Fluoride: The Ultimate Cluster-Flux And the Players Involved A

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
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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.
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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:
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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:
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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)
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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
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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
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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:
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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
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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
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The name of this organization shall be the American
Dental Association, hereinafter referred to as “the
Association” or “this Association.”
ARTICLE II • OBJECT
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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
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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.
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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.
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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.
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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.
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Section
50.
CONSTITUENT
SOCIETIES:
Constituent societies of this Association shall be
Constitution
Bylaws
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those dental societies or dental associations chartered
as such in conformity with Chapter II of
the Bylaws.
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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.
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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
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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.
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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
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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.
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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
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The annual session of this Association shall be
conducted in accordance with Chapters V and XV of
the Bylaws.
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Constitution
Bylaws
ARTICLE VII • PRINCIPLES OF ETHICS AND
CODE OF PROFESSIONAL CONDUCT
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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
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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
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8
Bylaws
• • • • • • • • • • • • • • • • • • • • • • • • • •
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CHAPTER I • MEMBERSHIP
Section 10. CLASSIFICATION: The members of this
Association shall be classified as follows:
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Active Members
Life Members
Retired Members
Nonpracticing Dentist Members
Student Members
Honorary Members
Provisional Members
Associate Members
Affiliate Members
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Section 20. QUALIFICATIONS, PRIVILEGES,
DUES AND SPECIAL ASSESSMENTS:
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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
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membership in the constituent or component
society because the dentist is not licensed in the
territorial jurisdiction of that constituent.
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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.
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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.
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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
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CHAPTER I • MEMBERSHIP
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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
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CHAPTER I • MEMBERSHIP
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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
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Bylaws
CHAPTER I • MEMBERSHIP
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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.
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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
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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.
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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
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CHAPTER I • MEMBERSHIP
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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.
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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.
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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
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CHAPTER I • MEMBERSHIP
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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.
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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
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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
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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.
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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
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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
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CHAPTER VI • CONFLICT OF INTEREST
CHAPTER VII • BOARD OF TRUSTEES
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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
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1704
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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
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1712
1713
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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
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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
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1729
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1734
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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.
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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.
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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.
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CHAPTER VII • BOARD OF TRUSTEES
1778
Seconding a nomination is not permitted.
1779
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1781
Section 50. ELECTION: The trustee shall be elected
by the House of Delegates according to the following
rules:
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1784
A. If there is only one (1) nominee from a trustee
district, the Speaker shall declare such nominee
elected.
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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
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1797
Section 60. INSTALLATION: The trustee shall be
installed by the President or by the President’s
designee.
1798
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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.
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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.
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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
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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
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1862
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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
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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
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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
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CHAPTER VII • BOARD OF TRUSTEES
1882
House of Delegates.
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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
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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.
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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
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CHAPTER VII • BOARD OF TRUSTEES
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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.
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2049
2050
2051
2052
2053
2054
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2057
2058
2059
2060
2061
2062
2063
2064
2065
2066
2067
2068
2069
2070
2071
2072
2073
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2077
2078
2079
2080
2081
2082
2083
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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
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CHAPTER VII • BOARD OF TRUSTEES
CHAPTER VIII • ELECTIVE OFFICERS
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2092
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2094
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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.
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Section 30. NOMINATIONS:
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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.
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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
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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.
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Section 40. ELECTIONS: The elective officers shall
be elected in accordance with Chapter V, Section 150.
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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.
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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.
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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.
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Section 80. VACANCIES:
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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
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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.
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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:
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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
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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.
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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.
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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.
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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.
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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.
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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
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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
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Section 10. TITLE: The appointive officer of this
Association shall be an Executive Director, as
provided in Article V of the Constitution.
2320
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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
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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.
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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
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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
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Section 10. NAME: The councils of this Association
shall be:
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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:
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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.
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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
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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
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2410
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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
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2417
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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
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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
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2458
2459
2460
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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.
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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
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2471
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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
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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.
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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.
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2501
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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
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2509
nominations open to all trustee districts, and the
current recipient of the Gold Medal Award for
Excellence in Dental Research.
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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
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2529
2530
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2533
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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
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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
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2546
2547
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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
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2553
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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.
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2560
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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.
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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:
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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
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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
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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
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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.
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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
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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
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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
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CHAPTER XII • PRINCIPLES OF ETHICS AND
CODE OF PROFESSIONAL CONDUCT AND
JUDICIAL PROCEDURE
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3119
3120
3121
3122
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3124
3125
3126
3127
3128
3129
3130
3131
3132
3133
3134
3135
3136
3137
3138
3139
3140
3141
3142
3143
3144
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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.
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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
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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
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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
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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.
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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
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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.
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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.
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Bylaws
CHAPTER XIII • AMERICAN DENTAL
ASSOCIATION FOUNDATION
CHAPTER XIV • COMMISSIONS
3333
Section 30. DUTIES:
3334
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3336
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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.
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3343
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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.
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3352
3353
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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.
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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
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3363
Section 10. NAME: The commissions of this
Association shall be:
Commission on Dental Accreditation
Joint Commission on National Dental Examinations
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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
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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.
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3405
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3408
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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.
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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:
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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.
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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.
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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.
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3470
D. No member of a commission may serve
concurrently as a member of a council or another
commission.
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3473
E. CHAIRS. The Commissions of this Association
shall elect their own chairs who shall be active, life or
retired members of this Association.
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3475
Section 50. CONSULTANTS, ADVISERS AND
STAFF:
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3484
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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
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Bylaws
71
CHAPTER XIV • COMMISSIONS
3489
auxiliary educational programs.
3490
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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.
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3501
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3504
3505
3506
3507
3508
3509
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3515
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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.
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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
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3546
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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.
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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.
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3562
3573
3574
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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.
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3581
3582
3583
3584
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3588
3589
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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
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3565
3566
3567
3568
3569
3570
3571
3572
Bylaws
73
CHAPTER XIV • COMMISSIONS
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3599
3600
3601
3602
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3604
3605
3606
3607
3608
3609
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3613
3614
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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.
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3620
3621
3622
3623
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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.
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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
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Australia
China
India
Indonesia
Japan
Malaysia
Pakistan
Philippines
South Korea
Singapore
Taiwan
Thailand
Vietnam
Africa
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Cote d'Ivoire
Ghana
Kenya
Malawi
Morocco
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Nigeria
South Africa
Tanzania
Zimbabwe
Central America/Caribbean
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Bonaire
Costa Rica
Dominican Republic
Guatemala
Honduras
Nicaragua
Europe
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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
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Egypt
United Arab Emirates
North America
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Canada
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Mexico
United States of America
South America
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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:
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Fluoride toothpaste
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Fluoride mouthrinse
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Fluoride supplements
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Fluoride gel and foam - professionally applied
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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)
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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]
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| 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]
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| 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]
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| 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]
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| 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]
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| 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]
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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]
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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]
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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]
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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]
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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.]
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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.]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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.]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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.]
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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]
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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]
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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.]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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.]
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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.]
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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.]
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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]
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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]
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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]
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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]
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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]
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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]
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"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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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.]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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;
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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
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Complimentary volumes are available to certain groups or subscribers, including public and
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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.
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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
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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
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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
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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
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Table 30: Fertilizer, Pesticide, and Agricultural Chemical Industry Participation in the 33/50 Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
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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
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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
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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
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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
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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.
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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
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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,
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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.
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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.
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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,
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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.
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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.
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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),
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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.
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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
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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)
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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
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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).
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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
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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
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Figure 7: Typical Process of Ammonia Synthesis
Source: United States EPA, 1993a.
(Hodge, 1994). Zinc oxide is replaced rather than regenerated, which lowers
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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
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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
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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
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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
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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.
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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.
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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)
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concentration
solids formation
finishing
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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.
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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
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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).
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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
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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.
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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
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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
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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
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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).
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Figure 14: Typical Process for Normal Superphosphate Manufacturing
Source: United States EPA, 1993a.
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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).
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Figure 15: Typical Process for Triple Superphosphate
Industrial Process Description
Source: United States EPA, 1993a
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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).
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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).
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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.
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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).
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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
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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.
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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).
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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).
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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
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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
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C
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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
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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
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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).
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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
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type of tower bed
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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
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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
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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:
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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
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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:
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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
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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).
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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
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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
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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
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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
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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).
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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.
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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
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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.
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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
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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)
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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.
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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
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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
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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
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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
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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)
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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
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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
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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
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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
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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
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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).
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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
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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.
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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
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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
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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.
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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
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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
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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
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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”).
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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
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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
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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),
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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
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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.
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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
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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.
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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.
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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
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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.
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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.
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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
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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
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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.
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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
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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:
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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
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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
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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.
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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.
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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
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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
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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)
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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
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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).
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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.
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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
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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).
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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
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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
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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.
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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.
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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
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•
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
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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.
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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.
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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.
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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
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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)
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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
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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.
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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.
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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
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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
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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
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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.
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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.
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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.
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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
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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
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Section II: Introduction to the Fertilizer, Pesticide, and Agricultural Chemical Industry
1992 Census of Manufacturers Industry Series: Agricultu