3632 3633 3634 3635 3636 3637 3638 3639 3640 3641 3642 3643 3644 3645 B. JOINT COMMISSION ON NATIONAL DENTAL EXAMINATIONS. The duties of the Joint Commission on National Dental Examinations shall be: a. To provide and conduct written examinations, exclusive of clinical demonstrations for the purpose of assisting state boards of dental examiners in determining qualifications of dentists who seek license to practice in any state or other jurisdiction of the United States. Dental licensure is subject to the laws of the state or other jurisdiction of the United States and the conduct of all clinical examinations for licensure is reserved to the individual board of dental examiners. b. To provide and conduct written examinations, exclusive of clinical demonstrations for the purpose of assisting state boards of dental examiners in determining qualifications of dental hygienists who seek license to practice in any state or other jurisdiction of the United States. Dental hygiene licensure is subject to the laws of the state or other jurisdiction of the United States and the conduct of all clinical examinations for licensure is reserved to the individual board of dental examiners. c. To make rules and regulations for the conduct of examinations and the certification of successful candidates. d. To serve as a resource of the dental profession in the development of written examinations. 3593 74 Bylaws CHAPTER XV • SCIENTIFIC SESSION CHAPTER XVI • PUBLICATIONS CHAPTER XV • SCIENTIFIC SESSION 3646 3647 3648 3649 3650 Section 10. OBJECT: The scientific session of this Association is established to foster the presentation and discussion of subjects pertaining to the improvement of the health of the public and the science and art of dentistry. 3651 3652 3653 3654 3655 Section 20. TIME AND PLACE: The scientific session of the Association shall be held annually at a time and place selected by the Board of Trustees. Such selection shall be made at least one (1) year in advance. 3656 3657 3658 3659 3660 Section 30. MANAGEMENT AND GENERAL ARRANGEMENTS: The Board of Trustees shall provide for the management of, and make all arrangements for, each scientific session unless otherwise provided in these Bylaws. 3661 3662 3663 3664 3665 3666 Section 40. TRADE AND LABORATORY EXHIBITS: Products of the dental trade and dental laboratories and other products may be exhibited at each scientific session under the direction of the Board of Trustees and in accordance with rules and regulations established by that body. 3667 3668 3669 3670 3671 Section 50. ADMISSION: Admission to meetings of the scientific sessions shall be limited to members of this Association who are in good standing and to others admitted in accordance with rules and regulations established by the Board of Trustees. CHAPTER XVI • PUBLICATIONS 3672 Section 10. OFFICIAL JOURNAL: 3673 3674 3675 3676 A. TITLE. This Association shall publish or cause to be published an official journal under the title of The Journal of the American Dental Association, hereinafter referred to as The Journal. 3677 3678 3679 3680 B. OBJECT. The object of The Journal shall be to report, chronicle and evaluate activities of scientific and professional interest to members of the dental profession. 3681 3682 3683 3684 C. FREQUENCY OF ISSUE AND SUBSCRIPTION RATE. The frequency of issue and the subscription rate of The Journal shall be determined by the Board of Trustees. 3685 3686 3687 3688 Section 20. OTHER JOURNALS: The Association may publish or cause to be published other journals in the field of dentistry subject to the direction and regulations of the Board of Trustees. 3689 3690 Section 30. OFFICIAL TRANSACTIONS: The official transactions of the House of Delegates and the Bylaws 75 CHAPTER XVI • PUBLICATIONS CHAPTER XVII • FINANCES 3691 3692 3693 Board of Trustees and the reports of officers, councils and committees shall be published under the direction of the Executive Director. 3694 3695 3696 Section 40. AMERICAN DENTAL DIRECTORY: This Association shall cause to be published an American Dental Directory. CHAPTER XVII • FINANCES 3697 3698 3699 Section 10. FISCAL YEAR: The fiscal year of the Association shall begin January 1 of each calendar year and end December 31 of the same year. 3700 3701 3702 3703 3704 3705 3706 3707 Section 20. GENERAL FUND: The General Fund shall consist of all monies received other than those specifically allocated to other funds by these Bylaws. This fund shall be used for defraying all expenses incurred by this Association not otherwise provided for in these Bylaws. The General Fund may be divided into Operating and Reserve Divisions at the direction of the Board of Trustees. 3708 3709 3710 3711 3712 3713 3714 3715 3716 3717 3718 3719 Section 30. OTHER FUNDS: The Association may establish other funds, at the direction of the Board of Trustees, for activities and programs requiring separate accounting records to meet governmental and administrative requirements. Such funds shall consist of monies and other assets received or allocated in accordance with the purpose for which they are established. Such funds shall be used for defraying all expenses incurred in their operation, shall serve only as separate accounting entities and continue to be held in the name of the American Dental Association as divisions of the General Fund. 3720 3721 3722 3723 3724 3725 3726 3727 3728 3729 3730 3731 3732 3733 3734 3735 3736 3737 3738 3739 3740 Section 40. SPECIAL ASSESSMENTS: In addition to the payment of dues required in Chapter I, Section 20 of these Bylaws, a special assessment may be levied by the House of Delegates upon active, active life, retired and associate members of this Association as provided in Chapter I, Section 20 of these Bylaws, for the purpose of funding a specific project of limited duration. Such an assessment may be levied at any annual or special session of the House of Delegates by a two-thirds (2/3) affirmative vote of the delegates present and voting, provided notice of the proposed assessment has been presented in writing at least ninety (90) days prior to the first day of the session of the House of Delegates at which it is to be considered. Notice of such a resolution shall be sent by a certifiable method of delivery to each constituent society not less than ninety (90) days before such session to permit prompt, adequate notice by each constituent society to its delegates and alternate delegates to the House of Delegates of this Association, and shall be announced to the general 76 Bylaws CHAPTER XVII • FINANCES CHAPTER XVIII • ALLIANCE OF THE AMERICAN DENTAL ASSOCIATION CHAPTER XIX • INDEMNIFICATION 3741 3742 3743 3744 3745 3746 3747 3748 3749 3750 3751 3752 3753 3754 3755 3756 3757 3758 3759 3760 3761 3762 3763 3764 membership in an official publication of this Association at least sixty (60) days in advance of the session. The specific project to be funded by the proposed assessment, the time frame of the project, and the amount and duration of the proposed assessment shall be clearly presented in giving notice to the members of this Association. Revenue from a special assessment and any earnings thereon shall be deposited in a separate fund as provided in Chapter XVII, Section 30 of these Bylaws. The House of Delegates may amend the main motion to levy a special assessment only if the amendment is germane and adopted by a two-thirds (2/3) affirmative vote of the delegates present and voting. The House of Delegates may consider only one (1) specific project to be funded by a proposed assessment at a time. However, if properly adopted by the House of Delegates, two (2) or more special assessments may be in force at the same time. Any resolution to levy a special assessment that does not meet the notice requirements set forth in the previous paragraph also may be adopted by a unanimous vote of the House of Delegates, provided the resolution has been presented in writing at a previous meeting of the same session. CHAPTER XVIII • ALLIANCE OF THE AMERICAN DENTAL ASSOCIATION 3765 3766 3767 3768 3769 3770 3771 Section 10. RECOGNITION: The Association recognizes the Alliance of the American Dental Association as an organization of the spouses of active, life, retired or student members in good standing of this Association, and of spouses of such deceased members who were in good standing at the time of death. 3772 3773 3774 3775 Section 20. CONSTITUTION AND BYLAWS: No provision in the constitution and bylaws of the Alliance shall be in conflict with the Constitution and Bylaws of this Association. 3776 3777 3778 3779 3780 3781 3782 3783 3784 3785 3786 3787 3788 CHAPTER XIX • INDEMNIFICATION Each trustee, officer, council member, committee member, employee and other agent of the Association shall be held harmless and indemnified by the Association against all claims and liabilities and all costs and expenses, including attorney’s fees, reasonably incurred or imposed upon such person in connection with or resulting from any action, suit or proceeding, or the settlement or compromise thereof, to which such person may be made a party by reason of any action taken or omitted to be taken by such person as a trustee, officer, council member, committee member, employee or agent of the Association, in good faith. This right of Bylaws 77 CHAPTER XIX • INDEMNIFICATION CHAPTER XX • CONSTRUCTION CHAPTER XXI • AMENDMENTS 3789 3790 3791 3792 3793 3794 3795 3796 indemnification shall inure to such person whether or not such person is a trustee, officer, council member, committee member, employee or agent at the time such liabilities, costs or expenses are imposed or incurred and, in the event of such person’s death, shall extend to such person’s legal representatives. To the extent available, the Association shall insure against any potential liability hereunder. CHAPTER XX • CONSTRUCTION 3797 3798 3799 3800 Where the context or construction requires, all titles and personal pronouns used in the Bylaws, whether used in the masculine, feminine or neutral gender, shall include all genders. CHAPTER XXI • AMENDMENTS 3801 3802 3803 3804 3805 3806 3807 Section 10. PROCEDURE: These Bylaws may be amended at any session of the House of Delegates by a two-thirds (2/3) affirmative vote of the delegates present and voting, provided the proposed amendments shall have been presented in writing at a previous session or a previous meeting of the same session. 3808 3809 3810 3811 3812 3813 3814 3815 3816 3817 3818 3819 3820 3821 3822 3823 3824 3825 3826 3827 3828 3829 3830 Section 20. AMENDMENT AFFECTING THE PROCEDURE FOR CHANGING THE DUES OF ACTIVE MEMBERS: An amendment of these Bylaws affecting the procedure for changing the dues of active members may be adopted only if the proposed amendment has been presented in writing at least ninety (90) days prior to the first day of the session of the House of Delegates at which it is to be considered. Notice of such a resolution shall be sent by a certifiable method of delivery to each constituent society not less than ninety (90) days before such session to permit prompt, adequate notice by each constituent society to its delegates and alternate delegates to the House of Delegates of this Association, and shall be announced to the general membership in an official publication of the Association at least sixty (60) days in advance of the annual session. Amendments affecting the procedure for changing the dues of active members may also be adopted by a unanimous vote provided that the proposed amendment has been presented in writing at a previous meeting of the same session. 78 Bylaws Articles of Incorporation • • • • • • • • • • • • • • • • • • • • • • • • • 3831 3832 1. NAME. The name of this corporation is AMERICAN DENTAL ASSOCIATION. 3833 3834 2. DURATION. The duration of the corporation is perpetual. 3835 3836 3837 3838 3. PURPOSE AND OBJECT. The purpose and object of this corporation are to encourage the improvement of the health of the public and to promote the art and science of dentistry. 3839 3840 4. OFFICE. The principal office of the corporation shall be in the City of Chicago, Cook County, Illinois. 3841 3842 3843 3844 3845 3846 3847 5. BYLAWS. The bylaws of the corporation shall be divided into two categories designated, respectively, “Constitution” and “Bylaws” and each category shall be amendable from time to time in the manner and by the method therein set forth, but in case of any conflict between the Constitution and the Bylaws the provisions of the Constitution shall control. 3848 3849 3850 3851 3852 3853 3854 6. MEMBERSHIP. The qualifications, the method of election, designation or selection, the privileges and obligations, and the voting rights, if any, of the various classes of members which are established by the Constitution and Bylaws of the corporation from time to time shall be set forth in and governed by such Constitution and Bylaws. 3855 3856 3857 3858 3859 3860 3861 3862 3863 3864 3865 7. EXERCISE OF CORPORATE POWERS. Except as otherwise provided by law, the affairs of this corporation shall be governed and the corporate powers of the corporation shall be exercised by a Board of Directors (to be known as the Board of Trustees), House of Delegates, officers, councils, committees, members, agents and employees as set forth in the Constitution and Bylaws and the titles, duties, powers, and methods of electing, designating or selecting all of the foregoing shall be as provided therein. 3866 3867 3868 3869 3870 3871 8. VOTING RIGHTS WITH RESPECT TO ARTICLES OF INCORPORATION. Only those members of the corporation shall have voting rights in respect to amendments to the Articles of Incorporation who shall have a right to vote on amendments to the Constitution of the corporation. 79 Articles of Incorporation American Dental Association A current electronic version of this document is available at www.ada.org American Dental Association Admits: Fluoride of Concern to Kidney Patients http://www.loveforlife.com.au/node/5036 by Sally Stride Opednews 29th June 2008 On June 19, 2008 the American Dental Association updated its website reporting that fluoride is a concern to all kidney patients, not just those on dialysis. Along with false assurances of safety, fluoride chemicals are added to some public and bottled water in the unscientific belief it reduces cavities. Fluoride-induced bone damage could occur in kidney patients who consume even "optimally" fluoridated water because malfunctioning kidneys do not properly sift fluoride from the blood and out of the body. Fluoride can build up in bones making them brittle and fracture For this reason, the National Kidney Foundation (NKF) withdrew its fluoridation endorsement in October 2007, which they made public in a fluoride paper dated April 15, 2008 with advice that “individuals with CKD [Chronic Kidney Disease] should be notified of the potential risk of fluoride exposure.” After the 2006 National Research Council's (NRC) fluoride toxicology report was brought to their attention, the NKF withdrew its fluoridation endorsement. The NRC fluoride report was created by a 12-member panel of scientists to review current fluoride toxicology data at the request of the Environmental Protection Agency (EPA) to determine whether the maximum contaminant level goal (4 mg/L) of fluoride in public water supplies is safe. The NRC says that level must be lowered. But neither the NRC nor the EPA has defined a safe level. At least three NRC panel members conclude that water fluoride levels should be close to zero, not only to protect kidney patients, but also thyroid patients, infants and high water drinkers This would effectively shut down fluoridation in the U.S. But organized dentistry isn't going to let go of its pet project and diminish its political viability by admitting fluoridation is a failed experiment. So they downplay anything negative about fluoride and in this case they want you to know that fluoride is only a secondary concern. And, of course, this writer wants you to know that secondary doesn't mean no concern. However, even the ADA seems to be covering their legal assets with this statement in their Fluoridation Facts booklet, “decreased fluoride removal may occur among persons with severely impaired kidney function who may not be on kidney dialysis.” Dr. Julie Gerberding, Director, Centers for Disease Control (CDC) claims that the CDC is "America's health protection leader." The CDC calls fluoridation one of the Ten Great Public Health Achievements of the last century. But, the CDC has not provided the fluoride/kidney toxiclogy information on their website. The CDC often follows the lead of the ADA concerning fluoride and fluoridation. So we'll be watching. The CDC’s website still erroneously claims, “The findings of the NRC report are consistent with CDC’s assessment that water is safe and healthy at the levels used for water fluoridation (0.7–1.2 mg/L)” The NRC reports “Early water fluoridation studies did not carefully assess changes in renal [kidney] function...Several investigators have shown that patients with impaired renal function, or on hemodialysis, tend to accumulate fluoride much more quickly than normal." New York State Department of Health employee and dentist, Dr. J. Kumar received the ADA’s fluoridation award. With money and support from the CDC Kumar is promoting fluoridation in New York State by conducting fluoridation spokesperson training, among other activies. Kumar is ignoring his own 1990 health department report published in Oral Biology and Medicine which concluded “The available data suggest that some individuals may experience hypersensitivity to fluoride-containing agents. Further studies on hypersensitivity are required" and "Studies on the effects of fluoride in individuals with renal insufficiency are needed." That advice wasn’t heeded. Those studies were never conducted. But Kumar and the NYS Department of Health is using our tax money to push even more fluoride into us. According to the Fluoride Action Network,: “The bone changes http://www.fluoridealert.org/health/kidney/index.html#osteo commonly found among patients with advanced kidney disease closely resemble http://www.fluoridealert.org/health/kidney/index.html#osteo the bone changes found among individuals with the osteomalacic-type http://www.fluoridealert.org/health/bone/fluorosis/osteomalacia.html of skeletal fluorosis http://www.fluoridealert.org/health/bone/fluorosis/ This raises the possibility that some individuals with kidney disease are suffering from undiagnosed skeletal fluorosis.” http://www.fluoridealert.org/health/bone/fluorosis http://www.fluoridealert.org/health/bone/fluorosis/mayo-clinic.html American Dental Association concedes: Excessive fluoride a risk to children http://www.enviroblog.org/2006/11/american_d ental_association_co.htm After years of downplaying the risks of excessive fluoride intake, the American Dental Association (ADA) has just released new guidelines that dramatically reduce the recommended fluoride exposure for infants and children. Though not ready to condemn fluoride entirely for its role in enamel fluorosis, the ADA has issued an “interim” advisory on fluoride intake until more research can be done. This is a promising step for the ADA, which has resolutely promoted the fluoridation of water in the past. While it's commendable that the Association is alerting parents to the risks of fluorosis, a primarily cosmetic condition, it would be even better to issue a similar moratorium on account of the recent research tying fluoridated water to bone cancer in boys. Until further notice, ADA recommends the following measures to reduce the risk of fluorosis: Infants - Feed infants breast milk whenever possible. - For infants who get most of their nutrition from formula, choose ready-to-feed formula over formula mixed with fluoridated water. - If liquid or powdered concentrate infant formula is the primary source of nutrition, mix with water that is fluoride free, including water that is labeled purified, demineralized, deionized, distilled or reverse osmosis filtered water. Children - Stay away from fluoride toothpaste before two years. - No fluoride mouth rinse or supplements unless prescribed by a dentist. - Check with your water supplier to make sure the fluoride level in your drinking water does not exceed the recommended 1.2 parts per million. American Dental Association http://en.wikipedia.org/wiki/American_Dental_Association The American Dental Association (ADA) is an American professional association established in 1859 and has more than 152,000 members. Based in Chicago, the ADA is the world's largest and oldest national dental association and promotes good oral health to the public while representing the dental profession. The ADA publishes a monthly journal of dental related articles named the Journal of the American Dental Association. The ADA was founded August 1859, at Niagara Falls, New York, by twenty-six dentists who represented various dental societies in the United States. Today, the ADA has more than 152,000 members, 55 constituent (state-territorial) and 545 component (local) dental societies. It is the largest and oldest national dental association in the world. The Association has more than 400 employees at its headquarters in Chicago and its office in Washington, D.C. The Paffenbarger Research Center (PRC), located on the campus of the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland, is an agency of the American Dental Association Foundation (ADAF) and a Department of the Division of Science. PRC scientists conduct basic and applied studies in clinical research, dental chemistry, polymer chemistry and cariology. The ADA established rigorous guidelines for testing and advertising of dental products and the first ADA Seal of Acceptance was awarded in 1931. Today, about 350 manufacturers participate in the voluntary program and more than 1300 products have received the Seal of Acceptance. The Board of Trustees, the administrative body of the Association, is composed of the President, the President-elect, two Vice Presidents and 17 trustees from each of the 17 trustee districts in the United States. The Treasurer and Executive Director serve as ex officio members. The House of Delegates, the legislative body of the Association, is composed of 460 delegates representing 53 constituent societies, five federal dental services and the American Student Dental Association. The House meets once a year during the Association's annual session. The Association's 11 councils serve as policy recommending agencies. Each council is assigned to study issues relating to its special area of interest and to make recommendations on those matters to the Board of Trustees and the House of Delegates. The Association's official publication is The Journal of the American Dental Association. Other publications include the ADA News and the ADA Guide to Dental Therapeutics. The Commission on Dental Accreditation, which operates under the auspices of the ADA, is recognized by the U.S. Department of Education as the national accrediting body for dental, advanced dental and allied dental education programs in the United States. The ADA formally recognizes 9 specialty areas of dental practice: dental public health, endodontics, oral and maxillofacial pathology, oral and maxillofacial surgery, orthodontics and dentofacial orthopedics, pediatric dentistry, periodontics, prosthodontics, and oral and maxillofacial radiology. The ADA library has an extensive collection of dental literature with approximately 33,000 books and 17,500 bound journal volumes. The ADA library also subscribes to more than 600 journal titles. The ADA Foundation is the charitable arm of the Association. The Foundation provides grants for dental research, education, scholarships, access to care and charitable assistance programs such as relief grants to dentists and their dependents who are unable to support themselves due to injury, a medical condition or advanced age; and grants to those who are victims of disasters. The ADA is a vociferous promoter of water fluoridation.[1] The ADA has purchased internet websites with names that mimic those of prominent websites that do not favor fluoridation. The ADA redirects visitors from the websites flouridation.com fluoridealert.com and fluoridealert.net to their own pro-fluoridation pages. The domain names of these websites are intentional misspellings of advocacy websites fluoridation.com and fluoridealert.org that do not favor fluoridation.[2][3] In November of 2006, the ADA began recommending to parents that infants from 0 through 12 months of age have their formula prepared with water that is fluoride-free or contains low levels of fluoride to reduce the risk of fluorosis.[4] • • • • • • • • 1840: First dental college, the Baltimore College of Dental Surgery; American Society of Dental Surgeons is established. 1845: American Society of Dental Surgeons ask members to sign a mandatory pledge promising not to use amalgam fillings. 1856: American Society of Dental Surgeons, because of its stance against dental amalgam, is disbanded in 1856 due to loss of membership. 1859: Twenty-six dentists meet in Niagara Falls, New York to form a professional society. 1860: First ADA constitution and bylaws are adopted. 1897: ADA merges with the Southern Dental Association to form the National Dental Association (NDA). 1908: NDA publishes the first patient dental education pamphlet. 1913: NDA adopts a new constitution and bylaws, establishing the House of Delegates and Board of Trustees. • • • • • • • • • • • • • • • • • 1913: The Journal of the National Dental Association is first published under the title, Bulletin of the National Dental Association 1922: NDA is renamed the American Dental Association (ADA). 1928: ADA affiliates with the NBS; National Board of Dental Examiners is established. 1930: Council of Dental Therapeutics established to oversee the evaluation of dental products. The Council establishes the ADA's Seal Program. 1931: First ADA Seal of Approval awarded; ADA headquarters located on north side of Chicago. 1936: ADA Council on Dental Education is formed. 1948: The National Institute of Dental Research (NIDR) is established (since renamed the NIDCR (National Institute of Dental and Craniofacial Research)). 1950: ADA works with Congress to proclaim February 6 as National Children's Dental Health Day; ADA endorses fluoridation. 1964: ADA produces the first color television Public Service Announcement by a non-profit health agency; ADA establishes the ADA Health Foundation, a501 (c)(3) non-profit organization for the purpose of engaging in dental health research and educational programs. 1970: ADA News is first published. 1978: Council on Dental Practice established. 1979: The Commission on Dental Accreditation established. 1987: ADA Commission on the Young Professional is formed (later becomes the Committee on the New Dentist). 1991: First woman ADA president, Dr. Geraldine Morrow. 1995: ADA Web site, ADA ONLINE, created (later becomes ADA.org) 2002: First minority ADA president, Dr. Eugene Sekiguchi. 2003: First “Give Kids a Smile” day held as part of National Children’s Dental Health Month. ROBERT J. H. MICK, PLAINTIFF-APPELLANT, v. AMERICAN DENTAL ASSOCIATION, A CORPORATION, LON W. MORREY AND HERBERT B. BAIN, DEFENDANTS-RESPONDENTS [NO NUMBER IN ORIGINAL] Superior Court of New Jersey, Appellate Division 49 N.J. Super. 262; 139 A.2d 570; 1958 N.J. Super. LEXIS 548 February 3, 1958, Argued March 13, 1958, Decided COUNSEL: [***1] Mr. Harry Green argued the cause for plaintiff-appellant (Mr. Mulford E. Emmel, attorney). Mr. Frank M. Lario argued the cause for defendants-respondents (Mr. Anthony M. Lario, attorney). JUDGES: Goldmann, Freund and Conford. The opinion of the court was delivered by Freund, J.A.D. OPINIONBY: FREUND OPINION: [*268] [**573] This is an action for libel brought by plaintiff, Robert J. H. Mick, a dentist, against the American Dental Association and its officers, based on a letter written by an official of the Association in response to a communication from Charles W. Yeates, another dentist, and upon a series of articles published by the Association on the subject of fluoridation. Plaintiff appeals from a judgment of dismissal, with prejudice, entered by the trial judge at the close of plaintiff's case. The judge held that the letter was not libelous as a matter of law but merely an opinion sent to a person [*269] who had a right to be informed, and that it was a non-malicious privileged communication. With respect to the articles, the court concluded that they dealt with subject matter of general public concern, without any direct or indirect reference to plaintiff. [***2] Robert J. H. Mick has engaged in the general practice of dentistry in Camden County since 1935, except for an interval of about 2 1/2 years, from September 1953 to February 1956, when he was in the military service of the United States with the rank of lieutenantcolonel, and stationed for the most part in Germany. He was associated in the military service with Major Charles W. Yeates. Both are members in good standing of the defendant, American Dental Association, a non-pecuniary professional association. The fluoridation of potable waters as an effective means of building an immunity in teeth to make them less susceptible to decay has for many years engaged the serious study and investigation of dentists, physicians, their professional organizations, and of public health authorities. Since about 1939 the United States Public Health Service has been making epidemiological surveys. In about 1951, the American Dental Association officially sponsored fluoridation. In this it has the support of the American Medical Association, National Research Council, American Public Health Association, and the public health services of the Federal Government and of various states. The position [***3] taken by the defendants was preceded by extensive discussions in its official publication, The Journal of the American Dental Association, as well as the distribution of pamphlets and brochures on various phases of the problem. Opponents of fluoridation were articulate and vehement and, in some areas, well organized. They, too, disseminated their views widely through all kinds of publications and public forums. [**574] Plaintiff was among the proponents of fluoridation for about four years, from 1944 to 1948, but then as a result of his independent research, studies and experimental work, he concluded that the artificial use of fluorides was harmful. Plaintiff thereupon embarked on a campaign in violent [*270] opposition to fluoridation. He talked at public forums in various states. He wrote letters to many newspapers, printed and mimeographed pamphlets containing his views and circulated them among newspapers and magazines throughout the United States. One of his letters was published in the Congressional Record. While in the military service in Germany, he wrote a letter to the mayor of the City of Kassel, Germany which had begun to use fluoridation, offering [***4] to go to that city to speak against and present his arguments on the harmful effects of fluoridation. On December 3, 1954 the plaintiff requested his army associate, Dr. Charles W. Yeates, to write the following letter to the defendant: "3 December 1954 American Dental Association Bureau of Public Information 222 East Superior Street Chicago 11, Ill. Gentlemen: From time to time the name of Dr. Robert J. H. Mick has come to my attention as being one of those apparently violently against fluoridation. I have read charges that he has made against our American Dental Association and certain members thereof, the American Medical Association, the United States Public Health Service and certain members thereof. I understand that he has made such accusations over the radio and television also. I do not believe he is aiding much in the cause of fluoridation. Is he a member in good standing in the American Dental Association? Do you know anything about him that could be used to discredit him? What is your opinion or answer to the accusations? If he is wrong -- what can be done to prevent his further connection with the American Dental Association and his [***5] accusations of fluoridation and the members of the American Dental Association and sponsoring same? Could charges be brought against him? Awaiting your answer as I need any suggestions that you may have, Sincerely, Charles W. Yeates Major DC 5th General Hospital APO 154, N.Y., N.Y." [*271] Plaintiff acknowledged that the foregoing letter was sent by Dr. Yeates at his request evidenced by the following notation in his handwriting on the copy of the letter: "27, January 1955 -- Above was sent at my request and with my knowledge. (Signed) Robert J. H. Mick." Dr. Mick testified that he had read that the Bureau of Public Information of the American Dental Association had invited inquiries with respect to the opposition to fluoridation and he requested Dr. Yeates to write the letter because he "was always being kidded [by all his associates] about being opposed to fluoridation * * *" "I had been so active in opposing fluoridation in the Army and before I went into the Service, I wondered if they had anything on me. It was curiosity." The following reply letter is plaintiff's primary basis for this suit. "December 21, 1954. Major Charles [***6] W. Yeates, DC 5th General Hospital APO 154 New York, New York. Dear Major Yeates: This is in reply to your registered letter of December 3 addressed to the American Dental Association in which [**575] you make inquiry regarding Dr. Robert J. H. Mick. Our records show that Dr. Mick is a member in good standing in the American Dental Association. As you know Dr. Mick is now on duty with the Armed Forces and I should like to suggest that if you wish an evaluation of Dr. Mick's personal or professional standing that you might make inquiry of the military authorities in charge. The American Dental Association, of course, is in total disagreement with Dr. Mick's charges relating to fluoridation. The Association believes Dr. Mick's views to be based on complete misinformation and to be totally irresponsible. Very truly yours, Herbert B. Bain Director Bureau of Public Information." [*272] The complaint alleges that the last paragraph of defendant's reply letter, and particularly the last sentence, is libelous -- "meaning that plaintiff is incompetent to evaluate scientific data relating to his profession and that plaintiff is irresponsible in his [***7] professional conduct and not a fit person to practice dentistry." The complaint also alleges that three publications circulated by the defendant, although they do not identify or name the plaintiff, are nevertheless libelous of plaintiff because he is a well-known opponent of fluoridation. In the August 1953 issue of its Journal, defendant published an article entitled "The Irresponsible Opposition to Fluoridation," written by Dr. J. Roy Doty, and containing the following language: "Because of the lies and half truths being disseminated by a relatively small but vocal group which is apparently dedicated to the perpetuation of misinformation," and further describing the leading opponents of fluoridation as "food faddists, purveyors of so called health foods, publicity seekers and writers of sensation articles, together with very few members of the health profession." Early in 1953 the Association published and distributed a pamphlet entitled How to Obtain Fluoridation For Your Community, in which it described the types and groups of opponents and their untrustworthy sources of information. In January 1955 it distributed a brochure entitled Comments on the Opponents [***8] of Fluoridation, wherein are listed biographical data concerning leading opponents of fluoridation and characterizing them as "quacks," "faith healers," "faddists," or "cultists." The plaintiff is not listed among those named in any of the articles, directly or indirectly, yet he claims that he was included. Plaintiff makes scant reference to this point in his brief. He merely says: "As to [the] question of applicability of the other publications to plaintiff, it was for [the] jury." Defendant urges that plaintiff should be deemed to have abandoned this portion of his complaint. We infer lack of confidence [*273] by plaintiff on this point, rather than abandonment, and shall deal with it. Defendants urge the affirmance of the judgment for several reasons: that the letter was not libelous; that it was qualifiedly privileged because it was written in response to a request for an opinion made by plaintiff or by his agent and because the words contained therein constituted fair comment and criticism; and that the publications did not refer, expressly or by implication, to plaintiff. Preliminarily, we must consider the proper law applicable to the issues presented for [***9] our determination. This question of conflict of laws is not free from difficulty. The Restatement, Conflict of Laws, § 377, p. 457, n. 5 (1934), formulates the rule that "* * * where harm is done to the reputation of a person, the place of wrong is where the defamatory statement is communicated." This view is criticized in 2 Harper and James, Law of Torts (1956), § 30.7, pp. 1700-1704. The Restatement [**576] rule is based upon the general tort principle that the lex loci delicti, the place where the wrong was committed, controls the rights and liabilities of the parties, cf. Clement v. Atlantic Casualty Ins. Co., 13 N.J. 439, 442 (1953), and therefore since the place of publication is generally the place where the tort of defamation is complete, Gnapinsky v. Goldyn, 23 N.J. 243, 252 (1957), that law should govern. See also Goodrich, Conflict of Laws (3d ed. 1949), § 93, p. 264, n. 13. This rule has not been universally accepted and, as suggested by Professors Harper and James there is strong argument for applying the law of the plaintiff's domicile. Mattox v. News Syndicate Co., Inc., 176 F. 2d 897, [***10] 12 A.L.R. 2d 988 (2 Cir. 1949), certiorari denied 338 U.S. 858, 70 S. Ct. 100, 94 L. Ed. 525 (1949). The rationale of this theory is that plaintiff is best known at his residence or domicile and his reputation is most likely to suffer there. But even this rule has its limitations where the plaintiff is a person of national prominence. However, in the instant case we need not determine the choice of law question. Since the law of Germany -- [*274] or, for that matter, the law of Illinois where the letter was dictated, in an appropriate case -- was not pleaded or proved, we would be justified in assuming it is the same as the law of the forum. Leary v. Gledhill, 8 N.J. 260, 268-270 (1951); Somerville Container Sales, Inc. v. General Metal Corp., 39 N.J. Super. 348, 358-359 (App. Div. 1956), modified on rehearing, 39 N.J. Super. 562; Uniform Judicial Notice of Foreign Law Act, § 5, 9A U.L.A., p. 329 (1957). It is generally accepted that words which impute to a dentist a general lack of professional knowledge, information or complete misinformation on a subject pertaining to or necessary for the proper practice of [***11] his profession, or incompetency or irresponsibility, constitute, in the absence of privilege, actionable libel. Such an attack against a practitioner exposes him to ridicule or contempt and subjects him to loss of confidence, one of the most precious assets for the successful practice of any profession. The natural tendency of such a charge is to cause injury to reputation, and the resultant damage is presumed. It is for the court in the first instance to determine whether the words are reasonably capable of a particular interpretation. If they are unambiguous and open only to a single interpretation -- whether a defamatory or non-defamatory meaning - the court makes that determination as a matter of law. If the language is ambiguous and is reasonably open to two meanings, one innocent and the other defamatory, then it is for the jury to determine as a question of fact which meaning was understood by those to whom the publication was made. In the evaluation of the issue, the writing must be considered as a whole; words and phrases are not to be taken out of context. These wellsettled principles have recently been restated and the authorities collated in Leers v. Green [***12] , 24 N.J. 239, 253, 255 (1957); Herrmann v. Newark Morning Ledger Co., 48 N.J. Super. 420, 430 (App. Div. 1958); Mosler v. Whelan, 48 N.J. Super. 491 (App. Div. 1958). [*275] Disregarding for the moment the circumstances under which the letter was written and confining our consideration to the question of whether the portion of the letter reading: "The Association believes Dr. Mick's views to be based on complete misinformation and to be totally irresponsible" in context, 1 Harper and James, op. cit., supra, § 5.6, p. 365, was non-defamatory as a matter of law, or whether a jury issue was presented, we hold to the latter view. While we incline to the defendants' factual contention that there was "no attack on the ability or competence of the plaintiff" but rather an assault upon his views and opinions on the subject of fluoridation, nevertheless we conclude that the language was not so unambiguous that a court could [**577] hold as a matter of law that it was capable only of the non-defamatory interpretation. A jury could find that readers of the publication would entertain lessened esteem for a dentist whose views on fluoridation were [***13] "irresponsible" and that his professional reputation would be lowered in their eyes. Therefore, in a non-privileged situation, it would be for a jury to determine whether the recipients of the communication understood the words in an innocent or a defamatory sense. On the issue of publication of the defendants' reply letter, it is admitted that Dr. Yeates, the addressee, was plaintiff's agent, and that the information supplied by the defendants was in effect solicited. When the publication of defamatory matter has been invited, instigated or procured by the one defamed, or by someone acting on his behalf, he generally cannot be heard to complain of the resulting injury, Taylor v. McDaniels, 139 Okl. 262, 281 P. 967, 66 A.L.R. 1246 (Sup. Ct. 1929); McDaniel v. Crescent Motors, Inc., 249 Ala. 330, 31 So. 2d 343, 172 A.L.R. 204 (Sup. Ct. 1947); Taylor v. Jones Bros. Bakery, 234 N.C. 660, 68 S.E. 2d 313 (Sup. Ct. 1951); Mims v. Metropolitan Life Ins. Co., 200 F. 2d 800 (5 Cir. 1952); Prosser, Torts (2d ed. 1955), § 95, p. 613; 1 Harper and James, op. cit., supra, § 5.17, pp. 398-402; [***14] 53 C.J.S. Libel and Slander § 80, p. 129, [*276] particularly, when it is elicited for the purposes of predicating an action thereon. Richardson v. Gunby, 88 Kan. 47, 127 P. 533, 42 L.R.A., N.S., 520 (Sup. Ct. 1912); Smith v. Dunlop Tire & Rubber Co., 186 S.C. 456, 196 S.E. 174 (Sup. Ct. 1938); 53 C.J.S. Libel and Slander § 95, p. 151; 33 Am. Jur., Libel & Slander, § 94, p. 106. However, the action would not be barred if the plaintiff, or someone at his request, made or caused the inquiry to be made in good faith so as to ascertain whether defamatory charges had been made against him or perhaps to seek clarification of an ambiguous remark. Richardson v. Gunby, supra; Smith v. Dunlop Tire & Rubber Co., supra; Prosser, op. cit., supra, § 95, p. 613; 33 Am. Jur., Libel & Slander, §§ 93, 94, pp. 105, 106, Annotation, 172 A.L.R. 208 (1948). While we are satisfied that, resolving doubts from the evidence in favor of the plaintiff, Gnapinsky v. Goldyn, supra (23 N.J. at page 252), the issue as to whether plaintiff caused the Yeates letter to be sent in order to elicit a basis for the [***15] present action is for the jury, we nevertheless conclude that the action is barred on the theory of invitation or consent. It is offensive to an elementary sense of justice that after securing defendant's candid expression of its opinion of plaintiff's views on fluoridation through his use of Dr. Yeates' letter as a provocative decoy, he should be permitted to sue for the injury he thus invited. We hold that the action of the trial court was justified on this basis, apart from the other defenses discussed hereinafter. Upon the oral argument, a request was made of counsel to submit supplemental briefs on the question of publication. In addition to the issue of publication to Dr. Yeates, counsel for plaintiff advanced a theory that the publication element of the case was satisfied by publication to a stenographer to whom the letter was dictated and who then transcribed the stenographic symbols. Plaintiff says that these facts were established by defendants' answers to propounded interrogatories. [*277] Our examination of the record fails to disclose that there was offered in evidence the demand for answers to interrogatories and the answers with regard to this issue, and [***16] therefore they cannot, under basic principles of evidence, now be advanced as proof of this essential element of a prima facie case. Were the case before us in a posture that required disposition of the question, we would follow the rule that dictation of defamatory words to an amanuensis is sufficient publication to support an action. Pullman v. Hill & Co., [**578] [1891] 1 Q.B. 524; Nelson v. Whitten, 272 F. 135 (D.C.E.D.N.Y. 1921); Ostrowe v. Lee, 256 N.Y. 36, 175 N.E. 505 (Ct. App. 1931, Cardozo, C.J.); Restatement, Torts, § 577, comments (e) and (h), pp. 194, 196 (1938); Prosser, op. cit., supra, § 94, p. 597, 1 Harper and James, op. cit., supra, § 5.15, pp. 392393, n. 16; Annotation, 18 A.L.R. 776 (1922); cf. Murphy v. Johns-Manville Products Corp., 45 N.J. Super. 478 (App. Div. 1957), certification denied 25 N.J. 55 (1957); Mims v. Metropolitan Life Ins. Co., supra. However, accepting such publication as sufficient, yet if the letter is the subject of a privileged communication between the writer and the addressee, that privilege extends to the dictation. Ostrowe [***17] v. Lee, supra; Boxsius v. Goblet Freres, [1894] 1 Q.B. 842; Osborn v. Boulter & Son, [1930] 2 K.B. 226; 1 Harper and James, op. cit., supra, § 5.15, p. 393, n. 17. Aside from the questions of publication and consent and assuming the letter to Dr. Yeates to be defamatory or capable of a defamatory purport, we consider the issues of qualified privilege and fair comment. It is urged that the letter falls within the classification of qualified or conditional privilege because it was (a) a communication between parties having a common interest; or (b) fair comment on a matter affecting the public interest. The burden of proof is upon the defendants to establish the existence of the common interest and privileged occasion; and, with respect to fair comment, that the subject was a legitimate matter of public concern. These are [*278] questions of law to be decided by the trial judge unless the material facts are in dispute. Once the existence of the privilege is established, the plaintiff bears the burden of proving that it has been abused, by use of the occasion for an improper purpose, or by the lack of belief in the truth of what was said. It [***18] is primarily the duty of the judge to determine whether there is any evidence of abuse of privilege for the jury's determination and, if he finds that there is none, to decide for the defendant. Leers v. Green, supra (24 N.J. at page 255); Murphy v. Johns-Manville Products Corp., supra (45 N.J. Super. at page 492); Dressler v. Mayer, 22 N.J. Super. 129 (App. Div. 1952); Prosser, op. cit., supra, § 95, p. 629; Annotation, 26 A.L.R. 830 (1923). Both plaintiff and Dr. Yeates, as noted, are members in good standing of the defendant Association. Plaintiff testified that he frequently wrote defendant to "ask for various information" and further: "Q. And as a member of the American Dental Association you are entitled to write and expect an answer on matters concerning dentistry? A. On matters pertaining to anything they have. Q. Anything that would be in their official capacity? A. What they consider in their official capacity." Communications between the Association and its members, on a matter of common interest pertinent to the group or affecting their mutual interests, are qualifiedly privileged. McKnight [***19] v. Hasbrouck, 17 R.I. 70, 20 A. 95 (Sup. Ct. 1890). The classic definition, as stated by Baron Parke in Toogood v. Spyring, 1 C.M. & R. 181, 149 Eng. Rep. 1044, 1050 (1834), was that a communication is privileged if "fairly made by a person in the discharge of some public or private duty, whether legal or moral, or in the conduct of one's own affairs in matters where his interest is concerned." Recently the opinions in Jorgensen v. Pennsylvania R.R. Co., 25 N.J. 541 (1958), and in Murphy v. Johns-Manville Products Corp., supra (45 N.J. Super. at page 492) restated and applied the principle which is established [*279] law that "a communication, made bona fide, upon any subject matter in which the party communicating has an interest, or in reference to which he has a duty, is privileged, [**579] if made to a person having a corresponding interest or duty, although it contain criminatory matter which, without this privilege, would be actionable." King v. Patterson, 49 N.J.L. 417 (E. & A. 1887); Rothholz v. Dunkle, 53 N.J.L. 438, 440 (E. & A. 1891); Finkelstein v. Geismar, 91 N.J.L. 46, 48 (Sup. [***20] Ct. 1917), affirmed 92 N.J.L. 251 (E. & A. 1918); Evans, "Legal Immunity for Defamation," 24 Minn. L. Rev. 607 (1940). Unlike absolute privilege, which affords complete protection, qualified privilege affords immunity only if there is no ill motive or malice in fact, and can be lost by abuse on the part of the defendant. Rainier's Dairies v. Raritan Valley Farms, Inc., 19 N.J. 552, 558 (1955). The facts presented during the plaintiff's case clearly indicate that the occasion of the publication of the letter by the American Dental Association to Dr. Yeates, a member of that professional group, was such as to give rise to the complete defense of qualified or conditional privilege as stated by the cited authorities. See also Restatement, Torts, § 596, p. 255 (1938). Nor do we have any facts showing express malice indicating an abuse of the afforded immunity. On this point alone, the trial court's decision in dismissing plaintiff's action, at least insofar as it proceeds on the allegedly libelous letter, must be affirmed. There is, furthermore, a more significant matter of general public concern that must be considered -- the defense of fair [***21] comment. The defendants, in advancing the argument that the publication of the letter to Dr. Yeates was fair comment, suggest that they consider this a matter of qualified or conditional privilege. There is a difference of opinion among the authorities as to the rationale of the rule. One view regards fair comment as a question of qualified privilege; the other places the defense entirely outside the scope of libel by stating that writings which come within the ambit [*280] of fair comment as opposed to unfair comment are not libelous. 1 Harper and James, op. cit., supra, § 5.28, p. 456 et seq. The theory which regards this as a question of privilege seems to us sound. Ibid. For example, proof of express malice will defeat this defense as it will the qualified privilege we have discussed. Leers v. Green, supra (24 N.J. at pages 254-255). However, this problem is not a matter of first impression, and under stare decisis we must follow the rule established and iterated by our highest courts. The recent decision in Leers v. Green, supra, firmly indicates that words which constitute fair comment are not defamatory, citing Schwarz Bros. [***22] Co. v. Evening News Publishing Co., 84 N.J.L. 486 (Sup. Ct. 1913); Merrey v. Guardian Printing & Publishing Co., 79 N.J.L. 177, 184 (Sup. Ct. 1909), affirmed 81 N.J.L. 632 (E. & A. 1911), and Campbell v. Spottiswoode, [1863] 32 L.J.Q.B. 185, 201 (3 B. & S. 769, 122 Eng. Rep. 288, 292 (1863)), albeit there is no discussion of the rationale underlying the result. In whatever manner one may characterize the issues, it is obvious that the result achieved is substantially the same, and so we will proceed to the merits of this defense. Fluoridation of drinking water, which affects the health of citizens in a community, is clearly a subject of wide public interest. The publication of scientific data, the evaluation thereof, and the arguments pro and con on the merits and effectiveness of fluoridation, by dental and medical associations, their members and other interested individuals and groups, are highly desirable and the question becomes a proper subject of public comment. The difficulty arises in distinguishing between misstatements of facts from statements of opinion. The distinction between "fact" and "comment" is not always [***23] clear; most communications contain an element of each, [**580] and the determination of what is fact or comment depends on what is said in the entire article. The immunity applies to bona fide opinion, comment or criticism, but not to false assertions of fact. By taking an active contentious position on a subject concerning [*281] the public welfare, plaintiff invited public controversy and is regarded as having invited public judgment. He is in no position to complain if that judgment, opinion, comment or criticism is adverse. One may criticize with severity but may not make false or libelous charges. "Criticism 'cannot be used as a cloak for mere invective, nor for personal imputations not arising out of the subject-matter or not based on fact'; 'invective is not criticism.' McQuire v. Western Morning News Co., [1903] 2 K.B. 100, 108." Leers v. Green, supra (24 N.J. at page 255). Merrey v. Guardian Printing & Publishing Co., supra; Schwarz Bros. Co. v. Evening News Publishing Co., supra; Prosser, op. cit., supra, § 95, p. 621. "Where the subject matter thus concerns the general welfare, it follows that however the conduct be assessed, [***24] * * * the question is whether the impugned statements are true in fact and the comment made has the essential quality of fairness, an attribute that is not necessarily tested by the choice of words or nicety of expression, but rather by the substance of the observations considered in context.' Leers v. Green, supra (24 N.J. at page 259). Fair comment must be based on facts truly stated or if not sufficiently stated, they must be identified by clear reference. "In either case, the defendant enables his readers to judge for themselves how far his opinion is well founded; and, therefore, what would otherwise have been an allegation of fact becomes merely a comment. But if he asserts that the plaintiff has been guilty of disgraceful conduct and does not state what that conduct was, this is an allegation of fact for which there is no defense but privilege or truth. The same considerations apply where a defendant has drawn from certain facts an inference derogatory to the plaintiff. If he states the bare inference without the facts on which it is based, such inference will be treated as an allegation of fact. But if he sets out the facts correctly, and then gives [***25] his inference, stating it as his inference from those facts, such inference will, as a rule, be deemed a comment." Odgers, Libel and Slander (6th ed. 1929), p. 166. See also Leers v. Green, supra (24 N.J. at page 251); 1 Harper and James, op. cit., supra, § 5.28, p. 459, n. 14, 15. Moreover it [*282] "must not contain imputations of corrupt or dishonourable motives on [the part of] the person whose conduct or work is criticised, save in so far as such imputations are warranted by the facts, and (c) must be the honest expression of the writer's real opinion; and if the comment complies with these conditions, it is fair comment, however incorrect be the views expressed by the critic, or however exaggerated or even prejudiced be the language of the criticism; the 'limits of criticism are exceedingly wide.' Gatley, Libel and Slander, sections 344, 354." Leers v. Green, supra (24 N.J. at pages 254-255). In the instant case, while the alleged defamatory letter from the defendants did not itself set forth the facts upon which they based their statements, there was sufficient identification of them. The [***26] letter from Dr. Yeates inviting the response read: "From time to time the name of Dr. Robert J. H. Mick has come to my attention as being one of those apparently violently against fluoridation. I have read charges that he has made against [**581] our American Dental Association and certain members thereof, the American Medical Association, the United States Public Health Service and certain members thereof. I understand that he has made such accusations over the radio and television also. I do not believe he is aiding much in the cause of fluoridation * * *." This letter exhibits not only a knowledge of the facts but also the public nature of the subject-matter and plaintiff's violent opposition and activity in the arena of public communication. Whether the matter commented upon is of public concern and whether there is any evidence of unfairness are primarily questions of law for the trial judge; and, when there are issues of fact, it is for the jury to determine whether the words are allegations of fact or expressions of opinion, and if the latter, whether or not they are fair comment. If the alleged libel does not exceed the bounds of fair comment or if [***27] there is no evidence upon which a rational verdict for plaintiff can be founded, judgment for defendant should be entered. Leers v. Green, supra (24 N.J. at page 255). There is perhaps no area of human activity more vital than that of public health. Honest and fearless investigation, [*283] professional discussion and challenge of means and methods for the cure and prevention of disease should be encouraged and not suppressed for fear of libelous action. The road of medical history in the conquest of disease is marked with signposts indicating that the most far-reaching and beneficial scientific achievements and their discoverers were subjected to violent attack. The discovery of vaccination for smallpox by Edward Jenner (1749-1823) in England met vehement opposition. In France, Louis Pasteur (1822-1895) was at first ridiculed and medical journals contained attacks upon his theories and experimentation with inoculation of cultures against anthrax. The techniques introduced by Ignaz Semmelweiss (1818-1865) in Hungary for the prevention of puerperal fever were mercilessly derided. The pioneers in the discovery of anesthetics and the dentists who first used them [***28] encountered much opposition. These few instances illustrate the survival against attack of medical discoveries which ultimately were proved beneficent to mankind. Undoubtedly, other proposals for prevention or cure were shown to be harmful and valueless as a result of challenge and assault. Scientific knowledge is only relative and partial, but we constantly seek more knowledge. In the midst of successes there are frequent failures. Indications of the present public controversy over the subject of fluoridation can be seen almost daily in various media. The point is that the widest freedom of discussion and publication of views and their exchange on every side of such questions of public interest should be permitted and even encouraged within the limits of fair comment, and this is the ultimate purpose of the rule. In discussing the parallel defense of qualified privilege as applied to quasi-judicial proceedings, Justice Jacobs well expressed this philosophy when in Rainier's Dairies v. Raritan Valley Farms, Inc., supra (19 N.J. at pages 557-558), he said: "Occasionally, however, that policy [freedom from defamatory remarks] conflicts with a counter-policy [***29] which suggests that in certain situations there is a paramount public interest that persons be [*284] permitted to speak or write freely without being restrained by the possibility of an ensuing defamation action." See also 1 Harper and James, op. cit., supra, § 5.28, p. 456. We are not unmindful that this case is before us upon an involuntary dismissal at the conclusion of plaintiff's case. Under oft-cited principles we are impelled on review of an involuntary dismissal, R.R. [**582] 4:42-2, as noted above in our discussion of the purpose of Dr. Yeates' solicitation of information, to give the plaintiff every legitimate inference, but such inferences as may be drawn "must be rooted in evidence." Gnapinsky v. Goldyn, supra (23 N.J. at page 252). Cf. Melone v. Jersey Central Power & Light Co., 18 N.J. 163, 170 (1955). The burden of proving the situation giving rise to the occasion of fair comment is on the defendant. Prosser, op. cit., supra, § 95, p. 629. Cf. King v. Patterson, supra (49 N.J.L. at pages 419-420). But as we have stated, where the facts are undisputed this is a matter of law for the court. [***30] Once the evidence shows that the situation is of such import that it becomes a matter for public comment, and such comment is made by the defendant, then the burden of proof is on the plaintiff to show express malice, the "unfairness" of the comment, or any other matter by way of avoidance of the defense. Ibid. The facts here conclusively establish the nature of plaintiff's position as coming within the scope of those situations giving rise to permissible fair comment and criticism. So, too, there is no evidence whatsoever that negates this total defense. The dismissal of the action with regard to the letter on the ground of fair comment was proper. One further issue remains to be considered and that is the Association's publications in which plaintiff is not named, directly or indirectly, but which he contends pertain to him as one of the group opposing fluoridation. The Association did not refer to or characterize the plaintiff among the "quacks," "faith-healers," "faddists" or "cultists," but he [*285] claims that he "was none the less damaged by these publications in that he was and still is widely known as an opponent to the fluoridation program." Actually, it [***31] distributed a brochure listing and furnishing biographical data on the individuals who were so characterized. By the absence of plaintiff's name from this compilation, one would think that he was not included, but since he himself charges that he was within this group, despite denial, the question is whether he has a cause of action. When defamatory words are directed at a group or class of persons rather than an individual, the plaintiff must show that he is a member of the defamed class and must establish some reasonable application of the words to himself. "The size of the group to which the defamatory allusion is made has been the most significant factor in determining whether relief should be granted. Where the group is small there is great likelihood that others will understand that the defendant intended to attribute certain qualities, beliefs, or acts to each member. Moreover, others are more likely to believe the statement to be based on information concerning each particular individual rather than that it is a generalization drawn from the observation of a few. As the group becomes larger, it is less likely that the statement will be understood as referring to [***32] each member of the group and its character as a generalization becomes clearer." Note, "Developments in the Law -- Defamation," 69 Harv. L. Rev. 875, 894 (1956). See also authorities cited in Golden North Airways v. Tanana Publishing Company, 218 F. 2d 612 (9 Cir. 1954). "If the group is a very large one, as in the case of such words as 'all lawyers are shysters,' they are considered to have no application to anyone in particular, since one might as well defame all mankind. Not only does the group as such have no action, but the plaintiff does not establish any personal reference to himself. But if the plaintiff is the only lawyer present, or for some other reason the words are understood by the hearers to be directed individually at him, the personal application may appear. [**583] The rule has been applied quite uniformly to comparatively large groups or classes of a definite number, exceeding, say twenty-five persons. When the group becomes smaller than that * * * the courts have been willing to permit the conclusion that the finger of defamation is pointed at each individual member." Prosser, op. cit., supra, § 92, pp. 583-584. [***33] [*286] See also 1 Harper and James, op. cit., supra, § 5.7, p. 367; Restatement, Torts, § 564, comment (c), pp. 151-152 (1938); Annotation, 97 A.L.R. 281 (1935). If the group is sufficiently small, and a particular member is by proper colloquium or innuendo shown to be referred to, such person has a right of action. 1 Harper and James, ubi cit., supra. Proper appreciation of this rule can be had only by a case-by-case analysis of applicable New Jersey and other authorities. In Gnapinsky v. Goldyn, supra, where a slanderous statement was allegedly made against "Mary" and where there was no evidence that it referred to plaintiff or was reasonably believed by some person who heard the remark that plaintiff was in fact intended, a judgment of dismissal was affirmed. Chief Justice Weintraub said: "It must appear that the third person understood the communication to relate to plaintiff * * * the identification of the person defamed may be so evident and the extent of publication such as to warrant an inference that the published statement was understood by at least some third person to bear upon plaintiff. But where, as here, the [***34] statement refers merely to 'Mary,' more than mere publication must be proved to warrant the inference that the listener in fact understood plaintiff was meant." The opinion in Merrey v. Guardian Printing & Publishing Co., supra, reveals a situation where there were two sets of accusations. One was confined to the city counsel and the other referred to "city officials" of Paterson, New Jersey. The plaintiff, who was city counsel, asserted that he was included in the term "city officials." There was sufficient evidence to sustain the innuendo concerning city officials and the court held that "whether a libel was published of the plaintiff, or whether by the persons mentioned in the libel the plaintiff was intended, is a question of fact for the jury." In Reilly v. Curtiss, 83 N.J.L. 77 (Sup. Ct. 1912), defendant made an accusation against the election board of the City of Elizabeth. There the court held: [*287] "A sweeping charge of misconduct leveled against a public board without exception, necessarily points the finger of condemnation at every member thereof, though none are named, and every member of the board may maintain an action therefor." [***35] In Kilpatrick v. Edge, 85 N.J.L. 7 (Sup. Ct. 1913), plaintiff, the owner of a public bath in Atlantic City, brought suit against the publisher of a local newspaper by reason of an article describing an orgy in a Turkish bath. The court held that the fact that plaintiff was not specifically named was not an adequate defense and permitted recovery. Lastly, in Neiman-Marcus v. Lait, 13 F.R.D. 311 (D.C.S.D.N.Y. 1952), an action was brought by saleswomen and salesmen of a department store against the author of a book which stated that "most of the salesmen are fairies" and that some of the salesgirls were "call girls." The court held that the salesmen had a cause of action under New York law but the saleswomen, in absence of anything tending to identify them individually from the large class of saleswomen, had no cause of action. The facts here are readily distinguishable from the cited cases. The groups or classes described in the articles are so [**584] amorphous and extensive as to preclude the maintenance of an action by plaintiff through claim of association with them because of his common opposition to the cause of fluoridation. The trial judge's [***36] action in granting an involuntary dismissal at the conclusion of the plaintiff's case is affirmed. Return to Fluoride-Related Court Cases Return to Fluoridation page Return to ACTION Center Homepage http://www.actionpa.org/fluoride/lawsandcourts/nj-libel-mick.html http://www.actionpa.org/fluoride/lawandcourts/index.html#courtcases Methamphetamine Destroys Your Teeth "Meth mouth" is too dry http://news.softpedia.com/news/Methamphetamine-Destroy-Your-Teeth-36398.shtml American Dental Association (ADA) says that your teeth can be destroyed by methamphetamine, a powerfully addictive drug. Once it enters a person's body, it provokes a release of a great amount of dopamine, leading to the typical euphoria. Short-term effects include extreme wakefulness, a lasting boost of energy and a lack of appetite. Longterm effects include a high blood pressure, stroke and serious heart problems. Methamphetamine (also known as meth, crank, crystal and speed) has been used by more than 12 million people in US. It can be taken orally, injected, snorted or smoked. Most users are 18 to 34 years old. In just one year, the drug users can achieve sensitive teeth to tooth loss, a condition called " meth mouth". Meth mouth robs people, especially young people of their teeth and frequently leads to full-mouth extractions and a lifetime of wearing dentures," says Robert M. Brandjord, ADA president. "Meth mouth is characterized by rampant tooth decay and teeth described by meth users as blackened, stained, rotting, crumbling or falling apart." The drug inhibits salivary glands' activity. Without the diluting saliva, food or bacteria produced acids in your mouth start dissolving tooth enamel. Moreover, the drug users may neglect their oral hygiene. And methamphetamine effect can last for 12 hours. During this time, personal hygiene may not enter on the view of the drugged person. Dr. Brandjord explains, "The extensive tooth decay of meth mouth is attributed to the drug's dry-mouth effect and its propensity to cause cravings for high-calorie carbonated beverages, tooth grinding and clenching, and extended periods of poor oral hygiene." "Very few people understand the broad dangers methamphetamine poses to the public health of our communities in addition to meth users themselves," says Stephen Pasierb, president and CEO, The Partnership for a Drug-Free America. "The ADA's warning should serve as a wake-up call to those who use this insidious drug as well as family and friends who are witness to this behavior, but not powerless to intervene and get the user the help they need. There is no safe level of meth use, but treatment and recovery are possible." Alcoa From Wikipedia, the free encyclopedia Alcoa, Inc. Type Public (NYSE: AA) Founded Pittsburgh, Pennsylvania, U.S. (1888) Founder Charles Martin Hall Headquarters Area served New York, New York Pittsburgh, Pennsylvania Worldwide Alain J. P. Belda Key people (Chairman) Klaus Kleinfeld (CEO), (President) & (Director) Industry Market cap Revenue Aluminum US$ 21.90 billion (2008) ▲ US$ 30.748 billion (2007) Operating income ▲ US$ 4.491 billion (2007) Net income ▲ US$ 2.564 billion (2007) Total assets ▲ US$ 38.803 billion (2007) Total equity ▲ US$ 16.016 billion (2007) Employees 107,000 (2008) Reynolds Metals Subsidiaries Halco Mining Kawneer Howmet Castings Website Alcoa.com Alcoa, Inc. (NYSE: AA) is the world's third largest producer of aluminum, behind Rio Tinto Alcan and Rusal. [3] Alcoa leads the world in alumina production and capacity. From its operational headquarters in Pittsburgh, Pennsylvania, Alcoa conducts operations in 44 countries. In May 2007 Alcoa made a hostile $27 billion bid for Alcan, a former subsidiary, aiming to unite the two companies and form the world's largest aluminum producer. The takeover bid was withdrawn after Alcan announced a friendly takeover by Rio Tinto in July 2007. Among Alcoa's other businesses are fastening systems, building products (Kawneer), Howmet Castings, and electrical distribution systems for cars.[4] The sale of the packaging unit was announced on December 21, 2007[5] and closed in the first quarter of 2008. History In 1886, Charles Martin Hall, a graduate of Ohio's Oberlin College, discovered the process of smelting aluminum, almost simultaneously with Paul Héroult in France. He realized that by passing an electrical current through a bath of cryolite and aluminum oxide, the then semi-rare metal aluminum remained as a byproduct. This discovery, now called the HallHéroult process, is still the only process used to make aluminum worldwide. Probably fewer than ten sites in the United States and Europe produced any aluminum at the time. In 1887, Hall made an agreement to try his process at the Electric Smelting and Aluminum Company plant in Lockport, New York but it was not used and Hall left after one year. On Thanksgiving day 1888, with the help of Alfred E. Hunt, started the Pittsburgh Reduction Company with an experimental smelting plant on Smallman Street in Pittsburgh, Pennsylvania. In 1891, the company went into production in New Kensington, Pennsylvania. In 1895 a third site opened at Niagara Falls. By about 1903, after a settlement with Hall's former employer, and while its patents were in force, the company was the only legal supplier of aluminum in the US.[6][7] "The Aluminum Company of America" -- became the firm's new name in 1907. The acronym "Alcoa" was coined in 1910, given as a name to two of the locales where major corporate facilities were located (although one of these has since been changed), and in 1999 was adopted as the official corporate name. It has been suggested that this section be split into a new article entitled United States v. Alcoa . Under President Franklin D. Roosevelt, the Justice Department charged Alcoa with illegal monopolization, and demanded that the company be dissolved. Trial began on June 1, 1938. Four years later, the trial judge dismissed the case. The government appealed. Two more years passed, and in 1944, the Supreme Court announced that it couldn’t assemble a quorum to hear the case so it referred the matter to the U.S. Court of Appeals for the Second Circuit. The following year, the year the world weary of war at last had a chance at peace, was also appropriately enough the year this litigation came to its end. Learned Hand wrote the opinion for the Second Circuit. Hand wrote that he could consider only the percentage of the market in "virgin aluminum" for which Alcoa accounted. Alcoa had argued that it was in the position of having to compete with scrap. Even if the scrap was aluminum that Alcoa had manufactured in the first instance, it no longer controlled its marketing. But no, Hand defined the relevant market narrowly in accord with the prosecution's theory. Alcoa said that if it was in fact deemed a monopoly, it acquired that position honestly, through outcompeting other companies through greater efficiencies. Hand applied a rule concerning practices that are illegal per se here, saying that it doesn’t matter how Alcoa became a monopoly, since its offense was simply to become one. Indeed, Hand seemed to be saying that in some circumstances inefficiency may be a requirement of the law. Hand acknowledged the possibility that a monopoly might just happen, without anyone's having planned for it. If it did, then there would be no wrong, no liability, and no need to remedy the result. But that acknowledgement has generally been seen as an empty one in the context of the rest of the opinion, because of course rivals in a market routinely plan to outdo one another, at the least by increasing efficiency and appealing more effectively to actual and potential customers. If one competitor succeeds through such plans to the extent of 90% of the market, that planning can be described given Hand's reasoning as the successful and illegal monopolization of the market. This leaves the question, what is the proper remedy once a wrongful monopolization is found? Here Hand remanded the matter to the trial court, and the whole narrative comes to an unsatisfactory conclusion – more of a dissipation, really, than a conclusion. In 1947, Alcoa made the argument to the court that there were two effective new entrants into the aluminum market – Reynolds and Kaiser – as a result of demobilization after the war and the government's divestiture of defense plants. In other words, the problem had solved itself and no judicial action would be required. On this basis, the district court judge ruled against divestiture in 1950, but the court retained jurisdiction over the case for five years, so that it could look over Alcoa's shoulder and ensure that there was no remonopolization. Until 1950, Alcoa was concerned with its domestic market, while its Canadian subsidiary Aluminum Limited (Alcan) took care of the international markets. Alcoa, Reynolds, and Kaiser were soon joined in the growing market by Anaconda Aluminum Company, a subsidiary of the copper-industry giant. In 1958 Harvey Machine Tools Company began primary aluminum production, marking the end of Alcoa's monopoly over the process which had led to its domination of the American market. Noted economist and former Federal Reserve chairman Alan Greenspan criticized the judgment of monopoly against Alcoa (Capitalism: The Unknown Ideal; see[8]) quotes Learned Hand, the judge in U.S. v Alcoa, who remarked, "It was not inevitable that it should always anticipate increases in the demand for ingot and be prepared to supply them. Nothing compelled it to keep doubling and redoubling its capacity before others entered the field. It insists that it never excluded competitors; but we can think of no more effective exclusion than progressively to embrace each new opportunity as it opened, and to face every newcomer with new capacity already geared into a great organization, having the advantage of experience, trade connections and the elite of personnel." Greenspan believes that the characterization of Alcoa as a threat to competition is erroneous, as "ALCOA is being condemned for being too successful, too efficient, and too good a competitor. Whatever damage the antitrust laws may have done to our economy, whatever distortions of the structure of the nation's capital they may have created, these are less disastrous than the fact that the effective purpose, the hidden intent, and the actual practice of the antitrust laws in the United States have led to the condemnation of the productive and efficient members of our society because they are productive and efficient." Greenspan grants that Alcoa was a monopoly, but maintains that it was not a coercive monopoly and, hence, should not have been subject to anti-trust action. Alcoa established an 8% stake in China's state-run aluminum industry and has formed a strategic alliance with Aluminium Corporation of China (Chalco), China's largest aluminum producer, at its Pingguo facility. Alcoa sold this stake on September 12, 2007.[9] Alcoa has also acquired two facilities in Russia, at Samara and Belaya Kalitva. Alcoa recently launched an offer to purchase the remaining 18% of the Belaya Kalitva plant from minority shareholders, giving it complete ownership in the facility. In 2004, Alcoa's specialty chemicals division was sold, taking on the name Almatis, Inc.. In 2005, under heavy criticism by local and international NGOs related to a controversial dam project exclusively dedicated to supplying electricity to this smelter, Alcoa began construction in Iceland on Alcoa Fjardaal, a state-of-the-art aluminum smelter and the company's first greenfield smelter in more than 20 years. Alcoa also signed a memorandum of understanding with the government of the Republic of Trinidad and Tobago to build a low-emissions aluminum smelter and related facilities there. However, there has been strong objection of this by the residents of the area of the proposed smelter sparking protests and marches frequently.Also, Alcoa is working with the government of Ghana on the development of the aluminum industry in that country. Furthermore, Alcoa has completed or is undergoing primary aluminum expansion projects in Brazil, Jamaica, and Pinjarra, Western Australia. In 2006, Alcoa relocated its top executives from its headquarters in Pittsburgh to New York City. Although the company's principal office is located in New York City, the company's operational headquarters are still located at its Corporate Center in Pittsburgh. Alcoa employs approximately 2,000 people at its Corporate Center in Pittsburgh and 60 at its principal office in New York.[10] Alcoa was named one of the top three most sustainable corporations in the world at the World Economic Forum in Davos, Switzerland. On 8 May 2008, Klaus Kleinfeld was appointed new CEO of ALCOA substituting Alain Belda. Environmental record Alcoa is ranked 9th in the Political Economy Research Institute's (PERI) Toxic 100 of 2002. The company released 9.88 million pounds of toxic air in 2002.[11] In April 2003, Alcoa Inc. agreed to spend an estimated $330 million to install a new coal-fired power plant with state-of-the-art pollution controls to eliminate the vast majority of sulfur dioxide and nitrogen dioxide emissions from the power plant at Alcoa's aluminum production facility in Rockdale, Texas. The settlement was the ninth case the Bush Administration pursued to bring the coal-fired power plant industry into full compliance with the Clean Air Act. Alcoa was unlawfully operated at the Rockdale facility since it overhauled the Rockdale power plant without installing necessary pollution controls and without first obtaining proper permits required by "New Source Review" program of the Clean Air Act.[12] In February 1999, Alcoa cleaned soils and sediment contaminated with polychlorinated biphenyls (PCB) and lead at the York Oil federal Superfund site in Moira, New York in accordance with the Environmental Protection Agency. The site, a former waste oil recycling storage facility, accepted waste oil from a number of companies, including Alcoa. The facility was improperly managed and operated and, as a result, soils on the York Oil Property and nearby wetlands sediments and groundwater were contaminated. The EPA issued a Superfund Unilateral Order on December 31, 1998 requiring Alcoa to excavate, treat and dispose of the contaminated wetlands sediments.[13] On the other hand, In 2005, BusinessWeek magazine, in conjunction with the Climate Group, ranked Alcoa as No.5 of "The Top Green Companies." in cutting their carbon gas emissions[14][15]. Alcoa in Ghana Alcoa's affiliate in Ghana, the Volta Aluminum Company, was completely closed between May 2003 and early 2006, due to problems with its electricity supply.[16][17] Alcoa in Iceland By the middle of September, over 50% of the Alcoa Fjardaál smelter construction in Iceland has been finished. The total workforce on site is 1,750 people, of which 80% are of Polish origin.[citation needed] It is expected to be on line by 2007. Alcoa and the government of Iceland have signed an agreement on instigating a thorough feasibility study for a new 250,000 tpy (Tons Per Year) smelter in Bakki by Húsavík in Northern Iceland. In order to power Alcoa's new smelters in Iceland, tracts of wilderness are being flooded to provide hydroelectric energy.[citation needed] Alcoa does not own the kárahnjúkar powerplant.[citation needed] Fjardaral, which is owned by Alcoa, created jobs in the nearby town of Reyðarfjörður for people that lost their jobs when the Icelandic government decided to lower their fishing quota.[citation needed] Alcoa In South Wales (Swansea) On November 21, 2006, Alcoa announced that it planned to close the Waunarlwydd works in Swansea, with the loss of 298 jobs. Production ceased at the Swansea plant on January 27, 2007. Decommissioning works are currently taking place. Although rolling operations at the plant have now ceased, a small workforce is still employed in homogenisation, where heat treatment takes place for the Kitts Green plant.[18][19] Alcoa in Australia Alcoa operates bauxite mines, alumina refineries and aluminum smelters through Alcoa World Alumina and Chemicals, which is a joint venture between Alumina Limited and Alcoa. Alcoa operates two bauxite mines in Western Australia - the Huntly and Willowdale mines. Alcoa World Alumina and Chemicals owns and operates three alumina refineries in Western Australia: Kwinana, Pinjarra and Wagerup. Two aluminum smelters are also operated in the state of Victoria at Portland and Point Henry. Alcoa in the United States ALCOA created a plant just outside of Maryville, TN in Blount County, Tennessee, which was the biggest provider of aluminum in the South. The area needed housing for workers, so ALCOA built many houses. The area eventually turned into a city and decided to name its self after the company. Alcoa, Tennessee, was founded 1919.[citation needed] Alcoa maintains several Research and Development Centers in the United States. The largest one, Alcoa Technical Center, is located East of its Pittsburgh Headquarters at Alcoa Center, PA. The "Tech Center" is as large as some college campuses, has its own Zip Code and maintains an extensive intellectual and physical resource for innovation. Alcoa's extensive safety program continuously improves safety at the Tech Center while enhancing quality of life and efficiency for the hundreds of elite level Researchers who are creating new avenues of business growth and technological development for the Company. Some experimental processes can be dangerous but Alcoa's 6S Culture of Safety and Environmental Responsibility has ensured Researcher safety and minimized environmental impact while enhancing cost effectiveness of development work and accelerating time to market.[citation needed] The Physical plant of the Tech Center is situated in a rural area and has managed to cultivate a large wooded area which acts as a nature preserve, sheltering deer and other wildlife. It is not uncommon to see Deer and other wildlife freely circulating through the environs of the Tech Center at all hours of the day.[citation needed] Alcoa World Alumina and Chemicals Alcoa owns and operates the majority of its alumina refineries through its 60% share of Alcoa World Alumina and Chemicals. Alcoa Primary Aluminum smelters Alcoa has interests in 25 primary aluminum smelters in 8 countries. Alcoa smelters[20][21] Country Location Equity ownership Plant Total Nameplate Alcoa's Capacity capacity (kt per year) (kt per year) Point Henry 100% 185 185 Portland 55% 353 194 Poços de Caldas 100% 96 São Luís (Alumar) 60% 438 263 Baie Comeau 100% 438 438 Bécancour 75% 409 307 Deschambault 100% 254 254 Fusina 100% 44 44 Portovesme 100% 150 150 Avilés 100% 90 90 A Coruña 100% 84 84 San Cibrao 100% 225 225 Alcoa Operations, 100% TN 215 215 Badin, NC 100% 60 60 Evansville, IN (Warrick) 100% 309 309 Ferndale, WA (Intalco) 100% 279 279 Frederick, MD (Eastalco) 100% 195 195 Massena (East Plant), NY 100% 125 125 Massena (West Plant), NY 100% 130 130 Mount Holly, SC 50% 229 115 Rockdale, TX 100% 267 267 Wenatchee, WA 100% 184 184 Tema 10% 200 20 Lista 50% 94 47 Mosjøen 50% 188 94 See also • • • • • Alumina List of alumina refineries Alcoa World Alumina and Chemicals Alcoa, Tennessee List of aluminum smelters References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. ^ "It all starts with dirt". Alcoa, Inc.. Retrieved on 2008-08-07. ^ "Alcoa, Inc.". Google Finance. Retrieved on 2008-08-07. ^ "Gimme Smelter". The Economist (2007-07-19). Retrieved on 2007-10-15. ^ "Alcoa About Alcoa". Alcoa, Inc.. Retrieved on 2007-10-15. ^ Alcoa, Inc.. "Form 8-K". United States Securities and Exchange Commission. Retrieved on 2007-12-31. ^ Hachez-Leroy, Florence. "Aluminum industry: a Heritage for Europe" (PDF). Proceedings, TICCIH Congress. Retrieved on 2007-11-03. ^ Rosenbaum, David Ira (1998). Market Dominance: How Firms Gain, Hold, or Lose It and the Impact on Economic Performance. Praeger Publishers via Greenwood Publishing Group, 56. ISBN 0275956040. Retrieved on 2007-11-03. ^ Antitrust by Alan Greenspan ^ Alcoa: News: News Releases: Alcoa Sells Its Stake in Chalco; Will Continue Its Commitment to Chinese Aluminum Industry ^ Alcoa's HQ relocation to NYC no big surprise ^ PERI - Political Economy Research Institute: Toxic 100 Table 12. ^ U. S. Announces Clean Air Act Coal-fired Power Plant Settlement with Alcoa Settlement Will Reduce Nitrogen Oxide and Sulfur Dioxide Emissions from Facility by More than 90 P... 13. ^ Alcoa To Carry Out EPA's Order and Expand Cleanup at Superfund Site in Moira, New York To Contaminated Wetlands Sediments | Newsroom | US EPA 14. ^ Unknown Author (December 6, 2005). "DuPont Tops BusinessWeek Ranking of Green Companies". GreenBiz News. 15. ^ Green Leaders Show The Way Business Week 16. ^ [1] 17. ^ Alcoa in Ghana: News: News From Ghana: Alcoa, Government of the Republic of Ghana Agree to Re-Start Valco Smelter 18. ^ BBC News 19. ^ Forum for former workers from the Swansea plant 20. ^ "Alcoa smelting capacity". Retrieved on 2007-08-20. 21. ^ "Alcoa: Worldwide: Markets: Aluminum Ingot Products: Global Capacity". Retrieved on 2007-08-28. American Water Works Association http://www.awwa.org/Membership/Content.cfm?ItemNumber=6023&NavItemNumber=29252 Applications: Individual, North America Individual Membership provides numerous career and educational opportunities. For information on Individual Membership benefits, please visit our Membership Benefits page. If you're ready to apply, there are two ways you can do so for Individual Membership. • • Apply Online: To apply online, please be aware that you will be asked for a login account username and password before you get to the application. If you have already created a login account, simply enter your username and password on the screen, and your contact information will automatically populate in the application. If you do not yet created have a login account, follow the steps shown on the next screen to create one. The information you provide in that process will help populate your membership application. Your login username and password will be good for all your future visits to the AWWA website! Apply via PDF: The PDF application is "writable," meaning when you open the document and fill in the information, you can simply click the "SUBMIT" button located at the end of the form to send us your information. You will need Adobe Reader software on your computer to open this PDF file. If you do not have Adobe Reader, you can download it for free from Adobe's website. AWWA Warned Not to Remove or Destroy Evidence for Water Fluoridation Injury Legal Actions June 9, 2008 http://fluoridealert.org/press/awwa.html Media Release from The Lillie Center, Inc June 9, 2008 Giant Water Group Warned Not to Remove or Destroy Evidence for Water Fluoridation Injury Legal Actions Ellijay, GA: June 9, 2008 – The largest association of water professionals in the world has been notified not to destroy, remove, or tamper with documents or video recordings in its possession that may be used in legal actions on behalf of persons injured by drinking fluoridated water. Robert Reeves, an attorney whose work helped force FDA to concede potential harm from mercury in dental fillings, sent a fluoride evidence preservation letter to the Denver-based 60,000-member American Water Works Association. The letter listed AWWA’s headquarters office, its regional section offices, and national and regional officers personally as “potentially responsible parties” that may be the subject of legal actions by kidney patients and others harmed by ingesting fluorides. The development comes on the heels of last week’s dramatic news that the National Kidney Foundation has admitted that chronic kidney disease patients “should be notified of the potential risk” from ingesting fluorides and fluoridated water. Kathleen Thiessen, PhD, one of the members of a National Research Council panel that issued a 500-page report on fluorides in 2006, says, “The NRC report indicated that kidney patients, diabetics, infants, and other groups are susceptible population groups. I am also personally concerned that black and other minority Americans are disproportionately harmed by fluoride, and I believe there is a potential risk of thyroid damage for overexposed Americans in general.” In a January 2008 Scientific American article about fluorides, toxicologist John Doull, the chairman of the NRC panel, admitted, “The thyroid changes do worry me.” Reeves’ letter demonstrates that attorneys across the country are becoming educated about fluoride, a substance acknowledged to rival arsenic and lead in toxicity. The letter also zeroes in on AWWA’s slogan that it is “The Authoritative Resource on Safe Water.” Reeves points out that AWWA doesn’t claim to be the authoritative resource on “pure or compliant” water, but on “safe” water, putting the organization and its directors in a position of “top tier accountability and responsibility” to disseminate even the bad news about fluoride. “Looks like AWWA has painted a made-forplaintiff-attorneys bulls-eye on themselves,” observes Daniel Stockin of The Lillie Center, Inc., a Georgia-based public health training firm that is working to end water fluoridation. AWWA chose not to include scientists opposing fluoridation in a web-cast about fluoridation in 2006. In AWWA’s written response to Reeves, the organization wrote, “AWWA looks to the medical and dental communities, the U.S. EPA, the Centers for Disease Control, and other…organizations for their information and research on medical and dental health.” “Well, which is it?” Stockin questions. “Either AWWA is ‘The Authoritative Resource on Safe Water’ or it isn’t,” he states. “AWWA apparently ignored the rather obvious conflicts of interest of dental and health organizations that gave glowing reports on the safety of fluorides. If AWWA doesn’t quickly distance itself from the old-school idea that fluoride is safe even for sensitive populations, it will probably result in AWWA member water districts being forced to name the headquarters or regional staff or offices of AWWA as third party defendants when they’re sued by kidney patients and other groups.” A growing number of cities have recently rejected water fluoridation, including the Canadian city of Quebec and Juneau, the capital of Alaska. For more information, contact: Daniel G. Stockin, MPH The Lillie Center, Inc. P.O. Box 839 Ellijay GA 30540 Ph: 706.669.0786 // Fax: 706.635.8170 Email: [email protected] • Attorney Robert Reeves’ letter to AWWA available at: http://fluoridealert.org/reeves.pdf • Video and news related to the National Kidney Foundation’s changed position on fluorides for kidney patients can be viewed at: http://www.fluoridealert.org/press/nfk2.html Fluoride Action Network | 802338-5577 | [email protected] Advertising: Bernays Discounts Persuasion http://www.nytimes.com/books/98/08/16/specials/bernays-discounts.html B September 26, 1962 y PETER BART Edward L. Bernays, the public relations man, is in a state of transition these days. He is moving his base of operations from New York to Cambridge, Mass., where he plans to slacken his pace and write his memoirs. All this will represent a change for the 70-year-old Mr. Bernays, who has operated a public relations counseling company in New York since 1919. The other day Mr. Bernays, who is a nephew of Sigmund Freud, paused for a few minutes to offer some provocative observations about the business of "paid persuasion." Mr. Bernays said the weight of persuasive material hurled at the consumer by advertising and public relations men amounted to "a basic attack on the human personality." Impact Weakened Persuasion has become such a massive industry, he observed, that its impact is often negated. A basic reason for this phenomenon, he said, was that business fails to understand the true nature of persuasion and communication. Too many advertisers believe that it is possible to change any consumer's mind if enough money is allocated for the purpose, he said. According to Mr. Bernays, this notion runs counter to all that is known about psychology and group dynamics. People have habits and preconceived ideas, he noted. No advertisement, no matter how shrewdly conceived, will convert a person who is passive and disinterested toward a product into a potential customer, according to Mr. Bernays. Persuasion Overdone And no public relations campaign, he said, will succeed in improving a company's "image" if that company's actions create an unfavorable impression. Mr.Bernays said he was dismayed by the role of public relations. Public relations men function merely as paid persuaders, he said, when persuasion should be only a small part of their role. The job of the public relations man, he said, should be to "study public opinion and social psychology" and to counsel his company on how to adjust to these "societal forces and to enlist public support for services, products and ideas." The public relations man's principal impact should be on corporate policy, Mr. Bernays said. The process of communicating to the public should be a secondary aim. Licenses Suggested All this may sound high-minded, but to Mr. Bernays, the public relations business will never reach maturity until it functions in this manner. As one step in this direction, Mr. Bernays said public relations men should be licensed by the state. This process would do much to keep out "marginal operators" who use the techniques of public relations for purposes that are "not in the public interest," he said. "Today's communicator has no sense of values whatsoever," Mr. Bernays said. "He simply does what he is hired to do. This is a distortion of the public relations function." Mr. Bernays also criticized the emphasis on corporate images. "All this is medicine man abracadabra," he remarked. "It represents a flight from reality. The job of the communicator should be to convey reality through words and pictures, not to practice medicine man incantations." Mr. Bernays, who has served such clients as the General Motors Corporation, the United Fruit Company, the American Tobacco Company and the Bank of America, said he found his new surroundings highly congenial to writing. "New York is hectic and full of tensions," he said. "In Cambridge if people know you are trying to do a book they do not look at you peculiarly. Cambridge is free of many of New York's pressures." Are We Victims of Propaganda? http://www.smokershistory.com/propagan.htm Exerpts from: Are We Victims of Propaganda? A Debate. Everett Dean Martin and Edward L. Bernays. Reprinted from The Forum Magazine, 1929 March. I. Our Invisible Masters, by Everett Dean Martin. "...To the extent that present methods of propaganda operate to increase general knowledge and to keep open in public life an arena in which truth may have a fair deal in its endless contest with ignorance and falsehood, no reasonable mind could possibly object to it. I am convinced, however, that propaganda does not often serve these ends. It is not designed, even at its best, for such service, but for something quite the reverse. Its aim is to 'put something over' on people, with or without their knowledge and consent, and its result is to produce a social situation in which neither truth nor the basic values of civilization get a fair hearing.... "Who, then decides whether the ulterior end to which the public is to be led or driven, with or without its assent, is good? Decision in this all important matter is left to a few people -- the very ones who have something to gain by manipulating the public. Furthermore, the identity of these people is seldom disclosed and they are responsible to no one. Propaganda is making these irresponsible and unknown persons the real rulers in American democracy. Let me quote a few passages from Mr. Edward L. Bernays' charmingly written book in defense of propaganda: (Propaganda; Liveright, 1928.) • For the masses promised to become king.... To-day, however, a reaction has set in. The minority has discovered a powerful help in influencing majorities. It has been found possible so to mould the mind of the masses that they will throw their newly gained strength in the desired direction.... The important thing is that it (propaganda) is universal and continuous, and in its sum total it is regimenting the public mind every bit as much as an army regiments the bodies of its soldiers.... • There are invisible rulers who control the destiny of millions. It is not generally realized to what extent the words and actions of our most influential public men are dictated by shrewd persons operating behind the scenes.... In some departments of our daily life in which we imagine ourselves free agents, we are ruled by dictators exercising great power.... The invisible government tends to be concentrated in the hands of the few because of the expense of manipulating the social machinery which controls the opinions and habits of the masses. "What are the qualifications of these invisible governors? Who are they that they should command? In what virtue or wisdom are they eminent? If there is to be any stability or order in society, those who rule must at least be known and something must be required of them; otherwise their rule is pure impertinence. When before have the governing few been unknown and hence so irresponsible? When before have the rewards been so great for wrong doing, or the means so certain and easy for those who have the power? It is not enough for gentlemen to say, 'Oh, yes, we admit that propaganda is sometimes abused.' An enterprise so uncontrollable, so susceptible of abuse, and so constantly under the temptation to abuse, is a public menace.... "But I am concerned about the methods and ultimate effects of propaganda even at its best. One effect of propagandist methods is greatly to increase the susceptibility of the public to slogans, catchwords, and vulgarly stated half-truths. Every real educator and political philosopher in history has noted the danger of this popular tendency. Now the 'knowing ones' are urged to see this mob psychology, not as a social menace, but as a natural resource to be exploited for private gain. Mr. Bernays says: • It was, of course, the astounding success of propaganda during the war that opened the eyes of the intelligent few in all departments of life to the possibilities of regimenting the public mind.... The manipulators of patriotic opinion made use of the mental cliches and emotional habits of the public to produce a mass reaction against alleged atrocities, the terror and tyranny of the enemy. It was only natural after the war ended that intelligent persons should ask themselves whether it was not possible to apply a similar technique to the problems of peace. "Precisely! The propagandist has learned to apply a wartime psychology to the accomplishment of any ends whatsoever! He proceeds by utilizing, for ulterior ends, the prejudices and passions and fixed ideas of the mob -- a new role, I assure you, for the 'intelligent few' in the history of civilization. Not even Machiavelli quite dared to propose such procedure. The intelligence of the community is thus told to abandon its historic role of keeping alive the values of civilization, and, by turning demagogue and sycophant, to pander ignorance in return for vulgar favors -- which means that prejudice and the wellknown weaknesses of human nature are to be exploited and thus encouraged. Moreover, the regimentation of opinion so achieved (for a consideration) means standardization on a low level and greater conformity to herd opinion. This accounts, in part, for the astounding growth of intolerance in American democracy after the war. In this way also, fundamentalism, censorship, and other forms of organized crowd insanity have now become a serious menace to American liberty. "It must be borne in mind that everything the propagandist does or says is for effect -most commonly the effect on fools. The public wants not truth but a show? Very well, he will play the mountebank. The responsibility for the intellectual integrity of the intelligent few is now for the first time in history passed on to the public. In the future, as Mr. Bernays says, "If the public becomes more intelligent in its commercial demands, commercial firms will meet new standards." So with all propagandists. This is to say, as long as the public may be manipulated by misrepresentation and by appeal to ignorance and prejudice, it is the public's own fault if the 'knowing ones' make use of questionable methods. Why worry about being decent, so long as the opposite cause has public approval? Just now it is the rule to be 'low brow,' to come down to the level of the man in the street. In striving for mass action, intelligence exhausts itself in the methods of gaining the attention of the ignorant and stupid... "Perhaps the most deadly thing about propaganda is that as it more and more organizes the vast agencies for communication and human intercourse in the interest of power and success and the dominance of certain influential groups, appealing always to 'cliches and emotional attitudes,' it sets up a vast system which excludes everything that is rare and challenging -- except that which may produce insignificant popular sensation. Mr. Bernays says that every means of human association and communication may be made a means of propaganda -- that is, may be organized for ulterior ends. Try to picture this state of affairs. This means that as such social forces become organized and controlled by the unknown few who can pay for such a vast enterprise, ideas that may not be utilized to the ends for which such organization exists cannot gain a hearing. Already we see many instances of censorship by such a controlling power. As Mr. Bernays says, 'of late a reaction has set in.' "When the future historian, an American Sallust or Tacitus, records the downfall of our republic and its loss of liberty, he will point out the leading place that organized propaganda played in this unhappy business. Sallust tells us how such propagandist tricks as the Roman manipulators discovered -- bread and circuses -- brought about an unholy alliance between the passions of the mob and the ambitions of 'the intelligent few.' Tacitus tells us that when Augustus assumed divine attributes, and tyranny and persecution were later universal, these evils were possible because no one was able to protest. This is also the inevitable end of modern organized propaganda. Once we had an uncomplimentary word for such an industry. We called it 'intrigue.' The ambitious few who destroyed the freedom of the ancients won over the mob by making themselves visible. To-day, as Mr. Bernays says, their successors are setting up an 'invisible government.' Republica Americana delenda est. "P.S. They got the job! III -- Rebuttal by Everett Dean Martin. "I specifically stated that I would discuss the evils of propaganda at its best; Mr. Bernays replies that I am like one who, in writing about the medical profession, 'would discuss only the fakers and quacks.' I quoted passages from Mr. Bernays' recent book to show that propaganda tends to set up an invisible and irresponsible government. The language quoted is plain.... "Mr. Bernays does not really discuss my argument, that the methods used by propagandists, even at best, in the necessary attempt to translate all things into such terms that one hundred and twenty millions of people can be 'reached,' make for cheapness, insincerity, and intolerance. His argument is in substance that propaganda serves the truth by giving both sides of an issue a hearing. But is it true that, as things are, each side of an issue gains a fair and equal hearing? Is it not a fact that the little business and the unpopular cause -- those that have not the money to pay for the services of high-pressure salesmen and large-circulation advertising, however worthy they may be -- are increasingly unable to compete for a hearing with forces organized on a nationwide scale?... "I did not, as Mr. Bernays seems to think, bring severest criticism against propaganda in business. I am primarily interested in preserving our cultural inheritance. Doubtless propaganda in the form of advertising works less harm than elsewhere. The man who advertises soap generally sells what he advertises. Even the sale of an occasional gold brick is not the worst evil of propaganda. What I object to is the nation-wide sale of cultural gold bricks. Cover Page - Are We Victims of Propaganda? / American Memory US Govt Every word of this is a precise fit for the way the secret government of anti-smoking vermin has rammed its will down our throats! And with our own tax dollars, no less! Anti-smoker America is an utterly evil tyranny, and deserves to be wiped off the face of the earth. Sample Anti-smoking Hate Propaganda From a description of an anti-secondhand smoke commercial in Wisconsin: • A man and a woman are in a car, driving along quietly. The woman is driving, the man is in the passenger seat. They both appear to be about thirty. The man pulls out a cigarette and lights it. The woman driver gives him a dirty look and then suddenly swerves off the road and hits the gas. The car heads over a bump and goes airborne. Then she heads straight for a tree, just barely avoiding it at the last second. The man is screaming in horror as this crazy woman, driving like a mountain rally professional, has one near fatal miss after another. When the car finally stops, the man, wide-eyed and clearly terrorized, yells, "What are you dpoing?" The woman gives him a fully disgusted, condescending look and replies, "You endangered my life, didn't you?" It is not intended as mere hyperbole. These vermin demand that public policymakers treat this despicable crap as literal truth. They trot out slimy, corrupt physicians to make pretenses like this. And as for a fair and equal hearing, forget it! Their filthy media whores only trot out stupid, ignorant, credulous, sniveling, despicable little worms, who crawl on their bellies and prattle about how they want to quit smoking. Throughout history, there have been inquisitions, persecutions, and repressions, and every one of them has been caused by subhuman excrement like the anti-smoker. Their kind are the very essence of evil! We should be proud to go to war against them! A California psychotic gibbers, "Children are effectively smoking a pack and a half a day for every hour they are exposed to smoke in a car." And out of respect for these nonsensical ravings, the California State Senate voted 23-14 to ban smoking in cars. The subhuman filth are so irrational they can't figure out that not even a smoker is exposed to a pack and a half a day for every hour they are in a car. (Senate votes to ban smoking in cars carrying young kids. By Steve Lawrence, AP. San Jose Mercury News, Aug. 28, 2006.) SPEWING LIES IS WHAT THE REPUBLICAN AND DEMOCRATIC PARTIES STAND FOR! Al-Qaida has the right plan: smash their putrid culture to rubble! Senate votes to ban smoking in cars carrying young kids, Aug. 28, 2006 / San Jose Mercury News The Lasker Syndicate PR Conspiracy The Anti-Smokers' Obsession With Advertising The anti-smokers' obsession with tobacco industry advertising makes no sense from a practical point of view. After all, plenty of people smoked cigarettes in communist countries where advertising was forbidden. The tobacco industry is clearly not dependent upon advertising for its existence. Their obession actually reflects the anti-smoking movement's insecurity about its own shady origins and dependence on constant hype. Mary Woodard Lasker's husband, Albert D. Lasker, had headed the biggest advertising agency in the world. The American National Business Hall of Fame credits his efforts for Lord and Thomas' success, and acclaims him as "the Founder of Modern Advertising." Edward L. Bernays Albert Lasker is given undue credit for supposed advertising genius for his advertising slogan for Lucky Strike cigarettes aimed at women. The story is that 1930s surveys showed that many women didn't buy that brand merely because the green color of the package didn't go with their wardrobes, so, in 1934, advertising huckster Edward L. Bernays set out to make green a fashionable color. "Under the auspices of a local charity, Bernays planned a Green Ball and dispatched a well-connected society matron to the Paris couturiers to coax them into providing green gowns for the event. He convinced a leading textile manufacturer to sponsor a Green Fashions Fall luncheon for fashion editors and invited an art historian and a psychologist to expatiate on the significance of green. He organized a Color Fashion Bureau, which disseminated trends to the press, naturally emphasizing the popularity of the color green." "Using green paper, he concocted a letter-writing campaign to interior decorators, artindustry groups, department stores and clubwomen describing the sudden 'dominance' of green. He induced department stores to feature green dresses and suits in their window displays, and he persuaded the Reinhardt Galleries to hold a "Green Exhibition" of paintings. The result of this six-month flurry: green became the hot new color of fashion." (The Lives They Lived: Edward L. Bernays and Henry C. Rogers; The Fathers of P.R. By Neal Gabler. The New York Times 1995 Dec. 31.) Gabler / The New York Times 1995 Note that Mary Woodard was employed at Reinhardt Galleries, and Paul Reinhardt was her first husband. Furthermore, she was for many years the only art dealer in New York with a degree in art history, and fashion magnate Eleanor Lambert was one of her close friends. The rest of the story about the Green Ball The Green Ball was held the night of Oct. 25, 1934, at the Waldorf-Astoria. It was actually a charity benefit for the New York Infirmary for Women and Children. Mrs. Frank A. Vanderlip, the president of the infirmary, was the honorary chairman. Mrs. Harold E. Talbott Jr. was executive chairman, with somewhere between six and ten assistants. Members of the younger set of "Society" posed in scenes from famous paintings, and the Radio City Music Hall ballet entertained at supper. The illustrious boxholders included Mrs. Frank C. Altschul, Mrs. George F. Baker [Jr.], Mrs. Walter P. Chrysler, Mrs. William Randolph Hearst, Mrs. William Goadby Loew [Florence Baker], Mrs. William S. Paley, and Mrs. Alfred P. Sloan. (Society Prepares Gala Green Ball. New York Times, Sep. 30, 1934; 1,000 See Tableaux at the Green Ball. New York Times, Oct. 26, 1934.) It was just one-shot publicity by and for wealthy and connected socialites, and the fashion world promptly returned to normal. (First Night. White Fox on Black Velvet is Liked. By Virginia Pope. New York Times, Nov. 11, 1934.) In 1938, Mrs. Bernays was on the board of the Infirmary, along with Mrs. Frank Altschul, Paul D. Cravath, Mrs. Marshall Field, Mrs. William Randolph Hearst, and Miss Elizabeth Lamont. (Spring Style Show to Help Infirmary. New York Times, Apr. 17, 1938.) Marshall Field's investment banking firm was a financier of Tobacco & Allied Stocks, which eventually took over Philip Morris. Mrs. Bernays (Doris E. Fleischman) had been involved in recent past fund-raisers for the Infirmary, along with such persons as Mrs. Alan A. Ryan Jr., Mrs. David Sarnoff, and Eleanor Lambert. Their patrons included Mrs. Juan T. Trippe, Mrs. Clendenin J. Ryan, Mrs. W. Goadby Loew, Mrs. August Belmont, and Mrs. William Randolph Hearst. (Two Social Events to Help Infirmary. New York Times, Apr. 15, 1934.) Mrs. Everett Dean Martin was among the Infirmary crowd. (Spring Fête to Aid Infirmary. New York Times, Feb. 26, 1933.) Doris Fleischman, fashion fascist, deplored diversity of style and proclaimed that "You can create fashions by coordinating your ideas, and you can create acceptance of them by coordinating your propaganda," and called for the creation of a "supercontrol" committee to centrally dictate fashions. (Style Curbs Are Urged. New York Times, Oct. 31, 1935.) Edward L. Bernays had been a member of the American Commission to Negotiate Peace in 1919, some of whom, including Bernays, Frank L. Polk, Bernard M. Baruch, Allen W. Dulles, and Christian Herter, later organized "a permanent but informal alumni group." (Organize Alumni of 1919 Peace Group. New York Times, Apr. 29, 1929.) Bernays was public relations counsel for the American Committee on Medical Costs, formed to support Secretary of the Interior Ray Lyman Wilbur, which advocated group medical care for the masses. (Prepare to Defend Socialized Medicine. New York Times, Dec. 1, 1932.) Bernays and William Green of the AFL were elected the board of directors of the Arthritis and Rheumatism Foundation, headed by Floyd B. Odlum. (Green, Bernays Elected. New York Times, Dec. 1, 1948.) Bernays and wife were friends of Prof. James Harvey Rogers of Yale University. (Dinner for Prof. Rogers. New York Times, Oct. 20, 1934.) Rogers was active in the Economic Committee of the League of Nations. (Dinner for Prof. J.H. Rogers. New York Times, Nov. 2, 1935.) They were also friends of cancer researcher Dr. Isabel Knowlton, who was married at their apartment. (Dr. Isabel Knowlton Wed. New York Times, Oct. 14, 1934; Dr. Isabel Knowlton Feted. New York Times, Nov. 14, 1935.) Their daughter, Doris Fleischman Bernays, married Richard M. Held, a teaching fellow in psychology at Harvard who recently received a grant in psychological research from the U.S. Public Health Service. (Doris F. Bernays Married in Home. New York Times, Jun. 30, 1951.) The ideology of deceit of Bernays and his co-conspirators: "Throughout our conversation, Bernays conveyed his hallucination of democracy: a highly educated class of opinion-molding tacticians are continuously at work, analyzing the social terrain and adjusting the mental scenery from which the public's mind, with its limited intellect, derives its opinions." (PR! A Social History of Spin. By Stuart Ewen, 1996. Chapter 1, Visiting Edward Bernays.) Actually, it is not a hallucination, but a description. It is those who imagine this corrupt system to be a democracy who are deluded. The anti-smoking movement, with its endless stream of smoking prevalence surveys and opinion polls and strategy evaluations and low-brow hate propaganda, illustrates this mentality so crassly and flagrantly that only a drooling imbecile could miss it. Furthermore, these manipulators are not the "highly educated" elite that they fancy themselves, but a bunch of shallow, charlatan-worshiping mediocrities, who use their financial and conspiratorial control to ensure that their lackeys and fellow travelers dominate the scene. PR! A Social History of Spin / Ewen "The Power of Public Relations," a discussion between Bernays; host David Suskind; Irwin Ross of the New York Post; and Rodger Tubby, former State Department press officer and press secretary to President Truman. (Radio Reports. for Hill & Knowlton Inc., on "Open End," Dec. 13, 1959, over WNTA-TV, Newark NJ.) The Power of Public Relations, 1959 / tobacco document Bernays' support of John Banzhaf's anti-smoking group ASH Bernays was a longtime sponsor of anti-smoker lawyer John Banzhaf's group, ASH. The group was created to manufacture hate propaganda after Newton Minow stacked the Federal Communications Commission with cronies from the Ford Foundation, who delivered the infamous "Fairness Doctrine" ruling to subsidize the anti-smokers. The Fairy Tale of John Banzhaf and the Fairness Doctrine Kloepfer Informational Memorandum, Tobacco Institute, 1968 / tobacco document John Banzhaf's letter to the Federal Trade Commission, Sep. 20, 1977, with list of Trustees and Sponsors, including Bernays et al. Banzhaf - ASH letter, 1977 / tobacco document Bernays is listed as a sponsor of ASH in the group's "Smoking and Health Review," May 1985. Smoking and Health Review, May 1985 / tobacco document Bernays participated in the 1981 National Conference on Smoking or Health Edward L. Bernays was a member of Work Group 8, "Countering Cigarette Advertising and Supporting the Rights of Nonsmokers Through the Media" -- that is how this nest of subhuman vermin mischaracterize their campaign of systematic psychopathic lies and defamations -- of the 1981 National Conference on Smoking or Health. Work Group 8, NCSH 1981 / tobacco document Project HOPE Mrs. Edward L. Bernays and Sen Jacob K. Javits were on the New York Committee for Project HOPE in 1964. Mary Lasker was a member of the Benefit Committee, along with Mrs. and Mrs. William Randolph Hearst Jr.; Hon. and Mrs. Robert B. Meyner (in that year, he was the first and only administrator of the Cigarette Advertising Code); Mrs. William S. Paley; and Mrs. Lowell P. Weicker. Patrons and sponsors of the organization included Mrs. John T. Cahill (wife of Albert Lasker's attorney); the Hearsts; Mary Lasker; Mr. and Mrs. Samuel I. Rosenman; Mrs. Stanley M. Rumbough Jr. (wife of the American Health Foundation trustee); and Mrs. Weicker. New York Committee for Project HOPE, 1964 / tobacco document Other Committees, Project HOPE / tobacco document cast 07-08-07 How Tobacco and PR Grew Up Together http://www.sourcewatch.org/index.php?title=How_Tobacco_and_PR_Grew_Up_Together The recent public controversy over tobacco companies and their role in misleading the public about the effects of smoking looks remarkably similar to the controversies of 40 years ago. The first scientific studies documenting tobacco's role in cancer and other fatal illness began to appear in the early 1950s. Internal memos from the industry-funded Tobacco Institute refer to the PR fallout from this discovery as the "1954 emergency." Fighting desperately for its economic life, the tobacco industry launched what must be considered the costliest, longest-running and most successful PR 'crisis management' campaign in history. In the words of the industry itself, the campaign was aimed at "promoting cigarettes and protecting them from these and other attacks," by "creating doubt about the health charge without actually denying it, and advocating the public's right to smoke, without actually urging them to take up the practice."[1] Welcome to the 20th Century The symbiotic relationship between cigarettes and PR goes back even further than the 1950s, to the early 20th century when both were fledgling industries, and the tobacco companies used PR's psychological marketing skills to first 'hook' women and then children to their drug. Edward Bernays, Ivy Lee and John Hill today are legends within the PR profession. Bernays in particular is often referred to as the "father of PR." All three worked on PR for tobacco, pioneering techniques that today remain the PR industry's stock in trade: third party advocacy, subliminal message reinforcement, junk science, phony front groups, advocacy advertising, and buying favorable news reporting with advertising dollars. During the Roaring Twenties, the American Tobacco Company turned to PR to develop a vast new market--American women--for sales of its Lucky Strike cigarettes. The company first hired adman A.D. Lasker, whose advertisements featured female opera stars, their soprano voices somehow unaffected by their love for Luckies. Lasker portrayed Lucky Strikes as a healthy cigarette by concocting surveys using spurious data to claim that doctors preferred Luckies as the "less irritating" brand. However, his most effective campaign urged women to "Reach for a Lucky instead of a sweet." The campaign increased Lucky sales threefold in just twelve months. (The message, "cigarettes help keep you thin," reverberates today in the brand name Virginia Slims.) What Do Women Want? It was Edward Bernays, however, who built both the theoretical and practical foundation of modern public relations, beginning with his promotion of women's smoking. Bernays was a nephew of Sigmund Freud who how to apply psychology on a mass scale while serving on the World War I Committee on Public Information. He never disguised the purpose of PR, saying those "who understand the mental processes and social patterns of the masses ... pull the wires which control the public mind." On behalf of Lucky Strike, Bernays sought the advice of the psychoanalyst A.A. Brill. Brill's message to Bernays and the American Tobacco company was "freedom": sell cigarettes to women as a symbol of liberation. Following this advice, Bernays staged a legendary publicity event that is still taught as an example in PR schools. He hired beautiful fashion models to march in New York's prominent Easter parade, each waving a lit cigarette and wearing a banner proclaiming it a "torch of liberty." Bernays made sure that publicity photos of his smoking models appeared world-wide. To his credit, an older Bernays expressed regret at his work, saying if he'd known of the dangers of tobacco he would have refused the account. His admission and opinion remains rare among PR practioners. Thanks to Bernays and other early pioneers of public relations, cigarettes built a marketing juggernaut upon an unshakeable identification with sex, youth, vitality and freedom. The work for the tobacco industry, in turn, earned PR widespread credibility and launched the rise of today's multi-billion dollar public relations industry. Decades of saturation cigarette advertising and promotion continued into the 1950s via billboards, magazine, movies, TV and radio. The Truth Hurts In 1952, smoking's link to lung cancer began receiving major media attention. Reader's Digest ran an influential article titled, "Cancer by the Carton." A 1953 report by Dr. Ernst L. Wynder heralded to the scientific community a definitive link between cigarette smoking and cancer. Over the next 24 months, dozen of articles appeared in the New York Times and other major public publications: Good Housekeeping, the New Yorker, Look, Woman's Home Companion. Sales of cigarettes went into an unusual, sudden decline. The tobacco czars were in a panic. For help, they turned to John Hill, the founder of the PR megafirm, Hill & Knowlton. Hill designed a brilliant and expensive campaign that the tobacco industry is still using today in its fight to save itself from public rejection and governmental action. Hill is remembered today as a shrewd but ethical businessman who tried to keep "quacks" out of the PR profession. In a letter, he once stated, "It is not the work of public relations ... to outsmart the American public by helping management build profits." Yet Hill's work to save tobacco in the 1950s is such an egregious example of "outsmarting the American public ... to build profits" that his company is still in court today answering criminal charges. Hill & Knowlton's role is described as follows in a 1993 lawsuit, State of Mississippi vs. the Tobacco Cartel: The presidents of the leading tobacco manufacturers ... hired the public relations firm of Hill & Knowlton. ... As a result of these efforts, the Tobacco Industry Research Committee (TIRC), an entity later know as The Council for Tobacco Research (CTR), was formed. The Tobacco Industry Research Committee immediately ran a full-page promotion in more than 400 newspapers aimed at an estimated 43 million Americans ... entitled "A Frank Statement to Cigarette Smokers."... In this advertisement, the participating tobacco companies recognized their "special responsibility" to the public, and promised to learn the facts about smoking and health. The participating tobacco companies promised to sponsor independent research on the subject. ... The participating tobacco companies also promised to cooperate closely with public health officials.... After thus beginning to lull the public into a false sense of security concerning smoking and health, the Tobacco Industry Research Committee continued to act as a front for tobacco industry interests. Despite the initial public statements and posturing, and the repeated assertions that they were committed to full disclosure and vitally concerned, the TIRC did not make the public health a primary concern.... In fact, there was a coordinated, industry-wide strategy designed actively to mislead and confuse the public about the true dangers associated with smoking cigarettes. Rather than work for the good of the public health as it had promised, and sponsor independent research, the tobacco companies and consultants, acting through he tobacco trade association, refuted, undermined, and neutralized information coming from the scientific and medical community. There is no question that the tobacco industry knew what scientists were learning about tobacco. The TIRC maintained a library with cross-indexed medical and scientific papers from 2,500 medical journals; as well as press clippings, government reports and other documents. TIRC employees culled this library for scientific data with inconclusive or contrary results regarding tobacco and the harm to human health. These were compiled into a carefully selected 18-page booklet, titled "A Scientific Perspective on the Cigarette Controversy," which was mailed to over 200,000 people, including doctors, members of Congress and the news media. Bringing in the Sheaves During the 1950s, tobacco companies more than doubled their advertising budgets, going from $76 million in 1953 to $122 million in 1957. The TIRC spent another $948,151 in 1954 alone, of which one-fourth went to Hill & Knowlton, another fourth went to pay for media ads, and most of the remainder went to administrative costs. Despite TIRC's promise to "sponsor independent research," Only $80,000, or less than 10% of the total budget for the year, actually went to scientific projects. Hill's work on behalf of tobacco was successful. For forty years now, thanks to Hill and the PR industry, the tobacco manufacturers have staved off serious regulation. Even today, as the annual global carnage amounts to millions of tobacco deaths, the modern tobacco barons are sitting pretty. Sitting pretty? Yes, because smoking's bottom line is that the industry makes more money off tobacco than ever, and is now opening up the vast Asian market to its deadly addiction. The future for tobacco profits are bright, thanks in very large part to public relations. External links Scott M. Cutlip, "The Tobacco Wars: A Matter of Public Relations Ethics," Journal of Corporate Public Relations, 1992-93, Volume 3. Richard W. Pollay, "Propaganda, Puffing and the Public Interest," PR Review, Fall, 1990. The Doors Of Perception: Why Americans Will Believe Almost Anything http://www.opednews.com/oshea%20doors_of_perception.htm by Dr. Tim O'Shea (www.thedoctorwithin.com) We are the most conditioned, programmed beings the world has ever known. Not only are our thoughts and attitudes continually being shaped and molded; our very awareness of the whole design seems like it is being subtly and inexorably erased. The doors of our perception are carefully and precisely regulated. Who cares, right? It is an exhausting and endless task to keep explaining to people how most issues of conventional wisdom are scientifically implanted in the public consciousness by a thousand media clips per day. In an effort to save time, I would like to provide just a little background on the handling of information in this country. Once the basic principles are illustrated about how our current system of media control arose historically, the reader might be more apt to question any given story in today's news. If everybody believes something, it's probably wrong. We call that Conventional Wisdom. In America, conventional wisdom that has mass acceptance is usually contrived: somebody paid for it. Examples: • • • • • • • Pharmaceuticals restore health Vaccination brings immunity The cure for cancer is just around the corner When a child is sick, he needs immediate antibiotics When a child has a fever he needs Tylenol Hospitals are safe and clean. America has the best health care in the world. • And many many more This is a list of illusions, that have cost billions and billions to conjure up. Did you ever wonder why you never see the President speaking publicly unless he is reading? Or why most people in this country think generally the same about most of the above issues? How This Set-Up Got Started In Trust Us We're Experts, Stauber and Rampton pull together some compelling data describing the science of creating public opinion in America. They trace modern public influence back to the early part of the last century, highlighting the work of guys like Edward L. Bernays, the Father of Spin. From his own amazing chronicle Propaganda, we learn how Edward L. Bernays took the ideas of his famous uncle Sigmund Freud himself, and applied them to the emerging science of mass persuasion. The only difference was that instead of using these principles to uncover hidden themes in the human unconscious, the way Freudian psychology does, Bernays used these same ideas to mask agendas and to create illusions that deceive and misrepresent, for marketing purposes. The Father Of Spin Bernays dominated the PR industry until the 1940s, and was a significant force for another 40 years after that. (Tye) During all that time, Bernays took on hundreds of diverse assignments to create a public perception about some idea or product. A few examples: As a neophyte with the Committee on Public Information, one of Bernays' first assignments was to help sell the First World War to the American public with the idea to "Make the World Safe for Democracy." (Ewen) A few years later, Bernays set up a stunt to popularize the notion of women smoking cigarettes. In organizing the 1929 Easter Parade in New York City, Bernays showed himself as a force to be reckoned with. He organized the Torches of Liberty Brigade in which suffragettes marched in the parade smoking cigarettes as a mark of women's liberation. Such publicity followed from that one event that from then on women have felt secure about destroying their own lungs in public, the same way that men have always done. Bernays popularized the idea of bacon for breakfast. Not one to turn down a challenge, he set up the advertising format along with the AMA that lasted for nearly 50 years proving that cigarettes are beneficial to health. Just look at ads in issues of Life or Time from the 40s and 50s. Smoke And Mirrors Bernay's job was to reframe an issue; to create a desired image that would put a particular product or concept in a desirable light. Bernays described the public as a 'herd that needed to be led.' And this herdlike thinking makes people "susceptible to leadership." Bernays never deviated from his fundamental axiom to "control the masses without their knowing it." The best PR happens with the people unaware that they are being manipulated. Stauber describes Bernays' rationale like this: "the scientific manipulation of public opinion was necessary to overcome chaos and conflict in a democratic society." Trust Us p 42 These early mass persuaders postured themselves as performing a moral service for humanity in general - democracy was too good for people; they needed to be told what to think, because they were incapable of rational thought by themselves. Here's a paragraph from Bernays' Propaganda: "Those who manipulate the unseen mechanism of society constitute an invisible government which is the true ruling power of our country. We are governed, our minds molded, our tastes formed, our ideas suggested largely by men we have never heard of. This is a logical result of the way in which our democratic society is organized. Vast numbers of human beings must cooperate in this manner if they are to live together as a smoothly functioning society. In almost every act of our lives whether in the sphere of politics or business in our social conduct or our ethical thinking, we are dominated by the relatively small number of persons who understand the mental processes and social patterns of the masses. It is they who pull the wires that control the public mind." Here Comes The Money Once the possibilities of applying Freudian psychology to mass media were glimpsed, Bernays soon had more corporate clients than he could handle. Global corporations fell all over themselves courting the new Image Makers. There were dozens of goods and services and ideas to be sold to a susceptible public. Over the years, these players have had the money to make their images happen. A few examples: Philip Morris Pfizer Union Carbide Allstate Monsanto Eli Lilly tobacco industry Ciba Geigy lead industry Coors DuPont Chlorox Shell Oil Standard Oil Procter & Gamble Boeing General Motors Dow Chemical General Mills Goodyear The Players Though world-famous within the PR industry, the companies have names we don't know, and for good reason. The best PR goes unnoticed. For decades they have created the opinions that most of us were raised with, on virtually any issue which has the remotest commercial value, including: pharmaceutical drugs vaccines medicine as a profession alternative medicine fluoridation of city water chlorine household cleaning products tobacco dioxin global warming leaded gasoline cancer research and treatment pollution of the oceans forests and lumber images of celebrities, including damage control crisis and disaster management genetically modified foods aspartame food additives; processed foods dental amalgams Lesson #1 Bernays learned early on that the most effective way to create credibility for a product or an image was by "independent third-party" endorsement. For example, if General Motors were to come out and say that global warming is a hoax thought up by some liberal tree-huggers, people would suspect GM's motives, since GM's fortune is made by selling automobiles. If however some independent research institute with a very credible sounding name like the Global Climate Coalition comes out with a scientific report that says global warming is really a fiction, people begin to get confused and to have doubts about the original issue. So that's exactly what Bernays did. With a policy inspired by genius, he set up "more institutes and foundations than Rockefeller and Carnegie combined." (Stauber p 45) Quietly financed by the industries whose products were being evaluated, these "independent" research agencies would churn out "scientific" studies and press materials that could create any image their handlers wanted. Such front groups are given high-sounding names like: Temperature Research Foundation Manhattan Institute International Food Information Council Center for Produce Quality Consumer Alert Tobacco Institute Research Council The Advancement of Sound Science Coalition Cato Institute Air Hygiene Foundation American Council on Science and Health Industrial Health Federation Global Climate Coalition International Food Information Council Alliance for Better Foods Sound pretty legit don't they? Canned News Releases As Stauber explains, these organizations and hundreds of others like them are front groups whose sole mission is to advance the image of the global corporations who fund them, like those listed on page 2 above. This is accomplished in part by an endless stream of 'press releases' announcing "breakthrough" research to every radio station and newspaper in the country. (Robbins) Many of these canned reports read like straight news, and indeed are purposely molded in the news format. This saves journalists the trouble of researching the subjects on their own, especially on topics about which they know very little. Entire sections of the release or in the case of video news releases, the whole thing can be just lifted intact, with no editing, given the byline of the reporter or newspaper or TV station - and voilá! Instant news - copy and paste. Written by corporate PR firms. Does this really happen? Every single day, since the 1920s when the idea of the News Release was first invented by Ivy Lee. (Stauber, p 22) Sometimes as many as half the stories appearing in an issue of the Wall St. Journal are based solely on such PR press releases.. (22) These types of stories are mixed right in with legitimately researched stories. Unless you have done the research yourself, you won't be able to tell the difference. The Language Of Spin As 1920s spin pioneers like Ivy Lee and Edward Bernays gained more experience, they began to formulate rules and guidelines for creating public opinion. They learned quickly that mob psychology must focus on emotion, not facts. Since the mob is incapable of rational thought, motivation must be based not on logic but on presentation. Here are some of the axioms of the new science of PR: • • • • • technology is a religion unto itself if people are incapable of rational thought, real democracy is dangerous important decisions should be left to experts when reframing issues, stay away from substance; create images never state a clearly demonstrable lie Words are very carefully chosen for their emotional impact. Here's an example. A front group called the International Food Information Council handles the public's natural aversion to genetically modified foods. Trigger words are repeated all through the text. Now in the case of GM foods, the public is instinctively afraid of these experimental new creations which have suddenly popped up on our grocery shelves which are said to have DNA alterations. The IFIC wants to reassure the public of the safety of GM foods, so it avoids words like: Frankenfoods Hitler biotech chemical DNA experiments manipulate money safety scientists radiation roulette gene-splicing gene gun random Instead, good PR for GM foods contains words like: hybrids natural order beauty choice bounty cross-breeding diversity earth farmer organic wholesome It's basic Freudian/Tony Robbins word association. The fact that GM foods are not hybrids that have been subjected to the slow and careful scientific methods of real crossbreeding doesn't really matter. This is pseudoscience, not science. Form is everything and substance just a passing myth. (Trevanian) Who do you think funds the International Food Information Council? Take a wild guess. Right - Monsanto, DuPont, Frito-Lay, Coca Cola, Nutrasweet those in a position to make fortunes from GM foods. (Stauber p 20) Characteristics Of Good Propaganda As the science of mass control evolved, PR firms developed further guidelines for effective copy. Here are some of the gems: • • • • • • dehumanize the attacked party by labeling and name calling speak in glittering generalities using emotionally positive words when covering something up, don't use plain English; stall for time; distract get endorsements from celebrities, churches, sports figures, street people - anyone who has no expertise in the subject at hand the 'plain folks' ruse: us billionaires are just like you when minimizing outrage, don't say anything memorable, point out the benefits of what just happened, and avoid moral issues Keep this list. Start watching for these techniques. Not hard to find - look at today's paper or tonight's TV news. See what they're doing; these guys are good! PAGE 2 http://articles.mercola.com/sites/articles/archive/2001/08/15/percep tion2.aspx Science For Hire PR firms have become very sophisticated in the preparation of news releases. They have learned how to attach the names of famous scientists to research that those scientists have not even looked at. (Stauber, p 201) This is a common occurrence. In this way the editors of newspapers and TV news shows are often not even aware that an individual release is a total PR fabrication. Or at least they have "deniability," right? Stauber tells the amazing story of how leaded gas came into the picture. In 1922, General Motors discovered that adding lead to gasoline gave cars more horsepower. When there was some concern about safety, GM paid the Bureau of Mines to do some fake "testing" and publish spurious research that 'proved' that inhalation of lead was harmless. Enter Charles Kettering. Founder of the world famous Sloan-Kettering Memorial Institute for medical research, Charles Kettering also happened to be an executive with General Motors. By some strange coincidence, we soon have the Sloan Kettering institute issuing reports stating that lead occurs naturally in the body and that the body has a way of eliminating low level exposure. Through its association with The Industrial Hygiene Foundation and PR giant Hill & Knowlton, Sloane Kettering opposed all anti-lead research for years. (Stauber p 92). Without organized scientific opposition, for the next 60 years more and more gasoline became leaded, until by the 1970s, 90% of our gasoline was leaded. Finally it became too obvious to hide that lead was a major carcinogen, and leaded gas was phased out in the late 1980s. But during those 60 years, it is estimated that some 30 million tons of lead were released in vapor form onto American streets and highways. 30 million tons. That is PR, my friends. Junk Science In 1993 a guy named Peter Huber wrote a new book and coined a new term. The book was Galileo's Revenge and the term was junk science. Huber's shallow thesis was that real science supports technology, industry, and progress. Anything else was suddenly junk science. Not surprisingly, Stauber explains how Huber's book was supported by the industry-backed Manhattan Institute. Huber's book was generally dismissed not only because it was so poorly written, but because it failed to realize one fact: true scientific research begins with no conclusions. Real scientists are seeking the truth because they do not yet know what the truth is. True scientific method goes like this: 1. Form a hypothesis 2. Make predictions for that hypothesis 3. Test the predictions 4. Reject or revise the hypothesis based on the research findings Boston University scientist Dr. David Ozonoff explains that ideas in science are themselves like "living organisms, that must be nourished, supported, and cultivated with resources for making them grow and flourish." (Stauber p 205) Great ideas that don't get this financial support because the commercial angles are not immediately obvious - these ideas wither and die. Another way you can often distinguish real science from phony is that real science points out flaws in its own research. Phony science pretends there were no flaws. The Real Junk Science Contrast this with modern PR and its constant pretensions to sound science. Corporate sponsored research, whether it's in the area of drugs, GM foods, or chemistry begins with predetermined conclusions. It is the job of the scientists then to prove that these conclusions are true, because of the economic upside that proof will bring to the industries paying for that research. This invidious approach to science has shifted the entire focus of research in America during the past 50 years, as any true scientist is likely to admit. Stauber documents the increasing amount of corporate sponsorship of university research. (206) This has nothing to do with the pursuit of knowledge. Scientists lament that research has become just another commodity, something bought and sold. (Crossen) The Two Main Targets Of "Sound Science" It is shocking when Stauber shows how the vast majority of corporate PR today opposes any research that seeks to protect • • public health the environment It's a funny thing that most of the time when we see the phrase "junk science," it is in a context of defending something that may threaten either the environment or our health. This makes sense when one realizes that money changes hands only by selling the illusion of health and the illusion of environmental protection. True public health and real preservation of the earth's environment have very low market value. Stauber thinks it ironic that industry's self-proclaimed debunkers of junk science are usually non-scientists themselves. (255) Here again they can do this because the issue is not science, but the creation of images. The Language Of Attack When PR firms attack legitimate environmental groups and alternative medicine people, they again use special words which will carry an emotional punch: outraged sound science junk science sensible phobia hoax alarmist hysteria scaremongering responsible The next time you are reading a newspaper article about an environmental or health issue, note how the author shows bias by using the above terms. This is the result of very specialized training. Another standard PR tactic is to use the rhetoric of the environmentalists themselves to defend a dangerous and untested product that poses an actual threat to the environment. This we see constantly in the PR smokescreen that surrounds genetically modified foods. They talk about how GM foods are necessary to grow more food and to end world hunger, when the reality is that GM foods actually have lower yields per acre than natural crops. (Stauber p 173) The grand design sort of comes into focus once you realize that almost all GM foods have been created by the sellers of herbicides and pesticides so that those plants can withstand greater amounts of herbicides and pesticides. (The Magic Bean) Kill Your TV? Hope this chapter has given you a hint to start reading newspaper and magazine articles a little differently, and perhaps start watching TV news shows with a slightly different attitude than you had before. Always ask, what are they selling here, and who's selling it? And if you actually follow up on Stauber & Rampton's book and check out some of the other resources below, you might even glimpse the possibility of advancing your life one quantum simply by ceasing to subject your brain to mass media. That's right - no more newspapers, no more TV news, no more Time magazine or Newsweek. You could actually do that. Just think what you could do with the extra time alone. Really feel like you need to "relax" or find out "what's going on in the world" for a few hours every day? Think about the news of the past couple of years for a minute. Do you really suppose the major stories that have dominated headlines and TV news have been "what is going on in the world?" Do you actually think there's been nothing going on besides the contrived tech slump, the contrived power shortages, the re-filtered accounts of foreign violence and disaster, and all the other non-stories that the puppeteers dangle before us every day? What about when they get a big one, like with OJ or Monica Lewinsky or the Oklahoma city bombing? Do we really need to know all that detail, day after day? Do we have any way of verifying all that detail, even if we wanted to? What is the purpose of news? To inform the public? Hardly. The sole purpose of news is to keep the public in a state of fear and uncertainty so that they'll watch again tomorrow and be subjected to the same advertising. Oversimplification? Of course. That's the mark of mass media mastery simplicity. The invisible hand. Like Edward Bernays said, the people must be controlled without them knowing it. Consider this: what was really going on in the world all that time they were distracting us with all that stupid vexatious daily smokescreen? Fear and uncertainty -- that's what keeps people coming back for more. If this seems like a radical outlook, let's take it one step further: What would you lose from your life if you stopped watching TV and stopped reading newspapers altogether? Would your life really suffer any financial, moral, intellectual or academic loss from such a decision? Do you really need to have your family continually absorbing the illiterate, amoral, phony, uncultivated, desperately brainless values of the people featured in the average nightly TV program? Are these fake, programmed robots "normal"? Do you need to have your life values constantly spoon-fed to you? Are those shows really amusing, or just a necessary distraction to keep you from looking at reality, or trying to figure things out yourself by doing a little independent reading? Name one example of how your life is improved by watching TV news and reading the evening paper. What measurable gain is there for you? Planet of the Apes? There's no question that as a nation, we're getting dumber year by year. Look at the presidents we've been choosing lately. Ever notice the blatant grammar mistakes so ubiquitous in today's advertising and billboards? Literacy is marginal in most American secondary schools. Three fourths of California high school seniors can't read well enough to pass their exit exams. (SJ Mercury 20 Jul 01) If you think other parts of the country are smarter, try this one: hand any high school senior a book by Dumas or Jane Austen, and ask them to open to any random page and just read one paragraph out loud. Go ahead, do it. SAT scales are arbitrarily shifted lower and lower to disguise how dumb kids are getting year by year. At least 10% have documented "learning disabilities," which are reinforced and rewarded by special treatment and special drugs. Ever hear of anyone failing a grade any more? Or observe the intellectual level of the average movie which these days may only last one or two weeks in the theatres, especially if it has insufficient explosions, chase scenes, silicone, fake martial arts, and cretinesque dialogue. Radio? Consider the low mental qualifications of the falsely animated corporate simians they hire as DJs -- they're only allowed to have 50 thoughts, which they just repeat at random. And at what point did popular music cease to require the study of any musical instrument or theory whatsoever, not to mention lyric? Perhaps we just don't understand this emerging art form, right? The Darwinism of MTV - apes descended from man. Ever notice how most articles in any of the glossy magazines sound like they were all written by the same guy? And this guy just graduated from junior college? And yet he has all the correct opinions on social issues, no original ideas, and that shallow, smug, homogenized corporate omniscience, which enables him to assure us that everything is going to be fine... All this is great news for the PR industry - makes their job that much easier. Not only are very few paying attention to the process of conditioning; fewer are capable of understanding it even if somebody explained it to them. Tea In the Cafeteria Let's say you're in a crowded cafeteria, and you buy a cup of tea. And as you're about to sit down you see your friend way across the room. So you put the tea down and walk across the room and talk to your friend for a few minutes. Now, coming back to your tea, are you just going to pick it up and drink it? Remember, this is a crowded place and you've just left your tea unattended for several minutes. You've given anybody in that room access to your tea. Why should your mind be any different? Turning on the TV, or uncritically absorbing mass publications every day - these activities allow access to our minds by "just anyone" - anyone who has an agenda, anyone with the resources to create a public image via popular media. As we've seen above, just because we read something or see something on TV doesn't mean it's true or worth knowing. So the idea here is, like the tea, the mind is also worth guarding, worth limiting access to it. This is the only life we get. Time is our total capital. Why waste it allowing our potential, our personality, our values to be shaped, crafted, and limited according to the whims of the mass panderers? There are many important issues that are crucial to our physical, mental, and spiritual well-being. If it's an issue where money is involved, objective data won't be so easy to obtain. Remember, if everybody knows something, that image has been bought and paid for. Real knowledge takes a little effort, a little excavation down at least one level below what "everybody knows." Cargill From Wikipedia, the free encyclopedia http://en.wikipedia.org/wiki/Cargill Cargill, Incorporated is a privately held, multinational corporation, and is based in the state of Minnesota in the United States. It was founded in 1865, and has grown into the country's second largest privately held corporation (in terms of revenue).[1] Were it a publicly held company, it would rank in the top 20 companies in the Fortune 500. Cargill's business activities include purchasing, processing, and distributing grain and other agricultural commodities, and the manufacture and sale of livestock feed and ingredients for processed foods and pharmaceuticals. It also operates a large financial services arm, which manages financial risks in the commodity markets for the company. In 2003 it split out a portion of its financial operations into a hedge fund called Black River Asset Management, with about $10 billion of assets and liabilities[1]. It owns 2/3 of the shares of The Mosaic Company, one of the world's leading producers and marketers of concentrated phosphate and potash crop nutrients. Currently the second largest privately owned company in the United States[2] (behind Koch Industries), Cargill declared revenues of $120 billion USD, and earnings of $3.64 billion USD in the 2008 fiscal year.[3] Employing over 160,000 employees at 1,100 locations in 67 countries[2], it is responsible for 25 percent of all United States grain exports. The company also supplies approximately 22 percent of the United States domestic meat market, exporting more product from Argentina than any other company and is the largest poultry producer in Thailand. All of the eggs used in McDonald's restaurants in the United States pass through Cargill's plants. It is the only producer of Alberger process salt in the U.S.A., which is highly prized in the fast and prepared food industries. It operates a unique (and antique) plant in St. Clair in the Thumb of Michigan. Despite its size, the corporation is still a family owned business; descendants of the founder (from the Cargill and MacMillan families) own about 85% of the company. This means that most of its growth has been due to reinvestment of the company's own earnings, rather than public financing. Greg Page is the chief executive officer of Cargill who succeeded Warren Staley in mid 2007. History Cargill was founded in 1865 by W. W. Cargill when he bought a grain flat house in Conover, Iowa. A year later W.W. was joined by his brother Sam forming W. W. Cargill and Brother. They built grain flat houses and opened a lumberyard. In 1875 W.W. moved to La Crosse, Wisconsin and brother James joined the family business. The city of La Crosse was strategically located at the junction of the Milwaukee Road and the Southern Minnesota Division. Sam left La Crosse in 1887 and moved to Minneapolis to manage the office there, which was identified as an important emerging grain center. Three years later the Minneapolis operation incorporated under Cargill Elevator Co., years after that the La Crosse operation was incorporated under W. W. Cargill Company of La Crosse, Wisconsin. In 1898 John H. MacMillan, Sr. and his brother Daniel began working for W.W. John Sr. would marry W.W.'s eldest daughter, Edna. Sam's death in 1903 W.W. became the solo own of the La Crosse office. John Sr. was named as general manager of Cargill Elevator Co. and moved his family to Minneapolis. W.W. died in 1909 creating a fiscal crisis for the company. John Sr. worked to resolve the credit issues and to force his brother-in-law, William S. out of the company. The current owners are descended from John Sr. two sons, John H. MacMillan Jr. and Cargill MacMillan Sr., and his youngest brother-in-law, Austen S. Cargill I. John Sr. ran the company until his retirement in 1936. Under his leadership Cargill grew several fold, expanding out of the Midwest by opening its first East coast offices in New York in 1923 and first Canadian, European and Latin American office in 1928, 1929 and 1930. During this time Cargill saw both record profits and major cash crunches. The first of these crisis was the debt left by the death of W.W. The company issued $2.25 million in Gold Notes, back by Cargill stock to pay off its creditors. The Gold Notes were due in 1917. But thanks for record grain prices caused by World War I all debts were paid back in 1915. As World War I continued into 1917 Cargill made record earning and faced criticisms of war profiteering. Four years later as a fallout from the financial crash of 1920 Cargill posted its first loss. One of the company's biggest criticisms has been its perceived arrogance. The MacMillans' aggressive management style led to a decades long feud with the Chicago Board of Trade. The feud began in 1934 when Cargill was denied membership by the Board. The U.S. government over turned the Board's ruling and force them to accept Cargill as member. The 1936 corn corp failed and with the 1937 crop unavailable until October, the Chicago Board of Trade ordered Cargill to sell some of its corn. Cargill refused to comply. Cargill was then accused of trying to corner the corn market by the U.S. Commodity Exchange Authority and Chicago Board of Trade. In 1938 the Chicago Board of Trade suspended Cargill and three of its officers trading floor. When the Board lifted its suspension a few years later, Cargill refused to rejoin. Cargill instead traded through independent traders. In 1962 Cargill did rejoin the Chicago Board of Trade, two years after the death of John Jr. Cargill's quarterly profits crossed $1 billion for the first time during the quarter ending on February 29, 2008 ($1.03 billion); the 86% rise was credited to global food shortages and the expanding biofuels industry that in turn caused a rise in demand for Cargill's core areas of agricultural commodities and technology.[4] Business Strategy Cargill's long-term business strategy is to shift its business from trading and processing large volumes of agricultural commodities, to higher margin activities. One of them is the research and development of advanced processing techniques, particularly at its plant in Eddyville, Iowa. For example, in a joint venture with Hoffman-LaRoche, it has developed a process for converting a waste by-product of soybean oil refining into vitamin E. It also produces fuel-grade ethanol, citric acid, and phytosterol esters from grain. The company intends to work as consultants for its customers to create new ingredients and new food processing methods. Political and Economic views Cargill is an active proponent of free trade policies. It lobbied for China's membership in WTO, as well as for increased trade with Cuba and Brazil. Cargill's position is based on its strong support of neo-liberal economic principles. First, lesser trade barriers in countries where Cargill does business will lower prices on Cargill's products, and likely increase their volume of business. Second, the decreases in the cost of food in developing countries theoretically result indirectly in higher income per capita but lower income for local farmers. Cargill benefits from increases in consumer income, because better-paid consumers become inclined to eat a diet higher in wheat, protein, vegetable oil, and processed foods. This improves opportunities for Cargill to sell its products. Cargill's economists have reasoned that this is true of the lower income countries in particular. As a developing country grows from $1,000 to $6,000 in mean income per capita, Cargill expects the greatest profit growth from its businesses in that country. Cargill has maintained a 100% rating on the Corporate Equality Index (CEI) released by the Human Rights Campaign since 2003. Countries in Which Cargill Operates Asia • • • • • • • • • • • • • Australia China India Indonesia Japan Malaysia Pakistan Philippines South Korea Singapore Taiwan Thailand Vietnam Africa • • • • • Cote d'Ivoire Ghana Kenya Malawi Morocco • • • • Nigeria South Africa Tanzania Zimbabwe Central America/Caribbean • • • • • • Bonaire Costa Rica Dominican Republic Guatemala Honduras Nicaragua Europe • • • • • • • • • • • • • • • • • • • • • Austria Belgium Denmark Finland France Germany Greece Hungary Ireland Italy Netherlands Poland Portugal Romania Russian Federation Spain Sweden Switzerland Turkey Ukraine United Kingdom Middle East • • Egypt United Arab Emirates North America • Canada • • Mexico United States of America South America • • • • • • • • • Argentina Bolivia Brazil Chile Colombia Paraguay Peru Uruguay Venezuela Criticism Deaths and Injuries Mercury Poisoning in Iraq In 1970, Cargill sold 63,000 tons of seed grain to Basra, Iraq. Although banned in many Western countries - Cargill agreed to treat the seed grain with Methylmercury. The shipment was sprayed red to mark its danger and indicate that it was not intended for human or animal consumption but only for use in agriculture. Once it arrived in Iraq in early October however, the surplus seed was given away by the government, and a number of recipients used it as food, since the only printed warnings about the poison were written in English and Spanish, as warnings to American dock workers. This led to the deaths of 93 people.[5] 2007 Beef Recall In October 2007 Cargill announced the recall of nearly 850 000 frozen beef patties produced at its packing plant in Butler, Wisconsin. The patties, processed between the 9th and 17th of August 2007, were suspected of being contaminated with E. coli. [6] The beef was sold mainly at Walmart and Sam's Club stores. Human Rights Abuses against Malian Children In July 2005, the International Labor Rights Fund filed suit against Cargill, Nestle and Archer Daniels Midland in Federal District Court in Los Angeles on behalf of a class of Malian children who were trafficked from Mali into the Ivory Coast and forced to work twelve to fourteen hours a day with no pay, little food and sleep, and frequent beatings. The three children acting as class representative plaintiffs are proceeding anonymously, as John Does, because of feared retaliation by the farm owners where they worked. The complaint alleges their involvement in the trafficking, torture, and forced labor of children who cultivate and harvest cocoa beans which the companies import from Africa. [7] Uzbek Cotton Cargill operates in Uzbekistan despite admissions made by two of its representatives on separate occasions that the company is concerned about the possible use of child labor in the production of its crops. Their concerns have been public since 2005 however they have not yet taken action to investigate or correct any possible labor violations existent in their Uzbek operations. [8] The Environmental Justice Foundation named Cargill as a major buyer of Uzbek cotton, which is produced widely using uncompensated workers and is implicated in human rights abuses.[9] Cargill claims to have no knowledge of misconduct in either case. Environmental Damage Broken Wastewater Pipeline in Australia June 2007 the Australian operation of Cargill was fined $37,500 (AUD) by the New South Wales Land and Environment Court after a waste water pipeline ruptured in January 2006 which flowed into a stormwater system and into the Bomen wetland[10]. Filling of San Francisco Bay Wetlands In 2008, an issue has arisen concerning proposed filling of a large marsh and wetland along San Francisco Bay, which had been used by Cargill in its salt operations (Cargill Salt, the former Leslie Salt Company, puchased by Cargill in 1978[11][12]). It has been reported that Cargill Inc. is planning to build a massive development on more than 1,400 acres (5.7 km2) of Bayfront salt ponds in Redwood City. Groups opposing the proposed development are planning action against Cargill on developing on the site.[13] They assert that the wetland should be aggregated into a national wildlife refuge, and not filled.[14][15] Cargill's supposed policy of only dealing with ethical companies has also been called into question recently after its biggest UK Customer of Oils and Fats, KTC, was discovered to have had 34 illegal immigrants working for them and living in appalling conditions.[16] In the U.S., anti-GMO activists object to Cargill's marketing of genetically modified (GMO) seeds.[citation needed] Cargill has been criticized for using contract labor rather than maintaining regular employees. Cargill outsourced a small portion of their information technology operations to Electronic Data Systems or EDS in 2007.[citation needed] Controversy around Santarém port and Amazon deforestation In 2003, Cargill completed a port for processing soya in Santarém in the Amazon region of Brazil. The port dramatically increased soya production in the area due to the proximity of easy transport and processing facilities. Although Cargill complied with state legislation, they failed to comply with a federal law requiring an Environmental Impact Statement. In late 2003 Greenpeace launched a campaign claiming the new port sped up deforestation of local rain forest as farmers have cleared land to make way for crops.[3] In February 2006, the federal courts in Brazil gave Cargill six months to complete an environmental assessment (EA), different from an Environmental Impact Statement (EIS). This ruling came as part of a broader popular backlash against the port; while it was initially supported by locals who hoped for jobs, opinion has turned against it as the jobs have not appeared. In July 2006, federal prosecutor Felicia Pontes Jr. suggested they were close to shutting down the port.[4] Cargill responded to criticisms of the port by focusing on the need for economic development for the local province, one of the poorest in Brazil. They claimed that "extreme measures" such as closing the port are not necessary because "Soy occupies less than 0.6 percent of the land in the Amazon biome today." They also pointed to their partnership with The Nature Conservancy to encourage farmers around Santarém to comply with Brazilian law that requires 80% of forest to be left intact in forest areas.[5] In April 2006, Greenpeace released another report criticising Cargill's report for its alleged role in deforestation of the Amazon. The report traced animal feed made from Amazonian soya to European food retailers who bought chicken and other meat raised on the feed. Greenpeace took its campaign to these major food retailers and quickly won agreement from McDonalds along with UK-retailers Asda, Waitrose and Marks & Spencer to stop buying meat raised on Amazonian soya. These retailers in turn put pressure on Cargill and Archer Daniels Midland, Bunge, André Maggi Group and Dreyfus to prove their soya was not grown on recently deforested land in the Amazon. In July 2006, the Star Tribune newspaper of Minneapolis reported that Cargill had joined other soy businesses in Brazil in enacting a two-year moratorium on the purchase of soybeans from newly deforested land [6]. Damage to Santarem archaeological site In addition to the criticisms of Cargill lanced in the public lawsuits by a public prosecutor on behalf of the "Ministerio Publico Federal do Brasil", it was stated that Cargill also violated Brazilian law about the preservation of archaeological sites. The city of Santarem and its Port is one of the larger archaeological sites in Brazil, apparently the center of an expansive late prehistoric culture named after the city. According to the suits, the company did not comply with Brazilian law about the necessity of obtaining an archaeological impact statement and any subsequent necessary protection or salvage of archaeological deposits when it excavated a large area of the Santarem Port site to place some of its soy storage building near the shore.[citation needed] Cargill has denied that there was any archaeological deposit where it excavated for the foundation of its building but archaeologists working at Santarem under Brazilian government authorizations have reported and photographed archaeological deposits at that site in various years.[citation needed] The company is also facing its first-ever markets campaign, as the activist group Rainforest Action Network is pressuring Cargill to stop expanding into tropical ecosystems to grow soy and palm oil.[17] References 1. 2. 3. 4. ^ Forbes.com - The Largest Private Companies ^ The Ten Largest Private Companies - Forbes.com ^ Cargill reports fourth-quarter and fiscal 2008 earnings ^ Matt McKinney, At $471,611 an hour, Cargill posts fine quarter, Star Tribune, April 15, 2008. 5. ^ Broehl, Wayne G., Jr. (1998) Cargill: Going Global. University Press of New. England, Hanover, NH. Pages 167-171, 6. ^ Wisconsin Firm Recalls Ground Beef Products Due to Possible E. coli O157:H7 Contamination 7. ^ ADM, Nestle & Cargill Sued for Sourcing Cocoa Beans for Chocolate from Slave Labor Plantations in Africa 8. ^ Ethical Corporation: Europe - Uzbekistan cotton – A thread of hope in the retail fabric 9. ^ "The Curse of Cotton: Central Asia's Destructive Monoculture," International Crisis Group, February 28, 2005, p. 39. http://www.crisisgroup.org/home/index.cfm?id=3294 see also page 2. 10. ^ "Meat processor fined after polluting wetland". Australian Broadcasting Corporation. Retrieved on 2008-03-24. 11. ^ Corporate Profile for Cargill Salt, dated Aug. 21, 1998, Business Wire, August 21, 1998. Accessed online at FindArticle 26 October 2008. 12. ^ Lorna Fernandes, Cargill Salt markets sweet bayfront site, Silicon Valley / San Jose Business Journal, June 28, 1996. Accessed online 26 October 2008. 13. ^ Cargill: Don't Fill San Francisco Bay!, Bay Area News items, Indybay, February 2, 2008. Accessed online 26 October 2008. 14. ^ Cargill: Don't Fill San Francisco Bay, Save The Bay webpage devoted to the issue. Accessed online 26 October 2008. 15. ^ See also Save The Bay's Flickr Photoset. 16. ^ Richard Down, 34 illegal workers found in raid on docks firm, Liverpool Echo (UK), March 20, 2008. Accessed online 26 October 2008. 17. ^ Rainforest Action Network CDC Fluoride http://www.enotalone.com/article/10674.html August 2005 - Tooth decay, also known as dental caries, is a health problem that has plagued humankind for centuries. Until as recently as 60 years ago, the damage caused by caries was an inevitable fact of life for most people. The disease often meant many visits to the dentist to have damage and painful teeth repaired or removed. Today, primarily as a result of fluoride, damage caused by decay can be reduced and, in many instances, prevented. Fluoride's benefits for teeth were discovered in the 1930s. Dental scientists observed remarkably low decay rates among people whose water supplies contained significant amounts of natural fluoride. Several studies conducted during the 1940s and 1950s confirmed that when a small amount of fluoride is added to the community water supply, decay rates among residents of that community decrease. Although these studies focused primarily on the benefits of water fluoridation for children, more recent studies demonstrate that decay rates in adults are also reduced as a result of fluoride in the drinking water. Water fluoridation (fluoride in water) prevents tooth decay two ways: primarily through direct contact with teeth throughout life, and when consumed by children during the tooth forming years. The most inexpensive way to deliver the benefits of fluoride to all residents of a community is through water fluoridation. All water naturally contains some fluoride. When a community fluoridates its water, it adjusts the level of fluoride in the water to the optimal level for preventing tooth decay. Currently, more than 170 million people in the United States using public water supplies drink water containing enough fluoride to protect teeth. One of the health objectives contained in Healthy People 2010, the plan that sets health goals for the nation for the year 2010, calls for at least 75 percent of the population served by community water systems to receive optimal levels of fluoride. The current level is 67 percent. To reach this goal, approximately 14.3 million more people must gain access to fluoridated water through public water systems. Other sources of fluoride are also available. Fluoride can be applied directly to teeth through toothpaste, mouth rinses, and professionally applied fluoride treatments available in the dental office. Children who have been evaluated by their dentists as being at high risk for tooth decay and whose home water supplies contain low amounts of fluoride can take dietary fluoride supplements. This daily supplement, which can be prescribed by a dentist or a physician, should be taken only by children if the home water supply has been verified to contain a low concentration of fluoride. These methods of delivering fluoride are more expensive than water fluoridation and require a conscious decision to use them. However, the widespread availability of fluorides, via water fluoridation, toothpaste, and other sources, has resulted in the steady decline of dental caries throughout the United States. The Benefits of Fluoride Community water fluoridation is an effective, safe, and inexpensive way to prevent tooth decay. This method of fluoride delivery benefits Americans of all ages and socioeconomic status. Brushing twice a day with a fluoride toothpaste is an easy way to prevent tooth decay. Fluoridation, which was started in Grand Rapids, Michigan in 1945, has been used successfully in the United States for more than 50 years. It benefits both children and adults. Fluoride works by stopping or even reversing the decay process. It keeps tooth enamel strong and solid. Community water fluoridation is considered one of 10 great public health achievements of the 20th century. Of the 50 largest cities in the United States, 42 have community water fluoridation (and 2 cities are have natural fluoride levels that are optimal). Fluoridation reaches 67 percent of the population on public water supplies - more than 170 million people. The annual cost of fluoridation is approximately $0.50 in communities of ≥ 20,000 to approximately $3.00 per person in communities ≤ 5,000 (in 1995 dollars) for all but the smallest water systems. Even so, 100 million Americans do not have access to fluoridated water. Communities with fluoridated drinking water in the United States, Australia, Britain, Canada, Ireland, and New Zealand show striking reductions in tooth decay - those with fluoridated drinking systems have 15-40 percent less tooth decay. Nearly all tooth decay can be prevented when fluoridation is combined with dental sealants and other fluoride products, such as toothpaste. Fluoride dietary supplements can provide fluoride to those who do not have adequate levels in their drinking water. They are available as tablets, drops, or lozenges. Over-the-counter fluoride dental products such as toothpastes and mouth rinses are effective in preventing decay. Products with high concentrations of fluoride that are applied in the dental office or prescribed for home use offer additional protection for those at increased risk of tooth decay. Because older Americans are now keeping their teeth longer, fluoride will continue to be important for preventing tooth decay in this age group. Older Americans are especially susceptible to tooth decay because of exposed root surfaces and mouth dryness that may result from many medications. In the United States, water fluoridation is not the only form of fluoride delivery that is effective in preventing tooth decay in people of all ages. Use the information listed below to compare the other fluoride products that may lower the risk for tooth decay, especially for people who are at higher risk for decay: • Fluoride toothpaste • Fluoride mouthrinse • Fluoride supplements • Fluoride gel and foam - professionally applied • Fluoride varnish Although all of these products reduce tooth decay, combined use with fluoridated water offers protection greater than any of these products used alone. Fluoride Toothpaste Concentrations of fluoride in toothpaste sold in the United States range from 1,000-1,500 ppm. Most people report brushing their teeth at least once per day, but more frequent use can offer additional protection. Fluoride in toothpaste is taken up directly by the dental plaque and demineralized enamel and also increases the concentration of fluoride in saliva. Fluoride toothpaste is available over-the-counter and makes up more than 95% of toothpaste sales in the United States. For most people (children, adolescents, and adults) brushing at least twice a day with a fluoride toothpaste when you get up in the morning and before going to bed - is recommended. Advice for Parents For children aged 6 years and younger, some simple recommendations are advised to reduce the risk of enamel fluorosis. Supervise brushing to discourage swallowing toothpaste. Place only a small pea-size amount of fluoride toothpaste on your child's toothbrush. Seek advice from a dentist or other health care professional before introducing fluoride toothpaste to children under 2 years of age. Fluoride Mouthrinse Fluoride mouthrinse is a concentrated solution intended for daily or weekly use. The most common fluoride compound used in mouthrinse is sodium fluoride. Over-the-counter solutions of 0.05% sodium fluoride (230 ppm fluoride) for daily rinsing are available for use by persons older than 6 years of age. Solutions of 0.20% sodium fluoride (920 ppm fluoride) are used in supervised, school-based weekly rinsing programs. Other concentrations also are available. Rinses are used daily or weekly for a prescribed amount of time. The fluoride from mouthrinse is retained in dental plaque and saliva to help prevent tooth decay. Mouthrinses intended for home use can be purchased over-the-counter. Higher strength mouthrinses for those at high risk of tooth decay must be prescribed by a dentist or physician. Children younger than 6 years of age should not use fluoride mouthrinse without consultation with a dentist or other health care provider because enamel fluorosis could occur if such mouthrinses are repeatedly swallowed. Because fluoride mouthrinse has resulted in only limited reductions in tooth decay among schoolchildren, especially as their exposure to other sources of fluoride has increased, its use should be targeted to individuals or groups at high risk for decay. Fluoride Supplements Tablets, lozenges, or liquids (including fluoride-vitamin preparations) are available. Most supplements contain sodium fluoride as the active ingredient. Tablets and lozenges are manufactured with 1.0, 0.5, or 0.25 mg fluoride. Fluoride supplements can be prescribed for children at high risk for tooth decay and whose primary drinking water has a low fluoride concentration. To maximize the topical effect of fluoride, tablets and lozenges are intended to be chewed or sucked for 1-2 minutes before being swallowed. All fluoride supplements must be prescribed by a dentist or physician. The prescription should be consistent with the 1994 dosage schedule developed by American Dental Association (ADA), American Academy of Pediatric Dentistry (AAPD), and American Academy of Pediatrics (AAP). For children aged less than 6 years, the dentist, physician, or other health care provider should weigh the risk for tooth decay without fluoride supplements, the decay prevention offered by supplements, and the potential for enamel fluorosis. Consideration of the child's other sources of fluoride, especially drinking water, is essential in determining this balance. Parents and caregivers should be informed of both the benefit of protection against tooth decay and the possibility of enamel fluorosis (reducing the risk of fluorosis). When practical, supplements should be prescribed as chewable tablets or lozenges to maximize the topical effects of fluoride. Fluoride Gel and Foam Fluoride gel is often formulated to be highly acidic (pH of approximately 3.0). Products available in the United States include gel of acidulated phosphate fluoride (1.23% [12,300 ppm] fluoride), gel or foam of sodium fluoride (0.9% [9,040 ppm] fluoride), and self-applied (i.e., home use) gel of sodium fluoride (0.5% [5,000 ppm] fluoride) or stannous fluoride (0.15% [1,000 ppm] fluoride). In a dental office, fluoride gel is applied for 1-4 minutes. Home use follows instructions provided on the prescription. Most fluoride gel and foam applications are delivered in a dental office by a dental professional. These higher strength products, if used in the home, must be prescribed by a dentist or physician. Because these applications are relatively infrequent, generally at 3 to 12-month intervals, fluoride gel poses little risk for enamel fluorosis, even among patients younger than 6 years of age. Routine use of professionally applied fluoride gel or foam likely provides little benefit to persons not at high risk for tooth decay, especially those who drink fluoridated water and brush daily with fluoride toothpaste. Fluoride Varnish Varnishes are available as sodium fluoride (2.26% [22,600 ppm] fluoride) or difluorsilane (0.1% [1,000 ppm] fluoride) preparations. High-concentration fluoride varnish is painted by dental or other health care professionals directly onto the teeth. Fluoride varnish is not intended to adhere permanently; this method holds a high concentration of fluoride in a small amount of material in close contact with the teeth for many hours. Varnishes must be reapplied at regular intervals with at least 2 applications per year required for effectiveness. All fluoride varnish must be applied by a dentist or other health care provider. No published evidence indicates that professionally applied fluoride varnish is a risk factor for enamel fluorosis, even among children younger than 6 years of age. Proper application technique reduces the possibility that a patient will swallow varnish during its application and limits the total amount of fluoride swallowed as the varnish wears off the teeth over several hours. Although it is not currently cleared for marketing by the Food and Drug Administration (FDA) as an anti-caries agent, fluoride varnish has been widely used for this purpose in Canada and Europe since the 1970s. Studies conducted in Canada and Europe have reported that fluoride varnish is as effective in preventing tooth decay as professionally applied fluoride gel. About the Author www.cdc.gov The Centers for Disease Control and Prevention (CDC) is one of the 13 major operating components of the Department of Health and Human Services (HHS), which is the principal agency in the United States government for protecting the health and safety of all Americans and for providing essential human services, especially for those people who are least able to help themselves. Background: Infant Formula and the Risk for Enamel Fluorosis The proper amount of fluoride from infancy through old age helps prevent and control tooth decay. In a minority of children, fluoride exposure during the ages when teeth are forming (from birth through age 8) also can result in a range of changes within the outer surface of the tooth called enamel fluorosis. Recent evidence suggests that mixing powdered or liquid infant formula concentrate with fluoridated water on a regular basis may increase the chance of a child developing the faint white markings of very mild or mild enamel fluorosis. This occurs on baby and permanent teeth while they are forming under the gums. Once the teeth come into the mouth, they are no longer able to develop this condition. Typically, very mild or mild fluorosis is barely noticeable, if noticed at all. Studies have not shown that teeth are likely to develop more esthetically noticeable forms of fluorosis, even with regular mixing of formula with fluoridated water. In children younger than 8 years of age, combined fluoride exposure from all sources— water, food, toothpaste, mouth rinse, or other products—contributes to enamel fluorosis. Currently one-third (33%) of children aged 12 to 15 years in the United States have very mild to mild forms of this condition. It is important to understand that some fluoride exposure to developing teeth also plays a long-term role in preventing tooth decay. Parents and health providers should weigh the balance between a child’s risk for very mild or mild enamel fluorosis and the benefit of fluoride for preventing tooth decay and the need for dental fillings. The possibility of an association between fluoride in infant formula and the risk for enamel fluorosis has been studied for many years. Until now, most researchers concluded that fluoride intake during a child's first 10 to12 months had little impact on the development of this condition in permanent teeth. A recent study, however, has raised the possibility that fluoride exposure during the first year of life may play a more important role on fluorosis development than was previously understood. It now appears that the amount of the fluoride contained in the water used for mixing infant formula may influence a child’s risk for developing enamel fluorosis, particularly if the child’s sole source of nutrition is from reconstituted infant formula. CDC will continue to assess the science regarding the use of fluoride in preventing tooth decay while limiting enamel fluorosis, and will modify its recommendations as warranted. CDC believes that community water fluoridation is safe and healthy and promotes its use for people of all ages. • • • • • • What is the best source of nutrition for infants? What type of water does CDC recommend for mixing infant formula? Why is there a focus on infant formula as a source of fluoride? What types of infant formula may increase the risk for enamel fluorosis? What is enamel fluorosis? Should all parents consider mixing formula with water from sources other than tap water? • How can I find out what the concentration of fluoride is in my tap water? • My city has community water fluoridation (adjusted fluoride in the public water supply). Is it safe to use this tap water for my baby? • Is all bottled water low in fluoride? • Can mixing formula with optimally fluoridated tap water cause moderate or severe fluorosis? • Are children today at greater risk for developing fluorosis from infant formula mixed with fluoridated water than children in the past? • Will using only low fluoride water to mix formula eliminate the risk for fluorosis? • What can be done to reduce my child’s chance of developing fluorosis? What is the best source of nutrition for infants? Breastfeeding is ideal for infants. CDC is committed to increasing breastfeeding rates throughout the United States and to promoting optimal breastfeeding practices. Both babies and mothers gain many benefits from breastfeeding. Breast milk is easy to digest and contains antibodies that can protect infants from bacterial and viral infections. More can be learned about this subject at http://www.cdc.gov/breastfeeding/ If breastfeeding is not possible, several types of formula are available for infant feeding. Parents and caregivers are encouraged to speak with their pediatrician about which type of infant formula is best suited for their child. Back to Top What type of water does CDC recommend for mixing infant formula? Parents should follow the advice of the formula manufacturer and their child’s doctor for the type of water appropriate for the formula they are using. Parents and caregivers of infants fed primarily with formula from concentrate who are concerned about the effect that mixing their infant’s formula with fluoridated water may have in developing enamel fluorosis can lessen this exposure by mixing formula with low fluoride water most or all of the time. This may be tap water, if the public water system is not fluoridated (check with your local water utility). If tap water is fluoridated or has substantial natural fluoride (0.7 mg/L or higher), a parent may consider using a low-fluoride alternative water source. Bottled water known to be low in fluoride is labeled as purified, deionized, demineralized, distilled, or prepared by reverse osmosis. Most grocery stores sell these types of low-fluoride water. Ready to feed (no-mix) infant formula typically has little fluoride and may be preferred for use at least some of the time. Back to Top Why is there a focus on infant formula as a source of fluoride? Infant formula manufacturers take steps to assure that infant formula contains low fluoride levels—the products themselves are not the issue. Although formula itself has low amounts of fluoride, when infant formula concentrate is mixed with fluoridated water and used as the primary source of nutrition, it may introduce fluoride at levels above the amount recommended to minimize the risk for fluorosis. Infants consume little other than breast milk or formula during the first four to six months of life, and continue to have a high intake of liquids during the entire first year. Therefore, proportional to body weight, fluoride intake from liquids is generally higher for younger or smaller children than for older children, adolescents, or adults. Mixing concentrate with fluoridated tap water on an occasional basis is unlikely to be of much risk. However, when used consistently as the primary source of nutrition over longer periods of the first year, a child may receive enough fluoride to increase his/her chances of developing very mild or mild fluorosis. Back to Top What types of infant formula may increase the risk for enamel fluorosis? There are three types of formula, including powder, which comes in bulk or single serve packets, concentrated liquid, or ready-to-feed formula. Ready-to-feed formula is more convenient, but also more expensive. Powder formula is usually the least expensive, but requires mixing with water, as does the liquid concentrate. Ready-to-feed formula contains little fluoride and does not contribute to enamel fluorosis. Those types of formula that require mixing with water—powdered or liquid concentrates—can be the child’s main source of fluoride intake (depending upon the water source) and may contribute to this condition. Back to Top What is enamel fluorosis? Enamel fluorosis is a hypomineralization of the enamel surface of the tooth that develops during tooth formation. Clinically, this appears as a range of cosmetic changes varying from barely noticeable white lines or spots to pitting and staining of the outer enamel layer. More cosmetically objectionable forms of this condition can occur when young children consume excess fluoride from all sources during critical periods of tooth development. More can be learned about enamel fluorosis at http://www.cdc.gov/fluoridation/safety/enamel_fluorosis.htm. Back to Top Should all parents consider mixing formula with water from sources other than tap water? There is no evidence that water containing low concentrations of fluoride introduces a risk for enamel fluorosis in the developing teeth of young children. Some tap water and most bottled water contain low concentrations of fluoride. Mixing concentrate with fluoridated tap water on an occasional basis is unlikely to be of much consequence. For infants whose primary nutrition source is formula from concentrates, parents should take into consideration the fluoride concentration in their water source when making decisions about mixing formula. Back to Top How can I find out what the concentration of fluoride is in my tap water? The best source of information on fluoride levels in your water system is your local water utility. Other knowledgeable sources may be a local public health authority, dentist, dental hygienist, or physician. My Water’s Fluoride on the CDC Web site allows consumers in currently participating states to learn the fluoridation status of their water system. Nearly all tap water contains some natural fluoride, but, depending on the water system, the concentration can range from very low (0.2 mg/L fluoride or less) to very high (2.0 mg/L fluoride or higher). Approximately 67% of all public water systems serving about 170 million people have optimally adjusted fluoride in their water—that is between 0.7 and 1.2 mg/L fluoride. Back to Top My city has community water fluoridation (adjusted fluoride in the public water supply). Is it safe to use this tap water for my baby? Water fluoridation is safe, effective, and healthy. Water fluoridated at a level optimal for oral health poses no known health risks for infants. However, some children may develop enamel fluorosis, a cosmetic condition. All persons should know whether the fluoride concentration in their primary source of drinking water is below optimal (less than 0.7 mg/L fluoride), optimal (0.7–1.2 mg/L fluoride), or above optimal (greater than 1.2 mg/L fluoride). Use of water below 0.7 mg/L fluoride contributes to a very small risk of developing this condition. The risk increases with an increasing level of fluoride and depends on other factors, such as age and weight of the child and how much formula they drink each day. Knowledge of the fluoride level in the drinking water is also the basis for other individual and professional decisions regarding use of fluoride products by children, such as fluoride toothpaste, mouth rinses, or dietary supplements. In addition, people living in areas where naturally occurring fluoride levels in drinking water are greater than 2 mg/L should consider an alternative water source or home water treatments to reduce the risk of fluorosis for young children. Contact your local water company or utility to learn the fluoride level in your water supply. Back to Top Is all bottled water low in fluoride? Most bottled water contains low fluoride concentrations; however, much variation exists—some brands may contain optimal or higher levels. Because there currently is no requirement to display the fluoride concentration on bottle labels, you may need to contact the bottler to learn the level of fluoride in bottled drinking water. Certain types of bottled water are, by definition, always low in fluoride and can reliably be used for mixing formula. Water labeled as purified, distilled, deionized, demineralized, or produced through reverse osmosis are always low in fluoride. Back to Top Can mixing formula with optimally fluoridated tap water cause moderate or severe fluorosis? For decades, parents have been mixing infant formula with optimally fluoridated tap water (a level determined by the U.S. Public Health Service between 0.7 mg/L fluoride and 1.2 mg/L fluoride and maintained by your water utility to maximize decay prevention and limit fluorosis potential) and no association has been observed between infant formula use and an increased risk for moderate or severe fluorosis. There is no clear evidence that using infant formula from concentrates as the primary souce of nutrition increases a child’s chances of developing the more severe forms of fluorosis; however, there may be an increased risk for very mild to mild forms. Back to Top Are children today at greater risk for developing fluorosis from infant formula mixed with fluoridated water than children in the past? Children today are at no greater risk of developing enamel fluorosis from infant formula than children in previous generations. Little has changed with regard to the amount of fluoride consumed or the concentration of fluoride in the formula. There has always been some level of very mild and mild fluorosis in children, but it was thought to be caused by fluoride intake after age one. However, new evidence indicates that fluoride exposure during the first year of life may play a greater role in developing fluorosis than was previously thought, so parents may consider reducing the potential for this condition by limiting fluoride from this source. Back to Top Will using only low fluoride water to mix formula eliminate the risk for fluorosis? Using only water with low fluoride levels to mix formula will not eliminate the risk of enamel fluorosis. But following such a practice may reduce the chance of fluorosis occurring. This condition occurs among some children in all communities, even in communities with a low natural concentration of fluoride in the water. Other factors that contribute to developing fluorosis include swallowing of toothpaste and use of dietary supplements that include fluoride (tablets or drops). Learn more about simple steps to take care of children’s teeth. (PDF–170K) Back to Top What can be done to reduce my child’s chance of developing fluorosis? CDC has developed recommendations to reduce the risk for enamel fluorosis. Remember, fluorosis can only occur during the time of enamel formation, before the teeth come into the mouth. Young children who use multiple sources of fluoride such as fluoride toothpaste, dietary supplements, and water with optimal or higher natural fluoride have a higher risk for this condition. Community water fluoridation is a safe, effective, and inexpensive way to prevent tooth decay, and CDC recommends continuing and extending this practice. Steps can be taken to reduce the potential for enamel fluorosis associated with drinking water and other fluoride products. Learn more about recommendations on how to reduce the risk for enamel fluorosis. Back to Top Date last reviewed: October 8, 2008 Date last modified: August 9, 2007 Content source: Division of Oral Health, National Center for Chronic Disease Prevention and Health Promotion Page Located on the Web at http://www.cdc.gov/FLUORIDATION/safety/infant_formula.htm (CDC) policy on "sensitive but unclassified" information FAS Note: This revised Centers for Disease Control and Prevention (CDC) policy on "sensitive but unclassified" information was posted on the CDC intranet in February 2006. There are several links to the CDC intranet that are embedded in the text below. These links cannot be accessed from outside the CDC. A prior edition of this policy, dated July 2005, may be found here. CDC has revised the policy titled Sensitive But Unclassified Information. The purpose of this revision is to provide policy and procedures that allow CDC to accomplish its public health mission while safeguarding data and documents that are sensitive enough to require protection but that may not otherwise be designated as classified information. This policy contains guidance on: • • • • Establishment of coordinating center and national center- and office-level document control officers. Policy and procedures for document control officers to review and designate documents as sensitive but unclassified. Storage, dissemination, and protection requirements of sensitive but unclassified information. Roles and responsibilities regarding implementation of the program. To go directly to the policy, enter the following [CDC Intranet] URL into the location line of your browser: http://intraspn.cdc.gov/maso/policy/Doc/policy464.htm The Office of Security and Emergency Preparedness is the proponent for this policy. If you have questions or comments about this policy, you may contact policy analyst Tom Jones at 404-498-1516, or send an e-mail message to the CDC Policy e-mailbox. James D. Seligman Chief Information Officer SENSITIVE BUT UNCLASSIFIED INFORMATION SECTIONS I. PURPOSE AND SCOPE II. BACKGROUND III. ACRONYMS AND DEFINITIONS IV. POLICY V. RESPONSIBILITIES VI. PROCEDURES VII. REFERENCES VIII. ADDITIONAL RESOURCES I. PURPOSE AND SCOPE The purpose of this issuance is to provide policy and procedures that allow the Centers for Disease Control and Prevention (CDC)[1] to accomplish its public health mission while safeguarding data and documents that are sensitive enough to require protection but that may not otherwise be designated as classified information. This policy applies to all employees, fellows, guest researchers, attached uniformed service members (United States Public Health Service [USPHS] Commissioned Corps, Department of Defense employees, and service members) contractors, subcontractors, or any other individual working at CDC or under the auspices thereof. II. BACKGROUND CDC is required by OMB Circular A-130, Management of Federal Information Resources, to “Protect government information commensurate with the risk and magnitude of harm that could result from the loss, misuse, or unauthorized access to or modification of such information.” Security programs and procedures already exist to protect classified matters. However, information generally available to the public as well as certain detectable activities may reveal the existence of, and sometimes details about, classified or sensitive information or undertakings. Such indicators may assist those seeking to neutralize or exploit U.S. Government actions (National Security Decision Directive Number 298). This policy is intended to minimize this risk. III. ACRONYMS AND DEFINITIONS A. For the purposes of this policy, the following acronyms apply: 1. CC/CO – coordinating centers and coordinating offices 2. CISO – Chief Information Security Officer 3. DCO – document control officer 4. HHS – Department of Health and Human Services 5. FOIA – Freedom of Information Act 6. ITSO – Information Technology Services Office 7. NC – national center 8. NSDD – National Security Decision Directive 9. OSEP - Office of Security and Emergency Preparedness 10. SDT – HHS Office of Security and Drug Testing 11. SBU – sensitive but unclassified B. For the purposes of this policy, the following definitions apply: 1. Document control officer a. NC[2]- and office-level DCO – Employees at the NC or office level who are given responsibility by their NC or office director for the proper maintenance of records related to monitoring, safeguarding, storing, transmitting, and destroying information that is categorized as SBU in compliance with NSDD-189, National Policy on the Transfer of Scientific, Technical, and Engineering Information. b. CC/CO DCO – Employees at the CC/CO-level who are given responsibility by their CC/CO director to review decisions made and/or to provide guidance to the NC or office DCO level. c. OSEP DCO – When questions of sensitivity arise that cannot be decided at the NC, office, or CC/CO levels, the OSEP DCO shall serve as the final approval authority. The OSEP DCO shall also be responsible for conducting necessary training related to this policy. 2. Electronic media Electronic media include magnetic tape reels, disk packs, diskettes, compact discs, removable hard disks, disk cartridges, optical disks, paper tape, reels, magnetic cards, tape cassettes, micro cassettes, videotapes, and any other device on which data are stored and that normally is removable from the system by the user or operator. 3. Exclusion area An exclusion area is a security area with barriers that identify the boundaries and encompass the designated space and includes access controls and intrusion detection to provide reasonable assurance that only authorized personnel are allowed to enter and exit the area without escort. Access to an exclusion area requires a proximity card, access authorization, and a demonstrated need to know. The CDC’s current and proposed select agent laboratories are designated as exclusion areas. 4. Export controlled information or material Export controlled information or material is information or material that cannot be released to foreign nationals or representatives of a foreign entity without first obtaining approval or license from the Department of State. This pertains to items controlled by the International Traffic in Arms Regulations or the Department of Commerce and includes items controlled by the Export Administration Regulations. Export controlled information must be controlled as SBU information and marked accordingly. 5. Freedom of Information Act The law that requires the release of publicly requested information with several exceptions: a. Exemption 1: Information that is currently and properly classified. b. Exemption 2: Information that pertains solely to the internal rules and practices of the agency and disclosure of which would allow circumvention of agency regulations. c. Exemption 3: Information specifically exempted by a statute establishing particular criteria for withholding. The language of the statute must clearly state that the information will not be disclosed. d. Exemption 4: Information such as trade secrets and commercial or financial information obtained from a company on a privileged or confidential basis that, if released, would result in competitive harm to the company, impair the government's ability to obtain like information in the future, or impair the government's interest in compliance with program effectiveness. e. Exemption 5: Intra-agency memoranda that are deliberative in nature. This exemption is appropriate for internal documents that are part of the decision-making process and contain subjective evaluations, opinions, and recommendations. f. Exemption 6: Information that, if released, could reasonably be expected to constitute a clearly unwarranted invasion of the personal privacy of individuals. g. Exemption 7: Records or information compiled for law enforcement purposes that: i. could reasonably be expected to interfere with law enforcement proceedings; ii. would deprive a person of a right to a fair trial or impartial adjudication; iii. could reasonably be expected to constitute an unwarranted invasion of personal privacy of others; iv. discloses the identity of a confidential source; v. discloses investigative techniques and procedures; or vi. could reasonably be expected to endanger the life or physical safety of any individual. h. Exemption 8: Certain records of agencies responsible for supervision of financial institutions. i. Exemption 9: Geological and geophysical information concerning wells. 6. Limited area A limited area is a security area residing within the property protection area (see definition of property protection areas) with barriers that identify its boundaries and encompass the designated space. The perimeter of a building often defines the boundaries of a limited area. It has access controls and intrusion detection in place to provide reasonable assurance that only authorized personnel are allowed to enter and exit the area without escort. Access to a limited area requires a proximity card and access authorization. 7. Property protection areas Property protection areas are defined by the outermost perimeter of the CDC facility, and this security area is established to protect against damage, destruction, and theft of CDC-owned property. At the Roybal site, the perimeter fence establishes the property protection area; it defines the boundaries of the Roybal Campus and controls personnel and vehicle access. 8. Proprietary Information Proprietary information is information such as trade secrets and commercial or financial information obtained from a company on a privileged or confidential basis that, if released, would result in competitive harm to the company, impair the government's ability to obtain like information in the future, or impair the government's interest in compliance with program effectiveness. 9. Sensitive but unclassified The “sensitive but unclassified” designation is applied to unclassified information that may be exempt from mandatory release to the public under FOIA. (For the nine FOIA exemptions, see the FOIA definition in this section.) SBU is the formal designation for information that, by law or regulation, requires some form of protection but is outside the formal system of classification, in accordance with Executive Order 12958, as amended. 10. Special exclusion area A special exclusion area is a security area with barriers that identify its boundaries and encompass the designated space. Further, it includes access controls to provide reasonable assurance that only authorized personnel are allowed to enter and exit the area without escort. Access to a special exclusion area requires a proximity card, access authorization, demonstrated need to know, and intrusion detection. Personnel authorized for access to these areas are required to hold the appropriate level of security clearance. IV. POLICY All CDC employees and otherwise affiliated persons shall protect SBU information by following the procedures contained in this policy document and/or related policies of CDC, HHS, Executive Orders, other Presidential Directives, United States Federal Court rulings, and applicable laws of the United States of America. V. RESPONSIBILITIES A. Responsibilities of CDC OSEP Director (or the director’s designee) with regard to SBU information 1. Appoint one or more OSEP DCO(s) to implement this policy and procedures. 2. Conduct SBU training. 3. Provide guidance and advice to CC/CO and NC and office DCOs. 4. Form an appeal board, as needed, to render timely judgments concerning appeals to sensitivity determinations. 5. Forward challenges to sensitivity decisions to the SDT. B. Responsibilities of CC/CO directors (or their designees) with regard to SBU information Each CC/CO director (or the CC/CO director’s designee) shall appoint one or more CC/CO DCO(s) to review decisions made at the NC or office DCO level and to provide guidance to NC and office DCOs. C. Responsibilities of NC and office directors (or their designees) with regard to SBU information Each NC or office director (or the NC or office director’s designee) shall appoint one or more NC or office DCO(s) to review all submitted materials; render a sensitivity determination; and maintain records related to monitoring, safeguarding, storing, transmitting, and destroying information that is categorized as SBU in conformance with NSDD-189, National Policy on the Transfer of Scientific, Technical, and Engineering Information. D. Responsibilities of NC and office DCO(s) with regard to SBU information The NC and office DCO(s) shall review all submitted materials and render a sensitivity determination in accordance with this policy and applicable other laws, orders, rules, and regulations. Sensitivity determinations shall be documented in writing. Files will be maintained in accordance with the CDC Records Control Schedule. NC- and office-level DCOs are responsible for reviewing and approving information for internal release, Web site content, and to clear policies and procedures for posting on the Intranet. NC- and office-level DCOs are authorized to make sensitivity determinations ensuring that certain information is not for public release, and that information should be marked as SBU. However, any request for information from the public must be forwarded to the FOIA office for a determination and response. E. Responsibilities of CC/CO DCO(s) with regard to SBU information The CC/CO DCO(s) shall review decisions made by the NC or office DCO, as necessary, and will provide guidance to the NC or office DCO, as appropriate. F. Responsibilities of OSEP DCO(s) with regard to SBU information The OSEP DCO(s) shall implement this policy and related procedures; conduct necessary training; and provide guidance and advice to CC/CO and NC or office DCOs. When questions of sensitivity arise that cannot be decided upon at the NC, office, or CC/CO level, the OSEP DCO shall serve as the final decision-making authority. G. Responsibilities of supervisors with regard to SBU information Supervisors shall ensure that only authorized individuals – as identified in this policy –have access to SBU information. On an annual basis, and more often if necessary, supervisors shall inform their employees of the need to protect SBU information and of the requirement to have all documents that they create that might contain SBU should be sent to the NC- or office-level DCO(s) for a sensitivity determination. Supervisors shall enforce the procedures of this policy among their employees and within the work spaces for which they are responsible. Supervisors shall report suspected or known violations of this policy or procedures to the CC/CO DCO(s) immediately. H. Responsibilities of employees and affiliated persons with regard to SBU information Employees and affiliated persons, as provided in Section I of this policy, shall become knowledgeable of this policy and procedures and comply with the requirements established. I. Responsibilities of CDC FOIA Officer with regard to SBU information The CDC FOIA Officer shall provide advice, assistance, policy, and technical guidance on FOIA SBU issues to DCOs and management, as needed. The CDC FOIA Officer will obtain a sensitivity determination prior to a final FOIA decision to release or deny CDC records to the public. J. Responsibilities of CDC CISO with regard to SBU information The CDC CISO shall provide advice, assistance, policy, and technical guidance on information systems security with emphasis on Federal Information Security and Management Act of 2002, and the Computer Security Act of 1987. VI. PROCEDURES The following procedures should be followed with regard to SBU: A. Review and approval of information prior to public release The CC/CO and NC- or office-level DCOs are authorized to review and approve information for posting on the CDC Intranet Web site and to make sensitivity determinations to ensure that certain information is not for public release and that the information is marked as SBU. CC/CO and NC- or office-level DCOs are responsible for establishing submission procedures and making these procedures known to affected personnel. Marking information SBU does not automatically qualify it for a public release exemption. If a public request for a SBU document is received, the information should be reviewed by the CC/CO DCO to determine if it actually qualifies for exemption. However, only the CDC FOIA Officer is delegated the authority to approve withholding information requested by the public under FOIA. In reviewing documents, the absence of the SBU or other related marking does not necessarily mean the information should be publicly released. Some types of records (e.g., most human resources and financial information) are not normally marked SBU but may still qualify for withholding under FOIA, unless otherwise authorized for release by the individual. Therefore, all information should be reviewed and approved prior to its public release. The requirement for a sensitivity review applies equally to hard copy and electronic documents. Electronic documents that require sensitivity review include, but are not limited to, submissions to online publications; documents that are drafted or stored on a publicly accessible home page; and submissions to another Internet site, regardless of site or location. When any portion of information proposed to be disclosed "might" be covered by a nondisclosure agreement, there must be no steps taken toward public disclosure until written permission from the OSEP DCO is received. This is a lifetime obligation that remains in effect as long as the information remains sensitive. B. Pre-publication review of Web site content Information on the Internet may be intended for a limited audience; however, it actually becomes available to a world-wide audience. The World Wide Web was not designed with security in mind, and unencrypted information is at high risk of compromise. CDC CISO and ITSO guidelines take into account what security access controls, if any, are in effect for specific sites, the sensitivity of the information, and the target audience to which the information is intended. Most types of SBU information shall not go on a Web site unless that site is protected by encryption. Before putting unmarked information on a Web site, the information should receive a sensitivity review by the NC or office DCO and/or the CC/CO DCO to which the information belongs. The CC/CO director or the director’s representative may also conduct a review of the information. CDC sensitivity determinations and classification decisions require that when judgments are made that consideration should be given to the potential consequences of aggregation. The term "sensitive by aggregation" refers to the fact that information on one Web site may seem unimportant, but, when combined with information from other Web sites, it may form a larger and more complete picture than was intended or desired. Similarly, the compilation of a large amount of information together on one site may increase the sensitivity of that information and make it more likely that the Web site will be accessed by those seeking information that can be used against CDC. Personal information – such as addresses; telephone numbers, other than those readily available to the public; social security numbers; dates of birth; names of family members in biographical summaries, etc. – should not be posted on the Internet. C. Sensitivity decision and notification If a sensitivity decision is in question after review by the NC- or office-level DCO and the CC/CO DCO, the decision should be referred by the CC/CO DCO to the OSEP DCO via e-mail or inter-office mail. The OSEP DCO shall issue a decision within 15 working days as to the sensitivity of information of a draft document. If a decision cannot be made, or if it is determined that the information should be classified, the document will be sent to either a security review panel at CDC OSEP and/or forwarded to SDT for a sensitivity determination. The originator will be promptly notified as to the status of the document by the OSEP DCO. D. Appeal of sensitivity decision Sensitivity determinations may be appealed by a formal written request via e-mail or inter-office mail from the originator through the affected CC/CO director and sent to the Director of OSEP for a final determination. E. Categories of SBU Information Sensitive information consists of any information exempted from FOIA and includes, but is not limited to, information related to personnel, security, and select agents. Examples include, but are not limited to: 1. Personnel General personnel information such as evaluation and performance data; security information, including background investigation results and adjudication, and infractions/incident reports; personal information, when associated with an individual’s work on topics where security is involved (e.g., names and details of those working with select agents, classified data, counterintelligence) or with those individuals who are authorized to have a level of access beyond the average CDC employee/contractor/visitor. 2. Security Facility blueprints and other detailed facility information; databases associated with the physical security system; vulnerabilities of such facilities or sensitive information; network security information; security procedures; access codes (combinations or passwords); badge design information; security audit results; physical security performance test results; results of response force exercises; incident reports and disciplinary actions; response force capabilities; and security plans. 3. Select agents Databases and lab records associated with the select agent program including, but not limited to, inventory databases and chain of custody records; select agent transfer records; documentation associated with an experiment resulting in an unexpected result banned by 9 CFR § 121.10; and information deemed too sensitive for public release by a review and approval panel. F. SBU mandatory release exemptions under FOIA Information in either electronic or hard copy form determined to be SBU must fall within one or more of the nine FOIA exemption categories identified in Section II. B. 5. to be exempt from mandatory release to the public. G. SBU personnel access requirements United States citizen direct-hire supervisory employees are responsible for access, dissemination, and release of SBU material. Employees will limit access to protect SBU information from unintended public disclosure. Employees may circulate SBU materials to others, including non-United States citizens, to carry out an official United States Government function, if not otherwise prohibited by law, regulation, or interagency agreement. H. SBU safeguarding and storage requirements 1. Protection of SBU information while in use Reasonable precautions should be taken to prevent access to sensitive information by persons who do not require the information to perform their jobs (e.g., sensitive documents should not be read in a public place or taken home). 2. Storage rules for SBU information Sensitive information, both in hard copy and electronic form, should be physically protected and should be stored in limited areas. Exclusion areas and special exclusion areas are also acceptable storage locations, but high containment laboratories should only be used as storage areas for sensitive information when absolutely necessary. Storing sensitive information in a property protection area or a public area is only acceptable if additional protections are taken to increase protection to a level comparable to that in a limited area. All sensitive information existing in hard copy should be stored within a locked container in a limited or exclusion area, an access controlled electronic environment, or under the physical control of an authorized individual. On occasions when an individual is traveling within the United States and limited or exclusion areas are not available, a locked container within a locked room will suffice (e.g., locked briefcase or suitcase within a locked hotel room or vehicle). Sensitive information should not be taken outside the United States. Information handled electronically and transmitted over the network is at a higher risk of being released or altered. Sensitive information stored on the CDC network should be protected at a level that can ensure that only those who are authorized to view the information are allowed access (e.g., machine-generated passwords, encryption). The CDC network systems should maintain a high level of electronic protection (e.g., firewalls, intrusion detection, defense-in-depth, isolation of sensitive information, good practices network administration) to ensure the integrity of sensitive information and to prevent unauthorized access into these systems. Regular review of the protection methods used and system auditing are also critical to maintain protection of these systems. The physical elements of the network systems that store and transmit sensitive information or that have direct access to sensitive information should be secured within a limited area or exclusion area. The more central the information resource is (e.g., a network or security system control room), the higher the level of access control that should be applied. I. SBU marking requirements Information that has been determined to be SBU should be designated as SBU with the following appropriate markings and labels: 1. Documents Documents containing sensitive information should be covered with a “Sensitive But Unclassified” cover page, and the outside of the back cover should be marked “Sensitive But Unclassified.” Internal pages of the document should be marked “Sensitive But Unclassified” at the top and bottom of each page in letters clearly distinguishable from the text. The acronym SBU may be used when space does not permit spelling out “Sensitive But Unclassified.” The first page should contain the following statement at the lower left hand corner and should be completed with the applicable FOIA exemption number(s): “Sensitive But Unclassified (SBU) This document contains information that may be exempt from public release under the Freedom of Information Act (FOIA) (5 U.S.C. 552),exemption(s) ______ apply. Approval by the Centers for Disease Control and Prevention Document Control Officer, Office of Security and Emergency Preparedness, and the CDC FOIA Officer, prior to public release via the FOIA Office is required.“ 2. Electronic media Electronic media containing sensitive information should be labeled “Sensitive But Unclassified.” The label should be plainly visible and should be applied in a way that does not interfere with the drive mechanism. The outer covering for any of the above removable storage media should also be marked “Sensitive But Unclassified.” Videotapes should also contain “Sensitive But Unclassified” at the beginning and end of the played video, if possible. Audio cassettes, if possible, should contain an audible statement at the beginning and end of the played portion that informs the listener that the tape contains SBU information. 3. Blueprints, engineering drawings, charts, and maps Blueprints, engineering drawings, charts, and maps containing sensitive information should be marked “Sensitive But Unclassified - Building Information” or "SBU-BI" at the top and bottom of each page. If the blueprints, drawings, charts, or maps are large enough that they are likely to be rolled or folded, “Sensitive But Unclassified - Building Information” should be placed so that the marking is visible when the item is rolled or folded. 4. Photographs and negatives Photographs containing sensitive information should be marked “Sensitive But Unclassified” on the face, if possible. If this cannot be done, the marking should be placed on the reverse side. Negatives, positives, or other film containing sensitive information should be marked “Sensitive But Unclassified” on the film itself, if possible; otherwise, it should be protected inside a marked container. J. Reproduction of SBU information SBU documents may be reproduced without the permission of the originator to the extent necessary to carry out official CDC activities. Copies should be protected in the same manner as originals. In the event of a copy machine malfunction, the copy machine should be cleared and all paper paths checked for papers containing sensitive information. K. SBU transfer requirements 1. Communicating sensitive information Sensitive information may be communicated in the following ways: From person to person in direct contact with one another; over a land-line telephone; via first class, priority, or overnight mail; via fax machine; via e-mail to and from CDC email addresses that reside completely within the CDC network ([...]@cdc.gov); via e-mail to and/or from an e-mail address outside of the CDC network, provided that the sensitive data is encrypted and authenticated. 2. Discussing sensitive information via telephone or video conference Although sensitive information may be discussed on landline telephones, sensitive information should not be discussed on cellular phones. Sensitive information should not be transmitted via open network communication channels, including online video conferencing unless such a conference is held on a restricted network. 3. Mailing of sensitive information Transmission of sensitive information should be done in a manner that informs those with a need-to-know of the level of sensitivity while not advertising the fact to the general public. It is also important to use a reliable means of shipping. These considerations help to avoid unauthorized disclosure or dissemination of sensitive information. 4. Internal mail Before transmitting sensitive information through the CDC internal mail, the information should have appropriate markings and cover sheet and should be placed in a SBU envelope. 5. External mail Sensitive information sent outside CDC premises should be transmitted via first class mail, priority, or overnight mail. The outer wrapping should not be marked in a manner that would reveal the contents of the envelope or package to unauthorized personnel. 6. Faxing of sensitive but unclassified Information Prior to faxing sensitive information, the sender should confirm that an authorized person will be present to accept the transmittal at the receiving end, or the sender should verify that the receiving facility is protected in a manner sufficient to preclude unauthorized access to the transmitted material. 7. Electronic transmission Sensitive information should be encrypted and authenticated if it is sent from the CDC network to an unsecured (non-CDC) network. Sensitive information should never be communicated over wireless technologies, such as cellular or cordless telephones or wireless data devices (e.g., BlackBerry™ devices). L. SBU disposal and destruction requirements and methods Sensitive information should be destroyed by shredding or burning; paper containing sensitive information should not be recycled. Deleting, erasing, or formatting will not sufficiently remove sensitive information from electronic storage formats. Instead, files should be removed by using multiple passes (10 times minimum) of a hard drive wiping program. Electronic or removable media should be physically damaged to the point of inoperability, via shredding, degaussing, melting, or other such methods before disposal. M. Enforcement A violation of this policy may be cause for punitive administrative action, including termination of employment, dismissal, or discharge from USPHS Commissioned Corps. Further civil and criminal prosecution may be sought under one or more of the laws codified in the United States Code of Federal Regulations. N. Implementation Marking requirements identified in this policy apply to documents produced after this policy’s implementation date. However, all items, regardless of when they were produced, are subject to the remaining provisions of this policy effective upon the date of this policy’s implementation. VII. REFERENCES A. CDC Freedom of Information Policy. March 19, 2002. B. CDC Records Control Schedule. May 15, 1998. C. Computer Security Act of 1987, Public Law 100-235 (H.R. 145). January 8, 1988. D. Executive Order 12958, National Security Information. April 17, 1995. E. Export Administration Regulations. January 27, 2006. F. Federal Information Security Management Act of 2002. December 2002. G. Freedom of Information Act. September 18, 1996. H. International Traffic in Arms Regulations. April 1, 1992. I. National Institute of Standards and Technology: Computer Security. July 2003. J. NSDD-189, National Policy on the Transfer of Scientific, Technical, and Engineering Information. September 21, 1985. K. United States Code of Federal Regulations (1996-present). February 1, 2006. VIII. ADDITIONAL RESOURCES A. Arms Export Control Act. 1994. B. CDC-IR-2002-06, Protection of Information Resources. CDC, April 2002. C. CDC-IR-2002-03, Classified Material. CDC, April 2002. D. CDC-IS-2005-03, Use of CDC Information Technology Resources. CDC, August 2005. E. CDC-AM-2004-02, Procurement Integrity Restrictions. CDC, February 2004. F. CDC-GA-2005-06, Clearance Of Information Products Distributed Outside CDC for Public Use. CDC, July 2005. G. CDC-GA-2000-01, Privacy Act. CDC, November 2000. H. CDC-GA-2002-02, Freedom of Information Act. CDC, March 2002. I. CDC-GA-1998-01, Export Controls for Biological, Chemical, and Related Technical Data and Equipment. CDC, June 1998. J. CDC-GA-2000-02, Federal Advisory Committee Meeting Minutes. CDC, December 2000. K. CDC-GA-2005-14, CDC/ATSDR Policy on Releasing and Sharing Data. CDC, September 2005. [1] References to CDC also apply to the Agency for Toxic Substances and Disease Registry (ATSDR). [2] For ease of reference within policy documents, “NC” will refer collectively to CDC’s national centers, institute, the National Immunization Program, the Office of Genomics and Disease Prevention, and the Agency for Toxic Substances and Disease Registry (an independent Health and Human Services Agency that is led by the CDC director and for which CDC provides administrative services). Why is the CDC Covering Up a Fifty Year Old Mistake? by Roger D. Masters, PhD, Professor, Dartmouth College Published on: September 20, 2001 Dartmouth professor, Roger Masters, criticizes the U.S. Centers for Disease Control (CDC) for conspicuously excluding the name of the fluoride chemicals used to fluoridate most of America’s drinking water, while the CDC carefully details the various fluoride compounds contained in all other dental products mentioned in their recent report “Recommendations for Using Fluoride to Prevent and Control Dental Caries in the United States.” The reason might be that the silicofluorides, used by most fluoridating communities, have never been safety tested in humans or animals. Masters’ recent studies show how silicofluorides can be harming our children Controversy over "fluoridating" public water supplies has been on the agenda for half a century. Although the specific chemicals in use raise genuine scientific questions, most proponents (from the Surgeon General to the American Dental Association) and critics talk about "fluoridation" without discussing the difference between sodium fluoride, familiar in toothpaste, and fluosilicic acid or sodium silicofluoride (jointly called "silicofluorides"), which are the main chemicals used for water fluoridation in the U.S. Does the difference matter? If so, why does a long-delayed CDC (Centers for Disease Control) report on fluoride treatments carefully list the chemicals in fluoridated gels and mouthwash, but refuse to mention the chemicals used in our water supplies? Water fluoridation was begun in the mid 1940's as a ten year experiment to see if drinking-water with sodium fluoride would reduce tooth decay. All tests of safety were conducted on sodium fluoride. In 1950, however, the Public Health Service authorized the substitution of silicofluorides, even though they had never been tested for effects on health and behavior. Today, over 90% of fluoridated water (delivered to over 140 million Americans) is treated with one of the silicofluorides. The switch to silicofluorides about 50 years ago may have been an enormous mistake. Three years of intensive research, supported by the Earhart Foundation, has indicated that 1. Silicofluorides have never been tested for health and safety, and the EPA admits it now has no information on the effects of "chronic exposure" to water treated with them. 2. Silicofluorides do not dissociate completely after injection in public water supplies and their biochemical effects are not benign. 3. Extensive data analysis (based on three large samples of over 400,000 children) reveals that where silicofluorides are in use, children absorb significantly higher levels of lead from environmental sources (such as old housing). 4. Additional studies show that where silicofluorides are in use, there are higher rates of behavioral problems that have been linked to lead toxicity (including hyperactivity and other learning disabilities, substance abuse, and violent crime). These findings are based on a "cumulative loading" model of environmental risk factors (for the foregoing see http://www.dartmouth.edu/~rmasters/ahabs... The CDC and EPA have constantly refused to support objective scientific testing and have apparently engaged in a cover-up of data suggesting toxicity and harmful effects due to silicofluorides. The pattern evident in prior reports and funding decisions is especially noteworthy in the long-delayed CDC report on "Recommendations for Using Fluroide to Prevent and Control Dental Caries in the United States" (MMWR, Aug. 17, 2001, 50 [RR14] 1-42). This document is silent on the different health and behavioral effects of silicofluoride treated water compared to that treated with sodium fluoride. Although the report identifies the specific chemicals used to add fluoride to mouth rinse (sodium fluoride), dietary fluoride supplements (sodium fluoride), gel and foam (acidulated phosphate fluoride, sodium fluoride, or stannous fluoride) or fluoride varnish (sodium fluoride or difluorsilane), there is no mention of the specific chemicals used to fluoridate public water supplies or toothpaste (the two principal sources of fluoride for caries control). Given the foregoing information, informed observers suspect that the CDC intentionally omitted information to "cover up" the fact that silicofluorides, although used in over 90 percent of water fluoridation in the U.S., have never been subjected to the tests conducted on sodium fluoride or other health products and medicines. Some CDC personnel know the research questioning silicofluorides, and in one case attended a presentation of research on their dangers. It is time to discuss openly a toxin that could well contribute to higher rates of hyperactivity (ADHD) and crime in many American communities. Why should we allow bureaucrats to block discussion of the differences between either fluosilicic acid or sodium silicofluoride (toxic byproducts of manufacturing phosphate fertilizer as well as nuclear fuel and warheads) and sodium fluoride? Since silicofluorides have never been tested, shouldn't there be a moratorium on their use until their safety has been proven? If you live in Manhattan, you can choose non-fluoridated toothpaste but not non-fluoridated tap water. It's time for Congressional hearings on an issue that could help our children at virtually no cost (except for lost revenue to some chemical corporations and embarrassment to the CDC, EPA, and American Dental Association). For more information about Roger Masters and his work: http://www.dartmouth.edu/~rmasters/ahabs... Gazette Front Page Water Links See Gazette Fair Use Policy 2008 Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics) Special Nutritional Products and Cosmetics: Aspire36, Aspire Lite Dietary Supplements (posted 03/04/2008) "Blue Steel" and "Hero" Dietary Supplement Products (posted 03/25/2008) Calcilo XD Low-Calcium & Vitamin D-Free Infant Formula With Iron Powder (posted 06/02/2008) Herbal Science International, Inc. Dietary Herbal Supplements (posted 04/14/2008) Infant Formula Manufactured in China (posted 09/12/2008; UPDATE 09/22/2008) Rize 2 The Occasion Capsules and Rose 4 Her Capsules (posted 07/02/2008; UPDATE 07/30/2008) Total Body Formula, Total Body Mega Formula (posted 03/28/2008; UPDATED 05/01/2008) Viapro 375mg Capsules (posted 07/31/2008) Viril-ity Power (VIP) Tablets (posted 05/30/2008) Xiadafil VIP Tablets (posted 05/27/2008) Return to Top Drugs and Therapeutic Biological Products (CDER): 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product (posted 06/30/2008) Abacavir (marketed as Ziagen) and Abacavir-containing Medications (posted 07/24/2008) Amiodarone (used with simvastatin) (posted 08/08/2008) Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% (posted 09/18/2008) Antiepileptic Drugs (posted 01/31/2008) Antipsychotics, Conventional and Atypical (posted 05/29/2008) Avandia (rosiglitazone maleate) (posted 02/26/2008) Avastin (bevacizumab) (posted 07/14/2008) B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution (posted 03/21/2008) Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) (posted 01/07/2008) Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B) (posted 02/06/2008) Byetta (exenatide) (posted 02/27/2008; UPDATE 08/18/2008) Cardinal Alcohol-Free Mouthwash (posted 05/06/2008; UPDATE 05/19/2008) CellCept (mycophenolate mofetil) (posted 04/10/2008; UPDATE 06/26/2008) Colchicine, Injectable (including drugs containing colchicine) (posted 02/06/2008) Compounded Menopause Hormone Therapy Drugs (posted 01/10/2008) Cubicin (daptomycin for injection) (posted 04/09/2008) Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) (UPDATED 08/07/2008) Dextroamphetamine Sulfate 5mg Tablets (posted 10/16/2008) Digitek (digoxin tablets, USP) (posted 04/28/2008) Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches (posted 02/15/2008) Edetate Disodium (marketed as Endrate and generic products) (posted 01/16/2008) Enbrel (etanercept) (posted 05/01/2008) Epoetin alfa - Early Communication about an Ongoing Safety Review (posted 09/26/2008) Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) (posted 07/31/2008; UPDATED 08/08/2008) Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) (posted 03/12/2008) Exubera (insulin human rDNA origin) Inhalation Powder (posted 04/09/2008) Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor), and Ezetimibe (marketed as Zetia): Early Communication About an Ongoing Safety Review (posted 08/21/08) Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communication about an Ongoing Data Review (posted 01/25/2008) Fentanyl transdermal system CII Patches (posted 02/19/2008; UPDATED 03/03/2008) Fluoroquinolone Antimicrobial Drugs (posted 07/08/2008) Foradil (formoterol fumarate inhalation powder) Capsules (posted 02/29/2008) Heparin Sodium USP Pre-Filled Syringes (Posted 04/02/2008) Heparin Sodium Injection (Posted 02/11/2008, UPDATED 02/28/2008, 03/11/2008, 04/29/2008; 05/09/2008; 05/15/2008) Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials (posted 01/19/2008; updated 01/29/2008) Herceptin 440 mg and Herceptin BWFI diluent (posted 07/08/2008) Leukine (sargramostim) (posted 01/19/2008) Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension) (posted 03/11/2008; UPDATE 04/24/2008) Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) (posted 07/17/2008) Mitoxantrone Hydrochloride (marketed as Novantrone and generics) (posted 07/29/2008) MOM Enterprises Mommy's Bliss Nipple Cream (posted 05/29/2008) Morphine Sulfate 60 mg Extended Release Tablets (posted 06/10/2008) Mycophenolate Mofetil [MMF] (marketed as CellCept) (posted 05/16/2008) Mycophenolic Acid [MPA] (marketed as Myfortic) (posted 05/16/2008) Myfortic (mycophenolate acid) (posted 04/10/2008; UPDATED 07/01/2008) Neupro (rotigotine transdermal system) (posted 04/09/2008) NuCel Labs Eye Drops and Eye/Ear Wash Products (posted 01/31/2008) Ortho Evra Contraceptive Transdermal Patch (posted 01/19/2008) Over The Counter Cough and Cold Medications (posted 10/09/2008) Phosphocol P 32 (Chromic Phosphate P 32 Suspension) (posted 09/18/2008) Prezista (darunavir) (posted 03/12/2008; UPDATED 03/21/2008) Raptiva (efalizumab) (posted 10/17/2008) Regranex (becaplermin) Gel (posted 03/27/2008; UPDATED 06/06/2008) Relenza (zanamivir) (posted 04/02/2008) Simvastatin Used With Amiodarone (posted 08/08/2008) Singulair (montelukast) (posted 03/27/2008) Sodium Polystyrene Sulfonate Suspension (posted 07/16/2008) Solodyn (minocycline HCL) Extended Release Tablets 90 mg (posted 05/19/2008) Spiriva (tiotropium bromide inhalation powder) Capsules (posted 02/29/2008) Tamiflu (oseltamivir phosphate) (posted 03/04/2008) Tarceva (erlotinib) (posted 09/23/2008) Tiotropium (marketed as Spiriva HandiHaler) (posted 03/18/2008; UPDATED 10/07/2008) Trasylol (aprotinin injection) (UPDATE 05/14/2008) Tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) (posted 09/04/2008) Rituxan (rituximab) (posted 09/11/2008) Tumor Necrosis Factor Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) (posted 06/03/2008) Tysabri (natalizumab) (posted 08/25/2008) Tysabri (natalizumab) (posted 02/27/2008) Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs (posted 03/06/2008) Varenicline (marketed as Chantix) (posted 02/01/2008) Videx (didanosine) (posted 03/27/2008) Vivitrol (naltrexone) (posted 08/12/2008) Ziagen (abacavir) (posted 03/27/2008) Return to Top Medical Devices: Blood Glucose Meters and Test Strips (posted 03/11/2008) Boston Scientific NexStent Monorail (posted 08/14/2008) Chattem Icy Hot Heat Therapy Products (posted 02/11/2008; UPDATED 03/11/2008) Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters (posted 01/25/2008; updated 01/28/2008) Denture Cleanser Allergic Reactions and Misuse (posted 02/26/2008) Disposable Battery Operated Lavage System (BOLS) (posted 09/08/2008) Electronic Medical Devices (posted 07/16/2008) Heparin and Normal Saline Pre-Filled Flushes (posted 01/18/2008; updated 01/28/2008, updated 01/30/2008) Heparin Sodium Injection (Baxter) (Posted 02/11/2008, UPDATED 02/28/2008, 03/11/2008, 04/29/2008, 05/09/2008) Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) (posted 08/01/2008) LifePak CR Plus Automated External Defibrillators (posted 09/11/2008) Medtronic AneuRx Stent Graft System (posted 03/18/2008) Medtronic INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit (posted 10/02/2008) Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps (posted 03/21/2008) Medtronic SynchroMed EL Implantable Infusion Pump (posted 02/04/2008) Nebion HLX-8 Magnetic Resonance Device (posted 10/03/2008) Pacific Consolidated brand Mobile Oxygen Storage Tank (posted 08/28/2008) Radio Frequency Ablation Devices (UPDATE to 12/12/2007 MedWatch notice, posted 09/26/2008) Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion (posted 07/02/2008) Thoratec HeartMate II Left Ventricular Assist System (posted 10/28/2008) Transvaginal Placement of Surgical Mesh (posted 10/21/2008) Unretrieved Device Fragments (posted 01/15/2008) Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator (posted 10/31/2008) Return to Top 2008 Medical Product Safety Alerts, listed in reverse chronological order (most recent first). For an alphabetical listing, return to the categories on this page. You may also search the entire MedWatch site by keyword at the top of this Safety Information page. = Adobe Acrobat file (.pdf file), viewed with free Acrobat Reader software. For more information, go to the MedWatch "downloads" page at http://www.fda.gov/MedWatch/getforms.htm Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator Audience: Healthcare professionals [Posted 10/31/2008] FDA notified healthcare professionals of a Class I Recall of the Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. The manufacturer has submitted no evidence to FDA to support any of their claims that the product could treat or cure such diseases as cancer, depression, infection and pain. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device. [October 31, 2008 - Recall Notice - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Thoratec HeartMate II Left Ventricular Assist System Audience: Cardiologists, cardiovascular surgeons, hospital risk managers [Posted 10/28/2008] Thoratec Corporation notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having Catalogue No. 1355 or 102139), distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead. [October 24, 2008 - Press Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Transvaginal Placement of Surgical Mesh Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals [Posted 10/21/2008] FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks. [October 21, 2008 - Public Health Notification - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Raptiva (efalizumab) Audience: Dermatological healthcare professionals, patients [Posted 10/17/2008] FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age. Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva. [October 16, 2008 - News Release - FDA] [October 2008 - Prescribing Information - Genentech] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Dextroamphetamine Sulfate 5mg Tablets Audience: Pharmacists, other healthcare professionals, patients [Posted 10/16/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions. [October 15, 2008 - Press Release - Ethex] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Over The Counter Cough and Cold Medications Audience: Pediatric and primary healthcare professionals, consumers [Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns. [October 09, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Nebion HLX-8 Magnetic Resonance Device Audience: Healthcare professionals, consumers [Posted 10/03/2008] FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device. [October 03, 2008 - Recall Notice - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Medtronic INDURA 1P Intrathecal Catheter Sutureless Pump Connector Revision Kit Intrathecal Catheter Pump Segment Revision Kit Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers [Posted 10/02/2008] Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals. [October 01, 2008 - Recall Notice - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Statin drugs and amyotrophic lateral sclerosis (ALS) Audience: Neurologists, cardiologists, consumers [Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo. The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins. [September 29, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Epoetin alfa - Early Communication about an Ongoing Safety Review Audience: Neurological healthcare professionals [Posted 09/23/2008] FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group. FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials. [September 26, 2008 - Early Communication about an Ongoing Safety Review - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Audience: Hospital ER and ICU medical and nursing personnel, risk managers [Posted 09/23/2008] Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may impact the safe use of Ammonul. To ensure optimal patient care, healthcare providers are being instructed to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm ) during the admixture process when injecting Ammonul into the 10% Dextrose IV bag. Since this particulate matter may not be readily seen on visual inspection, a filter must be employed in all cases regardless of whether particulate matter is seen in the vial. Testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul. Contact Ucyclyd Pharma, 1-888-829-2593, or 1-800-900-6389 -- a representative is available 24 hours, seven days a week. [September 15, 2008 - Letter - Ucyclyd Pharma, Inc.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Tarceva (erlotinib) Audience: Oncological healthcare professionals [Posted 09/23/2008] OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections. [September 2008 - Letter - OSI Pharmaceuticals, Inc. and Genentech, Inc.] [September 12, 2008 - Label - OSI Pharmaceuticals, Inc. and Genentech, Inc.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Phosphocol P 32 (Chromic Phosphate P 32 Suspension) Audience: Oncologists, other healthcare professionals [Posted 09/18/2008] Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32. [August 29, 2008 - Letter – Covidien] [August 2008 - Label – Covidien] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Infant Formula Manufactured in China Audience: Consumers, pediatricians [UPDATE 10/03/2008] FDA issued the results of its interim safety and risk assessment that evaluated the melamine exposure in infant formula and in other foods. FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. FDA continues to advise consumers not to purchase infant formula manufactured in China from internet sites or from other sources and to contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status. [UPDATE 09/22/2008] FDA contacted companies who manufacture infant formula for distribution in the United States and has learned that they are not importing formula or source materials from China. FDA, in conjunction with state and local officials, began a nationwide investigation to check Asian markets for Chinese-manufactured infant formula and have not found Chinese infant formula present on shelves in these markets. FDA is advising consumers not to purchase infant formula manufactured in China from internet sites or from other sources. [Posted 09/12/2008] FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formula have fulfilled the requirements to sell this product in the United States. FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Caregivers should not feed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formula manufactured in the United States. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status. [October 03, 2008 - News Release - FDA] [September 20, 2008 - Statement - FDA] [September 12, 2008 - News Release – FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch LifePak CR Plus Automated External Defibrillators Audience: Emergency medical personnel, other healthcare professionals [UPDATE 09/16/2008] Recall classified by FDA as Class I. See the Recall notice for product numbers affected by this recall. [Posted 09/11/2008] Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service, or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover. [September 11, 2008 - Recall Notice – FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Rituxan (rituximab) Audience: Oncologists, rheumatologists, other healthcare professionals, consumers [Posted 09/11/2008] Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a longterm safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated. [September 2008 - Letter – Genentech] [September 2008 - Label – Genentech, Biogen Idec] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Disposable Battery Operated Lavage System (BOLS) Audience: Operating room, outpatient and emergency room supervisory staff and physicians, risk managers [Posted 09/08/2008] FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems’ (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursing units. The cutting of the battery pack's cable can lead to a short circuit, causing the batteries to discharge rapidly, producing intense heat and flammable gases with a resulting explosion that expels flammable gases and toxic chemicals endangering both patients and staff. Recommendations for avoiding this risk are provided in the medical device safety alert. [September 04, 2008 - Medical Device Safety (Reprinted Article) – FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals [Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. [September 4, 2008 - Information for Healthcare Professionals - FDA] [September 4, 2008 - Press Release - FDA] Previous MedWatch Alerts: [June 3, 2008] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Pacific Consolidated brand Mobile Oxygen Storage Tank Audience: Emergency healthcare professionals, military emergency/disaster/field hospital/aviation personnel [Posted 08/28/2008] Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage tank is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities with the Mobile Oxygen Storage Tank should keep the device in quarantine until arrangements are made to ship the device back to the manufacturer. [August 28, 2008 - Recall Notice - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Tysabri (natalizumab) Audience: Neurologists, other healthcare professionals, patients [Posted 08/25/2008] FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies. Approximately 39,000 patients have received treatment with Tysabri worldwide, with approximately 12,000 patients receiving treatment for a least one year. No new cases have been seen in the US, where about 7,500 patients have received the drug for greater than one year and approximately 3,300 patients have received the drug for at least one and one-half years. In the U.S., Tysabri is available only to patients with relapsing multiple sclerosis or Crohn's disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under this program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications. Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy. Healthcare professionals should continue to monitor patients for sign and symptoms of PML. Additionally, Tysabri should not be infused if PML is suspected. [August 25, 2008 - Information for Healthcare Professionals - FDA] Previous MedWatch Alert: [February 27, 2008] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Ezetimibe/Simvastatin (marketed as Vytorin) Simvastatin (marketed as Zocor) Ezetimibe (marketed as Zetia) Audience: Endocrinologists, cardiologists, other healthcare professionals, patients [Posted 08/21/2008] FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study. FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency. [August 21, 2008 - Early Communication about an Ongoing Safety Review - FDA] Previous MedWatch Alerts: [January 25, 2008] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Boston Scientific NexStent Monorail NexStent Carotid Stent and Monorail Delivery System Audience: Cardiologists, hospital risk managers [Posted 08/14/2008] Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions. [August 14, 2008 - Recall Notice - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Vivitrol (naltrexone) Audience: Primary healthcare physicians, internists, other healthcare professionals [Posted 08/12/2008] FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection. [August 12, 2008 - Drug Information Page - FDA] [August 12, 2008 - Information for Healthcare Professionals - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Simvastatin Used With Amiodarone Audience: Cardiologic healthcare professionals, pharmacists, other healthcare professionals [Posted 08/08/2008] FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is doserelated and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone. [August 08, 2008 - Drug Information Page - FDA] [August 08, 2008 - Information for Healthcare Professionals - FDA] [Labels - Simvastatin - DailyMed] [Labels - Amiodarone - DailyMed] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Audience: Cardiothoracic healthcare professionals, perfusionists, hospital risk managers, biomedical engineers [Posted 08/01/2008] Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. The Blood Pumping System is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure. A July 24, 2008 Levitronix device correction letter informed physicians not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because use may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem. [August 01, 2008 - Recall Notice - FDA] [July 24, 2008 - Letter - Levitronix] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Viapro 375mg Capsules Audience: Consumers, healthcare professionals [Posted 07/31/2008] EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro. [July 23, 2008 - Press Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) Audience: Oncologists, other healthcare professionals [Posted 07/31/2008] FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time. [August 7, 2008 - Letter - Amgen, Ortho Biotech] [July 30, 2008 - Follow Up to Ongoing Safety Review - FDA] [July 30, 2008 - Label - Aranesp] [July 30, 2008 - Label - Procrit] [July 30, 2008 - Label - Epogen] Previous MedWatch Alerts: [03/12/2008] [01/03/2008] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Audience: Neurological and Oncological healthcare professionals, risk managers [Posted 07/29/2008] FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug. These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS. [July 29, 2008 - Information for Healthcare Professionals - FDA] [March 2005 - Label - Novantrone - Serono, Inc.] Previous MedWatch Alerts: [05/24/2005] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Abacavir (marketed as Ziagen) and Abacavir-containing Medications Audience: Infectious disease and medical genetics healthcare professionals [Posted 07/24/2008] FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701. [July 24, 2008 - Information for Healthcare Professionals - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Audience: Radiological healthcare professionals, cardiologists, hospital risk managers [Posted 07/17/2008] FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for microbubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.These changes reflect conclusions of FDA reviews of information received following the addition of new Contraindications and Warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions. [July 17, 2008 - Information for Healthcare Professionals - FDA] [June 2008 - Dear Healthcare Professional Letter - GE] [May 2008 - Dear Healthcare Professional Letter - Lantheus Medical Imaging] Previous MedWatch Alerts: [10/12/2007] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Electronic Medical Devices Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals [Posted 07/16/2008] FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients. [July 14, 2008 - Public Health Notification - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Sodium Polystyrene Sulfonate Suspension Audience: Pharmacists, hospital risk managers, other healthcare professionals [Posted 07/16/2008] Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 00540165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product. [July 14, 2008 - Recall - Roxane Laboratories, Inc.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Avastin (bevacizumab) Audience: Oncologists, other healthcare professionals [Posted 07/14/2008] Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin. [July 11, 2008 - Dear Healthcare Professional Letter - Genentech] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Herceptin 440 mg Vials and BWFI Diluent Audience: Healthcare professionals [Posted 07/10/2008] Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. The affected vials are NDC# 50242-0134-68, List # 15534. There is a risk that damaged vials may lead to a loss in sterility, which can cause infections in patients. Healthcare professionals should inspect cartons of the product for signs of leakage, cracks and other damage to the vials, observe the vials during reconstitution, and check for loss of vacuum in the vials. See the manufacturer's letter for specific details and recommendations, including instructions in the event a compromised vial is discovered. [June 28, 2008 - Dear Healthcare Professional Letter - Genentech] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Fluoroquinolone Antimicrobial Drugs Audience: Healthcare professionals, consumers [Posted 07/08/2008] FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non- fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria. [July 08, 2008 - Drug Information Page - FDA] [July 08, 2008 - Information for Healthcare Professionals - FDA] [July 08, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Rize 2 The Occasion Capsules Rose 4 Her Capsules Audience: Consumers, healthcare professionals [UPDATE 07/30/2008] Jack Distribution, LLC, announced a nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. Lab analysis by FDA of samples of random lots found the product contains a potentially harmful, undeclared ingredient, thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for erectile dysfunction. [Posted 07/02/2008] Jack Distribution, LLC issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, marketed as dietary supplements. The products were recalled because certain lots contained thiomethisosildenafil, an undeclared ingredient that is an analog of sildenafil, a FDA-approved drug used for Erectile Dysfunction. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have one of the above products should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking the products. See the manufacturer's press release for the specific lot numbers of the recalled products. [July 28, 2008 - Press Release - Jack Distribution, LLC] [July 01, 2008 - Press Release - Jack Distribution, LLC] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Audience: Orthopedic surgeons, neurosurgeons, hospital risk managers, surgical service staff [Posted 07/02/2008] FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies. FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices. [July 01, 2008 - Public Health Notification - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Audience: Hospital risk managers, pharmacists [Posted 06/30/2008] Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF. The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer. [June 27, 2008 - Press Release - Sage Products] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Antipsychotics, Conventional and Atypical Audience: Neuropsychiatric and geriatrics healthcare professionals [Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementiarelated psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. [June 16, 2008 - Information for Healthcare Professionals - FDA] [June 16, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Morphine Sulfate 60 mg Extended Release Tablets Morphine Sulfate 30 mg Extended Release Tablets Audience: Pharmacists, other healthcare professionals [UPDATE 06/16/2008] Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label between June 2006 and May 2008. [Posted 06/10/2008] ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider. [June 13, 2008 - Press Release - ETHEX Corp.] [June 09, 2008 - Press Release - ETHEX Corp.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) Audience: Rheumatologists, gastroenterologists, oncologists, other healthcare professionals [Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. [June 04, 2008 - Early Communication About an Ongoing Safety Review of TNF Blockers - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Calcilo XD Low-Calcium & Vitamin D-Free Infant Formula With Iron Powder Audience: Consumers, pediatricians, other healthcare professionals [Posted 06/02/2008] Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD LowCalcium/vitamin D-Free Infant Formula with Iron powder, a lowcalcium and Vitamin D-free infant formula specifically designed for the nutrition support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns. [May 30, 2008 - Press Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Viril-ity Power (VIP) Tablets Audience: Consumers, healthcare professionals [Posted 05/30/2008] International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product. [May 29, 2008 - Press Release - International Pharmaceuticals, Ltd.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Mommy's Bliss Nipple Cream Audience: Nursing mothers, pediatricians, other healthcare professionals [Posted 05/29/2008] FDA informed consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Potentially harmful ingredients in the product are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause slow or shallow breathing in infants. Phenoxyenthanol, a preservative that is primarily used in cosmetics and medications, can also depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants. Mothers and caregivers should seek immediate medical attention if their child shows signs and symptoms of decreases in appetite, difficulty in awakening, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color. [May 23, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Xiadafil VIP Tablets Audience: Consumers, healthcare professionals [Posted 05/27/2008] FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to lifethreatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product. [May 27, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Solodyn (minocycline HCL) Extended Release Tablets 90 mg Audience: Pharmacists, other healthcare professionals [Posted 05/19/2008] Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Tablets. The product was recalled because one of the bottles contained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets. Azasan is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking Azasan instead of Solodyn presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Additionally, unanticipated interactions with other drugs may also lead to serious adverse events. The recall is limited to the lots referenced above. Healthcare professionals are urged to check their inventory and pull the referenced lot numbers from their stock and make arrangements with the manufacturer to return the product. [May 16, 2008 - Press Release - Medicis] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Mycophenolate Mofetil [MMF] (marketed as CellCept) Mycophenolic Acid [MPA] (marketed as Myfortic) Inosine Monophosphate Dehydrogenase Inhibitors (IMPDH) Immunosuppressants Audience: Transplantation specialists, infectious disease specialists, other healthcare professionals [Posted 05/16/2008] FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy. FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure. See the FDA Healthcare Professional Information Sheet containing considerations and recommendations for clinicians prior to prescribing MMF or MPA to women of childbearing potential. [May 16, 2008 - Healthcare Professional Sheet - FDA] Previous MedWatch Alerts: [04/10/2008] [11/27/2007] [10/29/2007] [02/22/2007] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Cardinal Alcohol-Free Mouthwash Audience: Consumers, hospital and nursing home risk managers, healthcare professionals [UPDATE 05/19/2008] Hydrox Labs issued a voluntary recall of another lot of Alcohol-Free Mouthwash because samples of the product tested were positive for Burkholderia cepacia (B. cepacia). The affected product lot number is 26230. [Posted 05/06/2008] Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facilities with the recalled alcohol-free mouthwash should stop using the product and contact Cardinal Health for instructions on how to return the product. [May 16, 2008 - Press Release - Hydrox Labs] [May 02, 2008 - Press Release - Hydrox Labs] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Enbrel (etanercept) Audience: Rheumatologists, dermatologists, other healthcare professionals, patients [Posted 05/01/2008] Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued. [March 14, 2008 - Dear Healthcare Professional Letter Amgen/Wyeth] [February, 2008 - Label - Amgen/Wyeth] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Digitek (digoxin tablets, USP) Audience: Cardiologists, family physicians, pharmacists, other healthcare professionals, patients [Posted 04/28/2008] Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions. [April 25, 2008 - Press Release - Actavis Totowa LLC] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Herbal Science International, Inc. Dietary Herbal Supplements Audience: Consumers, healthcare professionals [Posted 04/14/2008] Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury. Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase. [April 10, 2008 - Press Release - Herbal Science International] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch CellCept (mycophenolate mofetil) Myfortic (mycophenolate acid) Audience: Transplantation specialists, infectious disease specialists, other healthcare professionals [Update] Novartis informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the Myfortic prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic. [Update] Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with CellCept. [Posted 04/10/2008] FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information. FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information. As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public. Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic. [June 2008 -- Dear Healthcare Professional Letter - Novartis] [June 2008 -- Dear Healthcare Professional Letter - Roche] [April 10, 2008 - Communication About an Ongoing Safety Review FDA] Previous MedWatch Alerts: [11/27/2007] [10/29/2007] [02/22/2007] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Neupro (rotigotine transdermal system) Audience: Neurologists, other healthcare professionals, patients [Posted 04/09/2008] Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease, at the end of April 2008, because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises. [April 8, 2008 - Drug Shortage Information - FDA.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Exubera (insulin human rDNA origin) Inhalation Powder Audience: Endocrinologists, pulmonologists, pharmacists, patients [Posted 04/09/2008] Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 postmarketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control. [April 9, 2008 - Dear Healthcare Professional Letter - Pfizer, Inc.] [April 9, 2008 - Dear Patient Letter - Pfizer, Inc.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Cubicin (daptomycin for injection) Audience: Infectious disease healthcare professionals, hospital risk managers, and nursing service managers [Posted 04/09/2008] Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed. [April, 2008 - Letter - Cubist Pharmaceuticals, Inc.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Heparin Sodium USP Pre-Filled Syringes Audience: Surgeons, hospital risk managers, pharmacists, other healthcare professionals [Posted 04/02/2008] Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product. [March 28, 2008 - Press Release - Covidien] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Relenza (zanamivir) Audience: Pediatric and infectious disease healthcare professionals [Posted 04/01/2008] GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient. [March, 2008 - Letter - GlaxoSmithKline] [Feb, 2008 - Label - GlaxoSmithKline] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Total Body Formula, Total Body Mega Formula Audience: Consumers, healthcare professionals [UPDATE 05/01/2008] FDA notified healthcare professionals and consumers that the Agency's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" detected hazardous amounts of chromium in addition to selenium. Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake can also interfere with certain medications. FDA continues to investigate how excessive amounts of selenium and chromium got into the products. [UPDATE 04/10/2008] The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium -- up to 200 times the amount of selenium indicated on the labels of the products. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products. [Posted 03/28/2008] The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA laboratories are analyzing samples of the products to identify the cause of the reactions. [May 01, 2008 - News Release - FDA] [April 09, 2008 - News Release - FDA] [March 27, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Ziagen (abacavir) Videx (didanosine) Audience: Infectious disease specialists, other healthcare professionals, patients [Posted 03/27/2008] The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. [March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Regranex (becaplermin) Gel Audience: Endocrinologists, other healthcare professionals, patients [UPDATE 06/06/2008] FDA informed healthcare professionals that a Boxed Warning was added to prescribing information for Regranex that describes an increased risk of death from cancer in patients treated with three or more tubes of Regranex compared with those patients who did not use the product. FDA recommends that Regranex be used only when the benefits can be expected to outweigh the risks. [Posted 03/27/2008] The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. [June 06, 2008 - Drug Information Page - FDA] [March 27, 2008 - Communication About an Ongoing Safety Review FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Singulair (montelukast) Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients [Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. [March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch "Blue Steel" and "Hero" Dietary Supplement Products Audience: Consumers [Posted 03/25/2008] The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products, marketed nationally as dietary supplements, because these products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level. They are considered unapproved drugs and have not been proven to be safe or effective. These products are promoted and sold over the Internet for the treatment of erectile dysfunction [ED] and for sexual enhancement. They contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in an FDA-approved prescription drug for ED. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. [March 25, 2008 - Press Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution Audience: Surgeons, dialysis center staff, hospital risk managers, other healthcare professionals [Posted 03/21/2008] B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. [March 21, 2008 - Press Release - B. Braun Medical] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps Audience: Physiatry and Pain management healthcare professionals [Posted 03/21/2008] FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. [March 21, 2008 - Recall Notice - FDA] [January, 2008 - Dear Healthcare Professional Letter - Medtronic] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Tiotropium (marketed as Spiriva HandiHaler) Audience: Pulmonary care health professionals and patients [UPDATE 10/07/2008] FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes. FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk. [Posted 03/18/2008] Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period. It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. [UPDATE October 07, 2008 - Early Communication about an Ongoing Safety Review - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Medtronic AneuRx Stent Graft System Audience: Vascular surgery healthcare professionals, hospital surgical service managers [Posted 03/18/2008] FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent abdominal aortic aneurysm rupture. [March 17, 2008 - Public Health Notification - FDA] Previous MedWatch Alerts: [12/17/2003] [04/30/2001] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) Audience: Oncological healthcare professionals [Posted 03/12/2008] Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL. [March 07, 2008 - Dear Healthcare Professional Letter - Amgen] Previous MedWatch Alert: [11/08/2007] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Prezista (darunavir) Audience: Infectious disease healthcare professionals [UPDATE 3/21/2008] FDA issued a new "Information for Healthcare Professionals" sheet highlighting the addition of hepatotoxicity information to the WARNINGS section of prescribing information for Prezista. [Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment. [March 21, 2008 - Information for Healthcare Professionals - FDA] [March 2008 - Dear Healthcare Professional Letter - Tibotec] [February 2008 - Prescribing Information - Tibotec] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension) Audience: Healthcare professionals, pharmacists, patients [UPDATE 04/24/2008] Dear Healthcare Professional Letter issued by UCB, Inc. [Posted 03/11/2008] FDA informed healthcare professionals of lifethreatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression. Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose. [April 16, 2008 - Dear Healthcare Provider Letter - UCB] [March 11, 2008 - Drug Information Page - FDA] [March 11, 2008 - Public Health Advisory - FDA] [January 2008 - Prescribing Information - UCB] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Blood Glucose Meters and Test Strips Audience: Diabetes healthcare professionals, pharmacists and patients [Posted 03/11/2008] FDA reminded glucose meter users to only use strips recommended for their specific brand of meter and to read the instructions for use carefully. It is important for users to understand that if they use a test strip that is not recommended for their meter, the device may fail to give results or may generate inaccurate results. While this problem has been identified recently as occurring with a unique meter-strip configuration, FDA recognizes that similar problems can also occur if other brands and models of meters and strips are not used in proper combination. [March 10, 2008 - News Release - FDA/CDRH/OIVD] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs Audience: Healthcare professionals, consumers [Posted 03/06/2008] FDA advised healthcare professionals and consumers that the Agency issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs). The products are marketed under the names Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The products pose a serious health threat to unsuspecting consumers who don't know that these products are not FDA approved and have not been proven safe or effective. Consumers who are currently using these products should stop using them immediately and consult their healthcare professional if they have experienced any adverse effects that they suspect are related to the use of these products. [March 06, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Aspire36, Aspire Lite Dietary Supplements Audience: Consumers, healthcare professionals [Posted 03/04/2008] Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were recalled because they were found to contain Aildenafil in trace amounts and Dimethyl sildenafil thione, an analog of Sildenafil, a drug used to treat erectile dysfunction. The presence of these ingredients in the dietary supplements may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have Aspire36 and Aspire Lite in their possession should stop using the products and return any unused product to the place of purchase. [February 28, 2008 - Press Release - Palo Alto Labs] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Tamiflu (oseltamivir phosphate) Audience: Pediatric and infectious disease healthcare professionals [Posted 03/04/2008, UPDATED 03/04/2008] Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza.The label has been revised as follows: Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamiflu usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient. [February, 2008 - Dear Healthcare Professional Letter - Roche] [January, 2008 - Tamiflu Prescribing Information - Roche] Previous MedWatch alert: [November 13, 2006] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Spiriva (tiotropium bromide inhalation powder) Capsules Foradil (formoterol fumarate inhalation powder) Capsules Audience: Pulmonologists, respiratory therapists, pharmacists, other healthcare professionals, patients [Posted 02/29/2008] FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the American Association of Poison Control Center’s (AAPCC) National Poison Data System have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public Health Advisory for important information on the correct use of both products. [February 29, 2008 - Public Health Advisory - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Tysabri (natalizumab) Audience: Neurologists, other healthcare professionals, patients [Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. [February, 2008 - Letter - Biogen Idec, Elan] [January, 2008 - Prescribing Information - Biogen Idec, Elan] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Denture Cleanser Allergic Reactions and Misuse Audience: Dental healthcare professionals, patients [Posted 02/26/2008] FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use. These events can occur soon after first use or after years of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for dental healthcare professionals and an 'Advice for Patients' document that can be accessed at the links below. FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse. [February 25, 2008 - Public Health Notification - FDA] [February 25, 2008 - Advice for Patients - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Avandia (rosiglitazone maleate) Audience: Endocrinologists, pharmacists, patients [Posted 02/26/2008] FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. A list of currently approved Medication Guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm. The Medication Guide and current Prescribing Information for Avandia are provided below. [February, 2008 - Medication Guide - GlaxoSmithKline] [January, 2008 - Prescribing Information - GlaxoSmithKline] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Fentanyl transdermal System CII Patches Audience: Pain management specialists, risk managers, other healthcare professionals, patients [UPDATED 08/12/2008] Watson Pharmaceuticals, Inc., issued a voluntary recall of one lot of 75mcg/hr Fentanyl Transdermal System patches (lot 92461850; Expiration Date: 8/31/2009) sold in the United States between January 30, 2008, and March 19, 2008. The product was recalled because a small number of the patches were leaking and may expose patients or caregivers directly to fentanyl gel. [UPDATED 03/03/2008] Actavis Inc. has voluntarily recalled of all lots of Fentanyl Transdermal System CII patches sold in the United States. [Posted 02/19/2008] Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labelled with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. The lots covered by this recall include doses of 25, 50, 75, and 100 mcg/hr and are listed in the firm's press release. [August 08, 2008 - Press Release - Watson] [March 01, 2008 - Press Release - Actavis] [February 17, 2008 - Press Release - Actavis] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches Audience: Pain management specialists, other healthcare professionals, patients [Posted 02/15/2008] PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation. [February 12, 2008 - Press Release - PriCara] Previous MedWatch alert: [December 21, 2007] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Heparin Sodium Injection Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals [UPDATE 05/15/2008] Atrium Medical Corporation announced that it is initiating a voluntary and precautionary recall of selected lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). [UPDATE 05/15/2008] Medtronic Inc., initiated a voluntary recall of selected products featuring the Carmeda BioActive surface. The recalled products are used during cardiopulmonary bypass heart surgeries. Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). It is unclear if exposure to Carmeda-coated medical devices, made with small amount of heparin, could cause adverse events similar to those observed with injectable heparin formulations. Patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. Medtronic is also advising customers that selected lots of Trilliumcoated products were also manufactured with heparin containing OSCS. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Based on current data, the benefit of using the affected products outweighs any potential risk to patients. The maximum possible patient exposure to heparin from Trillium is extremely low; therefore, customers can continue to use the affected Trillium products until a replacement is available. [UPDATE 05/09/2008] FDA requested that health professionals and facilities review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all recalled heparin products have been removed and are no longer available for patient use. In addition, FDA informed health professionals about other types of medical devices that contain, or are coated with, heparin. [UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. [UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions. [Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multipledose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses. The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection. [May 12, 2008 - Press Release - Atrium] [May 07, 2008 - Press Release - Medtronic] [April 25, 2008 - Information on Heparin Sodium Injection FDA/CDER] [April 25, 2008 - Update to Healthcare Facilities and Healthcare Professionals - FDA/CDRH] [March 07, 2008 - Updated Questions and Answers - FDA] [February 28, 2008 - Public Health Update - FDA] [February 28, 2008 - Press Release - Baxter] [February 11, 2008 - Public Health Advisory - FDA] UPDATED 02/28/2008 [February 11, 2008 - Questions and Answers - FDA] [February 11, 2008 - News Release - FDA] Previous MedWatch alert: [January 18, 2008] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Chattem Icy Hot Heat Therapy Products Audience: Consumers, healthcare professionals [UPDATED 03/11/2008] FDA issued a Class II Recall of all Icy Hot Heat Therapy products. [Posted 02/11/2008] Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. The products were recalled because of consumer reports of first, second and third degree burns as well as skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products were recalled: Icy Hot Heat Therapy Air Activated Heat - Back Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg Icy Hot Heat Therapy Air Activated Heal - Arm, Neck, and Leg single consumer use "samples" on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Cream. Consumers who have the Icy Hot Heat Therapy products under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer. [March 10, 2008 - Recall Notice - FDA] [February 25, 2008 - Consumer Questions and Answers - FDA] [February 08, 2008 - Press Release - Chattem, Inc.] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B) Audience: Cosmetic Surgeons, neurologists, other healthcare professionals, consumers [Posted 02/07/2008] FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals. [February 08, 2008 - Early Communication about an Ongoing Safety Review - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Injectable Colchicine (including drugs containing colchicine) Audience: Healthcare professionals [Posted 02/06/2008] FDA announced its intention to take enforcement action against companies marketing unapproved, injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure. This action does not affect colchicine products that are dispensed in tablet form. Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate. [February 06, 2008 - News Release - FDA] [February 06, 2008 - Questions and Answers - FDA] Previous MedWatch alert: [05/02/2007] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Medtronic SynchroMed EL Implantable Infusion Pump Audience: Pain management specialists, risk managers, other healthcare professionals, patients [Posted 02/04/2008] FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer. [February 04, 2008 - Recall Notice - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Varenicline (marketed as Chantix) Audience: Neuropsychiatric and other healthcare professionals, consumers [Posted 02/01/2008] FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients. [February 01, 2008 - Public Health Advisory - FDA] [February 01, 2008 - Prescribing Information - Pfizer] [February 01, 2008 - Healthcare Professional Information Sheet FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Antiepileptic Drugs Audience: Neuropsychiatric healthcare professionals, other healthcare professionals, patients [Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions. Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. The drugs included in the analyses include (some of these drugs are also available in generic form): Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR) Felbamate (marketed as Felbatol) Gabapentin (marketed as Neurontin) Lamotrigine (marketed as Lamictal) Levetiracetam (marketed as Keppra) Oxcarbazepine (marketed as Trileptal) Pregabalin (marketed as Lyrica) Tiagabine (marketed as Gabitril) Topiramate (marketed as Topamax) Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon) Zonisamide (marketed as Zonegran) Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. [January 31, 2008 - Healthcare Professional Information Sheet - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch NuCel Labs Eye Drops and Eye/Ear Wash Products Audience: Consumers, ophthalmologists, optometrists, other healthcare professionals [Posted 01/31/2008] NuCel Labs and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash Products. The products were recalled after testing indicated the presence of bacteria and particulate matter, deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. No illnesses or injuries have been reported to date. There are no lot numbers or expiration dates on the products. Consumers who have the product should discontinue use of the product and return it to NuCel Labs. See the manufacturer's press release for return shipping information. [January 31, 2008 - Press Release - NuCel Labs] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communication about an Ongoing Data Review Audience: Cardiovascular healthcare professionals and patients [Posted 01/25/2008] FDA provided healthcare professionals with an early communication about an ongoing data review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). This early communication is in keeping with FDA’s commitment to inform the public about ongoing postmarketing drug issues. Merck/Schering Plough Pharmaceuticals reported preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (ezetimibe plus simvastatin) or simvastatin alone. Merck/Schering Plough stated that there was no significant difference between Vytorin and simvastatin in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries despite greater lowering of LDL-cholesterol (bad cholesterol) with Vytorin compared to simvastatin. Once Merck/Schering Plough completes the analysis of the unblinded data from ENHANCE, it will submit a final study report to FDA. Once FDA receives the final study report, FDA estimates it will take approximately 6 months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted. Patients should talk to their doctors if they have any questions about the information from the ENHANCE trial. [January 25, 2008 - Early Communication about an Ongoing Data Review - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters Audience: Cardiovascular healthcare professionals, hospital risk managers [Posted 01/25/2008] Cordis Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death. [January 25, 2008 - Recall Notice - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Leukine (sargramostim) Audience: Oncologists, hematologists, other healthcare professionals [Posted 01/24/2008] Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer. [January 23, 2008 - Dear Healthcare Professional Letter - Bayer Healthcare] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Ortho Evra Contraceptive Transdermal Patch Audience: Reproductive healthcare professionals, patients [Posted 01/19/2008] FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE. FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options. [January 18, 2008 - News Release - FDA] [January 18, 2008 - Questions and Answers - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials Audience: Pharmacists, hospital risk managers, other healthcare professionals [Posted 01/18/2008; updated 01/29/2008] Baxter Healthcare and FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions. Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. There have been no reports involving fatality. See the recall notice for a list of affected lots. [January 25, 2008 - Press Release - Baxter Healthare] [January 17, 2008 - Recall Notice - Baxter Healthcare] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Heparin and Normal Saline Pre-Filled Flushes Audience: Pharmacists, hospital risk managers, other healthcare professionals, patients [Posted 01/18/2008; updated 01/30/2008] AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Normal Saline pre-filled flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Serratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor. For a complete list of the recalled products, see the Recall Notice. [January 30, 2008 - Class 1 Recall - FDA] [January 25, 2008 - News Release - FDA] [January 18, 2008 - Press Release - AM2 PAT, Inc.] [January 18, 2008 - Press Release - B. Braun] Previous MedWatch alert: [December 21, 2007] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Cough and Cold Medications in Children Less Than Two Years of Age Audience: Consumers, pediatric and primary care healthcare professionals [Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue. [January 17, 2008 - Public Health Advisory - FDA] Previous MedWatch alert: [Jan 12, 2007] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Edetate Disodium (marketed as Endrate and generic products) Audience: Hospital Risk Managers, pharmacists, other healthcare professionals, patients [Posted 01/16/2008] FDA notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Edetate Disodium was approved as an emergency treatment for certain patients with hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems as a result of very high amounts of digitalis in the blood. Edetate Calcium Disodium was approved to reduce dangerously high blood lead levels (severe lead poisoning). The two drugs have very similar names and are commonly referred to only as EDTA. As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them. Edetate Disodium and Edetate Calcium Disodium works by binding with heavy metals or minerals in the body allowing them to be passed out of the body through the urine. Read the FDA Public Health Advisory for recommended and important safety considerations for healthcare professionals until the FDA's ongoing evaluation of the risks and benefits of Edetate Disodium is complete. [January 16, 2008 - Public Health Advisory - FDA] [January 16, 2008 - Questions and Answers - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Unretrieved Device Fragments Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals [Posted 01/15/2008] FDA advised healthcare professionals of serious adverse events associated with unretrieved device fragments (UDFs). A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The FDA Center for Devices and Radiological Health receives nearly 1000 adverse event reports each year related to UDFs. The adverse events reported included local tissue reaction, infection, perforation and obstruction of blood vessels, and death. Contributing factors may include biocompatibility of the device materials, location of the fragment, potential migration of the fragment, and patient anatomy. During MRI procedures, magnetic fields may cause metallic fragments to migrate, and radiofrequency fields may cause them to heat, causing internal tissue damage and/or burns. See the FDA Public Health Notification for the Agency's recommendations regarding this issue. [January 15, 2008 - Public Health Notification - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Compounded Menopause Hormone Therapy Drugs Audience: Healthcare Professionals, patients [Posted 01/10/2008] FDA informed healthcare professionals and patients that the Agency sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDAapproved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer. FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other healthcare professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness. Patients who use compounded hormone therapy drugs should discuss menopausal hormone therapy options with their healthcare provider to determine if compounded drugs are the best option for their specific medical needs. [January 09, 2008 - News Release - FDA] Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) Audience: Orthopedic Surgeons, other healthcare providers, patients [Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown. Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug. [January 07, 2008 - Drug Information page - FDA] Agricultural Chemical Industry Sector Notebook Project EPA Office of Compliance Sector Notebook Project Profile of the Agricultural Chemical, Pesticide, and Fertilizer Industry September 2000 Office of Compliance Office of Enforcement and Compliance Assurance United States Environmental Protection Agency 1200 Pennsylvania Avenue, NW (MC 2221-A) Washington, DC 20460 Agricultural Chemical Industry Sector Notebook Project This report is one in a series of volumes published by the United States Environmental Protection Agency (EPA) to provide information of general interest regarding environmental issues associated with specific industrial sectors. The documents were developed under contract by Abt Associates (Cambridge, MA), Science Applications International Corporation (McLean, VA), and Booz-Allen & Hamilton, Inc. (McLean, VA). A listing of available Sector Notebooks is included on the following page. Obtaining copies: Electronic versions of all sector notebooks are available via Internetonthe Enviro$en$e World Wide Web at www.epa.gov/oeca/sector. Enviro$en$e is a free, public, environmental exchange system operated by EPA's Office of Enforcement and Compliance Assurance and Office of Research and Development. The Network allows regulators, the regulated community, technical experts, and the general public to share information regarding: pollution prevention and innovative technologies; environmental enforcement and compliance assistance; laws, executive orders, regulations, and policies; points of contact for services and equipment; and other related topics. The Network welcomes receipt of environmental messages, information, and data fromany public or private person or organization. Direct technical questions to the “Feedback” button on the bottom of the web page. Purchase printed bound copies from the Government Printing Office (GPO) byconsulting the order form at the back of this document or order via the Internet by visiting the on-line GPO Sales Product Catalog at https://orders.access.gpo.gov/su_docs/sale/prf/prf.html. Search using the exact title of the document “Profile of the XXXX Industry” or simply “Sector Notebook.” When ordering, use the GPO document number found in the order form at the back of this document. Complimentary volumes are available to certain groups or subscribers, including public and academic libraries; federal, state, tribal, and local governments; and the media from EPA’s National Service Center for Environmental Publications at (800) 490-9198. When ordering, use the EPA publication number found on the following page. The Sector Notebooks were developed by the EPA’s Office of Compliance. Direct general questions about the Sector Notebook Project to: Seth Heminway, Coordinator, Sector Notebook Project US EPA Office of Compliance 1200 Pennsylvania Avenue, NW (2223-A) Washington, DC 20460 (202) 564-7017 For further information, and for answers to questions pertaining to these documents, please refer to the contact names listed on the following page. Sector Notebook Project i September 2000 Agricultural Chemical Industry Sector Notebook Project SECTOR NOTEBOOK CONTACTS Questions and comments regarding the individual documents should be directed to the specialists listed below. See the Notebook web page at: www.epa.gov/oeca/sector for the most recent titles and staff contacts. EPA Publication Number EPA/310-R-95-001. EPA/310-R-95-002. EPA/310-R-95-003. EPA/310-R-95-004. EPA/310-R-95-005. EPA/310-R-95-006. EPA/310-R-95-007. EPA/310-R-95-008. EPA/310-R-95-009. EPA/310-R-95-010. EPA/310-R-95-011. EPA/310-R-95-012. EPA/310-R-95-013. EPA/310-R-95-014. EPA/310-R-95-015. EPA/310-R-95-016. EPA/310-R-95-017. EPA/310-R-95-018. EPA/310-R-97-001. EPA/310-R-97-002. EPA/310-R-97-003. EPA/310-R-97-004. EPA/310-R-97-005. EPA/310-R-97-006. EPA/310-R-97-007. EPA/310-R-97-008. EPA/310-R-97-009. EPA/310-R-98-001. EPA/310-R-97-010. EPA/310-R-99-006. EPA/310-R-00-003. EPA/310-R-00-001 EPA/310-R-00-002 Industry Contact Phone (202) Profile of the Dry Cleaning Industry Joyce Chandler 564-7073 Profile of the Electronics and Computer Industry* Steve Hoover 564-7007 Profile of the Wood Furniture and Fixtures Industry Bob Marshall 564-7021 Profile of the Inorganic Chemical Industry* Walter DeRieux 564-7067 Profile of the Iron and Steel Industry Maria Malave 564-7027 Profile of the Lumber and Wood Products IndustrySeth Heminway564-7017 Profile of the Fabricated Metal Products Industry*Scott Throwe564-7013 Profile of the Metal Mining Industry Maria Malave 564-5027 Profile of the Motor Vehicle Assembly Industry Anthony Raia 564-6045 Profile of the Nonferrous Metals Industry Debbie Thomas 564-5041 Profile of the Non-Fuel, Non-Metal Mining Industry Rob Lischinsky 564-2628 Profile of the Organic Chemical Industry * Walter DeRieux 564-7067 Profile of the Petroleum Refining Industry Tom Ripp 564-7003 Profile of the Printing Industry Ginger Gotliffe 564-7072 Profile of the Pulp and Paper Industry Seth Heminway 564-7017 Profile of the Rubber and Plastic Industry 564-2310 Profile of the Stone, Clay, Glass, and Concrete Ind.Scott Throwe564-7013 Profile of the Transportation Equip. Cleaning Ind. Virginia Lathrop 564-7057 Profile of the Air Transportation Industry Virginia Lathrop 564-7057 Profile of the Ground Transportation Industry Virginia Lathrop 564-7057 Profile of the Water Transportation Industry Virginia Lathrop 564-7057 Profile of the Metal Casting Industry Steve Hoover 564-7007 Profile of the Pharmaceuticals Industry Emily Chow 564-7071 Profile of the Plastic Resin and Man-made Fiber Ind. Sally Sasnett 564-7074 Profile of the Fossil Fuel Electric Power Generation Rafael Sanchez 564-7028 Industry Anthony Raia 564-6045 Profile of the Shipbuilding and Repair Industry 564-2310 Profile of the Textile Industry Anthony Raia 564-6045 Profile of the Aerospace Industry Seth Heminway 564-7017 Sector Notebook Data Refresh-1997 ** Dan Chadwick 564-7054 Profile of the Oil and Gas Extraction Industry 564-4153 Profile of the Agricultural Chemical, Pesticide, and Michelle Yaras Fertilizer Industry Profile of the Agricultural Crop Production Industry Ginah Mortensen 913-551-5211 Ginah Mortensen 913-551-5211 Profile of the Agricultural Livestock Production Industry Government Series EPA/310-R-99-001. Profile of Local Government Operations 564-2310 * Spanish translations available. ** This document revises compliance, enforcement, and toxic release inventory data for all profiles published in 1995. Sector Notebook Project ii September 2000 Agricultural Chemical Industry Sector Notebook Project TABLE OF CONTENTS LIST OF FIGURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v LIST OF TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi LIST OF ACRONYMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii I. INTRODUCTION TO THE SECTOR NOTEBOOK PROJECT . . . . . . . . . . . . . . . . . . . . . . . . 1 I.A. Summary of the Sector Notebook Project . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 I.B. Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 II. INTRODUCTION TO THE AGRICULTURAL CHEMICAL INDUSTRY . . . . . . . . . . . . . . . . 3 II.A. Introduction, Background, and Scope of the Notebook . . . . . . . . . . . . . . . . . . . . . . . 3 II.B. Characterization of the Fertilizer, Pesticide, and Agricultural Chemical Industry . . . 4 II.B.1. Product Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 II.B.2. Industry Size and Geographic Distribution . . . . . . . . . . . . . . . . . . . . . . . . 19 II.B.3. Economic Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 III. INDUSTRIAL PROCESS DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 III.A. Nitrogenous Fertilizers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 III.A.1. Synthetic Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 III.A.2. Nitric Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 III.A.3. Ammonium Nitrate and Urea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 III.B. Phosphatic Fertilizers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 III.B.1. Phosphoric Acid (Wet Process) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 III.B.2. Ammonium Phosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 III.B.3. Normal Superphosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 III.B.4. Triple Superphosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 III.C. Fertilizer Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 III.D. Pesticide Formulating Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 III.D.1. Liquid Formulating and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 III.D.2. Dry Formulating and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 III.D.3. Aerosol Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 III.D.4. Pressurized Gas Formulating and Packaging . . . . . . . . . . . . . . . . . . . . . . 57 III.D.5. Repackaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 III.E. Raw Material Inputs and Pollution Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 III.E.1. Fertilizers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 III.E.2. Pesticide Formulating, Packaging, and Repackaging . . . . . . . . . . . . . . . . 68 III.F. Management of Chemicals in Wastestream . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 IV. CHEMICAL RELEASE AND TRANSFER PROFILE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 IV.A. EPA Toxic Release Inventory for the Fertilizer, Pesticide, and Agricultural Chemical Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 IV.B. Summary of Selected Chemicals Released . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 IV.C. Other Data Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 IV.D. Comparison of Toxic Release Inventory Between Selected Industries . . . . . . . . 101 Sector Notebook Project iii September 2000 Agricultural Chemical Industry Sector Notebook Project V. POLLUTION PREVENTION OPPORTUNITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 V.A. Equipment Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 V.B. Process Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 V.C. Good Housekeeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114 VI. Summary of Applicable Federal Statutes and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . 120 VI.A. General Description of Major Statutes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 Imports and Exports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122 VI.B. Industry Specific Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 VI.C. State Regulation of Pesticides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150 VI.D. Pending and Proposed Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 152 VII. COMPLIANCE AND ENFORCEMENT HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 VII.A. Fertilizer, Pesticide, and Agricultural Chemical Industry Compliance History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 VII.B. Comparison of Enforcement Activity Between Selected Industries . . . . . . . . . . 161 VII.C. Review of Major Legal Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 VII.C.1. Review of Major Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 VII.C.2. Supplementary Environmental Projects (SEPs) . . . . . . . . . . . . . . . . . . 170 VIII. COMPLIANCE ASSURANCE ACTIVITIES AND INITIATIVES . . . . . . . . . . . . . . . . . . 171 VIII.A. Sector-Related Environmental Programs and Activities . . . . . . . . . . . . . . . . . . 171 VIII.B. EPA Voluntary Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173 VIII.C. Trade Association/Industry Sponsored Activity . . . . . . . . . . . . . . . . . . . . . . . . 178 VIII.C.1. State Advisory Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 VIII.C.2. Trade Associations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180 IX. CONTACTS/ACKNOWLEDGMENTS/RESOURCE MATERIALS . . . . . . . . . . . . . . . . . 187 Sector Notebook Project iv September 2000 Agricultural Chemical Industry Sector Notebook Project LIST OF FIGURES Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8: Figure 9: Figure 10: Figure 11: Figure 12: Figure 13: Figure 14: Figure 15: Figure 16: Figure 17: Figure 18: Figure 19: Number of Facilities and Value of Shipments of the Fertilizer, Pesticide, and Agricultural Chemical Manufacturing Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Product Distribution for SIC 2873, Nitrogenous Fertilizers . . . . . . . . . . . . . . . . . . . . 9 Product Distribution for SIC 2874, Phosphorous Fertilizers . . . . . . . . . . . . . . . . . . 11 Product Distribution for SIC 2879, Pesticides and Miscellaneous Agricultural Chemicals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Geographic Distribution of the Fertilizer Industry (SIC 2873, 2874, 2875) . . . . . . . 20 Geographic Distribution of the Pesticide Formulating and Miscellaneous Agrichemical Formulating Facilities (SIC 2879) . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Typical Process of Ammonia Synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Typical Process of Dual-Stage, Weak Nitric Acid Production . . . . . . . . . . . . . . . . . 35 Typical Process Diagram of High Strength Nitric Acid Production . . . . . . . . . . . . . 36 Typical Process for Ammonium Nitrate and Urea Manufacturing . . . . . . . . . . . . . . . 39 Typical Process of a Wet Process Dihydrate Phosphoric Acid Plant . . . . . . . . . . . . 42 Typical Vacuum Evaporator Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Simplified Process Flow Diagram of Diammnonium Phosphate Production . . . . . . . 44 Typical Process for Normal Superphosphate Manufacturing . . . . . . . . . . . . . . . . . . 46 Typical Process for Triple Superphosphate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Typical Process for Liquid Formulating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Typical Process for Dry Formulating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Raw Material Flowchart for Principal Fertilizer Materials . . . . . . . . . . . . . . . . . . . 59 Summary of 1995 TRI Releases and Transfers by Industry . . . . . . . . . . . . . . . . . . . 102 Sector Notebook Project v September 2000 Agricultural Chemical Industry Sector Notebook Project LIST OF TABLES Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: Table 11: Table 12: Table 13: Table 14: Table 15: Table 16: Table 17: Table 18: Table 19: Table 20: Table 21: Table 22: Table 23: Table 24: Table 25: Table 26: Table 27: Table 28: Table 29: Nitrogenous Fertilizer Products (SIC 2873) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Phosphatic Fertilizer Products (SIC 2874) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1990 Direct vs Mixed Application of Primary Fertilizer Nutrients . . . . . . . . . . . . . . 12 SIC 2879 Pesticides and Miscellaneous Agricultural Chemicals, List of Products . 13 Establishment Counts Based on Product Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Facility Size Distribution for the Fertilizer, Pesticide, and Agricultural Chemical Manufacturing Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 States with the Largest Number of Fertilizer Manufacturing Facilities . . . . . . . . . . . 21 Top United States Agricultural Chemical Companies . . . . . . . . . . . . . . . . . . . . . . . . 23 Fertilizer Materials Used in Bulk Blends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Approximate Quantities of Most Commonly Used Conventional Pesticides in United States Agricultural Crop Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Summary of Potential Pollution Outputs for the Agricultural Chemical Industry . . . . 73 Source Reduction and Recycling Activity for the Fertilizer Industry as Reported within TRI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Source Reduction and Recycling Activity for the Pesticide and Miscellaneous Agricultural Chemicals Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 1996 TRI Releases for Agricultural Chemicals Facilities (SICs 2873,2874,2875) by Number of Facilities Reporting (Releases reported in pounds/year) . . . . . . . . . . 84 1996 TRI Transfers for Agricultural Chemicals Facilities (SICs 2873,2874,2875) by Number and Facilities Reporting (Transfers reported in pounds/year) . . . . . . . . 85 1996 TRI Releases for Agricultural Chemicals Facilities (SIC 2879) by Number of Facilities Reporting (Releases reported in pounds/year) . . . . . . . . . . . . . . . . . . . . . 86 1996 TRI Transfers for Agricultural Chemicals Facilities (SIC 2879) by Number and Facilities Reporting (Transfers reported in pounds/year) . . . . . . . . 89 Top 10 TRI Releasing Fertilizer Manufacturing and Mixing Facilities (SIC 2873, 2874, 2875) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Top 10 TRI Releasing Facilities Reporting Fertilizer Manufacturing and Mixing SIC Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Top 10 TRI Releasing Pesticide and Miscellaneous Agricultural Chemicals Facilities (SIC 2879) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Top 10 TRI Releasing Facilities Reporting Pesticide and Miscellaneous Agricultural Chemicals SIC Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Air Pollutant Releases by Industry Sector (tons/year) . . . . . . . . . . . . . . . . . . . . . . . 100 1995 Toxics Release Inventory Data for Selected Industries . . . . . . . . . . . . . . . . . 102 Waste Minimization Methods for the Fertilizer, Pesticide, and Agricultural Chemical Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Five-Year Enforcement and Compliance Summary for the Fertilizer, Pesticide, and Agricultural Chemical Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Five-Year Enforcement and Compliance Summary for Selected Industries . . . . . . 162 One-Year Enforcement and Compliance Summary for Selected Industries . . . . . . . 163 Five-Year Inspection and Enforcement Summary by Statute for Selected Industries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 One-Year Inspection and Enforcement Summary by Statute for Selected Industries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165 Sector Notebook Project vi September 2000 Agricultural Chemical Industry Sector Notebook Project Table 30: Fertilizer, Pesticide, and Agricultural Chemical Industry Participation in the 33/50 Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175 Sector Notebook Project vii September 2000 Agricultural Chemical Industry Sector Notebook Project LIST OF ACRONYMS AAEA AAPCO AAPFCO ACPA AFS AI AIRS ASA BIFs BOD CAA CAAA CERCLA CERCLIS CFA CFCs CMA CO COD CSI CSMA CWA DAP DOT D&B EPA EPCRA FFDCA FIFRA FINDS FIRT FQPA HAPs HSDB IDEA IFDC LDR LEPCs MACT MAP MCLGs MCLs MEA MEK MSDSs American Agricultural Economics Association Association of American Pesticide Control Officials Association of American Plant Food Control Officials American Crop Protection Association AIRS Facility Subsystem (CAA database) Active Ingredient Aerometric Information Retrieval System (CAA database) American Society of Agronomy Boilers and Industrial Furnaces (RCRA) Biochemical Oxygen Demand Clean Air Act Clean Air Act Amendments of 1990 Comprehensive Environmental Response, Compensation and Liability Act CERCLA Information System California Fertilizer Association Chlorofluorocarbons Chemical Manufacturers Association Carbon Monoxide Chemical Oxygen Demand Common Sense Initiative Chemical Specialties Manufacturers Association Clean Water Act Diammonium Phosphate Department of Transportation Dun and Bradstreet Marketing Index United States Environmental Protection Agency Emergency Planning and Community Right-to-Know Act Federal Food, Drug, and Cosmetic Act Federal Insecticide, Fungicide, and Rodenticide Act Facility Indexing System Fertilizer Industry Round Table Food Quality Protection Act Hazardous Air Pollutants (CAA) Hazardous Substances Data Bank Integrated Data for Enforcement Analysis International Fertilizer Development Center Land Disposal Restrictions (RCRA) Local Emergency Planning Committees Maximum Achievable Control Technology (CAA) Monoammonium Phosphate Maximum Contaminant Level Goals Maximum Contaminant Levels Monoethanolamine Methyl Ethyl Ketone Material Safety Data Sheets Sector Notebook Project viii September 2000 Agricultural Chemical Industry Sector Notebook Project NACD National Association of Chemical Distributors NASDA National Association of State Departments of Agriculture NASHA North American Horticultural Supply Association NCDB National Compliance Database (for TSCA, FIFRA, EPCRA) NCP National Oil and Hazardous Substances Pollution Contingency Plan NEC Not Elsewhere Classified NEIC National Enforcement Investigation Center NESHAP National Emission Standards for Hazardous Air Pollutants NO2 Nitrogen Dioxide NOV Notice of Violation NOX Nitrogen Oxide NPCA National Pest Control Association NPDES National Pollution Discharge Elimination System (CWA) NPK Nitrogen-Phosphorous-Potassium NPL National Priorities List NRC National Response Center NRDC National Resources Defense Council NSP Normal Superphosphate NSPS New Source Performance Standards (CAA) OECA Office of Enforcement and Compliance Assurance OMB Office of Management and Budget OPA Oil Pollution Act OPPTSOffice of Prevention, Pesticides, and Toxic Substances OSHA Occupational Safety and Health Administration OSW Office of Solid Waste OSWER Office of Solid Waste and Emergency Response OW Office of Water P2 Pollution Prevention PCS Permit Compliance System (CWA Database) PRP Potentially Responsible Party POTW Publicly Owned Treatments Works PPI Potash and Phosphate Institute RCRA Resource Conservation and Recovery Act RCRIS RCRA Information System SARA Superfund Amendments and Reauthorization Act SDWA Safe Drinking Water Act SEPs Supplementary Environmental Projects SERCs State Emergency Response Commissions SFIREG State FIFRA Issues Research and Evaluation Group SIC Standard Industrial Classification SO2 Sulfur Dioxide SOX Sulfur Oxides TOC Total Organic Carbon TFI The Fertilizer Institute TRI Toxic Release Inventory TRIS Toxic Release Inventory System TCRIS Toxic Chemical Release Inventory System Sector Notebook Project ix September 2000 Agricultural Chemical Industry TSCA TSP TSS TVA UIC UPFDA USDA UST VOCs WCPA Sector Notebook Project Toxic Substances Control Act Triple Superphosphate Total Suspended Solids Tennessee Valley Authority Underground Injection Control (SDWA) United Products Formulators and Distributors Association United States Department of Agriculture Underground Storage Tanks (RCRA) Volatile Organic Compounds Western Crop Protection Association Sector Notebook Project x September 2000 Agricultural Chemical Industry Sector Notebook Project I. INTRODUCTION TO THE SECTOR NOTEBOOK PROJECT I.A. Summary of the Sector Notebook Project Integrated environmental policies based upon comprehensive analysis of air, water and land pollution are a logical supplement to traditional single-media approaches to environmental protection. Environmental regulatory agencies are beginning to embrace comprehensive, multi-statute solutions to facility permitting, enforcement and compliance assurance, education/outreach, research, and regulatory development issues. The central concepts driving the new policy direction are that pollutant releases to each environmental medium (air, water and land) affect each other, and that environmental strategies must actively identify and address these inter-relationships by designing policies for the “whole” facility. One way to achieve a whole facility focus is to design environmental policies for similar industrial facilities. By doing so, environmental concerns that are common to the manufacturing of similar products can be addressed in a comprehensive manner. Recognition of the need to develop the industrial “sector-based” approach within the EPA Office of Compliance led to the creation of this document. The Sector Notebook Project was originally initiated by the Office of Compliance within the Office of Enforcement and Compliance Assurance (OECA) to provide its staff and managers with summary information for eighteen specific industrial sectors. As other EPA offices, states, the regulated community, environmental groups, and the public became interested in this project, the scope of the original project was expanded to its current form. The ability to design comprehensive, common sense environmental protection measures for specific industries is dependent on knowledge of several inter-related topics. For the purposes of this project, the key elements chosen for inclusion are: general industry information (economic and geographic);a description of industrial processes; pollution outputs; pollution prevention opportunities; federal statutory and regulatory framework; compliance history; and a description of partnerships that have been formed between regulatory agencies, the regulated community and the public. For any given industry, each topic listed above could alone be the subject of a lengthy volume. However, in order to produce a manageable document, this project focuses on providing summary information for each topic. This format provides the reader with a synopsis of each issue, and references where more in-depth information is available. Text within each profile was researched from a variety of sources, and was usually condensed from more detailed sources pertaining to specific topics. This approach allows for a wide coverage of activities that can be further explored based upon the citations and references listed at the end of this profile. As a check on the informationincluded, each notebookwent through an external review process. The Office of Compliance appreciates the efforts of all those thatparticipated Sector Notebook Project 1 September 2000 Agricultural Chemical Industry Sector Notebook Project in this process who enabled us to develop more complete, accurate and up-to date summaries. Many of those who reviewed this notebook are listed as contacts in Section IX and may be sources of additional information. The individuals and groups on this list do not necessarily concur with all statements within this notebook. I.B. Additional Information Providing Comments OECA’s Office of Compliance plans to periodically review and update the notebooks and will make these updates available both in hard copy and electronically. If you have any comments on the existing notebook, or if you would like to provide additional information, please send a hard copy and computer disk to the EPA Office of Compliance, Sector Notebook Project (2223-A), 1200 Pennsylvania Avenue, NW, Washington, DC 20460. Comments can also be uploaded to the Enviro$en$e World Wide Web for general access to all users of the system. Follow instructions in Appendix A for accessing this system. Once you have logged in, procedures for uploading text are available from the on-line Enviro$en$e Help System. Adapting Notebooks to Particular Needs The scope of the industry sector described in this notebook approximates the national occurrence of facility types within the sector. In many instances, industries within specific geographic regions or states may have unique characteristics that are not fully captured in these profiles. The Office of Compliance encourages state and local environmental agencies and other groups to supplement or repackage the information included in this notebook to include more specific industrial and regulatory information that may be available. Additionally, interested states may want to supplement the “Summaryof Applicable Federal Statutes and Regulations” section with state and local requirements. Compliance or technical assistance providers may also want to develop the “Pollution Prevention” section in more detail. Please contact the appropriate specialist listed on the opening page of this notebookif your office is interested in assisting us in the further development of the information or policies addressed within this volume. If you are interested in assisting in the development of new notebooks for sectors not covered in the original eighteen, please contact the Office of Compliance at 202-564-2310. Sector Notebook Project 2 September 2000 Agricultural Chemical Industry Introduction and Scope II. INTRODUCTION TO THE AGRICULTURAL CHEMICAL INDUSTRY This section provides background information on the size, geographic distribution, employment, production, sales, and economic condition of the fertilizer, pesticide, and agricultural chemical industry. Facilities described within this document are described in terms of their Standard Industrial Classification (SIC) codes whenever possible. II.A. Introduction, Background, and Scope of the Notebook The scope of this Sector Notebook covers the manufacturing and production of fertilizers, the formulation of pesticide chemicals (both agricultural and non-agricultural) manufactured at separate facilities, and the production of other miscellaneous agricultural chemicals. It does not include the use, sale, distribution, or storage of such chemicals. The Fertilizer, Pesticide, and Agricultural Chemical Industry is classified by the Office of Management and Budget (OMB) under Standard Industrial Classification (SIC) Industry Group Number 287. This classification corresponds to SIC codes which were established by the OMB to track the flow of goods and services within the economy. Industry Group Number 287 includes SIC codes: 2873-- Nitrogenous Fertilizers 2874-- Phosphatic Fertilizers 2875-- Fertilizers, Mixing Only 2879-- Pesticides and Agricultural Chemicals, Not Elsewhere Classified (n.e.c) This notebook covers both fertilizer manufacturing and formulating operations including ammonia synthesis, nitric and phosphoric acid production, and the mixing, preparing, and packaging of nitrogenous and phosphatic fertilizers. Establishments engaged in manufacturing fertilizer materials or mixing fertilizers produced at the same establishment are classified under SIC codes 2873 and 2874. Mixing of fertilizer materials, such as compost, potting soil, and fertilizers made in plants not manufacturing fertilizer materials, is classified under SIC code 2875. This notebook does not include the mining or grinding of phosphate rock, which is classified under SIC code 1475, and it also does not include the use or application of fertilizers. SIC code 2879, pesticides and agricultural chemicals notelsewhere classified (n.e.c.), hereafter referred to as pesticides and miscellaneous agricultural chemicals, covers onlythe formulating, preparing, and packaging of ready-touse agricultural and household pest control chemicals. This industry code also includes establishments primarily engaged in the manufacturing or formulating of agricultural chemicals, not elsewhere classified, such as minor or trace elements and soil conditioners. This notebook does not discuss the use or Sector Notebook Project 3 September 2000 Agricultural Chemical Industry Introduction and Scope application of pesticide products. Establishments primarily engaged in the manufacturing of basic or technical agricultural pesticides are classified in IndustryGroup 281 if the chemicals produced are inorganic or IndustryGroup 286 if the chemicals produced are organic. This notebook also does not cover the agricultural supply sector, SIC 5191, which is engaged in the wholesale and distribution of various agricultural supplies including fertilizers and pesticides. Also, there is little discussion of the potassium fertilizer industry as potash is classified under SIC 2819, Inorganic Chemicals n.e.c. Federal government agencies, including United States EPA, are beginning to implement an industrial classification system developed by OMB to replace the SIC code system. The new system, which is based on similar production processes, is called the North American Industrial Classification System (NAICS). In the NAIC system, the manufacturing of nitrogenous fertilizers (SIC 2873) is classified as NAIC 325311, phosphatic fertilizers (SIC 2874) as NAIC 325312, and fertilizer mixing only (SIC 2875) as NAIC 325314. Pesticide formulating and agricultural chemicals n.e.c. (SIC 2879) is classified under NAIC 32532. Because EPA databases, and other databases used in this document, are still using the SIC system, the industry sectors described in this Sector Notebook are described in terms of their SIC codes. II.B. Characterization of the Fertilizer, Pesticide, and Agricultural Chemical Industry As the world population increases, crop lands are unable to meet the growing demand for food without employing some method of crop enhancement. There are five common practices used to meet the growing demand: C C C C C increasing tilled acreage improving plant strains introducing or expanding irrigation controlling pest by chemical or biological methods initiating or increasing fertilizer usage Increased utilization of the last two methods has created a large agrichemical industry which produces a wide variety of products designed to increase crop production and protect crops from disease and pests (Kent, 1992). Together, the production of fertilizers and the formulation of pesticides was a $18.8 billion industry in 1992, employing over 40,000 people (USDOC, 1995). Plants require 18 elements to grow, the most important being oxygen, carbon, hydrogen, nitrogen, phosphorous, and potassium. Oxygen, carbon, and hydrogen are obtained from the atmosphere and water, while nitrogen, phosphorous, and potassium are naturallyobtained fromsoil. However, under current high yield production methods, soils are stripped of the essential nutrients, requiring the addition of fertilizers (primarily consisting of nitrogen, phosphorous, and potassium) to resupply the land. The additional 12 essential nutrients are generally maintained in soil at sufficient levels for plant growth, Sector Notebook Project 4 September 2000 Agricultural Chemical Industry Introduction and Scope but they may be added to some fertilizers (Kent, 1992). Even before the addition of nutrients to farm lands, farmers were forced to protect their crops againstpests with chemicals. References to pesticide usage date back to 1000 B.C. Pests are continuously adapting to pesticide chemicals requiring new pesticides and the usage of multiple chemical agents. The industry is rapidly changing due to biological adaptation of pests, laboratory discoveries, and government regulation (Kent, 1992). The pesticide industry is faced with the need for new formulations and the abundance of possible combinations, but restricted by cost factors and a sometimes lengthy registration process. Pesticides are applied on about three-quarters of United States farms and households. Farmers’ expenditures on pesticides were equal to 4.6 percent of total farm production expenditures in 1995, up from 3.9 percent in 1993. About one billion pounds of active ingredient of conventional pesticides are used annually in the United States; this usage involves about 21,000 pesticide products (including non-agricultural products) and 875 active ingredients registered under the Federal Pesticide Law, according to the 1994 and 1995 Market Estimates for Pesticides Industry Sales and Usage (Aspelin, 1997). II.B.1. Product Characterization This notebook covers all aspects of fertilizer production and pesticide formulating and packaging. However, because the industrial processes, pollutant outputs, economics, size, and geographic distribution of the two industries are different, theyare dealt with separately throughout the notebook. Figure 1 compares the number of manufacturing facilities and value of shipments for each of the major sectors within the Fertilizer, Pesticide, and Agricultural Chemical Industry, as reported by the United States Bureau of Census. The figure shows that the fertilizer mixing industry has the largest number of facilities but the smallest value of shipments. This reflects that, compared to other sub-sectors withinthe Fertilizer, Pesticide and Agricultural Chemical Industry, these facilities produce a relatively small volume of product and sell a relatively low value product. Phosphatic fertilizer producers, on the other hand, comprise the smallest number of facilities but have a relatively large share of the industry’s value of shipments, reflecting that individual facilities produce a relatively large volume of product. Sector Notebook Project 5 September 2000 Agricultural Chemical Industry Introduction and Scope Figure 1: Number of Facilities and Value of Shipments of the Fertilizer, Pesticide, and Agricultural Chemical Manufacturing Industry Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, United States Department of Commerce, Bureau of the Census, May 1995. * United States EPA has identified over 8,000 establishments that could fall within this SIC code as it is defined by the OMB. See discussion in text below. The Census of Manufacturers reports 263 establishments that can be defined as producing pesticides and miscellaneous agricultural chemicals. These establishments reportedly account for almosthalfof the value of shipments for the sector. There are over 8,000 establishments identified by the United States EPA thatmanufacture, formulate and package pesticides and other agricultural chemicals and thatcould fall withinOMB’s SIC code definitionfor this sector. Many of these are small establishments and establishments thathave a primary line of business other than producing pesticides and other miscellaneous agricultural chemicals. The Census only counts those facilities which report an SIC code as their primary line of business, thus the number of facilities shownabove is notinclusive of all facilities involved in agricultural chemical production. Under the “Pesticides and Miscellaneous Agricultural Chemicals” heading later in this section, other pesticide producing establishment counts are presented based on EPA estimates and reporting under section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act. Sector Notebook Project 6 September 2000 Agricultural Chemical Industry Introduction and Scope Nitrogenous Fertilizers The nitrogenous fertilizer industry includes the production of synthetic ammonia, nitric acid, ammonium nitrate, and urea. Synthetic ammonia and nitric acid, however, are used primarily as intermediates in the production of ammonium nitrate and urea fertilizers. Table 1 lists specific products classified as nitrogenous fertilizers by OMB. Table 1: Nitrogenous Fertilizer Products (SIC 2873) Ammonia liquor Ammonium nitrate Ammonium sulfate Anhydrous ammonia Aqua ammonia Fertilizers, mixed, produced in nitrogenous fertilizer plants Fertilizers, natural Nitric acid Nitrogen fertilizer solutions Plant foods, mixed in nitrogenous fertilizer plants Urea Source: Standard Industrial Classification Manual, Office of Management and Budget, 1987. Synthetic Ammonia Synthetic ammonia refers to ammonia that has been synthesized from natural gas. In this process, natural gas molecules are reduced to carbon and hydrogen. The hydrogen is then purified and reacted with nitrogen to produce ammonia. Approximately 75 percent of the synthetic ammonia produced in the United States is used as fertilizer, either directly as ammonia or indirectly after fertilizer synthesis into urea, ammonium nitrate, and monoammonium or diammonium phosphates. One-third of the fertilizer nitrogen is applied directly to the land as anhydrous ammonia. The remaining 25 percent of ammonia produced in the United States is used as raw material in the manufacture of polymeric resins, explosives, nitric acid, and other products (USEPA, 1993a). Nitric Acid Nitric acid is formed by concentration, absorption, and oxidation of anhydrous ammonia. About 70 percent of the nitric acid produced is consumed as an intermediate in the manufacture of ammonium nitrate (NH4NO3), which is primarily used in fertilizers. Another 5 to 10 percent of the nitric acid produced is used in adipic acid manufacturing, an intermediate in nylon production. Explosive manufacturing utilizes nitric acid for organic nitrations to produce nitrobenzene, dinitrotoluenes, and other chemical intermediates. Other end uses of nitric acid are gold and silver separation, militarymunitions, Sector Notebook Project 7 September 2000 Agricultural Chemical Industry Introduction and Scope steel and brass pickling, photoengraving, and acidulation of phosphate rock (USEPA, 1993a). Ammonium Nitrate Ammonium nitrate is produced by neutralizing nitric acid with ammonia. Approximately 15 to 20 percent of ammonium nitrate is used for explosives and the balance for fertilizer. Ammonium nitrate is marketed in several forms, depending upon its use. Liquid ammonium nitrate may be sold as a fertilizer, generally in combination with urea. Liquid ammonium nitrate may also be concentrated to form an ammonium nitrate “melt” for use in solids formation processes. Solid ammonium nitrate may be produced in the form of prills, grains, granules or crystals. Prills, round or needle-shaped aggregates, can be produced in either high or low density form, depending on the concentration of the melt. High density prills, granules and crystals are used as fertilizer, grains are used solely in explosives, and low density prills can be used as either fertilizer or explosives (USEPA, 1993a). Urea Urea, also knownas carbamide or carbonyl diamide, is produced by reacting ammonia with carbon dioxide. Eighty-five percent of urea solution produced is used in fertilizer mixtures, with three percent going to animal feed supplements and 12 percent is used for plastics and other uses. Urea is marketed as a solution or in solid form. Most solids are produced as prills or granules for use as fertilizer or protein supplement in animal feed, and in plastics manufacturing (USEPA, 1993a). Ammonium sulfate It is not economically feasible to produce ammonium sulfate for use as a fertilizer. However, ammonium sulfate is formed as a by-product of other process such as acid scrubbing of coke oven gas, synthetic fiber production, and the ammoniation of process sulfuric acid (Hoffmeister, 1993). Therefore, the production of ammonium sulfate is not described in this notebook. Sector Notebook Project 8 September 2000 Agricultural Chemical Industry Introduction and Scope Figure 2: Product Distribution for SIC 2873, Nitrogenous Fertilizers Source: Fertilizer Institute data as reported in Chemical and Engineering News, June 23, 1998. Figures are based on Fertilizer Institute surveys and may not represent the entire industry. Phosphatic Fertilizers The phosphatic fertilizer industry can be divided into three major segments: phosphoric acid, granular ammonium phosphate, and normal and triple superphosphate. Table 2 lists these, and a few additional, less common products classified as phosphatic fertilizers by OMB. Table 2: Phosphatic Fertilizer Products (SIC 2874) Ammonium phosphates Calcium meta-phosphates Defluorinated phosphates Diammonium phosphates Fertilizers, mixed, produced in phosphatic fertilizer plants Phosphoric acid Plant foods, mixed in phosphatic fertilizer plants Superphosphates, ammoniated and not ammoniated Source: Standard Industrial Classification Manual, Office of Management and Budget, 1987. Sector Notebook Project 9 September 2000 Agricultural Chemical Industry Introduction and Scope Phosphoric Acid Phosphoric acid (H3PO4) can be manufactured using either a wet or a thermal process to react phosphate rock with sulfuric acid. Approximately 96 percent of the phosphoric acid produced in the United States is produced using the wet process. Wet process phosphoric acid has a phosphorous concentration typically ranging from 26-30% as phosphorous pentoxide (P2O5) and is used in the production of ammonium phosphates and triple superphosphates. Thermal process phosphoric acid is commonlyused in the manufacture of high grade chemicals requiring a much higher purity. Ammonium Phosphates Ammonium phosphate (NH4H2PO4) is produced by reacting phosphoric acid with anhydrous ammonia. Both solid and liquid ammonium phosphatic fertilizers are produced in the United States The most common ammonium phosphatic fertilizer grades are monoammonium phosphate (MAP) and diammonium phosphate (DAP). DAP has become one of the most commonly used fertilizers because it provides a large quantity of plant food, is compatible with most mix fertilizer ingredients, and is nonexplosive. It may be directly applied or used in irrigation systems as it is completely soluble in water. DAP is also preferred over MAP because it is capable of fixing twice as much ammonia per phosphorous pentoxide in solid form (Nielson, 1987.) MAP contains a higher concentration of phosphorous pentoxide than DAP. It is favored for use with alkaline soils and may be applied either directly or in a dry blend. Normal Superphosphates Like phosphoric acid, normal, or “ordinary,” superphosphate fertilizers are produced by reacting phosphate rock with sulfuric acid. However, normal superphosphate (NSP) retains calcium sulfate which forms by the reaction between phosphate rock and sulfuric acid. For this reason NSP retains its importance wherever sulphur deficiency limits crop yields (UNEP, 1996). NSP refers to fertilizer material containing 15 to 21 percent phosphorous as phosphorous pentoxide (P2O5). As defined by the Census Bureau, NSP contains not more than 22 percent of available P2O5 (USEPA, 1993a). Productionof NSP has givenway to the higher-yielding triple superphosphates and ammonium phosphates. In 1990, production of NSP accounted for only one percent by weight of the phosphorous fertilizer industry. Because of its low P2O5 concentration, shipping can be prohibitively expensive due to the large volumes required. NSP is favored in low cost Nitrogen-PhosphorousPotassium (NPK) mixes because it is a less expensive form of phosphorous, however, it is unacceptable for higher-grade mixes (Kent, 1992). Triple Superphosphates Triple superphosphates (TSP) are produced by reacting ground phosphate rock with phosphoric acid. Triple superphosphate is also knownas double, treble, or concentrated superphosphate. The phosphorus content of triple superphosphates is over 40 percent, measured as phosphorus pentoxide (P2O5), Sector Notebook Project 10 September 2000 Agricultural Chemical Industry Introduction and Scope which is its mainadvantage over other phosphatic fertilizers (USEPA, 1993a). TSP began to be produced in large quantities when wet process phosphoric acid production became available commercially. It is commonly produced along with phosphoric acid near phosphate rock supplies. TSP may be applied directly or as a bulk blend (Kent, 1992). Figure 3: Product Distribution for SIC 2874, Phosphorous Fertilizers Source: Chemical and Engineering News, June 23, 1998. Figures are based on Fertilizer Institute surveys and may not represent the entire industry. Fertilizers, Mixing Only A significant part of the fertilizer industry only purchases fertilizer materials in bulk from fertilizer manufacturing facilities and mixes them to sell as a fertilizer formulation. Phosphorous is the single nutrient most likely to be applied in a fertilizer mixture, as seen in Table 3. Sector Notebook Project 11 September 2000 Agricultural Chemical Industry Introduction and Scope Table 3: 1990 Direct vs Mixed Application of Primary Fertilizer Nutrients Method, % applied Nutrient Direct Mixtures Nitrogen 80 20 Phosphorous 8 92 Potassium 65 35 TOTAL 61 39 Source: Hoffmeister, G., “Fertilizers,” Kirk-Othmer Encyclopedia of Chemical Technology, V. 10, 1993. Although the Bureau of the Census onlycounts 401 facilities reporting the SIC code for fertilizer mixing (2875) in 1992, other sources estimated the true number of fertilizer mixing facilities to be closer to five or six thousand in 1984 (Adrilenas and Vroomen, 1990). About half of applied fertilizers are bulk blends. Fertilizer mixing facilities generally serve a small area such as farms within a tento fifty mile radius. The processes involved are simple and relatively little value is added to the raw materials purchased by mixing facilities. Nevertheless, there are many of these facilities and volume of production results in a $1.8 billion industry (value of annual shipments). The industrial process is simple and resembles that of the pesticide formulating sector. A brief discussion of fertilizer mixing processes is included in this notebook. Pesticides and Miscellaneous Agricultural Chemicals The pesticides and agricultural chemicals n.e.c. (referred to here as pesticides and miscellaneous agricultural chemicals) industry group (SIC 2879) formulates and prepares ready to use agricultural and household pesticides and other agricultural chemicals. The manufacture of pesticide active ingredients is classified under either Industry Group 281 for inorganic chemicals or 286 for organics which are not covered by this notebook. (See Profile of the Inorganic Chemicals Industry and Profile of the Organic Chemicals Industry Sector Notebooks.) In the United States, over 850 different pesticide formulations and preparations are produced. In 1995, 31 new active ingredients were registered in the United States (Aspelin, 1997). Mostof these pesticides can be classified as either insecticides, herbicides, or fungicides, although many other minor classifications exist. Also included in this category are blends of fertilizers and pesticides produced at pesticide formulating and Sector Notebook Project 12 September 2000 Agricultural Chemical Industry Introduction and Scope mixing facilities. Table 4 lists the pesticides and other products included in SIC 2879. Table 4: SIC 2879 Pesticides and Miscellaneous Agricultural Chemicals, List of Products Agricultural disinfectants Agricultural pesticides Arsenates and arsenites Bordeaux mixture Cattle dips and sheep dips DDT Defoliants Fly sprays Fungicides Growth regulants Herbicides Insecticides, agricultural and household Lime-sulfur, dry and solution Lindane, formulated Moth repellants Nicotine and salts Paris green Pesticides, household Phytoactin Plant hormones Poison, household Pyrethrin Rodenticides Rotenone Soil conditioners Sulfur dust Thiocyanates Trace elements (agrichemical) Xanthone Source: Standard Industrial Classification Manual, Office of Management and Budget, 1987. In 1995, 77 percent (by volume) of all pesticides were used for agriculture, 12 percent for industrial, commercial, or governmental lands or facilities, and 11 percent for homes and gardens (Aspelin, 1997). Non-agricultural pesticides and miscellaneous agricultural chemicals are included in the data presented for sales, production, waste management, and enforcement and compliance. However, since they represent a relatively small part of the industryand cover a wide range of chemicals and production processes, these products are not covered in the Industrial Processes and Pollutant Outputs sections of this document. Herbicides Herbicides (in both value and quantity) are the largest class of pesticides used in the United States, as well as in the world. This class of pesticides, which accounts for approximately fifty percent of the value of aggregate world pesticide usage, is used to destroy or control a wide variety of weeds and other unwanted plants. Because of its demonstrated farm labor savings, nearly all the agricultural land in the United States is currently being treated with some type of herbicide. In recent years, approximately fifty percent of total United States pesticide consumption (by value) was herbicides (USITC, 1994). Insecticides Insecticides are the second largest pesticide category (by value) used in the United States and in the world. In the early 1990s, insecticides accounted for approximatelytwenty-nine percent of the total value of United States pesticide consumption. Historically, the category of synthetic organic insecticides has been divided into one of four major chemical groups: C organochlorines (e.g., DDT and chlordane) Sector Notebook Project 13 September 2000 Agricultural Chemical Industry Introduction and Scope C organophosphates (e.g., parathion and diazinon) C carbamates (e.g., carbaryl) C pyrethroids (e.g., natural and synthetic) Several compounds, discovered during the 1950s, found widespread use in agriculture because of their high toxicity to a variety of insects. However, the qualities that made these chemicals so desirable also led to their eventual removal from the market, as these products also proved harmful to humans and to the environment. Spurred in part by increased environmental concern, researchers developed a new series of less toxic synthetic compounds called pyrethroids. These compounds are based on the natural pyrethroids, which are found in such plants as the chrysanthemum (USITC, 1994). Fungicides In recent years, fungicides accounted for approximately ten percent of the value of total United States pesticide consumption. Fungicides are used today primarily to protect agricultural crops and seeds from various fungi; farmers previously used inorganic products, such as elemental sulfur and copper sulfate. Initially, synthetic products were commercially unsuccessful, because of their high manufacturing costs. By the 1940s, however, newer, less expensive products became commercially successful. Today, fungicides are manufactured from a variety of chemical classes. Commercially, the most important fungicides are halogenated compounds, the carbamates and dithiocarbamates, and organophosphates (USITC, 1994). Other Pesticides Although small in total quantity consumed, a number of other classes of pesticide products are onthe market. Some of these pesticides are not covered by this Notebook. C Biologicalpesticides, also known as biopesticides, include true biological agents, living or reproduced biological entities suchas viruses or bacteria, and naturally occurring biochemicals such as plant growth regulators, hormones, and insect sexual attractants (pheromones) that function by modes of action other than innate toxicity. At the end of 1998, there were approximately 175 registered biopesticide active ingredients and 700 products. Generally, biological pesticides pose little or no risk to human health or the environment. Accordingly EPA generally requires much less data to register a biopesticide than to register a conventional pesticide (USEPA, 1999). To further facilitate the registration of biopesticides, in 1994, EPA established the Biopesticides and Pollution Prevention Division in the Office of Pesticide Programs. C Plant growth regulators have been developed by many companies to improve crop production. Plant growth regulators are produced for a variety of purposes, including loosening ripened fruits for faster harvest; controlling the size and firmness of fruits; and regulating the size of a plant Sector Notebook Project 14 September 2000 Agricultural Chemical Industry Introduction and Scope to increase branching. These products account for a small portion of world and United States usage. Future development will probably be directed toward selected crops for which the application of these specialty products is found to be the most cost effective (USITC, 1994). C Sex attractants may be used to attract insects to traps or to confuse specific male insects, making it difficult to locate females for mating. Commercially available sexual attractants are synthetically produced compounds. Insect growth regulators, such as juvenile growth hormones, are synthetic compounds similar to the natural chemicals that regulate insect growth. C Genetically modified plants are plants developed through the use of biotechnology. There are three types of plants that are relevant to pest control: herbicide-tolerant plants (which can tolerate certain types of herbicides), insect-resistant plants (which can withstand attacks by certain insects), and virus- and other pest-resistant plants (which are immune to some types of plant viruses and other plant pests). As of September 1994, several genetically modified plants had been commercialized and had elicited optimism that genetically modified plants would become an important new approach to controlling pests (USDA, 1995). The environmental benefits of reduced use of chemical pesticides are also significant. Environmental side effects of traditional pesticides include the cost of providing alternative sources of drinking water, increased treatment costs for public and private water systems, lost boating and swimming opportunities, worker safety concerns, exposure to nearby residents, increased exposures for farm children, possible loss of biodiversity, pressure on threatened and endangered species, and damage to recreational and fishery resources (USDA, 1995). Pesticide Formulations Pesticide formulations may exist in any of the three following physical states: liquid, dry, and pressurized gas. The liquid formulation may be applied directly in liquid form or propelled as an aerosol. Some common dry-based formulations are dusts, wettable powders, granules, treated seed, bait pellets, encapsulated, and cubes. Pressurized gas formulations are used primarily for soil fumigation (USEPA, 1996). Gaseous pesticides can be subjected to high pressures which oftenconvert the formulation to a liquid which can be stored, transported and applied from gas cylinders. Repackaging of pesticide formulations is common when materials are to be transferred from bulk storage to a smaller scale of packaging for use by a consumer. Products are typically repackaged in smaller containers and consumer-specific labeling is added (USEPA, 1996). In 1995, roughly 79 percent of all pesticides were used on agricultural Sector Notebook Project 15 September 2000 Agricultural Chemical Industry Introduction and Scope cropland. The remainder were used in private homes and gardens and on commercial and industrial property (Aspelin, 1997). Therefore, although nonagricultural pesticides are included in SIC code 2879 and thus the notebook, the specific packaging or formulating requirements of those products are not included. However, the sales, production, pollutant releases, and enforcement and compliance data reflect non-agricultural pesticides as well as agricultural pesticides. The majority of pesticides were used on only a few major crops: cotton, corn, soybeans, and apples. The major pesticide chemicals used in United States agricultural crop production are atrazine, metolachlor, metamsodium, methyl bromide1, and dichloropropene (Aspelin, 1997). Figure 4: Product Distribution for SIC 2879, Pesticides and Miscellaneous Agricultural Chemicals Source: American Crop Protection Association, as reported in Chemical and Engineering News, June 23, 1998. Establishment Reporting Under FIFRA Section 7 Information reported under section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is another source of facility level data for the pesticides 1 Production and importation of methyl bromide is currently being phased out. It will be reduced from 1991 levels and will be completely phased out in 2005. Sector Notebook Project 16 September 2000 Agricultural Chemical Industry Introduction and Scope industry. All establishments that produce pesticides in the United States or that import pesticides into the United States are required to register and report their production volume to the EPA. These data differ from the Census of Manufacturers data presented above for the agricultural chemical industry as a whole. The Census of Manufacturers data only covers facilities that are manufacturing these products, while the FIFRA data systemmore broadly includes establishments that “produce” these products. The term, “produce” has been defined under FIFRA and 40 CFR Part 167 to mean “to manufacture, prepare, propagate, compound, or process any pesticide, including any pesticide produced pursuant to section 5 of FIFRA, any active ingredient, or device, or to package, repackage, label, relabel, or otherwise change the container of any pesticide or device.” Repackaging or otherwise changing the container of any pesticide or device in bulk amounts constitutes pesticide production. Under FIFRA section 7, products are reported under one of four product types: 1) 2) 3) 4) Technical material or active ingredient End-use blend, formulation, or concentrate Repackaged or relabeled product Device The total number of establishments, domestic and foreign, that reported to EPA under FIFRA section 7 are presented in Table 5. Although there are approximatelytwelve to thirteen thousand Active Registered Pesticide-Producing Establishments, table 5 below only lists establishments that reported actual production for the calender year 1996. The establishments that reported either zero production or who were non-reporters for calender year 1996 are not included in the establishment number totals in the table. The significant difference between the pesticide producing establishment counts as reported under section 7 (8,612) and the pesticide and agricultural chemical manufacturers n.e.c. reported by the Census (263) can be attributed to the section 7 broad inclusion of producers vs. the relatively narrow, Census inclusion of manufacturers. In addition, the Census of Manufacturers uses SIC code definitions which lump many pesticide active ingredient manufacturers into SIC codes that represent organic or inorganic chemicals. Establishments classified under the first product type, as well as some of the second, may include facilities classified under the chemical manufacturing SIC codes 286 or 281. Also, the Census only counts a facility in an SIC code if theyreport a productin that SIC code as their primary line of business. Therefore, facilities producing a variety of products might not be classified under all applicable SIC codes. For example, a facility which produces many different types of fertilizers as well as some pesticides might only be counted under the fertilizer SIC codes by the Census Bureau to avoid double counting of facilities. Sector Notebook Project 17 September 2000 Agricultural Chemical Industry Introduction and Scope Table 5: Establishment Counts Based on Product Type * Type Product Total Domestic Foreign 1 Technical Material, Active Ingredient 555 410 145 2 End-Use Blend, Formulation, Concentrate 2,590 2,454 136 3 Repackaged or Relabeled Goods 5,267 5,243 24 4 Devices 200 166 34 8,612 8,273 339 Total Source: U.S.EPA, Enforcement, Planning, Targeting & Data Division,, FIFRA, section 7 Data System, United States EPA. 1996. Sector Notebook Project 18 September 2000 Agricultural Chemical Industry Introduction and Scope II.B.2. Industry Size and Geographic Distribution Table 6 lists the facility size distribution within the nitrogenous fertilizer, phosphatic fertilizer, fertilizer mixing, and pesticide and agrichemical formulating industries. For each industry code, the majority of facilities employ less than 50 people. Table 6: Facility Size Distribution for the Fertilizer, Pesticide, and Agricultural Chemical Manufacturing Industry FERTILIZERS PESTICIDES Nitrogenous Fertilizers (SIC 2873) Phosphatic Fertilizers (SIC 2874) Fertilizers, Mixing only (SIC 2875) Pesticides and other Agrichemicals (SIC 2879)* Number of Facilities Percentage of Facilities Number of Facilitie s Percentage of Facilities Number of Facilities Percentage of Facilities Number of Facilitie s Percentage of Facilities 1-9 60 39% 27 36% 205 51% 108 41% 10-49 47 31% 22 29% 166 41% 95 36% 50-249 43 28% 15 20% 30 8% 45 17% 250-499 1 1% 6 8% 0 0% 7 3% 500-2499 1 1% 5 7% 0 0% 8 3% Total 152 100% 75 100% 401 100% 263* 100% Employees per Facility Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, US Department of Commerce, Bureau of the Census, May 1995. Note: 1992 Census of Manufacturers data are the most recent available. Changes in the number of facilities, location, and employment figures since 1992 are not reflected in these data. * United States EPA has identified over 8,600 registered pesticide producing establishments. The SIC code as it is defined by the OMB only includes 263 of those establishments. Sector Notebook Project 19 September 2000 Agricultural Chemical Industry Introduction and Scope Figure 5 shows the United States distribution of fertilizer manufacturing and mixing facilities. The geographic distribution of nitrogenous and phosphatic fertilizer manufacturers is determined by natural resources and demand. Seventy percent of synthetic ammonia plants in the United States are concentrated in Louisiana, Texas, Oklahoma, Iowa, and Nebraska due to abundant natural gas supplies. The majority of nitric acid plants are located in agricultural regions such as the Midwest, South Central, and Gulf States in order to accommodate the high volume of fertilizer usage. Florida has the largest phosphate rock supply in the United States, thus phosphoric acid manufacturing is concentrated primarily in Florida and spreads into the Southeast. Figure 5: Geographic Distribution of the Fertilizer Industry (SIC 2873, 2874, 2875) Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, United States Department of Commerce, Bureau of the Census, May 1995. Sector Notebook Project 20 September 2000 Agricultural Chemical Industry Introduction and Scope Table 7 further divides the geographic distribution of fertilizer manufacturing and mixing facilities. The top states in which the nitrogenous fertilizer, phosphatic fertilizer, and fertilizer mixing industries are concentrated are given along with their respective number of establishments. Florida’s supply of phosphate rock causes a concentration of phosphatic and mixed fertilizer facilities, while nitrogenous fertilizer plants are often located near sources of raw materials. Table 7: States with the Largest Number of Fertilizer Manufacturing Facilities States in which industry is concentrated, based on number of establishments % of total Nitrogenous Fertilizers (SIC 2873) Phosphatic Fertilizers (SIC 2874) Top States Establish ments Top States Establish ments Top States Establish ments California Texas Louisiana 17 12 8 Florida North Carolina 15 9 Florida Ohio Texas 42 31 26 24% Fertilizers, Mixing only (SIC 2875) 32% 25% Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, US Department of Commerce, Bureau of the Census, May 1995. Note: 1992 Census of Manufacturers data are the most recent available. Changes in the number of facilities, location, and employment figures since 1992 are not reflected in these data. Sector Notebook Project 21 September 2000 Agricultural Chemical Industry Introduction and Scope Figure 6 shows the United States distribution of pesticide formulating and miscellaneous agrichemical formulating facilities. The distribution follows the general distributionof the petrochemical industry(coasts and Great Lakes) which the industry relies on for its raw materials, and the distribution of agricultural productionin the United States (Midwest and Great Plains states). Figure 6: Geographic Distribution of the Pesticide Formulating and Miscellaneous Agrichemical Formulating Facilities (SIC 2879)* Source: 1992 Census of Manufacturers, Industry Series: Agricultural Chemicals, United States Department of Commerce, Bureau of the Census, May 1995. * United States EPA has identified over 8,000 establishments that could fall within this SIC code as it is defined by the OMB. Sector Notebook Project 22 September 2000 Agricultural Chemical Industry Introduction and Scope Table 8: Top United States Agricultural Chemical Companies 1997 Sales (millions of dollars) Rank Company SIC Code(s) Reported 1 IMC Global - Northbrook, IL 2,981 2874, 2875, 2819, 1474, 1475 2 Zeneca Inc. - Wilmington, DE 2,822 2879, 2834,2899 3 Agrium United States Inc. - Spokane, WA 1,814 2873 4 CF Industries, Inc. - Lake Zurich, IL 1,383 2873, 2874 5 PCS Nitrogen Inc. - Memphis, TN 1,310 2873, 2874 6 Dowelanco (now named Dow AgriSciences) - Indianapolis, IN 1,288 2879 7 The Scotts Company - Marysville, OH 752 2873, 2874, 2879, 0139, 2499, 3524 8 Cargill Fertilizer - Riverview, FL 600 2874 9 ChemFirst Inc. - Jackson, MS 595 2873, 2865, 3567, 3312 10 La Roche Industries Inc. - Atlanta, GA 449 2873, 5191, 2812, 2869, 3291, 3569 Source: Dun & Bradstreet’s Million Dollar Directory, 1997 Note: Not all sales can be attributed to the companies agricultural chemical operations. Dun & Bradstreet’s Million Dollar Directory, compiles financial data on United States companies including those operating within the Fertilizer, Pesticide, and Agricultural Chemical Industry. Dun & Bradstreet ranks United States companies, whether they are a parent company, subsidiary or division, by sales volume within their assigned 4-digit SIC code. Readers should note that: (1) companies are assigned a 4-digit SIC code that resembles their principal industry most closely; and (2) sales figures include total company sales, including subsidiaries and operations (possibly not related to agricultural chemicals). Additional sources of company specific financial information include Standard & Poor’s Stock Report Service, Ward’s Business Directory of United States Public and Private Companies, Moody’s Manuals, and annual reports. The Bureau of the Census publishes concentration ratios, which measure the degree of competition in a market. They compute the value of shipments percentage controlled by the top 4, 8, 20, and 50 companies in a given industry. Within the agricultural chemical industry, the phosphatic fertilizer Sector Notebook Project 23 September 2000 Agricultural Chemical Industry Introduction and Scope industry had the highestconcentrationratio for the top four companies in 1992, 62 percent. The pesticide and other agricultural chemicals, nitrogenous fertilizers, and fertilizer mixing industries’ concentration ratios were 53, 48, and 19 percent respectively. II.B.3. Economic Trends The United States is a major producer and exporter of agricultural chemicals. It is the largest producer of phosphatic fertilizers and pesticides and the second largest producer of nitrogenous fertilizers in the world (USDOC, 1998). Domestic Market Trends The majority of important crops, such as corn and soybeans, are grown using fertilizers and pesticides. As a result, year-to-year changes in the domestic demand for agrichemicals reflect the level of planted acreage, which in turn is affected by grain prices and weather conditions. Increases in planted acreage of corn, feedgrains and other crops in recent years have resulted in increased demand and production of agrichemicals in the United States. Industry shipments of agricultural chemicals should show modest annual growth through the end of the decade (USDOC, 1998). The Federal Agricultural Improvement and Reform Act of 1996 could have a major long-termimpact on the agricultural chemical industry. This law gives farmers greater flexibility in making planting decisions and allows themto rely more on the marketplace as a guide for crop plantings. The bill eliminates the annual acreage set-aside program, thus potentially boosting the levels of crop acreage (USDOC, 1998). Agricultural chemical production showed little change between 1995 and 1996. Total production was approximately 103 million pounds each year. However, experts claimthatdue to lower dosage requirements for pesticides, agrichemical demand is actually higher than it would appear. Pesticides saw a six percent rise in production from 1995 to 1996. Nitrogenous fertilizer production was up approximately seven percent, and phosphate production increased slightlyexcept for its major product, diammonium phosphate. Prices for agricultural chemicals rose three percent from 1995 to 1996, while the number of production workers fell two percent (USDOC, 1998). International Market Trends The United States accounts for more than 50 percent of world trade in phosphatic fertilizers, with a two-thirds share of total trade in DAP (diammonium phosphate), the principal phosphatic fertilizer product. Exports generally account for about half of total shipments for the United States phosphatic fertilizer industry, with about half of all exports going to China. Sector Notebook Project 24 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers International markets, especially less developed nations in Asia and Latin America, hold greater market potential for the agrichemicals industry as population levels grow, income levels rise, and demands for better standards of living and diets increase the need for grain production. From the current level of about 5.8 billion, the world population is expected to increase by about 80 million each year between 1996 and 2000. Developing nations are becoming more sophisticated in agricultural practices, thus increasing their usage of fertilizers and pesticides to improve production (USDOC, 1998). The United States has been a net exporter of pesticide chemicals, and this is expected to continue through the turn of the century. Exports of pesticides accounted for about 25 percent of United States pesticide production in 1994, according to The American Crop Protection Association. United States pesticide producers benefit from a highly developed chemical sector and strong demand from developing regions of the world. Nevertheless, export opportunities are being restrained by industry-wide globalization as producers are choosing to site facilities closer to end-use markets. In addition, regulatoryreforms in WesternEurope, suchas the competitive access provider plan, are expected to limit prospects in that region, currently the largest destination for United States produced pesticides (USDOC, 1998). International competition for the United States phosphatic fertilizer industry generally comes from countries with phosphate rock reserves and capacity to convert rock into phosphate chemicals. Diammonium phosphate imports are expected to account for most of the growth in world trade, thus giving the United States a promising outlookfor this product. Morocco possesses at least 50 percent of the world’s rock reserves and is the largest phosphate rock exporter. China and Russia are also major phosphate rock and fertilizer producers, with Russia also a leading exporter of phosphate chemicals. In the world pesticide markets, major competitors are companies based in Germany, France, and Switzerland. The United States is a net importer of nitrogenous fertilizers. Trinidad and Tobago and Canada are the leading United States suppliers of nitrogen due to their low-cost supplies of natural gas. Agricultural biotechnology is beginning to play a major role in agricultural pest control, spurred on bygovernment pesticide restrictions, increased insect resistance to pesticides, and farmers’ demand for productivity gains. Genetically engineered plants will be higher yielding, more resistant to disease and insects, and tolerant to herbicides. A number of companies have received approvals for the use of genetically engineered seeds, including corn and cotton, that are resistant to insects and herbicide tolerant. Commercial usage should increase rapidly over the next few years (USDOC, 1998). Sector Notebook Project 25 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers This page left intentionally blank. Sector Notebook Project 26 September 2000 Agricultural Chemical Industry Industrial Process Description III. INDUSTRIAL PROCESS DESCRIPTION This section describes the major industrial processes within the Fertilizer, Pesticide, and Agricultural Chemical Industry, including the materials and equipment used, and the processes employed. The section is designed for those interested in gaining a general understanding of the industry, and for those interested in the inter-relationship between the industrial process and the topics described in subsequent sections of this profile -- pollutant outputs, pollutionpreventionopportunities, and federal regulations. This section does notattemptto replicate published engineering informationthatis available for this industry. Refer to Section IX for a list of resource materials and contacts that are available. This section specifically contains a description of commonlyused production processes, associated raw materials, the by-products produced or released, and the materials either recycled or transferred off-site. This discussion, coupled with schematic drawings of the identified processes, provide a concise description of where wastes may be produced in the process. This section also describes the potential fate (via air, water, and soil pathways) of these waste products. The three mostimportant nutrients for plant growth are nitrogen, phosphorous, and potassium. However, the production of the major potassium fertilizer salts, or potash as they are commonly known, is typically considered an inorganic chemical process (SIC 2819). Therefore, the discussion of fertilizer production in this notebook is restricted to nitrogenous and phosphatic mixtures. The fertilizer, pesticide, and agricultural chemical industry can be divided into Nitrogenous Fertilizers, Phosphatic Fertilizers, Fertilizers (Mixing-only), and the formulating and preparing of pesticides and other agricultural chemicals. A detailed description of the production processes for nitrogenous and phosphatic fertilizers is presented here, along with brief descriptions of the fertilizer mixing and pesticide formulating and preparing industry. III.A. Nitrogenous Fertilizers The major nitrogenous fertilizers include synthetic ammonia, ammonium nitrate, and urea. The various industrial processes used to manufacture these products are described, as well as the production process for nitric acid, an important intermediate in nitrogenous fertilizer production. III.A.1. Synthetic Ammonia Synthetic ammonia (NH3) is produced by reacting hydrogen with nitrogen at a molar ratio of three to one. Nitrogen is obtained from the air, which is primarily comprised of nitrogen (78 percent) and oxygen(21 percent) (Lewis, 1993). Hydrogen is obtained from either the catalytic steam reforming of Sector Notebook Project 27 September 2000 Agricultural Chemical Industry Industrial Process Description natural gas (methane) or naptha, or as the byproduct from the electrolysis of brine at chlorine plants. In the United States, about 98 percent of the hydrogen used to synthesize ammonia is produced bycatalytic steamreforming of natural gas, and only 2 percent is obtained from chlorine plants (USEPA, 1993a). Six process steps are required to produce synthetic ammonia using the catalytic steam reforming method: 1) natural gas desulfurization 2) catalytic steam reforming 3) carbon monoxide shift 4) carbon dioxide removal 5) methanation 6) ammonia synthesis. The first, third, fourth, and fifth steps remove impurities such as sulfur, CO, CO2 and water from the feedstock, hydrogen and synthesis gas streams. In the second step, hydrogen is manufactured and mixed with air (nitrogen). The sixth step produces anhydrous ammonia from the synthetic gas. An anhydrous compound is inorganic and does not contain water either adsorbed on its surface or combined as water of crystallization. While almost all ammonia plants use these basic process steps, details such as operating pressures, temperatures, and quantities of feedstock vary from plant to plant. Figure 7 shows a simplified process flow diagram of a typical ammonia plant (USEPA, 1993a). Natural gas desulfurization In the natural gas desulfurization step, the sulfur content (primarily as H2S) in natural gas feedstock is reduced to below 280 micrograms per cubic meter to prevent poisoning of the catalyst used in the catalytic steam reforming step. Desulfurization can be accomplished by passing the natural gas through a bed of either activated carbon or zinc oxide. In both systems, the hydrogen sulfide in the gas adsorbs to the surface of the activated carbon or zinc oxide medium and the desulfurized natural gas passes through. Over 95 percent of the ammonia plants in the United States use activated carbon fortified with metallic oxide additives for feedstock desulfurization. After a certain amount of impurities adsorb to the activated carbon, its effectiveness is reduced and it must be regenerated by passing superheated steam through the carbon bed. The superheated steam strips out the sulfur impurities, is condensed, and sent to the wastewater treatment plant. One disadvantage of the activated carbon system is that some of the heavy hydrocarbons in the natural gas adsorb to the carbon, decreasing its effectiveness and lowering the heating value of the desulfurized gas. The remaining five percent of plants use zinc oxide for desulfurization. The zinc oxide system is capable of absorbing up to 20 percent sulfur by weight Sector Notebook Project 28 September 2000 Agricultural Chemical Industry Industrial Process Description Figure 7: Typical Process of Ammonia Synthesis Source: United States EPA, 1993a. (Hodge, 1994). Zinc oxide is replaced rather than regenerated, which lowers Sector Notebook Project 29 September 2000 Agricultural Chemical Industry Industrial Process Description energy consumption and minimizes impact to the atmosphere. The higher molecular weight hydrocarbons are not removed; therefore, the heating value of the natural gas is not reduced. However, it is impractical and uneconomical to replace the zinc oxide beds so few plants use it (USEPA, 1993a). Catalytic steam reforming Next, the desulfurized natural gas is preheated by mixing with superheated steam. The mixture of steam and gas enters the primary reformer tubes which are filled with a nickel-based reforming catalyst, and the tubes are heated by natural gas or oil-fired burners. Approximately 70 percent of the methane (CH4) is converted to hydrogen (H2) and carbon dioxide (CO 2), according to the following reaction: 0.88CH4 + 1.26air + 1.24 H2O 6 0.88 CO2 +N2 + 3H2 The remainder of the CH4 is converted to H2 and CO. This process gas is then sent to the secondary reformer, where it is mixed with compressed hot air at 540°C (1004°F). Sufficient air is added to produce a final synthesis gas having a hydrogen-to-nitrogen mole ratio of three to one. The gas leaving the secondary reformer (primarily hydrogen, nitrogen, CO, CO2, and H20) is then cooled to 360°C (680°F) in a waste heat boiler before being sent to the carbon monoxide shift (USEPA, 1993a). Carbon monoxide shift After cooling, the secondary reformer effluent gas enters a high temperature (350-400°C) CO shift converter which converts the CO to CO2, followed by a low temperature (200-250°C) shift converter which continues to convert CO to CO2 (Kroschwitz and Howe-Grant, 1992). The high temperature CO shift converter is filled with chromium oxide initiator and iron oxide catalyst. The following reaction takes place (USEPA, 1993a): CO + H2O 6 CO2 + H2 The exit gas is then cooled in a heat exchanger before being sent to a low temperature shift converter for ammonia, amines, and methanol where CO continues to be converted to CO2 by a copper oxide/zinc oxide catalyst (Kent, 1992). In some plants, the gas is first passed through a bed of zinc oxide to remove any residual sulfur contaminants that would poison the low temperature shift catalyst. In other plants, excess low temperature shift catalyst is added to ensure that the unit will operate as expected. Final shift gas from this converter is cooled from 210 to 110°C (410 to 230°F) and unreacted steam is condensed and separated from the gas in a knockout drum. The final shift gas then enters the bottom of the carbon dioxide absorption system. The condensed steam(process condensate) contains ammonium carbonate ([(NH4)2 CO3 • H2O]) from the high temperature shift converter, methanol (CH3OH) from the low temperature shift converter, and small amounts of sodium, iron, copper, zinc, aluminum and calcium. Process condensate is sent to the stripper Sector Notebook Project 30 September 2000 Agricultural Chemical Industry Industrial Process Description to remove volatile gases such as ammonia, methanol, and carbon dioxide. Trace metals remaining in the process condensate are typically removed in an ion exchange unit (USEPA, 1993a). Carbon dioxide removal In this step, CO2 in the final shift gas is removed. CO2 removal can be done by using one of two methods: monoethanolamine (C2H4NH2OH) scrubbing or hot potassium scrubbing. Approximately 80 percent of the ammonia plants use monoethanolamine (MEA) for removing CO2. In this process, the CO2 gas is passed upward through an adsorption tower countercurrent to a 15 percent to 30 percent solution of MEA in water fortified with corrosion inhibitors. After absorbing the CO2, the amine-CO2 solution is preheated and regenerated in a reactivating tower. The reacting tower removes CO2 by steam stripping and then by heating. The CO2 gas (98.5 percent CO2) is either vented to the atmosphere or used for chemical feedstock in other parts of the plant complex. The regenerated MEA is pumped back to the absorber tower after being cooled in a heat exchanger and solution cooler (USEPA, 1993a). Methanation Carbon dioxide absorption is not 100 percent effective in removing CO2 from the gas stream, and CO2 can poison the synthesis converter. Therefore, residual CO2 in the synthesis gas must be removed by catalytic methanation. In a reactor containing a nickel catalyst and at temperatures of 400 to 600°C (752 to 1112°F) and pressures up to 3,000 kPa (435 psia) methanation follows the following reaction steps: CO2 + H2 6 CO + H2 O CO + 3H2 6 CH4 + H2O CH4 + 2H2 O 6 CO2 + 4H2 Exit gas from the methanator is almost a pure three to one mole ratio of hydrogen to nitrogen (USEPA, 1993a). Ammonia Synthesis In the synthesis step, the hydrogen and nitrogen synthesis gas from the methanator is converted to ammonia. N2 +3H2 6 2NH3 First, the gas is compressed to pressures ranging from 13,800 to 34,500 kPa (2000 to 5000 psia), mixed with recycled synthesis gas, and cooled to 0°C (32°F). This results in a portion of the gas being converted to ammonia which is condensed and separated from the unconverted synthesis gas in a liquidvapor separator and sent to a let-down separator. The unconverted synthesis gas is further compressed and heated to 180°C (356°F) before entering a synthesis converter containing an iron oxide catalyst. Ammonia gas exiting the Sector Notebook Project 31 September 2000 Agricultural Chemical Industry Industrial Process Description synthesis converter is condensed and separated, then sent to the let-down separator. A small portion of the overhead gas is purged to prevent the buildup of inert gases such as argon in the circulating gas system. Ammonia in the let down separator is flashed to atmospheric pressure (100 kPa (14.5 psia)) at 33°C (-27°F) to remove impurities from the make-up gas. The flash vapor is condensed in a let-down chiller where anhydrous ammonia is drawn off and stored at low temperature (USEPA, 1993a). Storage and Transport Ammonia is typically stored at ambient pressure and -33°C (-28°F) in large 20,000 ton tanks. Some tanks are built with a double wall to minimize leakage and insulate. If heat leaks into the tank and ammonia is vaporized, the vapors are typically captured, condensed, and returned to the tank. Ammonia is mostly transported by barge to key agricultural areas, but there is also a small system of interstate ammonia pipelines (Kent, 1992). III.A.2. Nitric Acid Nitric acid (HNO3) is produced by two methods. The first method utilizes oxidation, condensation, and absorption of ammonia to produce a “weak” nitric acid. Weak nitric acid has a concentration ranging from30 to 70 percent nitric acid. The second method combines dehydrating, bleaching, condensing, and absorption to produce “high strength” nitric acid from weak nitric acid. High strength nitric acid generally contains more than 90 percent nitric acid (USEPA, 1993a). The following text discusses each of these processes. Weak Nitric Acid Production Nearly all the weak nitric acid produced in the United States is manufactured bythe high temperature catalytic oxidation of ammonia as shown schematically in Figure 8. This process typically consists of three steps: 1) ammonia oxidation 2) nitric oxide oxidation 3) absorption. Each step corresponds to a distinct chemical reaction. Ammonia Oxidation During ammonia oxidation, a one to nine ammonia to air mixture is oxidized at a temperature of 750 to 800°C (1380 to 1470°F) as it passes through a catalytic converter, according to the following reaction: 4NH3 + 5O2 6 4NO + 6H2O The most commonly used catalyst is made of gauze squares of fine wire constructed of 90 percent platinum and 10 percent rhodium. Under these Sector Notebook Project 32 September 2000 Agricultural Chemical Industry Industrial Process Description conditions the oxidation of ammonia to nitric oxide (NO) proceeds in an exothermic reaction with 93 to 98 percent yield. Higher catalyst temperatures increase reaction selectivity toward nitric oxide (NO) production. Lower catalyst temperatures tend to be more selective toward nitrogen (N2) and nitrous oxide (N 2O) (USEPA, 1993a). The nitric oxide then passes through a waste heatboiler and a platinum filter in order to recover the precious metal platinum (Kent, 1992). Nitric Oxide Oxidation The nitric oxide formed during the ammonia oxidation is further oxidized in another process step. The nitric oxide process stream is passed through a cooler/condenser and cooled to 38°C (100°F) or less at pressures up to 800 kPa (116 psia). The nitric oxide reacts noncatalytically with residual oxygen to form nitrogen dioxide and its liquid dimer, dinitrogen tetroxide: 2NO + O2 6 2NO2 + N2O4 (A dimer is a small polymer whose molecule is composed of two molecules of the same composition(Lewis, 1993).) This slow, homogeneous reaction is temperature and pressure dependent. Operating at low temperatures and high pressures promotes maximum production of NO2 within a minimum reaction time (USEPA, 1993a). Nitrogen dioxide absorption The final step introduces the gaseous nitrogen dioxide/dimer mixture into an absorption process after being cooled. The mixture is pumped into the bottom of an absorption tower with trays, while liquid dinitrogen tetroxide (N2O4) is added at a higher point. Deionized water enters the top of the column. Both liquids flow countercurrent to the dioxide/dimer gas mixture. The exothermic reaction occurs as follows (USEPA, 1993a): 3NO2 + H2O 6 2HNO3 + NO A secondary air stream is introduced into the column to re-oxidize the NO that is formed. This secondary air also removes NO2 from the product acid. Oxidation of NO to NO2 takes place in the free space between the trays, while absorption of NO2 into the water occurs on the trays. An aqueous solution of 55 to 65 percent (typically) nitric acid is withdrawn from the bottom of the tower. The acid concentration can vary from 30 to 70 percent nitric acid depending upon the temperature, pressure, number of absorption stages, and concentration of nitrogen oxides entering the absorber (USEPA, 1993a). There are two variations of the process described above to produce weak nitric acid: single-stage pressure process and dual-stage pressure process. In the past, nitric acid plants have been operated at a single pressure, ranging from atmospheric pressure to 1400 kPa (14.7 to 203 psia). However, since the oxidation of ammonia is favored by low pressures and the oxidation of Sector Notebook Project 33 September 2000 Agricultural Chemical Industry Industrial Process Description nitric oxide and the absorption of nitrogen dioxide are favored by higher pressures, newer plants tend to operate a dual-stage pressure system, incorporating a compressor between the ammonia oxidizer and the condenser. The oxidation reaction is carried out at pressures from slightly negative to about 400 kPa (58 psia), and the absorption reactions are carried out at 800 to 1,400 kPa (116 to 203 psia) (USEPA, 1993a). In the dual-stage pressure system, the nitric acid formed in the absorber (bottoms) is usually sent to an external bleacher where air is used to remove (bleach) any dissolved oxides of nitrogen(NO, NO2, etc.). The bleacher gases are then compressed and againpassed through the absorber. The absorber tail gas (distillate) is sent to an entrainment separator for acid mistremoval. Next, the tail gas is reheated in the ammonia oxidation heat exchanger to approximately 200°C (392°F). The gas is then passed through catalytic reduction units for NOx emissions control. The final step expands the gas in the power-recovery turbine. The thermal energy produced in this turbine can be used to drive the compressor. Sector Notebook Project 34 September 2000 Agricultural Chemical Industry Industrial Process Description Figure 8: Typical Process of Dual-Stage, Weak Nitric Acid Production Source: United States EPA, 1993a. High Strength Nitric Acid High strength nitric acid (98 to 99 percent concentration) can be obtained by concentrating weak nitric acid (30 to 70 percent concentration) using extractive distillation. Extractive distillation is distillation carried out in the presence of a dehydrating agent. Concentrated sulfuric acid (typically 60 percent sulfuric acid) is most commonly used for this purpose. The weak nitric acid cannot be concentrated by simple fractional distillation, in which acid is concentrated by removing water vapor in a column with trays or plates. Sector Notebook Project 35 September 2000 Agricultural Chemical Industry Industrial Process Description The nitric acid concentration process consists of feeding strong sulfuric acid and 55 to 65 percent nitric acid into the top of a packed dehydrating column at approximately atmospheric pressure. The acid mixture flows downward and concentrated nitric acid leaves the top of the column as 99 percent vapor, containing a small amount of NO2 and O2 resulting fromdissociation of nitric acid. The concentrated acid vapor then goes to a bleacher and a countercurrent condenser system to condense strong nitric acid and the separate out the oxygen and nitrogenoxide by-products. The bleacher uses air to strip nitrogen oxides out of the nitric acid and the countercurrent condenser systemcools the vapor by flowing air through the vapor causing droplets to separate out. These nitrogenoxide by-products then flow to an absorption column where the nitric oxide mixes with auxiliary air to formNO2, which is recovered as weak nitric acid. Inert and unreacted gases are vented to the atmosphere from the top of the absorption column. Emissions from this process are relatively small compared to weak acid production (USEPA, 1993a). Figure 9 illustrates a typical high strength nitric acid production process. Figure 9: Typical Process Diagram of High Strength Nitric Acid Production Source: Adapted from United States EPA, 1993a. III.A.3. Ammonium Nitrate and Urea The manufacture steps for ammonium nitrate (NH4NO2) and urea (CO(NH2)2) are similar. In both cases, several major unit operations are involved, including: 1) 2) 3) 4) 5) Sector Notebook Project solution formation concentration solids formation finishing screening 36 September 2000 Agricultural Chemical Industry Industrial Process Description 6) coating 7) product bagging and/or bulk shipping. These operations are shown schematically in Figure 10. Not all steps are always necessary depending on the end product desired. For example, plants producing ammonium nitrate or urea liquid solutions alone use only the solution formation, solution blending and bulk shipping operations. Plants producing a solid product may employ all of the operations. Solution synthesis Ammonium nitrate. Ammonium nitrate plants produce an aqueous ammonium nitrate solution through the reaction of ammonia and nitric acid in a neutralizer where water is evaporated by the heat of the reaction as follows: NH3 + HNO3 6 NH4NO3 + 26 kcal/g mol The temperature, pressure, and final concentrationof the ammoniumnitrate are interdependent. Higher temperatures and pressures can be used to produce a higher concentration of ammonium nitrate (Hodge, 1994); however, the temperature of the operation should be below 120°C (250°F) in order to prevent explosions. Up to 99.5 percent of the ammonia and nitric acid is typically converted to ammonium nitrate (Kent, 1992). Ammonium nitrate solution can then be used as an ingredient for nitrogen solution fertilizers or concentrated to a solid form. Urea. In the urea solution synthesis operation, ammonia (NH3) and carbon dioxide (CO2) are reacted to form ammonium carbamate (NH 2CO 2NH 4) as follows: 2NH3 + CO2 6 NH2CO2NH4 Typical operating conditions include temperatures from 180 to 200°C (356 to 392°F), pressures from 14,000 to 25,000 kPa (140 to 250 psia), molar ratios of NH3 to CO2 from 3:1 to 4:1, and a retention time of twenty to thirty minutes. The ammonium carbamate is thendehydrated to yield 70 to 77 percent aqueous urea solution. This reaction follows: (USEPA, 1993a) NH2CO2NH4 6 NH2CONH2 + H2O Urea solution can be used as an ingredient of nitrogen solution fertilizers, or it can be concentrated further to produce solid urea. Sector Notebook Project 37 September 2000 Agricultural Chemical Industry Industrial Process Description Solids Concentration Ammonium nitrate. To produce a solid product, the aqueous ammonium nitrate solution is concentrated in an evaporator or concentrator. The resulting liquid “melt” contains about 95 to 99.8 percent ammonium nitrate at approximately 149°C (300°F). This melt is then used to make solid ammonium nitrate products (USEPA, 1993a). Urea. The three methods of concentrating the urea solutionare vacuumconcentration, crystallization, and atmospheric evaporation. The method chosen depends upon the level of biuret (NH2CONHCONH2) impurity allowable in the end product. Biuret can cause mottling in urea solutions, reducing the fertilizers effectiveness in foliar applications (Kent, 1992). Aqueous urea solution decomposes with heat to biuret and ammonia. Therefore, if only a low level of biuret impurity is allowed in the end product, the method with the least heat requirement will be chosen, such as crystallization and vacuum concentration (Kent, 1992). However, the simplest and most common method of solution concentration is atmospheric evaporation. Solids Formation Prilling and granulation are the mostcommonprocesses used to produce solid ammonium nitrate and urea. Prills are round or needle-shaped artificially prepared aggregates of a material. To produce prills, concentrated melt is sprayed into the top of a prill tower. In the tower, melt droplets fall countercurrent to a rising air stream that cools and solidifies the falling droplets into prills. Prill density can be varied by using different concentrations of ammonium nitrate melt. Low density prills, in the range of 1.29 specific gravity, are formed from a 95 to 97.5 percent ammonium nitrate melt, and high density prills, in the range of 1.65 specific gravity, are formed from a 99.5 to 99.8 percent melt. Low density ammonium nitrate prills are used for making blasting agents because theyare more porous thanhigh density prills and will absorb oil. Most high density prills are used as fertilizers (USEPA, 1993a). Granulated ammonium nitrate and urea are produced by spraying a concentrated melt (99.0 to 99.8 percent) onto small seed particles of ammonium nitrate or urea in a long rotating cylindrical drum. As the seed particles rotate in the drum, successive layers of the nitrogenous chemical are added to the particles, forming granules. Pan granulators operate on the same principle as drum granulators, except the solids are formed in a large, rotating circular pan. Pan granulators produce a solid product with physical characteristics similar to those of drum granules (USEPA, 1993a). Although not widely used, additives such as magnesium nitrate or magnesium oxide may be injected directly into the melt stream. Additives can serve three Sector Notebook Project 38 September 2000 Agricultural Chemical Industry Industrial Process Description purposes: to raise the crystalline transition temperature of the final solid product in order to retain its strength and density; to act as a desiccant, drawing water into the final product to reduce caking; and to allow solidification to occur at a low temperature by reducing the freezing point of molten ammonium nitrate. (Kent, 1992) Solids Cooling The temperature of the nitrogenous product exiting the solids formation process is approximately 66 to 124°C (150 to 255°F). To prevent deterioration and agglomeration, the product must be cooled before storage and shipping. Typically, rotary drums or fluidized beds are used to cool granules and prills leaving the solids formationprocess. Because low density prills have a high moisture content, they require drying in rotary drums or fluidized beds before cooling (USEPA, 1993a). Solids Screening Since the solids are produced in a wide variety of sizes, they must be screened for consistently sized prills or granules. After cooling, off size prills are dissolved and recycled back to the solution concentration process. Granules are screened before cooling. Undersize particles are returned directly to the granulator and oversize granules may be either crushed and returned to the granulator or sent to the solution concentration process (USEPA, 1993a). Solids Coating Following screening, products can be coated in a rotary drum to prevent agglomeration during storage and shipment. The most common coating materials are clays and diatomaceous earth. However, the use of additives in the melt before solidification may preclude the use of coatings. The solid product is stored and shipped in either bulk or bags. The majority of solid product is bulk shipped in trucks, enclosed railroad cars, or barges, and approximately ten percent of solid ammonium nitrate and urea produced in the United States is bagged (USEPA, 1993a). Sector Notebook Project 39 September 2000 Agricultural Chemical Industry Industrial Process Description Figure 10: Typical Process for Ammonium Nitrate and Urea Manufacturing Source: United States EPA, 1993a. III.B. Phosphatic Fertilizers The primary products of the phosphatic fertilizers industry are phosphoric acid, ammonium phosphate, normal superphosphate, and triple superphosphate. Phosphoric acid is sold as is or is used as an intermediate in producing other phosphatic fertilizers. Monoammonium phosphate is favored for its high phosphorous content, while diammonium phosphate is favored for its high nitrogencontent. Normal superphosphate has a relatively low concentrationof phosphorous, however it is used in mixtures because of its low cost. Triple superphosphate provides a high concentration of phosphorous, more than40% phosphorous pentoxide. The industrial processes for each of these products are described below. III.B.1. Phosphoric Acid (Wet Process) In a wet process phosphoric acid facility (shown schematically in Figure 11), phosphoric acid is produced by reacting sulfuric acid (H2SO4) with naturally occurring phosphate rock. The phosphate rock is mined, dried, crushed until 60 to 70 percent of the rock is less than 150 µm in diameter, and then continuously fed into the reactor along with sulfuric acid (UNEP, 1996). The reaction also combines calcium from the phosphate rock with sulfate, forming calcium sulfate (CaSO4), commonly referred to as gypsum. Gypsum is separated from the reaction solution by filtration. Facilities in the United States generally use a dihydrate process that produces gypsum in the form of calcium sulfate with two molecules of water (CaSO4 C 2H 2O or calcium sulfate dihydrate). Japanese phosphoric acid facilities use Sector Notebook Project 40 September 2000 Agricultural Chemical Industry Industrial Process Description a hemihydrate process which produces calcium sulfate with a half molecule of water (CaSO4 C ½ H2O). This one-step hemihydrate process has the advantage of producing wet process phosphoric acid with a higher phosphate pentoxide (P2O5) concentrationand less impurities than the dihydrate process. Due to these advantages, some United States companies have recently converted to the hemihydrate process. However, since most wet process phosphoric acid is still produced by the dihydrate process, the hemihydrate process will not be discussed in detail here. A simplified reaction for the dihydrate process is as follows: Ca3(PO4)2 + 3H2SO4 6 2H3PO4 + 3[Ca3SO4 • 2H2O] 9 To make the strongest phosphoric acid possible and to decrease evaporation costs, a highlyconcentrated 93 percent sulfuric acid is normallyused. Because the proper ratio of acid to rock in the reactor is critical, precise automatic process control equipment is employed in the regulation of these two feed streams (USEPA, 1993a). During the reaction, gypsum crystals are precipitated and separated from the acid by filtration. The separated crystals must be washed thoroughly to yield at least a 99 percent recovery of the filtered phosphoric acid. After washing, the slurried gypsum is pumped into a gypsum settling pond for storage. Water is siphoned off and recycled through a surge cooling pond to the phosphoric acid process. Depending on a variety of factors, such as average ambient temperature and annual rainfall, settling and cooling ponds may require between 0.25 and 1.0 acre for each ton of daily P205 capacity (TFI, 1999). Considerable heat is generated in the reactor when the sulfuric acid and phosphate rock react. In older plants, this heat was removed by blowing air over the hot slurry surface. Modern plants vacuum flash cool a portion of the slurry, and then recycle it back into the reactor. Wet process phosphoric acid normallycontains 26 to 30 percent P2O5. In most cases, the acid must be further concentrated to meet phosphate feed material specifications for fertilizer production. Depending on the types of fertilizer to be produced, phosphoric acid is usually concentrated to 40 to 55 percent P2O5 by using two or three vacuum evaporators (USEPA, 1993a). These evaporators operate with a forced circulation and generate a vacuum through vacuum pumps, steam ejectors, or an entraining condenser downstream of the evaporator. Figure 12 illustrates a vacuum evaporator. Sector Notebook Project 41 September 2000 Agricultural Chemical Industry Industrial Process Description Figure 11: Typical Process of a Wet Process Dihydrate Phosphoric Acid Plant Source: Adapted from United States EPA, 1993a. Figure 12: Typical Vacuum Evaporator Process Source: United States EPA, 1993a Sector Notebook Project 42 September 2000 Agricultural Chemical Industry Industrial Process Description III.B.2. Ammonium Phosphate Diammonium phosphate (DAP) and monoammonium phosphate are the major types of ammonium phosphatic fertilizer. Ammonium phosphates are produced by reacting phosphoric acid with ammonia. The ammonium phosphate liquid slurry produced is thenconverted to solid granules. Approximately 95 percent of ammoniation-granulationplants in the United States use a rotary drum mixer developed and patented by the Tennessee Valley Authority (TVA). In the TVA DAP process, phosphoric acid is mixed in an acid surge tank with 93 percent sulfuric acid (H2SO4) and recycled acid from wet scrubbers. The mixed acids are then partially neutralized with liquid or gaseous anhydrous ammonia in a brick-lined acid reactor. All of the phosphoric acid and approximately 70 percent of the ammonia needed to complete the reaction are introduced into this vessel. A slurry of ammonium phosphate and 22 percent water are produced and sent through steam-traced lines to the ammoniator granulator. Slurry from the reactor is distributed in the rotary drum granulator, and the remaining ammonia (approximately 30 percent) is sparged under the slurry. The basic rotary drum granulator consists of an open-ended, slightly inclined rotary cylinder, with retaining rings at each end and a scraper or cutter mounted inside the drum shell. A rolling bed of dry material is maintained in the unit while the slurry is introduced through distributor pipes set lengthwise in the drum. Gravity forces the slurry to travel through the turning granulator to the lower end. Moist DAP granules are then discharged into a rotary dryer, where excess water is evaporated and the chemical reaction is accelerated to completion by the dryer heat. Dried granules are cooled and then sized on vibrating screens. The product ranges in granule diameter from one to four millimeters (mm). The oversized granules are crushed, mixed with the undersized, and recycled back to the ammoniator-granulator. Product-size DAP granules are allowed to cool, screened, bagged, and shipped. Before being exhausted to the atmosphere, particulate and ammonia rich off-gases from the granulator, cooler, and screening operations pass through cyclones and wet scrubbers (USEPA, 1993a). TVA developed two minor modifications in their DAP process to produce MonoammoniumPhosphate (MAP). In one, the phosphoric acid is ammoniated to an ammonia to phosphoric acid ratio of only 0.6 in the preneutralizer and then 1.0 in the granulator. This compares to a ratio of about 1.4 for DAP. With the second modification, the ammonium to phosphoric acid ratio is brought to 1.4 in the preneutralizer, then additional phosphoric acid is added in the granulator to bring the ratio back to 1.0. The second method is preferred by industry because higher temperatures may be used to dry the MAP, increasing production rates (Kent, 1992). A schematic diagram of the ammonium phosphate process flow diagram is Sector Notebook Project 43 September 2000 Agricultural Chemical Industry Industrial Process Description shown in Figure 13. Source: U.S.EPA, 1993a and TFI, 1999 Figure 13: Simplified Process Flow Diagram of Diammnonium Phosphate Production GYPSUM POND WATER SECONDARY SCRUBBER CYCLONE PRIMARY SCRUBBER AMMONIATOR GRANULATOR PHOSPHORIC ACID ACID SULFURIC ACID OVERSIZE MILL COOLING AIR REACTOR SURGE TANK DUST SUPPRESSANT FUEL, AIR ANHYDROUS AMMONIA ROTARY DRYER SCREENS ROTARY COOLER PRODUCT UNDERSIZE DUST SUPPRESSANT III.B.3. Normal Superphosphate Normal superphosphates (NSP) are prepared by reacting ground phosphate rock with 65 to 75 percent sulfuric acid to produce a solid fertilizer material. NSP is most often used as a high-phosphate additive in the production of granular fertilizers. It can also be granulated for sale as granulated superphosphate or granular mixed fertilizer. There are two primary types of sulfuric acid used in superphosphate manufacture: virgin and spent acid. Virgin acid is produced from elemental sulfur, pyrites, and industrial gases and is relatively pure. Spent acid is a recycled waste product from various industries that use large quantities of sulfuric acid. Problems encountered with using spent acid include unusual Sector Notebook Project 44 September 2000 Agricultural Chemical Industry Industrial Process Description color, unfamiliar odor, and toxicity. An important factor in the production of normal superphosphates is the amount of iron and aluminum in the phosphate rock. Aluminum (as Al2O3) and iron (as Fe2O3) above five percent imparts an extreme stickiness to the superphosphate and makes it difficult to handle (USEPA, 1993a). A generalized process diagramof normal superphosphate productionis shown in Figure 14. Ground phosphate rock is weighed and mixed with sulfuric acid (H2SO4) and held in an enclosed area for about 30 minutes until the reaction is partially completed. The mixing may be done in a cone mixer, which relies on an inputted swirling motion of the acid to mix the rock and acid, a pug mill, which operates with one or two mixing shafts, or a pan mixer, which agitates the solution. The reaction is (AWMA, 1992): Ca10(PO4)6F2CaCO3 + 11H2SO4 6 6H3PO4 + 11CaSO4*nH2O + 2HF + CO2 + H2O The mixture is then transferred, using an enclosed conveyer knownas the den, through the cutter which breaks up clumps, and finally to a storage pile for curing. Off-gases from the reactor are typically treated in a wet scrubber. Particulates throughout the process are controlled with cyclones and baghouses (USEPA, 1993a). To produce granulated normal superphosphate, cured superphosphate is fed through a clod breaker and sent to a rotary drum granulator where steam, water, and acid may be added to aid in granulation. Material is processed through a rotary drum granulator, a rotary dryer, and a rotary cooler, and is thenscreened to specification similar to the process used for ammonium nitrate and urea. Finally, it is stored in bagged or bulk form prior to being sold (USEPA, 1993a). Sector Notebook Project 45 September 2000 Agricultural Chemical Industry Industrial Process Description Figure 14: Typical Process for Normal Superphosphate Manufacturing Source: United States EPA, 1993a. Sector Notebook Project 46 September 2000 Agricultural Chemical Industry Industrial Process Description III.B.4. Triple Superphosphate Triple superphosphate provides a high concentration of phosphorous. Two processes have been used to produce triple superphosphate: run-of-the-pile (ROP-TSP) and granular (GTSP). GTSP yields larger, more uniform particles with improved storage and handling properties than ROP-TSP. At this time, no facilities in the United States are producing ROP-TSP, so only the GTSP process is described here. Most GTSP material is made with the Dorr-Oliver slurry granulation process, illustrated in Figure 15. This process is similar to that for normal superphosphates with the major exception being that phosphoric acid is used instead of sulfuric acid. In this process, ground phosphate rock or limestone is reacted with phosphoric acid in one or two reactors in series (USEPA, 1993a). The reaction is: Ca5F(PO4)3+ 7H3PO4 + 5H2O 6 5Ca(H2PO4)2•H2O +HF (Hodge, 1994) The phosphoric acid used in this process has a relatively low concentration (40 percent P2O5). The lower strength acid maintains the slurry in a fluid state during a mixing period of one to two hours. A small sidestream of slurry is continuously removed and distributed onto dried, recycled fines in a granulator, where it coats the granule surfaces and builds up its size. Granules are thendried in a rotary dryer, elevated and passed through screens to eliminate oversize and undersize granules. Oversize granules are crushed and sent back to the first screen, while undersize ones are sent into the emission control systems. The granules within the size range of the product are then cooled and stored in a curing pile where the reaction is completed. Particulates from the rock handling, drying, screening, cooling, and storing processes are typically controlled with cyclones and bag houses and off-gases from the reactor, granulator, and cyclones and baghouses are typically treated with wet scrubbers (USEPA, 1993a). Sector Notebook Project 47 September 2000 Agricultural Chemical Industry Figure 15: Typical Process for Triple Superphosphate Industrial Process Description Source: United States EPA, 1993a Sector Notebook Project 48 September 2000 Agricultural Chemical Industry Industrial Process Description III.C. Fertilizer Mixing A significant part of the fertilizer industry only purchases fertilizer materials in bulk from fertilizer manufacturing facilities and mixes them to sell as a fertilizer formulation. Fertilizer mixing facilities use many different materials in their blends. The most common granular fertilizer materials are listed in Table 9. Table 9: Fertilizer Materials Used in Bulk Blends Typical Grade Percent of N-P2O5-K2O fertilizer plants using this material Ammonium nitrate 31-0-0 41% Urea 46-0-0 66% Ammonium sulfate 21-0-0 22% Diammonium phosphate (DAP) 18-46-0 95% Monoammonium phosphate (MAP) 11-52-0 11% Triple Superphosphate 0-46-0 78% Normal superphosphate 0-20-0 4% Potassium chloride 0-0-60 94% Source: “Retail Marketing of Fertilizers in the United States,” by Hargett, Norman and Ralph Pay, 1980 . DAP is favored for fertilizer mixing because of its ease in storage and handling, convenient low nitrogen and high phosphorous content, and compatibility with almost any other material. Granular triple superphosphate is also very popular, but is incompatible with urea, a commonnitrogensource. Therefore, TSP is commonly used in no-nitrogen blends necessary for legumes. Ammonium sulfate has the lowest nitrogen content of the major nitrogen sources, however its production cost is quite low. Potassium chloride is the only major potassium source used in fertilizer blending. Additional materials may also be added to the blends, such as micronutrients and pesticides (Nielson, 1987). Sector Notebook Project 49 September 2000 Agricultural Chemical Industry Industrial Process Description Inert ingredients may also be added to fertilizer mixtures to improve the consistency or ease of application. Inert ingredients include sands, clays, and water. Fertilizer mixing plants consist of five primary phases: 1. 2. 3. 4. 5. mixing and storing moving materials to mixers proportioning of materials mixing, and moving the finished blend to holding bins or transport containers Fertilizer materials may be mixed as bulk blends or formed into granulations by a variety of processes. Bulk blending is a dry process, where different fertilizers are combined. Materials are typically received by rail cars and transferred through elevators to storage areas. Front-end loaders then carry the materials to weighing hoppers which feed into the mixers. There are two types of mixers most commonly used: the horizontal axis rotary drum mixer and the inclined axis rotary drum mixer. The inclined axis mixer is similar to a cement mixer in design and appearance. Ribbon-type bulk-blend mixers are also used in some plants. A ribbon-type mixer has an axial shaft with mixing spokes radiating out of the shaft in a configuration which forces the blend to flow in a ribbon-like pattern through the mixture (Nielson, 1987). After preparation and initial bulk blending of materials, granulation may be employed in order to form larger fertilizer particles with multi-nutrient compositions. Granulation of mixed fertilizers may be accomplished by steam granulation, slurry granulation, melt, or compaction granulation. Steam granulation is primarily used in Europe and Australia. The process results in little chemical reaction in order to maintain the P2O5 content of the fertilizer. Plasticity and agglomeration of the fertilizer materials is promoted by the injection of steam into rotating pans, rotary drums, or pug mills. The particles are then dried with heated air in a rotary drum dryer and cooled in a rotary drum cooler. In some cases, particles may be coated with chalk or clay to prevent caking (Hoffmeister, 1993). Slurry granulation is more commonly used in the United States The process involves a chemical reaction of the feed ingredients. In slurry granulation, one of the feed ingredients is prepared as a slurry and reacted with the others in a preneutralizer. The slurry is then fed to a granulator such as the ammoniator granulator developed by the TVA. Fertilizer producers in the United States found that higher concentrations of acid could be fed to this preneutralizer granulator process than to a granulator alone, thus increasing the grades of fertilizers and making the TVA process popular in the United States (Hoffmeister, 1993). Sector Notebook Project 50 September 2000 Agricultural Chemical Industry Industrial Process Description Another granulation process similar to slurry granulation is melt granulation. The slurry feed is replaced by a hot, concentrated, almost anhydrous melt of feed fertilizer, typicallyammoniumphosphate, prepared in a pipe reactor. The hot melt provides the plasticity necessary for granulation. The granules cool first in the granulator and then in the cooler, eliminating the need for a dryer. Compactiongranulationis based onthe fact thatmostmaterials are semiplastic and whensubjected to high pressures, the materials will compact, deform, and it is possible to roll them out into flat, stable sheets. These sheets are then cracked, forming granule-size chips which are most stable and less prone to caking than other granulations. This process has been successful for many fertilizer mixtures, particularly those including potassium chloride and ammonium phosphates and superphosphates. Ammonium sulfate, however, has limited crystal plasticity, making it unsuitable for compaction granulation (Hoffmeister, 1993). The mixtures are then typically bagged in woven polypropylene bags for strength and resistance, with liner bags to prevent leaks. The bags are either clamped, tied, heat sealed, or sewn, sewing being the cheapest and most common method (Nielson, 1987). III.D. Pesticide Formulating Processes Pesticide formulationinvolves the process of mixing, blending, or diluting one or more pesticide active ingredients (AIs) and inert ingredients to obtain a product used for additional processing or an end-use (retail) product. Formulation does not involve an intended chemical reaction (i.e., chemical synthesis). AIs are produced at separate facilities not included in this notebook. Pesticide formulations take many forms: water-based liquid; organic solvent-based liquid; dry products in granular, powder, and solid forms; pressurized gases; and aerosols. The formulations can be in a concentrated formrequiring dilution before application, or they can be ready to apply. The packaging of the formulated pesticide product depends on the type of formulation. Liquids generally are packaged into jugs, cans, or drums; dry formulations generally are packaged into bags, boxes, drums, or jugs; pressurized gases are packaged into cylinders; and aerosols are packaged into aerosol cans. Formulating, packaging, and repackaging is performed in a variety of ways, ranging fromvery sophisticated and automated formulating and packaging lines to completelymanual lines. Descriptions of liquid formulating and packaging, dry formulating and packaging, aerosol packaging, pressurized gas formulating and packaging, and repackaging operations are provided below. Sector Notebook Project 51 September 2000 Agricultural Chemical Industry Industrial Process Description III.D.1. Liquid Formulating and Packaging Liquid formulations contain mixtures of several raw materials, including AIs, inert ingredients suchas base solvents, emulsifiers, or surfactants. The solvent must be able to dissolve the AIs and other ingredients. It may be water or an organic chemical, such as isopropyl alcohol or petroleum distillate. In some cases, the formulation is an emulsion and contains both water and an organic solvent. Solid materials, such as powders or granules, may also be used as part of a liquid formulation by dissolving or emulsifying the dry materials to form a liquid or suspension. The formulated product may be in a concentrated form requiring dilution before application, or may be ready to apply. Typical liquid formulating lines consist of storage tanks or containers to hold active and inert raw materials and a mixing tank for formulating the pesticide product. A storage tank may also be used on the formulating line to hold the formulated pesticide product, prior to a packaging step. Facilities may receive their raw materials in bulk and store them in bulk storage tanks, or they may receive the raw materials in smaller quantities, such as 55-gallon drums, 50pound bags, or 250-gallon minibulk refillable containers or “totes.” These raw materials are either piped to the formulation vessel from bulk storage tanks or added directly to the vessel from drums, bags, or minibulks. Typically, water or the base solvent is added to the formulation vessel in bulk quantities (USEPA, 1996). A typical liquid formulating line is shown in Figure 16. The formulating line may also include piping and pumps for moving the raw material fromthe storage tanks to the mixing tank, and for moving formulated pesticide product to the packaging line. Other items that may be part of the line are premixing tanks, stirrers, heaters, bottle washers, and air pollution control equipment. Some lines may also have refrigeration units for formulation and storage equipment, scales, and other equipment. Many liquid formulations are packaged by simply transferring the final product into containers. Small quantities of product are often manually packaged by gravity feeding the product directly from the formulation tank into the product container. For larger quantities, the process is often automated. Formulated product is transferred to the packaging line through pipes or hoses, or is received from a separate formulating facility and placed in a filler tank. A conveyor belt is used to carry product containers, such as jugs, bottles, cans, or drums, through the filling unit, where nozzles dispense the appropriate volume of product. The belt then carries the containers to a capper, which may be automated or manual, and to a labeling unit. Finally, the containers are packed into shipping cases (USEPA, 1996). Sector Notebook Project 52 September 2000 Agricultural Chemical Industry Industrial Process Description Figure 16: Typical Process for Liquid Formulating Source: United States EPA, 1996 III.D.2. Dry Formulating and Packaging Dry formulations also contain active and inert ingredients. The final product maybe in many different forms, such as powders, dusts, granules, blocks, solid objects impregnated with pesticide (e.g., flea collars), pesticides formed into a solid shape (e.g., pressed tablets), microencapsulated dusts or granules (AI coated with a polymeric membrane to prevent premature degradation), or encapsulated water soluble packaging. They are formulated in various ways, including: C mixing powdered or granular AIs with dry inert carriers; C spraying or mixing a liquid active ingredient onto a dry carrier; C soaking or using pressure and heat to force active ingredients into a solid matrix; C mixing active ingredients with a monomer and allowing the mixture to polymerize into a solid; and C drying or hardening an active ingredient solution into a solid form. These dry pesticide products may be designed to be applied in solid form or dissolved or emulsified in water or solvent prior to application (USEPA, 1996). Because there are many types of dry pesticide products, dry pesticide formulating lines can vary considerably. In general, though, dry formulating Sector Notebook Project 53 September 2000 Agricultural Chemical Industry Industrial Process Description lines have tanks or containers to hold the active ingredients and inert raw materials, and may include mixing tanks, ribbon blenders, extruding equipment, high pressure and temperature tanks for impregnating solids with active ingredient, vacuums or other types of drying equipment, tanks or bins for storage of the formulated pesticide product, pelletizers, presses, milling equipment, sieves, and sifters (USEPA, 1996). Raw materials for dry pesticide products may be liquid or solid. Liquid raw materials may be stored in rail tank cars, tank trucks, minibulks, drums, or bottles. Dry raw materials may be stored in silos, rail cars, tank trucks, minibulks, metal drums, fiber drums, bags, or boxes. Liquid raw materials may be pumped, poured or sprayed into formulation vessels, while dry raw materials are frequently transferred to formulation equipment by screw conveyors (consisting of a helix mounted on a shaft and turning in a trough), elevators, or by pouring. Dry formulating lines may also include piping and pumps to move raw materials from storage tanks to the formulation equipment, and to move formulated pesticide productto the packaging equipment. Other items thatmay be included in the dry pesticide product line are premixing tanks, tanks for storing formulated product prior to packaging, stirrers, heaters, refrigeration units on formulation and storage equipment, scales, and air pollution control equipment (e.g., cyclones, filters, or baghouses) (USEPA, 1996). Dry pesticide products may be packaged into rail tank cars, tank trucks, totes, and minibulks, but are typically packaged into bags, boxes, and drums. As with many liquid formulations, dry formulations are packaged by simply transferring the final productinto boxes, drums, jugs, or bags. Small quantities or bags are typically packaged manually using a gravity feed from the formulating unitinto the containers or bags. Larger quantities may be packaged on an automated line, similar to liquid packaging lines. Figure 17 illustrates a dry pesticide formulation line. Sector Notebook Project 54 September 2000 Agricultural Chemical Industry Industrial Process Description Figure 17: Typical Process for Dry Formulating Source: United States EPA, 1996 III.D.3. Aerosol Packaging Some pesticide products (typically water-based or solvent-based liquids) are packaged as aerosols, which can be applied to surfaces or dispersed in the air. The product is placed in spray cans that are put under pressure and a propellant is added, which forces the product out of the can in an aerosol spray. An aerosol packaging line typically includes a filler, a capper, a propellant injector, and a United States Department of Transportation (DOT) test bath. In the filler, formulated pesticide product is dispensed into empty aerosol cans, in much the same way as the liquid packaging lines fill containers. The cans are then sent to the capper, where a cap with a nozzle is placed on the can. The can enters a separate room, where the propellent is injected into the can, a vacuum is pulled, and the cap is crimped to make the can airtight. In order to comply with DOT regulations on the transport of pressurized containers, each can must then be tested for leaks and rupturing in a DOT test bath. Test baths indicate leaks by the appearance of bubbles at the point of leakage on the cylinder. The aerosol packaging line may also include a can washer to remove residue from can exteriors prior to entering the test bath (to reduce contaminant buildup in the bath), a dryer to dry can exteriors, and machinery to package aerosol cans into boxes for shipment (USEPA, 1996). Sector Notebook Project 55 September 2000 Agricultural Chemical Industry Industrial Process Description III.D.4. Pressurized Gas Formulating and Packaging Some pesticide products are formulated and packaged as pressurized gases, primarily for the purpose of soil fumigation. Soil fumigation is used where the nematodic and fungal populations in soil prohibit successful seed planting. Volatile general toxicants, such as low molecular weight halogenated compounds, are typically injected into the soil before planting, but are also occasionally used once plants have reached maturity (Kent, 1992). The active and inert ingredients are received as liquid, pressurized liquids, or gases, and are stored in tanks, tank trucks, rail cars, or minibulk storage containers. Liquid ingredients are placed in a holding tank prior to formulation. Formulating and packaging operations for these products usually occurs in one step in a closed-loop system. The ingredients are metered by weight through pressurized transfer lines into DOT-approved steel application cylinders. Other equipment that may be included in a pressurized gas line include pump and piping, and heating and refrigerating units to maintain gas pressures and temperatures in storage (USEPA, 1996). The cylinders may be refilled at a later date, after they have been tested to ensure that they are still capable of containing pressurized fluids. DOT requires hydrostatic pressure testing, as well as visual examination of the cylinder (USEPA, 1996). III.D.5. Repackaging Repackaging operations are similar to packaging operations, except the “raw material” is an already formulated product that has been packaged for sale. Repackagers often purchase formulated pesticide products, transfer the product to new containers with customer-specific labeling, and sell them to distributors (USEPA, 1996). A separate type of repackaging, called refilling, is usually performed by agrichemical facilities thattransfer pesticide products from bulk storage tanks into minibulks. These refillable containers are typically constructed of plastic and typically have capacities ranging from 100 to 500 gallons. Minibulks may be owned by the refilling establishment, the pesticide registrant, or by the end user. Production lines usually consist of a bulk storage tank, a minibulk tank into which the productis repackaged, and any interconnecting hoses or piping. The bulk storage tanks may be dedicated by product and clustered together in a diked area. The products are dispensed to the minibulks bythe use of manual system or a computer-regulated systemof pumps and meters (USEPA, 1996). Sector Notebook Project 56 September 2000 Agricultural Chemical Industry Industrial Process Description III.E. Raw Material Inputs and Pollution Outputs Raw material inputs and pollution outputs of fertilizer products and pesticide products differ considerably, and, therefore, are discussed separately below. The pollution outputs are discussed both specifically by product as well as generally by process since there are some similarities in the fertilizer and pesticide production processes and pollutant outputs. III.E.1. Fertilizers The primary raw materials for fertilizer manufacturing are phosphate rock, natural gas, sulfuric acid, and carbon dioxide. These materials are combined by several methods and in different proportions to produce a variety of fertilizer products, as described in section III. Figure 18 summarizes the fertilizer material inputs for the principal fertilizer products. Figure 18: Raw Material Flowchart for Principal Fertilizer Materials Source: Adapted from Manual on Fertilizer Statistics, Food and Agriculture Organization of the United Nations, Rome 1991. Because the basic fertilizer nutrients are found in many natural and manmade materials, raw materials for fertilizers can also be derived from sources other than the virgin materials described above. Common sources of fertilizer ingredients are sewerage treatment sludges and certain industrial wastes. Although these waste-derived fertilizers may contain essentially the same Sector Notebook Project 57 September 2000 Agricultural Chemical Industry Industrial Process Description nutrients as fertilizers derived from virgin materials, they also may contain additional constituents that were present in the waste material and which may not be beneficial, or are potentially harmful to crops, human health, or the environment. Such constituents may enter the food chain or groundwater and could become concentrated in the soil after repeated use. Lead, cadmium and arsenic are some of the more common fertilizer ingredients that could be harmful if sufficient quantities are present. It should be noted, however, that fertilizers derived from virgin materials also have the potential to contain harmful levels of these constituents if significant quantities are naturally present in the raw materials. One waste material input which has received some attentionrecentlyis cement kiln dust (CKD). Although there has been a considerable amount of research conducted on CKD use as a fertilizer, existing applications of CKD for this purpose have been mostly anecdotal, and there is only limited evidence that commercial CKD use as a fertilizer is growing significantly (USEPA, 1993b). Like agricultural lime, CKD is alkaline and contains a number of essential plant nutrients. Because of these parallel characteristics, CKD has been used as an agricultural soil amendment. CKD possesses significant fertilizer potential, particularly because of its high potassium content. Soil scientists have also suggested that other key plant nutrients contained in CKD, such as calcium, phosphorous, and zinc, might be beneficial in some fertilizer applications. However, some concern has been raised over hazardous wastes in CKD (USEPA, 1993b). Coal combustion by-products are also receiving attention for their potential agricultural benefits., including alleviating soil trace elemental deficiencies, modifying soil pH, and increasing levels of Ca and S, infiltration rates, depth of rooting, and drought tolerance. Flue gas desulfurization residues, which contain gypsum, have the potential to improve water use efficiency, product quality, and productivity of soil-crop systems. The short term benefits of coal combustion by-products usage has been demonstrated, however, long term effects have not been documented. Future hazards and benefits are yet to be determined (Korcak, 1995). Electric-arc furnace dust is also used as a fertilizer ingredient since it contains a number of trace elements required by plants, including zinc. Pollution outputs are summarized in terms of air emission, wastewater, and residual wastes. Air Emissions Synthetic Ammonia Air pollutants from the manufacture of synthetic anhydrous ammonia are emitted primarily from four process steps: Sector Notebook Project 58 September 2000 Agricultural Chemical Industry C C C C Industrial Process Description regeneration of the desulfurization bed, heating of the catalytic steam, regeneration of carbon dioxide scrubbing solution, steam stripping of process condensate. More than 95 percent of the ammonia plants in the United States use activated carbon fortified with metallic oxide additives for feedstock desulfurization. Vented regeneration steam contains sulfur oxides (SOx) and hydrogen sulfide (H2S), depending on the amount of oxygenin the steam. Regeneration may also emit hydrocarbons and carbon monoxide (CO). The reformer, heated with natural gas or fuel oil, may emit combustion products such as NOx, CO, SOx, hydrocarbons, and particulates (USEPA, 1993a). Carbon dioxide (CO2) is removed from the synthesis gas by scrubbing with monoethanolamine (C2H4NH2OH) or hot potassium carbonate solution. Regeneration of this CO2 scrubbing solution with steam produces emissions of water, NH3, CO, CO2 and monoethanolamine (USEPA, 1993a). Cooling the synthesis gas after low temperature shift conversion forms a condensate containing NH3, CO2, methanol (CH3OH), and trace metals. Condensate steam strippers are used to remove NH3 and methanol from the water, and steam from this may be vented to the atmosphere, emitting NH3, CO2, and methanol (USEPA, 1993a). Nitric Acid Emissions from nitric acid manufacturing consist primarily of NO and NO2 (which account for visible emissions), and trace amounts of HNO3 mist and NH3. The major source of nitrogen oxides is the tail gas from the acid absorption tower. In general, the quantity of nitrogen oxides (NOx) emissions is directly related to the kinetics of the nitric acid formation reaction and absorption tower design. NOx emissions can increase when there is: C C C C C C insufficient air supply to the oxidizer and absorber, low pressure, especially in the absorber, high temperatures in the cooler/condenser and absorber, production of an excessively high-strength product acid, operation at high throughput rates, faulty equipment such as compressors or pumps which lead to lower pressures, leaks, and reduced plant efficiency (USEPA, 1993a). Comparatively small amounts of nitrogen oxides are also lost from acid concentrating plants. These losses (mostly NO2) are from the condenser system, but the emissions are small enough to be controlled easily by absorbers. Acid mist emissions do not occur from the tail gas of a properly operated Sector Notebook Project 59 September 2000 Agricultural Chemical Industry Industrial Process Description plant. The small amounts that may be present in the absorber exit gas streams are typicallyremoved by a separator or collector prior to entering the catalytic reduction unit or expander. The acid production system and storage tanks can be a significant source of visible NOx emissions at nitric acid plants. Emissions from acid storage tanks are most likely to occur during tank filling (USEPA, 1993a). Ammonium Nitrate The primary air emissions from ammonium nitrate production plants are particulate matter (ammonium nitrate and coating materials), ammonia and nitric acid. Ammonia and nitric acid are emitted primarily from solution formation and granulators. Particulate matter (largely as ammonium nitrate) can be emitted from most of the process operations (USEPA, 1993a). The emission sources in solution formation and concentration processes are neutralizers and evaporators, emitting nitric acid and ammonia. The vapor stream off the top of the neutralization reactor is primarily steam with some ammonia and NH4NO3 particulates present. Specific plant operating characteristics, however, make these emissions vary depending upon use of excess ammonia or acid in the neutralizer. Particulate emissions from these operations tend to be smaller in size than those from solids production and handling processes and generally are recycled back to the process (USEPA, 1993a). Emissions from solids formation processes are ammonium nitrate particulate matter and ammonia. The sources of primary importance are prill towers (for high density and low density prills) and granulators (rotary drum and pan). Emissions from prill towers result from carryover of fine particles and fume by the prill cooling air flowing through the tower. These fine particles are from microprill formation, attrition of prills colliding with the tower or one another, and rapid transition of the ammonia nitrate between crystal states (USEPA, 1993a). Microprill formation resulting from partially plugged orifices of melt spray devices can increase fine dust loading and emissions. Certain designs (spinning buckets) and practices (vibration of spray plates) help reduce plugged orifices and thus microprill formation. High ambient air temperatures can cause increased emissions because of entrainment as a result of higher air flow required to cool prills and because of increased fume formation at the higher temperatures (USEPA, 1993a). Emissions from screening operations are generated by the attrition of the ammonium nitrate solids against the screens and against one another. Almost all screening operations used in the ammonium nitrate manufacturing industry are enclosed or have a cover over the uppermostscreen. Emissions are ducted from the process for recovery or reuse (USEPA, 1993a). Sector Notebook Project 60 September 2000 Agricultural Chemical Industry Industrial Process Description Bagging and bulk loading operations are also a source of particulate emissions. Dust is emitted from each type of bagging process during final filling when dust laden air is displaced from the bag by the ammonium nitrate. The potential for emissions during bagging is greater for coated than for uncoated material. It is expected that emissions from bagging operations are primarily the kaolin, talc or diatomaceous earth coating matter. About 90 percent of solid ammonium nitrate produced domestically is bulk loaded. While particulate emissions from bulk loading are not generally controlled, visible emissions are within typical state regulatory requirements (below 20 percent opacity) (USEPA, 1993a). Urea Emissions from urea manufacture are mainly ammonia and particulate matter. Formaldehyde and methanol, hazardous air pollutants, may be emitted if additives are used. FormalinT M, used as a formaldehyde additive, may contain up to 15 percent methanol. Ammonia is emitted during the solution synthesis and solids production processes. Particulate matter is emitted during all urea processes (USEPA, 1993a). In the synthesis process, some emission control is inherent in the recycle process where carbamate gases and/or liquids are recovered and recycled. Typical emission sources from the solution synthesis process are noncondensable vent streams from ammonium carbamate decomposers and separators. Emissions from synthesis processes are generally combined with emissions from the solution concentration process and are vented through a common stack. Combined particulate emissions from urea synthesis and concentration operations are small compared to particulate emissions from a typical solids-producing urea plant. The synthesis and concentration operations are usually uncontrolled except for recycle provisions to recover ammonia (USEPA, 1993a). Uncontrolled emission rates from prill towers may be affected by the following factors: C product grade being produced C air flow rate through the tower C type of tower bed C ambient temperature and humidity (USEPA, 1993a) The total of mass emissions per unit is usually lower for feed grade prill production than for agricultural grade prills, due to lower airflows. Uncontrolled particulate emission rates for fluidized bed prill towers are higher than those for nonfluidized bed prill towers making agricultural grade prills, and are approximately equal to those for nonfluidized bed feed grade prills (USEPA, 1993a). Ambient air conditions can affect prill tower emissions. Available data indicate that colder temperatures promote the formation of smaller particles Sector Notebook Project 61 September 2000 Agricultural Chemical Industry Industrial Process Description in the prill tower exhaust. Since smaller particles are more difficult to remove, the efficiency of prill tower control devices tends to decrease with ambient temperatures. This can lead to higher emission levels for prill towers operated during cold weather. Ambient humidity can also affect prill tower emissions. Air flow rates must be increased with high humidity, and higher air flow rates usually cause higher emissions (USEPA, 1993a). In the solids screening process, dust is generated by abrasion of urea particles and the vibration of the screening mechanisms. Therefore, almost all screening operations used in the urea manufacturing industry are enclosed or are covered over the uppermostscreen. Emissions attributable to coating include entrained clay dust fromloading, inplant transfer, and leaks from the seals of the coater (USEPA, 1993a). Phosphoric Acid Gaseous fluorides such as silicon tetrafluoride (SiF4) and hydrogen fluoride (HF) can be major emissions from wet process acid production. Phosphate rock contains 3.5 to 4.0 percent fluorine. Part of the fluorine from the rock is precipitated with the gypsum, another part is leached out with the phosphoric acid product, and the remaining portion is vaporized in the reactor or evaporator. The relative quantities of fluorides in the filter acid and gypsum depend on the type of rock and the operating conditions. Final disposition of the volatilized fluoride depends on the design and operation of the plant (USEPA, 1993a). The reactor in which phosphate rock is reacted with sulfuric acid is the main source of emissions. Fluoride emissions accompany the air used to cool the reactor slurry. Vacuum flash cooling has replaced the air cooling method to a large extent, since emissions are minimized in the closed system. Acid concentration by evaporation is another source of fluoride emissions. Approximately 20 to 40 percent of the fluorine originally present in the rock vaporizes in this operation. Particulate matter containing fluorides can be emitted directly from process equipment. About three to six percent of the particulates can be fluorides, as measured at one facility (USEPA, 1993a). Ammonium Phosphates The major sources of air emissions from the production of ammonium phosphatic fertilizers include the reactor, the ammoniator-granulator, the dryer and cooler, product sizing and material transfer, and the gypsum pond. The reactor and ammoniator-granulator produce emissions of gaseous ammonia, gaseous fluorides such as hydrogen fluoride (HF) and silicon tetrafluoride (SiF4), and particulate ammonium phosphates. These two exhaust streams are generally combined and passed through primary and secondary scrubbers (USEPA, 1993a). Exhaust gases from the dryer and cooler also contain ammonia, fluorides and Sector Notebook Project 62 September 2000 Agricultural Chemical Industry Industrial Process Description particulates, and these streams are commonly combined and passed through cyclones and primaryand secondaryscrubbers. Particulate emissions and low levels of ammonia and fluorides from product sizing and material transfer operations are controlled the same way (USEPA, 1993a). Normal Superphosphates Sources of emissions at a normal superphosphate plant include rock unloading and feeding, mixing operations (in the reactor), storage (in the curing building), and fertilizer handling operations. Rock unloading, handling and feeding generate particulate emissions of phosphate rock dust. The mixer, den and curing building emit gases in the form of silicon tetrafluoride (SiF4), hydrogen fluoride (HF) and particulates composed of fluoride and phosphate material (USEPA, 1993a). Triple Superphosphates Emissions of fluorine compounds and dust particles occur during the production of granulated triple superphosphate. Silicon tetrafluoride (SiF4) and hydrogen fluoride (HF) are released by the acidulation reaction and they evolve from the reactors, den, granulator, and dryer. Evolution of fluoride is essentially finished in the dryer and there is little fluoride evolved from the storage pile in the curing building (USEPA, 1993a). Sources of particulate emissions include the reactor, granulator, dryer, screens, cooler, mills, and transfer conveyors. Additional emissions of particulate result from the unloading, grinding, storage, and transfer of ground phosphate rock. Facilities may also use limestone, which is received in granulated form and does not require additional milling (USEPA, 1993a). Wastewater Wastewater from the fertilizer industry can be classified into four groups: C C C C process effluents resulting from contact with gas, liquids, or solids dedicated effluents which may be separated for use in one process or for recycling at a controlled rate effluents from general services such as cleaning or pretreatment occasional effluents such as leaks or spills A number of process wastewater streams from the nitrogenous fertilizer industry have been identified. Frequently these wastewaters contain high levels of nitrogenous compounds such as ammonia, nitrates, and organic nitrogen. In ammonia production, wastewater is generated from process condensate stripping. Ammonium nitrate manufacturing produces process wastewater in the neutralization process, the evaporation unit, and air cooling equipment. The vacuum condenser in urea plants is a source of wastewater. Most scrubbing operations are also a source of wastewater. Nitric acid Sector Notebook Project 63 September 2000 Agricultural Chemical Industry Industrial Process Description production generates relatively little wastewater since there is no process wastewater source. Steam generated in nitrogenous fertilizer processing may contain dissolved and suspended solids, alkalinity, and hardness (USEPA, 1974). The most common methods for removing nitrogenous compounds include: C C C C Biological nitrification/denitrification Air or steam stripping Ion exchange Breakpoint chlorination(Water Environment Federation, 1994). The major source of wastewater from any phosphatic fertilizer manufacturing process is referred to as “pond water.” Phosphoric acid production creates large quantities of pond water for cooling of the process, concentration of the product and for processing and storage of the gypsum byproduct. Gypsum slurry water is decanted from the top of the gypsum stacks and sent to the cooling pond through collection ditches (USEPA, 1993a). Through evaporation and recycling, contaminant concentrations in pond water can reach several grams per liter of phosphates and fluoride. Additional elemental contaminants in pond water which originate in phosphate rock are arsenic, cadmium, uranium, vanadium, and radium (USEPA, 1974). The most common industry treatment for removing phosphorous is lime neutralization and settling. Occasional wastewater is generated in any fertilizer production facility by leaks, spills, cleaning, maintenance, and laboratory tests. Cleaning of cooling and pollution control systems also produces process wastewater. Cooling water may contain ammonia, sulfate, chloride, phosphate, chromate, and dissolved solids which become concentrated through evaporation (USEPA, 1974). The laundry of workers’ clothing is another source of wastewater originating outside the actual process. Solid/Hazardous/Residual Wastes One of the largest solid wastes in the fertilizer industry is phosphogypsum which is produced during phosphoric acid production. Approximately 1.5 tons of phosphogypsum is produced per tonof phosphate rock fed, or 5 tons per ton of phosphoric acid produced (expressed as P2O5). Gypsum (calcium sulphate dihydrate) is a mineral which also occurs in nature. Phosphogypsum is produced by the reaction of phosphate rock with sulphuric acid during the process of producing phosphoric acid. The term “phosphogypsum” is used to specify the particular gypsum arising fromthe acidulation of phosphate rock, because it contains trace amounts of many of the mineral impurities that accompany phosphate rock. One of these impurities is radium, the parent of radon. Other trace impurities found in phosphogypsum include arsenic, nickel, cadmium, lead, aluminum, fluoride, and phosphoric acid. Mainly because of Sector Notebook Project 64 September 2000 Agricultural Chemical Industry Industrial Process Description the radiumcontent, the EPA restricts use of phosphogypsum and stipulates that no phosphogypsum with radium over tenpCi/g can be removed fromthe stacks adjacent to the agricultural chemical plants (UNEP, 1996). The use of waste phosphogypsum for other purposes has been widely encouraged, but economic and/or quality problems and/or the demand for the resulting products frequently inhibit or prevent this. These problems relate not only to the impurities in the gypsum, but also to its relatively high moisture content. Plasterboard, plaster, and cement are the main possibilities. It is also possible to recycle phosphogypsum in sulphuric acid production. The ready availability of natural gypsum and the high cost of gypsum-based sulphuric acid, as well as the presence of trace contaminants, are the main obstacles to its use (Miller, 1995). However, in countries where gypsum and other sulphurous raw materials are scarce, phosphogypsum has been successfully used for these purposes (UNEP, 1996). Dumping gypsum on land is not possible everywhere because the material settles and dries slowly and requires an adequate land area and certain climatic and soil conditions where the stack is situated. Gypsum stacks are being increasingly regulated in terms of lining and cap systems to prevent contaminated leaching or runoff (UNEP, 1996). All phosphate ores contain traces of radioactive elements and a number of metals. During processing, these are partitioned between beneficiation process wastes, the waste from the further processing into intermediate and finished fertilizer production, and some end up in the final product (UNEP, 1996). Cadmium is a heavy metal which accumulates in living systems and can become toxic above certain limits. The quantity of cadmium contained in a phosphatic fertilizer depends on the source of the rock or waste material from which it was made. The cadmium content of phosphate rocks varies from almost zero to over 300 mg/kg P2O5. The acidulation of phosphate rock partitions the cadmium between the fertilizer product and the by-products, mainly the phosphogypsum arising from phosphoric acid production (UNEP, 1996). The fertilizer industry has for some decades tried to develop cadmium separation processes. Processes studied so far have shown serious limitations and problems, with regard to safety, cost, energy consumption or environmental concerns. Currently available processes are expensive and are not economically viable except for phosphates destined for human or animal consumption, which have a greater added value. A process developed for removing cadmium from phosphoric acid, which is used in the production of many phosphatic fertilizers (except normal superphosphate), has shown promise on a laboratory scale, but needs further testing before being used on an industrial scale (UNEP, 1996). Sector Notebook Project 65 September 2000 Agricultural Chemical Industry Industrial Process Description Off-specification product, spills, and dusts collected in emission control systems are potential sources of residual wastes. Products are occasionally suspended or canceled, leaving stockpiles of residual product. Other possible sources of solid wastes are spent catalysts, spent containers, wastewater treatment sludges, and spent filters. Many of these wastes are transported offsite for disposal. However, with good housekeeping techniques and dedicated systems, some of these wastes may be recycled back into the process instead of being wasted. Catalysts used in the steam reforming process need to be replaced every two to six years. Spent catalysts contain oxides of hexavalent chromium, zinc, iron, and nickel. They are typically returned to the manufacturer or other metal recovery companies for recycling and reclamation of valuable materials (UNEP, 1996). III.E.2. Pesticide Formulating, Packaging, and Repackaging As listed below, input raw materials include the pesticide concentrates from pesticide manufacturing plants as well as diluents and other chemical additives used in the formulating process: C Active Ingredients Organic/inorganic pesticides: insecticides, herbicides, fungicides, and others. (See Table 10.) C Formulation and preparation materials Dry formulations: organic flours, sulfur, silicon oxide, lime, gypsum, talc, pyrophyllite, bentonites, kaolins, attapulgite, and volcanic ash. Liquid formulations: Solvents: xylenes, kerosenes, methyl isobutyl ketone, amyl acetate, and chlorinated solvents. Propellants: carbon dioxide and nitrogen. Others: wetting and dispersing agents, masking agents, deodorants, and emulsifiers (USEPA, 1990). In addition to pesticide materials, some facilities listed under SIC code 2879 produce fertilizer/pesticide blends. A variety of nitrogenous, phosphatic, and mixed fertilizers may be inputted into bulk blending tanks to produce these combinations. Sector Notebook Project 66 September 2000 Agricultural Chemical Industry Industrial Process Description Table 10: Approximate Quantities of Most Commonly Used Conventional Pesticides in United States Agricultural Crop Production Chemical 1995 Consumption (Million pounds active ingredient) Chemical 1995 Consumption (Million pounds active ingredient) Atrazine 68-73 Chlorpyrifos 9-13 Metolachlor 59-64 Chlorothalonil 8-12 Metam Sodium 449-54 Copper Hydroxide 7-11 Methyl Bromide 39-46 Propanil 6-10 Dichloropropene 38-43 Dicamba 6-10 2,4-D 31-36 Terbufos 6-9 Glyphosate 25-30 Mancozeb 6-9 Cyanazine 24-29 Fluometuron 5-9 Pendimethalin 23-28 MSMA 4-8 Trifluralin 23-28 Bentazone 4-8 Acetochlor 22-27 Parathion 4-7 Alachlor 19-24 Sodium Chlorate 4-6 EPTC 9-13 Source: Pesticide Industry Sales and Usage, 1994 and 1995 Market Estimates, EPA, August 1997. Air Emissions Air emissions can be generated throughout the pesticide formulating and packaging processes, mostly when fine particulates of pesticide dust become suspended in air while the materials are being moved, processed, or stored. Most dust or granule blending mills are equipped with vacuum systems, cyclones, and wet scrubbers to collect fugitive dust. Some vacuumsystems are dedicated to certain processes to facilitate reuse of the dust. Other systems are used to collect dust from a number of areas (USEPA, 1990). Dust generated by pesticide formulation processes contain AIs which may be toxic to humans and the environment. Thus, they are important to contain. Volatile organic compound (VOC) emissions such as xylene may also arise when solvent-based liquid formulations are produced. VOC emissions may also be generated during equipment cleaning with solvents. Sector Notebook Project 67 September 2000 Agricultural Chemical Industry Industrial Process Description Wastewater Process wastewater is defined in 40 CFR 122.2 as “any water which, during manufacturing or processing, comes into direct contactwith or results from the production or use of any raw material, byproduct, intermediate product, finished product, or waste product.” Wastewater from the pesticide formulating industry is typically due to cleaning of equipment and related process areas and not the actual formulating processes (USEPA, 1996). Cleaning and decontaminating blending and liquid pesticide mixing and storage equipment generates pesticide-contaminated wastewater or solvent, depending upon whether the equipment is used to formulate water or solventbased pesticides. Decontamination is performed between batches of different types of formulations to prevent cross contamination of the subsequent batch. Decontaminationis also performed prior to taking the equipment out of service for maintenance. The decontamination is commonly performed using high pressure water hoses equipped with spray nozzles, portable steam generators, or by running a batch of solvent through the formulating equipment (USEPA, 1990). Active ingredient containers, such as 55-gallon drums, are often decontaminated by triple rinsing. The decontamination is usually performed using a high pressure water hose equipped with a spray nozzle or a portable steam jenny. The containers can then be sold or given to commercial recycling firms, depending on label directions (USEPA, 1990). Floor, wall, and equipment exterior washing is typically performed using water hoses equipped with spray nozzles. It may also involve the use of mops and squeegees. Wastewater is also generated by clean-up of spills and leaks. Wastewater fromthese operations typicallycontains AIs, solvents, and wetting agents (USEPA, 1990). Other sources of wastewater include: C C C C C C C C Pollution control scrubber water Department of Transportation leak test water Safety equipment wash water Laboratory equipment wash water Shower water Laundry water Fire protection test water Contaminated precipitation runoff (USEPA, 1996) Solid/Hazardous/Residual Wastes Residual wastes include containers and container liners potentially contaminated with pesticides, as well as off-spec product, dustcollected from Sector Notebook Project 68 September 2000 Agricultural Chemical Industry Industrial Process Description emission control equipment, and product spills. Contaminated laboratory equipment and protective workers clothing are other potential solid waste sources (USEPA, 1990). Decontamination of the solid-based pesticide blending mills may generate solid diluent contaminated with pesticides. The diluent typically consists of clay for dust mills and sand for granule mills (USEPA, 1990). In case of pesticide products which have been suspended or canceled, there may be existing stocks of these products remaining. EPA may allow the use of existing stocks or prohibit such use. State environmental agencies occasionally collect unusable pesticides. Procedures for pesticide management have been proposed by EPA, as authorized under section 19 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). For more details, refer to section VI.C on pending and proposed regulatory requirements. Sector Notebook Project 69 September 2000 Agricultural Chemical Industry Industrial Process Description Table 11: Summary of Potential Pollution Outputs for the Agricultural Chemical Industry Process Air Emissions Process Wastewater Residual Waste Nitric Acid Absorption Tower NO, NO2, HNO3 in tailgas NA Spent tower materials, trays Solution Formulation and Granulation NH3, HNO3 particulates Condensed steam with NH4NO3 and NH3 NA Solids Formation Particulates, NOx, SiF4, HF NA Dusts Regeneration of Desulfurization and Filter Beds Hydrocarbons, CO, NH3, CO2 Condensed steam, NH3, CO2 Spent bed material Screening Dust NA Mixed undersized captured dusts, used screens Wet Process Phosphoric Acid Production SiF4, HF Pond water Gypsum Unloading of materials into blending tanks Dust/particulates released in transfer NA Leftover raw material containers Open processing and storage equipment VOC’s NA NA Equipment and facility cleaning NA Washwater, waste solvent Waste sands and clays, used mops/ squeegees/etc. Laboratory procedures VOC’s and dusts released Washwater, lab testing water Off-spec product used for testing/analysis Spills and runoff Dust/particulates released by spill Contaminated rainfall/runoff Contaminated solid product Pollution control systems NA Contaminated scrubber water Spent filter material Source: Guide to Pollution Prevention, The Pesticide Formulating Industry, Center for Environmental Research Information, United States EPA, Washington D.C., 1990. Sector Notebook Project 70 September 2000 Agricultural Chemical Industry Industrial Process Description III.F. Management of Chemicals in Wastestream The Pollution Prevention Act of 1990 (PPA) requires facilities to report informationabout the management of Toxic Release Inventory (TRI) chemicals in waste and efforts made to eliminate or reduce those quantities. These data have been collected annually in section 8 of the TRI reporting Form R beginning with the 1991 reporting year. The data summarized below cover the years 1995-1998 and are meant to provide a basic understanding of the quantities of waste handled by the industry, the methods typically used to manage this waste, and recent trends in these methods. TRI waste management data can be used to assess trends in source reduction within individual industries and facilities, and for specific TRI chemicals. This information could then be used as a tool in identifying opportunities for pollution prevention or compliance assistance activities. While the quantities reported for 1995 and 1996 are estimates of quantities already managed, the quantities listed by facilities for 1997 and 1998 are projections only. The PPA requires these projections to encourage facilities to consider future source reduction, not to establish any mandatory limits. Future-year estimates are not commitments that facilities reporting under TRI are required to meet. . Fertilizers Table 12 shows that the TRI reporting fertilizer manufacturing and mixing facilities managed about 566 million pounds of production related wastes (total quantity of TRI chemicals in the waste from routine production operations in column B) in 1996. From the yearly data presented in column B, the total quantity of production related TRI wastes decreased between 1995 and 1996. Production related wastes are projected to increase in 1997 and 1998. Note that the affects of production increases and decreases on the quantities of wastes generated are not evaluated here. In 1996, about 84 percent of the industry’s TRI wastes were managed on-site through recycling, energy recovery, or treatment as shown in columns C, D, and E, respectively. Most of these on-site managed wastes were recycled onsite. There is a negligible amount (<1%) of wastes being transferred off-site for recycling, energy recovery, or treatment. The remaining portion of the production related wastes (12 percent in 1995 and 16 percent in 1996), shown in column I, is either released to the environment through direct discharges to air, land, water, and underground injection, or is transferred off-site for disposal. Sector Notebook Project 71 September 2000 Agricultural Chemical Industry Industrial Process Description Table 12: Source Reduction and Recycling Activity for the Fertilizer Industry as Reported within TRI A B I On-Site Off-Site Year Quantity of ProductionRelated Waste (106 lbs.)a % Recycled 1995 719 76% 8% 4% 0% 0% 0% 12% 1996 566 77% 1% 6% 0% 0% 0% 16% 1997 606 77% 1% 7% 0% 0% 0% 15% 1998 617 78% 1% 7% 0% 0% 0% 14% C D E % Energy Recovery % Treated F % Recycled G H % Energy Recovery % Treated % Released and Disposedc Offsite Source: 1996 Toxics Release Inventory Database. a Within this industry sector, non-production related waste < 1% of production related wastes for 1996. b Total TRI transfers and releases as reported in section 5 and 6 of Form R as a percentage of production related wastes. c Percentage of production related waste released to the environment and transferred off-site for disposal. Pesticides and Miscellaneous Agricultural Chemicals Table 13 shows thatthe TRI reporting pesticide and miscellaneous agricultural chemicals facilities managed about 252 million pounds of production related wastes (total quantity of TRI chemicals in the waste from routine production operations in column B) in 1996. From the yearly data presented in column B, the total quantity of production related TRI wastes increased between 1995 and 1996. Production related wastes were projected to continue to increase in 1997 and 1998. Note that the affects of production increases and decreases on the quantities of wastes generated are not evaluated here. In 1996, about 95 percent of the industry’s TRI wastes were managed on-site through recycling, energy recovery, or treatment as shown in columns C, D, and E, respectively. Most of these on-site managed wastes were recycled onsite. A small portion of the remaining wastes (4% in 1996) are transferred off-site for recycling, energy recovery, or treatment. The remaining one percent of the production related wastes, shown in column I, is either released to the environment through direct discharges to air, land, water, and underground injection, or is transferred off-site for disposal. Sector Notebook Project 72 September 2000 Agricultural Chemical Industry Industrial Process Description Table 13: Source Reduction and Recycling Activity for the Pesticide and Miscellaneous Agricultural Chemicals Industry as Reported within TRI A B I On-Site Off-Site C D E Year Quantity of ProductionRelated Waste (106 lbs.)a % Recycled % Energy Recovery % Treated 1995 245 85% 0% 10% 2% 1% 1% 2% 1996 252 84% 0% 11% 2% 1% 1% 1% 1997 266 84% 0% 11% 1% 1% 2% 1% 1998 279 85% 0% 11% 1% 1% 1% 1% F G H % Energy % Recycled Recovery % Treated % Released and Disposedc Offsite Source: 1996 Toxics Release Inventory Database. a Within this industry sector, non-production related waste < 1% of production related wastes for 1996. b Total TRI transfers and releases as reported in section 5 and 6 of Form R as a percentage of production related wastes. c Percentage of production related waste released to the environment and transferred off-site for disposal. Sector Notebook Project 73 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers THIS PAGE WAS INTENTIONALLY LEFT BLANK Sector Notebook Project 74 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers IV. CHEMICAL RELEASE AND TRANSFER PROFILE This section is designed to provide background information on the pollutant releases that are reported by this industry in correlation with other industries. The best source of comparative pollutant release information is the Toxic Release Inventory (TRI). Pursuant to the Emergency Planning and Community Right-to-Know Act, TRI includes self-reported facility release and transfer data for over 600 toxic chemicals. Facilities within SIC Codes 20 through 39 (manufacturing industries) that have more than 10 employees, and that are above weight-based reporting thresholds are required to report TRI on-site releases and off-site transfers. The information presented within the sector notebooks is derived from the most recently available (1996) TRI reporting year (which includes over 600 chemicals), and focuses primarily on the onsite releases reported by each sector. Because TRI requires consistent reporting regardless of sector, it is an excellent tool for drawing comparisons across industries. TRI data provide the type, amount and media receptor of each chemical released or transferred. Although this sector notebook does not present historical information regarding TRI chemical releases over time, please note that in general, toxic chemical releases have been declining. In fact, according to the 1996 Toxic Release Inventory Public Data Release, reported onsite releases of toxic chemicals to the environment decreased by 5 percent (111.6 million pounds) between 1995 and 1996 (not including chemicals added and removed from the TRI chemical list during this period). Reported releases dropped by 48 percent between 1988 and 1996. Reported transfers of TRI chemicals to off-site locations increased by 5 percent (14.3 million pounds) between 1995 and 1996. More detailed information can be obtained from EPA's annual Toxics Release Inventory Public Data Release book (which is available through the EPCRA Hotline at 800-535-0202), or directly from the Toxic Release Inventory System database (for user support call 202-260-1531). Wherever possible, the sector notebooks present TRI data as the primary indicator of chemical release within each industrial category. TRI data provide the type, amount and media receptor of each chemical released or transferred. When other sources of pollutant release data have been obtained, these data have been included to augment the TRI information. TRI Data Limitations Certain limitations exist regarding TRI data. Within some sectors, (e.g. dry cleaning, printing and transportation equipment cleaning) the majority of facilities are not subject to TRI reporting because they are not considered manufacturing industries, or because they are below TRI reporting thresholds. For these sectors, release information from other sources has been included. In addition, many facilities report TRI more under thanone SIC code reflecting the multiple operations carried out onsite whether or not the operation is the Sector Notebook Project 75 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers facilities primary area of business as reported to the U.S. Census Bureau. Reported chemicals are limited to the approximately 600 TRI chemicals. A portion of the emissions fromagricultural chemical facilities, therefore, are not captured by TRI. Also, reported releases and transfers may or may not all be associated with the industrial operations described in this notebook. The reader should also be aware that TRI “pounds released” data presented within the notebooks is not equivalent to a “risk” ranking for each industry. Weighting each pound of release equally does not factor in the relative toxicity of each chemical that is released. The Agency is in the process of developing an approach to assign toxicological weightings to each chemical released so that one can differentiate between pollutants with significant differences in toxicity. As a preliminary indicator of the environmental impact of the industry’s most commonly released chemicals, the notebook briefly summarizes the toxicological properties of the top five chemicals (by weight) reported by each industry. Definitions Associated With Section IV Data Tables General Definitions SIC Code -- is the Standard Industrial Classification (SIC) code, a statistical classification standard used for all establishment-based federal economic statistics. The SIC codes facilitate comparisons between facility and industry data. TRI Facilities -- are manufacturing facilities that have 10 or more full-time employees and are above established chemical throughput thresholds. Manufacturing facilities are defined as facilities in Standard Industrial Classification primary codes 20-39. Facilities must submit estimates for all chemicals that are on the EPA’s defined list and are above throughput thresholds. Data Table Column Heading Definitions The following definitions are based upon standard definitions developed by EPA’s Toxic Release InventoryProgram. The categories below represent the possible pollutant destinations that can be reported. RELEASES -- are on-site discharges of a toxic chemical to the environment. This includes emissions to the air, discharges to bodies of water, releases at the facility to land, as well as contained disposal into underground injection wells. Releases to Air (Point and Fugitive Air Emissions) -- include all air emissions from industry activity. Point emissions occur through confined air streams as found in stacks, vents, ducts, or pipes. Fugitive emissions include Sector Notebook Project 76 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers equipment leaks, evaporative losses from surface impoundments and spills, and releases from building ventilation systems. Releases to Water (Surface Water Discharges) -- encompass any releases going directly to streams, rivers, lakes, oceans, or other bodies of water. Releases due to runoff, including storm water runoff, are also reportable to TRI. Releases to Land -- occur within the boundaries of the reporting facility. Releases to land include disposal of toxic chemicals in landfills, land treatment/application farming, surface impoundments, and other disposal on land (such as spills, leaks, or waste piles). Underground Injection -- is a contained release of a fluid into a subsurface well for the purpose of waste disposal. Wastes containing TRI chemicals are injected into either Class I wells or Class V wells. Class I wells are used to inject liquid hazardous wastes or dispose of industrial and municipal wastewaters beneath the lowermost underground source of drinking water. Class V wells are generally used to inject non-hazardous fluid into or above an underground source of drinking water. TRI reporting does not currently distinguish between these two types of wells, although there are important differences in environmental impact between these two methods of injection. TRANSFERS -- are transfers of toxic chemicals in wastes to a facility that is geographically or physically separate from the facility reporting under TRI. Chemicals reported to TRI as transferred are sent to off-site facilities for the purpose of recycling, energy recovery, treatment, or disposal. The quantities reported represent a movement of the chemical away from the reporting facility. Except for off-site transfers for disposal, the reported quantities do not necessarily represent entry of the chemical into the environment. Transfers to POTWs -- are wastewater transferred through pipes or sewers to a publicly owned treatments works (POTW). Treatment or removal of a chemical from the wastewater depends on the nature of the chemical, as well as the treatment methods present at the POTW. Not all TRI chemicals can be treated or removed by a POTW. Some chemicals, such as metals, may be removed but not destroyed and may be disposed of in landfills or discharged to receiving waters. Transfers to Recycling -- are wastes sent off-site for the purposes of regenerating or recovery by a variety of recycling methods, including solvent recovery, metals recovery, and acid regeneration. Once these chemicals have been recycled, they may be returned to the originating facility or sold commercially. Transfers to Energy Recovery -- are wastes combusted off-site in industrial Sector Notebook Project 77 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers furnaces for energy recovery. Treatment of a chemical by incineration is not considered to be energy recovery. Transfers to Treatment -- are wastes moved off-site to be treated through a variety of methods, including neutralization, incineration, biological destruction, or physical separation. In some cases, the chemicals are not destroyed but prepared for further waste management. Transfers to Disposal -- are wastes taken to another facility for disposal, generally as a release to land or as an injection underground. IV.A. EPA Toxic Release Inventory for the Fertilizer, Pesticide, and Agricultural Chemical Industry This section summarizes the TRI data of fertilizer manufacturing and mixing facilities reporting SIC codes 2873, 2874, or 2875 as their primary SIC code and of pesticide and miscellaneous agricultural chemicals formulating facilities reporting SIC code 2879 as their primary SIC code. According to the 1995 Toxics Release Inventory (TRI) data, 190 fertilizer and pesticide facilities reporting SIC 2873, 2874, 2875, or 2879 released (to the air, water, or land) and transferred (shipped off-site or discharged to sewers) a total of 106 million pounds of toxic chemicals during calendar year 1996. This represents approximately 2 percent of the 5.6 billion pounds of releases and transfers from all manufacturers (SICs 20-39) reporting to TRI that year. The top two chemicals released by weight are ammonia and phosphoric acid (both from fertilizer manufacturing). These two account for about 89 percent (82 million pounds) of the industry’s total releases. Xylene, methanol, and ethylbenzene are the three top chemicals transferred by weight (all from pesticide formulating). These three account for about 71 percent (9 million pounds) of the total TRI chemicals transferred by the industries. The variability in facilities’ TRI chemical profiles may be attributed to the variety of processes and products in the industries. Eighty-seven percent of the 243 different chemicals reported were reported by fewer than 10 facilities. Fertilizers (SIC 2873, 2874, 2875) According to 1996 TRI data, fertilizer manufacturing and mixing facilities released and transferred approximately93 million pounds of pollutants during calendar year 1996. One hundred and ninety facilities reported TRI emissions for 46 chemicals. Only 13 of the 46 chemicals (28 percent) were reported (as releases and/or transfers) by ten or more facilities, evidence of the diversity of the industry. Fertilizer facilities released an average of 481,000 pounds per facility and transferred an average of 8,000 pounds per facility. The high release per facility values are, in a large part, a result of significant releases for ammonia and phosphoric acid from seventy or more facilities. Sector Notebook Project 78 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Releases Table 14 presents the number and weights of chemicals released by fertilizer manufacturing and mixing facilities reporting SIC 2873, 2874, and 2875 in 1996. The total quantity of releases was 91.3 million pounds or 98 percent of the total weight of chemicals reported to TRI by the fertilizer industry (i.e., releases and transfers). The top chemical released by this industry is ammonia, accounting for 54 percent of the total releases. Phosphoric acid is the next largest release at 35 percent of the total. Fifty-eight percent of all TRI releases in the fertilizer industry were air emissions, 53 percent as point source and 5 percent as fugitive. Ammonia accounts for 91 percent of air releases. The majority of the other releases were land disposed (32 percent) with phosphoric acid accounting for 99 percent of land disposals. The remaining nine percent was released as water discharges or underground injections. Transfers Table 15 presents the number and weights of chemicals transferred off-site by fertilizer manufacturing and mixing facilities reporting SIC 2873, 2874, or 2875 in 1996. The total amount of transfers was about 1.5 million pounds or only two percent of the total amount of chemicals reported to TRI by the fertilizer industry (i.e., releases and transfers). Transfers to recycling facilities accounted for the largest amount, 51 percent of the total transfers. The next greatest percentage went for disposal and the rest to treatment facilities. No energy recovery transfers were reported for this industry. Copper compounds, phosphoric acid, and zinc compounds represented the largest transfers (primarily to recycling), as 60 percent of the total transfers. Ammonia only accounted for 4 percent of the transfers compared to 54 percent of releases. Pesticides and Miscellaneous Agricultural Chemicals (SIC 2879) According to 1996 TRI data, pesticide formulating facilities released and transferred approximately13 million pounds of pollutants during calendar year 1996. One hundred and ninety-three facilities reported TRI emissions for 197 chemicals in 1996. Only 18 (9 percent) of these chemicals were reported by ten or more facilities, evidence of the particularly diverse nature of the industry. Pesticide formulating facilities released an average of 10,000 pounds of pollutants per facility and transferred an average of 59,000 pounds per facility. The high average transfer per facility is due mostly to high average xylene, ethylbenzene, and methanol transfers. Releases Table 16 presents the number and weights of chemicals released by pesticide and miscellaneous agricultural chemicals formulating facilities reporting SIC Sector Notebook Project 79 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers 2879 in 1996. The total amount of releases was 2.0 million pounds or 15 percent of the total quantity of TRI chemicals reported by the pesticide and miscellaneous agricultural chemicals industry (i.e., releases and transfers). This is substantially less than the 98 percent of reported chemicals released by the fertilizer industry. The top two chemicals released by this industry are methanol (23 percent of releases) and dichloromethane (13 percent of releases). About 69 percent (1.4 million pounds) of all the chemicals released by the pesticide industry were released to air in the form of point source emissions (50 percent) and fugitive air releases (19 percent). Air releases were primarily comprised of dichloromethane, carbon disulfide, and methyl isobutyl ketone. Approximately 29 percent of the releases were by underground injection, and the remaining releases were to water (2 percent) and land disposal (1 percent). The relatively large number of chemicals reported to TRI under SIC 2879 compared to the fertilizer industry illustrates the variety of chemical formulations produced by the pesticide industry. Transfers Table 17 presents the number and weights of chemical transfers by the pesticide and miscellaneous agricultural chemicals formulating facilities reporting SIC 2879 in 1996. The total amount of transfers off-site was 11.3 million pounds or 85 percent of the total amount of chemicals reported to TRI by the pesticide industry (i.e., releases and transfers). Xylene, methanol, and ethylbenzene accounted for 58, 12, and 10 percent, respectively, of the chemical TRI transfers. Transfers to recycling facilities accounted for the largest quantity (51 percent) although only eight facilities reported recycling transfers. Xylene accounted for 84 percent of all recycling transfers. Energy recovery and treatment accounted for 23 and 31 percent respectively. The remainder of transfers consisted of off-site disposals. Sector Notebook Project 80 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 14: 1996 TRI Releases for Agricultural Chemicals Facilities (SICs 2873,2874,2875) by Number of Facilities Reporting (Releases reported in pounds/year) Chemical Name Ammonia Phosphoric Acid Zinc Compounds Manganese Compounds Nitrate Compounds Copper Compounds Sulfuric Acid (1994 and after "Acid Aerosols" Only) Nitric Acid Chlorine Methanol Formaldehyde Chromium Compounds Nickel Compounds Copper Zinc (Fume or Dust) Lead Compounds Hydrogen Fluoride Diethanolamine 2,4-D Manganese Diazinon Benfluralin Atrazine Trifluralin Chromium Cadmium Compounds Cobalt Compounds Diisocyanates Certain Glycol Ethers Carbaryl N-butyl Alcohol Quintozene Mecoprop Methoxone Ethylene Glycol Methyl Isobutyl Ketone Dicofol 2,4-DP Asbestos (Friable) Dicamba Nickel Vanadium (Fume or Dust) Hydrochloric Acid (1995 and after "Acid Aerosols" Only) Thiophanate-methyl Pendimethalin Oxyfluorfen Avg. Releases Per Facility # Reporting Chemical 106 72 56 43 42 37 32 Fugitive Air 4,590,371 1,452 3,946 5,292 1,529 1,477 3,237 Point Air 43,967,432 8,631 2,969 1,696 261,250 525 1,435,613 Water Discharges 427,065 2,939,394 7,817 1,500 3,108,211 1,443 5 Underground Injection 539,900 0 65 0 971,850 60 15,000 Land Disposal 78,814 29,071,310 4,023 500 125,960 528 25,587 Total Releases 49,603,582 32,020,787 18,820 8,988 4,468,800 4,033 1,479,442 30 30 20 13 11 10 8 8 7 7 6 5 5 4 4 3 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 22,388 5,345 38,447 730 251 255 5 5 17 15,325 5 21 5 0 445 140 239 400 . . 10 0 5 5 0 10 5 750 73,325 250 7 0 12 400 . 0 17,418 25,787 3,068,775 20,874 0 250 10 8 270 13,820 7,907 251 10 2 258 0 0 0 . . 70 0 5 0 0 250 250 0 16,241 0 250 0 250 0 . 0 10 7,818 63,362 10 536 795 0 0 510 15 31,470 0 0 0 0 0 0 0 . . 0 0 0 0 0 0 0 13,000 0 . 0 0 0 0 . 0 0 0 20 220 90 270 0 0 0 0 0 0 0 0 0 0 0 0 . . 0 0 0 0 0 0 0 0 0 0 0 0 0 0 . 260,000 7,655 0 185 5 1,430 565 0 0 0 3,309 0 0 0 0 0 0 0 0 . . 0 0 0 0 0 0 0 250 0 0 0 0 0 0 . 0 47,471 38,950 3,170,789 21,839 2,307 2,135 15 13 797 32,469 39,382 272 15 2 703 140 239 400 . . 80 0 10 5 0 260 255 14,000 89,566 250 257 0 262 400 . 260,000 1,582 1,298 158,539 1,680 210 214 2 2 114 4,638 6,564 54 3 1 176 47 120 200 . . 80 0 10 5 0 260 255 14,000 89,566 250 257 0 262 400 . 260,000 1 1 1 _________ 190** 0 0 0 _________ 4,766,111 0 0 0 _________ 48,851,072 0 0 0 _________ 6,603,991 0 0 0 _________ 1,787,475 0 0 0 _________ 29,320,121 0 0 0 _________ 91,327,740 0 0 0 _________ 480,672 467,958 444,733 336 209 106,400 109 46,233 ** Total number of facilities (not chemical reports) reporting to TRI in this industry sector. Sector Notebook Project 81 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 15: 1996 TRI Transfers for Agricultural Chemicals Facilities (SICs 2873,2874,2875) by Number and Facilities Reporting (Transfers reported in pounds/year) Chemical Name Ammonia Phosphoric Acid Zinc Compounds Manganese Compounds Nitrate Compounds Copper Compounds Sulfuric Acid (1994 and after "Acid Aerosols" Only) Nitric Acid Chlorine Methanol Formaldehyde Chromium Compounds Nickel Compounds Copper Zinc (Fume or Dust) Lead Compounds Hydrogen Fluoride Diethanolamine 2,4-D Manganese Diazinon Benfluralin Atrazine Trifluralin Chromium Cadmium Compounds Cobalt Compounds Diisocyanates Certain Glycol Ethers Carbaryl N-butyl Alcohol Quintozene Mecoprop Methoxone Ethylene Glycol Methyl Isobutyl Ketone Dicofol 2,4-DP Asbestos (Friable) Dicamba Nickel Vanadium (Fume or Dust) Hydrochloric Acid (1995 and after "Acid Aerosols" Only) Thiophanate-methyl Pendimethalin Oxyfluorfen Treatment Transfers 11477 418 45834 3834 750 11000 . Energy Recovery Transfers . . . . . . . Total Transfers 63077 289946 226226 4834 110407 407280 0 Avg Transfer Per Facility 595 4,027 4,040 112 2,629 11,008 0 . . . . 63230 81600 14657 14657 . . . . . . . . . 14657 . . . . . . . . . 185 . . . . . 14657 . . . . . . . 20000 . 5 . . 20000 4613 . 4608 1250 107880 . . . . . . 591 . 4358 250 250 . . . 250 . 250 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 25 1542 250 77437 101600 14657 15167 10 0 39940 4613 0 4608 1250 107880 0 14657 . . 0 0 591 0 4358 250 250 185 0 250 250 19300 250 14657 . 0 8 1 77 19 7,040 10,160 1,832 1,896 1 0 6,657 923 0 1,152 313 35,960 0 7,329 . . 0 0 591 0 4,358 250 250 185 0 250 250 19,300 250 14,657 . 0 . . . _________ 782,046 4358 4358 4358 _________ 250,692 . . . _________ 0 4358 4358 4358 _________ 1,539,071 4,358 4,358 4,358 _________ 8,100 # Reporting Chemical 106 72 56 43 42 37 32 Potw Transfers 51600 0 5 0 95000 0 0 Disposal Transfers . 289528 1060 1000 . 11861 . Recycling Transfers . . 179327 . 14657 384419 . 30 30 20 13 11 10 8 8 7 7 6 5 5 4 4 3 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 25 1542 250 0 0 0 0 0 0 19940 0 0 0 0 0 0 0 . . 0 0 0 0 0 0 0 0 0 0 0 0 0 0 . 0 250 . . . 14207 . . 505 10 . . . . . . . . . . . . . . . . . . . . 250 . 19300 . . . . 1 1 1 _________ 190** 0 0 0 _________ 168,362 . . . _________ 337,971 ** Total number of facilities (not chemical reports) reporting to TRI in this industry sector. Sector Notebook Project 82 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 16: 1996 TRI Releases for Agricultural Chemicals Facilities (SIC 2879) by Number of Facilities Reporting (Releases reported in pounds/year) Chemical Name 1,2,4-trimethylbenzene Xylene (Mixed Isomers) Ethylene Glycol Naphthalene Malathion Diazinon Ammonia 2,4-D Carbaryl Methanol N-butyl Alcohol Captan Quintozene Trifluralin Chlorothalonil 2,4-d 2-ethylhexyl Ester Ethylbenzene Atrazine Copper Compounds Zinc Compounds Dimethylamine Arsenic Compounds Certain Glycol Ethers Lindane Bromomethane Chloropicrin Cumene Permethrin Dicamba Piperonyl Butoxide Dimethoate Mecoprop Toluene Thiram Methyl Parathion Diuron Prometryn Chlorine Manganese Compounds Nitrate Compounds 1,1,1-trichloroethane Carbon Disulfide Methoxone Metham Sodium N-methyl-2-pyrrolidone Carbofuran Bromoxynil Octanoate Maneb Cyanazine Formaldehyde Chloromethane Dichloromethane O-xylene Methyl Isobutyl Ketone Simazine Hydrochloric Acid (1995 and after "Acid Aerosols" Only) Phosphoric Acid Sulfuric Acid (1994 and after "Acid Aerosols" Only) Metribuzin Acephate Chromium Compounds Chlorodifluoromethane Maleic Anhydride M-xylene Dicofol Aldicarb Linuron Ethyl Dipropylthiocarbamate Paraquat Dichloride Avg. Releases Per Facility # Reporting Chemical 24 24 22 21 17 17 14 13 12 12 12 12 11 11 11 11 10 10 9 9 9 8 8 8 8 8 8 8 7 6 6 6 6 6 6 6 6 6 5 5 5 5 5 5 5 5 5 5 5 4 4 4 4 4 4 4 Fugitive Air 5310 24494 7856 4536 571 21 20529 1926 1005 12434 1498 519 1050 1304 622 2160 1065 4000 547 2299 3547 267 10501 255 9398 2240 108 976 348 35 225 510 11676 510 716 261 250 6020 6657 5 1729 6817 265 1266 310 22 270 0 285 3020 7434 12585 5602 105310 1005 3698 Point Air 3185 16327 819 3402 280 227 36889 1535 9005 35850 1668 12106 561 2578 1005 1065 421 2430 188 2307 7560 1089 250 255 63421 5835 78 509 324 6 260 920 27350 1000 312 1250 268 2455 75 6 7400 112994 510 258 10 274 251 0 1625 8018 82165 256135 35250 58755 1005 48257 Water Discharges 0 0 2521 17 10 10 4908 5 10 8217 0 5 0 87 0 5 0 5 11 0 0 14 0 5 0 0 0 0 132 0 10 0 39 0 0 8 0 0 0 22000 0 0 250 1 5 1 0 0 0 1083 0 100 5 5 5 0 Underground Injection 0 17760 2290 0 0 0 2300 0 0 400300 0 5 0 0 0 0 0 1 0 0 250 0 0 0 0 0 0 0 59200 0 0 0 536 0 0 0 0 5 0 0 0 5 0 0 750 0 0 0 0 0 0 0 0 0 0 0 Land Disposal 0 0 7922 20 0 0 360 255 2500 51 0 0 0 0 1670 0 0 0 5 0 0 0 0 250 0 0 0 0 0 0 0 255 71 0 0 0 0 0 0 0 0 0 250 2 5 0 0 0 0 5 9 23 5 5 0 56 Total Releases 8495 58581 21408 7975 861 258 64986 3721 12520 456852 3166 12635 1611 3969 3297 3230 1486 6436 751 4606 11357 1370 10751 765 72819 8075 186 1485 60004 41 495 1685 39672 1510 1028 1519 518 8480 6732 22011 9129 119816 1275 1527 1080 297 521 0 1910 12126 89608 268843 40862 164075 2015 52011 4 4 438 1009 0 1 0 0 0 0 0 15 438 1025 110 256 4 4 3 3 3 3 3 3 3 3 3 2 255 250 11406 1079 508 210 21 5 6706 500 1010 1250 88 2441 2385 250 0 1205 5 619 500 5 0 3 0 5 0 0 0 5 2 0 0 0 0 0 0 0 0 0 0 29 0 0 0 0 0 0 0 0 5 0 0 0 1017 1505 341 13847 3469 758 210 1231 15 7356 1000 254 376 114 4,616 1,156 253 70 410 5 2,452 333 Sector Notebook Project 83 September 2000 354 2,441 973 380 51 15 4,642 286 1,043 38,071 264 1,053 146 361 300 294 149 644 83 512 1,262 171 1,344 96 9,102 1,009 23 186 8,572 7 83 281 6,612 252 171 253 86 1,413 1,346 4,402 1,826 23,963 255 305 216 59 104 0 382 3,032 22,402 67,211 10,216 41,019 504 13,003 Agricultural Chemical Industry Chemical Releases and Transfers Table 16: 1996 TRI Releases for Agricultural Chemicals Facilities (SIC 2879) by Number of Facilities Reporting (Releases reported in pounds/year) Chemical Name Propachlor Fluometuron Dimethylamine Dicamba Carboxin Copper Ethoprop Thiophanate-methyl Pendimethalin Hexazinone Ethylenebisdithiocarbamic Acid, Salts and Esters Trichlorfon Parathion Dichlorvos S,s,s-tributyltrithiophosphate 2,4-db 1,4-dichlorobenzene 1,2-dichloroethane Chlorobenzene Phenol Diethanolamine 2,4-dp Naled Hydrazine 1,3-dichloropropylene Propanil Ametryn Cycloate Bromoxynil 2,4-d Butoxyethyl Ester Sodium Dicamba Dipotassium Endothall Molinate Chlorpyrifos Methyl Zinc (Fume or Dust) Nitric Acid Resmethrin Desmedipham Thiophanate Ethyl Thiobencarb Thiodicarb Propiconazole Cyfluthrin Fomesafen Quizalofop-ethyl Lactofen Bifenthrin Myclobutanil Antimony Compounds Chlorophenols Cyanide Compounds Diisocyanates Lead Compounds Carbon Tetrachloride Formic Acid Isopropyl Alcohol (Manufacturing, Strong-acid Process Only, No Supplies) N,n-dimethylformamide Methoxychlor Vinyl Chloride Tert-butyl Alcohol 2-methyllactonitrile Triphenyltin Hydroxide Hexachlorocyclopentadiene Dicyclopentadiene Dimethyl Sulfate Methyl Ethyl Ketone Dichloran P-xylene 1,3-butadiene Cyclohexanol Avg. Releases Per Facility # Reporting Chemical 3 3 3 3 3 3 3 3 3 2 Fugitive Air 0 260 580 8 0 250 70 970 17 1057 Point Air 0 512 5 0 5 615 9 260 283 57 Water Discharges 0 0 0 0 0 0 0 22 0 0 Underground Injection 0 0 0 0 0 0 0 0 0 0 Land Disposal 0 0 5 0 0 0 0 140 0 0 Total Releases 0 772 590 8 5 865 79 1392 300 1114 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 1 1 1 1 1 1 1 . . 0 1325 470 340 6300 320 533 255 250 0 201 2301 250 255 0 5 262 5 39 315 5 250 4000 1 15 . 530 250 5 3 255 1 847 6 . 0 250 15 . 130 66 810 0 . . 0 473 250 1371 57000 0 0 255 5 50 12 120 2627 298 49 10 401 750 4 271 5 0 398 0 0 . 281 1000 5 13 250 0 29 1 . 2 250 41 . 139 41000 700 15 . . 0 2 0 0 33 0 1 0 0 0 0 0 0 5 1 0 0 0 0 1 0 . 5 0 0 . 0 0 0 0 0 . 0 0 . 0 0 5 . 0 0 29 0 . . 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 . 0 0 0 0 0 0 0 0 . 0 73400 0 . 0 5 0 0 . . 0 8 0 0 250 0 0 0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 280 0 0 . 0 250 0 350 0 0 0 0 . 0 0 5 . 0 0 0 0 . . 0 1808 720 1711 63583 320 534 510 260 50 213 2421 2877 558 52 15 663 755 43 587 10 250 4683 1 15 . 811 1500 10 366 505 1 876 7 . 2 73900 66 . 269 41071 1539 15 . . 0 904 360 856 31,792 160 267 255 130 25 107 1,211 1,439 279 26 8 332 378 22 294 5 125 2,342 1 8 . 406 750 5 183 253 1 438 4 . 2 73,900 66 . 269 41,071 1,539 15 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 5 552 20 0 . 5 141 . 32 . 5 77 0 38 5 644 121 180 . 5 562 . 240 . 5 1200 18 0 0 0 0 0 . 0 0 . 0 . 0 0 0 0 0 0 0 0 . 250 0 . 0 . 0 0 0 0 0 0 0 0 . 0 0 . 0 . 0 0 0 39 10 1196 141 180 . 260 703 . 272 . 10 1277 18 39 10 1,196 141 180 . 260 703 . 272 . 10 1,277 18 Sector Notebook Project 84 September 2000 0 257 197 3 2 288 26 464 100 557 Agricultural Chemical Industry Chemical Releases and Transfers Table 16: 1996 TRI Releases for Agricultural Chemicals Facilities (SIC 2879) by Number of Facilities Reporting (Releases reported in pounds/year) Chemical Name N-hexane Pyridine Propoxur Di(2-ethylhexyl) Phthalate Hexachlorobenzene 1,2,4-trichlorobenzene 2,4-dichlorophenol Triethylamine Hydroquinone Folpet Merphos Oxydemeton Methyl Bromacil Methyl Isothiocyanate Perchloromethyl Mercaptan Methyl Isocyanate Pebulate Benfluralin Nitrapyrin Triallate Dodine Dimethyl Chlorothiophosphate Temephos Terbacil Hydrogen Fluoride Bromine Mevinphos Phosphine Creosote Zineb Fenbutatin Oxide Alachlor Benomyl Oryzalin Oxydiazon Aluminum Phosphide Bendiocarb Pronamide Toluene Diisocyanate (Mixed Isomers) Propetamphos Amitraz Tebuthiuron Diflubenzuron Sulprofos Dinocap Fenpropathrin Profenofos Oxyfluorfen Triadimefon Vinclozolin Fenvalerate Dimethipin Triclopyr Triethylammonium Salt Fenarimol Acifluorfen, Sodium Salt Chlorsulfuron Fluvalinate Chlorimuron Ethyl Tribenuron Methyl # Reporting Chemical 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 _________ 193** Fugitive Air 2910 4836 . 10 5 8000 2630 3298 250 0 200 . 6 0 0 0 250 . . 250 5 0 . . 0 0 0 0 15 . . 2100 . . 5 . . 5 . 5 . 0 . . . . . . . . 1 . 0 . 0 0 . 0 0 _________ 369,954 Point Air 5560 5617 . 25 0 750 250 101 5 5 0 . 0 0 510 0 250 . . 250 5 0 . . 0 0 0 1076 25 . . 0 . . 250 . . 250 . 5 . 5 . . . . . . . . 0 . 6 . 0 1 . 1 1 _________ 995,519 Water Discharges 0 0 . 0 0 0 0 0 0 0 0 . 0 0 0 0 0 . . 0 0 0 . . 0 0 0 0 0 . . 0 . . 0 . . 0 . 0 . 0 . . . . . . . . 0 . 0 . 2 . . . . _________ 39,600 Underground Injection 0 0 . 0 0 750 15390 0 0 0 0 . 0 0 0 0 . . . 0 0 0 . . 0 0 0 0 0 . . 0 . . 0 . . 0 . 0 . 0 . . . . . . . . 0 . 0 . 0 0 . 0 0 _________ 573,228 Land Disposal 0 0 . 0 0 0 0 0 0 0 0 . 0 0 0 0 0 . . 0 0 0 . . 0 0 0 0 0 . . 0 . . 0 . . 0 . 250 . 0 . . . . . . . . 0 . 0 . 5 0 . 0 0 _________ 15,287 Total Releases 8470 10453 . 35 5 9500 18270 3399 255 5 200 . 6 0 510 0 500 . . 500 10 0 . . 0 0 0 1076 40 . . 2100 . . 255 . . 255 . 260 . 5 . . . . . . . . 1 . 6 . 7 1 . 1 1 _________ 1,993,588 Avg. Releases Per Facility 8,470 10,453 . 35 5 9,500 18,270 3,399 255 5 200 . 6 0 510 0 500 . . 500 10 0 . . 0 0 0 1,076 40 . . 2,100 . . 255 . . 255 . 260 . 5 . . . . . . . . 1 . 6 . 7 1 . 1 1 _________ 10,329 ** Total number of facilities (not chemical reports) reporting to TRI in this industry sector. Sector Notebook Project 85 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 17: 1996 TRI Transfers for Agricultural Chemicals Facilities (SIC 2879) by Number and Facilities Reporting (Transfers reported in pounds/year) Chemical Name 1,2,4-trimethylbenzene Xylene (Mixed Isomers) Ethylene Glycol Naphthalene Malathion Diazinon Ammonia 2,4-d Carbaryl Methanol N-butyl Alcohol Captan Quintozene Trifluralin Chlorothalonil 2,4-d 2-ethylhexyl Ester Ethylbenzene Atrazine Copper Compounds Zinc Compounds Dimethylamine Arsenic Compounds Certain Glycol Ethers Lindane Bromomethane Chloropicrin Cumene Permethrin Dicamba Piperonyl Butoxide Dimethoate Mecoprop Toluene Thiram Methyl Parathion Diuron Prometryn Chlorine Manganese Compounds Nitrate Compounds 1,1,1-trichloroethane Carbon Disulfide Methoxone Metham Sodium N-methyl-2-pyrrolidone Carbofuran Bromoxynil Octanoate Maneb Cyanazine Formaldehyde Chloromethane Dichloromethane O-xylene Methyl Isobutyl Ketone Simazine Hydrochloric Acid (1995 and after "Acid Aerosols" Only) Phosphoric Acid Sulfuric Acid (1994 and after "Acid Aerosols" Only) Metribuzin Acephate Chromium Compounds Chlorodifluoromethane Maleic Anhydride M-xylene Dicofol Aldicarb Linuron Ethyl Dipropylthiocarbamate Sector Notebook Project # Reporting Chemical Total Transfers 43794 6606309 31611 7830 1207 3370 72645 14980 64421 1317401 4739 4272 614128 12055 3778 25803 1172473 33907 11521 2995 525 332520 58239 1664 0 0 1458 2867 130 2082 3091 6398 2171 38616 2480 630 6842 6319 6340 10 22147 0 5724 21023 9811 17525 18053 1358 14722 30200 26 22832 1310 2570 1510 0 Avg Transfer Per Facility 1,825 275,263 1,437 373 71 198 5,189 1,152 5,368 109,783 395 356 55,830 1,096 343 2,346 117,247 3,391 1,280 333 58 41,565 7,280 208 0 0 182 358 19 347 515 1,066 362 6,436 413 105 1,140 1,053 1,268 2 4,429 0 1,145 4,205 1,962 3,505 3,611 272 2,944 7,550 7 5,708 328 643 378 0 24 24 22 21 17 17 14 13 12 12 12 12 11 11 11 11 10 10 9 9 9 8 8 8 8 8 8 8 7 6 6 6 6 6 6 6 6 6 5 5 5 5 5 5 5 5 5 5 5 4 4 4 4 4 4 4 Potw Transfers 5 9 463 0 0 0 25397 263 5 4367 5 0 4 5 255 5 0 73 0 5 5 10 57107 0 0 0 0 0 5 0 0 5 0 2 0 250 12 6319 5 5 0 0 5 1 0 0 0 0 62 0 0 0 0 940 5 0 Disposal Transfers 475 2599 3600 823 . . . 6017 2750 5 584 2191 . 2278 2005 2077 231 5673 9267 260 . 100655 . 276 . . 5 1250 . . . 3896 . 533 360 . 250 . 5 5 . . 4778 15862 1770 . 16605 250 755 1200 26 . . . 1255 . Recycling Transfers . 4851510 16070 . . . . . . . . . . . . . 807182 . 754 2730 . . . . . . . . . . . . . . . . . . 21 . . . . . . . . . . . . 19277 . . . . Treatment Transfers 43314 731777 11478 6962 1207 3370 47248 8700 61666 126038 4150 2081 392714 9772 1518 23721 150224 28161 1500 . 520 231855 1132 1388 . . 1453 1617 125 2082 3091 2497 2171 38081 2120 380 6580 . 6309 . 22147 . 941 4603 8041 17525 1448 1108 13905 29000 . 3555 1310 1630 250 . Energy Recovery Transfers . 1020414 . 45 . . . . . 1186991 . . 221410 . . . 214836 . . . . . . . . . . . . . . . . . . . . . . . . . . 557 . . . . . . . . . . . . 4 4 0 0 25549 . . . . . . . 25549 0 6,387 0 4 4 3 3 3 3 3 3 3 3 0 250 1 0 0 0 0 0 0 5 . . 11257 . . . . . . 590 . . . . . . . . . . 13213 15800 155 . . 410 250 32289 . 9610 . . . . . . . . . . 13213 16050 11413 0 0 410 250 32289 0 10205 3,303 4,013 3,804 0 0 137 83 10,763 0 3,402 86 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 17: 1996 TRI Transfers for Agricultural Chemicals Facilities (SIC 2879) by Number and Facilities Reporting (Transfers reported in pounds/year) Chemical Name Paraquat Dichloride Propachlor Fluometuron Dimethylamine Dicamba Carboxin Copper Ethoprop Thiophanate-methyl Pendimethalin Hexazinone Ethylenebisdithiocarbamic Acid, Salts and Esters Trichlorfon Parathion Dichlorvos S,s,s-tributyltrithiophosphate 2,4-db 1,4-dichlorobenzene 1,2-dichloroethane Chlorobenzene Phenol Diethanolamine 2,4-dp Naled Hydrazine 1,3-dichloropropylene Propanil Ametryn Cycloate Bromoxynil 2,4-d Butoxyethyl Ester Sodium Dicamba Dipotassium Endothall Molinate Chlorpyrifos Methyl Zinc (Fume or Dust) Nitric Acid Resmethrin Desmedipham Thiophanate Ethyl Thiobencarb Thiodicarb Propiconazole Cyfluthrin Fomesafen Quizalofop-ethyl Lactofen Bifenthrin Myclobutanil Antimony Compounds Chlorophenols Cyanide Compounds Diisocyanates Lead Compounds Carbon Tetrachloride Formic Acid Isopropyl Alcohol (Manufacturing, Strong-acid Process Only, No Supplies) N,n-dimethylformamide Methoxychlor Vinyl Chloride Tert-butyl Alcohol 2-methyllactonitrile Triphenyltin Hydroxide Hexachlorocyclopentadiene Dicyclopentadiene Dimethyl Sulfate Methyl Ethyl Ketone Dichloran P-xylene 1,3-butadiene Sector Notebook Project # Reporting Chemical 3 3 3 3 3 3 3 3 3 3 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 1 1 1 1 1 1 1 Potw Transfers 32 15 235 0 2 0 0 0 0 250 0 0 . 0 0 0 0 0 0 0 5 0 5 0 0 0 0 0 0 0 750 0 0 0 0 0 0 0 . 0 5 0 0 0 0 0 0 . 0 0 0 . 0 0 0 0 Disposal Transfers 5 . 1505 255 384 . 250 1167 . 250 . . . . . . . . . . 51 39 . . . . . 28 1388 . . . 4405 . . . . . . 4930 250 1332 . 2501 . 250 . . 132 2290 . . . . 830 . Recycling Transfers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65000 . . . Treatment Transfers 250 6490 13785 . 390 . 1105 . . 250 12830 . . 145 116 792 1365 . 1700 . 5 3 3176 . 51325 1744 9700 1006 8 3256 . 250 1256 500 . . 600 492 . . 18411 . 1019 5 . 3069 48 . . 1198 4 . . . 2800 . Energy Recovery Transfers . . . . . . . . . . . . . 104 . . . . . . . . . . . . . . . . . . 21 . . . . . . . . . . . . . . . . 670 . . . . . 529 1 1 1 1 1 1 1 1 1 1 1 1 1 250 . 0 0 0 . 0 0 0 0 . 0 0 54765 . . . . . . . . . . . . . . . . . . . . . . . . . 4055 500 . 416 . . 3735 . . 814 . 250 . 2331 . . . . . 800 . . . . . . 87 Total Transfers 287 6505 15525 255 776 0 1355 1167 0 750 12830 0 . 249 116 792 1365 0 1700 0 61 42 3181 0 51325 1744 9700 1034 1396 3256 750 250 5682 500 0 0 600 492 . 4930 18666 1332 1019 2506 0 3319 48 . 132 4158 4 . 65000 0 3630 529 Avg Transfer Per Facility 96 2,168 5,175 85 259 0 452 389 0 250 6,415 0 . 125 58 396 683 0 850 0 31 21 1,591 0 25,663 872 4,850 517 698 1,628 375 125 2,841 250 0 0 300 246 . 2,465 9,333 666 510 1,253 0 1,660 24 . 132 4,158 4 . 65,000 0 3,630 529 61401 500 0 416 0 . 4535 0 0 814 . 250 0 61,401 500 0 416 0 . 4,535 0 0 814 . 250 0 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 17: 1996 TRI Transfers for Agricultural Chemicals Facilities (SIC 2879) by Number and Facilities Reporting (Transfers reported in pounds/year) Chemical Name Cyclohexanol N-hexane Pyridine Propoxur Di(2-ethylhexyl) Phthalate Hexachlorobenzene 1,2,4-trichlorobenzene 2,4-dichlorophenol Triethylamine Hydroquinone Folpet Merphos Oxydemeton Methyl Bromacil Methyl Isothiocyanate Perchloromethyl Mercaptan Methyl Isocyanate Pebulate Benfluralin Nitrapyrin Triallate Dodine Dimethyl Chlorothiophosphate Temephos Terbacil Hydrogen Fluoride Bromine Mevinphos Phosphine Creosote Zineb Fenbutatin Oxide Alachlor Benomyl Oryzalin Oxydiazon Aluminum Phosphide Bendiocarb Pronamide Toluene Diisocyanate (Mixed Isomers) Propetamphos Amitraz Tebuthiuron Diflubenzuron Sulprofos Dinocap Fenpropathrin Profenofos Oxyfluorfen Triadimefon Vinclozolin Fenvalerate Dimethipin Triclopyr Triethylammonium Salt Fenarimol Acifluorfen, Sodium Salt Chlorsulfuron Fluvalinate Chlorimuron Ethyl Tribenuron Methyl # Reporting Chemical 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 _________ 193** Potw Transfers 0 0 8506 . 2 0 0 0 0 250 0 0 . 0 0 0 0 0 . . 0 0 0 . . 0 750 0 0 5 . . 0 . . 0 . . 0 . 0 . 0 . 0 . . . . 0 . 0 . 0 . 0 0 . 0 0 _________ 106,917 Disposal Transfers . . . . . . . . . . . . . . . . . 500 . . 509 . . . . . . . . . . . . . . . . . . . 1000 . . . . . . . . . . . . . . . . . . . _________ 306,983 Recycling Transfers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . _________ 5,762,544 Treatment Transfers 35289 20740 . . 1033 3849 7920 . 61668 . . . . 868 . . . 250 . . 676 500 . . . . . . . 602 . . 8600 . . 250 . . 500 . . . 937 . . . . . . . . 3994 . 82 . . 9807 . 36604 17387 _________ 2,494,611 Energy Recovery Transfers . 56 . . . 2215 890 . 2568 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . _________ 2,654,437 Total Transfers 35289 20796 8506 . 1035 6064 8810 0 64236 250 0 0 . 868 0 0 0 750 . . 1185 500 0 . . 0 750 0 0 607 . . 8600 . . 250 . . 500 . 1000 . 937 . 0 . . . . 0 . 3994 . 82 . 0 9807 . 36604 17387 _________ 11,325,492 ** Total number of facilities (not chemical reports) reporting to TRI in this industry sector. Sector Notebook Project 88 September 2000 Avg Transfer Per Facility 35,289 20,796 8,506 . 1,035 6,064 8,810 0 64,236 250 0 0 . 868 0 0 0 750 . . 1,185 500 0 . . 0 750 0 0 607 . . 8,600 . . 250 . . 500 . 1,000 . 937 . 0 . . . . 0 . 3,994 . 82 . 0 9,807 . 36,604 17,387 _________ 58,681 Agricultural Chemical Industry Chemical Releases and Transfers Top 10 TRI Releasing Agricultural Chemical Companies The TRI database contains a detailed compilation of self-reported, facilityspecific chemical releases. The top reporting facilities for the agricultural chemical industries are listed below in Tables 18,19, 20, and 21. Facilities that have reported the primary SIC codes covered under this notebook appear on Table 18 for fertilizers and Table 20 for pesticides and miscellaneous agricultural chemicals. Tables 19 and 21 contain additional facilities that have reported the SIC codes covered within this report, and one or more SIC codes thatare notwithinthe scope of this notebook. Therefore, the second list includes facilities that conduct multiple operations -- some that are under the scope of this notebook, and some that are not. Currently, the facility-level data do not allow pollutant releases to be broken apart by industrial process. Sector Notebook Project 89 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 18: Top 10 TRI Releasing Fertilizer Manufacturing and Mixing Facilities (SIC 2873, 2874, 2875)* Rank Facility Total TRI Releases in Pounds 1 PCS Phosphate Co., Inc. - Aurora, NC 13,202,617 2 CF Ind. Inc. - Donaldsonville, LA 5,823,740 3 Unocal Agricultural Products - Kenai, AK 4,715,420 4 Terra Nitrogen - Catoosa, OK 4,147,000 5 PCS Nitrogen Fertilizer LP - Millington, TN 3,957,624 6 IMC Nitrogen Co. - East Dubuque, IL 3,954,025 7 IMC-Agrico - Uncle Sam, LA 3,570,548 8 Triad Chemical - Donaldsonville, LA 3,478,835 9 IMC-Agrico - Mulberry, FL 3,161,160 10 Farmland Ind. Inc. - Enid, OK 2,804,790 Total 45,615,759 Source: US Toxics Release Inventory Database, 1996. * Being included on this list does not mean that the release is associated with non-compliance with environmental laws. Table 19: Top 10 TRI Releasing Facilities Reporting Fertilizer Manufacturing and Mixing SIC Codes * Rank Total TRI Releases in Pounds Facility SIC Codes Reported in TRI 1 PCS Phosphate Co. Inc. - Geismar, LA 2873, 2874, 2819 23,192,580 2 PCS Phosphate Co. Inc. - Aurora, NC 2874 13,202,617 3 IMC Agrico Co. - St. James, LA 2873, 2874, 2819 12,794,917 4 Du Pont - Beaumont, TX 2822, 2865, 2869, 2873 10,880,836 5 Rubicon Inc. - Geismar, LA 2865, 2869, 2873 8,327,597 6 Monsanto Co. - Luling, LA 2879, 2834, 2873, 2869, 2819 7,742,540 7 Coastal Chemical Co. - Cheyenne, WY 2813, 2819, 2869, 2873, 2899 7,674,410 8 PCS Phosphate - White Springs, FL 2874, 2819 6,961,770 9 Vicksburg Chemical Co. - Vicksburg, MS 2819, 2873, 2812 6,139,460 10 CF Ind. Inc. - Donaldsonville, LA 2873 5,823,740 Total 102,740,467 Source: US Toxics Release Inventory Database, 1996. * Being included on this list does not mean that the release is associated with non-compliance with environmental laws. Sector Notebook Project 90 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 20: Top 10 TRI Releasing Pesticide and Miscellaneous Agricultural Chemicals Facilities (SIC 2879)* Rank Facility Total TRI Releases in Pounds 1 BASF Corp. - Beaumont, TX 649,472 2 Rhone-Poulenc Ag. Co. - Woodbine, GA 242,293 3 American Cyanamid Co. - Palmyra, MO 227,942 4 Zeneca Inc. - Perry, OH 178,291 5 Farmland Ind. Inc. - Saint Joseph, MO 162,037 6 Zeneca Inc. - Pasadena, TX 149,968 7 Bayer Corp. - Kansas City, MO 45,881 8 Trical Inc. - Hollister, CA 32,447 9 FMC Corp. - Institute, WV 22,195 10 McLaughlin Gormley King Co. - Chaska, MN 21,611 Total 1,732,137 Source: US Toxics Release Inventory Database, 1996. * Being included on this list does not mean that the release is associated with non-compliance with environmental laws. Table 21: Top 10 TRI Releasing Facilities Reporting Pesticide and Miscellaneous Agricultural Chemicals SIC Codes * Rank Facility Total TRI Releases in Pounds SIC Codes Reported in TRI 1 Monsanto Co. - Luling, LA 2879, 2834, 2873, 2869, 2819 7,742,540 2 Monsanto - Alvin, TX 2869, 2819, 2841, 2879 7,718,029 3 Uniroyal Chemical Co. - Geismar, LA 2822, 2869, 2879 2,936,127 4 Du Pont - La Porte, TX 2819, 2869, 2879 2,633,242 5 Dow Chemical USA - Midland, MI 2800, 2819, 2821, 2834, 2869, 2879 1,523,414 6 Novartis Crop Protection Inc. - St. Gabriel, LA 2819, 2865, 2869, 2879 1,488,589 7 Tippecanoe Laboratories - Shadeland, IN 2834, 2879 1,206,435 8 Clinton Laboratories - Clinton, IN 2833, 2879 1,158,105 9 Ciba Specialty Chemicals Corp. - McIntosh, AL 2879, 2821, 2865, 3069 1,067,347 10 Du Pont - Belle, WV 2821, 2869, 2879 795,378 Total 28,269,206 Source: US Toxics Release Inventory Database, 1996. * Being included on this list does not mean that the release is associated with non-compliance with environmental laws. Sector Notebook Project 91 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers IV.B. Summary of Selected Chemicals Released The following is a synopsis of current scientific toxicity and fate information for the top chemicals (by weight) thatfacilities withinthis sector self-reported as released to the environment based upon 1995 TRI data. Because this section is based uponself-reported release data, it does not attempt to provide information on management practices employed by the sector to reduce the release of these chemicals. Information regarding pollutant release reduction over time may be available from EPA’s TRI and 33/50 programs, or directly from the industrial trade associations that are listed in Section IX of this document. Since these descriptions are cursory, please consult these sources for a more detailed description of both the chemicals described in this section, and the chemicals that appear on the full list of TRI chemicals appearing in Section IV.A. The brief descriptions provided below were taken from the Hazardous Substances Data Bank (HSDB) and the Integrated Risk Information System (IRIS), both accessed via TOXNET.2 The discussions of toxicity describe the range of possible adverse health effects that have been found to be associated with exposure to these chemicals. These adverse effects may or may not occur at the levels released to the environment. Individuals interested in a more detailed picture of the chemical concentrations associated with these adverse effects should consult a toxicologist or the toxicity literature for the chemical to obtain more information. The effects listed below must be taken in context of these exposure assumptions that are explained more fully within the full chemical profiles in HSDB. For more information on TOXNET, contact the TOXNET help line at 1-800-231-3766. 2 TOXNET is a computer system run by the National Library of Medicine that includes a number of toxicological databases managed by EPA, National Cancer Institute, and the National Institute for Occupational Safety and Health. For more information on TOXNET, contact the TOXNET help line at 800-231-3766. Databases included in TOXNET are: CCRIS (Chemical Carcinogenesis Research Information System), DART (Developmental and Reproductive Toxicity Database), DBIR (Directory of Biotechnology Information Resources), EMICBACK (Environmental Mutagen Information Center Backfile), GENE-TOX (Genetic Toxicology), HSDB (Hazardous Substances Data Bank), IRIS (Integrated Risk Information System), RTECS (Registry of Toxic Effects of Chemical Substances), and TRI (Toxic Chemical Release Inventory). HSDB contains chemical-specific information on manufacturing and usage, chemical and physical properties, safety and handling, toxicity and biomedical effects, pharmacology, environmental fate and exposure potential, exposure standards and regulations, monitoring and analysis methods, and additional references. Sector Notebook Project 92 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Ammonia3 (CAS: 7664-41-7) Sources. Ammonia is the primary nitrogen source for all nitrogenous fertilizers and ammonium phosphatic fertilizers. Toxicity. Anhydrous ammonia is irritating to the skin, eyes, nose, throat, and upper respiratory system. Ecologically, ammonia is a source of nitrogen(an essential element for aquatic plant growth), and may therefore contribute to eutrophication of standing or slow-moving surface water, particularly in nitrogen-limited waters suchas the Chesapeake Bay. In addition, aqueous ammonia is moderately toxic to aquatic organisms. Carcinogenicity. There is currently no evidence to suggest that ammonia is carcinogenic. EnvironmentalFate. Ammonia combines with sulfate ions in the atmosphere and is washed out by rainfall, resulting in rapid return of ammonia to the soil and surface waters. Ammonia is a central compound in the environmental cycling of nitrogen. Ammonia in lakes, rivers, and streams is converted to nitrate. PhysicalProperties. Ammonia is a colorless gas at atmospheric pressure, but is shipped as a liquefied compressed gas. It is soluble to about 34 percent in water and has a boiling point of -28 degrees F. Ammonia is corrosive and has a pungent odor. Phosphoric Acid (CAS: 7664-38-2) Sources. Phosphoric acid is the primary phosphorous source used for phosphatic fertilizers. Toxicity. Phosphoric acid is toxic by ingestion and inhalation, and is an irritant to skin and eyes. The toxicity of phosphoric acid is related to its corrosivity as an acid, with ulceration of membranes and tissues with which it comes in contact. Because it is a source of phosphorous, an essential element for aquatic plant growth, phosphoric acid may contribute to eutrophication of standing or slow-moving surface water, particularly in phosphorous-limited waters such as the Great Lakes. 3 The reporting standards for ammonia were changed in 1995. Ammonium sulfate is deleted from the list and threshold and release determinations for aqueous ammonia are limited to 10 percent of the total ammonia present in solution. This change will reduce the amount of ammonia reported to TRI. Complete details of the revisions can be found in 40 CFR Part 372. Sector Notebook Project 93 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Carcinogenicity. There is currently no evidence to suggest that phosphoric acid is carcinogenic. EnvironmentalFate. The acidity of phosphoric acid may be reduced readily by natural water hardness minerals. The phosphate will persist until used by plants as a nutrient. Physical Properties. Phosphoric acid is a thick, colorless, and odorless crystalline solid, often used in an aqueous solution. Its boiling point is 415° F and it is soluble in water. Nitrate compounds Sources. Many different nitrate compounds are formed during nitrogenous fertilizer production. Toxicity. Nitrate compounds that are soluble in water release nitrate ions which can cause both human health and environmental effects. Human infants exposed to aqueous solutions of nitrate ion can develop a condition in which the blood’s ability to carry oxygen is reduced. This reduced supply of oxygen can lead to damaged organs and death. Because it is a source of nitrogen, an essential element for aquatic plant growth, nitrate ion may contribute to eutrophication of standing or slow-moving surface water, particularly in nitrogen-limited waters, such as the Chesapeake Bay. Carcinogenicity. There is currently no evidence to suggest that nitrate compounds are carcinogenic. Environmental Fate. Nitrogen in nitrate is the form of nitrogen most available to plants. In the environment, nitrate ion is taken up by plants and becomes part of the natural nitrogen cycle. Excess nitrate can stimulate primary production in plants and can produce changes in the dominant species of plants, leading to cultural eutrophication and ultimately to deterioration of water quality. Methanol (CAS: 67-56-1) Sources. Methanol is generated in ammonia production. It is also used as a solvent and for equipment cleaning in pesticide formulations. Toxicity. Methanol is readily absorbed from the gastrointestinal tract and the respiratory tract and is toxic to humans in moderate to high doses. In the body, methanol is converted into formaldehyde and formic acid. Methanol is excreted as formic acid. Observed toxic effects at high dose levels generally include central nervous system damage and blindness. Long-term Sector Notebook Project 94 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers exposure to high levels of methanol via inhalation cause liver and blood damage in animals. Ecologically, methanol is expected to have low toxicity to aquatic organisms. Concentrations lethal to half the organisms of a test population are expected to exceed one mg methanol per liter water. Methanol is not likely to persist in water or to bioaccumulate in aquatic organisms. Carcinogenicity. There is currently no evidence to suggest that methanol is carcinogenic. Environmental Fate. Methanol is highly volatile and flammable. Liquid methanol is likely to evaporate when left exposed. Methanol reacts in air to produce formaldehyde which contributes to the formation of air pollutants. In the atmosphere it can react with other atmospheric chemicals or be washed out by rain. Methanol is readily degraded by microorganisms in soils and surface waters. Physical Properties. Methanol is a colorless liquid with a characteristic pungent odor. It is miscible with water, and its boiling point is 147°F. Sulfuric Acid (CAS: 7664-93-9) Sources. Sulfuric acid is a raw material of most fertilizer products. Toxicity. Concentrated sulfuric acid is corrosive. In its aerosol form, sulfuric acid has been implicated in causing and exacerbating a variety of respiratory ailments. Ecologically, accidental releases of solution forms of sulfuric acid may adversely affect aquatic life by inducing a transient lowering of the pH (i.e., increasing the acidity) of surface waters. In addition, sulfuric acid in its aerosol form is also a component of acid rain. Acid rain can cause serious damage to crops and forests. Carcinogenicity. There is currently no evidence to suggest that sulfuric acid is carcinogenic. Environmental Fate. Releases of sulfuric acid to surface waters and soils will be neutralized to an extent due to the buffering capacities of both systems. The extent of these reactions will depend on the characteristics of the specific environment. Physical Properties. Sulfuric acid is an oily, odorless liquid which can be colorless to dark-brown. It is miscible, and its boiling point is 554°F. Sector Notebook Project 95 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Sulfuric acid reacts violently with water with evolution of heat and is corrosive to metals. Pure sulfuric acid is a solid below 51°F. IV.C. Other Data Sources The toxic chemical release data obtained from TRI captures only about 236 of the facilities in the Fertilizer, Pesticide, and Agricultural Chemical Industry. However, it allows for a comparison across years and industry sectors. Reported chemicals are limited to the approximately 600 TRI chemicals. A portion of the emissions fromagricultural chemical facilities, therefore, are not captured by TRI. The EPA Office of Air Quality Planning and Standards has compiled air pollutant emissionfactors for determining the total air emissions of priority pollutants (e.g., total hydrocarbons, SOx, NOx, CO, particulates, etc.) from many chemical manufacturing and formulating sources. The Aerometric Information Retrieval System (AIRS) contains a wide range of information related to stationary sources of air pollution, including the emissions of a number of air pollutants which may be of concern within a particular industry. With the exception of volatile organic compounds (VOCs), there is little overlap with the TRI chemicals reported above. Table 22 summarizes annual releases (from the industries for which a Sector Notebook Profile was prepared) of carbon monoxide (CO), nitrogen dioxide (NO2), particulate matter of 10 microns or less (PM10), sulfur dioxide (SO2), and volatile organic compounds (VOCs). Sector Notebook Project 96 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Table 22: Air Pollutant Releases by Industry Sector (tons/year) Industry Sector Metal Mining Non-Fuel, Non-Metal Mining Textiles CO NO2 PM10 PT SO2 VOC 4,951 49,252 21,732 9,478 1,202 119,761 31,008 21,660 44,305 16,433 9,183 138,684 8,164 33,053 1,819 38,505 26,326 7,113 Lumber and Wood Products Wood Furniture and Fixtures 139,175 3,659 45,533 3,267 30,818 2,950 18,461 3,042 95,228 84,036 74,028 5,895 Pulp and Paper 584,817 365,901 37,869 535,712 177,937 107,676 8,847 3,629 539 1,772 88,788 1,291 242,834 93,763 6,984 150,971 52,973 34,885 15,022 6,389 36,424 17,091 2,027 1,623 65,875 24,506 71,416 31,645 7,580 4,733 112,999 177,094 13,245 129,144 162,488 17,765 12,906 38,102 4,733 14,426 62,848 8,312 299,546 334,795 25,271 592,117 292,167 36,421 2,463 92,463 10,977 335,290 3,391 58,398 24,366 290,017 110,739 21,092 6,302 198,404 Iron and Steel 982,410 158,020 36,973 241,436 67,682 85,608 Metal Castings 115,269 10,435 14,667 4,881 17,301 21,554 Nonferrous Metals 311,733 31,121 12,545 303,599 7,882 23,811 Fabricated Metal Products 7,135 11,729 2,811 17,535 108,228 5,043 Electronics and Computers 27,702 7,223 1,230 8,568 46,444 3,464 Motor Vehicle Assembly 19,700 31,127 3,900 29,766 125,755 6,212 4,261 5,705 890 757 3,705 10,804 109 866 762 2,862 4,345 707 153,631 179 594,672 476 2,338 676 9,555 712 101,775 3,514 5,542 3,775 1,244 960 133 147 1,815 144 221,787 13,477,36 7 42,726 719,644 7,920 40 Printing Inorganic Chemicals Plastic Resins and Man-made Fibers Pharmaceuticals Organic Chemicals Agricultural Chemicals Petroleum Refining Rubber and Plastic Stone, Clay, Glass and Concrete Aerospace Shipbuilding and Repair Ground Transportation Water Transportation Air Transportation Fossil Fuel Electric Power Dry Cleaning 399,585 5,661,468 145 781 10 725 Source: United States EPA Office of Air and Radiation, AIRS Database, 1997. Sector Notebook Project 97 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers IV.D. Comparison of Toxic Release Inventory Between Selected Industries The following information is presented as a comparison of pollutant release and transfer data across industrial categories. It is provided to give a general sense as to the relative scale of TRI releases and transfers within each sector profiled under this project. Please note that the following figure and table do notcontainreleases and transfers for industrial categories thatare notincluded in this project, and thus cannot be used to draw conclusions regarding the total release and transfer amounts that are reported to TRI. Similar information is available within the annual TRI Public Data Release Book. Figure 19 is a graphical representation of a summary of the TRI data for the Fertilizer, Pesticide, and Agricultural Chemical Industryand the other sectors profiled in separate notebooks. The bar graph presents the total TRI releases and total transfers on the vertical axis. Industry sectors are presented in the order of increasing SIC code. The graph is based on the data shown in Table 23 and is meant to facilitate comparisons between the relative amounts of releases and transfers both within and between these sectors. Table 23 also presents the average releases per facility in each industry. The reader should note that differences in the proportion of facilities captured by TRI exist between industry sectors. This can be a factor of poor SIC matching and relative differences in the number of facilities reporting to TRI from the various sectors. In the case of the Fertilizer, Pesticide, and Agricultural Chemical Industry, the 1995 TRI data presented here covers 236 facilities. These facilities listed SIC 2873, 2874, 2875, or 2879 as a primary SIC code. Sector Notebook Project 98 September 2000 Agricultural Chemical Industry Chemical Releases and Transfers Figure 19: Summary of 1995 TRI Releases and Transfers by Industry 600 Total Pounds (millions) 500 400 300 200 3731 371 36 34 333, 334 332, 336 331 32 30 2911 287 2861-2869 2833, 2834 2821, 2823, 2824 2812-2819 2711-2789 25 24 22 0 2611-2631 100 SIC Range Total Releases Total Transfers Source: US EPA 1995 Toxics Release Inventory Database. SIC Range Industry Sector SIC Range Industry Sector SIC Range Industry Sector 22 Textiles 2833, 2834 Pharmaceuticals 332, 336 Metal Casting 24 Lumber and Wood Products 2861-2869 Organic Chem. Mfg. 333, 334 Nonferrous Metals 25 Furniture and Fixtures 287 Agricultural Chemicals 34 Fabricated Metals 2611-2631 Pulp and Paper 2911 Petroleum Refining 36 Electronic Equip. and Comp. 2711-2789 Printing 30 Rubber and Misc. Plastics 371 Motor Vehicles, Bodies, Parts, and Accessories 2812-2819 Inorganic Chemical Manufacturing 32 Stone, Clay, and Concrete 3731 Shipbuilding 2821, 2823, 2824 Resins and Plastics 331 Iron and Steel Sector Notebook Project 99 September 2000 Sector Notebook Project 100 2861-2869 Pharmaceuticals Organic Chemical Mfg. 34 36 371 Fabricated Metals Electronic Equip. and Comp. Motor Vehicles, Bodies, Parts, and Accessories 43 754 407 2,676 282 654 423 623 1,947 180 236 402 200 410 413 262 305 336 397 339 # TRI Facilities 2.4 79.3 4.3 83.5 201.7 36.0 90.7 43.9 143.1 73.8 77.1 148.3 29.9 64.1 60.7 33.9 232.6 37.6 30.0 17.8 56,000 105,000 11,000 31,000 715,000 55,000 214,000 70,000 73,000 410,000 326,788 598,000 150,000 156,000 468,000 129,000 763,000 112,000 76,000 53,000 Total Ave. Releases Releases per (million lbs.) Facility (pounds) Source: US EPA Toxics Release Inventory Database, 1995. 3731 333, 334 Nonferrous Metals Shipbuilding 331 332, 336 Metal Casting 32 Iron and Steel 30 Stone, Clay, and Concrete 2911 Rubber and Misc. Plastics Petroleum Refining 287 2833, 2834 Resins and Plastics Agricultural Chemicals 2812-2819 2821,2823, 2824 Inorganic Chem. Mfg. 2711-2789 Printing 25 Furniture and Fixtures 2611-2631 24 Lumber and Wood Products Pulp and Paper 22 SIC Range Textiles Industry Sector TRI Releases 4.1 194 68.8 350.5 164 73.9 513.9 31.8 102.6 29.2 11.4 208.6 147.2 192.4 21.7 10.4 56.5 9.9 4.1 7.0 Total Transfers (million lbs.) 95,000 257,000 169,000 131,000 582,000 113,000 1,215,000 51,000 53,000 162,000 48,461 631,000 736,000 469,000 191,000 40,000 185,000 29,000 10,000 21,000 Ave. Trans. per Facility (pounds) TRI Transfers Table 23: 1995 Toxics Release Inventory Data for Selected Industries 6.5 273.3 73.1 434.0 365.7 109.9 604.6 75.7 245.7 103.0 88.5 946.8 177.1 256.5 438.5 44.3 289.1 47.5 34.1 24.8 Total Releases +Transfers (million lbs.) 151,000 362,000 180,000 162,000 1,297,000 168,000 1,429,000 121,000 126,000 572,000 375,000 1,229,000 886,000 625,000 659,000 169,000 948,000 141,000 86,000 74,000 Average Releases + Transfers per Facility (pounds) Agricultural Chemical Industry Chemical Releases and Transfers September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities V. POLLUTION PREVENTION OPPORTUNITIES The best way to reduce pollution is to prevent it in the first place. Some companies have creatively implemented pollution prevention techniques that improve efficiency and increase profits while at the same time minimizing environmental impacts. This can be done in many ways such as reducing material inputs, re-engineering processes to reuse by-products, improving management practices, and substituting toxic chemicals with those less toxic. Some smaller facilities are able to actually get below regulatory thresholds just by reducing pollutant releases through aggressive pollution prevention policies. The Pollution Prevention Act of 1990 established a national policy of managing waste through source reduction, which means preventing the generationof waste. The Pollution Prevention Act also established as national policy a hierarchy of waste management options for situations in which source reduction cannot be feasiblely implemented. In the waste management hierarchy, if source reduction is not feasible the next alternative is recycling of wastes, followed by energy recovery, and waste treatment as a last alternative. In order to encourage these approaches, this section provides both general and company-specific descriptions of some pollution prevention advances that have been implemented within the Fertilizer, Pesticide, and Agricultural Chemical Industry. While the list is not exhaustive, it does provide core information that can be used as the starting point for facilities interested in beginning their own pollution prevention projects. This section provides summary information from activities thatmaybe, or are being implemented by this sector. When possible, information is provided that gives the context in which the technique can be used effectively. Please note that the activities described in this section do not necessarily apply to all facilities that fall within this sector. Facility-specific conditions must be carefully considered when pollution prevention options are evaluated, and the full impacts of the change must examine how each option affects air, land and water pollutant releases. The Fertilizer, Pesticide, and Agricultural Chemical Industry uses many pollution prevention (P2), recycle and reuse, and water conservation practices. Wastewaters are primarily generated not by the production or formulating processes themselves but by cleaning operations of the process areas and associated equipment. Because the wastewaters are mostly cleaning rinsates and not waters of reaction, the pollution prevention practices are not process-specific. There are many P2, recycle and reuse, and water conservation practices that are widely accepted and practiced by the Fertilizer, Pesticide, and Agricultural Chemical Industry today. Sector Notebook Project 101 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities These pollution prevention, recycle and reuse, and water conservation practices fall into three groups: production practices, housekeeping practices, and practices that use equipment that, by design, promote pollutionprevention. Some of these practices and equipment conserve water, others reduce the amount of fertilizer or pesticide productin the wastewater, and still others may prevent the generation of a wastewater altogether (USEPA, 1996). A number of common P2 practices are listed below. Production practices include: C triple-rinsing raw material shipping containers directly into the formulation C scheduling production to minimize cleanouts C segregating processing/formulating/packaging equipment by: - individual product - solvent-based versus water-based formulations - products that contain similar active ingredients in different concentrations C storing interior equipment rinse waters for use in formulating the same product C packaging products directly from formulation vessels C using raw material drums for packaging final products C dedicating equipment (possibly only mix tank or agitator) for “hard-to-clean” formulations Housekeeping practices include: C performing preventive maintenance on all valves, fittings, and pumps C placing drip pans under leaky valves and fittings or under any valves or fittings where hoses or lines are routinely connected and disconnected C cleaning up spills or leaks in outdoor bulk containment areas to prevent contamination of storm water Sector Notebook Project 102 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities Equipment that promotes pollution prevention by reducing or eliminating wastewater generation includes: C low-volume/high-pressure hoses C spray nozzle attachments for hoses C squeegees and mops C low-volume/recirculating floor scrubbing machines C portable steam cleaners C drum triple rinsing stations C roofs over outdoor tank farms (USEPA, 1996) Sector Notebook Project 103 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities Table 24: Waste Minimization Methods for the Fertilizer, Pesticide, and Agricultural Chemical Industry Waste Stream Waste Minimization Methods Equipment Cleaning Wastes Maximize production runs. Store and reuse cleaning wastes. Use of wiper blades and squeegees. Use of low-volume, high-efficiency cleaning. Use of plastic or foam “pigs.” Spills and Area Washdowns Use of dedicated vacuum system. Use of dry cleaning methods. Use of recycled water for initial cleanup. Actively involved supervision. Off-Specification Products Strict quality control and automation. Reformulating off-spec batches. Containers Return containers to supplier and or reuse as directed. Triple rinse containers. Drums with liners versus plastic drums or bags. Segregating solid waste. Air Emissions Control bulk storage air emissions. Dedicate dust collection systems. Use automatic enclosed cut-in hoppers. Eliminate emissions of ammonia from reaction of anhydrous ammonia and phosphoric acid. Miscellaneous Wastewater Streams Pave high spillage areas. Source: Guides to Pollution Prevention, The Pesticide Formulating Industry, Center for Environmental Research Information, United States EPA, Cincinnati, Ohio, 1990. Sector Notebook Project 104 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities V.A. Equipment Cleaning Shipping Container/Drum Cleaning Operations Fertilizer and pesticide facilities frequently receive raw materials in containers such as 55-gallon plastic or steel drums or 30-gallon fiber drums. In some cases, the empty drums are returned to the supplier, but usually the facility is responsible for disposal of the drums. The simplest, most costeffective, and best approach to prevent pollution associated with cleaning drums and shipping containers is to rinse empty drums prior to disposal to capture the raw material residue for direct reuse in future formulations of the same product. In this way, the facility not only eliminates a potential highly contaminated wastewater source, but is also able to recover the product value of the raw material and avoids costs associated with storage of the wastewater (USEPA, 1996). However, pesticide chemicals formulating and packaging facilities and pesticide repackaging and refilling facilities should consult the Listof PollutionPreventionAlternative Practices and ensure compliance with the effluent guidelines and standards found in 40 CFR 455 Subparts C and E before implementing pollution prevention techniques listed in this section. Rinsing procedures for pesticide drums are provided in 40 CFR Part 165. The most common method of drum rinsing in the agrichemical industry is triple rinsing. After a drum containing AIs or pesticide products is emptied, it should be triple rinsed with the solvent that will be used in the formulation. This method prevents the creation of a rinsate that cannot be added directly to the formulation (e.g., a facility will not create a water-based rinsate when producing a solvent-based product). Note in some cases the label may specify how to rinse. Some facilities use a high-pressure, low-volume wash system equipped with a hose and a spray nozzle to triple rinse drums; volumes of five to fifteen gallons of water per drum have been reported. EPA has identified many facilities that reuse these rinsates directly in product formulations. Other facilities treat drumrinsate and reuse the effluent for further drumor equipment rinsing. If the rinsate cannot be reused directly in product formulations, another effective method to reduce wastewater generation during shipping container/drumcleaning processes is the use of drumrinsing stations (USEPA, 1996). One facility uses a three-cell station for triple-rinsing drums. The water in the first cell is used for the first rinse, the water in the second cell is used for the second rinse, and the water in the third cell is used for the final rinse. The rinse water in the first cell is reused until it is visually too contaminated to effectively clean the drums. At that time, it is removed from the cell (for treatment) and the rinse water from the second cell is transferred into the first cell. The rinse water from the third cell is transferred into the second cell, and the third cell is refilled with treated effluent fromtheir treatment system. Each Sector Notebook Project 105 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities cell contains approximately100 gallons of water; approximately 70 drums can be rinsed before the first cell requires water changing (USEPA, 1996). Another site uses a unique, closed-loop set-up for emptying and triple rinsing raw material drums. The system was designed by the facility for several purposes: to aid it in emptying and cleaning drums and performing the triple rinse, to eliminate the need for storage of the water (or solvent) for reuse, and to prevent mathematical errors by the operators during the weighing out of raw materials and water (or solvent). The system consists of two 55-gallon drums, a formulation tank, and connecting hoses. One of the drums is permanently fixed on top of the formulation tank. The formulation tank and drum are situated on a load cell (used for weighing). The second drum, which is full of raw material, is placed on the ground next to the formulation tank. One hose is used to vacuum out the raw material and transfer it to the drum on the formulations tank/load cell. The other hose is equipped with a doughnutshaped nozzle that provides the triple rinse by spraying the interior of the now empty raw material drum. The rinsate that is created by the triple rinse procedure is automatically removed by the vacuum line and is transferred to the drum on the formulation tank/load cell. The load cell can be used to weigh the amount of raw material and/or rinsate that is added to the formulation by zeroing out the weight of the tank and drum. This allows the volume of both raw material and rinse water (or solvent) to be factored into the total volume of water (or solvent) required in the formulation. The drum on top of the formulation tank is equipped with a spring-loaded valve that enables the operator to take weight measurements prior to emptying the contents of the drum into the mix tank. This set-up has almost completely eliminated operator math errors and related formulation specification problems. Bulk Tank and Equipment Cleaning Pesticide formulating and fertilizer mixing facilities sometimes produce large quantities of formulated pesticide and fertilizer products and receive large quantities of raw materials used to produce those products. Those products and raw materials are stored on site in bulk tanks. The tanks are typically rinsed only when it becomes necessary to use the tank to store a different material. Each time the facility switches the product stored in a bulk tank, the tank is rinsed. Bulk tanks are sometimes also rinsed at the end of a season as a part of general maintenance (USEPA, 1996). Pesticide formulating and fertilizer mixing facilities should consult the List of Pollution Prevention Alternative Practices and ensure compliance with the effluent guidelines and standards found in 40 CFR Part 455 Subparts C and E before implementing pollution prevention techniques involving bulk tank and other equipment cleaning. Product changeover cleanings can be eliminated or greatly reduced by Sector Notebook Project 106 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities dedicating equipment to specific products or groups of products. Although entire lines are not generally dedicated, there are many facilities thatdedicate tanks to formulation mixing only, thereby eliminating one of the most highly contaminated wastewater streams generated at pesticide formulating and packaging facilities. Facilities also dedicate lines to the production of a specific product type, such as water-based versus solvent-based products, thereby reducing the number of cleanings required, and allowing greater reuse of the cleaning water or solvent. Another effective pollution prevention technique is to schedule production to reduce the number of product changeovers, which reduces the number of equipment interior cleanings required. Facilities may also reduce the number of changeover cleanings required or the quantity of water or solvent used for cleaning by scheduling products in groups. Products may lend themselves to a particular production sequence if they have common active ingredients, assuming the products also have the same solvent base (including water). Where other raw material cross-contamination problems are nota concern, no cleaning would be required between changeover. Facilities that have implemented this technique have conducted testing to ensure that product quality is not adversely affected (USEPA, 1996). Scheduling production according to packaging type can reduce changeover cleanings of packaging equipment. Packaging lines are often able to handle containers of different sizes; a slight adjustment to one packaging line, such as adding a short length of hose, may prevent the use of an entirely different set of packaging equipment that would also require cleaning. Packaging can also be performed directly out of the formulation vessels to avoid using and subsequently cleaning interim storage tanks and transfer hoses. Another effective pollution prevention and water conservation technique to minimize the quantity of rinse water generated by equipment interior cleaning is the use of water hoses equipped with hand-control devices (for example, spray-gun nozzles suchas those used on garden hoses). This practice prevents the free flow of water from unattended hoses. Another technique to conserve water is the use of high-pressure, low-volume washers instead of ordinary hoses. One of the facilities visited indicated that, by using high-pressure washers, they reduced typical equipment interior rinse volumes from twenty gallons per rinse to ten gallons per rinse (USEPA, 1996). Steam cleaning can also be a particularly effective method to clean viscous products that otherwise require considerable volumes of water and/or the addition of a detergent to remove. Many facilities have access to steam from boilers onsite; however, if there is no existing source of steam, steam cleaning equipment can be purchased. Although steam generation can increase energy consumption and add NOx and SOx pollutants to the atmosphere, there are benefits to be gained. Facilities may end up creating a much smaller volume of wastewater and may potentially avoid the need to use detergents or other Sector Notebook Project 107 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities cleaning agents that could prevent product recovery. However, steam would be a poor choice for cleaning applications where volatile organic solvents or inerts are part of the product, as the steam would accelerate the volatilization of the organic compounds. Facilities also clean equipment interiors by using squeegees to remove the product from the formulation vessel and by using absorbent “pigs” to clean products out of the transfer lines before equipment rinsing. These techniques minimize the quantity of cleaning water required, although they generate a solid waste stream requiring disposal. Regardless of whether or not residual product is removed from equipment interiors before rinsing, if certain conditions are met, equipment interior rinsate can typically be reused as make up water the next time that a water-based product is being formulated with the same chemical (USEPA, 1996). Pesticide chemicals formulating and packaging facilities and pesticide repackaging and refilling facilities should consult the List of Pollution Prevention Alternative Practices and ensure compliance with the effluent guidelines and standards found in 40 CFR Part 455 Subparts C and E before implementing pollution prevention techniques involving bulk tank and other equipment cleaning. One facility uses a unique method of cleaning to reduce the volume of water needed to clean equipment interiors. At this facility, the production lines are hooked to dedicated product storage tanks. Prior to rinsing these production lines, the facility uses air to “blow” the residual product in the line back to product storage. Not only will these lines require less water to clean, but the residual product that is blown back to storage is not diluted and should not affect the product specifications in any way. Another facility drastically reduced dichloromethane usage at several plants by switching to soap and water for cleaning. This change enabled the facility to cut its target chemicals by two-thirds. The facility also reduced the release of carbon tetrachloride, and installed a closed-loop recycling system, to reduce water usage (CMA, 1993). Aerosol Container Leak Testing No method of eliminating wastewater from test baths has been identified. However, the volume of water used may be minimized by using a contained (or batch) water bath as opposed to a continuous overflow water bath. A contained water bath is completely emptied and refilled with water when required, based uponvisual inspectionby the operator. Therefore, the quantity of wastewater generated depends on the frequency of refilling and the volume of the bath (200 gallons is a typical volume of the contained water baths). One facility uses a contained water bath and heats the bath with steam to ensure that the temperature of the cans reaches 130°F. This facility indicated that steam condensation causes some overflow that exits the bath via a standpipe. A continuous overflow bath would probably generate more wastewater per Sector Notebook Project 108 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities production unit than a batch water bath (USEPA, 1996). One facility has installed a diatomaceous earth filter on one DOT test bath. The facility recirculates the bath water through the filter to remove contaminants such as oil and grease and suspended solids. The filtered water is then reused in the bath, thereby extending the usefulness of the bath water. The facility anticipates they will dispose of the filter as nonhazardous waste. Another facility uses a can-washing step prior to the DOT test bath, presenting an additional source of wastewater. This can washing is performed at the operator’s discretion to reduce the quantity of contaminants entering the bath water. The effectiveness of this step has not been quantitatively determined (USEPA, 1996). Laboratory Equipment Cleaning Many pesticide formulating and packaging facilities operate on-site laboratories for conducting quality control tests of raw materials and formulated products. Wastewater is generated from these tests and from cleaning glassware used in the tests. One effective pollution prevention/reuse technique during laboratory equipment cleaning operations is to dedicate laboratory sinks to certain products, and collect any wastewater generated from the testing of those products either for reuse in the same product or for transfer back to the AI manufacturer or product registrant. In the cases where the facility uses solvents in conjunction with the quality control tests performed in the laboratory, the solvent-contaminated water may not be able to be reused in the process (USEPA, 1996). V.B. Process Changes Storage Tanks One method to reduce the amount of wastewater from ammonium nitrate production is to incorporate a wastewater evaporator system which reduces the amount of contaminated cooling water discharge. The wastewater passes through a series of evaporation steps whereby the vapors are used as wash water in the calcium carbonate filters and the concentrated solution is pumped to the neutralizers where it is mixed with the acidic nitrogen-phosphate solution and used to regulate the nitrogen-phosphate nutrient ratio of the fertilizer. Through this modified technology, steam and electric energy consumptionincreases somewhat, but suchincreases are balanced bythe more effective utilization of nitrogen and the reduction of wastewater. More information onthis method can be found in “Waste Water Evaporation Process for Fertilizer Production Technology,” Compendium on Low and Non-waste Technology, United Nations Economic and Social Counsel. (http://es.inel.gov/studies/cs244.html) Sector Notebook Project 109 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities Many methods are available for reducing the amount of emissions resulting from fixed roof storage tanks. Some of these methods include use of conservation vents, conversion to floating roof tanks, use of nitrogen blanketing to suppress emissions and reduce material oxidation, use of refrigerated condensers, use of lean-oil or carbon absorbers, or use of vapor equilibration lines. When dealing with volatile materials, employment of one or more of these methods can result in cost savings to the facility by reducing raw material losses and improving compliance with local air quality requirements (USEPA, 1996). Air Emission Control Systems Agricultural chemical facilities often produce large quantities of dust which are collected from numerous sources. The chemical composition of the various dust sources can vary widely. Opportunities often exist to reduce waste generation through segregation of these waste dusts and particulates. At Daly-Herring Co., in Kingston, NC, dust streams from several different production areas were handled by a single baghouse. Since all of the streams were mixed, none of the waste could be recycled to the process that generated them. By installing separate dedicated baghouses for each production line, all of the collected pesticide dust could be recycled. The initial investment for the equipment was $9,600. The payback period was only ten months. DalyHerring saved over $9,000 per year in disposal costs and $2,000 per year in raw material costs (Hunt, 1989). At FMC Corp. in Fresno, CA, common dust collectors were used by multiple production systems. Due to the cross contamination of materials, recycling was impossible. To promote recycling, the company compartmentalized the dust collectors with each compartment serving a single source. All collected materials are analyzed for cross contamination and if none exists, they are reused in the succeeding product batch. Other work involved the installation of self-contained dust collectors at each inlet hopper dump station so that captured dust can be returned to the system (USEPA, 1996). Facilities mayalso use wet scrubbers to control air emissions. Some facilities may only need a wet scrubber on one particular process (i.e., a dedicated scrubber). These facilities have been able to reuse the scrubber blowdown or changed-out scrubber water as make-up water in the formulation of that particular product. Some facilities with nondedicated scrubbers have been Sector Notebook Project 110 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities able to use the scrubber blowdown or changed-out scrubber water for floor or equipment exterior cleaning (USEPA, 1996). Microprill Formation Microprill formation resulting from partially plugged orifices of melt spray devices can increase fine dust loading and emissions. Certain designs (spinning buckets) and practices (vibration of spray plates) help reduce microprill formation. Reducing the ambient air temperature reduces emissions because the air flow required to cool prills and the formation of fumes are decreased at lower temperatures. V.C. Good Housekeeping Floor/Wall/Equipment Exterior Cleaning During processing, formulating, and packaging operations, the exteriors of equipment may become soiled from drips, spills, and dust (especially equipment located near dry lines). The floors in the area become dirty in the same manner and also from normal traffic. Facility workers clean the equipment exteriors and floors for general housekeeping purposes, and to keep sources of product contamination to a minimum. When water is used, these cleaning procedures become a source of wastewater. Wastewater can again be minimized through the use of high-pressure, lowvolume washers rather than ordinary water hoses. Additionally, some facilities practice steam cleaning rather than water cleaning of equipment exteriors to reduce the amount of wastewater generated (USEPA, 1996). Instead of hosing down the exterior of a piece of equipment, some facilities wipe equipment exteriors with rags or use a solvent cleaner, such as a commercially available stainless steel cleaner. This practice avoids generating a wastewater stream, but does create a solid waste that, depending on the solvent used, could be considered a hazardous waste. Squeegees are also used to clean equipment exteriors and floors, and are not disposed of after single uses. It may be possible to dedicate squeegees to a certain line or piece of equipment, but using squeegees maystill require using some water (USEPA, 1996). Some facilities use automated floor scrubbers, which replace the practice of hosing down floors. Floor scrubbers are mechanical devices that continually recirculate cleaning water to clean flat, smooth surfaces with circulating brushes. During operation, the scrubber collects the cleaning water in a small tank that is easily emptied after the cleaning process, or at a later date. Using a floor scrubbing machine can require as little as five to fifteen gallons of cleaning solution (typically water) per use. A mop and a single bucket of Sector Notebook Project 111 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities water can also be used in place of a hose. Floor mopping can generate as little as ten gallons of water per cleaning depending on the size of the surface to be cleaned (USEPA, 1996). A number of facilities reuse their floor wash water with and without filtering. One facility has set up its production equipment on a steel-grated platform directly above a collection sump. Following production, the equipment and the floor of the platform, on which the operator stands when formulating product, are rinsed and the water is allowed to flow into the sump. A pump and a filter have been installed in the sump area to enable the operator to transfer this rinsate back into the formulation tank for the next formulation. This sump is also connected to floor trenches in the packaging area for the same product. When the exterior of the packaging equipment and the floors in this area are rinsed, this water is directed to the trenches and eventually ends up in the collection sump for reuse (USEPA, 1996). Leaks and Spills Clean-Up Dry products that have leaked or spilled can be vacuumed or swept without generating any wastewater. Liquid leaks and spills can be collected into a trench or sump (for reuse, discharge, or disposal) with a squeegee, leaving only a residue to be mopped up or hosed down if further water cleanup is required. Liquid leaks and spills can also be cleaned up using absorbent material, such as absorbent pads or soda ash. For an acidic product, soda ash or a similar base material will also serve to neutralize the spill. If a residue remains, some water may be used for mopping up or hosing the area down, but methods to reduce floor wash should be implemented whenever possible. Many facilities clean up leaks and spills from water-based products with water and then solvent-based products with absorbent materials. Using an absorbent material may be the best practice for cleaning up small scale solvent-based leaks and spills; however, EPA does recognize that this material then needs to be disposed of (cross-media transfer). Therefore, good housekeeping practices may be even more important in the case of organic solvent-based product spills and leaks because, if not prevented, these spills and leaks may have to be cleaned up with absorbent material and disposed of (USEPA, 1996). Direct reuse of products which have leaked or spilled is another possible pollution prevention technique. If drip pans or other containers are used to catch leaks and spills, the material (either water-based or solvent-based) can be immediately reused in the product being processed, formulated, or packaged, or stored for use in the next product batch. Collection hoppers or rubs can be installed beneath packaging fillers to capture spills and immediately direct the spills back to the fillers. Leaks or spills around bulk Sector Notebook Project 112 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities storage tanks can be contained by dikes, which, in fact, are often required by state regulations (USEPA, 1996). Precipitation Runoff Precipitation runoff includes all precipitation thatfalls on facility surfaces that are believed to be contaminated. Contaminated precipitation runoff can be prevented by bringing all operations indoors, as many facilities have done, or by covering outdoor storage tanks and dikes with roofs, which has also been done at many facilities. The roofs would ideally extend low enough to prevent crosswinds from blowing rain into spill-containment dikes. To prevent rainwater contamination, the drain spouts and gutters should conduct roof runoff to areas away from process operations, and the roofs should be kept in good repair (USEPA, 1996). If operations remain outdoors, a transfer, or containment pad should be installed with a sump or other means of collecting rinse water. The pad should be constructed of asphalt or concrete and maintained with crack sealer and a top coat sealer to control infiltration. The pad should also be large enough to contain wind-blown particulates from dry materials. If pads are cleaned before a rainfall, then uncontaminated precipitation runoff may be directly discharged to surface drains (CFA, 1996). Facilities can also monitor the water in a containment system by periodically testing for a variety of contaminants. It may be difficult for facilities that do not require large volumes of water to reuse all the precipitation collected in the containment system. These facilities could keep the containment systemfree of any spilled pesticides through good housekeeping practices so thatprecipitation falling into the containment system does not become contaminated. Some facilities house their pesticide bulk storage area inside a building or under a covered area to eliminate precipitation from collecting in the containment system, as well as to protect the area from vandalism and severe weather (USEPA, 1996). Containment Pad in the Loading/Unloading Area Agrichemical dealers sometimes install loading/containment pads in the operation area to contain and collect any product spills that may occur during pesticide loading operations. The pad is usually installed contiguous to the bulk storage tanks and the repackaging of products into smaller containers. Facilities may also conduct all their portable cleaning operations, such as rinsing minibulk containers, directly on the pad in order to contain and collect the rinsates. The pad is normally constructed of concrete and is sloped to a sump area. Some facilities divide the sump area into individual collection basins so that the facilities can segregate wastewaters contaminated by different products Sector Notebook Project 113 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities and reuse these wastewaters for applications. For instance, facilities in the Midwest frequently have two collection basins; one basin collects wastewaters contaminated with corn herbicides and the other collects wastewaters contaminated with soybean herbicides. As part of this collection system, some facilities install one or more tanks to store wastewater until it can be applied to land, while other facilities use portable minibulk tanks to store the wastewater. When facilities collect wastewaters that must be segregated by different types of products, multiple storage tanks are used to avoid contamination (USEPA, 1996). V. D. Energy Efficiency Installation of a Feed-Gas Saturator A mixture of steam and natural gas with a volumetric ratio of steam to carbon of about 3.5:1 is reacted in the primary reformer of reforming ammonia plants. Most of the steam is generated from heat sources within the plant, but the balance of the steam has to be produced in auxiliary boilers. This retrofit permits the use of low-level heat from the flue gases, which would otherwise be lost, to be used in saturating the feed natural gas with water. This generates extra steam which replaces some of the steam generated in the boiler (UNEP, 1996). Modification of Convection Coils As a result of other modifications, the temperature profile of the flue gases may change considerably in the cold-leg section of the primary reformer. This change can be compensated for by replacing the low steamsuperheat coil with a new one with additional rows of tubes and heavier fins on all tubes (UNEP, 1996). Low-heat Removal of Carbon Dioxide The traditional systems used for removal of carbon dioxide from the process steam uses hotpotassiumcarbonate which requires heatfor regeneration. This heat comes from process heat but needs to be supplemented with external steam. A new low-heat removal system is now available, which uses flashing for part of the regeneration process, and requires less external heat (UNEP, 1996). Ammonia Synthesis Modifications Ammonia Converter Retrofit The vertical quench-type converters are changed from axial flow to radial flow, greatly decreasing the pressure drop across the converter which in turn allows the use of smaller size catalyst with a larger surface area. This improved catalyst yields a higher conversion per pass, generating a lower Sector Notebook Project 114 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities recycle volume. The lower recycle volume and the lower pressure drop result in reduced energy requirements. This modification yields an increase effective capacity of the ammonia converter of about 35 percent (UNEP, 1996). Addition of Process Computer A dedicated process computer can be installed along with other on-line analysis and control systems to monitor and control key variables. With this system, continuous set point changes are possible to optimize the operation of several plant areas such as hydrogen/nitrogen ratio, steam/carbon ratio, synthesis loop purge, methane leakage, converter control, and refrigeration purge (UNEP, 1996). Hydrogen Recovery from the Purge Gas Inert gases must be pumped from the plant to avoid their buildup in the system. This purge is carried out by removing a side stream of synthesis gas after recovering the ammonia. By installing the proper recovery system, the hydrogen in this gas mixture can be recovered decreasing the energy requirements of the process by about five percent or permitting an increase of about five percent in production capacity (UNEP, 1996). Sector Notebook Project 115 September 2000 Agricultural Chemical Industry Pollution Prevention Opportunities THIS PAGE WAS INTENTIONALLY LEFT BLANK Sector Notebook Project 116 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations VI. SUMMARY OF APPLICABLE FEDERAL STATUTES AND REGULATIONS This section discusses the federal regulations that may apply to this sector. The purpose of this section is to highlight and briefly describe the applicable federal requirements, and to provide citations for more detailed information. The three following sections are included: C Section VI.A contains a general overview of major statutes C Section VI.B contains a list of regulations specific to this industry C Section VI.C contains a general discussion on State regulation of C pesticides Section VI.D contains a list of pending and proposed regulatory requirements The descriptions withinSectionVI are intended solely for general information. Depending upon the nature or scope of the activities at a particular facility, these summaries may or may not necessarily describe all applicable environmental requirements. Moreover, they do not constitute formal interpretations or clarifications of the statutes and regulations. For further information, readers should consult the Code of Federal Regulations (CFR) and other state or local regulatory agencies. EPA Hotline contacts are also provided for each major statute. VI.A. General Description of Major Statutes Federal Insecticide, Fungicide, and Rodenticide Act The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was first passed in 1947, and amended numerous times, most recently by the Food Quality Protection Act (FQPA) of 1996. FIFRA provides EPA with the authority to oversee, among other things, the registration, distribution, sale and use of pesticides. The Act applies to all types of pesticides, including insecticides, herbicides, fungicides, rodenticides, and antimicrobials. FIFRA covers both intrastate and interstate commerce. Establishment Registration Section 7 of FIFRA requires that establishments producing pesticides, or active ingredients used in producing a pesticide subject to FIFRA, register with EPA. Registered establishments must report the types and amounts of pesticides and active ingredients they produce. The Act also provides EPA inspection authority and enforcement authority for facilities/persons that are not in compliance with FIFRA. Product Registration Under section 3 of FIFRA, all pesticides (with few exceptions) sold or distributed in the United States must be registered by EPA. Pesticide registration is very specific and generally allows use of the product only as Sector Notebook Project 117 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations specified on the label. Each registration specifies the use site, i.e., where the product may be used, and amount that may be applied. The person who seeks to register the pesticide must file an application for registration. The application process often requires either the citation or submission of extensive environmental, health, and safety data. To register a pesticide, the EPA Administrator must make a number of findings, one of which is that the pesticide, when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment. FIFRA defines “unreasonable adverse effects on the environment” as “(1) any unreasonable risk to manor the environment, taking into account the economic, social, and environmental costs and benefits of the use of the pesticide, or (2) a human dietary risk from residues thatresult froma use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a).” Under FIFRA section 6(a)(2), after a pesticide is registered, the registrant must also notify EPA of any additional facts and information concerning unreasonable adverse environmental effects of the pesticide. Also, if EPA determines that additional data are needed to support a registered pesticide, registrants maybe required to provide additional data. If EPA determines that the registrant(s) did not comply with their request for more information, the registration can be suspended under FIFRA section 3(c)(2)(B) and section 4. Use Restrictions As a part of the pesticide registration, EPA must classify the product for general use, restricted use, or general for some uses and restricted for others (Miller, 1993). For pesticides that may cause unreasonable adverse effects on the environment, including injury to the applicator, EPA may require that the pesticide be applied either by or under the direct supervision of a certified applicator. Reregistration Due to concerns that much of the safety data underlying pesticide registrations becomes outdated and inadequate, in addition to providing that registrations be reviewed every 15 years, FIFRA requires EPA to reregister all pesticides that were registered prior to 1984 (section 4). After reviewing existing data, EPA may approve the reregistration, request additional data to support the registration, cancel, or suspend the pesticide. Sector Notebook Project 118 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Tolerances and Exemptions A tolerance is the maximum amount of pesticide residue that can be on a raw product and still be considered safe. Before EPA can register a pesticide that is used on raw agricultural products, it must grant a tolerance or exemption from a tolerance (40 CFR sections 163.10 through 163.12). Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a raw agricultural productis deemed unsafe if it contains a pesticide residue, unless the residue is within the limits of a tolerance established by EPA or is exempt from the requirement. Cancellation and Suspension EPA can cancel a registration if it is determined that the pesticide or its labeling does not comply with the requirements of FIFRA or causes unreasonable adverse effects on the environment (Haugrud, 1993). In cases where EPA believes that an “imminent hazard” would exist if a pesticide were to continue to be used through the cancellation proceedings, EPA may suspend the pesticide registration through an order and thereby halt the sale, distribution, and usage of the pesticide. An “imminent hazard” is defined as an unreasonable adverse effect on the environment or an unreasonable hazard to the survival of a threatened or endangered species that would be the likely result of allowing continued use of a pesticide during a cancellation process. When EPA believes an emergency exists that does not permit a hearing to be held prior to suspending, EPA can issue an emergency order which makes the suspension immediately effective. Imports and Exports Under FIFRA section 17(a), pesticides not registered in the United States and intended solely for export are not required to be registered provided that the exporter obtains and submits to EPA, prior to export, a statement from the foreign purchaser acknowledging that the purchaser is aware that the product is not registered in the United States and cannot be sold for use there. EPA sends these statements to the government of the importing country. FIFRA sets forth additional requirements thatmustbe metby pesticides intended solely for export. The enforcement policy for exports is codified in sections 40 CFR sections 168.65, 168.75, and 168.85. Under FIFRA section 17(c), imported pesticides and devices must comply with United States pesticide law. Except where exempted by regulation or statute, imported pesticides mustbe registered. FIFRA section 17(c) requires that EPA be notified of the arrival of imported pesticides and devices. This is accomplished through the Notice of Arrival (NOA) (EPA Form 3540-1), which is filled out by the importer prior to importation and submitted to the EPA regional office applicable to the intended port of entry. United States Customs regulations prohibit the importation of pesticides without a completed NOA. The EPA-reviewed and signed form is returned to the importer for Sector Notebook Project 119 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations presentation to United States Customs when the shipment arrives in the United States NOA forms can be obtained from contacts in the EPA Regional Offices or www.epa.gov/oppfead1/international/noalist.htm. Additional information on FIFRA and the regulation of pesticides can be obtained from a variety of sources, including EPA’s Office of Pesticide Programs’ homepage at www.epa.gov/pesticides, EPA’s Office of Compliance, Agriculture and Ecosystem Division at http://es.epa.gov/oeca/agecodiv.htm, or The National Agriculture Compliance Assistance Center toll-free at 888-663-2155 or http://es.epa.gov/oeca/ag. Other sources include the National Pesticide Telecommunications Network toll-free at 800-858-7378 and the National Antimicrobial Information Network toll-free at 800-447-6349. Clean Water Act The primary objective of the Federal Water Pollution Control Act, commonly referred to as the Clean Water Act (CWA), is to restore and maintain the chemical, physical, and biological integrity of the nation's surface waters. Pollutants regulated under the CWA are classified as either “toxic” pollutants; “conventional” pollutants, such as biochemical oxygen demand (BOD), total suspended solids (TSS), fecal coliform, oil and grease, and pH; or “nonconventional” pollutants, including any pollutant not identified as either conventional or priority. The CWA regulates both direct and “indirect” dischargers (those who discharge to publicly owned treatment works). The National Pollutant Discharge Elimination System (NPDES) permitting program (CWA section 402) controls direct discharges into navigable waters. Direct discharges or “point source” discharges are fromsources suchas pipes and sewers. NPDES permits, issued by either EPA or an authorized state (EPA has authorized 43 states and 1 territory to administer the NPDES program), contain industryspecific, technology-based and water quality-based limits and establish pollutant monitoring and reporting requirements. A facility that proposes to discharge into the nation’s waters must obtain a permit prior to initiating a discharge. A permit applicant must provide quantitative analytical data identifying the types of pollutants present in the facility’s effluent. The permit will then set forth the conditions and effluent limitations under which a facility may make a discharge. Water quality-based discharge limits are based on federal or state water quality criteria or standards, that were designed to protect designated uses of surface waters, suchas supporting aquatic life or recreation. These standards, unlike the technology-based standards, generally do not take into account technological feasibility or costs. Water quality criteria and standards vary from state to state, and site to site, depending on the use classification of the receiving body of water. Most states follow EPA guidelines which propose Sector Notebook Project 120 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations aquatic life and human health criteria for many of the 126 priority pollutants. Storm Water Discharges In 1987 the CWA was amended to require EPA to establish a program to address storm water discharges. In response, EPA promulgated NPDES permitting regulations for storm water discharges. These regulations require that facilities with the following types of storm water discharges, among others, apply for an NPDES permit: (1) a discharge associated with industrial activity; (2) a discharge from a large or medium municipal storm sewer system; or (3) a discharge which EPA or the state determines to contribute to a violation of a water quality standard or is a significant contributor of pollutants to waters of the United States. The term“storm water discharge associated with industrial activity” means a storm water discharge from one of 11 categories of industrial activity defined at 40 CFR section 122.26. Six of the categories are defined by SIC codes while the other five are identified through narrative descriptions of the regulated industrial activity. If the primary SIC code of the facility is one of those identified in the regulations, the facility is subject to the storm water permit application requirements. If any activity at a facility is covered by one of the five narrative categories, storm water discharges from those areas where the activities occur are subject to storm water discharge permit application requirements. Those facilities/activities that are subject to storm water discharge permit application requirements are identified below. To determine whether a particular facility falls within one of these categories, the regulationshould be consulted. Category i: Facilities subject to storm water effluent guidelines, new source performance standards, or toxic pollutant effluent standards. Category ii: Facilities classified as SIC 24-lumber and wood products (except wood kitchen cabinets); SIC 26-paper and allied products (except paperboard containers and products); SIC 28-chemicals and allied products (except drugs and paints); SIC 29-petroleum refining; SIC 311-leather tanning and finishing; SIC 32 (except 323)-stone, clay, glass, and concrete; SIC 33primary metals; SIC 3441-fabricated structural metal; and SIC 373-ship and boat building and repairing. Category iii: Facilities classified as SIC 10-metal mining; SIC 12-coal mining; SIC 13-oil and gas extraction; and SIC 14-nonmetallic mineral mining. Category iv: Hazardous waste treatment, storage, or disposal facilities. Category v: Landfills, land application sites, and open dumps that receive or have received industrial wastes. Sector Notebook Project 121 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Category vi: Facilities classified as SIC 5015-used motor vehicle parts; and SIC 5093-automotive scrap and waste material recycling facilities. Category vii: Steam electric power generating facilities. Category viii: Facilities classified as SIC 40-railroad transportation; SIC 41- local passenger transportation; SIC 42-trucking and warehousing (except public warehousing and storage); SIC 43-U.S. Postal Service; SIC 44-water transportation; SIC 45-transportation by air; and SIC 5171-petroleum bulk storage stations and terminals. Category ix: Sewage treatment works. Category x: Construction activities except operations that result in the disturbance of less than five acres of total land area. Category xi: Facilities classified as SIC 20-food and kindred products; SIC 21-tobacco products; SIC 22-textile mill products; SIC 23-apparel related products;SIC 2434-wood kitchencabinets manufacturing; SIC 25-furniture and fixtures;SIC 265-paperboard containers and boxes; SIC 267-converted paper and paperboard products; SIC 27-printing, publishing, and allied industries; SIC 283-drugs; SIC 285-paints, varnishes, lacquer, enamels, and allied products; SIC 30-rubber and plastics; SIC 31-leather and leather products (except leather and tanning and finishing); SIC 323-glass products; SIC 34- fabricated metal products (except fabricated structural metal); SIC 35- industrial and commercial machinery and computer equipment; SIC 36- electronic and other electrical equipment and components; SIC 37- transportation equipment (except ship and boat building and repairing); SIC 38-measuring, analyzing, and controlling instruments; SIC 39-miscellaneous manufacturing industries; and SIC 4221-4225-public warehousing and storage. Pretreatment Program Another type of discharge that is regulated by the CWA is one that goes to a publicly owned treatment works (POTW). The national pretreatment program (CWA section 307(b)) controls the indirect discharge of pollutants to POTWs by “industrial users.” Facilities regulated under section 307(b) must meet certain pretreatment standards. The goal of the pretreatment program is to protect municipal wastewater treatment plants from damage that may occur whenhazardous, toxic, or other wastes are discharged into a sewer systemand to protect the quality of sludge generated by these plants. EPA has developed technology-based standards for industrial users of POTWs. Different standards apply to existing and new sources within each category. “Categorical” pretreatment standards applicable to an industry on a nationwide basis are developed by EPA. In addition, another kind of pretreatment standard, “local limits,” are developed by the POTW in order to Sector Notebook Project 122 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations assist the POTW in achieving the effluent limitations in its NPDES permit. Regardless of whether a state is authorized to implement either the NPDES or the pretreatment program, if it develops its own program, it may enforce requirements more stringent than federal standards. Wetlands Wetlands, commonly called swamps, marshes, fens, bogs, vernal pools, playas, and prairie potholes, are a subset of “waters of the United States,” as defined in section 404 of the CWA. The placement of dredge and fill material into wetlands and other water bodies (i.e., waters of the United States) is regulated bythe United States Army Corps of Engineers (Corps) under 33 CFR Part 328. The Corps regulates wetlands by administering the CWA section 404 permit program for activities thatimpactwetlands. EPA’s authority under section 404 includes veto power of Corps permits, authority to interpret statutory exemptions and jurisdiction, enforcement actions, and delegating the section 404 program to the states. EPA’s Office of Water, at (202) 260-5700, will direct callers with questions about the CWA to the appropriate EPA office. EPA also maintains a bibliographic database of Office of Water publications which can be accessed through the Ground Water and Drinking Water Resource Center at (202) 260-7786. Oil Pollution Prevention Regulation Section 311(b) of the CWA prohibits the discharge of oil, in such quantities as maybe harmful, into the navigable waters of the United States and adjoining shorelines. The EPA Discharge of Oil regulation, 40 CFR Part 110, provides information regarding these discharges. The Oil Pollution Prevention regulation, 40 CFR Part 112, under the authority of section 311(j) of the CWA, requires regulated facilities to prepare and implement Spill Prevention Control and Countermeasure (SPCC) plans. The intent of a SPCC plan is to prevent the discharge of oil from onshore and offshore non-transportation-related facilities. In 1990, Congress passed the Oil Pollution Act which amended section 311(j) of the CWA to require facilities that because of their location could reasonably be expected to cause “substantial harm” to the environment by a discharge of oil to develop and implement Facility Response Plans (FRP). The intent of a FRP is to provide for planned responses to discharges of oil. A facility is SPCC-regulated if the facility, due to its location, could reasonably be expected to discharge oil into or upon the navigable waters of the United States or adjoining shorelines, and the facility meets one of the following criteria regarding oil storage: (1) the capacity of any aboveground storage tank exceeds 660 gallons, or (2) the total aboveground storage capacity exceeds 1,320 gallons, or (3) the underground storage capacity exceeds 42,000 gallons. The 40 CFR section 112.7 contains the format and content Sector Notebook Project 123 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations requirements for a SPCC plan. In New Jersey, SPCC plans can be combined with DPCC plans required by the state provided there is an appropriate cross reference index to the requirements of both regulations at the front of the plan. According to the FRP regulation, a facility can cause “substantial harm” if it meets one of the following criteria: (1) the facility has a total oil storage capacity greater than or equal to 42,000 gallons and transfers oil over water to or from vessels; or (2) the facility has a total oil storage capacity greater than or equal to 1 million gallons and meets any one of the following conditions: (i) does nothave adequate secondary containment, (ii) a discharge could cause “injury” to fish and wildlife and sensitive environments, (iii) shut down a public drinking water intake, or (iv) has had a reportable oil spill greater than or equal to 10,000 gallons in the past 5 years. Appendix F of 40 CFR Part 112 contains the format and content requirements for a FRP. The FRPs that meet EPA’s requirements can be combined with United States Coast Guard FRPs or other contingency plans, provided there is an appropriate cross-reference index to the requirements of all applicable regulations at the front of the plan. For additional information regarding SPCC plans, contact EPA’s RCRA, Superfund, and EPCRA Hotline, at (800) 424-9346. Additional documents and resources can be obtained from the hotline’s homepage at www.epa.gov/epaoswer/hotline. The hotline operates weekdays from 9:00 a.m. to 6:00 p.m., EST, excluding federal holidays. Safe Drinking Water Act The Safe Drinking Water Act (SDWA) mandates that EPA establish regulations to protect human health from contaminants in drinking water. The law authorizes EPA to develop national drinking water standards and to create a joint federal-state system to ensure compliance with these standards. The SDWA also directs EPA to protect underground sources of drinking water through the control of underground injection of fluid wastes. EPA has developed primary and secondarydrinking water standards under its SDWA authority. EPA and authorized states enforce the primary drinking water standards that are contaminant-specific concentration limits that apply to certain public drinking water supplies. Primary drinking water standards consist of maximum contaminant level goals (MCLGs), which are non-enforceable health-based goals, and maximum contaminant levels (MCLs), which are enforceable limits set generally as close to MCLGs as possible, considering cost and feasibility of attainment. The SDWA Underground Injection Control (UIC) program (40 CFR Parts 144-148) is a permit programwhich protects underground sources of drinking water by regulating five classes of injection wells. The UIC permits include design, operating, inspection, and monitoring requirements. Wells used to Sector Notebook Project 124 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations inject hazardous wastes must also comply with RCRA corrective action standards in order to be granted a RCRA permit, and must meet applicable RCRA land disposal restrictions standards. The UIC permit programis often state/tribe-enforced, since EPA has authorized many states/tribes to administer the program. Currently, EPA shares the UIC permit program responsibility in seven states and runs the program in 10 states and on all tribal lands. The SDWA also provides for a federally-implemented Sole Source Aquifer program, which prohibits federal funds from being expended on projects that may contaminate the sole or principal source of drinking water for a given area, and for a state-implemented Wellhead Protection program, designed to protect drinking water wells and drinking water recharge areas. The SDWA Amendments of 1996 require states to develop and implement source water assessment programs (SWAPs) to analyze existing and potential threats to the quality of the public drinking water throughout the state. Every state is required to submit a program to EPA and to complete all assessments within 3 ½ years of EPA approval of the program. SWAPs include: (1) delineating the source water protection area; (2) conducting a contaminant source inventory; (3) determining the susceptibility of the public water supply to contamination from the inventories sources; and (4) releasing the results of the assessments to the public. EPA’s Safe Drinking Water Hotline, at (800) 426-4791, answers questions and distributes guidance pertaining to SDWA standards. The Hotline operates from 9:00 a.m. through 5:30 p.m., EST, excluding federal holidays. Visit the website at http://www.epa.gov/ogwdw for additional material. Resource Conservation and Recovery Act The Solid Waste Disposal Act (SWDA), as amended by the Resource Conservation and Recovery Act (RCRA) of 1976, addresses solid and hazardous waste management activities. The Act is commonly referred to as RCRA. The Hazardous and Solid Waste Amendments (HSWA) of 1984 strengthened RCRA’s waste management provisions and added Subtitle I, which governs underground storage tanks (USTs). Regulations promulgated pursuant to Subtitle C of RCRA (40 CFR Parts 260-299) establish a “cradle-to-grave” system governing hazardous waste from the point of generation to disposal. RCRA hazardous wastes include the specific materials listed in the regulations (discarded commercial chemical products, designated with the code “P” or “U”; hazardous wastes from specific industries/sources, designated with the code “K”; or hazardous wastes from non-specific sources, designated with the code “F”) or materials which exhibit a hazardous waste characteristic (ignitability, corrosivity, reactivity, or toxicity and designated with the code “D”). Sector Notebook Project 125 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Entities that generate hazardous waste are subject to waste accumulation, manifesting, and recordkeeping standards. A hazardous waste facility may accumulate hazardous waste for up to 90 days (or 180 days depending on the amount generated per month) without a permit or interim status. Generators may also treat hazardous waste in accumulation tanks or containers (in accordance with the requirements of 40 CFR section 262.34) without a permit or interim status. Facilities that treat, store, or dispose of hazardous waste are generally required to obtain a RCRA permit. Subtitle C permits for treatment, storage, or disposal facilities contain general facility standards such as contingency plans, emergency procedures, recordkeeping and reporting requirements, financial assurance mechanisms, and unit-specific standards. RCRA also contains provisions (40 CFR Part 264 Subparts I and S) for conducting corrective actions which govern the cleanup of releases of hazardous waste or constituents from solid waste management units at RCRA treatment, storage, or disposal facilities. Although RCRA is a federal statute, many states implement the RCRA program. Currently, EPA has delegated its authority to implement various provisions of RCRA to 47 of the 50 states and two United States territories. Delegation has not been given to Alaska, Hawaii, or Iowa. Most RCRA requirements are not industry specific but apply to any company that generates, transports, treats, stores, or disposes of hazardous waste. Here are some important RCRA regulatory requirements: C Criteria for Classification of SolidWaste DisposalFacilitiesand Practices (40 CFR Part 257) establishes the criteria for determining which solid waste disposal facilities and practices pose a reasonable probability of adverse effects on health or the environment. The criteria were adopted to ensure nonmunicipal, non-hazardous waste disposal units that receive conditionally exempt small quantity generator waste do notpresent risks to human health and environment. C Criteria for Municipal Solid Waste Landfills (40 CFR Part 258) establishes minimum national criteria for all municipal solid waste landfill units, including those that are used to dispose of sewage sludge. • Identificationof Solidand Hazardous Wastes (40 CFR Part 261) establishes the standard to determine whether the material in question is considered a solid waste and, if so, whether it is a hazardous waste or is exempted from regulation. • Standards for Generators of Hazardous Waste (40 CFR Part 262) establishes the responsibilities of hazardous waste generators including obtaining an EPA ID number, preparing a manifest, ensuring proper packaging Sector Notebook Project 126 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations and labeling, meeting standards for waste accumulation units, and recordkeeping and reporting requirements. Generators can accumulate hazardous waste on-site for up to 90 days (or 180 days depending on the amount of waste generated) without obtaining a permit. • Land Disposal Restrictions (LDRs) (40 CFR Part 268) are regulations prohibiting the disposal of hazardous waste on land without prior treatment. Under the LDRs program, materials must meet treatment standards prior to placement in a RCRA land disposal unit (landfill, land treatment unit, waste pile, or surface impoundment). Generators of waste subject to the LDRs must provide notification of such to the designated TSD facility to ensure proper treatment prior to disposal. • Used Oil Management Standards (40 CFR Part 279) impose management requirements affecting the storage, transportation, burning, processing, and re-refining of the used oil. For parties that merely generate used oil, regulations establish storage standards. For a party considered a used oil processor, re-refiner, burner, or marketer (one who generates and sells off-specificationused oil directly to a used oil burner), additional tracking and paperwork requirements must be satisfied. • Tanks and Containers Standards (40 CFR Part 264-265, Subpart CC) contains unit-specific standards for all units used to store, treat, or dispose of hazardous waste. Tanks and containers used to store hazardous waste with a high volatile organic concentration must meet emission standards under RCRA. Regulations require generators to test the waste to determine the concentration of the waste, to satisfy tank and container emissions standards, and to inspect and monitor regulated units. These regulations apply to all facilities who store such waste, including large quantity generators accumulating waste prior to shipment offsite. • Underground Storage Tanks (USTs) containing petroleum and hazardous substances are regulated under Subtitle I of RCRA. Subtitle I regulations (40 CFR Part 280) contain tank design and release detectionrequirements, as well as financial responsibility and corrective action standards for USTs. The UST program also includes upgrade requirements for existing tanks that were to be met by December 22, 1998. • Boilers and Industrial Furnaces (BIFs) that use or burn fuel containing hazardous waste must comply with design and operating standards. BIF regulations (40 CFR Part 266, Subpart H) address unit design, provide performance standards, require emissions monitoring, and, in some cases, restrict the type of waste that may be burned. EPA's RCRA, Superfund, and EPCRA Hotline, at (800) 424-9346, responds to questions and distributes guidance regarding all RCRA regulations. Additional documents and resources can be obtained from the hotline’s Sector Notebook Project 127 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations homepage at http://www.epa.gov/epaoswer/hotline. The RCRA Hotline operates weekdays from 9:00 a.m. to 6:00 p.m., EST, excluding federal holidays. Comprehensive Environmental Response, Compensation, and Liability Act The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), a 1980 law commonly knownas Superfund, authorizes EPA to respond to releases, or threatened releases, of hazardous substances that may endanger public health, welfare, or the environment. The CERCLA also enables EPA to force parties responsible for environmental contamination to clean it up or to reimburse the Superfund for response or remediation costs incurred by EPA. The Superfund Amendments and Reauthorization Act (SARA) of 1986 revised various sections of CERCLA, extended the taxing authority for the Superfund, and created a free-standing law, SARA Title III, also known as the Emergency Planning and Community Right-to-Know Act (EPCRA). The CERCLA hazardous substance release reporting regulations (40 CFR Part 302) direct the person in charge of a facility to report to the National Response Center (NRC) any environmental release of a hazardous substance which equals or exceeds a reportable quantity. Reportable quantities are listed in 40 CFR section 302.4. A release report may trigger a response by EPA or by one or more federal or state emergency response authorities. EPA implements hazardous substance responses according to procedures outlined in the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) (40 CFR Part 300). The NCP includes provisions for cleanups. The National Priorities List (NPL) currently includes approximately 1,300 sites. Both EPA and states can act at other sites; however, EPA provides responsible parties the opportunity to conduct cleanups and encourages community involvement throughout the Superfund response process. EPA's RCRA, Superfund and EPCRA Hotline, at (800) 424-9346, answers questions and references guidance pertaining to the Superfund program. Documents and resources can be obtained from the hotline’s homepage at http://www.epa.gov/epaoswer/hotline. The Superfund Hotline operates weekdays from 9:00 a.m. to 6:00 p.m., EST, excluding federal holidays. Emergency Planning and Community Right-To-Know Act The Superfund Amendments and ReauthorizationAct (SARA) of 1986 created the Emergency Planning and Community Right-to-Know Act (EPCRA, also known as SARA Title III), a statute designed to improve community access to information about chemical hazards and to facilitate the development of chemical emergency response plans by state and local governments. Under EPCRA, states establish State Emergency Response Commissions (SERCs), Sector Notebook Project 128 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations responsible for coordinating certain emergency response activities and for appointing Local Emergency Planning Committees (LEPCs). EPCRA and the EPCRA regulations (40 CFR Parts 350-372) establish four types of reporting obligations for facilities which store or manage specified chemicals: • EPCRA section 302 requires facilities to notify the SERC and LEPC of the presence of any extremely hazardous substance at the facility in an amount in excess of the established threshold planning quantity. The list of extremely hazardous substances and their threshold planning quantities is found at 40 CFR Part 355, Appendices A and B. • EPCRA section 303 requires that each LEPC develop an emergency plan. The plan must contain (but is not limited to) the identification of facilities within the planning district, likely routes for transporting extremely hazardous substances, a description of the methods and procedures to be followed by facility owners and operators, and the designation of community and facility emergency response coordinators. • EPCRA section 304 requires the facility to notify the SERC and the LEPC in the event of a release exceeding the reportable quantity of a CERCLA hazardous substance (defined at 40 CFR Part 302) or an EPCRA extremely hazardous substance. • EPCRA sections 311 and 312 require a facility at which a hazardous chemical, as defined by the Occupational Safety and Health Act, is present in an amount exceeding a specified threshold to submit to the SERC, LEPC and local fire department material safety data sheets (MSDSs) or lists of MSDSs and hazardous chemical inventory forms (also knownas Tier I and II forms). This information helps the local government respond in the event of a spill or release of the chemical. • EPCRA section 313 requires certain covered facilities, including SIC codes 20 through 39 and others, which have ten or more employees, and which manufacture, process, or use specified chemicals in amounts greater than threshold quantities, to submit an annual toxic chemical release report. This report, commonly known as the Form R, covers releases and transfers of toxic chemicals to various facilities and environmental media. EPA maintains the data reported in a publically accessible database known as the Toxics Release Inventory (TRI). All information submitted pursuant to EPCRA regulations is publicly accessible, unless protected by a trade secret claim. EPA's RCRA, Superfund, and EPCRA Hotline, at (800) 535-0202, answers questions and distributes guidance regarding the emergency planning and community right-to-know regulations. Documents and resources can be Sector Notebook Project 129 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations obtained from the hotline’s homepage at http://www.epa.gov/epaoswer/hotline. The EPCRA Hotline operates weekdays from 9:00 a.m. to 6:00 p.m., EST, excluding federal holidays. Clean Air Act The Clean Air Act (CAA) and its amendments are designed to “protect and enhance the nation's air resources so as to promote the public health and welfare and the productive capacity of the population.” The CAA consists of six sections, knownas Titles, which direct EPA to establish national standards for ambient air quality and for EPA and the states to implement, maintain, and enforce these standards through a variety of mechanisms. Under the CAA, many facilities are required to obtain operating permits that consolidate their air emission requirements. State and local governments oversee, manage, and enforce many of the requirements of the CAA. CAA regulations appear at 40 CFR Parts 50-99. Pursuant to Title I of the CAA, EPA has established national ambient air quality standards (NAAQSs) to limit levels of “criteria pollutants,” including carbon monoxide, lead, nitrogen dioxide, particulate matter, ozone, and sulfur dioxide. Geographic areas that meet NAAQSs for a given pollutant are designated as attainment areas; those thatdo not meet NAAQSs are designated as non-attainment areas. Under section 110 and other provisions of the CAA, each state must develop a State Implementation Plan (SIP) to identify sources of air pollution and to determine what reductions are required to meet federal air quality standards. Revised NAAQSs for particulates and ozone were finalized in 1997. However, these revised NAAQSs are currently being challenged before the U.S. Supreme Court. Title I also authorizes EPA to establish New Source Performance Standards (NSPS), which are nationally uniform emission standards for new and modified stationarysources falling within particular industrial categories. The NSPSs are based onthe pollutioncontrol technology available to that category of industrial source (see 40 CFR Part 60). Under Title I, EPA establishes and enforces National Emission Standards for Hazardous Air Pollutants (NESHAPs), nationally uniformstandards oriented toward controlling specific hazardous air pollutants (HAPs). Section 112(c) of the CAA further directs EPA to develop a list of sources that emit any of 188 HAPs and to develop regulations for these categories of sources. To date EPA has listed 185 source categories and developed a schedule for the establishment of emission standards. The emission standards are being developed for both new and existing sources based on “maximum achievable control technology” (MACT). The MACT is defined as the control technology achieving the maximumdegree of reductionin the emissionof the HAPs, taking into account cost and other factors. Sector Notebook Project 130 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Title II of the CAA pertains to mobile sources, such as cars, trucks, buses, and planes. Reformulated gasoline, automobile pollution control devices, and vapor recovery nozzles on gas pumps are a few of the mechanisms EPA uses to regulate mobile air emission sources. Title IV-Aestablishes a sulfur dioxide and nitrogenoxides emissions program designed to reduce the formation of acid rain. Reduction of sulfur dioxide releases will be obtained by granting to certain sources limited emissions allowances that are set below previous levels of sulfur dioxide releases. Title V of the CAA establishes an operating permit program for all “major sources” (and certain other sources) regulated under the CAA. One purpose of the operating permit is to include in a single document all air emissions requirements that apply to a given facility. States have developed the permit programs in accordance with guidance and regulations from EPA. Once a state program is approved by EPA, permits are issued and monitored by that state. Title VI of the CAA is intended to protect stratospheric ozone by phasing out the manufacture of ozone-depleting chemicals and restrict their usage and distribution. Production of Class I substances, including 15 kinds of chlorofluorocarbons (CFCs), were phased out (except for essential uses) in 1996. Methyl bromide, a common pesticide, has been identified as a significant stratospheric ozone depleting chemical. The production and importation of methyl bromide, therefore, is currently being phased out in the United States and internationally. As specified in the Federal Register of June 1, 1999 (Volume 64, Number 104) and in 40 CFR Part 82, methyl bromide productionand importation will be reduced from1991 levels by 25% in 1999, by 50% in 2001, by 70% in 2003, and completely phased out by 2005. Some uses of methyl bromide, such the production, importation, and consumption of methyl bromide to fumigate commodities entering or leaving the United States or any state (or political subdivision thereof) for purposes of compliance with Animal and Plant Health Inspection Service requirements or with any international, federal, state, or local sanitation or food protection standard, will be exempt from this rule. After 2005, exceptions may also be made for critical agricultural uses. The United States EPA and the United Nations Environment Programme have identified alternatives to using methyl bromide in agriculture. Information on the methyl bromide phase-out, including alternatives, can be found at the EPA Methyl Bromide Phase-Out Web Site: (http://www.epa.gov/docs/ozone/mbr/mbrqa.html). EPA's Clean Air Technology Center, at (919) 541-0800 and at the Center’s homepage at http://www.epa.gov/ttn/catc, provides general assistance and information on CAA standards. The Stratospheric Ozone Information Hotline, at (800) 296-1996 and at http://www.epa.gov/ozone, provides general information about regulations promulgated under Title VI of the CAA; EPA's EPCRA Hotline, at (800) 535-0202 and at Sector Notebook Project 131 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations http://www.epa.gov/epaoswer/hotline, answers questions about accidental release prevention under CAA section 112(r); and information on air toxics can be accessed through the Unified Air Toxics website at http://www.epa.gov/ttn/uatw. In addition, the Clean Air Technology Center’s website includes recent CAA rules, EPA guidance documents, and updates of EPA activities. Toxic Substances Control Act The Toxic Substances Control Act (TSCA) granted EPA authority to create a regulatoryframeworkto collect data on chemicals in order to evaluate, assess, mitigate, and control risks which may be posed by their manufacture, processing, and use. TSCA provides a variety of control methods to prevent chemicals fromposing unreasonable risk. It is important to note that pesticides as defined in FIFRA are not included in the definition of a “chemical substance” when manufactured, processed, or distributed in commerce for use as a pesticide. TSCA standards may apply at any point during a chemical’s life cycle. Under TSCA section 5, EPA established an inventory of chemical substances. If a chemical substance is not already on the inventory, and has not been excluded by TSCA, a premanufacture notice (PMN) must be submitted to EPA prior to manufacture or import. The PMN must identify the chemical and provide available information on health and environmental effects. If available data are not sufficient to evaluate the chemical’s effects, EPA can impose restrictions pending the development of information on its health and environmental effects. EPA can also restrict significant new uses of chemicals based upon factors such as the projected volume and use of the chemical. Under TSCA section 6, EPA can ban the manufacture or distribution in commerce, limit the use, require labeling, or place other restrictions on chemicals that pose unreasonable risks. Among the chemicals EPA regulates under section 6 authority are asbestos, chlorofluorocarbons (CFCs), lead, and polychlorinated biphenyls (PCBs). Under TSCA section 8(e), EPA requires the producers and importers (and others) of chemicals to report information on a chemical’s production, use, exposure, and risks. Companies producing and importing chemicals can be required to report unpublished health and safety studies on listed chemicals and to collect and record any allegations of adverse reactions or any information indicating that a substance may pose a substantial risk to humans or the environment. EPA’s TSCA Assistance Information Service, at 202 554-1404, answers questions and distributes guidance pertaining to Toxic Substances Control Act standards. The Service operates from 8:30 a.m. through 4:30 p.m., EST, excluding federal holidays. Sector Notebook Project 132 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Coastal Zone Management Act The Coastal Zone Management Act (CZMA) encourages states/tribes to preserve, protect, develop, and where possible, restore or enhance valuable natural coastal resources such as wetlands, floodplains, estuaries, beaches, dunes, barrier islands, and coral reefs, as well as the fish and wildlife using those habitats. It includes areas bordering the Atlantic, Pacific, and Arctic Oceans, Gulfof Mexico, Long Island Sound, and Great Lakes. A unique feature of this law is that participation by states/tribes is voluntary. In the Coastal Zone Management Act Reauthorization Amendments (CZARA) of 1990, Congress identified nonpoint source pollution as a major factor in the continuing degradation of coastal waters. Congress also recognized that effective solutions to nonpoint source pollution could be implemented at the state/tribe and local levels. In CZARA, Congress added section 6217 (16 U.S.C. section 1455b), which calls upon states/tribes with federally-approved coastal zone management programs to develop and implement coastal nonpoint pollution control programs. The section 6217 programis administered at the federal level jointly by EPA and the National Oceanic and Atmospheric Agency (NOAA). Section 6217(g) called for EPA, in consultation with other agencies, to develop guidance on “management measures” for sources of nonpoint source pollution in coastal waters. Under section 6217, EPA is responsible for developing technical guidance to assist states/tribes in designing coastal nonpoint pollution control programs. On January 19, 1993, EPA issued its Guidance Specifying Management Measures For Sources of Nonpoint Pollution in Coastal Waters, which addresses five major source categories of nonpoint pollution: (1) urban runoff, (2) agriculture runoff, (3) forestry runoff, (4) marinas and recreational boating, and (5) hydromodification. Additional information on coastal zone management may be obtained from EPA’s Office of Wetlands, Oceans, and Watersheds at http://www.epa.gov/owow or from the Watershed Information Network at http://www.epa.gov/win. The NOAA website at http://www.nos.noaa.gov/ocrm/czm/ also contains additional information on coastal zone management. Sector Notebook Project 133 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations VI.B. Industry Specific Requirements The agricultural chemical industry is affected by several major federal environmental statutes. In addition, the industry is subject to numerous laws and regulations from state and local governments designed to protect health, safety, and the environment. A summary of the major federal regulations affecting the agricultural chemical industry follows. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Every regulation promulgated under FIFRA affects the agricultural chemical industry in some way. The FIFRA regulations are found in 40 CFR Parts 152 through 186. Each part and its title are listed below. Part 152 Part 153 Part 154 Part 155 Part 156 Part 157 Part 158 Part 160 Part 162 Part 163 Part 164 - Part 166 Part 167 Part 168 Part 169 Part 170 Part 171 Part 172 Part 173 Part 177 Sector Notebook Project Pesticide Registration and Classification Procedures Registration Policies and Interpretations Special Review Procedures Registration Standards Labeling Requirements for Pesticides and Devices Packaging Requirements for Pesticides and Devices Data Requirements for Registration Good Laboratory Practice Standards State Registration of Pesticide Products Certification of Usefulness of Pesticide Chemicals Rules of Practice Governing Hearings, Under FIFRA, Arising from Refusals to Register, Cancellations of Registrations, Changes of Classifications, Suspensions of Registrations and Other Hearings Called Pursuant to section 6 of the Act Exemption of Federal and State Agencies for Use of Pesticides Under Emergency Conditions Registration of Pesticide and Active Ingredient Producing Establishments, Submission of Pesticide Reports Statements of Enforcement Policies and Interpretations Books and Records of Pesticide Production and Distribution Worker Protection Standards Certification of Pesticide Applicators Experimental Use Permits Procedures Governing the Rescission of State Primary Enforcement Responsibility for Pesticide Use Violations Issuance of Food Additive Regulations 134 September 2000 Agricultural Chemical Industry Part 178 Part 179 Part 180 Part 185 Part 186 - Federal Statutes and Regulations Objections and Requests for Hearings Formal Evidentiary Public Hearing Tolerances and Exemptions from Tolerances for Pesticide Chemicals in or on Raw Agricultural Commodities Tolerances for Pesticides in Food Pesticides in Animal Feed Please refer to the general discussion of FIFRA in Section VI.A for additional requirements not discussed below. Product Registration Data Requirements EPA requires the citation or submission of extensive environmental, health, and/or safety data during the registration application process. The categories of data required include the product’s chemistry; environmental fate; residue chemistry, hazards to humans, domestic animals, and nontarget organisms; spray drift characteristics; reentry protection requirements; and performance (40 CFR Part 158). Under the “product chemistry” category, applicants must supply technical information describing the product’s active and inert ingredients, manufacturing or formulating processes and physical and chemical characteristics. Data from “environmental fate” studies are used to assess the effects of pesticide residues on the environment, including its toxicity to people through consumption or exposure to applied areas and its effect on nontarget organisms and their habitat. Residue chemistry information includes the expected frequency, amounts, and time of application, and test results of residue remaining on treated food or feed. Information under “hazards to humans, domestic animals, and non-target organisms” includes specific test data assessing acute, subchronic, and chronic toxicity. All studies required to be submitted must satisfy Good Laboratory Practice (GLP) regulations (40 CFR Part 160). Guidelines for studies of product chemistry, residue chemistry, environmental chemistry, hazard evaluation and occupational and residential exposure can be found in 40 CFR Part 158. Registration of Establishments Any person producing a pesticide or device, except a custom blender,4 is subject to section 7 and 40 CFR. Part 167; and is required to register his establishment with EPA prior to beginning production. Foreign establishments also must register with EPA if they produce a pesticidal product for import to 4 A custom blender means any establishment which provides the service of mixing pesticides to a customer’s specifications, usually a pesticide(s)-fertilizer(s), pesticide-pesticide, or a pesticide animal feed mixture, when: (1) The blend is prepared to the order of the customer and is not held in inventory by the blender; (2) the blend is to be used on the customer’s property (including leased or rented property); (3) the pesticide(s) used in the blend bears end-use labeling directions which do not prohibit use of the product in such a blend; (4) the blend is prepared from registered pesticides; (b) the blend is delivered to the end-user along with a copy of the end-use labeling of each pesticide used in the blend and a statement specifying the composition of mixture; and (6) no other pesticide production activity is performed at the establishment. Sector Notebook Project 135 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations the United States. Establishments must be registered with EPA if they intend that a substance produced will be used as an active ingredient of a pesticide or if they have actual or constructive notice that the substance will be used as an active ingredient. If a pesticide is produced for export, whether registered or unregistered, or is produced under an experimental use permit, the producing establishment must be registered. In order to register an establishment with EPA, contact the EPA Regional office where the establishment is located, or for a foreign establishment, the Washington, DC EPA office. The following information must be submitted on EPA Form 3540-1 when registering an establishment: (1) the name and address of the company; (2) the type of ownership; and (3) the name and address of each producing establishment for which registration is sought. Any changes to the information provided must be submitted to EPA within thirty days after such changes occur. Upon receiving a complete application, EPA will assign a registration number for each listed establishment. This number must appear on the label. Establishment Reporting Requirements Under section 7(c)and 40 CFR. section 167.85, each registered pesticide producing establishment must submit an annual production report to EPA by March1 of each year. Domestic establishments submit their report to the EPA regional office where the company headquarters is located. Foreign establishment production reports are submitted to the Washington, DC EPA office. Custom blenders are exempt from this requirement. The report must cover any pesticide, active ingredient, or device produced. The report, to be submitted on specific EPA forms, includes the following information: (1) the name and address of the establishment; (2) the amount of each pesticide produced, repackaged, or relabeled in the past year; (3) the amount of each pesticide sold, distributed, or exported in the past year; and (4) the amount of the pesticide estimated to be produced, repackaged, or relabeled in the current year. Foreign establishments only are required to submit a report on pesticides imported into the United States. Maintenance of Records All producers of pesticides, devices, or active ingredients used in producing any pesticide must maintain records concerning the production and shipment of each pesticide under 40 CFR Part 169. These records are independent of other required records, including in-plant maintenance, extermination, or sanitation programs. Each establishment must maintain these records for two years. In addition, records on disposal methods must be maintained for 20 years, as well as authorized human trials. Records containing research data must be maintained as long as the registration is valid and the producer is in business. All required records must be available if requested by an inspector. Sector Notebook Project 136 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Prior Informed Consent As part of its participation in a voluntary international program known as the Prior Informed Consent procedure, EPA prepares the following lists of pesticides that are suspended, canceled or severely restricted. These lists were last updated by EPA in August of 1997. A “Suspended or Canceled” pesticide is defined as a pesticide for which all registered uses have been prohibited by final government action, or for which all requests for registration or equivalent action for all uses have, for health or environmental reasons, not been granted. C Suspended or Canceled 1. aldrin 2. benzene hexachloride [BHC] (voluntary cancellation) 3. 2,3,4,5-Bis(2-butylene)tetrahydro-2-furaldehyde [Repellent-11] 4. bromoxynil butyrate (voluntary cancellation) 5. cadmium compounds (voluntary cancellation) 6. calcium arsenate (voluntary cancellation) 7. captafol (voluntary cancellation) 8. carbon tetrachloride 9. chloranil (voluntary cancellation) 10. chlordane 11. chlordimeform (voluntary cancellation) 12. chlorinated camphene [Toxaphene] (voluntary cancellation) 13. chlorobenzilate (voluntary cancellation) 14. chloromethoxypropylmercuric acetate [CPMA] 15. copper arsenate (voluntary cancellation) 16. cyhexatin (voluntary cancellation) 17. DBCP 18. decachlorooctahydro-1,3,4-metheno-2H-cyclobuta(cd) pentalen-2 one[chlordecone] 19. DDT 20. dieldrin 21. dinoseb and salts 22. Di(phenylmercury)dodecenylsuccinate [PMDS] (voluntary cancellation) 23. EDB 24. endrin (voluntary cancellation) 25. EPN (voluntary cancellation) 26. ethyl hexyleneglycol [6-12] (voluntary cancellation) 27. hexachlorobenzene [HCB] (voluntary cancellation) 28. lead arsenate (voluntary cancellation) 29. leptophos (Never received initial registration) 30. mercurous chloride 31. mercuric chloride Sector Notebook Project 137 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations 32. mevinphos 33. mirex (voluntary cancellation) 34. monocrotophos (voluntary cancellation) 35. nitrofen (TOK) (voluntary cancellation) 36. OMPA (octamethylpyrophosphoramide) 37. phenylmercury acetate [PMA] 38. phenylmercuric oleate [PMO] (voluntary cancellation) 39. potassium 2,4,5-trichlorophenate [2,4,5-TCP] 40. pyriminil [Vacor] (voluntary cancellation) 41. safrole (voluntary cancellation) 42. silvex 43. sodium arsenite 44. TDE (voluntary cancellation) 45. Terpene polychlorinates [Strobane] (voluntary cancellation) 46. thallium sulfate 47. 2,4,5-Trichlorophenoxyacetic acid [2,4,5-T] 48. vinyl chloride A “Severely Restricted” pesticide means a pesticide for which virtually all registered uses have been prohibited by final government regulatory action, but for which certain specific registered use or uses remain authorized. C Severely Restricted 1. arsenic trioxide 2. azinphos methyl 3. carbofuran (voluntary cancellation) 4. daminozide (voluntary cancellation) 5. heptachlor 6. methyl parathion 7. sodium arsenate 8. tributyltin compounds Federal Food, Drug, and Cosmetics Act Under the Federal Food, Drug, and Cosmetics Act (FFDCA), EPA sets tolerances for pesticide residues in food. This authority originally belonged to the Food and Drug Administration (FDA), but was transferred when EPA was formed in 1970. FDA still has responsibility for enforcing compliance with the tolerances. An agricultural product is deemed unsafe under the FFDCA if it contains pesticide residues above the tolerance level established by EPA or if there is no tolerance, unless it is exempt from the requirement for tolerances. The FFDCA also contains the Delaney Clause that bars the establishment of food additive regulations covering substances that induce cancer in humans or animals. Prior to the Food Quality Protection Act of 1996, this provision Sector Notebook Project 138 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations applied to certain pesticide residues in processed food. With the 1996 amendments, pesticide residues are now governed bya single safety clause set forth in section 408. Toxic Substances Control Act (TSCA) TSCA gives EPA comprehensive authority to regulate any chemical substance whose manufacture, processing, distribution in commerce, use, or disposal may present an unreasonable risk of injury to health or the environment. EPA keeps an inventory of existing chemicals regulated under TSCA (TSCA section 8(b)). Certain chemicals are specifically excluded from the TSCA inventory, such as pesticides, as defined when manufactured, processed, or distributed in commerce for use as a pesticide under FIFRA (40 CFR section 710.2(h)(2)). However, if a chemical has multiple uses, those uses not subject to FIFRA are regulated by TSCA. In addition, certain mixtures of chemicals are exempt from TSCA (40 CFR section 710.2(h)(1)) (Landfair, 1993). Four sections are of primary importance to the remainder of the agricultural chemical industry. Section5 mandates thatchemical companies submit to EPA pre-manufacture notices thatprovide information on health and environmental effects for each new product and test existing products for these effects (40 CFR Part 720). Over 20,000 premanufacture notices have been filed. Section 4 authorizes EPA to require testing of certain substances (40 CFR Part 790). Section 6 gives EPA the authority to prohibit, limit, or ban the manufacture, process, and usage of chemicals (40 CFR Part 750). Among the chemicals EPA regulates under section 6 are asbestos, chlorofluorocarbons (CFCs), and polychlorinated biphenyls (PCBs). For certain chemicals, TSCA section 8 also imposes record-keeping and reporting requirements including substantial risk notification; record-keeping for data relative to adverse reactions; and periodic updates to the TSCA Inventory. Resource Conservation and Recovery Act (RCRA) The Resource Conservation and Recovery Act (RCRA) was enacted in 1976 to address problems related to hazardous and solid waste management. RCRA gives EPA the authority to establish a list of solid and hazardous wastes and to establish standards and regulations for the treatment, storage, and disposal of these wastes. Regulations in Subtitle C of RCRA address the identification, generation, transportation, treatment, storage, and disposal of hazardous wastes. These regulations are found in 40 CFR Part 124 and CFR Parts 260279. Under RCRA, persons who generate waste must determine whether the waste is defined as solid waste or hazardous waste. Solid wastes are considered hazardous wastes if they are listed by EPA as hazardous or if they exhibitcharacteristics of a hazardous waste: toxicity, ignitability, corrosivity, or reactivity. Sector Notebook Project 139 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Products, intermediates, and off-specification products potentially generated at agricultural chemical facilities that are considered hazardous wastes are listed in 40 CFR Part 261. Some of the handling and treatment requirements for RCRA hazardous waste generators are covered under 40 CFR Part 262 and include the following: determining what constitutes a RCRA hazardous waste (Subpart A); manifesting (Subpart B); packaging, labeling, and accumulation time limits (Subpart C); and record keeping and reporting (Subpart D). Many agricultural chemical facilities store some hazardous wastes at the facility beyond the accumulation time limits available to generators (e.g., 90 or 180 days). Such facilities are required to have a RCRA treatment, storage, and disposal facility (TSDF) permit(40 CFR Part 262.34). Some agricultural chemical facilities are considered TSDF facilities and are subject to a number of regulations, including but not limited to those covered under 40 CFR Part 264: contingency plans and emergency procedures (40 CFR Part 264 Subpart D); manifesting, record keeping, and reporting (40 CFR Part 264 Subpart E); use and management of containers (40 CFR Part 264 Subpart I); tank systems (40 CFR Part 264 Subpart J); surface impoundments (40 CFR Part 264 Subpart K); land treatment (40 CFR Part 264 Subpart M); corrective action of hazardous waste releases (40 CFR Part 264 Subpart S); air emissions standards for process vents of processes that process or generate hazardous wastes (40 CFR Part 264 Subpart AA); emissions standards for leaks in hazardous waste handling equipment (40 CFR Part 264 Subpart BB); and emissions standards for containers, tanks, and surface impoundments that contain hazardous wastes (40 CFR Part 264 Subpart CC). Many agricultural chemical facilities are also subject to the underground storage tank (UST) program (40 CFR Part 280). The UST regulations apply to facilities that store either petroleum products or hazardous substances (except hazardous waste) identified under the Comprehensive Environmental Response, Compensation, and Liability Act. UST regulations address design standards, leak detection, operating practices, response to releases, financial responsibility for releases, and closure standards. A number of RCRA wastes have been prohibited from land disposal unless treated to meet specific standards under the RCRA Land Disposal Restriction (LDR) program. The wastes covered by the RCRA LDRs are listed in 40 CFR Part 268 Subpart C and include a number of wastes that could potentially be generated at agricultural chemical facilities. Standards for the treatment and storage of restricted wastes are described in Subparts D and E, respectively. The LDRs also apply to the use of fertilizers containing hazardous wastes. Therefore, fertilizers containing hazardous wastes that do not meet the applicable land disposal treatment standards cannot be spread on the land, with some exceptions. Specific exemptions to the use of certain recycled materials and hazardous wastes in fertilizers have been provided in 40 CFR Part 266, Subpart C - Recycled Materials Used in a Manner Constituting Sector Notebook Project 140 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Disposal. Subpart C states that products containing recyclable materials are not subject to regulation under RCRA if the recyclables are physically inseparable from the product or if they meet the standards of 40 CFR Part 268, Subpart D “for each recyclable material (i.e., hazardous waste) that they contain.” These standards include limits on heavy metals. Subpart C also states that zinc-containing fertilizers using hazardous waste K061 (emission control dust/sludge from the primary production of steel in electric furnaces) which is listed as hazardous due to its hexavalent chromium, lead, and cadmium content, are not subject to the land disposal requirements. Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) and the Superfund Amendments and Reauthorization Act of 1986 (SARA) provide the basic legal framework for the federal “Superfund” program to clean up abandoned hazardous waste sites (40 CFR Part 300 et seq.). The 1986 SARA legislation extended CERCLA taxes for five years and adopted a new broad-based corporate environmental tax, applicable to the allied chemicals (SIC 28) industry, which includes the agricultural chemical industry. In 1990, Congress passed a simple reauthorization that did not substantially change the law but extended the program authority until 1994 and the taxing authority until the end of 1995. A comprehensive reauthorizationwas considered in 1994, but not passed. Since the expiration of the taxing authority on December 31, 1995, taxes for Superfund have been temporarilysuspended. The taxes can only be reinstated by reauthorization of Superfund or an omnibus reconciliation act which could specifically reauthorize taxing authority. The allied chemical industry paid about $300 million a year in Superfund chemical feedstock taxes. Joint and several liability generally requires Potentially Responsible Parties (PRPs) to perform or pay for their fair share of cleanup costs. Title III of the 1986 SARA amendments (also knownas Emergency Response and Community Right-to-Know Act, EPCRA) requires all manufacturing facilities, including agricultural chemical facilities, to report annual information about stored toxic substances, as well as release of these substances into the environment, to local and state governments and to the public. This is known as the Toxic Release Inventory (TRI). EPCRA also establishes requirements for federal, state, and local governments regarding emergencyplanning. In 1994, over 300 more chemicals were added to the list of chemicals for which reporting is required. Clean Air Act (CAA) The original CAA authorized EPA to set limits on agricultural chemical facility emissions. The new source performance standards (NSPS) for fertilizer manufacturers can be found in 40 CFR Part 60: Sector Notebook Project 141 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Subpart G - Standards of Performance for Nitric Acid Plants (40 CFR section 60.70 - 60.74) Subpart T - Standards of Performance for the Phosphate Fertilizer Industry: Wet Process Phosphoric Acid Plants (40 CFR section 60.200 - 60.204) Subpart U - Standards of Performance for the Phosphate Fertilizer Industry: Superphosphoric Acid Plants (40 CFR section 60.210 - 60.214) Subpart V - Standards of Performance for the Phosphate Fertilizer Industry: Diammonium Phosphate Plants (40 CFR section 60.220 - 60.224) Subpart W - Standards of Performance for the Phosphate Fertilizer Industry: Triple Superphosphate Plants (40 CFR section 60.230 - 60.234) Subpart X - Standards of Performance for the Phosphate Fertilizer Industry: Granular Triple Superphosphate Storage Facilities (40 CFR section 60.240 - 60.244) These standards primarily consist of emission and monitoring standards for nitrogen oxides (Nitric Acid Plants) and fluorides (Phosphatic Fertilizer Industry) . The Clean Air Act Amendments of 1990 set National Emission Standards for Hazardous Air Pollutants (NESHAP) fromindustrial sources for 41 hazardous air pollutants to be met by 1995 and for 148 other hazardous air pollutants to be reached by 2003. National emission standards for new and existing major sources in phosphoric acid manufacturing, phosphate fertilizers production and pesticide active ingredient production are listed in 40 CFR Parts 9 and 63. 40 CFR Parts 61 and 63 contains several provisions dealing with emissions sources potentially found at an agricultural chemical facility (e.g. equipment leaks, tanks, surface impoundments, separators, and waste treatment operations) may affect the agricultural chemical industry. A number of the chemicals used and produced at agricultural chemical manufacturing and formulating facilities are hazardous air pollutants under CAA. Under section 112(r) of CAA, owners and operators of stationarysources who produce, process, handle, or store substances listed under CAA section 112(r)(3) or any other extremely hazardous substance have a “general duty” to initiate specific activities to prevent and mitigate accidental releases. Since the general duty requirements apply to stationary sources regardless of the quantity of substances managed at the facility, many agricultural chemical manufacturing and formulating facilities are subject. Activities such as identifying hazards which may result from accidental releases using Sector Notebook Project 142 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations appropriate hazard assessment techniques; designing, maintaining and operating a safe facility; and minimizing the consequences of accidental releases if they occur are considered essential activities to satisfy the general duty requirements. These statutory requirements have been in affect since the passage of the Clean Air Act in 1990. Although there is no list of “extremely hazardous substances,” EPA’s Chemical Emergency Preparedness and Prevention Office provides some guidance at its website: http://www.epa.gov/swercepp.html. Also under section 112(r), EPA was required to develop a list of at least 100 substances that, in the event of an accidental release, could cause death, injury, or serious adverse effects to human health or the environment. The list promulgated by EPA is contained in 40 CFR section 68.130 and includes acutely toxic chemicals, flammable gases and volatile flammable liquids. Under section 112(r)(7), facilities handling more than a threshold quantity (ranging from 500 to 20,000 pounds) of these substances are subject to chemical accident prevention provisions including the development and implementation of a risk management program (40 CFR sections 68.15068.220). The requirements in 40 CFR Part 68 begin to go into effect in June 1999. Many of the chemicals on the 112(r) list are commonly handled by agricultural chemical manufacturers and formulators in quantities greater than the threshold values. Ammonia held by farmers for use as an agricultural nutrient is exempt from the chemical accident prevention provisions. Standards in 40 CFR Part 61 Subpart R - National Emission Standards for Radon Emissions from Phosphogypsum Stacks (40 CFR sections 61.200 61.210) deal specifically with the phosphatic fertilizer industry. The standards require monitoring and reporting of radon-222 emissions from the stacks and sets limits on the amounts of radon-222 that can be emitted into the air. EPA has also set standards for the maximum concentration of radium-226 allowed in phosphogypsum removed from stacks for use in agriculture. Clean Water Act (CWA) The Clean Water Act, first passed in 1972 and amended in 1977 and 1987, gives EPA the authority to regulate effluents from sewage treatment works, chemical plants, and other industrial sources into waters. The act sets standards for treatment of wastes for both direct and indirect (to a Publicly Owned Treatment Works (POTW)) discharges. EPA has set effluent guidelines for both the fertilizer manufacturing and formulating, and pesticide formulating, packaging and repackaging point source categories. The implementation of the guidelines is left primarily to the states who issue National Pollutant Discharge Elimination System (NPDES) permits for each facility (EPA has authorized 43 states to operate the NPDES program). Effluent guidelines specific to the fertilizer manufacturing and formulating point source category are contained in 40 CFR Part 418 and are divided into Sector Notebook Project 143 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations product specific effluent guidelines as follows: Subpart A - Phosphates (40 CFR section 418.10 - 418.17) Subpart B - Ammonia (40 CFR section 418.20 - 418.27) Subpart C - Urea (40 CFR section 418.30 - 418.36) Subpart D - Ammonium Nitrate (40 CFR section 418.40 - 418.46) Subpart E - Nitric Acid (40 CFR section 418.50 - 418.56) Subpart F - Ammonium Sulfate (40 CFR section 418.60 - 418.67) Subpart G - Mixed and Blend Fertilizer Production (40 CFR section 418.70 - 418.77) In 1997, revised effluent guidelines were finalized for the Pesticide Formulating, Packaging and Repackaging Subcategory. These regulations replace the effluent guidelines established in 1978 for the Pesticide Formulating and Packaging Subcategory. The revised guidelines are contained in 40 CFR Part 455 and are divided into the following subcategories: Subpart C - Pesticide Chemicals Formulating and Packaging Subcategory Subpart E - Repackaging of Agricultural Pesticides Performed at Refilling Establishments Each Subpart consists of effluent standards representing the amount of effluent reductionpossible by using either best practicable control technologies (BPT), best conventional pollutiontechnologies (BCT), or best available technologies (BAT). The states and EPA give effect to these standards through NPDES permits that they issue to direct dischargers. BCT standards limit the discharge of conventional pollutants, while BPT and BAT standards represent successive levels of control of priority pollutants and non-conventional pollutants. For Subcategory C, EPA established effluent limitations and pretreatment standards which allow each facility a choice of meeting a zero discharge limitation or to comply with a pollution prevention alternative that authorizes the discharge of some pesticide active ingredients (AIs) and priority pollutants after various pollution prevention practices are followed and treatment is conducted as needed. For Subcategory E, EPA has established a zero discharge limitation and pretreatment standard. The Storm Water Rule (40 CFR section 122.26) requires fertilizer manufacturing and formulating and pesticide formulating facilities discharging storm water associated with industrial activities (40 CFR section 122.26 (b)(14)(ii)) to apply for NPDES permits for those discharges. Sector Notebook Project 144 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations Under 40 CFR 503 Subpart B - Land Application, EPA regulates the land application of sewerage treatment sludge, which includes fertilizers derived from sewerage treatment sludge. Subpart B regulations include specific limitations on heavy metal content, as well as general operational and management standards. VI.C. State Regulation of Pesticides All states have their own pesticide laws and many states have their own pesticide registration requirements. States have primary use enforcement authority if EPA has determined that the state has adequate pesticide use laws and has adopted adequate procedures to enforce those laws. The EPA may enter into a cooperative agreement with a state to carry out enforcement of state laws and train and certify applicators. The FIFRA allows states to administer their own EPA-approved applicator certifications program. Also, each state is allowed to regulate the sale and use of pesticides as long as the regulations are at least as stringent as EPA’s and the regulations do not conflict or differ from EPA’s labeling and packaging restrictions. States typicallyrequire that fertilizer products be registered with the state and that claims made on fertilizer labels can be substantiated. States also regulate the efficacy of fertilizers through labeling requirements. State fertilizer labeling requirements typically require that the label indicate the product name, the brand and grade, the percentage of each nutrient (nitrogen, available phosphate, potassium, etc.), and the name and address of the registrant. Some states also require thatthe label indicate materials fromwhich the nutrients are derived. Additional information on specific state requirements can be obtained from the Association of American Pesticide Control Officials, Inc. (AAPCO) at: http://aapco.ceris.purdue.edu/index.html. This website contains a list of state pesticide control officials that includes contact information. Sector Notebook Project 145 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations VI.D. Pending and Proposed Regulatory Requirements FIFRA Registration • In order to reduce the potential for groundwater contamination from certain pesticides, EPA proposed the Ground Water Pesticide Management Plan Rule in June of 1996 (61 FR 33259). EPA is proposing to restrict the use of certain pesticides by providing states and tribes with the flexibility to protect the ground water in the most appropriate way for local conditions, through the development and use of Pesticide Management Plans (PMPs). When finalized, the regulations will likely give states and tribes the authority to develop management plans that specify risk reduction measures for the following four pesticides: atrazine, alachlor, simazine, and metolachlor. Without EPA-approved plans, use of these chemicals would be prohibited. A final rule is expected to be published in late 2000. (Contact: Arty Williams, United States EPA Office of Prevention, Pesticides and Toxic Substances, 703-305-5239) • In response to the Food Quality Protection Act of 1996, EPA is planning to propose revisions to antimicrobial registration and classification procedures (40 CFR Part 152) that will reduce to the extent possible the review time for antimicrobial pesticides. Revisions to labeling requirements (40 CFR Part 156) and data requirements for antimicrobial registration (40 CFR Part 158) are also being proposed. The revisions are expected to be released in early 2001. This regulation would also implement some general provisions of FIFRA that pertain to all pesticides, including labeling requirements and notification procedures. (Contact: Jean Frane, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-305-5944 and Paul Parsons, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-308-9073) • In order to evaluate the registrability of pesticide products, EPA is expected to propose revisions to the data requirements for FIFRA registration (40 CFR Part 158). These revisions would clarify all data requirements to reflect current practice and are expected to be published in 2001. (Contact: Jean Frane, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-305-5944) Use Restrictions • In May of 1991, EPA proposed amendments to the existing Restricted Use Classification (RUC) regulations (40 CFR Part 152, Subpart I) to add criteria pertaining to the groundwater contamination potential of pesticides (56 FR 22076). The criteria would be used to determine Sector Notebook Project 146 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations which pesticides should be considered for restricted use classifications to protect groundwater. A policy statement is expected to be issued in late 2000. (Contact: Joseph Hogue, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-3089072) Tolerances and Exemptions • EPA expects to reassess pesticide tolerances and exemptions for raw and processed foods established prior to August3, 1996 (40 CFR Part 180, 40 CFR Part 185, 40 CFR Part 186), to determine whether they meet the standard of the Federal Food, Drug and Cosmetic Act (FFDCA). FFDCA section 408 (q), as amended by the Food Quality Protection Act, requires that EPA conduct this reassessment on a phased 10-year schedule. For the current phased schedule, EPA is required to complete reassessments as follows: 33% by August 3, 1999, 66% by August 3, 2002, and 100% by August 3, 2006. Based on its reassessment, EPA will likely propose a series of regulatory actions to modify or revoke tolerances. (Contacts: Robert McNally, United States EPA, Office of Prevention, Pesticides and Toxic Substances, 703-308-8085 and Joseph Nevola, United States EPA Office of PreventionPesticides and Toxic Substances, 703-308-8037) • Regulations specifying policies and procedures under which the EPA can establish food tolerances associated with the use of pesticides under emergency exemptions (40 CFR Part 176) are expected to be finalized in late 2000. The EPA issues emergency exemptions for temporary use of pesticides where emergency conditions exist. Under FFDCA, as amended by the Food Quality Protection Act, EPA must establish time-limited tolerances for suchpesticides if the use is likely to result in residues in food. (Contact: Joseph Hogue, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-3089072) • EPA proposed a rule to adjust and update the fee structure and fee amounts for tolerance actions, which are required under FFDCA (40 CFR section 180.33). The rule is expected to finalized in late 2000. (Contact: Carol Peterson, United States EPA, Office of Prevention, Pesticides, and Toxic Substances, 703-305-6598) • Revisions to regulations onemergencyexemptions under section 18 of FIFRA, are expected to be issued in late 2001 (40 CFR Part 166). EPA is considering revisions in four areas: 1) Options for increased authority for states to administer certain aspects of the exemption process, and/or increased use by the EPA of multi-year exemptions;2) the use of emergencyexemptions to address pesticide resistance; 3) the Sector Notebook Project 147 September 2000 Agricultural Chemical Industry Federal Statutes and Regulations possibility of granting exemptions based upon reduced risk considerations; and 4) definitions of emergency situation and significant economic loss, which would affect whether or not an exemption may be granted. (Contact: Joseph Hogue, United States EPA Office of Prevention, Pesticides, and Toxic Substances, 703-3089072) Pesticide Storage and Disposal • In 1994, EPA proposed a rule, authorized under section 19 of FIFRA, to establish standards for pesticide containers and secondary containment relating to the distribution and sale of pesticides (59 FR 6712). Standards are expected to be developed for the removal of pesticides from containers, rinsing containers, container design, container labeling, container refilling, the containment of stationary bulk containers and for the containment of pesticide dispensing areas (40 CFR Part 165, 40 CFR Part 156). A final rule is expected to be published in late 2000. (Contact: Nancy Fitz, United States EPA, Office of Prevention, Pesticides and Toxic Substances, 703-305-7385) Exports • The RotterdamAgreement, signed in 1998, requires that certain banned or severely restricted hazardous chemicals are subject to intensive information exchange procedures, and if an importing country decides against import, exporting countries are obligated to prohibit export to that country. Twenty-four pesticides are currently covered by the treaty. As a result of the United States signing of this treaty, EPA has drafted legislation that allows it in the future to propose revisions to its pesticide export policy. (Contact: Cathleen Barnes, United States EPA Office of Prevention, Pesticides and Toxic Substances, 703-3057101) Worker Protection • EPA has proposed a change to the Worker Protection Standards (WPS) of FIFRA (40 CFR Part 170). Specifically, the glove requirements may be modified to allow glove liners to be worn inside chemically resistant gloves. The proposed rule will be finalized in 2001. (Contact: Kevin Keaney, United States EPA Office of Prevention, Pesticides and Toxic Substances, 703-305-5557) Sector Notebook Project 148 September 2000 Agricultural Chemical Industry Compliance and Enforcement History VII. COMPLIANCE AND ENFORCEMENT HISTORY Background Until recently, EPA has focused much of its attentionon measuring compliance with specific environmental statutes. This approach allows the Agency to track compliance with the Federal Insecticide, Fungicide, and Rodenticide Act, the Clean Air Act, the Resource Conservation and Recovery Act, the Clean Water Act, and other environmental statutes. Within the last several years, the Agency has begun to supplement single-media compliance indicators with facility-specific, multimedia indicators of compliance. In doing so, EPA is in a better position to track compliance with all statutes at the facility level, and within specific industrial sectors. A major step in building the capacity to compile multimedia data for industrial sectors was the creation of EPA's Integrated Data for Enforcement Analysis (IDEA) system. IDEA has the capacity to “read into” the Agency's singlemedia databases, extract compliance records, and match the records to individual facilities. The IDEA system can match Air, Water, Waste, Toxics/Pesticides/EPCRA, TRI, and Enforcement Docketrecords for a given facility, and generate a list of historical permit, inspection, and enforcement activity. IDEA also has the capability to analyze data by geographic area and corporate holder. As the capacity to generate multimedia compliance data improves, EPA will make available more in-depth compliance and enforcement information. Additionally, sector-specific measures of success for compliance assistance efforts are under development. Compliance and Enforcement Profile Description Using inspection, violation and enforcement data from the IDEA system, this section provides information regarding the historical compliance and enforcement activity of this sector. In order to mirror the facility universe reported in the Toxic Chemical Profile, the data reported within this section consists of records only from the TRI reporting universe. With this decision, the selection criteria are consistent across sectors with certain exceptions. For the sectors that do not normally report to the TRI program, data have been provided from EPA’s Facility Indexing System (FINDS) which tracks facilities in all media databases. Please note, in this section, EPA does not attempt to define the actual number of facilities that fall within each sector. Instead, the section portrays the records of a subset of facilities within the sector that are well defined within EPA databases. As a check on the relative size of the full sector universe, most notebooks contain an estimated number of facilities within the sector according to the Bureau of Census (See Section II). With sectors dominated by small businesses, such as metal finishers and printers, the reporting universe within Sector Notebook Project 149 September 2000 Agricultural Chemical Industry Compliance and Enforcement History the EPA databases may be small in comparison to Census data. However, the group selected for inclusion in this data analysis section should be consistent with this sector’s general make-up. Following this introduction is a list defining each data column presented within this section. These values represent a retrospective summary of inspections and enforcement actions, and reflect solely EPA, state, and local compliance assurance activities that have been entered into EPA databases. To identify any changes in trends, the EPA ran two data queries, one for the past five calendar years (April 1, 1992 to March 31, 1997) and the other for the most recent twelve-month period (April 1, 1996 to March 31, 1997). The five-year analysis gives an average level of activity for that period for comparison to the more recent activity. Because most inspections focus on single-media requirements, the data queries presented in this section are taken from single media databases. These databases do not provide data on whether inspections are state/local or EPA led. However, the table breaking downthe universe of violations does give the reader a crude measurement of the EPA’s and states’ efforts withineach media program. The presented data illustrate the variations across EPA regions for certain sectors.5 This variation may be attributable to state/local data entry variations, specific geographic concentrations, proximity to population centers, sensitive ecosystems, highly toxic chemicals used in production, or historical noncompliance. Hence, the exhibited data do not rank regional performance or necessarily reflect which regions may have the most compliance problems. Compliance and Enforcement Data Definitions General Definitions Facility Indexing System (FINDS) -- assigns a common facility number to EPA single-media permit records. The FINDS identification number allows EPA to compile and review all permit, compliance, enforcement, and pollutant release data for any given regulated facility. Integrated Data for Enforcement Analysis (IDEA) -- is a data integration system that can retrieve information from the major EPA program office databases. IDEA uses the FINDS identification number to link separate data records from EPA’s databases. This allows retrieval of records from across 5 EPA Regions include the following states: I (CT, MA, ME, RI, NH, VT); II (NJ, NY, PR, VI); III (DC, DE, MD, PA, VA, WV); IV (AL, FL, GA, KY, MS, NC, SC, TN); V (IL, IN, MI, MN, OH, WI); VI (AR, LA, NM, OK, TX); VII (IA, KS, MO, NE); VIII (CO, MT, ND, SD, UT, WY); IX (AZ, CA, HI, NV, Pacific Trust Territories); X (AK, ID, OR, WA). Sector Notebook Project 150 September 2000 Agricultural Chemical Industry Compliance and Enforcement History media or statutes for any givenfacility, thus creating a “master list” of records for that facility. Some of the data systems accessible through IDEA are: AFS (Air Facility Indexing and Retrieval System, Office of Air and Radiation), PCS (Permit Compliance System, Office of Water), RCRIS (Resource Conservation and Recovery Information System, Office of Solid Waste), NCDB (National Compliance Data Base, Office of Prevention, Pesticides, and Toxic Substances), CERCLIS (Comprehensive Environmental and Liability InformationSystem, Superfund), and TRIS (Toxic Release InventorySystem). IDEA also contains information from outside sources such as Dun and Bradstreet and the Occupational Safety and Health Administration (OSHA). Most data queries displayed in notebook sections IV and VII were conducted using IDEA. Data Table Column Heading Definitions Facilities in Search -- are based on the universe of TRI reporters within the listed SIC code range. For industries not covered under TRI reporting requirements (metal mining, nonmetallic mineral mining, electric power generation, ground transportation, water transportation, and dry cleaning), or industries in which only a very small fraction of facilities report to TRI (e.g., printing), the notebook uses the FINDS universe for executing data queries. The SIC code range selected for each search is defined by each notebook's selected SIC code coverage described in section II. Facilities Inspected --- indicates the level of EPA and state agency inspections for the facilities in this data search. These values show what percentage of the facility universe is inspected in a one-year or five-year period. Numberof Inspections -- measures the total number of inspections conducted in this sector. An inspection event is counted each time it is entered into a single media database. Average Time Between Inspections -- provides an average length of time, expressed in months, between compliance inspections at a facility within the defined universe. Facilities with One or More Enforcement Actions -- expresses the number of facilities that were the subject of at least one enforcement action within the defined time period. This category is broken down further into federal and state actions. Data are obtained for administrative, civil/judicial, and criminal enforcement actions. Administrative actions include Notices of Violation (NOVs). A facility with multiple enforcement actions is only counted once in this column, e.g., a facility with 3 enforcement actions counts as 1 facility. Sector Notebook Project 151 September 2000 Agricultural Chemical Industry Compliance and Enforcement History Total Enforcement Actions -- describes the total number of enforcement actions identified for an industrial sector across all environmental statutes. A facility with multiple enforcement actions is counted multiple times, e.g., a facility with 3 enforcement actions counts as 3. State Lead Actions -- shows what percentage of the total enforcement actions are taken by state and local environmental agencies. Varying levels of usage by states of EPA data systems may limit the volume of actions recorded as state enforcement activity. Some states extensively report enforcement activities into EPA data systems, while other states may use their own data systems. Federal Lead Actions -- shows what percentage of the total enforcement actions are taken by the United States Environmental Protection Agency. This value includes referrals fromstate agencies. Many of these actions result from coordinated or joint state/federal efforts. Enforcement to Inspection Rate -- is a ratio of enforcement actions to inspections, and is presented for comparative purposes only. This ratio is a rough indicator of the relationship between inspections and enforcement. It relates the number of enforcement actions and the number of inspections that occurred within the one-year or five-year period. This ratio includes the inspections and enforcement actions reported under the Clean Water Act (CWA), the Clean Air Act (CAA) and the Resource Conservation and Recovery Act (RCRA). Inspections and actions from the TSCA/FIFRA/ EPCRA database are not factored into this ratio because most of the actions taken under these programs are not the result of facility inspections. Also, this ratio does not account for enforcement actions arising from non-inspection compliance monitoring activities (e.g., self-reported water discharges) that can result in enforcement action within the CAA, CWA, and RCRA. Facilities with One or More Violations Identified -- indicates the percentage of inspected facilities having a violation identified in one of the following data categories: In Violation or Significant Violation Status (CAA); Reportable Noncompliance, Current Year Noncompliance, Significant Noncompliance (CWA); Noncompliance and Significant Noncompliance (FIFRA, TSCA, and EPCRA); Unresolved Violation and Unresolved High Priority Violation (RCRA). The values presented for this column reflect the extent of noncompliance within the measured time frame, but do notdistinguish between the severity of the noncompliance. Violation status may be a precursor to an enforcement action, but does not necessarily indicate that an enforcement action will occur. Media Breakdownof Enforcement Actions and Inspections -- four columns identify the proportion of total inspections and enforcement actions within Sector Notebook Project 152 September 2000 Agricultural Chemical Industry Compliance and Enforcement History EPA Air, Water, Waste, and TSCA/FIFRA/EPCRA databases. Each column is a percentage of either the “Total Inspections,” or the “Total Actions” column. VII.A. Fertilizer, Pesticide, and Agricultural Chemical Industry Compliance History Table 25 provides an overview of the reported compliance and enforcement data for the Fertilizer, Pesticide, and Agricultural Chemical Industryover five years fromApril 1992 to April 1997. These data are also broken out by EPA Regions thereby permitting geographical comparisons. A few points evident from the data are listed below. C About 75 percent of agricultural chemical facility inspections and 73 percent of enforcement actions occurred in EPA Regions IV, V, VI, and VII. C Region IX had the highest ratio of enforcement actions to inspections (0.13) and the longest average time between inspections (21 months). This indicates that fewer inspections were conducted in relation to the number of facilities in the Region, but that these inspections were more likely to result in an enforcement action than inspections conducted in other Regions. C With the exception of Region I, in which no inspections or enforcement actions were carried out in between 1992 and 1997, Region VIII had the lowest enforcement to inspection rate (0.03). Sector Notebook Project 153 September 2000 Agricultural Chemical Industry Compliance and Enforcement History Table 25: Five-Year Enforcement and Compliance Summary for the Fertilizer, Pesticide, and Agricultural Chemical Industry A B C Region Facilities in Search Facilities Inspected D E F G H I J Number of Inspections Average Months Between Inspections Facilities with 1 or More Enforcement Actions Total Enforcement Actions Percent State Lead Actions Percent Federal Lead Actions Enforcement to Inspection Rate I II III IV 3 11 18 77 0 8 16 44 0 50 123 449 -13 9 10 0 3 2 15 0 4 10 41 0% 75% 80% 83% 0% 25% 20% 17% -0.08 0.08 0.09 V 35 23 128 16 4 7 57% 43% 0.05 VI VII VIII IX 34 43 9 25 21 31 5 10 167 225 33 72 12 11 16 21 5 8 1 5 9 17 1 9 56% 71% 100% 78% 44% 29% 0% 22% 0.05 0.08 0.03 0.13 X 8 6 46 10 4 4 25% 75% 0.09 263 164 1,293 12 47 102 74% 26% 0.08 TOTAL Source: Data obtained from EPA’s Integrated Data for Enforcement Analysis (IDEA) system in 1997. Sector Notebook Project 154 September 2000 Agricultural Chemical Industry Compliance and Enforcement History VII.B. Comparison of Enforcement Activity Between Selected Industries Tables 26 and 27 allow the compliance history of the agricultural chemical sector to be compared to the other industries covered by the industry sector notebooks. Comparisons between Tables 26 and 27 permit the identification of trends in compliance and enforcement records of the various industries by comparing data covering five years (April 1992 to April 1997) to that of the last year for which data were available (April 1996 to April 1997). Some points evident from the data are listed below. C The agricultural chemical sector was inspected more frequently than most of the sectors shown (12 months on average between inspections). C Between 1992 and 1997, the industry had a higher enforcement to inspectionrate thanmostsectors (0.08); however, in 1997 the ratio decreased to 0.05 which is lower than most sectors. C The agricultural chemical sector had one of the highestpercentages of facilities inspected with one or more violations (97 percent) in 1997, but one of the lowest percentages of facilities with one or more enforcement actions (5 percent). Tables 28 and 29 provide a more in-depth comparison between the Fertilizer, Pesticide, and Agricultural Chemical Industry and other sectors by breaking out the compliance and enforcement data by environmental statute. As in the previous Tables (Tables 26 and 27), the data cover the years 1992 to 1997 (Table 28) and 1997 (Table 29) to facilitate the identificationof recent trends. A few points evident from the data are listed below. C The percent of inspections carried out under each environmental statute has changed only slightly between the average of the years 1992 to 1997 and that of the past year. The Clean Air Act accounted for the most inspections (43 percent) during this period. This increased to almost half of all agricultural chemical facility inspections (49 percent) in 1997. C The percent of enforcement actions taken under each environmental statute changed significantly from the 1992 to 1997 period to the past year. Enforcement actions taken under the Clean Air Act increased from 39 percent to 55 percent and enforcement actions takenunder RCRA increased from30 percent to 36 percent. At the same time, the enforcement actions taken under the Clean Water Act went from 20 percent in 1992 to 1995 to no actions in 1997. Sector Notebook Project 155 September 2000 B Sector Notebook Project 484 Pulp and Paper 156 444 Air Transportation 3,270 514 Water Transportation Fossil Fuel Electric Power 44 7,786 Ground Transportation 1,260 Automobile Assembly Shipbuilding and Repair 1,250 Electronics 203 2,906 Fabricated Metal Products Nonferrous Metals Rubber and Plastic 669 156 1,818 Petroleum Refining 349 263 Agricultural Chemicals Metal Castings 425 Organic Chemicals Iron and Steel 164 Pharmaceuticals 615 329 Resins and Manmade Fibers Stone, Clay, Glass and Concrete 441 Inorganic Chemicals 5,862 499 Furniture Printing 712 5,256 Non-Metallic Mineral Mining 355 4,676 Oil and Gas Extraction Lumber and Wood 3,256 Coal Mining Textiles 1,232 Facilities in Search Metal Mining Industry Sector A 2,166 231 192 3,263 37 927 863 1,858 161 424 275 388 981 148 164 355 129 263 286 2,092 430 386 473 267 2,803 1,902 741 378 Facilities Inspected C 14,210 973 816 12,904 243 5,912 4,500 7,914 1,640 2,535 4,476 3,474 4,383 3,081 1,293 4,294 1,201 2,430 3,087 7,691 4,630 2,379 2,767 1,465 12,826 6,071 3,748 1,600 Number of Inspections D 14 27 38 36 9 13 17 22 7 16 5 11 25 3 12 6 8 8 9 46 6 13 15 15 25 46 52 46 Average Months Between Inspections E 403 48 36 375 20 253 150 365 68 113 121 97 178 124 47 153 35 93 89 238 150 65 134 53 385 149 88 63 Facilities with 1 or More Enforcement Actions F Table 26: Five-Year Enforcement and Compliance Summary for Selected Industries G 789 97 70 774 32 413 251 600 174 191 305 277 276 763 102 468 122 219 235 428 478 91 265 83 622 309 132 111 Total Enforcement Actions H 76% 88% 61% 84% 84% 82% 80% 75% 78% 71% 71% 75% 82% 68% 74% 65% 80% 76% 74% 88% 80% 81% 70% 90% 77% 79% 89% 53% Percent State Lead Actions I 24% 12% 39% 16% 16% 18% 20% 25% 22% 29% 29% 25% 18% 32% 26% 35% 20% 24% 26% 12% 20% 19% 30% 10% 23% 21% 11% 47% Percent Federal Lead Actions J 0.06 0.10 0.09 0.06 0.13 0.07 0.06 0.08 0.11 0.08 0.07 0.08 0.06 0.25 0.08 0.11 0.10 0.09 0.08 0.06 0.10 0.04 0.10 0.06 0.05 0.05 0.04 0.07 Enforcement to Inspection Rate Agricultural Chemical Industry Compliance and Enforcement History September 2000 Sector Notebook Project 499 484 Furniture Pulp and Paper 157 514 444 Water Transportation Air Transportation 1,260 Automobile Assembly 7,786 1,250 Electronics Ground Transportation 2,906 Fabricated Metal 44 203 Shipbuilding and Repair 669 Nonferrous Metals 1,818 Rubber and Plastic Metal Castings 156 Petroleum Refining 349 263 Agricultural Chemicals Iron and Steel 425 Organic Chemicals 615 164 Pharmaceuticals Stone, Clay, Glass and Concrete 329 441 Resins and Manmade Fibers Inorganic Chemicals 5,862 712 Printing 355 Lumber and Wood 5,256 Non-Metallic Mineral Mining Textiles 4,676 Oil and Gas Extraction 96 84 1,585 22 507 420 849 108 234 197 255 466 132 105 259 80 173 200 892 317 254 279 172 1,481 874 362 Facilities Inspected 142 Facilities in Search 1,232 3,256 C B Coal Mining Industry Sector Metal Mining A 151 141 2,499 51 1,058 780 1,377 310 433 866 678 791 565 206 837 209 419 548 1,363 788 459 507 295 2,451 1,173 765 Number of Inspections 211 D 69 53 681 19 431 402 796 98 240 174 151 389 129 102 243 84 152 155 577 248 136 192 96 384 127 90 Number 102 72% 63% 43% 86% 85% 96% 94% 91% 103% 88% 59% 83% 98% 97% 94% 105% 88% 78% 65% 78% 54% 69% 56% 26% 15% 25% Percent* 72% Number 9 8 10 85 3 35 27 63 17 24 22 19 33 58 5 42 8 26 19 28 43 9 44 10 73 26 20 8% 12% 5% 14% 7% 6% 7% 16% 10% 11% 7% 7% 44% 5% 16% 10% 15% 10% 3% 14% 4% 16% 6% 5% 3% 6% Percent* 6% F Facilities with 1 or more Enforcement Actions E Facilities with 1 or More Violations Table 27: One-Year Enforcement and Compliance Summary for Selected Industries 12 11 103 4 47 43 83 28 26 34 27 41 132 11 56 14 36 31 53 74 11 52 12 91 34 22 10 Total Enforcement Actions G 0.08 0.08 0.04 0.08 0.04 0.06 0.06 0.09 0.06 0.04 0.04 0.05 0.23 0.05 0.07 0.07 0.09 0.06 0.04 0.09 0.02 0.10 0.04 0.04 0.03 0.03 Enforcement to Inspection Rate 0.05 H Agricultural Chemical Industry Compliance and Enforcement History September 2000 Sector Notebook Project 386 430 Pulp and Paper 158 981 388 275 424 161 1,858 Rubber and Plastic Stone, Clay, Glass and Concrete Iron and Steel Metal Castings Nonferrous Metals Fabricated Metal 2,360 Air Transportation Dry Cleaning 231 Water Transportation 2,166 192 Ground Transportation Fossil Fuel Electric Power 37 3,263 Shipbuilding and Repair 927 148 Petroleum Refining Automobile Assembly 164 Agricultural Chemicals 863 355 Organic Chemicals Electronics 129 263 Resins and Manmade Fibers Pharmaceuticals 286 Inorganic Chemicals 2,092 473 Lumber and Wood Furniture Printing 267 2,803 Non-Metallic Mineral Mining Textiles 1,902 741 Oil and Gas Extraction 378 Coal Mining Facilities Inspected Metal Mining Industry Sector 3,813 14,210 973 816 12,904 243 5,912 4,500 7,914 1,640 2,535 4,476 3,474 4,383 3,081 1,293 4,294 1,201 2,430 3,087 7,691 4,630 2,379 2,767 1,465 12,826 6,071 3,748 1,600 Total Inspections 66 789 97 70 774 32 413 251 600 174 191 305 277 276 763 102 468 122 219 235 428 478 91 265 83 622 309 132 111 Total Enforcement Actions 56% 57% 25% 39% 59% 39% 47% 38% 40% 48% 55% 45% 56% 51% 42% 43% 37% 35% 35% 38% 60% 51% 62% 49% 58% 83% 75% 57% 39% % of Total Inspections 23% 59% 32% 29% 41% 25% 39% 32% 33% 43% 44% 35% 57% 44% 59% 39% 42% 49% 43% 44% 64% 59% 42% 47% 54% 81% 65% 64% 19% % of Total Actions Clean Air Act 3% 32% 27% 23% 12% 14% 8% 13% 12% 18% 11% 26% 13% 12% 20% 24% 16% 15% 23% 27% 5% 32% 3% 6% 22% 14% 16% 38% 52% % of Total Inspections 6% 26% 20% 34% 11% 25% 9% 11% 11% 17% 10% 26% 9% 11% 13% 20% 25% 25% 28% 21% 3% 28% 0% 6% 25% 13% 14% 28% 52% % of Total Actions Clean Water Act Table 28: Five-Year Inspection and Enforcement Summary by Statute for Selected Industries 41% 11% 48% 37% 29% 42% 43% 47% 45% 33% 32% 28% 31% 35% 36% 28% 44% 45% 38% 34% 35% 15% 34% 44% 18% 3% 8% 4% 8% % of Total Inspections 71% 10% 48% 33% 45% 47% 43% 50% 43% 31% 31% 31% 30% 34% 21% 30% 28% 20% 23% 30% 29% 10% 43% 31% 14% 4% 18% 8% 12% % of Total Actions RCRA 0% 1% 0% 1% 1% 5% 2% 2% 2% 1% 2% 1% 1% 2% 2% 5% 4% 5% 4% 1% 1% 2% 1% 1% 2% 0% 0% 1% 1% % of Total Inspections 0% 5% 0% 4% 3% 3% 9% 7% 13% 10% 14% 8% 4% 11% 7% 11% 6% 5% 6% 5% 4% 4% 14% 16% 6% 3% 3% 1% 17% % of Total Actions FIFRA/TSCA/ EPCRA/Other Agricultural Chemical Industry Compliance and Enforcement History September 2000 Sector Notebook Project 874 Oil and Gas Extraction 254 317 892 200 173 Furniture Pulp and Paper Printing Inorganic Chemicals Resins and Manmade Fibers 159 255 197 234 108 849 420 507 22 1,585 Stone, Clay, Glass and Concrete Iron and Steel Metal Castings Nonferrous Metals Fabricated Metal Electronics Automobile Assembly Shipbuilding and Repair Ground Transportation 1,318 1,234 Fossil Fuel Electric Power Dry Cleaning 96 466 Rubber and Plastic Air Transportation 132 Petroleum Refining 84 105 Agricultural Chemicals Water Transportation 259 Organic Chemicals 80 279 Lumber and Wood Pharmaceuticals 172 Textiles 1,481 362 Non-Metallic Mineral Mining 142 Coal Mining Facilities Inspected Metal Mining Industry Sector 1,436 2,430 151 141 2,499 51 1,058 780 1,377 310 433 866 678 791 565 206 837 209 419 548 1,363 788 459 507 295 2,451 1,173 765 211 Total Inspections 16 135 12 11 103 4 47 43 83 28 26 34 27 41 132 11 56 14 36 31 53 74 11 52 12 91 34 22 10 Total Enforcement Actions 69% 59% 28% 38% 64% 54% 53% 44% 46% 44% 60% 52% 62% 55% 49% 48% 40% 43% 38% 35% 63% 54% 66% 51% 66% 87% 82% 56% 52% % of Total Inspections 56% 73% 33% 9% 46% 0% 47% 37% 41% 43% 58% 47% 63% 64% 67% 55% 54% 71% 51% 59% 77% 73% 45% 30% 75% 89% 68% 82% 0% % of Total Actions Clean Air Act 1% 32% 15% 24% 11% 11% 7% 14% 11% 15% 10% 23% 10% 10% 17% 22% 13% 11% 24% 26% 4% 32% 2% 6% 17% 10% 10% 40% 40% % of Total Inspections 6% 21% 42% 36% 10% 50% 6% 5% 2% 20% 8% 29% 7% 13% 8% 0% 13% 14% 38% 9% 0% 19% 0% 5% 17% 9% 9% 14% 40% % of Total Actions Clean Water Act Table 29: One-Year Inspection and Enforcement Summary by Statute for Selected Industries 30% 9% 57% 38% 26% 35% 41% 43% 43% 41% 30% 26% 28% 35% 34% 30% 47% 45% 38% 39% 33% 14% 32% 44% 17% 3% 9% 4% 8% % of Total Inspections 38% 5% 25% 45% 44% 50% 47% 53% 57% 30% 35% 24% 30% 23% 15% 36% 34% 14% 5% 25% 23% 7% 45% 25% 8% 2% 24% 5% 30% % of Total Actions RCRA 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% % of Total Inspections 0% 0% 0% 9% 1% 0% 0% 5% 0% 7% 0% 0% 0% 0% 10% 9% 0% 0% 5% 6% 0% 1% 9% 40% 0% 0% 0% 0% 30% % of Total Actions FIFRA/TSCA/ EPCRA/Other Agricultural Chemical Industry Compliance and Enforcement History September 2000 Agricultural Chemical Industry Compliance and Enforcement History VII.C. Review of Major Legal Actions Major Cases/Supplemental Environmental Projects This section provides summary information about major cases that have affected this sector, and a list of Supplemental Environmental Projects (SEPs). VII.C.1. Review of Major Cases As indicated in EPA’s Enforcement Accomplishments Report, FY1995 and FY1996 publications, about 17 significant enforcement actions were resolved between 1995 and 1996 for the Fertilizer, Pesticide, and Agricultural Chemical Industry. American Cyanamid Company On June 28, 1995, Region II issued an administrative complaint against AmericanCyanamid Company for violations at its Lederle Laboratories facility located in Pearl River, New York. The complaint proposed assessment of a $272,424 fine for the company’s failure to submit timely TRI Form Rs for 1,1,1-trichloroethane, naphthalene, phosphoric acid, toluene, manganese compounds and zinc compounds for the reporting years 1990, 1991, 1992, and 1993. Precision Generators, Inc. The Regional Administrator signed a consent order in the Precision Generators, Inc., a FIFRA case, in which the respondent agreed to pay the proposed penalty of $4,000. The administrative complaint cited the respondent’s sale and misbranding of its unregistered pesticide product ethylene fluid used to accelerate the ripening of fruits and vegetables. Such a product is a “plant regulator” falling within the definition of “pesticide” in FIFRA. E.C. Geiger, Inc. On August 18, 1995, the Regional Administrator signed a consent agreement and consent order finalizing settlement of the administrative proceeding against E.C. Geiger, Inc. of Harleysville, Pennsylvania, for violations of sections 12(a)(1)(A) and (B) of FIFRA, 7 U.S.C. section 136j(a)(1)(A) and (B). The complaint alleged that during 1992, Geiger sold or distributed an unregistered and misbranded pesticide product, a rooting hormone called “Indole-3-butyric Acid-Horticultural Grade.” For these violations the complaint sought a $14,000 penalty. Geiger has agreed to pay a penalty of $8,900. Rhone-Poulenc, Inc. Region III reached a settlement with Rhone-Poulenc, Inc., in a Part II administrative action brought for violations of RCRA boiler and industrial furnace (BIF) regulations at Rhone-Poulenc’s Institute, West Virginia plant. The settlement calls for Rhone-Poulenc to pay a penalty of over $244,000 and to undertake numerous compliance tasks. IMC-Agrico Company On November 8, 1994, the Regional Administrator ratified a consent decree between the United States and IMC-Agrico Company Sector Notebook Project 160 September 2000 Agricultural Chemical Industry Compliance and Enforcement History concerning IMC’s violations of section 301(a) of the CWA. IMC owns and operates phosphate rock mines and associated processing facilities in Florida and Louisiana. Eight of its mineral extraction operations located throughout Florida and its Port Sutton Phosphate Terminal located in Tampa, Florida, were the subject of this referral. The action arose out of IMC’s violation of its permit effluent limits for a variety of parameters including dissolved oxygen, suspended solids, ammonia, and phosphorous, as well as non reporting and stormwater violations at the various facilities-over 1,500 permit violations total. The case was initiated following review of the facility discharge monitoring reports and EPA and state inspections of the sites. The consent decree settlement involved an up-front payment of $835,000 and a $265,000 Supplemental Environmental Project (SEP). The pollution prevention SEP involved converting IMC’s scrubber discharge and intake water systems into a closed loop system, greatly reducing pollution loading at the Port Sutton facility, by April 1995. J.T. Eaton & Company, Inc. J.T. Eaton & Company, Inc. distributed and sold at least 13 unregistered pesticides (mostly rodenticides). These unregistered pesticides resulted from varying the form of the rodent bait and the packaging of several of Eaton’s registered products (e.g., registered as a bulk product) but sold in ready-to-use place packs. The company also distributed and sold a misbranded pesticide product and made inaccurate claims in advertising for another product. A stop sale, use, or removal order and an administrative complaint were issued simultaneously on March 23, 1995. The penalty assessed in the complaint was $67,500. The complaint was settled on August 25, 1995, for $40,000. Citizens Elevator Co., Inc. Citizens Elevator Co. repackaged and distributed and sold the pesticide “Preview” in five gallon buckets, many bearing pie filling labels, to at least 24 customers, constituting the distribution and sale of an unregistered pesticide. The complaint, issued June 30, 1994, assessed a penalty of $108,000. In supplemental environmental projects for the prevention of spills of pesticides and fertilizers and the safer, more efficient storage and application of pesticides and fertilizer. The respondent spent $184,771. A consent agreement signed June 30, 1995, settled the case for $8,400. NitrogenProducts, Inc. On September 25, 1995, a joint stipulation and order of dismissal was filed in the United States District Court for the Eastern District of Arkansas. Nitrogen Products, Inc. (NPI), agreed to pay a civil penalty of $243,600 to the United States for violations of the Clean Air Act, and Subparts A and R of 40 CFR Part 61. The foreign parent corporation, Internationale Nederlanden Bank, N.V., acquired the facility through Sector Notebook Project 161 September 2000 Agricultural Chemical Industry Compliance and Enforcement History foreclosure and expended over $2 million to cover the phosphogypsum stack and regrade. Micro Chemical, Inc. The illegal transportation of hazardous waste by a Louisiana pesticide formulation company, Micro Chemical, Inc., to an unpermitted disposal facility in violation of RCRA resulted in a $500,000 fine, five years of probation, and compliance with corrective action measures contained in a corrective action administrative order on consent. In March 1990, Micro Chemical transported 100 cubic yards of hazardous waste from its facility to a field in Baskin, Louisiana-a location that did not have a RCRA permit. After its discovery, it was removed under the Louisiana Department of Agriculture’s guidance. Micro Chemical has taken measures to stabilize and prevent the spread of pesticide contamination from the Micro Chemical facility site, as required by a RCRA 3008(h) corrective action administrative order on consent. The order will result in the removal of all contaminated soil at the site, and the remediation of all off-site contamination that has migrated into a drainage basin located adjacent to the site. Chempace Corporation OnSeptember 26, 1996, RegionVPTES filed a civil administrative complaint against Chempace corporation of Toledo, Ohio alleging 99 counts for the distribution or sale of unregistered and misbranded pesticides, and pesticide productionin unregistered establishments. The total proposed penalty in the complaint is $200,000. The case is significant in that Chempace had, previous to the complaint, canceled all of the company’s pesticide productregistrations pursuant to section 4 of FIFRA, as well as their establishment registration pursuant to section 7. However, the company continued to produce and sell those canceled pesticides in a facility that was not registered. Northrup King Co. On September 30, 1996, as a result of a FIFRA inspection conducted by RegionVonMarch27-28, 1996, Region V issued a FIFRA civil complaint to Northrup King Co. of Golden Valley, Minnesota. The pesticide involved in the case is a genetically engineered corn seed that protects against the corn borer. Because this case is the first FIFRA complaint involving a genetically engineered pesticide, the case is nationally significant. The complaint alleged 21 counts of sale and distribution of an unregistered pesticide, 21 counts for failure to file a Notice of Arrival for pesticide imports, and 8 counts of pesticide production in unregistered establishments, for a total proposed penalty of $206,500. A consent agreement and consent order was filed simultaneously with, and in resolution of the complaint. The respondent agreed to pay $165,200, which is the largest penalty collected by Region V under FIFRA. Micro Chemical. Micro Chemical is a pesticide formulating, mixing, and packaging facility 3,000 feet up gradient of the Winnsboro’s groundwater well complex. In March 1990, a release from the facility was reported by a citizen. Investigations revealed that the company had attempted to dump 100 cubic yards of pesticide contaminated soil offsite. People living near the dump site Sector Notebook Project 162 September 2000 Agricultural Chemical Industry Compliance and Enforcement History became ill from the fumes and the state ordered the soil to be returned to Micro Chemical. Ultimately a criminal case was initiated for the midnight dumping. Other storage violations detected were the subject of an administrative complaint issued in September 1992. A RCRA 3008(h) order on consent was entered into on September 1994 to remediate the site. In resolving the September 1992 complaint, a final order was issued on March 28, 1996. Micro Chemical agreed to pay a penalty of $25,000 and agreed to fund a SEP valued at $25,000. The SEP established collection events for household waste and waste pesticides in the Franklin Parish area. During FY96, the SEP enabled about 100 tons of waste to be collected and properly disposed. Terra Industries, Inc. At the request of the Chemical Emergency Prevention and Preparedness Office (CEPPO), and in accordance with section 112(r) of the CAA, EPA released the results of its investigation into the cause of an explosion of the ammonium nitrate plant at this nitrogen fertilizer manufacturing facility. The report released in January 1996 identifies numerous unsafe operating procedures at the plant as contributing factors to the explosion, and recommends certain standard operating procedures which would help prevent similar occurrences at ammonium nitrate production facilities. The Terra explosion occurred on December 13, 1994, killing four individuals and injuring 18 others. It also resulted in the release of approximately 5,700 tons of anhydrous ammonia to the air and approximately 25,000 gallons of nitric acid to the ground and required evacuation over a two-state area of over 2,500 persons from their homes. In a subsequent action, an administrative civil complaint alleging violations of EPCRA sections 213 and 313, and section 8(a) of TSCA, was filed citing that Terra International failed to submit Toxic Release Inventory (TRI) information to EPA in a timely manner, and data submitted to EPA by Terra failed to include releases of more than 17 million pounds of toxic chemicals to the environment on-site. Pfizer/AgrEvo Reporting of unreasonable adverse effects information is required under FIFRA section 6(a)(2), and failure to submit such reports has resulted in a $192,000 settlement involving AgrEvo Environmental Health, Inc. and Pfizer, Inc. The case arose in early 1994 after an individual reported disabling neurological symptoms and chemical sensitivity after using RID products to kill lice. The ensuing EPA investigation revealed numerous additional unreported incidents involving RID which is manufactured by AgrEvo and distributed by Pfizer. EPA amended the complaint charging 24 counts against each company. FIFRA 6(a)(2) requires pesticide registrants to submit to EPA any additional information (beyond that submitted in the pesticide registration process) that they have regarding unreasonable adverse effects of their pesticides onhumanhealth or the environment. The information is used by the Agency in the determination of risks associated with pesticides. Sector Notebook Project 163 September 2000 Agricultural Chemical Industry Compliance and Enforcement History Rohm and Haas Company This complaint cited Rohm and Haas for 66 violations under FIFRA section 12(a)(1)(c), for the distribution or sale of a registered pesticide the composition of which differed from the composition as described in its registration under FIFRA section 3. EPA registers pesticides based upon the accurate assessment of components used in the manufacture of the product. Use of an unapproved formula can lead to production of a pesticide for which no assessment of risk has been determined or result in unknown synergistic effects. Following settlement negotiations, and in accordance with the FIFRA Enforcement Response Policy, the original penalty of $330,000 was reduced to $118,800, based on a 20% reduction to the gravity level, a 40% reduction for immediate self-disclosure, mitigation, and corrective actions, and a 15% reduction for good attitude, cooperation, and efforts to comply with FIFRA. VII.C.2. Supplementary Environmental Projects (SEPs) SEPs are compliance agreements that reduce a facility’s non-compliance penalty in return for an environmental project that exceeds the value of the reduction. Often, these projects fund pollution prevention activities that can reduce the future pollutant loadings of a facility. Information on SEP cases can be accessed via the Internet at http://es.epa.gov/oeca/sep. Sector Notebook Project 164 September 2000 Agricultural Chemical Industry Activities and Initiatives VIII. COMPLIANCE ASSURANCE ACTIVITIES AND INITIATIVES This section highlights the activities undertaken by this industry sector and public agencies to voluntarily improve the sector’s environmental performance. These activities include those initiated independently by industrial trade associations. In this section, the notebook also contains a listing and description of national and regional trade associations. VIII.A. Sector-Related Environmental Programs and Activities National Agricultural Compliance Assistance Center (Ag Center) EPA's Office of Compliance, with the support from the United States Department of Agriculture (USDA), developed EPA’s National Agriculture Compliance Assistance Center (Ag Center). The Ag Center offers comprehensive, easy-to-understand information about approaches to compliance that are both environmentally protective and agriculturallysound. The Ag Center focuses on providing information about EPA’s own requirements. In doing so, the center relies heavily on existing sources of agricultural informationand established distribution channels. Educational and technical informationon agricultural production is provided by the USDA and other agencies, but assistance in complying with environmental requirements has not traditionally been as readily available. The Ag Center is currently working with USDA and other federal and state agencies to provide the agricultural community, including regional and state regulatoryagencies, with a definitive source for federal environmental compliance information. The Ag Center offers information on a variety of topics, including the following: • • • • • • Pesticides Animal waste management Emergency planning and response Groundwater and surface water Tanks / containment Solid / hazardous waste Through a toll-free telephone number and a website that is regularly updated and expanded, the Ag Center offers a variety of resources including: • current news, compliance policies and guidelines, pollution prevention information, sources of additional information and expertise, and summaries of regulatory initiatives and requirements • user-friendly materials that consolidate informationabout compliance requirements, pollutionprevention, and technical assistance resources for use by regional and state assistance and educational programs, trade associations, businesses, citizens, and local governments Sector Notebook Project 165 September 2000 Agricultural Chemical Industry Activities and Initiatives • agriculture-related information on reducing pollution and using the latest pollution prevention methods and technologies • information on ways to reduce the costs of meeting environmental requirements, including identification of barriers to compliance The Ag Center's toll-free number is 1-888-663-2155 and the website address is: http://es.epa.gov/oeca/ag/ National Pesticide Information Retrieval System (NPIRS) Purdue University has developed a collection of databases through their Center for Environmental and Regulatory Information Systems, one of which is the National Pesticide Information Retrieval System. NPIRS is a collection of six databases related to pesticides, including product registration document information, data submitter information, residue tolerances, fact sheets, material safety data sheets, and the daily federal register. Full search access to the NPIRS databases is by annual subscription. Association of American Plant Food Control Officials (AAPFCO) Label Recommendations The AAPFCO is considering a set of recommendations issued by a task force of fertilizer producers and state officials. These recommendations call for labeling and standards for non-nutrient constituents in fertilizer and directions that will allow users to apply fertilizers at a rate that will not exceed these standards. One proposed addition to labels is to list all raw materials, including recycled wastes; however, the concentration of these materials will not be required (ARA, 1997). Agricultural Research Institute ARI was founded in 1951 as a part of the National Academy of Sciences, then incorporated separately in 1973. ARI analyzes agricultural problems and promotes research by its members to solve them. ARI publishes annual meeting minutes, a directory, books, pamphlets, and newsletters. National Association of State Departments of Agriculture (NASDA) NASDA was founded in 1916 by directors of state and territorial departments of agriculture to coordinate policies, procedures, laws, and activities between the states and federal agencies and Congress. NASDA conducts research, holds a trade show, and distributes several bulletins, newsletters, and directories. ChemAlliance EPA’s Office of Compliance developed ChemAlliance, a new Compliance Assistance Center for the chemical industry. Among its features is an exciting “expert help,” which offers an interactive guide to finding compliance Sector Notebook Project 166 September 2000 Agricultural Chemical Industry Activities and Initiatives resources specific to a user’s needs. Take a “virtual plant tour” to find out which regulations apply to your company’s operations by clicking on a detailed chemical plant illustration. ChemAlliance can be reached at 1-800-672-6048; its web site is located at . http://www.chemalliance.org, VIII.B. EPA Voluntary Programs Pesticide Environmental Stewardship Program (PESP) The Pesticide Environmental Stewardship Program (PESP) is a broad effort by EPA, USDA, and the FDA to reduce pesticide use and risk in both agriculture and nonagricultural settings. In September 1993, the three agencies announced a federal commitment to two major goals: 1) developing specific use/risk reduction strategies thatinclude reliance on biological pesticides and other approaches to pest control that are thought to be safer than traditional chemical methods, and 2) by the year 2000, having 75 percent of United States agricultural acreage adopt integrated pest management programs. A key part of the PESP is the public/private partnership which began when EPA, USDA, and FDA announced the partnership and more than 20 private organizations signed on as charter members. All organizations with a commitment to pesticide use/risk reduction are eligible to join the PESP, either as Partners or Supporters. The PESP program has 35 partners. Together, these partners represent at least 45,000 pesticide users. The program has a goal of adding 35 new partners per year. 33/50 Program The 33/50 Program is a ground breaking program that has focused on reducing pollution from seventeen high-priority chemicals through voluntary partnerships with industry. The program’s name stems from its goals: a 33% reduction in toxic releases by 1992, and a 50% reduction by 1995, against a baseline of 1.5 billion pounds of releases and transfers in 1988. The results have been impressive: 1,300 companies have joined the 33/50 Program (representing over 6,000 facilities) and have reached the national targets a year ahead of schedule. The 33% goal was reached in 1991, and the 50% goal -- a reduction of 745 million pounds of toxic wastes -- was reached in 1994. The 33/50 Program can provide case studies on many of the corporate accomplishments in reducing waste (Contact 33/50 ProgramDirector David Sarokin -- 202-260-6396). Table 30 lists those companies participating in the 33/50 program that reported the SIC codes 2873, 2874, 2875, and 2879 to TRI. Some of the companies shown also listed facilities that are notproducing agricultural chemicals. The number of facilities within each company that are participating in the 33/50 program and that report SIC codes 2873, 2874, 2875, and 2879 is shown. Where available and quantifiable against 1988 releases and transfers, each company’s 33/50 goals for 1995 and the actual total releases and transfers and percent reduction between 1988 and 1995 are presented. Eleven of the seventeen target chemicals were reported to TRI by agricultural chemical facilities in 1995. Sector Notebook Project 167 September 2000 Agricultural Chemical Industry Activities and Initiatives Table 30 shows that 24 companies comprised of 78 facilities reporting SIC 287 participated in the 33/50 program. For those companies shown with more than one agricultural chemical facility, all facilities may not have participated in 33/50. The 33/50 goals shown for companies with multiple facilities, however, were companywide, potentially aggregating more than one facility and facilities not carrying out agricultural chemical operations. In addition to company-wide goals, individual facilities within a company may have had their own 33/50 goals or may have been specifically listed as not participating in the 33/50 program. Since the actual percent reductions shownin the last column apply to onlythe companies’ agricultural chemical facilities, direct comparisons to those company goals incorporating non-agricultural chemical facilities or excluding certain facilities maynotbe possible. For information on specific facilities participating in 33/50, contact David Sarokin (202-260-6907) at the 33/50 Program Office. Sector Notebook Project 168 September 2000 Agricultural Chemical Industry Activities and Initiatives Table 30: Fertilizer, Pesticide, and Agricultural Chemical Industry Participation in the 33/50 Program Parent Company (Headquarters Location) Company-Owned Facilities Reporting 33/50 Chemicals Company- Wide % Reduction Goal1 (1988 to 1995) 1988 TRI Releases and Transfers of 33/50 Chemicals (pounds)2 1995 TRI Releases and Transfers of 33/50 Chemicals (pounds)2 % of Change per Facility (1988-1995) AMERICAN HOME PRODUCTS CORP. MADISON, NJ 2 49 47,950 73,876 -54 ARCADIAN CORP. MEMPHIS, TN 6 0 4,340 10,127 -133 BAY ZINC CO. INC. MOXEE CITY, WA 1 50 77,250 252 100 CHEM-TECH LTD. DES MOINES, IA 1 90 800 0 100 CHEVRON CORP. SAN FRANCISCO, CA 3 50 8,746 0 100 CONAGRA INC. OMAHA, NE 6 8 17,086 5,238 69 E.I. DU PONT DE NEMOURS & CO WILMINGTON, DE 2 50 144,412 440,370 -205 ELF AQUITAINE INC. NEW YORK, NY 1 49 3,068 0 100 FIRST MISSISSIPPI CORP. JACKSON, MS 7 0 701,144 214,334 69 FMC CORPORATION CHICAGO, IL 5 50 6,190 2,339 62 GLAXO WELLCOME INC. RESEARCH TRIANGLE PARK, NC 1 37 1,125 0 100 GOWAN COMPANY YUMA, AZ 1 0 0 2,207 --- IMC FERTILIZER GROUP INC. NORTHBROOK, IL 7 0 56,350 51,548 9 ISK AMERICAS INC. ATLANTA, GA 2 50 884,412 726,713 18 LAROCHE HOLDINGS INC. ATLANTA, GA 1 0 17,590 0 100 MALLINCKRODT GROUP INC. SAINT LOUIS, MO 1 44 0 0 --- MILES INC. PITTSBURGH, PA 1 38 39,822 6,650 83 MONSANTO COMPANY SAINT LOUIS, MO 1 23 0 1,260 --- 21 50 3,128,263 1,392,117 55 SC JOHNSON & SON INC. RACINE, WI 1 50 19,086 20,096 -5 SANDOZ CORPORATION NEW YORK, NY 3 50 207,086 87,000 58 TALLEY INDUSTRIES PHOENIX, AZ 1 0 8,243 2,289 72 UNIVERSAL COOPERATIVES INC. MINNEAPOLIS, MN 1 70 17,750 1,265 93 UNOCAL CORPORATION LOS ANGELES, CA 2 50 0 9 --- 78 --- 5,390,713 3,037,690 44 RHONE-POULENC INC. MONMOUTH JUNCTION, NJ Total Source: United States EPA 33/50 Program Office, 1997. 1 Company-Wide Reduction Goals aggregate all company-owned facilities which may include facilities not producing agricultural chemicals. 2 Releases and Transfers are from facilities only. 1995 33/50 TRI data were not available at time of publication. * = Reduction goal not quantifiable against 1988 TRI data. ** = Use reduction goal only. *** = No numeric reduction goal. Sector Notebook Project 169 September 2000 Agricultural Chemical Industry Activities and Initiatives Project XL Project XL was initiated in March 1995 as a part of President Clinton’s Reinventing Environmental Regulation initiative. The projects seek to achieve cost effective environmental benefits byproviding participants regulatoryflexibility on the condition that they produce greater environmental benefits. EPA and program participants will negotiate and sign a Final Project Agreement, detailing specific environmental objectives that the regulated entity shall satisfy. EPA will provide regulatory flexibility as an incentive for the participants’ superior environmental performance. Participants are encouraged to seek stakeholder support from local governments, businesses, and environmental groups. There have been at least two Project XL proposals relating to fertilizer production, however both of these have been either rejected or withdrawn. PCS Nitrogen(formerlyArcadian Fertilizer) had proposed to reuse stockpiled phosphogypsumas an ingredient in a soil enhancer. Another proposal by Dow Chemical Company in Louisiana was to trade off equipment leak reductions for relief from some emissions control, monitoring, reporting and recordkeeping requirements. EPA hopes to implement fifty pilot projects in four categories, including industrial facilities, communities, and government facilities regulated by EPA. Applications will be accepted on a rolling basis. For additional information regarding XL projects, including application procedures and criteria, see the May 23, 1995 Federal Register Notice. (Contact: Fax-on-Demand Hotline 202-260-8590, Web: http://www.epa.gov/ProjectXL, or Christopher Knopes at EPA’s Office of Policy, Planning and Evaluation 202-260-9298) Climate Wise Program EPA’s ENERGY STAR Buildings Program is a voluntary, profit-based program designed to improve the energy-efficiency in commercial and industrial buildings. Expanding the successful Green Lights Program, ENERGY STAR Buildings was launched in 1995. This programrelies on a 5-stage strategy designed to maximize energy savings thereby lowering energy bills, improving occupant comfort, and preventing pollution -- all at the same time. If implemented in every commercial and industrial building in the United States, ENERGY STAR Buildings could cut the nation’s energy bill by up to $25 billion and prevent up to 35% of carbon dioxide emissions. (This is equivalent to taking 60 million cars of the road). ENERGY STAR Buildings participants include corporations; small and medium sized businesses; local, federal and state governments; non-profit groups; schools; universities; and health care facilities. EPA provides technical and non-technical support including software, workshops, manuals, communication tools, and an information hotline. EPA’s Office of Air and Radiation manages the operation of the ENERGY STAR Buildings Program. (Contact: Green Light/Energy Star Hotline at 1-888-STAR-YES or Maria Tikoff Vargas, EPA Program Sector Notebook Project 170 September 2000 Agricultural Chemical Industry Activities and Initiatives Director at 202-233-9178 or visit the ENERGY STAR Buildings Program website at http://www.epa.gov/appdstar/buildings/) Green Lights Program EPA’s Green Lights program was initiated in 1991 and has the goal of preventing pollution by encouraging United States institutions to use energy-efficient lighting technologies. The program saves money for businesses and organizations and creates a cleaner environment by reducing pollutants released into the atmosphere. The program has over 2,345 participants which include major corporations, small and medium sized businesses, federal, state and local governments, non-profit groups, schools, universities, and health care facilities. Each participant is required to survey their facilities and upgrade lighting wherever it is profitable. As of March 1997, participants had lowered their electric bills by $289 million annually. EPA provides technical assistance to the participants through a decision support software package, workshops and manuals, and an information hotline. EPA’s Office of Air and Radiation is responsible for operating the Green Lights Program. (Contact: Green Light/Energy Star Hotline at 1-888-STARYES or Maria Tikoff Vargar, EPA Program Director, at 202-233-9178) WasteWi$e Program The WasteWi$e Program was started in 1994 by EPA’s Office of Solid Waste and Emergency Response. The program is aimed at reducing municipal solid wastes by promoting waste prevention, recycling collection and the manufacturing and purchase of recycled products. As of 1997, the program had about 500 companies as members, one third of whom are Fortune 1000 corporations. Members agree to identify and implement actions to reduce their solid wastes setting waste reduction goals and providing EPA with yearly progress reports. To member companies, EPA, in turn, provides technical assistance, publications, networking opportunities, and national and regional recognition. (Contact: WasteWi$e Hotline at 1-800-372-9473 or Joanne Oxley, EPA Program Manager, 703-308-0199) NICE3 The United States Department of Energy is administering a grant program called The National Industrial Competitiveness through Energy, Environment, and Economics (NICE3). By providing grants of up to 45 percent of the total project cost, the program encourages industry to reduce industrial waste at its source and become more energyefficient and cost-competitive through waste minimizationefforts. Grants are used by industry to design, test, and demonstrate new processes and/or equipment with the potential to reduce pollution and increase energy efficiency. The program is open to all industries; however, priority is given to proposals from participants in the forest products, chemicals, petroleum refining, steel, aluminum, metal casting and glass manufacturing sectors. (Contact: http//www.oit.doe.gov/access/ nice3, Chris Sifri, DOE, 303-275-4723 or Eric Hass, DOE, 303-275-4728) Sector Notebook Project 171 September 2000 Agricultural Chemical Industry Activities and Initiatives Design for the Environment (DfE) DfE is working with several industries to identify cost-effective pollution prevention strategies that reduce risks to workers and the environment. DfE helps businesses compare and evaluate the performance, cost, pollutionpreventionbenefits, and human health and environmental risks associated with existing and alternative technologies. The goal of these projects is to encourage businesses to consider and use cleaner products, processes, and technologies. For more information about the DfE Program, call (202) 260-1678. To obtain copies of DfE materials or for general information about DfE, contact EPA’s Pollution Prevention Information Clearinghouse at (202) 260-1023 or visit the DfE Website at http://es.inel.gov/dfe. VIII.C. Trade Association/Industry Sponsored Activity VIII.C.1. State Advisory Groups Association of American Pesticide Control Officials (AAPCO) P.O. Box 1249 Members: 55 Hardwick, VT 05843 Staff: 1 Phone: 802-472-6956 Fax: 802-472-6957 E-mail: [email protected] Formed in 1947, the Association of American Pesticide Control Officials (AAPCO) consists of state and federal pesticide regulatory officials. All federal and provincial Canadian officials, officials of all North American countries involved with the regulation of pesticides may be members of AAPCO as well. AAPCO holds meetings twice a year and publishes an annual handbookthat contains uniform policies and model pesticide legislation that the association has adopted. AAPCO aims to promote uniformand effective state legislation and pesticide regulatory programs. Its other objectives are to develop inspection procedures, to promote labeling and safe use of pesticides, to provide opportunities for members to exchange information, and to work with industry to promote the usefulness and effectiveness of pesticide products. State FIFRA Issues Research and Evaluation Group (SFIREG) P.O. Box 1249 Members: Hardwick, VT 05843 10 state representatives Phone: 802-472-6956 Fax: 802-472-6957 E-mail: [email protected] The State FIFRA Issues Research and Evaluation Group evolved in 1978 out Sector Notebook Project 172 September 2000 Agricultural Chemical Industry Activities and Initiatives of a cooperative agreement between the EPA’s Office of Pesticide Programs (OPP) and the Association of American Pesticide Control Officials (AAPCO). SFIREG is an independent but related body of AAPCO that provides state comments to the Office of Pesticide Programs on issues relating to the manufacture, use and disposal of pesticides. Its membership is comprised of ten state representatives, who represent and are selected by the states in each of the ten EPA Regions. Sector Notebook Project 173 September 2000 Agricultural Chemical Industry Activities and Initiatives VIII.C.2. Trade Associations Association of American Plant Food Control Officials (AAPFCO) University of Kentucky Members: 200 Division of Regulatory Services 103 Regional Services Building Lexington, KY 40546-0275 Phone: 606-257-2668 606-257-2970 Fax: 606-257-7351 The AAPFCO is an organization of state fertilizer control officials from the United States and Canada who are involved in the administration of fertilizer regulations and laws. The AAPFCO’s purpose is to achieve uniformity throughout their membership with regards to promoting effective legislation, adequate sampling, accurate labeling, and safe use of fertilizers, as well as to study and discuss relevant issues. Agricultural Retailers Association (ARA) 11701 Borman Dr., Ste. 110 Members:1,100 St. Louis, MO 63146 Staff: 17 Phone: 800-844-4900 Fax: 314-567-6808 The Agricultural Retailers Association was founded in 1954 and is made up of dealers, manufacturers, and suppliers of fluid fertilizers and agrichemicals, as well as equipment manufacturers, retail affiliations, and state association affiliates. ARA was formerly known as the National Nitrogen Solutions Association. Their publications include Agricultural Retailers AssociationMembership Directory and Buyer’s Guide (annual), Connections, a bimonthly newsletter, and the Fluid Fertilizer Manual. Fertilizer Industry Round Table (FIRT) 5234 Glen Arm Rd. Nonmembership Glen Arm, MD 21057 Phone: 410-592-6271 Fax: 410-592-5796 The Fertilizer Industry Round Table was founded in 1951. Participants include production, technical, and research personnel in the fertilizer industry. FIRT acts as a forum for discussion of technical and production problems. They hold an annual meeting and publish the proceedings. Sector Notebook Project 174 September 2000 Agricultural Chemical Industry Activities and Initiatives The Fertilizer Institute (TFI) 501 2nd St., NE Washington, DC 20002 Phone: 202-675-8250 Fax: 202-544-8123 Members: 300 Staff: 22 The Fertilizer Institute was founded in 1970 and now has 48 affiliated groups. Members include producers, manufacturers, retailers, trading firms, and equipment manufacturers. TFI represents members in various legislative, educational, and technical areas, and provides information and public relations programs. Publications include: Directory of Fertilizer References, annual; Fertilizer Facts and Figures, annual; Fertilizer Institute--Action Letter, monthly; Fertilizer Record, periodic. Chemical Manufacturers Association (CMA) 1300 Wilson Blvd. Members: 185 Arlington, VA 22209 Staff: 280 Phone: 703-741-5000 Fax: 703-741-6000 The Chemical Manufacturers Association was founded in 1872 and now has a budget of $36 million. CMA conducts advocacy and administers research areas of broad importto chemical manufacturing, such as pollution prevention and other special research programs. CMA also conducts committee studies, operates the Chemical Emergency Center (CHEMTREC) for guidance to emergency service on handling emergencies involving chemicals and the Chemical Reference Center which offers health and safety information about chemicals to the public. Publications include semi-monthly newsletters, ChemEcology and CMA News, and the CMA Directory and User’s Guide. Chemical Specialties Manufacturers Association (CSMA) 1913 Eye St., NW Members: 425 Washington, DC 20006 Staff: 31 Phone: 202-872-8110 Fax: 202-872-8114 The Chemical Specialties Manufacturers Association was founded in 1914 and is made up of manufacturers, marketers, formulators, and suppliers of household, industrial, and personal care chemical specialty products such as pesticides, cleaning products, disinfectants, sanitizers, and polishes. CSMA serves as a liaison to federal and state agencies and public representatives, provides information and sponsors seminars on governmental activities and scientific developments. Sector Notebook Project 175 September 2000 Agricultural Chemical Industry Activities and Initiatives American Crop Protection Association (ACPA) 1156 15th St., NW, Ste. 400 Members: 82 Washington, DC 20005 Staff: 29 Phone: 202-296-1585 Fax: 202-463-0474 The AmericanCrop Protection Association was founded in 1933 and now has a budget of $7 million. Members include companies involved in producing or formulating agricultural chemical products including agricultural fumigants, agricultural scalicides, chemical plant sprays and dusts, defoliants, soil disinfectants, weed killers, and others. It is comprised of legislative, regulatoryand science departments and publishes a periodic bulletin, manuals, Growing Possibilities, quarterly, and This Week and Next, weekly. Western Crop Protection Association (WCPA) 3835 N. Freeway Blvd. Ste. 140 Members: 170 Sacramento, CA 95834 Staff: 6 Phone: 916-568-3660 Fax: 916-565-0113 The WCPA is a regional organization of manufacturers, formulators, distributors, and dealers of basic pesticide chemicals and suppliers of solvents, diluents, emulsifiers, and containers. They are affiliated with the American Crop Protection Association. They publish several bulletins and periodicals. National Pest Control Association (NPCA) 8100 Oak St. Members: 2,300 Dunn Loring, VA 22027 Staff: 21 Phone: 703-573-8330 Fax: 703-573-4116 The National Pest Control Association was founded in 1933 and now has a budget of $2.8 million. Members include companies engaged in control of insects, rodents, birds, and other pests. NPCA provides advisory services on control procedures, new products, and safety and business administration practices. NPCA sponsors research at several universities, furnishes, technical information and advice to standards and code writing groups, and maintains an extensive library onpests. NPCA publishes many titles including manuals, newsletters, membership guides, technical releases, and reports. International Fertilizer Development Center (IFDC) PO Box 2040 Sector Notebook Project 176 Muscle Shoals, September 2000 Agricultural Chemical Industry Activities and Initiatives AL 35662 Phone: 205-381-6600 Fax: 205-381-7408 Nonmembership Staff: 180 The International Fertilizer Development Center was founded in 1974 and includes participants such as scientists, engineers, economists and specialists in market research and development and communications. IFDC uses a $13.5 million budget to try to alleviate world hunger by increasing agricultural production in the tropics and subtropics through development of improved fertilizers. IFDC sponsors and conducts studies in fertilizer efficiencies and offers courses on fertilizer production, environmental issues, and crop sustainability. They maintain greenhouses and laboratories, and publish several periodicals and manuals. United Products Formulators and Distributors Association(UPFDA) 1 Executive Concourse No. 103 Members: 102 Duluth, GA 30136 Staff: 1 Phone: 404-623-8721 Fax: 404-623-1714 The United Products Formulators and Distributors Association was founded in 1968 and is made up of companies engaged in formulating and distributing pesticide products. The UPFDA works to solve problems of member companies and promote sound and beneficial legislation and to cooperate with allied industries. North American Horticultural Supply Association (NAHSA) 1790 Arch St. Members: 135 Philadelphia, PA 19103 Staff: 3 Phone: 215-564-3484 Fax: 215-564-2175 The North American Horticultural Supply Association was founded in 1988 and represents horticultural supplies suchas greenhouse building materials and supplies, pesticides, and fertilizers. The NAHSA works to strengthen and enhance the relationship between manufacturers and distributors and promotes distribution in the market. They publish a quarterly newsletter, NAHSANews, and an annual Industry Calendar. American Agricultural Economics Association (AAEA) 1110 Buckeye Ave. Members: 4,500 Ames, IA 50010-8063 Staff: 6 Phone: 515-233-3202 Fax: 515-233-3101 Sector Notebook Project 177 September 2000 Agricultural Chemical Industry Activities and Initiatives The American Agricultural Economics Association, founded in 1910, is a professional society of state, federal, and industrial agricultural economists, teachers, and extension workers. The AAEA works to further knowledge of agricultural economics through scientific research, instruction, publications, meetings, and other activities. They publish a bimonthly newsletter, a semi- bimonthly American Journal of Agricultural Economics, a quarterly magazine Choices, and a biennial Handbook Directory. Institute for Agriculture and Trade Policy (IATP) 1313 5th St., SE, No. 303 Minneapolis, MN 55414 Phone: 612-379-5980 Fax: 612-379-5982 The IATP was founded in 1986 and has an annual budget of $1.15 million. They maintain a speakers bureau and conduct research programs on trade agriculture, global institutions, North-South relations, and the Third World. They publish several periodical bulletins. California Fertilizers Association (CFA) 1700 I St., Ste. 130 Sacramento, CA 95814 Phone: 916-441-1584 Fax: 916-441-2569 The CFA represents fertilizer manufacturers, distributors, wholesalers, and retail dealers that sell products within California. They maintain a legislative hotline and publish studies and handbooks on issues pertaining to fertilizers. Sector Notebook Project 178 September 2000 Agricultural Chemical Industry Activities and Initiatives American Society of Agronomy (ASA) 677 S. Segoe Rd. Members: 12,500 Madison, WI 53711 Staff: 30 Phone: 608-273-8080 Fax: (608) 273-2021 The ASA was founded in 1907 and presently operates on a budget of 2.5 million dollars per year. ASA is a professional society of plant breeders, soil scientists, chemists, educators, technicians, and other concerned with crop production and soil management. ASA sponsors fellowship programs and provides placement service. ASA publishes annual, bimonthly, and monthly periodicals as well as special publications. Potash and Phosphate Institute (PPI) 655 Engineering Drive No. 110 Norcross, GA 30092 Phone: 770-447-0335 Fax: 770-448-0439 Members: 14 Staff: 30 PPI supports scientific research in the areas of soil fertility, soil testing, plant analysis, and tissue testing. PPI participates in farmers meetings, workshops, and training courses and publish a quarterly magazine, Better Crops with Plant Food. Sector Notebook Project 179 September 2000 Agricultural Chemical Industry Activities and Initiatives THIS PAGE WAS INTENTIONALLY LEFT BLANK Sector Notebook Project 180 September 2000 Agricultural Chemical Industry Contacts and References IX. CONTACTS/ACKNOWLEDGMENTS/RESOURCE MATERIALS For further information on selected topics within the Fertilizer, Pesticide, and Agricultural Chemical Industry, a list of contacts and publications are provided below. Contacts6 Name Organization Telephone Subject Michelle C. Yaras EPA, Office of Enforcement and Compliance Assurance (OECA), Agriculture and Ecosystems Division, Agriculture Branch 202 564-4153 Notebook Contact Arty Williams EPA, Office of Prevention, Pesticides and Toxic Substances (OPPT) 703 305-5239 Ground Water Pesticide Management Plan Rule Jean Frane EPA, OPPT 703 305-5944 Food Quality Protection Act Paul Parsons EPA, OPPT 703 308-9073 FIFRA Data Requirements David Stangel EPA, OECA 202 564-4162 Stored or Suspended Pesticides; Good Laboratory Practice Standards; Pesticide Management and Disposal Joseph Hogue EPA, OPPT 703 308-9072 FIFRA Restricted Use Classifications Robert McNally EPA, OPPT 703 308-8085 FIFRA Pesticide Tolerances Joseph Nevola EPA, OPPT 703 308-8037 FIFRA Pesticide Tolerances Ellen Kramer EPA, OPPT 703 305-6475 FIFRA Pesticide Tolerances Carol Peterson EPA, OPPT 703 305-6598 FIFRA Tolerance Fee Structure Robert A. Forrest EPA, OPPT 703 308-9376 FIFRA Exemptions Nancy Fitz EPA, OPPT 703 305-7385 FIFRA Pesticide Management and Disposal Cathleen Barnes EPA, OPPT 703 305-7101 FIFRA Prior Informed Consent John MacDonald EPA, OPPT 703 305-7370 Certification and Training Kevin Keaney EPA, OPPT 703 305-5557 FIFRA Worker Protection Standards 6 Many of the contacts listed above have provided valuable information and comments during the development of this document. EPA appreciates this support and acknowledges that the individuals listed do not necessarily endorse all statements made within this notebook. Sector Notebook Project 181 September 2000 Agricultural Chemical Industry Contacts and References The following people received a draft copy of this Sector Notebook and may have provided comments. Name Organization Telephone Paul Bangser EPA, Office of General Counsel, Water Division 202 260-7630 Philip J. Ross EPA, Office of General Counsel, Pesticides and Toxic Substances Division 202 260-0779 Don Olson, Chief EPA, Industrial Branch, OECA, Office of Regulatory Enforcement, Water Enforcement Division 202 564-5558 Jon Jacobs EPA, OECA, Office of Regulatory Enforcement, Case Development, Policy and Enforcement Branch -Eastern Regions, Toxics and Pesticides Enforcement Division 202 564-4037 Jerry Stubbs EPA, Case Development, Policy and Enforcement BranchWestern Regions, Toxics and Pesticides Enforcement Division, Office of Regulatory Enforcement 202 564-4178 Anne E. Lindsay, Director EPA, Field and External Affairs Division Office of Pesticide Programs 703 305-5265 Marcia E. Mulkey, Director EPA, Office of Pesticide Programs 703 305-7090 Artie Williams, Chief EPA, Environmental Field Branch, Field and External Affairs Division, Office of Pesticide Programs 703 305-5239 Seth Heminway EPA, OC Sector Notebook Coordinator 202 564-7017 Sam Silverman EPA, Enforcement Coordinator Region 1 617 565-3443 Laura Livingston EPA, Enforcement Coordinator Region 2 212 637-4059 Samantha Fairchild EPA, Enforcement Coordinator Region 3 215 814-5710 Sherri Fields EPA, Enforcement Coordinator Region 4 404 562-9684 Tinka Hyde EPA, EPA, Enforcement Coordinator Region 5 312 886-9296 Robert Lawrence EPA, Enforcement Coordinator Region 6 214 665-6580 Diane Callier EPA, Enforcement Coordinator Region 7 913 551-7459 Mike Gaydosh EPA, Enforcement Coordinator Region 8 303 312-6773 Jo-Ann Semones EPA, Enforcement Coordinator Region 9 415 744-1547 Ron Kreizenbeck EPA, Enforcement Coordinator Region 10 206 553-1265 Edward M. White Assistant Pesticide Administrator, Indiana State Chemist Office, Purdue University 765 494-1587 Sector Notebook Project 182 September 2000 Agricultural Chemical Industry Contacts and References Dale Dubberly, Chief Bureau of Compliance Monitoring Florida Department of Agriculture & Consumer Services 850 488-8731 Robin Rosenbaum Pesticide Registration Manager, Pesticide & Plant Pest Management Division, Michigan Department of Agriculture 517 335-6542 Buzz Vance Nebraska Department of Agriculture 402 471-6853 Donnie Dippel Assistant Commissioner, Pesticide Programs, Texas Department of Agriculture 512 463-7476 Paul Kindinger Agricultural Retailers Association (ARA) 314 567-6655 Joel Padmore Association of American Plant Food Control Officials (AAPFCO), Food & Drug Protection Division North Carolina Department of Agriculture 919 733-7366 Renee Pinel California Fertilizers Association 916 441-1584 Mark Muller Institute for Agriculture and Trade Policy 612 870-3420 Rick Kirchhoff National Association of State Departments of Agriculture (NASDA) 202 296-9680 Robert Rosenberg National Pest Control Association 703 573-8330 Robert E. Roberts Executive Director Environmental Council of States (ECOS) 202 624-3660 Diane Bateman The Fertilizer Institute (TFI) 202 675-8250 Jay Vroom American Crop Protection Association 202 296-1585 Sector Notebook Project 183 September 2000 Agricultural Chemical Industry Contacts and References Section II: Introduction to the Fertilizer, Pesticide, and Agricultural Chemical Industry 1992 Census of Manufacturers Industry Series: Agricultu
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