Minnesota Department of Health Environmental Health Tracking and Biomonitoring Advisory Panel Meeting June 7, 2011 1:00 p.m. – 4:00 p.m. Snelling Office Park Red River Room 1645 Energy Park Drive St. Paul, Minnesota Time Agenda item Presenter(s) Item type/Anticipated outcome 1:00 Welcome and introductions Bruce Alexander, Chair Members and audience members are invited to introduce themselves. TRACKING 1:05 New State Tracking Content Initiatives 1. Environmental Tobacco Smoke (ETS) 2. Arsenic in Private Wells 1:40 MDH staff: Jeannette Sample Blair Sevcik Larry Souther Mike Convery Decision Item Staff will review the selection process for new Minnesota-specific content areas for Tracking and review the progress through that selection process for ETS Exposure and Private Wells. Panel members are invited to ask questions or provide input on new content areas. The chair will invite panel members to vote to recommend the ETS content area for ongoing tracking. (see proposed language) Tracking Updates 1.Portal launch 2.Communications 3. CDC initiatives Updates are provided on Tracking topics in the panel meeting materials. No presentation is planned. Panel members are invited to ask questions about any of these topics. BIOMONITORING 1:45 CDC Biomonitoring Communication Research Claudia Vousden, CDC Jean Johnson Information sharing Claudia Vousden (CDC) and Jean Johnson will describe results of recent collaboration on a biomonitoring communications research project in Minnesota’s East Metro PFC project community. Panel members are invited to ask questions or offer input on ways to improve future biomonitoring communications with affected communities. i Time Agenda item 2:15 Project Updates: 1. East Metro PFC Follow-up 2. Lake Superior Mercury 2:25 Presenter(s) Item type/Anticipated outcome Brief updates on the biomonitoring projects are provided (tentative). Panel members are invited to ask questions or provide input about the status of any of these projects. Break 2:40 Riverside Prenatal Project: Preliminary results for environmental phenols Jessica Nelson Logan Spector Discussion Item Staff will present preliminary results from the Riverside prenatal biomonitoring study and describe plans for disseminating the results. Panel members are invited to offer feedback on the analyses, and to make recommendations for communicating the findings and for further action based on pilot study results. UMN PI Logan Spector will join the discussion, in which panel members are asked to respond to the following questions: Considering the limitations in study size and the available data presented, what conclusions can be drawn and what, if any, additional analyses are recommended? Is further biomonitoring in this community recommended? 3:20 Strategic Planning Barbara Scott Murdock 3:45 Legislative Update Jeanne Ayers/ Aggie Leitheiser Discussion item. Update on stakeholder involvement & suggestions for an ongoing MDH biomonitoring program: target populations & analytes. Panel members are invited to ask questions and provide input on future planning, partnerships and funding strategies. Assistant Commissioners will discuss the current state budget proposals for fiscal years 2012-2013 and likely impact on EHTB program. 3:55 New business Bruce Alexander 4:00 Adjourn The chair will invite panel members to suggest topics for future meetings. Next meeting: Tuesday, September 13, 2011, 1-4 p.m. Red River Room, Snelling Office Park ii TABLE OF CONTENTS Agenda............................................................................................................. i Table of Contents ........................................................................................... iii MATERIALS RELATED TO SPECIFC AGENDA ITEMS Section overview: New Content Areas for Tracking in Minnesota .................... 1 Section overview: Tracking Updates.............................................................. 15 Section overview: CDC Biomonitoring Communications Evaluation Project ... 21 Section overview: Biomonitoring Updates .................................................... 23 Section overview: Riverside Prenatal Biomonitoring Pilot Project .................. 27 Section overview: Strategic Planning for an MDH Biomonitoring Program ..... 35 Section overview: Other Information ............................................................. 41 iii This page intentionally left blank. iv SECTION OVERVIEW: New Content Areas for Tracking in Minnesota Minnesota state law (Minn. Stat. Section 144.998) states that the EHTB advisory panel shall advise the commissioner of MDH and the Legislature on priorities for tracking, including specific chronic diseases and specific environmental hazards. In March 2010, the advisory panel provided input on a draft set of criteria for evaluating new tracking content areas and/or new measures within existing content areas. In September 2010, MN EPHT staff presented a refined selection process that incorporated feedback from panel members (such as a phased approach and earlier input by the advisory panel). In March 2011, the refined selection process was used to present a new Minnesota‐specific content area that is under consideration: ETS Exposure. In June 2011, another new Minnesota-specific content area of Arsenic in Private Wells will be discussed using Phase I of the selection process. Selection Process The selection process, as currently conceived, is broken down into several phases: exploration, feasibility, recommendation, and implementation. The selection process includes many points at which the Advisory Panel may be approached or updated throughout the selection process. The full selection process and list of criteria for new Minnesota-specific content areas and measures can be found in the March 2011 Advisory Panel meeting materials. ETS Exposure as a New Content Area for Tracking in Minnesota ETS Exposure was used to pilot the selection process criteria. At the March 2011 meeting, MN EPHT staff provided an overview of the selection process for ETS Exposure. The panel considered a motion to recommend the new content, but had no quorum. At this meeting (June 2011), panel members will be invited to make a motion and vote to recommend to the Commissioner that the ETS Exposure content area be adopted and implemented as part of the Tracking program. Arsenic in Private Wells as a New Content Area for Tracking in Minnesota Staff will present evaluation criteria from Phase I of the selection process, exploring Arsenic in Private Wells as a new Minnesota-specific content area. Panel members are invited to ask questions (no vote is expected). The following items are included in this section of the meeting materials: Summary of evaluation criteria for ETS exposure Selected data & measures for ETS exposure Phase I of evaluation criteria for Arsenic in Private Wells ACTION NEEDED: Panel members are invited to ask questions or provide input on ETS Exposure and Arsenic in Private Wells as new content areas for Tracking. The chair will invite panel members to make a motion and vote to recommend to the Commissioner of Health that the ETS Exposure content area be adopted as a new content area for ongoing Tracking in Minnesota. Suggested motion: I move that the panel recommend adding ETS as a new content area for the environmental health tracking program. 1 Data Sources: (1) Youth Tobacco Survey and (2) Adult Tobacco Survey NOTE: Both data sources are survey data Phase I: Exploration Prevalence Question Is there a high estimated proportion of the population that is exposed to ETS? Answer Yes, a high proportion of the general population of nonsmoking adults and children in the US are exposed to ETS; 43% of nonsmokers ≥4 years of age have cotinine levels that indicate exposure to tobacco smoke (≥0.5µg/dL). Causality Question Is there evidence that ETS exposure is a component cause of adverse health outcomes? Answer Yes, several known adverse health effects are linked to ETS exposure in children and adults. Known human carcinogen(s) Developmental and respiratory effects in children Respiratory, carcinogenic, and cardiovascular effects in adults Actionability Question Are there existing prevention or control programs at MDH or other Minnesota organizations for ETS exposure or its adverse health outcomes? Can the level of ETS exposure be modified through policy, regulatory, or personal actions? Is ETS exposure tied to state or federal public health objectives? Answer Yes, several existing programs measure or attempt to prevent ETS exposure or its adverse health outcomes: Youth and Adult Tobacco Surveys Tobacco Prevention & Control Program (MDH) Center for Health Statistics (MDH) Asthma Program (MDH) Minnesota Cancer Surveillance System (MDH) American Lung Association of Minnesota ClearWay Minnesota and QUITPLAN Yes, smoking bans enforced by adults or other nonsmokers and other personal actions can reduce ETS exposure. Freedom to Breathe (FTB), enacted in Oct 2007, prohibits smoking in virtually all indoor public places and indoor places of employment. FTB does not prohibit smoking in outdoor places or private spaces such as a car or home. Yes, five Healthy People 2020 Objectives under the Tobacco Use (TU) topic target ETS exposure. 1. TU-11: Reduce the proportion of nonsmokers exposed to secondhand smoke. 2 Can data and measures in this content area be used to develop new program initiatives? 2. TU-12: Increase the proportion of persons covered by indoor worksite policies that prohibit smoking. 3. TU-13: Establish laws… on smoke-free indoor air that prohibit smoking in public places and worksites. 4. TU-14: Increase the proportion of smoke-free homes. 5. TU-15: Increase tobacco-free environments in schools, including all school facilities, property, vehicles, and school events. www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?to picid=41 Existing programs target either ETS exposure or its adverse health outcomes. Tracking this content area can link the topics of exposure with health outcome by bringing together information on MN EPHT’s online data access portal. Public Health Impact Question Can the population attributable risk (PAR) or public health impact of exposure to ETS be estimated from available data? Or is the PAR known? Answer Yes, Waters et al. (2009) estimated the economic impact and PAR of ETS exposure in Minnesota in 2003. PAR: Waters et al. (2009) also provides the PAR for several adverse health outcomes (see table below) among Minnesota children and adults in 2003. Public health impact: the total cost of treatments that are causally linked to ETS (2006 U.S. Surgeon General’s Report) was estimated at about $229 million, adjusted to 2008 dollars. Table: Costs of Conditions Attributable to Secondhand Tobacco Smoke (SHS), by Age Group, Minnesota, 2003. Aged 0-17 years Low birthweight Acute lower-respiratory illnesses Otitis media & middle-ear effusion Asthma, wheeze illness Aged 18-64 years Lung cancer Coronary heart disease Aged 65+ years Lung cancer Coronary heart disease Grand total Episodes PAR, % Episodes attributable to ETS Cost per episode, 2003 $ Total cost, millions, 2008 $ 4,413 31,953 235,333 18.0 25.0 14.0 794 7,988 32,947 41,790 848 521 40.3 8.2 20.9 50,135 35.0 17,547 1,052 22.4 3,466 73,914 4.9 6.9 170 5100 23,200 9,650 4.8 59.7 4,450 28,033 4.9 6.9 218 1934 58,303 24,252 15.4 56.9 228.7 Source: Table 4 from Waters HR, Foldes SS, Alesci NL, Samet J. The Economic Impact of Exposure to Secondhand Smoke in Minnesota. Am J Public Health. 2009; 99 (4): 754-759. 3 (Initial) Feasibility Question Is there a data source for exploration of “trackable” indicators? Answer Yes, two data sources have data on ETS exposure among nonsmokers in Minnesota: Minnesota Youth Tobacco (and Asthma) Survey and Minnesota Adult Tobacco Survey (Center for Health Statistics, MDH). Yes, the Center for Health Statistics has legal authority to collect and use these data. Yes, private data are classified and protected. Personal identifiers do not exist in data provided to the Tracking program. Suppression could be applied to small cell counts for privacy. Does MDH have the legal authority to collect and use the data? Are private data classified and protected according to state and federal law? **END OF PHASE I: EXPLORATION** Phase II: Feasibility Detailed Feasibility Question What is the level of quality of the data? Is there continuity? Are the data timely? Are the data comparable? Is aggregation possible at different geographic levels? What is the cost to MDH to obtain data? Piloted Data & Measures Answer The data are: population-based representative of ETS exposure assumed to be reliable and valid Yes, data collection has been consistent over time; the YTS and ATS have been conducted since 2000 and 2003, respectively. Yes, datasets for both surveys are typically available within a year of data collection. Youth Tobacco Survey (YTS): It is possible to compare the youth survey to its national counterpart and to other states that conduct that survey. For example, CDC’s Office on Smoking & Health indicates that Minnesota and 15 other states conducted the YTS in 2008. Adult Tobacco Survey (ATS): The National ATS was conducted in 2009-2010 and should have data on ETS exposure in different settings. CDC has a set of core questions for states conducting an ATS, but it is unclear how many states ask standardized questions on ETS exposure. Comparability at the state-level could be explored. For both surveys, data are available at the state level; in addition, it is possible to compare regions, particularly the Twin Cities metro area vs. nonmetro regions. Aggregation is possible between years for both surveys. The cost to MDH to obtain data is minimal staff time to complete these steps is reasonable. Measure: count (#) and percent (%) of nonsmokers exposed to ETS in Minnesota. **END OF PHASE II: FEASIBILITY** 4 Phase III: Recommendation Emerging Issues Question Is the degree or level of exposure changing or perceived to be changing? Answer The level of exposure in indoor public spaces (such as worksites, restaurants, and bars) has decreased with the enactment of Freedom to Breathe in October 2007. The degree of exposure in homes, cars, and outdoor spaces has likely remained the same on a population level. It’s possible that the individual level of exposure is decreasing where parents or guardians enforce smoking bans in the home or car. Potential for Information Building Question Is this a hazard with unknown associations to health outcomes or unknown levels of exposure in the population? Would other programs at MDH be interested in this content area? Answer Exposure to ETS has many known adverse health outcomes. It’s possible that unknown associations are yet to be discovered. The level of exposure to ETS at the population level is measured via cotinine (NHANES) and via surveys (such as the Youth and Adult Tobacco Surveys). Yes, the Center for Health Statistics, the Asthma Program, and the Tobacco Prevention & Control Program could all potentially benefit from display of these data and measures on MN EPHT’s web-based data access portal and/or from topical reports on this content area. For example, the Asthma Program is interested in resources that would be generated on this new content area, such as a data brief on ETS exposure. Outside Interest or Public Concern Question Is there a high concern about the proportion of the population exposed to the hazard? Is ETS exposure a priority that has previously been identified by environmental health organizations? Would this content area utilize existing datasets in a new way? Answer The proportion of the population exposed to ETS should not have increased in recent years, especially among nonsmokers. However, concern about exposure to ETS among vulnerable populations, such as children and pregnant women, remains high. Healthy People 2020 has several objectives that target reducing the level of exposure to ETS, especially among vulnerable populations like children and pregnant women; increasing smoke-free venues is one way to achieve this. NHANES measures cotinine to track the level of ETS exposure among nonsmokers. The Minnesota Center for Health Statistics (MDH) currently publishes detailed reports using Youth or Adult Tobacco Survey data. MN EPHT would present data and measures on ETS exposure among nonsmokers, which is not currently addressed by existing reports. By focusing on nonsmokers, MN EPHT would present these data in a new way. 5 Balance among content areas Question Is there balance between hazard/exposure and disease content areas? Is there balance between age groups affected among content areas? Answer Yes, there is balance. MN EPHT currently tracks four hazard/exposure content areas and four disease content areas. Exposure to ETS would be a content area that especially affects children, but also affects adults and the elderly. Moreover, the current representation of age groups affected by the content areas that MN EPHT tracks is balanced. Economic Impact Question What is the economic impact in Minnesota of adding this content area? Answer Adoption of ETS exposure will require the time and resources of MN EPHT staff to incorporate the content area into Tracking. Adoption will also require the resources of Minnesota Center for Health Statistics staff as the data steward for both data sources. Adoption may also affect the work of the Tobacco Prevention & Control Program (MDH) as well as local public health programs that have ongoing initiatives to reduce or measure ETS exposure. Adoption would require collaboration with Tobacco Prevention & Control staff to produce standardized messaging and interpretation of data. **END OF PHASE III: RECOMMENDATION** 6 Youth Tobacco Survey (YTS) Table 1. Proportion of youth exposed to ETS* in past week among nonsmokers, Minnesota, 2000-2008. Year Count N % 2000 5144 8551 60.2% 2002 4702 8367 56.2% 2005 4121 8199 50.3% 2008 1499 3737 40.1% Aggregated 15466 28854 53.6% * Exposed in the setting of “same room” OR “in a car” Weighted % 58.8% 56.5% 50.8% 41.1% 51.5% Percent of nonsmokers exposed to ETS in same room or same car Figure 1. Proportion of youth exposed to ETS* in past week among nonsmokers, Minnesota, 2000-2008. 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 2000 2002 2005 Year * Exposed in the setting of “same room” OR “in a car” 7 2008 Adult Tobacco Survey (ATS) Table 1. Proportion of nonsmokers exposed to ETS in the past week by exposure setting, Minnesota adults, 2003-2010. Year 2003 2007 2010 Aggregated Count 497 399 157 1053 N 6996 10608 5922 23526 At home % 7.1% 3.8% 2.7% 4.5% Weighted % 7.4% 4.4% 3.5% 5.0% Year 2003 2007 2010 Aggregated Count 651 566 187 1404 N 4559 6264 3337 14160 At work % 14.3% 9.0% 5.6% 9.9% Weighted % 13.9% 11.1% 7.4% 10.8% N 7000 10622 5930 23552 In a car % 10.5% 8.1% 6.1% 8.3% Weighted % 10.5% 9.8% 8.2% 9.5% Year 2003 2007 2010 Aggregated Count 734 860 359 1953 Figure 1. Proportion of nonsmokers exposed to ETS in the past week by exposure setting, Minnesota adults, 2003-2010. At home At work In a car Percent of nonsmokers exposed to ETS by exposure setting 16.0% 14.0% 12.0% 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% 2003 2007 8 2010 Table 2. Proportion of nonsmokers exposed to ETS in the past week in the community,† Minnesota adults, 2003-2010. Year Count N % Weighted % 2003 3541 6946 51.0% 54.5% 2007 4236 10587 40.0% 41.0% 2010 1561 5896 26.5% 29.0% Aggregated 9338 23429 39.9% 40.5% † Exposure in the community is measured by the following survey question: “In Minnesota, in the past 7 days, has anyone smoked near you at any place besides your home, workplace or car?” Figure 2. Proportion of nonsmokers exposed to ETS in the past week in the community, † Minnesota adults, 2003-2010. Percent of nonsmokers exposed to ETS at any location 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 2003 2007 2010 † Exposure in the community is measured by the following survey question: “In Minnesota, in the past 7 days, has anyone smoked near you at any place besides your home, workplace or car?” 9 Content Area: Arsenic in Private Wells Data Sources: Wells (linked to County W ell Index) Phase I: Exploration Resources available Question Is there staff time/interest/expertise? Are there financial and technical resources available? Answer Staff have expertise and interest; their time on the content area depends on funding. Completion of Phase II onward is resource dependent. Resources after June 30, 2011 are unknown. Prevalence Question Is there a high estimated proportion of the population that is exposed? [OR] Is there a high estimated prevalence of disease or outcome? Answer Nearly 37 million Americans, many living in remote areas outside of the public drinking water distribution system, obtain their drinking water from private wells or other small systems known as unregulated drinking water sources (UDWS).1 About 1 million Minnesotans rely on private wells.2 The U.S. Environmental Protection Agency (U.S. EPA) regulates the levels of arsenic and other contaminants allowed in public drinking water. The standard for arsenic in public drinking water supplies is a maximum contaminant level (MCL) of 10 micrograms per liter (μg/L). After an initial test at the time a private well is drilled, private drinking water wells are not required to meet federal MCLs or any state standards.3 Surveys of U.S. drinking water indicate that about 2% of water supplies exceed 20 μg/L of arsenic.4 In Minnesota, 9% of new 1 Backer, Lorraine C. and Tosta, Nancy. “Unregulated Drinking Water Initiative for Environmental Surveillance and Public Health.” Journal of Environmental Health. 73(7):31-32. 2 Minnesota Department of Health. Well Management Program. http://www.health.state.mn.us/divs/eh/wells/ Accessed May 17, 2011. 3 Minnesota Department of Health. “Arsenic in Drinking Water and Your Patients’ Health.” Available at: http://www.health.state.mn.us/divs/eh/hazardous/topics/arsenicfct.pdf 4 Agency for Toxic Substances and Disease Registry (ATSDR). Toxicology Profile for Arsenic. August 2007. 10 wells sampled for arsenic levels exceeded 10 μg/L.5 Some groundwater in Minnesota has arsenic as high as 150 μg/L.3 Arsenic can occur in groundwater nearly anywhere in Minnesota. Groundwater from the Twin Cities to the South Dakota border, and north along Minnesota’s border with the Dakotas is more likely to contain elevated levels of arsenic. However, arsenic levels can vary from one well to the next, even within a very small area.6 Causality Question Is there evidence that exposure is a component cause of adverse health outcomes? [OR] Is there evidence that that the disease has an environmental component cause? Answer The health effects of arsenic depend on its chemical form, how much enters the body, how it enters the body, how long it stays in the body, and on the unique health status of the exposed person. Inorganic arsenic is fatal at doses much higher—60,000 micrograms (µg)—than naturally occurring concentrations in the environment (most people consume about 3.5 micrograms of inorganic arsenic per day from food and water).7 Over time, daily consumption of relatively lower concentrations of arsenic found in drinking water, combined with arsenic naturally occurring in the diet, can cause a number of harmful effects on the human body. Arsenic is not significantly absorbed through the skin, so activities such as dishwashing and bathing or showering are not significant exposure routes.8 Long-term consumption of drinking water with arsenic levels over 100 μg/L has been associated with health effects including nervous system problems, diabetes, and several circulatory diseases.8 Some studies have now shown that arsenic levels below 100 μg/L may also cause some health effects, including nervous system problems, skin problems, high blood pressure, and reduced intelligence in children.8 The most characteristic effect of long-term oral exposure to inorganic arsenic is a pattern of skin changes. These include 5 Minnesota Department of Health. Minnesota Well Management News. “Arsenic Occurrence in Minnesota Wells.” Volume 29, No. 2. Fall 2009/Winter 2010. 6 Minnesota Department of Health. Well Management: Arsenic in Minnesota’s Well Water. http://www.health.state.mn.us/divs/eh/wells/waterquality/arsenic.html/ Accessed May 17, 2011. 7 Agency for Toxic Substances and Disease Registry (ATSDR). Toxicology Profile for Arsenic. August 2007. 8 Minnesota Department of Health. Minnesota Well Management News. “Arsenic Occurrence in Minnesota Wells.” Volume 29, No. 2. Fall 2009/Winter 2010. 11 patches of darkened skin and the appearance of small "corns" or "warts" on the palms, soles, and torso; these changes are often associated with changes in the blood vessels of the skin.7 The U.S. Department of Health and Human Services (DHHS), the EPA, and the International Agency for Research on Cancer (IARC) has determined that inorganic arsenic is carcinogenic to humans.7 Long-term consumption of drinking water containing arsenic has been linked to several cancers. The most common types of cancers described in reports include cancer of the skin, bladder, lungs, liver, and prostate. Other cancers that may be associated with arsenic in drinking water include cancers of the kidney, colon, bone, larynx, stomach, lymph nodes, and nasal cavities.9 Actionability Question Are there existing prevention or control programs at MDH or other Minnesota organizations for the exposure or its adverse health outcomes? Can the level of exposure or disease be modified through policy, regulatory, or personal actions? Is the exposure or disease tied to state or federal public health objectives? Answer The national drinking water standard set by the EPA for arsenic is a MCL of 10 μg/L. This standard applies to community water-supply systems. Although Minnesota Administrative Rules, Chapter 4725, Wells and Borings, require that new wells must be tested for arsenic, no enforceable standard for arsenic in private wells exists in Minnesota. MDH recommends that people not consume water with arsenic levels that exceed 10 μg/L. The MDH Well Management Program provides information on re-testing of private wells and methods for reducing arsenic in drinking water. If the arsenic level in a well exceeds 10 μg/L, the well owner is encouraged to look at options for reducing arsenic exposure, including water treatment, connection to a public water-supply system, or construction of a new well in a different aquifer. Several types of water treatment systems can effectively reduce arsenic levels in drinking water. These include systems with special arsenic-removal media, reverse osmosis with pre-oxidation, and distillation systems. Yes. Healthy People 2020 Environmental Health Objective 24: Reduce the global burden of disease due to poor water quality, sanitation, and insufficient hygiene. Healthy People 2020 Environmental Health Objective 20.1: 9 Minnesota Department of Health. “Arsenic in Drinking Water and Your Patients’ Health.” Available at: http://www.health.state.mn.us/divs/eh/hazardous/topics/arsenicfct.pdf 12 Can data and measures in this content area be used to develop new program initiatives? Reduce exposure to selected environmental chemicals in the population, as measured by blood and urine concentrations of the substances or their metabolites. The data may support the creation of drilling recommendations, well construction recommendations, special well construction areas, and public outreach programs. Public Health Impact Question Is the population attributable risk (PAR) or public health impact of exposure known or be estimated from available data? [OR] Is the severity of the disease effect known and contributes to mortality or morbidity? Answer The estimates of cancer risk (for lung and bladder cancer alone) associated with arsenic in water at 3 μg/L may be between 4 and 10 additional cases in a population of 10,000.10 (Initial) Feasibility Question What are the data sources for exploration of “trackable” indicators? Answer The joining of the County Well Index to the Wells database provides a statewide database of Arsenic measurements. The County Well Index (CWI) is a PC-based database system developed by the Minnesota Geological Survey (MGS) for the storage, retrieval, and editing of water well information. Data are entered into the database by staff at the MGS and the Minnesota Department of Health (MDH). The CWI database contains basic information such as location (UTM coordinates), depth, and static water level for wells drilled in Minnesota. The database also includes information on well construction, stratigraphy/geology, water level, and some water chemistry for many of the wells. Each well record uses a unique number. The unique number is the key identifier for the location and geology of the well and can be joined to water quality databases, such as the Wells database. Since August 2008, Minnesota water well construction code requires all new potable water-supply well (public or private) be tested for arsenic. This requirement generates data for the Well database run by MDH Well Management. The reporting level for total arsenic is 2 µg/L, and testing is done 10 Minnesota Department of Health. “Arsenic in Drinking Water and Your Patients’ Health.” Available at: http://www.health.state.mn.us/divs/eh/hazardous/topics/arsenicfct.pdf. Data from National Research Council. “Arsenic in Drinking Water: 2001 Update”. The National Academy Press. 2001. 13 Does MDH have the legal authority to collect and use the data? by MDH certified labs. Approximately 10,000 new wells are drilled in Minnesota each year. MDH has the authority to collect and use the data under Minnesota Administrative Rules, Chapter 4725, Wells and Borings. Most information in the County Well Index is entered from the Water Well Driller Log form, which is submitted by the well driller to MDH at the time the well was constructed. Submission of a Water Well Driller Log is a requirement of the Minnesota Water Well Construction Code, passed by the State Legislature in 1974. Are private data classified and protected according to state and federal law? Revisions to the well code rules went into effect on August 4, 2008. These require all well contractors licensed by the MDH, and any other person constructing a water-supply well for personal use on their own property, to collect a water sample and have it tested for arsenic by an MDH-certified laboratory. The Wells database and County Well Index do not contain 'non public' data. 14 SECTION OVERVIEW: Tracking Updates Updates for the following projects describe progress in program areas that are not part of today’s agenda or that might alert panel members to material that will be discussed in greater depth in a future meeting. Status reports in this section include… The Tracking Data Portal Communications and Outreach CDC Tracking Content Initiatives ACTION NEEDED: Currently, no action is needed. Panel members are invited to ask questions or comment on these projects during the time listed on the meeting agenda. 15 This page intentionally left blank 16 Tracking Updates: Tracking Data Portal May 2011 MN EPHT has implemented several enhancements to the tracking data portal (Minnesota Public Health Data Access) since the March 2011 Advisory Panel meeting. These include the addition of 2 new topic areas (air quality and cancer), as well as usability improvements to increase flexibility and customization across all queries. For example, portal users can now easily select, view, and compare state and county data for 2 queries (asthma, carbon monoxide poisonings), as well as download (export) results in a standard format for analysis. Currently, tracking data are available for 10 topic areas: Air Quality Asthma Birth Defects Cancer Carbon Monoxide Poisonings Childhood Lead Poisoning Chronic Obstructive Pulmonary Disease (COPD) Drinking Water Quality Heart Attacks Reproductive Outcomes Access the tracking data portal via the MN EPHT program web site: http://www.health.state.mn.us/tracking Press Release In May, MDH issued a broad public announcement about the tracking data portal, including a press release to MN news networks and other media announcements (e.g., web pages, newsletters, email subscription lists). In addition, MN EPHT completed demonstrations (in person and via webinar) to increase portal awareness and use. Usability Testing In May, MN EPHT conducted external usability testing with 12 participants to evaluate the tracking data portal. This activity provided valuable feedback about the portal’s content and design, including GIS maps that are planned for release in August 2011. Summary results about the usability testing of the portal are in a report that is available on request. To receive a copy, contact the EPHT Program Consultant, Dave Stewart, by email, [email protected] or phone, 651/201-5913. Next Steps MN EPHT is preparing to roll out GIS maps for asthma hospitalizations and childhood lead poisonings by August 2011. These maps allow users to view and analyze data in an interactive format, as well as download images for presentations and reports. MN EPHT also is preparing to update the portal by including new years of data on existing topics, and adding new measures that are adopted by the National EPHT Network. In addition, we will be adding county-level data for 4 topic areas (i.e., air quality, childhood lead poisoning, cancer, and reproductive and birth outcomes). 17 Tracking Updates: Communications and Outreach Overview May 2011 In year 2 of the CDC tracking grant, MN EPHT communication activities continue to focus on reaching staff throughout the Minnesota Department of Health (MDH), other Minnesota state agencies, and local public health agencies to introduce or update them about The MN EPHT program and the Minnesota Public Health Tracking Network (MN Tracking Network) portal; The MN EPHT partnership with CDC’s national tracking program; The value of using the MN Tracking Network and the CDC National Tracking Network. Our goal now is to broaden our target audience’s knowledge of tracking and to promote the MN Tracking Network as an asset in their work. Since the MN EPHT Communications Team last updated the Advisory Panel book in March 2011, MN EPHT communications outreach has focused primarily on the May 25, 2011 launch of the MN Tracking Network. The team has developed an outreach plan, a bookmark about the portal, and prepared announcements of the portal launch (MDH press release, MDH intranet announcement, Gov.Delivery announcement, information for the Local Public Health Association of Minnesota website’s home page), as well as working with Minnesota Pollution Control Agency communications staff on channels for announcing the launch. In grant year 3, we will continue outreach activities, including an application to the Community Health Services Conference in September 2011. In summer 2011, MN EPHT will offer a new brownbag seminar and will continue to offer seminars in 2011 to a broader audience via the program website and our email subscription service (GovDelivery). Seminars will also be available as webinars. MN EPHT collaboration with CDC national and state tracking outreach efforts MN EPHT communications staff serve on several CDC national tracking marketing workgroups/subcommittees that develop education and outreach materials to promote the national and state grantee tracking efforts. In addition, Staff recently attended the CDC Tracking Workshop in April 2011 and participated in training on a variety of topics, including Plain Language writing. MN EPHT staff now co-chair the Public Health Environmental Practitioner workgroup, one of our important target audiences. The EPHT PowerPoint presentation template is under going through final review for approval and should be released in summer 2011. MN EPHT Outreach materials developed since March 2011 report to Advisory Panel MN Tracking Network bookmark Plans for 2011 Seminars available via webinar to a broader audience; Needs assessment survey of local public health staff to help guide our communications and outreach; 18 Development of the state tracking data portal: Minnesota Public Health Tracking Network; Development of a MN EPHT 101 as a recorded webinar presentation; Printed materials to inform people about the data portal. CDC email list The National Environmental Public Health Tracking Network sends program announcements to an email list service. If you would like to keep abreast of major developments at the national level (e.g., new data sets added to the national network) via the CDC’s email list, please go to http://ephtracking.cdc.gov/showAbout.action. In the right-hand column under Resources, click on “Join our List-serv.” 19 Tracking Updates: CDC Tracking Content Initiatives May 2011 The CDC recently asked state Tracking grantees to submit proposals for new Tracking content initiatives. Currently, the CDC has established 10 content workgroups for the development and implementation of tracking data in the following core content areas: Reproductive/birth outcomes Birth defects Cancers Carbon monoxide poisoning Hospitalizations (respiratory and heart disease outcomes) Blood lead Drinking water quality (public water supply data ) Air quality (particulate matter and ozone monitoring) Pesticides (hazard and health outcomes) Climate change The CDC received 10 proposals from grantees and after initial review, 5 proposals were presented and discussed at a meeting of the state principal investigators and program managers (PI/PM) on April 25, 2011. Proposals for new tracking content centered on a statement of public health concern or need, relevance to Tracking program goals, potential leadership and interested parties, available data sources, and potential deliverables. All proposed activities were to fit within a 12-month timeframe. The five proposals still under consideration for future tracking content development are: Radon Private wells (arsenic) Biomonitoring Occupational indicators (adult blood lead, mesothelioma, occupational asthma, and pesticide exposure) NASA aerosol data for estimating particulate matter exposure in data linkages State PI/PMs have recommended all five content initiatives for consideration by the CDC. A decision by the CDC to move forward with support for this work is pending. Other new content development is proposed within the existing 10 content workgroup teams for continued work in the year ahead. MDH EPHT staff and partners will participate in these national workgroups and new initiatives as resources allow. 20 SECTION OVERVIEW: CDC Biomonitoring Communications Evaluation Project Background Investigators at the CDC Public Health Laboratory and Westat (contractor) have conducted a formative evaluation study to learn more about communicating biomonitoring information to target audiences that use, interpret, or communicate about biomonitoring data. The Minnesota East Metro PFC pilot project communities of Oakdale, Lake Elmo, and Cottage Grove, are part of this research effort as “affected communities.” In collaboration with MDH EHTB biomonitoring program staff, CDC identified several key audiences for biomonitoring information in the community, including PFC biomonitoring project participants, public health officials, community advocacy organizations, healthcare providers, the business community, legislators, and the media. Individual interviews with these audiences were conducted from August 2010 through January 2011. The project is intended to gather information that will benefit MDH/Minnesota as well as CDC in developing future biomonitoring communications. Jean Johnson will introduce CDC investigator Claudia Vousden, who will present (by telephone) the methods and findings of the case study in our East Metro PFC study community. Project results will be presented at the Council of State and Territorial Epidemiologists annual conference in June 2011. The case study provides empirical evidence of the need for and value of integrating strategic communication planning, implementation, and evaluation into the broader planning of biomonitoring studies. Please see the presentation abstract in this section of the panel meeting materials for more information. ACTION NEEDED: No action on this item is necessary. After the presentation, Panel members are invited to ask questions and provide input on future biomonitoring communications with affected communities. In particular, members will be asked to consider the questions: How important is communications planning, implementation, and evaluation in overall design and implementation of ongoing state biomonitoring activities? Are there any specific recommendations for improving state biomonitoring communications in the future? 21 CSTE 2011 Annual Meeting Communicating biomonitoring study results: A case study on one state’s experience Background In their 2006 report, Human Biomonitoring for Environmental Chemicals, the National Research Council describes communicating biomonitoring results as the most challenging issue facing the field, yet critical to the accurate interpretation and use of biomonitoring data. The dearth of research in this area has hindered progress toward filling the gap in knowledge about how to communicate effectively about biomonitoring and the results of biomonitoring studies with lay audiences and others outside the field. In 2008-09, the Minnesota Department of Health conducted a biomonitoring study among residents of two communities in the Minneapolis-St. Paul metropolitan area who were exposed to perfluorochemicals through contamination of their drinking water. This study provided the Centers for Disease Control and Prevention’s National Biomonitoring Program with a case for documentation of the process, characteristics and effects of strategic communication implemented to support a community based biomonitoring study. Methods This case study research used qualitative methods to explore and describe communication practices before, during and after a biomonitoring study through collection and analysis of primary and secondary data. A review of documents and archival records contributed to an understanding of the context of the study and chronology of events. In-depth interviews with key informants provided insight into the knowledge, attitudes, perceptions and responses of the target audiences that participated or had vested interest in the local biomonitoring study and its findings. These informants included participants in the community based biomonitoring study, state public health officials, state legislators, advocates and industry representatives. The data was analyzed using a descriptive framework based on chronologic and thematic organization, classification and presentation of the case. Results The primary data collected from over 20 in-depth interviews combined with the data from secondary sources supported development of a narrative that describes a biomonitoring communication process generally characterized as collaborative and open and the variable responses of key audiences to the local biomonitoring study communication activities, messages and materials. Conclusions The case study provides empirical evidence of the need for and value of integrating strategic communication planning, implementation, and evaluation into the broader planning of biomonitoring studies. The study also highlights how communication needs across key audiences can vary and the importance of understanding and addressing such variations during development and implementation of communication plans. This case study contributes to the formation of a database for future comparison and theory building for development of best practices in biomonitoring communication. 22 SECTION OVERVIEW: Biomonitoring Updates Updates for the following projects describe progress in program areas that are not part of today’s agenda or that might alert panel members to material that will be discussed in greater depth in a future meeting. Status reports in this section include… The East Metro PFC Biomonitoring Follow-up (PFC2) Project Update The Lake Superior Mercury in Newborns Project Update ACTION NEEDED: Currently, no action is needed. Panel members are invited to ask questions or comment on these projects during the time listed on the meeting agenda. 23 This page intentionally left blank. 24 Biomonitoring Update: East Metro PFC Biomonitoring Follow-up (PFC2) Project Update Project summary May 12, 2011 The East Metro PFC Biomonitoring Follow-up Project will measure the two-year change in blood levels of 7 perfluorochemicals (PFCs) in residents of the East Metro area in order to assess whether improvements to the community’s water systems have successfully reduced PFC exposures. Status Participant recruitment and sample collection are complete. One hundred sixty-four people (out of 186 contacted, or 88%) consented, filled out the study questionnaire, and provided a blood sample. All serum samples were collected from the HealthEast Oakdale Clinic, where participants’ blood was drawn, and delivered to the MDH Public Health Laboratory. Laboratory analysis is underway. This has not gone as quickly as expected because of issues with the instruments being used, but the problems have been resolved and results are expected this summer. Timeline Pending continued funding for this project, the current plan is to communicate individual results to participants as soon as laboratory analysis is complete. The results letter will include the participant’s 2008 and 2010 levels, and will say that overall study results will be communicated in a subsequent mailing. Participants will be given the opportunity to speak with a physician working with the study, and staff will provide seminars for healthcare providers in the area. Overall study results will be presented at the September meeting of the Advisory Panel. After receiving feedback from the Panel, results will be communicated to participants and to the community at large via a community factsheet and public meetings. A journal article and/or technical report will also be written. 25 Biomonitoring Update: Lake Superior Mercury in Newborns Project February 2011 Recruitment: Participant recruitment is complete. There were 1,130 Minnesota newborns enrolled with parental consent. Blood Spot Mercury Analysis: All specimens have been received by the MDH Public Health Lab. We expect mercury analysis to be complete by the end of May. One partial batch of samples remains to be analyzed. This batch will be completed following final internal MDH PHL quality review of the completed samples. Status Details: Data analysis and reporting will be complete by September 30, 2011. Some of the measured mercury concentrations in blood spots in our study were higher than expected. A second, higher, calibration curve was developed and we have revised our SOP to include running these samples using this second calibration curve. Additional time was needed to complete the re-analysis of these high samples. Given this and the maternity leave of a key staff member, our mercury analyst, a no-cost extension of our grant period to September 30, 2011 was requested from EPA. 26 SECTION OVERVIEW: Riverside Prenatal Biomonitoring Pilot Project Recruitment, sample collection, and laboratory analysis have all been completed for the Riverside Prenatal Biomonitoring Pilot Project. Staff presented preliminary results for cotinine to the Advisory Panel in June 2010. At this meeting, staff will provide an overview of the project, laboratory methods, and project population, and will review results for cotinine. Staff will present preliminary results for environmental phenols. In accordance with Minnesota Statutes 144.996, the Advisory Panel is asked to make recommendations related to interpreting the results, communicating findings to the public, and planning follow-up stages of biomonitoring work (if any). The following item is included in this section of the meeting materials: Riverside Prenatal Biomonitoring Pilot Project: Preliminary Results ACTION NEEDED: At this time, no formal action is needed by the Advisory Panel. Panel members are invited to ask questions or provide input. In particular, Panel members are asked to respond to the following questions: Do Panel members agree with the data analysis and interpretation presented? Are additional analyses recommended? For the community factsheet, staff proposes to present results for environmental phenols by income and race/ethnicity, with appropriate caveats about the small sample size. Given that the data are consistent with NHANES findings, do Panel members consider this acceptable? 1. Do Panel members agree with the following approaches to data analysis? For measurements <LOD, assign a value of LOD/2 2. Include participants with creatinine <20 mg/dL Based on these pilot project findings, is further biomonitoring for environmental phenols and cotinine recommended in this community (pregnant women)? Should MDH continue biomonitoring work with this target population for a different set of chemicals or a different specimen type? 27 PRELIMINARY RESULTS PLEASE DO NOT CITE OR DISTRIBUTE Riverside Prenatal Biomonitoring Pilot Project: Preliminary Results May 12, 2011 Overview and data collection This pilot project measured certain chemicals in the urine of pregnant women who delivered at Fairview Riverside Hospital in Minneapolis. Chemicals included environmental phenols, used in plastics and personal care products, and cotinine, an indicator of exposure to tobacco. The project was ancillary to the Riverside Birth Study (RBS) conducted by Dr. Logan Spector at the University of Minnesota. Women who had consented to the RBS and agreed to future contact received information about the project. Those who indicated interest were given a urine collection kit. Participants collected and froze a single urine sample, which was delivered via courier to the MDH Public Health Laboratory (PHL). MedTox Laboratory analyzed samples for cotinine, and the PHL analyzed samples for environmental phenols. The environmental phenol values presented below are total concentrations, i.e., free plus conjugated species. MDH received variables of interest from the RBS, including age, ethnicity, income, and pre-pregnancy height and weight. Differences in log-transformed environmental phenol concentrations by demographic factors were assessed with two-sample t tests and ANOVA. Samples and data provided to MDH were de-identified. Preliminary Results Study population. Sixty-six women agreed to participate and provided a urine sample. Table 1 presents participants’ demographic characteristics. Cotinine. Ten women (15%) had detectable levels of cotinine in their urine, with levels ranging from 129 ng/mL to over 1400 ng/mL. Nine women (14%) would be classified as active smokers using the MedTox definition (cotinine plus nicotine > 200 ng/mL), and one as exposed to secondhand smoke (<= 200 ng/mL). Fifty-six women (85%) did not have detectable cotinine in their urine. The LOD was 20 ng/mL. Women with lower household incomes were more likely to have detectable cotinine, though findings are limited by the small sample size. Environmental phenols. Table 2 shows the distribution of analytes, with and without adjustment for creatinine to account for dilution of the urine sample. Bisphenol A (BPA) was detected in the urine of 56% of women, methyl paraben in 94%, propyl paraben in 85%, ethyl paraben in 44%, and butyl paraben in 11%. (Because of a difference in LODs, these percent detections are not directly comparable to NHANES.) Differences in concentrations by income level and race/ethnicity are displayed in Table 3. Concentrations, particularly of BPA and methyl paraben, were highest in the lowest income group, though these results are limited by the small sample size and not statistically significant 28 PRELIMINARY RESULTS PLEASE DO NOT CITE OR DISTRIBUTE (p > 0.05). Concentrations were higher in non-white than white women, with results statistically significant for methyl and propyl paraben. Methyl paraben levels were 3.5 times higher in nonwhite than white women (p = 0.01). Because the sample size was small, we combined all nonwhite racial/ethnic groups, including people who self-identified as Black/African American, Hispanic, Asian, and other groups. Comparison to other studies According to U.S. data from 1999-2006 NHANES, 13% of pregnant women were active smokers, as determined by self-reported information and blood levels of cotinine. In Minnesota, 13.8% of pregnant women with babies born in 2008 were estimated to have smoked during pregnancy, as measured by self-reported information from the Minnesota Pregnancy Risk Assessment Monitoring Survey (MN PRAMS) and birth certificates. Results from this project are comparable. Average BPA levels in Riverside project women were similar to those in U.S. women (pregnant and non-pregnant) measured by NHANES in 2007-2008 (2.2 compared to 2.4 g/g). Paraben levels were lower than in NHANES. An analysis of NHANES data from 2003-2004 found disparities in paraben levels by race/ethnicity that were similar to those seen in this project. Other studies have measured BPA in pregnant women, with average levels ranging from 1.7 g/g in Cincinnati and the Netherlands to 4.1 g/g in Norway. Very few studies have measured parabens in pregnant women. Table 4 displays a summary of results from other studies. Issues with data analysis 1. Non-detect values. Different approaches are used in assigning a value to biomonitoring measurements below the limit of detection (LOD). The most common approach, used by NHANES, is to use LOD/sqrt2; other investigators use LOD/2. Because the LODs for certain chemicals (BPA, propyl paraben, and butyl paraben) in this project are higher than in NHANES, the non-detect values assigned are different. An example is BPA: The LOD in this project is 1 g/L; the LOD in NHANES is 0.4 g/L. The BPA GM presented in Table 2 differs according to which non-detect value is used: with LOD/sqrt2, GM = 2.5 g/g; with LOD/2, GM = 2.2 g/g; with the NHANES non-detect value, GM = 1.7 g/g. These preliminary analyses used LOD/2. 2. Exclusion based on creatinine values. Some analyses exclude participants whose creatinine values are below a certain level, such as 20 mg/dL.11 The reasoning is that low creatinine values may inflate results because the analyte is divided by creatinine for the creatinineadjusted concentration. For example, two participants have BPA <LOD, but have very different creatinine-adjusted concentrations: Participant A (creatinine=10) = 5.0 g/g; participant B (creatinine=116) = 0.43 g/g. These preliminary analyses did not exclude the five participants with creatinine <20 mg/dL. 11 Wolff et al. Prenatal phenol and phthalate exposures and birth outcomes. Environ Health Perspect. 2008 Aug;116(8):1092-7. 29 PRELIMINARY RESULTS PLEASE DO NOT CITE OR DISTRIBUTE Timeline for project completion Factsheets summarizing results have been drafted, and will be completed once results are final. These will be mailed with a letter to project participants, and results will be presented to healthcare providers at the Fairview Women’s Clinic. Depending on continued funding, outreach will be conducted to other stakeholder groups such as Healthy Legacy, city and county public health officials, maternal and child public health nurses, and the tobacco prevention community. Also depending on funding, we will write a technical report and/or article about the project. 30 PRELIMINARY RESULTS PLEASE DO NOT CITE OR DISTRIBUTE Table 1 Project population (n=66) Age mean (sd) 19-27 28-31 32-41 Annual household income < $10,000 > $10,000 - < $20,000 > $20,000 - < $40,000 > $40,000 - < $60,000 > $60,000 - < $80,000 > $80,000 - < $100,000 > $100,000 N 29.8 (5.4) 20 23 23 % 30% 35% 35% 10 6 9 8 6 11 16 15% 9% 14% 12% 9% 17% 24% 46 8 4 4 70% 12% 6% 6% 3 1 5% 2% 55 10 83% 15% Race/ethnicity White Black/African American Hispanic/Latino Asian Other (E. European, South African, Russian Jewish) East Indian Birthplace US Outside US Pre-pregnancy BMI Table 2. Distribution phenols meanof (sd)environmental 26 (6.2) Bisphenol A Methyl paraben Propyl paraben Ethyl paraben Butyl paraben <25 (normal) 39 59% 25 - <30 (overweight) 15 Unadjusted 23% ( g/L) LOD % > 30 (obese) 12 18% ( g/L) detect GM Median IQR Min 1 56% 1.6 1.6 0.5 - 3.5 0.5 1 94% 53.8 84 15.5 - 186 0.5 1 85% 10.1 13.8 1.8 - 35.7 0.5 1 44% * <LOD <LOD - 4.0 0.5 1 11% * <LOD <LOD - <LOD 0.5 * Not calculated: proportion of results <LOD too high to provide valid result 31 Creatinine-adjusted ( g/g) Max 25.5 1760 552 373 36.3 GM 2.2 73.3 13.8 * * Median 2.4 110.9 18.1 1.6 0.6 IQR 0.6 - 5.3 30 - 247.5 2.9 - 60.9 <LOD - 5.0 <LOD - 1.4 Min 0.2 0.4 0.4 0.3 0.2 Max 46.9 1157.9 363.2 384.5 45.9 PRELIMINARY RESULTS PLEASE DO NOT CITE OR DISTRIBUTE Table 3. GM concentrations by income and race/ethnicity BPA (GM) MePb (GM) PrPb (GM) g/g g/g g/g creatinine creatinine creatinine Income <$20,000 (n=16) $20-80,000 (n=23) >$80,000 (n=27) p-value (ANOVA on log values) 3.5 1.6 2.1 0.23 120.9 54.9 69.7 0.39 17.9 9.6 16.1 0.48 White v. non-white Non-white (n=20) White (n=46) 3.3 1.8 181.7 49.4 27.5 10.2 p-value (t test on log values) 0.1 0.01 0.04 32 PRELIMINARY RESULTS PLEASE DO NOT CITE OR DISTRIBUTE Table 4. Other studies of BPA, parabens in pregnant women LOD ( g/L) ND approach Unadjusted GM ( g/L) third trimester 0.4 LOD/2 2.2 389 3 samples: 16 wks, 26 wks, birth 0.4 LOD/sqrt2 16 wks = 2.0 26 wks = 1.8 birth = 1.3 16 wks = 1.7 26 wks = 2.0 birth = 2.0 16 wks = +90 26 wks = +90 birth = 87 60 third trimester 0.4 LOD/2 1.52 1.95 80 10 pools, 110 women 17-18 wks? 0.26 LOD/sqrt2 2.81 4.11 87 unknown 0.4 LOD/sqrt2 2.52 2.04 404 third trimester 0.36 100 after 20 wks 0.26 LOD/sqrt2 1.08 1.67 82 0.4 LOD/sqrt2 2.4 2.8 93** MePb = 123 + EtPb = nr PrPb = 23.9 BuPb = 1.1 MePb = 100 EtPb = 88 PrPb = 98 BuPb = 90 MePb = 99** EtPb = 42 PrPb = 93 BuPb = 47 Year collected Population N Casas 2011* 2004-2008 Pregnant women in INMA Project in Spain 120 Braun 2010* 2003-2006 Cantonwine 2010 2001-2003 Citation Ye 2009 2004 2003-2004 Wolff 2008* 1998-2002 Ye 2008 2004 - 2006 Calafat 2008 2003-2004 Casas 2011* Calafat 2010 2004-2008 2005-2006 Pregnant women in HOME study in Cincinnati Pregnant women in ELEMENT study in Mexico City Pregnant women in MoBa study in Norway Pregnant women in NHANES Pregnant women in Children's EH Study in NYC Pregnant women in Generation R study in the Netherlands Women in NHANES Pregnant women in INMA Project in Spain Women in NHANES 1288 120 1278 Timing in pregnancy BPA NA Parabens third trimester NA MePb = 1 EtPb = 1 PrPb = 0.2 BuPb =0.2 MePb = 1 EtPb = 1 PrPb = 0.2 BuPb = .2 LOD/2 LOD/sqrt2 MePb = 191 EtPb = 8.8 PrPb = 29.8 BuPb = 2.4 MePb = 104 + EtPb = nr PrPb = 20.4 BuPb = 0.9 % detect 91 1.3 * Median values are reported, not GMs ** For BPA and all parabens, % detect are for whole population, not just women + nr = not reported, due to the fact that the proportion of values below LOD was too high to provide a valid result 33 Adjusted GM ( g/g) 91 PRELIMINARY RESULTS PLEASE DO NOT CITE OR DISTRIBUTE Questions for Advisory Panel discussion 1. Do Panel members agree with the data analysis and interpretation presented? Are additional analyses recommended? 2. For the community factsheet, staff propose to present results for environmental phenols by income and race/ethnicity, with appropriate caveats about the small sample size. Given that the data are consistent with NHANES findings, do panel members consider this acceptable? 3. Do Panel members agree with the following approaches to data analysis: a) For measurements <LOD, assign a value of LOD/2 b) Include participants with creatinine <20 mg/dL 4. Based on these pilot project findings, is further biomonitoring for environmental phenols and cotinine recommended in this community (pregnant women)? 5. Should MDH continue biomonitoring work with this target population for a different set of chemicals or a different specimen type? 34 SECTION OVERVIEW: Strategic Planning for an MDH Biomonitoring Program Background During 2010, the EHTB staff conducted strategic planning to develop a framework for biomonitoring based on the findings and recommendations gleaned from the biomonitoring pilot program, as directed under Minnesota state law (Minn. Stat. 144.997, sub-div. 2). Staff and management from MDH developed recommendations in consultation with the Advisory Panel. To date, MDH has adopted a statement of vision, program goals, and the framework for development of targeted strategies to achieve the recommended goal. The vision describes Minnesota’s biomonitoring program as having the capacity to accurately and efficiently measure and track exposures in people from the environment, and to protect public health by improving the understanding of risk and disease so that Minnesotans will lead healthier lives and live in safer environments. The long-term goal of Minnesota’s ongoing biomonitoring program is to monitor the distribution of exposure to designated chemicals in the environment among the general population of Minnesota and communities within the population, so as to… Track trends in exposure over time. Identify exposure disparities and sub-populations that are vulnerable to exposure. Assess the need for public health interventions. Evaluate the effectiveness of statewide and community-level interventions and policies that are implemented to reduce exposure. The planning identified three main approaches to biomonitoring: Statewide population exposure tracking; Targeted population exposure tracking; and Special investigations in response to local events, concerns, and threats. In consultation with the Advisory Panel, MDH decided to focus on biomonitoring in targeted populations, with special investigations, if needed and funded, in response to local threats and community concerns. Strategic Planning for Biomonitoring Phase II The next phase of strategic planning aims to gather stakeholder recommendations for target populations and suggestions for funding, partnerships, and collaborations. The objective is to identify target population categories, data gaps, categories of chemicals, and suggestions for funding sources, partnerships, and collaborations. ACTION NEEDED: No action is needed on this item. We invite the panel to ask questions, provide input on the request, and consider these questions: What criteria should we use to narrow down suggestions for target populations? What funding mechanisms, partnerships, or collaborations can you suggest? 35 Phase II Planning Earlier EHTB development of the vision and goals for a state biomonitoring program had identified systematic biomonitoring of targeted populations as the most cost-effective route to achieving the program vision and goals including measurement of baseline exposure data in a targeted segment of Minnesota’s population, and identifying disparities and highly exposed groups within the targeted population. Goals and Objectives of Phase II Planning The immediate objectives are to share with stakeholders the lessons learned from our pilot program, and to gather advice about target populations, high priority chemical classes, gaps in knowledge, and ideas for funding sources, partnerships, and collaborations. This information will be used to inform continued development of the strategic plan for ongoing biomonitoring in Minnesota. The intermediate objectives are to develop a detailed strategic plan focused on specific target populations and analytes; explore potential partnerships and collaborations; and develop and submit proposals. The long-term objective is to obtain funding to monitor one or more specific target populations for a short list of chemical analytes of interest in Minnesota. The long-term goal is to protect public health by improving the understanding of risk and disease so Minnesotans can lead healthier lives and live in safer environments (Program Vision statement). Methods We developed a concise summary of the Biomonitoring Program achievements to date to share with stakeholders, plus a set of questions to ask each stakeholder or stakeholder group. We also developed a PowerPoint presentation to show larger stakeholder groups what the program has achieved over the last four years. We’ve asked stakeholders the following questions: 1) 2) 3) 4) 5) 6) 7) 8) How would state biomonitoring data help you in your work? Which target populations are the most important, and why? What criteria should the state use in selecting target populations for biomonitoring? What population target would be most valuable for linking biomonitoring data with other health outcome data? What data gaps do you see in the biomonitoring realm (in general)? Can you suggest any funding sources or partnerships MDH should pursue? In thinking about the projects or programs that you work on (current and upcoming), are there areas of collaboration that we might explore? What biomonitoring information would be useful for your programs or projects? To date, we have met with representatives from three key stakeholder groups: 1. Academic scientists 2. Health and environmental advocacy groups 3. Local Public Health 36 We have gathered recommendations from six UMN faculty members and will be scheduling a meeting and interview with the seventh academic stakeholder. We have met with representatives from three stakeholder groups affiliated with Healthy Legacy, which represents interests that include healthcare, citizens with disabilities, environmental justice, and environmental health. Healthy Legacy’s steering committee comprises representatives from six advocacy groups: IATP, Clean Water Action, Preventing Harm Minnesota, MPIRG, LDA Minnesota, and the Women’s Environmental Institute at Amador Hill. We are trying to arrange a meeting with representatives from MCEA (Minnesota Center for Environmental Advocacy), an organization that was instrumental in promoting Minnesota Statutes 144.995-144.998, which has funded the EHTB program to date. On May 19, we presented our program and questions at the LPHA environmental health directors Networking Lunch during the Local Public Health Association membership meeting; later in the month, we took part in a conference call with members of the LPHA’s Policy & Practices Committee. Outcomes to Date The stakeholders with whom we’ve met so far see both a need for, and benefits from, an ongoing biomonitoring program. We’ve received suggestions for Target populations Major classes of chemicals of concern Health outcomes of interest Needs for Minnesota biomonitoring data Suggestions for possible partnerships, collaborations, or funding sources so far include: NIEHS (Partnerships for Environmental Public Health, if available) NCS (National Children’s Study sub-programs) Food Safety Act (focuses on microbial contaminants; could address pesticides) TIDES (The Infant Development & Environment Study) Health insurance companies/foundations (BCBS, HP Foundation) Foundations interested in health (e.g., Robert Wood Johnson Foundation) Program Value Biomonitoring measures exposure as the concentration of environmental chemicals that get into people’s bodies from all sources (e.g., air, water, foods, consumer products). Thus, biomonitoring reduces the uncertainties that public health practitioners face with standard exposure assessment formulas for making public health decisions. With more accurate exposure data, public health scientists can conduct studies of whether and how environmental chemicals can influence health and sensitive systems, such as reproductive or cognitive functions. With improved scientific evidence, public health advocates legislators and community leaders can promote evidence-based policies for protecting the health of communities. 37 Although the Minnesota EHTB program may lose a significant portion of state funding in FY2012, continued Phase II planning for biomonitoring through July 2012 will likely be supported through a national Environmental Public Health Tracking program initiative. The challenge of ongoing funding at the state and federal level may be resolved when the utility of biomonitoring to public health is well enough known and understood by the public to attract bi-partisan support. Please see the timeline on the next page. 38 Biomonitoring Strategic Planning TimeLine Milestones Interview stakeholder s to obtain guidance on target populations, chemicals, data gaps, & funding sources/partnerships/collaborations. Stakeholders include academics, key health & environmental advocacy groups, LPHAs, legislators, policymakers, professional organizations/associations, state agencies 1) Academic stakeholders Logan Spector & Ruby Nguyen Bruce Alexander Pat McGovern Bill Toscano David Jacobs & Jose Suarez 2) Advocacy groups a) Healthy Legacy affiliates Clean Water Action IATP Preventing Harm Minnesota b) MCEA LPHA Environmental Health directors meeting Conference call with Policy & Practice Committee Interview 3-4 Additional Stakeholders/Groups (TBD) Summary Report of Recommendations Present to Advisory Panel Funding Searches Exploration of partnerships or collaborations Preparation of funding proposals Chemical Selection Population Sampling Strategy Communications strategy; laboratory methods 39 Anticipated date of completion August 2011 Apr 19 Apr 20 May 6 TBA June 6 May 4 May 26 May 19 May 25 July 31 August 22 September 13 June ‘11→ July ‘12 July ‘11 → July ‘12 Sept ‘11→ July 2012 December 2011 March 2012 June 2012 This page intentionally left blank. 40 SECTION OVERVIEW: Other Information These documents are included in this meeting packet as items that may be of interest to panel members: March 2011 Meeting Summary EHTB Advisory Panel 2011 Meeting Dates EHTB Advisory Panel Roster Glossary of terms used in EHTB Acronyms used in EHTB EHTB Statute: Minnesota Statutes 2010, section 144.995-144.998 Additional reference materials are available online at www.health.state.mn.us/tracking/. 41 This page intentionally left blank. 42 Summary of the Minnesota Department of Health (MDH) Environmental Health Tracking & Biomonitoring Advisory Panel Meeting March 8, 2011 1-4 p.m. Advisory panel members – Present: Greg Pratt, (chair), Fred Anderson, Alan Bender, Pat McGovern, Cathy Villas-Horns. Advisory panel members – Regrets: Bruce H. Alexander, Jill Heins Nesvold, Beth Baker, Cathi Lyman-Onkka, Thomas Hawkinson, Geary Olsen, Lisa Yost. Welcome and Introductions Greg Pratt, serving as chair for Beth Baker, convened the meeting. Jean Johnson introduced Barbara Scott Murdock, who will serve as program planner, replacing Michonne Bertrand. Tracking Update Chuck Stroebel and David Stewart reviewed the development of the MN DATA secure portal. Chuck framed his discussion of the development of the portal in terms of four questions: What are the key audiences for the Secure DATA system? What features, data or services, would make this system most useful? What are the key challenges, concerns or issues with its implementation? What uses would key audiences likely have for custom data sets? Goals are To provide secure access to EPHT data for authorized users; To meet a July 31 deliverable to CDC To develop and pilot a system for sharing data among authorized EPHT users. Target audiences for the secure portal include Public health professionals in the EPHT network Researchers and public health professionals in state and local agencies Researchers at universities Issues and challenges CDC requirements are poorly defined Few states have secure portals State standards for identity management are in development The timeline for Phase 1 is tight (July 31, 2011) 43 Phase 1 includes developing standards, procedures, and data dictionaries that allow users to look at available data and request access. Finally, it involves evaluating what users want in the way of tools and access to data. Phases 2 and 3 will use the information collected above to enhance and expand the portal.. Dave Stewart demonstrated the draft portal design on MDH’s web-test server. The login is on the right side of the screen; users must establish a valid need for access. The data steward also must approve the user’s access to the requested data in accordance with applicable laws that govern data use and practices. MN EPHT is developing an internal process and criteria for vetting such requests. Access agreement with data users. Hard copy would be submitted with terms & conditions for users. For now, the focus is on gathering information from potential users to see what they need and want. MN EPHT will evaluate resource constraints and need for access to determine whether it can meet data requests. Security is the key element; Chuck and Dave are working with ISTM and the MDH Chief Information Security Officer on password policies; permission settings at file level (users will be allowed access only to certain files); and tracking of users’ activities for audits. In addition, MN EPHT will work with ISTM to plan implementation of the anticipated state standards for identity management. Local public health staff in the Metro area who work with datasets will meet with Chuck & Dave to identify their needs and wishes. CDC will evaluate the system in 2011-12. Alan Bender questioned the use of the word ―secure,‖ concerned that the term suggests that private information would be on the website. Further discussion about how portal users could get data on the secure portal clarified the issue. Staff anticipate that professional users (researchers or state or local health professionals) may want to request unsuppressed data from MN EPHT and the data steward for research or public health practice purposes. Unsuppressed data is private data, subject to the MN Government Data Practices Act, and could contain information that might identify an individual. Staff noted that the MDH Legal Unit is reviewing a terms and practices document that is intended to serve as a contract, and that users would know what their responsibilities and obligations are for protecting the data in accordance with the law. Each user given access would be limited to the dataset requested and could gain access to other datasets only by requesting another dataset and signing another contract. Preparing custom data sets for the secure portal could become burdensome to MN EPHT. Pat McGovern suggested assessing the burden in the pilot phases. Because students might be interested in using the data for field projects, she suggested that enabling students to use the data would build an audience of professionals over time. User fees might be reasonable. 44 Chuck stated that MN EPHT would follow the current model at MDH, in which MDH asks the data stewards to answer requests that MN EPHT is unable to fulfill. Greg Pratt asked about the CDC’s secure portal. The presenters said that only approved staff can see and review their own state data on CDC’s portal. Wisconsin and Missouri also have secure portals. The term secure is CDC’s use. Pat McGovern suggested developing a list of key terms and their definitions. Environmental Tobacco Smoke Exposure as a New Content Area for Tracking Jeannette Sample reviewed the criteria and selection process used to identify new content areas for Tracking in Minnesota (pp 9-11) and Blair Sevcik presented Phase III of the selection process for ETS Exposure as a new content area (pp 15-22). The data sources used were the Youth Tobacco Survey (YTS) and the Adult Tobacco Survey (ATS). The advisory panel first considered the questions for consideration list on page 7. Alan Bender noted that the first two questions are related: Whether the data are informative at only the state-level depends on what inferences you want to draw. One can point out what the limits are in the data, and you want precision of estimates to support inferences. If users want county-level or metro vs. non-metro information, the statewide data won’t support that. For other questions, these data will suffice. The panel agreed that having state-level data only, as long as it was reliable and representative, was a good place to start. Pat McGovern asked whether the datasets gave any idea of how long people were exposed and whether one can get a sense of a dose-response relationship. Blair answered that the Youth Tobacco Survey questions do include an estimated of the number of days in the past week that the respondent was exposed to ETS but that the Adult Tobacco Survey questions are yes/no questions and would not allow an ―exposure-response‖ association to be calculated. Greg Pratt asked whether these surveys were randomly sampled and representative, and whether the data were weighted. Pete Rode (Center for Health Statistics, MDH), representing the data steward, responded that the data come from randomly sampled populations in Minnesota and that both data sources were population-based and randomly sampled. Moreover, the CDC questions for the Youth Tobacco Survey have been reviewed, and the Center for Health Statistics is confident that the questions are reliable. The questions from the Adult Tobacco Survey expand on a core bank of CDC questions and draw from Behavioral Risk Factor Surveillance System (BRFSS) questions, although no special reliability studies have been done. Pete is confident of the ATS data because he is confident of the survey contractor (Westat) but no special studies have been done on reliability or validity. Although the surveys ask what county people live in, Pete doesn’t think we have sufficient data to be confident of smoking rates within a county, but probably can be 45 confident about adult smoking rates within a region. The project has surveyed the metro area vs. non-metro. Fred Anderson asked about the intent behind tracking these measures, given that ETS exposure is trending downward and that we have public initiatives to reduce smoking. Pat McGovern noted that because laws can change (e.g., can be repealed), it would be good to have monitoring data to track the effects of any changes. Greg asked what the prevalence of active smoking is in these groups and whether that should be included as a measure in this new content area. In response to panel discussion, Pete noted that tracking ETS exposure in nonsmokers could determine whether declining exposure in nonsmokers reflects declining prevalence of smoking (already documented in tobacco reports) or whether it is related to new policies designed to reduce exposure in nonsmokers. He added that it would be informative for the Tracking program to look at this subpopulation of nonsmokers rather than behavioral risk factors, such as smoking status. Pete Rode pointed out that we have data on the prevalence of smoking and on ETS exposure among smokers, already published by the Center for Health Statistics and the Tobacco Prevention and Control Program, both at MDH. Jeannette noted that the CDC national EPHT program wants to add behavioral risk factors from Behavioral Risk Factor Surveillance System (BRFSS) survey data. The group considered a motion to recommend the new content, but had no quorum, so Pat McGovern moved to query everyone by email, Al Bender seconded the motion, and all agreed. The group then amended the motion to ask everyone to vote for or against recommendation to the Commissioner of Health that ETS Exposure be adopted as a new content area for Tracking in Minnesota by email by March 22.12 Jean Johnson then asked whether the panel had any comments on the process of selection. One panel member asked what would happen if the Advisory Panel did not recommend this content area. Jean and Jeannette responded that MDH would write up the reasons why the panel did not recommend a new content area be adopted and would send the report to the Steering Committee, who would make the final decision. Al Bender also pointed out that staff will not terminate a content area without consulting the Advisory Panel. Section Overview: Project Year 3 Proposal for Tracking and Biomonitoring Jean Johnson reviewed the program goals: 1. Develop a strong environmental public health tracking system based on the collection and analysis of high-quality data. 2. Ensure that environmental public health data are accessible and used. 12 Later, because of a question from a panel member and a question from a member of the Chamber of Commerce, staff conferred with panel chair Beth Baker, and the decision about the ETS content area was postponed to the June 7 meeting, when more panel members would be present to confer and vote. 46 3. Build awareness, knowledge and skills among potential data users related to environmental public health tracking in order to inform actions to improve public health. 4. Build collaborations that enhance environmental public health tracking in Minnesota. She then showed a PowerPoint that listed content for new measures added. Plan to propose new areas to add to the tracking list ETS if the Advisory Panel so recommends; Important covariates include behavioral risks (e.g., smoking prevalence data) and population demographics. Having these will allow MDH staff to look at trends and demographic factors, such as poverty, that put people at risk. Asthma and chronic obstructive pulmonary disease (COPD) Additional cancers (15 cancers have been added in the portal), and the program proposes to add all 36 cancers for which data are routinely published by the state cancer registry. Air quality data: particulate monitoring data (air quality) & are working with the PCA on the use of continuous monitoring air quality data New drinking water & blood lead measures will be added as the CDC adds them Climate change measures, as adopted by CDC Possible new data sources National Air Toxics Assessment (NATA) data Pesticide sales data, NHANES biomonitoring data, pesticide poisonings (Poison Control Center data) Radon in homes Child health Chuck Stroebel reported on proposed activities for goals 2 and 3. For goal 2, the EPHT program supplies metadata in reports. Staff are enhancing the program’s portal, adding new or updated data to existing data, and will add maps for cancer (MN cancer surveillance) and demographic information. The staff plan to add blood lead and asthma maps in July, to evaluate GIS platforms, and to develop a glossary of terms and a users’ guide. For the secure portal, they will implement enhancements based on what the CDC requires in a secure portal and add custom data sets. For goal 3, the staff offer portal demonstrations for groups, presentations and displays at conferences, and a brown bag seminar series for state agency staff on such topics as the health effects of climate change, air quality, and other environmental issues. They will expand presentations to broader areas as available. The program website will offer updates and webinars. Staff will evaluate EPHT communications and program activities to see if people are in fact using the portal and the data. Jean Johnson updated progress toward goal 4. The EPHT program plans to continue current collaborations with the following groups: 47 The American Lung Association (COPD & asthma outcomes), The University of Illinois-Chicago research collaboration, The Hennepin County EPA Care Grant to study the Hiawatha Light Rail corridor for contamination and health issues, The Center for Occupational Health grant (CDC/NIOSH funded) to develop occupational parameters for dissemination over the MN DATA portal. The local Public Health Association of MN, The MDH climate change committee, and The MPCA air monitoring division. In addition, the program proposes to collaborate in the future with Wisconsin and Iowa on tracking radon, private well monitoring, and, possibly, biomonitoring, with the MDH Office of Statewide Health Improvement, which studies obesity & tobacco use, & with the Child Health Initiative to look at sources to track child health. Discussion Jean asked the panel whether they had any other priorities to suggest and ideas for how MN might supplement CDC’s work. Greg asked Chuck Stroebel about how much of the portal is public, and how much of it will be secure. Chuck explained that the primary emphasis has been on the public portal, to make as much data public as possible. Staff will limit effort on the secure portal until they can get advice and feedback from potential users of the secure portal about applications and content, which would determine the final proportions. Pat McGovern suggested a possible collaboration on the child health initiative. The National Children’s Study (NCS) in Ramsey County is in the pilot phase. As it moves into the main phase in 2012, it would be interesting if some of the MN child health outcomes followed are the same as the NCS outcomes of interest. Doing this might add value and cost efficiency for both groups. Al Bender noted that the last two years of the project call for strong epidemiologic input and involvement, as there will be pressure from users to correlate findings from the exposure side with the disease side, which could have severe consequences for the state. He observed that the recommendation of the Pew Report was to examine ecologic associations and to increase the dialog about the role of the environment in disease burden. This approach has the potential to consume a lot of energy on issues that have little or no plausibility—and this will increase the time and resources burden [on health departments]. Jean noted that MN EPHT is currently engaged in two ―linkage‖ projects: one with the University of Illinois (linking agrichemicals in drinking water with child health outcomes) and the other is linking MPCA air pollution data with monitoring of respiratory and cardiovascular disease outcomes. Al Bender noted that linkages can be of two kinds: ecological correlation and the kind of studies that follow a group of people and link their individual outcomes to other datasets. The first is much more prone to the ecological fallacy. It’s important to draw a distinction between the two kinds of 48 correlations. Chuck noted that the linkage of health outcome data with demographic data is a useful one for examining health disparities. Fond du Lac (FDL) Biomonitoring Project (ATSDR-funded 3-year study) David Jones and Rita Messing (MDH) presented the project, described on pp 39-43 in the background book. The project is funded by the CDC/Agency for Toxic Substances and Disease Registry. The focus is on looking at the body burden of contaminants in the Great Lakes in populations near Areas of Concern (AOCs). The ATSDR is funding three state agencies: MDH, the MI Dept of Community Health, and the NY Dept of Health. The objectives are to see which contaminants people are exposed to, to compare these with other populations (NHANES data), and to determine pathways of exposure. The analytes include a list of chemicals specified by ATSDR, plus chemicals of local concern to Minnesota’s study group. MDH chose the FDL tribe of Native Americans as a highly exposed population of interest in MN, because members of the group eat traditional diets, use more foods from the region, have vulnerable community members, and assign a greater cultural value to their traditional foods. Ultimately, the goal is to develop a public health action plan at the end of the study. MDH will include omega-3 fatty acids to quantify the benefits of fish consumption. The PIs will also measure some clinical parameters, in part to offer participants some direct benefit (for identifying diabetes, for example). They plan to measure height, weight, and blood pressure as part of the physical to get a sense of participants’ risk for CVD and diabetes and will also get the participants’ lipid content and triglycerides to offer some direct benefit to the participants. Rita Messing noted that the study is not research; it is meant only to characterize exposures in this population and not to contribute to generalizable knowledge. If the biomonitoring results show high levels of lead, cadmium, mercury or arsenic, MDH staff know how to interpret these results and will tell the participants about them. Because people are concerned about risks from eating traditional foods, if we find that the exposures are low, that will be a benefit to the community. MDH will work with the FDL health services and will share the project report with the community and with the advice committee in the community. This public health action plan is unique to the project and will give something back to the community. Discussion Al Bender said that he understood why the project is taking clinical information, but that taking clinical information raises a number of issues. Relevant questions include: What are the implications of offering clinical findings? What this will mean for the Tennessen warning given to participants? Who will review the results? What does one say about MDH’s responsibility if the study found something bad? Will the results be reported to the participant’s physician or to the participant? Is a physician involved in the study to help people understand their results? What does one say to a participant about MDH’s 49 responsibility, once one has clinical information about an individual? Do all participants have access to the Indian Health Service? Rita Messing referred to the slide that described how the study participants will be chosen: they must be members or descendents of members of an Indian tribe, a designation that, according to local sources, appears to cover nearly everyone in the FDL community. FDL human services are available to almost all of the people in the community through a clinic in Cloquet or Duluth. She said that individual results will probably be reported to the individual. And, although project procedures are still in development, the PIs will probably structure the informed consent procedure to specify that, if clinically relevant results for metals or other clinical information are found in the samples, they will contact the individuals and make medical advice available. The PIs will put a system in place for early notification and physician consultation about any exposures above health guidelines, as they learn about them. They will try to get the participant to get to the physician. Al Bender noted that this issue must be considered carefully because it is MDH’s responsibility to get information back consistent with the Tennessen warning. Al Bender asked whether anyone is helping to choose the clinical parameters, since markers such as liver enzymes can be helpful. Rita Messing said that the investigators had decided the parameters themselves (cholesterols and triglycerides). The project includes no parameters related to alcohol or drug consumption, but the investigators would try to get someone to a physician if they found evidence of problems. Pat McGovern suggested contacting Jean Forester at UMN, who has worked with the FDL; Pat would be willing to facilitate the contact. She also suggested snowball recruiting if the PIs have trouble recruiting. Asked whether the investigators planned surveys to find out how much fish people eat and other variables, the investigators replied that they are developing the questions now, and will discuss the survey with the project’s Advice Council (in Fond du Lac) to learn about consumption of fish and other traditional foods, basic demographics, and other characteristics, including occupational histories. There are actually two contaminated sites near the community. The major contaminants of concern to ATSDR at those sites are the polyaromatic hydrocarbons (PAHs), so the study is measuring 1, hydroxypyrene, an indicator of PAH exposure, a major concern in the superfund sites in the AOC. The PIs will also measure cotinine to estimate tobacco use. They plan to speciate Hg (to see whether it is elemental or methyl Hg) so they can better understand its sources and toxicity. They will also measure Se, Cd, PFCs, phenols (partly because of a plan to treat pilings with phenols), and toxaphene, which is of concern in Lake Superior. They do not plan to measure dioxins and furans because one needs too much blood for analysis. Because fish advisories are based on total PCBs, the project will measure total PCBs. In response to a question from Pat McGovern, the PIs said that, because the study is not a research study, it has no control population, but the data will be compared to the NHANES dataset and with the other study populations (MI, NY). 50 Greg asked about the difficulty of recruiting. Rita answered that participants will get an incentive – probably of $50, but the PIs are debating a 2nd $50 incentive because the survey is getting long, and the study may ask for 7 tubes of blood from each person. Al Bender inquired about the cost of the lab work. Rita Messing estimated that the study has about $1.5 million for lab work for 500 people (about $3000/person); the project will do only one blood draw per person. The PIs do not intend to save the serum. They will destroy the samples when they’re through with them, because they believe the tribe will not want to have their samples saved. The study will keep the personal identifiers so the PIs can go back to the people for more, if necessary. East Metro PFC Biomonitoring Follow-up Project (PFC2) Update Jessica Nelson and Carin Huset presented a brief update on the PFC2 project. Jessica reviewed the goals of the project and reported on participant recruitment and sample collection, which are now complete. Of the 186 participants contacted for PFC2, 164 gave a blood sample; this participation rate is 88% of those contacted, and 84% of participants in the 2008 study (10 of whom declined contact for future studies). The 22 non-participants fell into different categories: three returned the consent and questionnaire but did not give a blood sample; seven declined to participate in PFC2 but were willing to answer a short phone survey re: residential, water use, and occupational history; 12 did not respond. Carin discussed an issue that arose with the serum samples received from the clinic. She showed a series of photos documenting that, while most serum tubes were yellow in color, in some cases, tubes from the same individual were different colors (i.e. three yellow and one orange/pink tube). This indicates that hemolysis occurred during sample preparation. In a more limited number of cases, all tubes from an individual were pink or orange, indicating hemolysis during blood collection or sample preparation. Carin reexamined samples from 2008, which displayed a similar range of colors; the difference was that all tubes from an individual were the same color. Carin contacted different sources for input. Antonia Calafat (CDC) said they have not observed problems with method performance due to pink samples, though no systematic study has been done. Based on the photos Carin sent, Charles Dodson (CDC) said that, based on the colors observed, the quality of samples would not be a problem. Nathan Kendrick (MDH PHL) said that there does not appear to have been significant hemolysis and that the samples would still be usable for their purposes. Carin thus concludes that the samples are usable. She will analyze only the yellow tubes when an individual’s samples have multiple colors. But the multiple-color tubes offer an opportunity to do an analysis comparing PFC concentrations in yellow v. orange/pink serum samples from the same individuals. Carin and Jessica asked the Panel for feedback on whether staff have addressed this concern sufficiently or if there are outstanding questions. Jessica added that staff received an email from Panel member Geary Olsen, who could not attend the meeting. He commented that the serum color issue is likely related to hemolysis, and that it would be useful to consider if differences were a function of clinic, medical technician/phlebotomist, or amount of time from blood collection to storage in a freezer. 51 Jessica stated that only one clinic was used in this project (in contrast to the 2 clinics used in 2008), that information was not collected on technician/phlebotomist, and that staff assume that the clinic followed the standard protocol re: sample processing and freezing. Alan Bender recommended that staff write up the issue thoroughly, but that it seems to have been reported with due diligence. Greg Pratt recommended re-analyzing samples from 2008 as a quality control check. Carin responded that this is something to consider, though she is confident of the QA/QC measures in place. Still, if there were a difference in results, it would not be clear which were correct. Updates Panel members had no questions about the updates on biomonitoring and tracking projects in the background book. The meeting was adjourned. Finalized May 13, 2011 52 EHTB Advisory Panel 2011 Meeting Dates Tuesday, March 8, 2011 Tuesday, June 7, 2011 Tuesday, September 13, 2011 Tuesday, December 13, 2011 All meetings will be held from 1 - 4 pm and will take place at MDH’s Snelling Office Park location at 1645 Energy Park Drive. 53 As of April 2011 Bruce Alexander, PhD University of Minnesota School of Public Health Environmental Health Sciences Division MMC 807 Mayo 420 Delaware Street SE Minneapolis, Minnesota 55455 612-625-7934 [email protected] At-large representative David DeGroote, PhD St. Cloud State University 740 4th Street South St. Cloud, MN 56301 320-308-2192 [email protected] Minnesota House of Representatives appointee Thomas Hawkinson, MS, CIH, CSP Toro Company 8111 Lyndale Avenue S Bloomington, MN 55420 [email protected] Statewide business org representative Fred Anderson, MPH Washington County Department of Public Health and Environment 14949 62nd St N Stillwater MN 55082 651-430-6655 [email protected] At-large representative Jill Heins Nesvold, MS American Lung Association of Minnesota 490 Concordia Avenue St. Paul, Minnesota 55103 651-223-9578 [email protected] Nongovernmental organization representative Alan Bender, DVM, PhD Minnesota Department of Health Health Promotion and Chronic Disease Division 85 East 7th Place PO Box 64882 Saint Paul, MN 55164-0882 651-201-5882 [email protected] MDH appointee 54 Cathi Lyman-Onkka, MA Preventing Harm Minnesota 372 Macalester Street St. Paul, MN 55105 Gregory Pratt, PhD Minnesota Pollution Control Agency Environmental Analysis and Outcomes Division 520 Lafayette Road St. Paul, MN 55155-4194 651-757-2655 [email protected] MPCA appointee Home office 651-647-9017 [email protected] Nongovernmental organization representative Cathy Villas-Horns, MS, PG Minnesota Department of Agriculture Pesticide and Fertilizer Management Division 625 Robert Street North St. Paul, Minnesota 55155-2538 651-201-6291 [email protected] MDA appointee Pat McGovern, PhD, MPH University of Minnesota School of Public Health Environmental Health Sciences Division MMC Mayo 807 420 Delaware St SE Minneapolis MN 55455 612-625-7429 [email protected] University of Minnesota representative Lisa Yost, MPH, DABT Exponent, Inc. 15375 SE 30th Pl, Ste 250 Bellevue, Washington 98007 Local office St. Paul, Minnesota 651-225-1592 [email protected] At-large representative Geary Olsen, DVM, PhD 3M Medical Department Corporate Occupational Medicine MS 220-6W-08 St. Paul, Minnesota 55144-1000 651-737-8569 [email protected] Statewide business organization representative Vacant Minnesota Senate appointee 55 GLOSSARY OF TERMS USED IN ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING Biomarker: According to the National Research Council (NRC), a biomarker is an indicator of a change or an event in a human biological system. The NRC defines three types of biomarkers in environmental health, those that indicate exposure, effect, and susceptibility. Biomarker of exposure: An exogenous substance, its metabolites, or the product of an interaction between the substance and some target molecule or cell that can be measured in an organism. Biomarker of effect: A measurable change (biological, physiological, etc.) within the body that may indicate an actual or potential health impairment or disease. Biomarker of susceptibility: An indicator that an organism is especially sensitive to exposure to a specific external substance. Biomonitoring: As defined by Minnesota Statute 144.995, biomonitoring is the process by which chemicals and their metabolites are identified and measured within a biospecimen. Biomonitoring data are collected by analyzing blood, urine, milk or other tissue samples in the laboratory. These samples can provide physical evidence of current or past exposure to a particular chemical. Biospecimen: As defined by Minnesota Statute 144.995, biospecimen means a sample of human fluid, serum, or tissue that is reasonably available as a medium to measure the presence and concentration of chemicals or their metabolites in a human body. Community: As defined by Minnesota Statute 144.995, community means geographically or nongeographically based populations that may participate in the biomonitoring program. A nongeographical community includes, but is not limited to, populations that may share a common chemical exposure through similar occupations; populations experiencing a common health outcome that may be linked to chemical exposures; populations that may experience similar chemical exposures because of comparable consumption, lifestyle, product use; and subpopulations that share ethnicity, age, or gender. Designated chemicals: As defined by Minnesota Statute 144.995, designated chemicals are those chemicals that are known to, or strongly suspected of, adversely impacting human health or development, based upon scientific, peer-reviewed animal, human, or in vitro studies, and baseline human exposure data. They consist of chemical families or metabolites that are included in the federal Centers for Disease Control and Prevention studies that are known collectively as the National Reports on Human Exposure to Environmental Chemicals Program and any substances specified by the commissioner after receiving recommendations from the advisory panel in accordance with the criteria specified in statute for the selection of specific chemicals to study. Environmental data: Concentrations of chemicals or other substances in the land, water, or air. Also, information about events or facilities that release chemicals or other substances into the land, water, or air. 56 Environmental epidemiology: According to the National Research Council, environmental epidemiology is the study of the effect on human health of physical, biologic, and chemical factors in the external environment. By examining specific populations or communities exposed to different ambient environments, environmental epidemiology seeks to clarify the relation between physical, biologic, and chemical factors and human health. Environmental hazard: As defined by Minnesota Statute 144.995, an environmental hazard is a chemical or other substance for which scientific, peer-reviewed studies of humans, animals, or cells have demonstrated that the chemical is known or reasonably anticipated to adversely impact human health. People can be exposed to physical, chemical, or biological agents from various environmental sources through air, water, soil, and food. For EPHT, environmental hazards include biological toxins, but do not include infectious agents (e.g. E. coli in drinking water is not included). Environmental health indicators: Environmental health indicators or environmental public health indicators are descriptive summary measures that identify and communicate information about a population’s health status with respect to environmental factors. Within the environmental public health indicators framework, indicators are categorized as hazard indicators, exposure indicators, health effect indicators, and intervention indicators. See www.cste.org/OH/SEHIC.asp and www.cdc.gov/nceh/indicators/introduction.htm for more information. Environmental justice: The fair treatment and meaningful involvement of all people regardless of race, national origin, color or income when developing, implementing and enforcing environmental laws, regulations and policies. Fair treatment means that no group of people, including a racial, ethnic, or socioeconomic group, should bear more than its share of negative environmental impacts. Environmental health tracking: As defined in Minnesota Statute 144.995, environmental health tracking is the collection, integration, integration, analysis, and dissemination of data on human exposures to chemicals in the environment and on diseases potentially caused or aggravated by those chemicals. Environmental health tracking is synonymous with environmental public health tracking. Environmental public health surveillance: Environmental public health surveillance is public health surveillance of health effects integrated with surveillance of environmental exposures and hazards. Environmental Public Health Tracking Network: The National Environmental Public Health Tracking Network is a web-based, secure network of standardized health and environmental data. The Tracking Network draws data and information from state and local tracking networks as well as national-level and other data systems. It will provide the means to identify, access, and organize hazard, exposure, and health data from these various sources and to examine and analyze those data on the basis of their spatial and temporal characteristics. See http://ephtracking.cdc.gov/ Environmental Public Health Tracking (EPHT) Program: The Congressionally-mandated national initiative that will establish a network that will enable the ongoing collection, integration, analysis, and interpretation of data about the following factors: (1) environmental hazards, (2) exposure to environmental hazards, and (3) health effects potentially related to exposure to environmental hazards. Visit www.cdc.gov/nceh/tracking/ for more information. Epidemiology: The study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to the control of health problems. 57 Exposure: Contact with a contaminant (by breathing, ingestion, or touching) in such a way that the contaminant may get in or on the body and harmful effects may occur. Exposure indicator: According to the Council of State and Territorial Epidemiologists (CSTE), an exposure indicator is a biological marker in tissue or fluid that identifies the presence of a substance or combination of substances that may potentially harm the individual. Geographic Information Systems (GIS): Software technology that enables the integration of multiple sources of data and displaying data in time and space. Hazard: A factor that may adversely affect health. Hazard indicator: A condition or activity that identifies the potential for exposure to a contaminant or hazardous condition. Health effects: Chronic or acute health conditions that affect the well-being of an individual or community. Health effect indicator: The disease or health problem itself, such as asthma attacks or birth defects, that affect the well-being of an individual or community. Health effects are measured in terms of illness and death and may be chronic or acute health conditions. Incidence: The number of new events (e.g., new cases of a disease in a defined population) within a specified period of time. Indicator: In Tracking, an indicator is a numeric measure or other characteristic found within each content area that will be assessed to provide information about a population's health status and their environment with the goal of monitoring trends, comparing situations, and better understanding the link between the environment and health. Institutional Review Board: An Institutional Review Board (IRB) is a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. IRBs check to see that research projects are well designed, legal, ethical, do not involve unnecessary risks, and include safeguards for participants. Intervention: Taking actions in public health so as to reduce adverse health effects, regulatory, and prevention strategies. Intervention indicator: Programs or official policies that minimize or prevent an environmental hazard, exposure or health effect. Minnesota Data on Tracking and Assessment (MN DATA): MN DATA is a web based system that provides the user with access to Minnesota public health data, the environment, and other risk factors that could impact public health. 58 Minnesota Environmental Public Health Tracking Program (MN EPHT): MN EPHT is defined in Minnesota Statutes, section 144.995 as a state program for the ongoing collection, integration, interpretation, and dissemination of environmental hazard, exposure, and health effects data. MN EPHT produces a network or system of integrated data in the state about environmental hazards, population exposure, and health outcomes. MN EPHT works in partnership with other states as part of CDC’s National Environmental Public Health Tracking Network (Tracking Network). National Health and Nutrition Examination Survey (NHANES): A continuous survey, conducted by CDC, of the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations. Since 1970, children in the survey were biomonitored for lead poisoning, and since 1999, an increasing number of environmental contaminants has been included in the survey. Visit www.cdc.gov/exposurereport/report.htm for more information. National Human Exposure Assessment Survey (NHEXAS): An EPA survey designed to evaluate comprehensive human exposure to multiple chemicals on a community and regional scale. The study was carried out in EPA Region V, of which Minnesota is a part. Individual households from four Minnesota Counties were included in the survey. Visit www.epa.gov/heasd/edrb/nhexas.htm for more information. Nationally Consistent Data and Measures (NCDM): An NCDM is an adaptation of a single set of national standards for data collection, analysis and reporting to enable CDC to compile a core set of nationally consistent data and measures across multiple states. Persistent chemicals: Chemical substances that persist in the environment, bioaccumulate through the food web, and pose a risk of causing adverse effects to human health and the environment. Population-based approach: A population-based approach uses a defined population or community as the organizing principle for targeting the broad distribution of diseases and health determinants. A populationbased approach attempts to measure or shape a community’s overall health status profile, seeking to affect the determinants of disease within an entire community rather than simply those of single individuals. Prevalence: The number of events (e.g., instances of a given health effect or other condition) in a given population at a designated time. Public health surveillance: The systematic collection, analysis, interpretation, and dissemination of health data on an ongoing basis. Surveillance is conducted in order to identify potential public health threats or patterns of disease occurrence and risk in a community. Query: A tool that allows a user to retrieve information from a database. Standard: Something that serves as a basis for comparison. A technical specification or written report drawn up by experts based on the consolidated results of scientific study, technology, and experience; aimed at optimum benefits; and approved by a recognized and representative body. Revised February 24, 2011 59 ACRONYMS USED IN ENVIRONMENTAL HEALTH TRACKING & BIOMONITORING ACGIH ATSDR American Conference of Governmental Industrial Hygienists Agency for Toxic Substances and Disease Registry, DHHS CDC Centers for Disease Control and Prevention, DHHS CERCLA Comprehensive Environmental Response; Compensation and Liability Act (Superfund) CSTE Council of State and Territorial Epidemiologists DHHS US Department of Health and Human Services, including the US Public Health Service, which includes the CDC, ATSDR, NIH and other agencies EPA US Environmental Protection Agency EHTB Environmental Health Tracking and Biomonitoring (the name of Minnesota Statutes 144.995-144.998 and the program established therein) EPHI Environmental Public Health Indicators ICD International Classification of Diseases IRB Institutional Review Board MARS Minnesota Arsenic Study, conducted by MDH in 1998-1999 MDA Minnesota Department of Agriculture MDH Minnesota Department of Health MN DATA Minnesota Data Access for Tracking & Assessment MN EPHT Minnesota Environmental Public Health Tracking MNPHIN Minnesota Public Health Information Network, MDH MPCA Minnesota Pollution Control Agency NCDM Nationally Consistent Data & Measures NCEH National Center for Environmental Health, CDC NCHS National Center for Health Statistics 60 NGO Non-governmental organization NHANES National Health and Nutrition Examination Survey, National Center for Health Statistics (NCHS) in the CDC NHEXAS National Human Exposure Assessment Survey, EPA NIOSH National Institute for Occupational Safety and Health, CDC NIEHS National Institute of Environmental Health Sciences, NIH NIH National Institutes of Health, DHHS NLM National Library of Medicine, NIH NPL National Priorities List (Superfund) NTP National Toxicology Program, NIEHS, NIH PFBA Perfluorobutanoic acid PFC Perfluorochemicals, including PFBA, PFOA and PFOS PFOA Perfluorooctanoic acid PFOS Perfluorooctane sulfonate PHL Public Health Laboratory, MDH PHIN Public Health Information Network, CDC POP Persistent organic pollutant SEHIC State Environmental Health Indicators Collaborative Revised February 24, 2011 61 EHTB statute: Minn. Statutes 144.995-144.998 Minnesota: Environmental Health Tracking and Biomonitoring $1,000,000 each year is for environmental health tracking and biomonitoring. Of this amount, $900,000 each year is for transfer to the Minnesota Department of Health. The base appropriation for this program for fiscal year 2010 and later is $500,000. studies of humans, animals, or cells have demonstrated that the chemical is known or reasonably anticipated to adversely impact human health. (j) "Environmental health tracking" means collection, integration, analysis, and dissemination of data on human exposures to chemicals in the environment and on diseases potentially caused or aggravated by those chemicals. 144.995 DEFINITIONS; ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING. (a) For purposes of sections 144.995 to 144.998, the terms in this section have the meanings given. (b) "Advisory panel" means the Environmental Health Tracking and Biomonitoring Advisory Panel established under section 144.998. (c) "Biomonitoring" means the process by which chemicals and their metabolites are identified and measured within a biospecimen. (d) "Biospecimen" means a sample of human fluid, serum, or tissue that is reasonably available as a medium to measure the presence and concentration of chemicals or their metabolites in a human body. (e) "Commissioner" means the commissioner of the Department of Health. (f) "Community" means geographically or nongeographically based populations that may participate in the biomonitoring program. A "nongeographical community" includes, but is not limited to, populations that may share a common chemical exposure through similar occupations, populations experiencing a common health outcome that may be linked to chemical exposures, populations that may experience similar chemical exposures because of comparable consumption, lifestyle, product use, and subpopulations that share ethnicity, age, or gender. (g) "Department" means the Department of Health. (h) "Designated chemicals" means those chemicals that are known to, or strongly suspected of, adversely impacting human health or development, based upon scientific, peer-reviewed animal, human, or in vitro studies, and baseline human exposure data, and consists of chemical families or metabolites that are included in the federal Centers for Disease Control and Prevention studies that are known collectively as the National Reports on Human Exposure to Environmental Chemicals Program and any substances specified by the commissioner after receiving recommendations under section 144.998, subdivision 3, clause (6). (i) "Environmental hazard" means a chemical or other substance for which scientific, peer-reviewed 144.996 ENVIRONMENTAL HEALTH TRACKING; BIOMONITORING. Subdivision 1. Environmental health tracking. In cooperation with the commissioner of the Pollution Control Agency, the commissioner shall establish an environmental health tracking program to: (1) coordinate data collection with the Pollution Control Agency, Department of Agriculture, University of Minnesota, and any other relevant state agency and work to promote the sharing of and access to health and environmental databases to develop an environmental health tracking system for Minnesota, consistent with applicable data practices laws; (2) facilitate the dissemination of aggregate public health tracking data to the public and researchers in accessible format; (3) develop a strategic plan that includes a mission statement, the identification of core priorities for research and epidemiologic surveillance, and the identification of internal and external stakeholders, and a work plan describing future program development and addressing issues having to do with compatibility with the Centers for Disease Control and Prevention's National Environmental Public Health Tracking Program; (4) develop written data sharing agreements as needed with the Pollution Control Agency, Department of Agriculture, and other relevant state agencies and organizations, and develop additional procedures as needed to protect individual privacy; (5) organize, analyze, and interpret available data, in order to: (i) characterize statewide and localized trends and geographic patterns of population-based measures of 62 chronic diseases including, but not limited to, cancer, respiratory diseases, reproductive problems, birth defects, neurologic diseases, and developmental disorders; (ii) characterize statewide and localized trends and geographic patterns in the occurrence of environmental hazards and exposures; (iii) assess the feasibility of integrating disease rate data with indicators of exposure to the selected environmental hazards such as biomonitoring data, and other health and environmental data; (iv) incorporate newly collected and existing health tracking and biomonitoring data into efforts to identify communities with elevated rates of chronic disease, higher likelihood of exposure to environmental hazards, or both; (v) analyze occurrence of environmental hazards, exposures, and diseases with relation to socioeconomic status, race, and ethnicity; (vi) develop and implement targeted plans to conduct more intensive health tracking and biomonitoring among communities; and (vii) work with the Pollution Control Agency, the Department of Agriculture, and other relevant state agency personnel and organizations to develop, implement, and evaluate preventive measures to reduce elevated rates of diseases and exposures identified through activities performed under sections 144.995 to 144.998; and (6) submit a biennial report to the chairs and ranking members of the committees with jurisdiction over environment and health by January 15, beginning January 15, 2009, on the status of environmental health tracking activities and related research programs, with recommendations for a comprehensive environmental public health tracking program. Subd. 2. Biomonitoring. The commissioner shall: (1) conduct biomonitoring of communities on a voluntary basis by collecting and analyzing biospecimens, as appropriate, to assess environmental exposures to designated chemicals; (2) conduct biomonitoring of pregnant women and minors on a voluntary basis, when scientifically appropriate; (3) communicate findings to the public, and plan ensuing stages of biomonitoring and disease tracking work to further develop and refine the integrated analysis; (4) share analytical results with the advisory panel and work with the panel to interpret results, communicate findings to the public, and plan ensuing stages of biomonitoring work; and (5) submit a biennial report to the chairs and ranking members of the committees with jurisdiction over environment and health by January 15, beginning January 15, 2009, on the status of the biomonitoring program and any recommendations for improvement. Subd. 3. Health data. Data collected under the biomonitoring program are health data under section 13.3805. 144.997 BIOMONITORING PILOT PROGRAM. Subdivision 1. Pilot program. With advice from the advisory panel, and after the program guidelines in subdivision 4 are developed, the commissioner shall implement a biomonitoring pilot program. The program shall collect one biospecimen from each of the voluntary participants. The biospecimen selected must be the biospecimen that most accurately represents body concentration of the chemical of interest. Each biospecimen from the voluntary participants must be analyzed for one type or class of related chemicals. The commissioner shall determine the chemical or class of chemicals to which community members were most likely exposed. The program shall collect and assess biospecimens in accordance with the following: (1) 30 voluntary participants from each of three communities that the commissioner identifies as likely to have been exposed to a designated chemical; (2) 100 voluntary participants from each of two communities: (i) that the commissioner identifies as likely to have been exposed to arsenic; and (ii) that the commissioner identifies as likely to have been exposed to mercury; and (3) 100 voluntary participants from each of two communities that the commissioner identifies as likely to have been exposed to perfluorinated chemicals, including perfluorobutanoic acid. Subd. 2. Base program. (a) By January 15, 2008, the commissioner shall submit a report on the results of the biomonitoring pilot program to the chairs and ranking members of the committees with jurisdiction over health and environment. (b) Following the conclusion of the pilot program, the commissioner shall: (1) work with the advisory panel to assess the usefulness of continuing biomonitoring among members of communities assessed during the pilot program and to identify other communities and other designated chemicals to be assessed via biomonitoring; (2) work with the advisory panel to assess the pilot program, including but not limited to the validity and accuracy of the analytical measurements and adequacy of the guidelines and protocols; (3) communicate the results of the pilot program to the public; and (4) after consideration of the findings and recommendations in clauses (1) and (2), and within 63 the appropriations available, develop and implement a base program. Subd. 3. Participation. (a) Participation in the biomonitoring program by providing biospecimens is voluntary and requires written, informed consent. Minors may participate in the program if a written consent is signed by the minor's parent or legal guardian. The written consent must include the information required to be provided under this subdivision to all voluntary participants. (b) All participants shall be evaluated for the presence of the designated chemical of interest as a component of the biomonitoring process. Participants shall be provided with information and fact sheets about the program's activities and its findings. Individual participants shall, if requested, receive their complete results. Any results provided to participants shall be subject to the Department of Health Institutional Review Board protocols and guidelines. When either physiological or chemical data obtained from a participant indicate a significant known health risk, program staff experienced in communicating biomonitoring results shall consult with the individual and recommend follow-up steps, as appropriate. Program administrators shall receive training in administering the program in an ethical, culturally sensitive, participatory, and communitybased manner. Subd. 4. Program guidelines. (a) The commissioner, in consultation with the advisory panel, shall develop: (1) protocols or program guidelines that address the science and practice of biomonitoring to be utilized and procedures for changing those protocols to incorporate new and more accurate or efficient technologies as they become available. The commissioner and the advisory panel shall be guided by protocols and guidelines developed by the Centers for Disease Control and Prevention and the National Biomonitoring Program; (2) guidelines for ensuring the privacy of information; informed consent; follow-up counseling and support; and communicating findings to participants, communities, and the general public. The informed consent used for the program must meet the informed consent protocols developed by the National Institutes of Health; (3) educational and outreach materials that are culturally appropriate for dissemination to program participants and communities. Priority shall be given to the development of materials specifically designed to ensure that parents are informed about all of the benefits of breastfeeding so that the program does not result in an unjustified fear of toxins in breast milk, which might inadvertently lead parents to avoid breastfeeding. The materials shall communicate relevant scientific findings; data on the accumulation of pollutants to community health; and the required responses by local, state, and other governmental entities in regulating toxicant exposures; (4) a training program that is culturally sensitive specifically for health care providers, health educators, and other program administrators; (5) a designation process for state and private laboratories that are qualified to analyze biospecimens and report the findings; and (6) a method for informing affected communities and local governments representing those communities concerning biomonitoring activities and for receiving comments from citizens concerning those activities. (b) The commissioner may enter into contractual agreements with health clinics, community-based organizations, or experts in a particular field to perform any of the activities described under this section. 144.998 ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING ADVISORY PANEL. Subdivision 1. Creation. The commissioner shall establish the Environmental Health Tracking and Biomonitoring Advisory Panel. The commissioner shall appoint, from the panel's membership, a chair. The panel shall meet as often as it deems necessary but, at a minimum, on a quarterly basis. Members of the panel shall serve without compensation but shall be reimbursed for travel and other necessary expenses incurred through performance of their duties. Members appointed by the commissioner are appointed for a three-year term and may be reappointed. Legislative appointees serve at the pleasure of the appointing authority. Subd. 2. Members. (a) The commissioner shall appoint eight members, none of whom may be lobbyists registered under chapter 10A, who have backgrounds or training in designing, implementing, and interpreting health tracking and biomonitoring studies or in related fields of science, including epidemiology, biostatistics, environmental health, laboratory sciences, occupational health, industrial hygiene, toxicology, and public health, including: (1) at least two scientists representative of each of the following: (i) nongovernmental organizations with a focus on environmental health, environmental justice, children's health, or on specific chronic diseases; and (ii) statewide business organizations; and (2) at least one scientist who is a representative of the University of Minnesota. (b) Two citizen panel members meeting the scientific qualifications in paragraph (a) shall be appointed, one by the speaker of the house and one by the senate majority leader. 64 (c) In addition, one representative each shall be appointed by the commissioners of the Pollution Control Agency and the Department of Agriculture, and by the commissioner of health to represent the department's Health Promotion and Chronic Disease Division. Subd. 3. Duties. The advisory panel shall make recommendations to the commissioner and the legislature on: (1) priorities for health tracking; (2) priorities for biomonitoring that are based on sound science and practice, and that will advance the state of public health in Minnesota; (3) specific chronic diseases to study under the environmental health tracking system; (4) specific environmental hazard exposures to study under the environmental health tracking system, with the agreement of at least nine of the advisory panel members; (5) specific communities and geographic areas on which to focus environmental health tracking and biomonitoring efforts; (6) specific chemicals to study under the biomonitoring program, with the agreement of at least nine of the advisory panel members; in making these recommendations, the panel may consider the following criteria: (i) the degree of potential exposure to the public or specific subgroups, including, but not limited to, occupational; (ii) the likelihood of a chemical being a carcinogen or toxicant based on peer-reviewed health data, the chemical structure, or the toxicology of chemically related compounds; (iii) the limits of laboratory detection for the chemical, including the ability to detect the chemical at low enough levels that could be expected in the general population; (iv) exposure or potential exposure to the public or specific subgroups; (v) the known or suspected health effects resulting from the same level of exposure based on peer- reviewed scientific studies; (vi) the need to assess the efficacy of public health actions to reduce exposure to a chemical; (vii) the availability of a biomonitoring analytical method with adequate accuracy, precision, sensitivity, specificity, and speed; (viii) the availability of adequate biospecimen samples; or (ix) other criteria that the panel may agree to; and (7) other aspects of the design, implementation, and evaluation of the environmental health tracking and biomonitoring system, including, but not limited to: (i) identifying possible community partners and sources of additional public or private funding; (ii) developing outreach and educational methods and materials; and (iii) disseminating environmental health tracking and biomonitoring findings to the public. Subd. 4. Liability. No member of the panel shall be held civilly or criminally liable for an act or omission by that person if the act or omission was in good faith and within the scope of the member's responsibilities under sections 144.995 to 144.998. INFORMATION SHARING. On or before August 1, 2007, the commissioner of health, the Pollution Control Agency, and the University of Minnesota are requested to jointly develop and sign a memorandum of understanding declaring their intent to share new and existing environmental hazard, exposure, and health outcome data, within applicable data privacy laws, and to cooperate and communicate effectively to ensure sufficient clarity and understanding of the data by divisions and offices within both departments. The signed memorandum of understanding shall be reported to the chairs and ranking members of the senate and house of representatives committees having jurisdiction over judiciary, environment, and health and human services. Effective date: July 1, 2007 This document contains Minnesota Statutes, sections 144.995 to 144.998, as these sections were adopted in Minnesota Session Laws 2007, chapter 57, article 1, sections 143 to 146. The appropriation related to these statutes is in chapter 57, article 1, section 3, subdivision 4. The paragraph about information sharing is in chapter 57, article 1, section 169. The following is a link to chapter 57: http://ros.leg.mn/bin/getpub.php?type=law&year=2007&sn=0&num=57 65
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