Minnesota Department of Health Environmental Health Tracking and Biomonitoring Advisory Panel Meeting September 14, 2010 1:00 p.m. – 4:00 p.m. Snelling Office Park Red River Room 1645 Energy Park Drive St. Paul, Minnesota ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING ADVISORY PANEL MEETING AGENDA Time Agenda item Presenter(s) 1:00 Welcome and introductions Beth Baker, Chair Item type/Anticipated outcome TRACKING 1:05 Minnesota-specific tracking content areas Jeannette Sample Jean Johnson Discussion Item Staff will describe progress made and next steps in exploring several potential new content areas that could eventually be incorporated into MN EPHT. Panel members are invited to provide input, ask questions, and respond to the following questions: Does the process for selecting new content provide appropriate opportunities for the panel to make recommendations on the priorities for tracking that are important to Minnesota? Do the three examples presented (radon, secondhand smoke, and atrazine) provide useful insight into understanding how the selection criteria can be applied? 1:40 Tracking updates MN EPHT webbased information system EPHTN collaborations MN EPHT communications and outreach -- Information sharing. No formal presentations will be made on these topics. Panel members are invited to ask questions or provide input on any of the written tracking updates included in the meeting materials. L Time Agenda item Presenter(s) Item type/Anticipated outcome 1:50 Tracking Needs Assessment -- Information sharing. 2:00 No formal presentation will be made on this topic. Panel members are invited to ask questions or provide input on plans for conducting a needs assessment to identify the informational needs that are important to local public health officials BreakPoster session Panel members are invited to view posters on biomonitoring and tracking projects BIOMONITORING 2:15 Discussion item. Jean Johnson Lessons learned from biomonitoring Adrienne Kari Pat McCann pilot program: targeting vulnerable populations Staff will review a draft document describing a few of the lessons learned from the Riverside and Lake Superior biomonitoring studies thus far. Panel members are invited to provide input on the summary of lessons learned. In particular, panel members are asked to respond to the following questions: These two pilots could be described as special investigations designed to measure chemicals in vulnerable populations (e.g., pregnant women and newborns). o If Minnesota were to continue using this approach to biomonitoring, what recommendations would you make with regard to population selection? o With regard to chemical selection? o With regard to recruitment, consent and participation? o With regard to communication? When is biomonitoring an appropriate response to concerns about vulnerable populations’ exposures to environmental contaminants? 2:50 Biomonitoring framework Andrea Baeder Jean Johnson Adrienne Kari Discussion item. Staff will review a draft document outlining the strengths and limitations of three public health approaches to biomonitoring, and a recommendation LL Time Agenda item Presenter(s) Item type/Anticipated outcome for the scope of future program planning. Panel members are invited to provide input on and ask questions about the draft biomonitoring framework. In particular, panel members are asked to respond to the following questions: What additional information or recommendations should be incorporated into the framework? Does the document provide enough information for the panel to support the staff recommendation for future program planning at this time? OTHER 3:50 3:55 Administrative details Jean Johnson New business Beth Baker Information sharing Staff will provide an update on the status of filling vacancies on the panel. Discussion item The chair will invite panel members to suggest topics for future discussion. 4:00 Adjourn Beth Baker Next meeting: Tuesday, December 14, 2010, 1-4 p.m. Red River Room, Snelling Office Park LLL This page intentionally left blank. LY TABLE OF CONTENTS Agenda ................................................................................................................................... i Table of contents ..................................................................................................................v Materials related to specific agenda items Minnesota-specific environmental public health tracking content areas Section overview: Minnesota-specific environmental public health tracking content areas ............................................................................................................................1 Selection process and criteria for new Minnesota-specific tracking content areas ..........3 Updates on potential new MN EPHT content areas .........................................................7 Tracking updates Section overview: Tracking updates...............................................................................11 Status update on the MN EPHT web-based information system....................................13 Status update on EHTB collaborations............................................................................15 Status update on MN EPHT communications and outreach...........................................17 Tracking Needs Assessment for Local Public Health Section overview: Tracking Needs Assessment .............................................................19 Policymaker Priority Assessment Survey.......................................................................21 Lessons learned from biomonitoring pilot program Section overview: Lessons learned from biomonitoring pilot program .........................27 Background information on MDH biomonitoring pilot program ...................................29 Lessons learned about biomonitoring in vulnerable populations (draft) ........................35 Biomonitoring framework Section overview: Biomonitoring framework ................................................................37 Biomonitoring framework (working draft).....................................................................38 Other information Section overview: Other information.....................................................................................51 Public inquiry to the panel .........................................................................................53 Local, national and global biomonitoring and tracking news…................................55 EHTB advisory panel meeting summary (for June 8, 2010) .....................................57 Y This page intentionally left blank. vi SECTION OVERVIEW: MINNESOTA-SPECIFIC ENVIRONMENTAL PUBLIC HEALTH TRACKING CONTENT 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. Staff have incorporated this feedback into the criteria and are now working to refine and test the process used to select new content areas. Selection process The selection process, as currently conceived, is broken down into several phases: Preinitiation, initiation, exploration, recommendation, and adoption. The selection process includes many points at which the advisory panel may be approached: At the initiation stage in order to help prioritize numerous priorities, particularly if program resources limit the number of new content areas that can be explored At the end of the initiation stage, if it is deemed that data are not available for an area of high public health importance (in which case the panel may recommend that the state find resources to gather new data) At the end of the initiation stage, if it is deemed that a new content area should not be further explored because it does not meet criteria for selection. After the exploration (piloting) stage, if it is determined that the data sources are not adequate enough to support further work After the exploration (piloting) stage, when it is determined that a new content area should or should not be incorporated into the program on an ongoing basis. The panel may be also be provided with updates at any stage of the process. New content areas As reported in writing in June 2010, three potential new content areas are under exploration (residential radon, secondhand smoke, and pesticides). The criteria and selection process are being piloted using these three content areas and will continue to be revised based on lessons learned during the piloting. At the September advisory panel meeting, MN EPHT staff will provide an overview of the selection process and an update on the status of the three content areas currently being explored. The following items are included in this section of the meeting materials: Selection process and criteria for new Minnesota-specific tracking content areas and measures (draft) 1 Updates on potential new MN EPHT content areas o residential radon o secondhand smoke o pesticides ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on this topic during the designated time on the meeting agenda. In particular, panel members are asked to respond to the following questions: Does the process provide appropriate opportunities for the Advisory Panel to have input and make recommendations on the priorities for tracking chronic diseases and environmental hazards that are important in Minnesota? Are there any additional steps or special considerations that are missing? Do the three examples presented (radon, secondhand smoke, and atrazine) provide useful insight in to how these criteria may be applied at the initiation stage? 2 Selection process and criteria for new Minnesotaspecific tracking content areas and measures (DRAFT) The selection of new content areas and measures to be incorporated into MN EPHT will be done on an ongoing basis throughout the year. The technical team plays a vital role in identifying, exploring and recommending new content areas and measures. The process described below includes general guidelines for how new content areas and measures may be selected. In practice, the process will be fluid and specific decisions related to the process will be made at the discretion of MN EPHT program management. PRE-INITIATION STAGE The Program Manager (PM) assigns members of the technical team to initiate the development of a content area. The primary factor to be considered at this stage is whether resources are available to identify and explore new content areas. Staff and student interests are one driver for identifying new content areas and measures to initiate. Recommendations for new content areas or measures may also come from other sources, including advisory panel members and local public health. In future years, the EPHT program may seek recommendations for new content from the public through a more formal process. Specific criteria that are considered in the pre-initiation stage include the following, which may influence whether a decision is made to begin the process of identifying new content areas. 1. Resources Available a) Staff time, staff interest, staff expertise (including outside staff, interns, student workers) b) Financial and technical resources are available INITIATION STAGE: Assigned members of the technical team build a rationale for the new content area(s) that addresses the public health importance of the issue in Minnesota. Factors to be considered at this stage include prevalence, causation, public health impact and actionability. Assigned staff should also address preliminary issues of feasibility by making contact with data stewards to collect information on available data sources and legal authority (e.g., data fields and years, statutes that govern data collection and use) and complete a data source inventory template describing the available data sources in detail. 3 The initial rationale submitted to the technical team should make recommendations for which data sources are most appropriate for further development and exploration. The initial rationale should also include a list of potential indicators or measures. The preliminary rationale/proposal is presented for discussion at a technical team meeting. Team members ask questions, suggest additional data sources, provide technical advice, etc. The program manager(PM) and principal investigator (PI) will determine if the rationale provided supports further exploration, and give the green light for further exploration. Alternately, if the rationale does not support further exploration, the PI or PM will present a recommendation to the advisory panel to discontinue work. At this stage, each new content area and measure is considered on its own merits rather than rated against other content areas and measures. If input is needed by PI/PM to help reach consensus among numerous priorities that could be further pursued (e.g., if staffing resources limit the number of options that can realistically be pursued), the advisory panel will be consulted. If data are not available for a content area of high public health importance, the advisory panel may be asked to make a recommendation for gathering new data. Specific criteria that are considered in the initiation stage include the following, which may influence whether a decision is made to move on to the stage of exploring and piloting a new content area. 1. Degree of prevalence a) High estimated prevalence of disease/outcome in U.S. population, state or MN sub-population. b) High estimated proportion of population in state or sub-population potentially exposed to hazard within particular media. 2. Causality a) Evidence exists that the disease has an environmental component cause. b) Evidence exists that the hazard or exposure is a component cause of an adverse health outcome. 3. Public health impact c) Population attributable risk or public health impact of the hazard is known or can be estimated from the available data. d) Severity of the disease effect is known and contributes to mortality or morbidity in the population. 4. Actionability a) Disease or hazard has existing prevention or control program (intervention, education, service) at MDH, local public health or other organization. b) Level of hazard, exposure or disease can be modified through policy, regulatory or personal actions. c) Disease or hazard prevention is tied to state or federal public health objectives d) Data and measures can be used to develop new program initiatives 5. Feasibility a) One or more data sources exist for exploration of “trackable” indicators. b) MDH has the legal authority to collect and use the data. c) Private data are classified and protected according to state and federal law. 4 EXPLORATION STAGE: Assigned staff select data source(s) and measures to be piloted to assess feasibility. Feasibility criteria at this stage include data quality, timeliness, continuity of data over time, comparability to other jurisdictions, and aggregation possibilities. Assigned staff obtain a sample “cut” of the data from the data steward (which may require developing a data use agreement) and develop new measures. New measures are displayed in tables, maps and/or graphs to show temporal and/or geographic trends. Assigned staff continue piloting the indicators, possibly over a period of many months, and present to the technical team to get feedback and to refine the measures. Assigned staff document the work done to develop and refine the measures. When the content areas/measures have been fully piloted and feasibility has been assessed, the technical team (or a subgroup of the technical team) decides whether to recommend to the advisory panel that the content area or measure be adopted as an ongoing part of the tracking program. If the piloting process shows that the available data sources are not adequate for tracking a content area of high public health importance, the advisory panel may be asked to make a recommendation regarding strengthening the data sources. Specific criteria that are considered in the exploration stage include the following, which may influence whether a decision is made to make a recommendation to adopt a new content area. 1. Feasibility a) Data quality Population-based Representative of disease, hazard or exposure in the state. Reliability Validity b) Continuity, consistent ongoing data collection over time c) Timeliness, lag times are acceptable for surveillance purposes d) Comparability of indicators/measures to other jurisdictions. e) Aggregation possible at different geographic levels (e.g., state, county, ZIP code, census block) f) Cost to MDH of obtaining necessary data is not prohibitive RECOMMENDATION STAGE: Assigned staff provide written summaries of the content areas and measures with recommendations for consideration by the advisory panel. For content areas that are recommended for inclusion in the tracking program, assigned staff will assemble background information that addresses all of the 5 selection criteria, including whether the content area is an emerging issue, the potential for information building, outside interest, the balance between hazard/exposure and disease content areas, and economic impact. The advisory panel will make a recommendation about which content areas and measures should be adopted as an ongoing part of the tracking program. The commissioner is informed about the recommendations of the advisory panel and makes a final decision about the adoption of new content areas or measures. Specific criteria that may be considered by advisory panel members in the recommendation stage, in addition to those listed above, include the following, which may influence whether a new content area is adopted as an ongoing part of MNEPHT. 1. Emerging issues a) Incidence or prevalence of disease is changing or perceived to be changing. b) Degree or level of exposure is changing or perceived to be changing. 2. Potential for information building a) Disease with unknown environmental etiology or unknown prevalence. b) Hazard with unknown association to health outcomes or unknown level of exposure in the population. Can be used to inform or guide research initiatives 3. Outside interest or public concern a) High concern regarding prevalence and etiology of disease or outcome. b) High concern regarding proportion of the population exposed to a hazard or changes in exposure to a hazard. c) Priority previously identified by environmental health professionals and organizations(e.g. CDC, WHO, NHANES, EPA, NIOSH, ASTHO, etc.). 4. Balance between hazard/exposure and disease content areas tracked. 5. Balance in age groups affected (children, adults, elderly). 6. Economic impact ADOPTION STAGE: Once adopted, assigned technical team members incorporate the new content areas and measures into the tracking program. Assigned staff develop documentation related to the new content areas and measures, including a description of how measures are calculated, and a description of metadata. 6 Updates on potential new MN EPHT content areas Radon As reported in the June 2010 advisory panel materials, staff are continuing to explore the potential for adding residential radon as a new, Minnesota-specific tracking content area. After a preliminary assessment of available data sources and a consideration of the public health importance of the issue, the technical team recommended further exploring this potential new content area. It was determined that radon meets all the criteria at the initiation step (high prevalence of the hazard, strong evidence of disease causation, actionability, and available data). However, several questions regarding the data quality were raised. The next step has been to evaluate feasibility and data quality issues. Data on the prevalence and magnitude of a radon hazard in homes can be obtained from residential radon test data collected by the MDH Indoor Air Unit (IAU). IAU collects radon test information from laboratories at the zip code level but lacks street addresslevel information. One data quality concern was that homes with higher radon concentrations may be more likely to re-test or conduct multiple tests. Duplicate tests from the same household in the dataset may be skewing the summary estimates. A sensitivity analysis was conducted by EPHT staff to determine if multiple tests from the same home introduce bias when reporting summary concentrations by geographic area. Address-level data for this analysis were provided by AirChek, the laboratory that analyzes approximately 50% of short-term radon tests conducted in Minnesota. When comparing the “full” dataset to a “modified” dataset (in which same-home results were first averaged together), county-level mean concentrations were generally higher in the full dataset. This is consistent with the assumption that homes with higher concentration results are more likely to re-test. As a result of this work, IAU is now looking into the possibility of routinely collecting street address-level radon test data from laboratories, including results from the past 10 years. The decision to collect address-level data was prompted both by EPHT’s data quality concerns as well as other factors that would make the dataset more useful to the IAU’s programmatic activities. EPHT staff will be moving forward in the “exploration” stage, piloting potential radon indicators and measures using the improved dataset. Secondhand smoke EPHT staff have reviewed available datasets for developing an indicator of population exposure to secondhand smoke (also known as environmental tobacco smoke or ETS). Staff found that secondhand smoke exposure fulfills expectations and requirements within these four criteria: Prevalence of the hazard: There is a high prevalence of adults and children in Minnesota that are exposed to ETS. According to the 2008 Minnesota Youth Tobacco 7 and Asthma Survey, 38% of middle school students and 48% of high school students report being exposed to ETS in the last week. Evidence of causality: There are several known adverse health outcomes linked to ETS exposure, both in children and adults, such as: developmental effects in children, low birthweight, induction and exacerbation of asthma in children, and carcinogenic effects in adults like lung cancer and nasal sinus cancer. Actionability: o There are several existing MDH programs and other non-agency organizations that measure or attempt to prevent ETS exposure. o There are several policies to pursue or uphold to prevent or reduce ETS exposure, like smoke-free policies in the school or workplace and household smoking rules. o There are four Healthy People 2020 objectives directly related to reducing and preventing ETS exposure. o Indicators in this content area could be understood by diverse populations and would inform the public about how the environment and public health are affected by ETS exposure at the community level. Feasibility/Availability of Data: Using a data source inventory, the Minnesota Youth Tobacco Survey (conducted in 2000, 2002, 2005, and 2008) and the Minnesota Adult Tobacco Survey (conducted in 1999, 2003, 2007, and 2010) obtained from the Center for Health Statistics at the Minnesota Department of Health were identified as feasible data sources with which to create new indicators/measures under this potential content area. Based on this evaluation, further exploration of this indicator is ongoing. The next steps will be to pilot proposed measures and to further evaluate the feasibility of selected measures for ongoing tracking. The tracking program aims to present a measure of the prevalence of secondhand smoke exposure among non-smokers in Minnesota as part of this new content area, especially among children. Pesticides: Atrazine in Groundwater EPHT staff, with assistance from MDA staff, have reviewed pesticide datasets available at the state level to determine if any lend themselves to pesticide hazard indicator development. Four MDA datasets were reviewed in detail: 1) pesticide sales; 2) applicator licensing; 3) pesticide waste disposal; and 4) groundwater monitoring. After reviewing the strengths and limitations of these datasets, the initiation criteria were assessed against the groundwater monitoring dataset as an indicator of potential exposure to pesticides in private wells. Staff evaluated a potential indicator for atrazine in groundwater for multiple reasons: 1) it is the most commonly detected pesticide in MN groundwater; 2) the MDA monitoring network in central Minnesota, a geologically susceptible area for groundwater contamination, is designed around atrazine; and 3) atrazine is a known endocrine disruptor in mammalian studies, and some studies in humans have suggested associations with human health outcomes. During a review of the initiation criteria by the EPHT Technical team, the question was raised about whether an indicator of the prevalence of atrazine detections in groundwater 8 would meet the “evidence of causality” and public health impact criteria established for moving the development of this particular measure to the exploration stage. According to a December 2009 MDH Human Health Assessment, the weight of epidemiological evidence was summarized as “insufficient to establish causal relationships between atrazine exposure and certain adverse effects, atrazine remains a subject of ongoing, active research and review”. A decision was made to table further development of this measure of atrazine in groundwater until new information from an EPA Scientific Advisory Panel (SAP) meeting (to be held September 2010) is available for the team to review. The EPA SAP will review the epidemiologic evidence for atrazine. Atrazine indicators are also under review and discussion by the national EPHT content workgroups. In the interim, staff will work on putting together a team to follow-up on other pesticide data sources for consideration. 9 This page intentionally left blank. 10 SECTION OVERVIEW: TRACKING UPDATES Given the limited time available for advisory panel meetings, updates on some items will be provided to the panel as information items only. This information is intended to keep panel members apprised of progress being made in program areas that are not a featured part of the current meeting’s agenda and/or to alert panel members to items that will need to be discussed in greater depth at a future meeting. Included in this section of the meeting packet are status updates on the following: MN EPHT web-based information system EPHTN collaborations MN EPHT communications and outreach ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on any of these topics during the designated time on the meeting agenda. 11 This page intentionally left blank. 12 Status update on MN EPHT web-based information system (MN DATA) Background MDH is developing a web-based information system to disseminate health and environment data on the department’s web site by fall 2010. This system will allow the public to access standard graphs and tables, and to conduct limited customized queries of public health data and measures. MDH is designing this system so that it can provide access to broad sets of public health data in the future – beyond those developed by the MN EPHT Program. This approach is consistent with similar tracking systems developed by several other grantees in the National Tracking Network. The department has selected the name (MN DATA, which stands for Minnesota Data Access for Tracking and Assessment) to be consistent with this vision. (*Note MN DATA replaces the system formerly known as IBIS or “Indicator Based Information System”). The initial roll out of MN DATA will provide access to aggregate data on: Drinking water quality (Community Water Systems) Carbon monoxide poisonings Asthma Heart attacks Chronic obstructive pulmonary disease (COPD) Additional content areas and features will be added to the system over the next year (2011). Progress to date In August 2010 MDH promoted the MN DATA to the MDH web services test server. MN EPHT Program and IT staff currently are working together to enter messaging, test the application (e.g., query tool) and review the data. Staff also are working to ensure that the application meets state web and information security standards. In addition, MDH has executed data use agreements with data stewards and MDH Legal Unit for 5 of 8 content areas. These agreements provide a critical foundation for ongoing access to the data to develop measures for MN DATA, as well as the National Tracking Network (CDC web site). MDH has hired a full-time Query Technician, Henry Lu, to assist with all matters related to the data on the database, including loading, retrieving via queries, and working with MN EPHT staff to apply cell suppression rules to protect data privacy. Other IT team members working on the development and implementation of MN DATA include: Project Manager, Michelle DeMist, and Application Developer, Tim McGuire. MN EPHT will soon add a new staff member whose primary responsibility will be to train data users, and to promote and enhance MN DATA based on the needs of system users. 13 Future Plans MDH will conduct a soft launch of MN DATA in October 2010. At this time, key audiences (state and local public health data users) will be encouraged to test the system and to provide comments and suggestions for enhancing user training, web features and content. In December 2010 the MN EPHT Program will conduct a demonstration of MN DATA for the EHTB Advisory Panel. Advisory panel members will be encouraged to provide comments and suggestions to further enhance the system. Developing, updating, and enhancing MN DATA will be an ongoing process over the next year. By the end of 2011, MDH plans to expand the portal to include 5 additional content areas including: air quality, blood lead, reproductive outcomes, birth defects, and cancer. By 2011, MDH also plans to implement new analysis features supported by geographic information systems (GIS). For questions or additional information about the MN DATA, please contact the MN EPHT Program Manager, Chuck Stroebel at [email protected] or 651/201-5662. 14 Status update on EHTB collaborations CDC Strategic Planning for Tracking On July 13-15, MN EPHT program leaders, Jean Johnson and Chuck Stroebel, joined with CDC and leaders from all Tracking program states to engage in a strategic planning session in Atlanta to guide the next five years of the national program, 2011-2015. Content area workgroups will be restructured and content will likely be expanded to include new tracking initiatives. Proposed new content measures will be identified within existing core data sources, such as new disease hospitalizations and new drinking water measures. In addition, new data sources, such as national biomonitoring data, will be explored. CDC Biomonitoring Communications Evaluation Project in the East Metro EHTB biomonitoring program staff are working in collaboration with investigators at the CDC Public Health Laboratory and Westat (contractor) to design and conduct a formative evaluation study to learn more about communicating biomonitoring information to target audiences that use, interpret, or communicate about biomonitoring data. The east metro communities of Oakdale, Lake Elmo and Cottage Grove, are now part of this effort as “affected communities” which recently were involved in a biomonitoring project. CDC has identified several key audiences for biomonitoring information in the community including project participants, public health officials, community advocacy organizations, health care providers, legislators and the media. Individual interviews with some of these audiences began in August. This fall, EHTB staff (with IRB approval) will obtain consent from 8-10 selected project participants for release of contact information to the CDC investigators. The project is intended to gather information that will benefit MDH/Minnesota as well as CDC in developing future biomonitoring communications. National Biomonitoring Plan and Guidance Documents with APHL, CSTE, ASTHO MDH’s Jean Johnson, Joanne Bartkus, and Rita Messing have all been contributing to the development of the Association of Public Health Laboratories (APHL) National Biomonitoring Plan. The plan includes the development of a guidance document for state laboratories. For more information, visit http://www.aphl.org/aphlprograms/eh/Pages/nationalbioplan.aspx. APHL has enlisted the help of two other national organization partners: the environmental committees of the Association of State and Territorial Health Officials (ASTHO) and the Council of State and Territorial Epidemiologists (CSTE). Rita Messing joined ASTHO representatives at meeting in August to provide policy guidance for the national plan. Jean Johnson is part of a new CSTE biomonitoring subcommittee to develop a companion guidance document for public health epidemiologists. A CSTE-sponsored webinar was held in August and a face-to-face meeting of the CSTE subcommittee is planned for September, hosted by the Minnesota Department of Health EHTB program. 15 This page intentionally left blank. 16 Status update on EHTB/EPHT communications and outreach Brown bag seminars On July 8, the EHTB program held its second brown bag seminar series with a presentation on the biomonitoring. Over fifty people attended the presentation, held at the MDH Freeman Building in St. Paul, and included staff from MDH as well as other state agencies. The next brown bag seminar, scheduled for October 27, will address geographic visualization of public health data using GIS and other tools. Information is posted on the EHTB website. MN EPHT data reports Four tracking reports are available on the MN EPHT website at www.health.state.mn.us/tracking: Carbon Monoxide Data and Measures (2000-2007) Drinking Water Quality – Community Water Data and Measures (1999-2007) Hospitalizations: Asthma, Heart Attack and COPD Data and Measures (1999-2007) Lead Poisoning – Childhood Blood Data and Measures Birth Years 2000 – 2004 Additional reports in the series that will be released include data and measures for air quality, birth defects, reproductive outcomes and cancer. Advisory panel members who would like copies of the reports may request individual copies or a binder containing the full set of reports (beginning with the four currently available reports). To place a request, please email Mary Jeanne Levitt at [email protected]. MN EPHT communications planning The MN EPHT program recently finalized its communications plan for grant year two. The plan includes the promotion of the launch of the data portal. The primary audiences for promoting the portal in grant year 2 are local public health staff and state agency staff. In future years, the target audiences will be expanded to include other potential data users. Other MN EPHT outreach efforts Several marketing and outreach items are in development: revised MN EPHT website will be launched this fall with links to the MN DATA portal and other resources; MN EPHT program brochure will go to print this month; CDC program fact sheet on MN EPHT was submitted to CDC in April and will be available for distribution in November. In addition, MN EPHT staff partnered with the MDH Tobacco Prevention and MDH Asthma staff to provide outreach materials at the Statewide Health Improvement Program conference Making Strides – Toward a Better State of Health” held in early August. And, MN EPHT is reaching out to other divisions and units of MDH to communicate who and what MN EPHT is. In that capacity, staff presented at the quarterly MDH INHALE meeting. INHALE is open to all MDH employees whose work relates to 17 addressing asthma in Minnesota. As we did last year, MN EPHT will staff the MDH booth at the Minnesota State Fair and provide information about the program. CDC email list The CDC National Environmental Public Health Tracking Network sends out program announcements to an email list service. If you are interested in keeping abreast of major developments at the national level (e.g., new data sets added to the national network) and would like to be added to the CDC’s email list, please email Mary Jeanne Levitt at [email protected]. 18 SECTION OVERVIEW: TRACKING NEEDS ASSESSMENT FOR LOCAL PUBLIC HEALTH In this second year of the federal EPHT funding period, MN EPHT has identified local public health as a primary audience for outreach and will be conducting an assessment of the needs of local public health officials throughout the state to inform our communications and training activities. The needs assessment will seek to identify the data and informational needs that are important to local public health in responding to health and environmental issues in their communities. This needs assessment is likely to overlap with MN DATA demonstrations and system user testing. Approaches for conducting the assessment will likely include online survey tools, similar to one described below for state policymakers. **Policymakers Assessment Results from the Policymaker Priority Assessment, a web-based questionnaire developed by the federal Tracking program and deployed by the National Conference of State Legislatures (NCSL) were recently made available. The assessment tool went out to state legislatures in 26 states (including all of the Tracking states) who sit on health committees to help gauge their understanding of environmental health issues and gather information on their specific environmental health priorities. (No policy makers from Minnesota responded.) The CDC EPHT Policymakers Audience Team will continue to work with NCSL to do follow-up work with the state legislatures who responded to the assessment. The questionnaire included 6 questions and there were 24 respondents from 13 states. Here are some highlights: The survey asked respondents to identify the top 3 environmental issues impacting their constituents’ health. The top issues included outdoor air quality (46%), contaminated drinking water (42%), and pesticide and chemical spraying (29%) followed by climate change (29%) and lead in paint and consumer products (21%). The 3 top health issues identified were cancer, (71%); asthma (67%); respiratory illness (46%) followed by healthy pregnancy and birth (25%). Legislators were split down the middle (38%) regarding whether they thought they had enough information to respond to constituent concerns about their health and environmental exposures. 17% were unsure. ACTION NEEDED: At this time, no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on this topic during the designated time on the meeting agenda. 19 This page intentionally left blank. 20 Policymaker Priority Assessment Survey Responses 1. What State are you located in? Response Response Total Percent Illinois 5 21% Iowa 1 4% Kansas 1 4% Maine 1 4% Maryland 1 4% New Hampshire 5 21% New Mexico 2 8% New York 1 4% Oregon 1 4% Pennsylvania 1 4% Utah 1 4% Vermont 3 12% Washington 1 4% 24 Total Respondents 21 2. What are the top 3 environmental issues that you are concerned may impact the health of residents in your community? Response Response Total Percent Contaminated drinking water 10 42% Arsenic 1 4% Indoor air quality (e.g., carbon monoxide, radon, etc.) 3 12% 11 46% 7 29% 10 42% Plastics (i.e., phthalates, BPA) 4 17% Lead (in paint and consumer products) 5 21% Cadmium (in consumer products) 0 0% Mercury (in fish and consumer products) 5 21% Other chemicals in consumer products 5 21% Waste sites 3 12% Electromagnetic fields (from electric and cell phone towers) 1 4% Nuclear waste 4 17% Other (see response(s) below) 1 4% Outdoor air quality (e.g., diesel emissions, particulate matter) Climate change Pesticide and chemical spraying Total Respondents Other responses 1. "Toxic" food environment Note: "nuclear waste" includes in our case a larger concern with all the environmental risks of our still operating nuclear power plant, e.g. radiation leaks and other potential dangers 22 24 3. What are the top 3 health issues that you are concerned may be caused or affected by the environment in your community? Response Response Total Percent Asthma 16 67% Childhood lead poisoning 5 21% Birth defects 2 8% Healthy pregnancy and birth 6 25% 17 71% Carbon monoxide poisonings 1 4% Heart attacks 1 4% 11 46% 4 17% Cancer Respiratory illness Other (see response(s) below) Total Respondents 24 Other responses 4. 1. autism 2. We have very high rates of MS in our area -- why? Same for cancer and asthma. 3. obesity 4. 1) Obesity, caused by a food environment in which processed foods filled with sugars and additives are cheaper than healthier foods. 2) General immune system compromise as a result of general environmental toxins. In general, do you think you have enough information or data to respond to constituent concerns about their health and environmental exposures? Response Response Total Percent Yes 9 38% No 9 38% Not Sure 4 17% Comments 2 8% Total Respondents 24 Comments 1. 2. There is alot of information available. I am not sure I fully grasp all of the policy implications. I don't have all the data I need at my fingertips but know whom to ask and where to go to find out information. 23 5. Where do you get information about health and environmental exposures? Response Response Total Percent State health department 17 71% Local health department 6 25% 10 42% U.S. Centers for Disease Control and Prevention 7 29% U.S. Department of Health and Human Services 1 4% Print media (please list specific sources in text box below) 6 25% Radio and television (please list specific sources in text box below) 2 8% Non-governmental organizations (please list specific sources in text box below) 6 25% Online resources (please list in specific sources in text box below) 3 12% Other (see response(s) below) 4 17% U.S. Environmental Protection Agency Total Respondents Other responses 1. Ken Cook at Environmental Working Group and the constellation working with him. 2. cancer publications and resouces 3. State EPA and health resources; federal EPA and health resources. 4. Medical journals & reports via my work as a registered nurse 24 24 6. Please add any additional questions or comments below Total Respondents 3 (skipped this question) 21 Comments 1. We need to include water quality issues in everything we do - we have the plastic soup in the gyres of every one of our oceans; we have pollution running into all our water bodies - we have massive dead zones along our coasts - it is not just pesticides that are polluting - or oil spills such as the gulf - it is lack of stewardship - 2. In NH public health policy has not been a high priority. There needs to be an agenda that melds a public private partnership for environmental health policy 3. I do not trust much of the print and other media as being science based and unbiased 25 This page intentionally left blank. 26 SECTION OVERVIEW: LESSONS LEARNED FROM BIOMONITORING PILOT PROGRAM The statute that created the EHTB program directs MDH and the advisory panel to assess the pilot program and to make recommendations for future biomonitoring stemming from that assessment. Staff are continuing to gather and compile information about what worked well and what could be improved related to the biomonitoring pilot projects. From this information, recommendations for future biomonitoring efforts will be developed and included as part of the program’s legislative report due in January 2011. At the March meeting, advisory panel members were asked to discuss lessons learned related to the selection of pilot project communities when there has been a site contamination. This discussion focused on the East Metro PFC and South Minneapolis arsenic projects. At the September meeting, staff will present some initial input on lessons learned and recommendations related to the final two pilot projects: the Lake Superior Basin Mercury in Newborns project and the Riverside Prenatal Biomonitoring project). These two pilots did not take place in communities selected on the basis of a location with site contamination; instead they can be described as special investigations in communities selected because they are uniquely “vulnerable” populations to a particular contaminant. The following items are included in this section of the meeting materials: Background information on the MDH biomonitoring pilot program Lessons learned about biomonitoring in vulnerable populations ACTION NEEDED: At this time, no formal action is needed by the advisory panel. Panel members are invited to provide input on the summary of lessons learned from the biomonitoring pilot program. In particular, panel members are asked to respond to the following questions: These two pilots could be described as special investigations designed to measure chemicals in vulnerable populations (e.g., pregnant women and newborns). In other words, they did not take place in geographical communities with site contamination. If Minnesota were to continue using this approach to biomonitoring (focused on vulnerable populations), what recommendations would you make with regard to population selection? With regard to chemical selection? With regard to recruitment, consent and participation? With regard to communication? When is biomonitoring an appropriate response to concerns about vulnerable populations’ exposures to environmental contaminants? When is it not? 27 This page intentionally left blank. 28 Background information on the MDH biomonitoring pilot program In 2007 the Minnesota State Legislature passed Minnesota Statutes 144.995 – 144.998, which established the Environmental Health Tracking and Biomonitoring (EHTB) program and directed the Minnesota Department of Health (MDH) to design and implement four pilot biomonitoring projects in communities “likely to be exposed”: A project to measure arsenic in 100 voluntary participants likely to have been exposed to arsenic. A project to measure PFCs in 100 voluntary participants from each of two communities likely to have been exposed to PFCs, including PFBA. A project to measure mercury in 100 voluntary participants likely to have been exposed to mercury. A project to measure a designated chemical (to be recommended by the advisory panel) in 30 voluntary participants in each of three communities. MDH was further directed to collect one biospecimen from each participant. Each biospecimen was to be analyzed for one type or class of related chemicals. By statute, community is defined as “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.” The four pilot studies are summarized in the table below. 29 Table: Comparison of four pilot projects Two of the projects (arsenic and PFCs) were completed and discussed during the March 2010 advisory panel meeting. The remaining two projects (Lake Superior and Riverside) are nearing completion. Recruitment and specimen collection is complete, specimens are currently being analyzed by the MDH public health laboratory and results are pending. Cotinine and demographic results were presented at the June advisory panel meeting. Riverside Prenatal Biomonitoring Study The Riverside Prenatal Biomointoring Study was designed to measure the range and distribution of 7 environmental phenols and cotinine in 90 pregnant women. The EHTB legislation specifically directs MDH to conduct biomonitoring in pregnant women where appropriate. However, it was recognized that the recruitment of pregnant women requires targeted methods that are different from general population recruitment methods. This project was designed to test those methods in a clinic-based population of pregnant women. Chemical selection was based predominantly on the unique vulnerability of pregnant women and the fetus to chemical exposure, but also on the opportunity to develop new laboratory analytical capacity. 30 The 7 environmental phenols and cotinine were selected for the project by the EHTB science advisory panel in September 2008. Environmental phenols, which include BPA, parabens, and benzophenone, were chosen because of their toxicity classification as endocrine disruptors and concerns about possible effects on growth and development of the fetus. They were also selected in part because of the ubiquitous nature with which they appear in consumer products, such as food, cosmetics, sunscreens, perfumes, lotions, plastics, etc. Cotinine was selected for inclusion as it is a metabolite of nicotine and a measure or biomarker of cigarette smoke exposure, a known health hazard in pregnancy, affecting growth and development. Both of these chemicals are able to be measured in urine, which is the biospecimen that was most readily available. To complete the project the EHTB team members partnered with Dr. Logan Spector at the University of Minnesota and Principal Investigator of the Riverside Birth Study. The MDH biomonitoring pilot project became an ancillary project of Dr. Spector’s research. The Riverside Birth Study had a recruitment goal of 500 pregnant women from 2 women’s health clinics in south Minneapolis. From these 500 women, those that agreed to be contacted for future research were to be invited to participate in the MDH biomonitoring pilot project, until 90 women had been recruited. The initial recruitment for the MDH biomonitoring pilot project was to include 30 non-Hispanic white women, 30 non-Hispanic black women, and 30 Hispanic women. Only women who were enrolled in the RBS during the biomonitoring project recruitment time periods and who agreed to be contacted for future research were eligible. Women identified in the clinic at the time enrollment in the RBS were handed a flyer with information about the biomonitoring project and were mailed a postcard to obtain their consent to collect a urine specimen. Women who returned the card were mailed a specimen collection kit. Kits were delivered by courier directly to the MDH public health laboratory for analysis. Participants received a thank you and gift card (incentive) after the specimen was received. To date recruitment and sample collection are complete. Once the laboratory and statistical analyses for the environmental phenols are done, aggregate results and general information on exposure and health effects will be communicated back to participants and the community at large. Recruitment results are shown as follows: Riverside Birth Study (RBS) Total Enrollment: 425 pregnant women (Sept. 2008-June 2010) Women enrolled in RBS during MDH biomonitoring project: 209 (May 2009-March 2010) Women eligible for MDH project who agreed to be contacted for future research: 130 Women who consented to participate: 79 Women who completed the specimen collection: 66 A summary of demographic results for the 66 study participants along with cotinine results were presented and discussed at the June advisory panel meeting. 31 Lake Superior Mercury Biomonitoring Study The Lake Superior Mercury Biomonitoring Study (LSMBS) was designed to establish a reference range and a baseline level for concentrations of mercury in newborns from the Lake Superior Basin using residual blood spots from newborn screening programs. The study is funded primarily by the U.S. EPA Great Lakes National Program Office (GLNPO) and is conducted in collaboration with state newborn screening programs in Minnesota, Wisconsin and Michigan. The EHTB program provided financial and staff support to the LSMBS. Use of residual blood spots provided a convenient sample of a vulnerable population of newborns. The MDH Newborn Screening Program (NBS) database, which includes all babies screened in Minnesota, provided a running list of available blood spot specimens with mother’s residential zip code within the geographic region of the study. During the study, a weekly query of the NBS data was run to identify potential study participants. In an effort to not cause unnecessary stress, babies were excluded if any of the following criteria were true (some babies fit multiple criteria): Families have directed that their child’s blood spot card be destroyed. Risk factors have been checked on the specimen card including: sick baby, deceased sibling, congenital anomalies, and maternal pregnancy complications. Newborn screening results are abnormal. Babies known to have been admitted to a Neonatal Intensive Care Unit (NICU) or with a birth weight under 2000 grams Deceased babies Specimens from St. Mary’s hospital in Duluth, MN taken less than 24 hours from birth Newborn screening cards were also excluded if the blood was thought to not produce representative results. The following criteria were established by MDH NBS (specimens from WI and MI were also rejected for these criteria): Specimens other than the initial specimen collected from an infant. Specimens collected at greater than 9 days from birth. Specimen came from an infant identified as transfused on the specimen card. Specimens with more adult hemoglobin than fetal hemoglobin. Prior to seeking informed consent, a total of 3,434 NBS cards (blood spots) were checked to determine if the residual blood was sufficient for mercury analysis and met quality control requirements. Eight hundred sixty eight cards (25%) were excluded for insufficient blood or other quality issues. LPH had received consent for 46 of those rejected. Cards in MI and WI were excluded for these same criteria. Initially eight disks were punched from each NBS card for mercury analysis and large number of specimens were rejected due to insufficient blood. The mercury analysis method was modified and the process was changed to punch 4 disks per NBS card. The overall rejection rate for the study for insufficient blood and quality issues was 25%. Starting November 1, 2008, parents of 2,566 newborns were contacted by MDH to request written informed consent for use of newborn RBS for mercury analysis. Informed consent was 32 not sought prenatally or at the birthing hospital due to concern that these actions could negatively impact participation in NBS. Recruitment consisted of sending two letters to mothers followed by three attempts to contact mothers by phone. Phone calling was discontinued in May 2009 due to lack of staffing resources. The first letter was sent three weeks after birth. If no response was received within three weeks, a second letter was sent. Local Public Health (LPH) assisted with informed consent by requesting consent during home visits. As of May 13, 2010, 1128 (44% of potential participants) consented to participate. The last letter was sent June 19, 2010 but consent forms continue to be received. Approximately 880 specimens have been punched and delivered to the MDH metals laboratory for analysis. Blood spot specimens were anonymized to ensure individual specimens could not be identified. Data retained for each individual from the newborn screening data are: state of residence, month and year of birth, sex, and urban versus non-urban residence as determined by mother’s zip code and US Census data. Mercury analysis is expected to be complete in November 2010. 33 This page intentionally left blank. 34 Preview of “lessons learned” about biomonitoring in vulnerable populations Conducting biomonitoring investigations in vulnerable populations provided opportunity for learning some of the unique benefits and challenges. A few of the observations and lessons taken from the projects thus far are summarized below, particularly focused on issues with chemical selection, recruitment, specimen collection and communications. Chemical selection With these projects, sources of exposure tend to be more ubiquitous in the population, such as food sources and consumer products. For the mercury project, the major source of exposure to newborns is maternal fish consumption while for the BPA/cotinine projects the sources were consumer products and secondhand smoke at home or work. A focus on vulnerable populations considerably broadens the list of possible chemicals to be selected and will require significant resources and stakeholder input to prioritize and select from that list the chemicals most relevant for biomonitoring. Recruitment methods Both projects were conducted by working in partnership with another research study. The advantage of a research partnership is that recruitment costs can be significantly reduced by leveraging these other resources, and by using specimens collected for multiple purposes. The mercury project was able to use convenience samples collected by the newborn screening program, eliminating the need to collect new specimens. Costs to mail letters to mothers identified through the newborn screening database for consent were minimal compared to more intensive population enumeration and recruitment methods, and the method resulted in a 44% response rate. The Newborn Screening program staff were very open about sharing knowledge and helpful with carrying out the study, and were particularly conscientious regarding the sensitive matter of approaching mothers who’ve recently given birth. Using local public health nurses to assist during home visits was also successful in most counties. The Riverside Biomonitoring Project was able to capitalize on the success of a clinic-based research study, enrolling participants who were already enrolled in another study. This also simplified the steps and reduced the cost. The relationship of the University study coordinator and recruiter with the clinic staff, nurses and doctors gave them direct contact with patients, and clinic staff were able to help with recruitment. However, there are drawbacks to this approach of “piggy-backing” state biomonitoring projects on other research efforts. For both projects, biomonitoring project staff were precluded from having direct contact or knowing the identities of project participants. The University of Minnesota IRB did not allow MDH to provide biomonitoring results to participants due to concerns that the information did not have a clinical interpretation but was instead “research”. All communication with Riverside participants was made through the University staff. In the mercury project, the research protocol agreed to by the research partners required that all 35 specimens by anonymized prior to analysis in the laboratory. This precluded any notification of individual participants of their results. Changes in research recruitment strategies occurred several times during the course of the Riverside Birth Cohort study. The biomonitoring project recruitment suffered as a result. If possible, biomonitoring investigators should be collaborators in the research so that they have a role in decisions which affect the success of the project. Convenience specimens, collected for another purpose and stored for later use, are not always useful. Although unlikely to affect the overall results, a large number (25%) of residual newborn screening specimens were rejected due to insufficient blood or specimen quality issues. Some studies that bank specimens for research have lengthy procedures and waiting periods before they are willing to give access, and the available quantity of the specimens for analyses are very small. Both projects will be limited in their ability to generalize the results to a larger population (eg all newborns in the LSB region, or all pregnant women at the Riverside clinic). The potential for bias in the results from non-participation and selection/exclusion criteria is unknown. Better sampling and recruitment strategies and more resources are needed to increase participation so that populations are well represented and comparisons across time periods and with other populations are valid. Communications It is important to recognize the heightened sensitivities of women and new mothers with regard to their health and any environmental risk that may threaten their health. Environmental phenols are found in a wide variety of products women use regularly. Most women are not aware of the concerns about endocrine disruptors. Emphasis of communication is on informing individual choice with respect to consumer products, yet there is only very limited evidence to show that individual actions of consumers (changing products) are effective in reducing exposure. For some products, like sunscreens, the health benefits of the product outweigh the risk. There are several advocacy groups for women’s and children’s health that may be helpful in developing messages for these study populations. Similarly with fish consumption there is the challenge of weighing the health benefits of fish consumption against the hazard of mercury exposure. Fortunately, there are many materials that have been developed for the fish consumption advisory program at MDH that address fish exposure during pregnancy. Biomonitoring often personalizes the message, which may increase women’s fears and require increased communication efforts. Although both of these projects did not provide individual results to participants, the group results will be made public. Group results will likely show the range of exposure and some participants may become concerned that high results were not communicated to them. In all projects but particularly in vulnerable populations, MDH policy should address the question of when MDH has a responsibility to return high results that indicate a potentially harmful exposure to a vulnerable individual, even if the participant has not specifically requested it. 36 SECTION OVERVIEW: BIOMONITORING FRAMEWORK EHTB legislation directs the Minnesota Department of Health (MDH), in consultation with the advisory panel to conduct a pilot biomonitoring program and, upon completion of the pilot program, to plan and implement an ongoing base program within the appropriations available. With direction from the EHTB steering committee, program staff are now drafting a biomonitoring framework to assist the advisory panel and the commissioner in defining the scope for planning the base program. This document builds upon the strategic planning work of the past two years to define a vision and purpose for biomonitoring. It sets forth a comprehensive program model and describes the benefits and challenges of various approaches that could potentially be employed. Finally, it makes recommendations for planning an approach that is likely to be most effective in meeting program goals within the appropriations available. This working draft will be further developed to incorporate the recommendations of the advisory panel and will become part of the program’s required report to the legislature in January 2011. At the September meeting, program staff will provide an overview of the draft framework. Panel members are asked to provide input on the draft and recommended approach for future planning of an ongoing base program at MDH. The following item is included in this section of the meeting materials: Biomonitoring framework (working draft, August 2010) ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel members are invited to provide input on and ask questions about the draft biomonitoring framework. In particular, panel members are asked to respond to the following questions: What additional lessons or recommendations should be incorporated into the framework? Does the document provide enough information for the panel to decide whether to support or modify the staff recommendation? 37 FRAMEWORK FOR PLANNING A MINNESOTA STATE BIOMONITORING PROGRAM (WORKING DRAFT, AUGUST 2010) In 2007, the Minnesota Legislature established the Environmental Health Tracking and Biomonitoring (EHTB) Program, directing the Minnesota Department of Health (MDH), in consultation with an advisory panel of scientists, to conduct a pilot biomonitoring program and, upon completion of the pilot program, to plan and implement an ongoing base program within the appropriations available [Appendix]. Three pilots were completed in 2010. These projects have included investigations of exposures to arsenic, perfluorochemicals, and bisphenol A in communities identified as likely to be exposed to these substances. Lessons learned from these pilots are being documented to aid in providing guidance for planning and implementing an ongoing program. In addition, under the statute, MDH has established specific guidelines for ensuring that state biomonitoring activities are scientifically and ethically sound, and protect the legal rights of human subjects. [Appendix] Minnesota’s program has received much recognition and notice as a model for other states by national organizations including the National Conference of State Legislatures and the Association of Public Health Laboratories [References]. Biomonitoring is the direct measurement of chemicals (or the products that chemicals break down into) in people’s bodies – in their blood, urine, or some other body fluid or tissue. Biomonitoring is a way to measure people’s exposure to toxic substances in the environment. According to the Centers for Disease Control and Prevention (CDC), biomonitoring is the most health relevant measure of such exposure. It has the potential to help bridge the data gap between environmental monitoring and chronic disease surveillance, thus contributing to our understanding of how hazards in the environment affect population health. [insert national biomonitoring success stories: blood lead, cotinine] Biomonitoring can be conducted for a wide variety of reasons, ranging from monitoring patient health in medical settings to conducting environmental health research in academic settings. In recent years, several federal granting agencies, including the EPA and the CDC, have provided funding to support biomonitoring activities in states to meet specific federal program goals and objectives. Federal funding of state public health agencies have supported goals including building public health laboratory capacity, or responding to location-specific public health threats. However, when conducting biomonitoring activities within a state public health context with state funds, care must be taken to ensure that public health practice goals consistent with our mission to protect and maintain the health of all Minnesotans are met and that public resources are used wisely. The framework described below builds on the experiences gained through the pilot program, and establishes a vision and framework for guiding the scope and direction of future planning and implementation. 38 As part of the biomonitoring pilot program, MDH program staff and stakeholders – including steering committee and advisory panel members – engaged in a strategic planning process to arrive at the following vision and purpose for Minnesota’s state biomonitoring program. Vision Minnesota’s biomonitoring program will have the capacity to accurately and efficiently measure and track exposures in people from the environment, and to protect public health through improving the understanding of risk and disease so that Minnesotans will lead healthier lives and live in safer environments. In addition, specific elements of this vision were further defined through the strategic planning process: Biomonitoring data are collected and effectively used to protect public health Biomonitoring will protect the health of all Minnesotans by measuring and tracking the concentrations of chemicals that get in to people’s bodies from the environment. Knowing more about people’s exposure to chemicals will help state and local officials, advocacy groups, industry, and decision makers better determine the health risk and take actions that can best help to reduce risk, promote health, and eliminate disparities. Risk and disease are better understood Biomonitoring will provide a base of information that will help public health scientists to study the connections between environmental hazards and disease. Public health officials will better understand and be able to share new information with the public, and will be better able to track progress in improving public health. Minnesotans will know more about the risks of chemicals in their environment in order to make wise choices to promote their own health and the health of their communities. Adequate capacity and resources are maintained Minnesota’s biomonitoring program will have the capacity and expertise needed to measure environmental chemicals in people’s bodies accurately and efficiently. The program will be a resource for public health officials to use as needed for providing a scientifically grounded response to the public health concerns of communities in Minnesota. Purpose As articulated through the strategic planning process, the core purpose of Minnesota’s biomonitoring program is to monitor and track trends over time in the distribution of exposure to designated chemicals among the general population of Minnesota and communities within the population in order to: Monitor and track trends over time in the distribution of exposure to designated chemicals in the environment to identify exposure disparities. Monitor and track trends over time in the distribution of exposure to designated chemicals in the environment to assess the need for public health interventions. 39 Evaluate the effectiveness of statewide and community-level interventions and policies that are implemented to reduce exposure to designated chemicals over time. Aside from this core purpose, other important ancillary purposes are anticipated. These secondary purposes may be pursued as resources allow after the core purpose has been achieved. Investigate sentinel exposure events, emerging contaminants, and highly exposed individuals identified by public health officials for targeted exposure assessments and interventions. Provide information about exposures to local public health officials and community representatives in response to community concerns about chemicals in the environment. Provide data about exposure distributions and trends to support research studies that measure the association of health outcomes with exposure and identify the sources of exposure. Provide data about exposure distributions and trends to support the establishment of health-based criteria for regulating chemicals in the environment. Having a base biomonitoring program in place would ensure that the infrastructure and capacity exist to more quickly and effectively address secondary purposes as needs arise. It is likely that secondary purposes will best be accomplished through collaborations with external and internal partners and by leveraging supplemental resources. MDH biomonitoring program goals above do not include the conduct of research for the purpose of contributing new, generalizable knowledge. However, data generated through the program can be made available to the academic community and can be used to support and promote research collaborations. 40 Strategies To fulfill all identified program purposes, a comprehensive model for a state biomonitoring program was developed that includes three distinct approaches to biomonitoring. Each approach helps to achieve a different set of goals or purposes. A comprehensive state program designed to achieve all of the stated goals would necessarily include all three components. However, the state may choose to do only one or two components as resources permit, understanding that some program goals will not be met. Statewide Population Exposure Tracking Goals: Monitor and track exposures in a statewide sample; Establish MN baseline and reference values; Identify vulnerable sub-populations for targeted surveillance; Evaluate efficacy of statewide programs and policies to reduce exposures. Ongoing, systematic tracking Targeted Population Exposure Tracking Goals: Monitor and track vulnerable subpopulations; Evaluate efficacy of targeted programs and policies to reduce exposures. Special Investigation s Exposed Exposed Exposed Community Community Community Goals: Respond to local events, concerns, threats; identify need for community public health action; evaluate community public health action. The benefits and challenges of each of these approaches are described in detail below. 41 Statewide Population Exposure Tracking The broadest and most comprehensive approach to biomonitoring would be a program to monitor and track exposures to chemicals on an ongoing, periodic basis using a representative sample of the state population. This approach is consistent with a broad range of public health surveillance activities, including long-standing infectious and chronic disease surveillance programs that guide disease prevention and control activities at the local and state level. One of the primary goals of this approach would be to monitor and track trends in population exposure over time and observe geographical patterns in order to guide exposure prevention and control programs. Statewide values that are established for the general population can be used as reference values for comparing and interpreting measurements in community investigations. The data can be analyzed for the identification of vulnerable sub-populations that might benefit from subsequent targeted measurements and/or targeted public health intervention. Because an ongoing tracking approach to biomonitoring would involve repeated measurements over time, this approach could also be used to evaluate the efficacy of statewide programs and policies enacted to reduce exposure to chemicals. Example: New York City Biomonitoring In New York City, a biomonitoring program was first implemented in 2004 and was conducted as part of a citywide health and nutrition exam survey (HANES). NYC HANES assessed many health variables, including smoking status, depression, body mass index, blood pressure, cholesterol, diabetes, and other health-related outcomes in addition to chemical exposures. Though clearly not a statewide example, the NYC program is an example of biomonitoring that is conducted on a population-wide basis. As part of the survey, 1,811 participants provided a blood and urine sample. The biospecimens were analyzed for the presence of chemicals thought to be of particular concern to people in New York City: urban pesticides (metabolites of organophosphates and pyrethrins/pyrethroids), cotinine (a marker for exposure to tobacco smoke), and heavy metals (lead, cadmium and mercury). Because the survey was designed as a population-based, representative, random sample, these measurements could be used to determine 1) how New Yorkers’ exposures were different than the nation as a whole, 2) whether exposures differed among demographic sub-groups, and 3) what characteristics were associated with higher and lower exposures. Results from the biomonitoring program brought about important public health actions to reduce exposures to chemicals. For example, high mercury levels among those born in the Dominican Republic led to the discovery of illegally imported skin-lightening creams containing mercury. Higher levels of mercury were also found those who self-identified as Asian, most likely due to fish consumption. These discoveries in turn led to public health actions, such as product embargos, expanded inter-governmental oversight of mercury in fish, and education campaigns for physicians and the public about fish consumption. 42 Strengths of a statewide exposure tracking approach Ongoing, systematic collection of biomonitoring data using a statewide sample has the potential to achieve the greatest number of objectives for realizing our program’s vision and purposes for all Minnesotans. The program could initially focus on a limited number of chemicals that are judged to be most important to Minnesotans and expanded over time. It has the potential to measure a broader spectrum of chemicals because specimens (with informed consent for such additional use) can be banked in the laboratory for later analyses. This approach has the greatest potential for promoting rapid response to emerging health threats. Banked specimens from a statewide population sample provides a useful resource for Minnesota’s public health laboratory to rapidly develop new laboratory methods and assess exposure for emerging contaminants of concern. New specimens could be collected on a cycle of three to five years and in different regions of the state, which would allow adequate time for planning, collection and analysis of specimens, and data analysis, and would spread costs out over several years. Because the sampling protocols are consistent across time, the creation of new protocols, project materials, and approvals are not needed with each repeat survey, thus providing significant cost savings in subsequent years. This approach provides relevant and timely population-based reference data for special investigations in the state. Currently, national biomonitoring data collected by the CDC can not be used to estimate the exposure of Minnesotans due to the sampling methods used. Collecting statewide population exposure tracking data would help fill this gap. Biomonitoring data collected on an ongoing basis have the greatest potential to be integrated with the state’s Environmental Public Health Tracking (EPHT) program and for supporting the work of researchers investigating health impacts. Tracking exposures using the same temporal and geographic scales (state, county, zipcode) as chronic disease tracking allows for data integration and creates opportunities to study the relationships between chemical exposures and health. Statewide exposure tracking could be used to measure whether statewide policies and programs to reduce exposure to environmental contaminants are effective. For example, ongoing biomonitoring of cotinine levels among non-smokers can be useful for evaluating whether smoking cessation policies and actions now being implemented across the state are making a difference in reducing the health risk from secondhand smoke. Challenges of a statewide exposure tracking approach One challenge to a program based on ongoing exposure tracking is the relative insecurity of ongoing funding. This could be addressed through identifying key partnerships and programs that could provide leverage and help to sustain the program. For example, laboratories would need sustained funding to support trained chemists and maintain state of the art analytical instrumentation. Federal funding partners, such as the CDC, will be important to sustaining laboratory capacity. It is also possible to limit the expense by limiting the number of chemicals 43 tested to a few high priority chemicals of concern, and by extending the time period of repeat collections and analysis. Partnerships will also be needed to ensure the most cost-efficient means of enrolling participants and collecting specimens. For example, enrollment that is conducted in partnership with other state health surveys, such as the Behavioral Risk Factor Surveillance Survey (BRFSS) would reduce the costs of the program. An MDH project measuring mercury in newborns was able to increase enrollment through partnership with local public health agencies and made use of specimens already collected for newborn screening. Several states have used specimens already collected for other purposes (called “convenience samples”) for biomonitoring. The New York City biomonitoring program (see box above) and the National Biomonitoring Program at CDC are both using specimens collected in partnership with established health and nutrition examination surveys (HANES). Targeted Population Exposure Tracking Another approach is to implement ongoing tracking of exposures to chemicals in one or a few targeted sub-populations. Similar to the statewide population exposure tracking approach, this approach would utilize systematic surveillance strategies for repeated sampling in the target group. The goals would be to monitor and track trends and observe geographic and demographic patterns in exposure in the target group, and to inform and evaluate exposure prevention programs in that group. Targeted sub-populations would need to be identified according to a set of criteria, such as populations that are particularly vulnerable to chemical exposures or their effects. This could include groups such as women of child-bearing age and young children, people of a particular cultural or economic background, people who are vulnerable due to special medical conditions, or workers exposed in certain occupations. Another targeted approach is to focus on one or more selected geographic areas (counties or cities) to represent populations throughout the state. This approach could be more cost effective than statewide exposure tracking and potentially be expanded in the future to include more geographic areas as more resources are identified. A targeted approach could be further defined by focusing on specific chemicals of concern among vulnerable populations, such as pesticide exposures (targeted chemical) in children (targeted population) in selected rural and urban counties (targeted geography). 44 Example: Minnesota’s Blood Lead Information System Minnesota’s Blood Lead Information System monitors lead testing activities and tracks the occurrence of elevated blood lead cases in children in the state and is an example of how biomonitoring measurements can be conducted within targeted populations perceived to be at greater risk for or from chemical exposures. Children living at or below the poverty line who live in older housing are at greatest risk for lead poisoning. National studies have shown that Medicaid-enrolled children are three times more likely to have elevated blood lead levels than non-enrolled children. Children enrolled in Medicaid or other medical assistance programs are more likely to live in older homes in poor condition, have poor nutrition, and live in urban areas that may contain lead contaminated soils. The MDH Lead Program found that children enrolled in Minnesota Health Care Programs (MHCP) had higher lead poisoning rates than non-MHCP children, from 2004 to 2007. Since not all Minnesota children have a high risk for lead exposure, targeted screening (testing children at high risk) is recommended for most areas of the state as of the time of this report (August 2010), rather than universal screening (testing all young children). In Minnesota, healthcare providers test for lead poisoning in children and adults by drawing blood and submitting the specimen to a laboratory for analysis. Laboratories conducting the blood lead analysis are required by state statute to report the lead level and additional demographic information to MDH. The reported data are private and are used by state and local public health officials for identifying children and pregnant women with elevated blood lead levels. Once identified, public health staff educate families on the hazards of lead in their home environment and work to help lower their blood lead levels. Analysis of the blood lead data on an aggregate level is used for identification of areas throughout the state where children may be at higher risk for lead poisoning and the development of state screening guidelines Strengths of a targeted population exposure tracking approach This approach preserves many of the benefits of statewide exposure tracking but it reduces the scope and the cost. Program goals are achieved but are limited to the targeted population. Repeated sampling could be scheduled every 3-5 years and selected chemicals limited to reduce cost. The approach could also be used to build and maintain laboratory capacity to address emerging contaminants through specimen banking. The data could serve as a reference for special investigations in the target population, and it can be integrated with Environmental Public Health Tracking disease and exposure data. A targeted population exposure tracking approach could potentially provide greater opportunities for partnerships and collaborations with other programs and organizations who share an interest in a particular sub-group of the population. MDH leadership has identified programs and initiatives that are focused on the protection of the health of children and the prevention of health disparities as key goals of the Department. Biomonitoring, conducted in collaboration with these initiatives, offers a potentially powerful tool for evaluating the efficacy of targeted programs and 45 policies designed to reduce risk factors and prevent disease to address these department priorities. Challenges of a targeted population exposure tracking approach Because the scope is limited to a target group, generalizations to other populations in the state are not appropriate. For example, trends observed in a tribal population, could not be assumed to be occurring statewide. A stratified, random sampling of counties, however, may enable generalization to the state population as a whole. Selection of a target population, chemical, or geographic area would likely involve a process for gathering background information, engaging stakeholders and establishing clear criteria for guiding decisions and priorities. This selection process would potentially add to the planning cost in the first year of the program. Chemical selection has been particularly challenging for biomonitoring programs due to the large number of chemicals and scientific uncertainties in understanding health effects. In Minnesota, past decisions regarding chemical selection have focused on criteria such as public health impact (prevalence and toxicity), public concern, the likelihood of interpretable results and actionable findings. Because all populations in the state would not be represented in a targeted approach, the potential for the program to discover new, previously unknown vulnerable subpopulations or exposure sources in the state is limited. Selecting a target population assumes prior knowledge of exposure sources, public concern and population vulnerability. Special investigations Special investigations are designed to answer a specific question or questions about exposure in a given community or population, often in response to a particular public health concern or event, such as the discovery of contamination in a community, or an unusual occurrence of a disease. Investigations follow a scientific process, may be hypothesis-driven and have an end date, when data collection and analysis and conclusions are complete. As such, they can be easily distinguished from tracking (surveillance) activities which are planned to be ongoing over time. Special investigations are common in public health practice. They can be distinguished from research activities by the fact that the results are intended to describe only the population under investigation; they are not intended to contribute to generalizable knowledge. One common approach to biomonitoring in public health is to conduct special investigations to measure chemicals in communities where specific exposures are suspected or known to have occurred. This approach was used in the state’s pilot program. In this context, a biomonitoring study could identify the range and distribution of exposures in the selected communities and in subgroups in the community. Studies could identify individuals or groups who are most highly exposed in the community who might need additional medical follow-up or counseling. Combined with a thorough exposure assessment and/or adequate follow-up investigation, special investigations can help to identify the exposure pathways that led to high chemical concentrations. Community measurements could be compared to statewide measurements, if available, or to national measurements obtained by the CDC in order to determine whether community measurements are the same as or different than the general population. The approach could be used to identify the need for or to evaluate prior community public health action. 46 Example: Perfluorochemicals (PFCs) in the East Metro The East Metro PFC Biomonitoring Study, which was one of the pilot projects conducted as part of the EHTB program, in a community identified as likely to be exposed. It measured seven PFCs in the blood of 196 residents, age 20-86, living in a community with known PFC contamination in drinking water. Three of the chemicals were detected in all participants. Average exposures to two chemicals (PFOA and PFOS) were 2-4 times higher than the average levels found in the general US population, but lower than levels found in other contaminated communities and in occupational groups. Exposures for three chemicals increased with age and were higher in men. No health- or clinic-based values exist for interpreting PFC levels in blood and no medical follow-up was recommended for participants. The EHTB advisory panel recommended a follow-up study, which will be conducted in 2010-2011, to determine whether PFC levels are decreasing in the population over time due to remediation efforts implemented since 2005 that have removed PFCs from the drinking water. Strengths of a special investigations approach Special investigations that are well designed, timely and conducted in a manner that is responsive to community concerns can provide a benefit to the community under investigation. They have the potential to provide valuable information about whether community members have been exposed to an environmental contaminant in order to plan an appropriate public health response. It can identify individuals or subgroups whose exposures are elevated above the community or national norm. It can potentially lead to additional investigation, community health education or other positive public health action. With appropriate planning and follow up, it can lead to an evaluation to measure whether community remediation efforts were effective. If data on environmental exposure (e.g., soil levels, water levels) is readily available, timely and of good quality – this can result in the ability to test whether higher environmental exposure is associated with higher levels in the body. In the short term, a single investigation can be costeffective with appropriate design and implementation that stays focused on specific questions that the community wants answered. Challenges of a special investigations approach While special investigations can be a useful tool for responding to community concerns about chemical exposures, it is important to note the challenges and limitations of conducting biomonitoring in this context. The pilot projects conducted by MDH have provided helpful insights in to understanding these challenges. First, ample time needs to be allowed to adequately design, plan and implement a biomonitoring study. From the first identification of an exposure concern, a minimum of one year is needed to develop a high quality study design, obtain appropriate approvals to ensure that ethical guidelines are met, and develop laboratory methods. If the community is to be involved then more time is needed in order to establish community relationships and to learn how to appropriately communicate within each community. These time delays may not be acceptable to 47 community members and local officials, who understandably wish action to be taken as soon as possible. Because of this time delay, a state biomonitoring program should not be viewed as a tool for gathering specimens as part of an emergency response to a chemical event. If an emergency response is needed, the state must look to hospitals and medical professionals for assistance in rapidly obtaining specimens from exposed victims of the event. The role of the Public Health laboratory is defined in a state emergency response plan. Biomonitoring may not be a feasible response to many contamination incidents, particularly for chemicals that are quickly eliminated from the body or when remediation efforts have already removed the risk from the environment. Measuring the contaminant exposure after the intervention has been implemented is likely to miss the highest exposures that likely occurred in the past. Another issue associated with a state-run community-based biomonitoring program is the considerable expense associated with initiating each new project and the cost of one or more community investigations each year could potentially be the same as implementing ongoing exposure tracking. Each project presents a challenge to laboratory scientists, epidemiologists and toxicologists who would need to build capacity anew for each new chemical. Developing proficiency with laboratory methods, in particular, can add significantly to the timeframe for implementing a biomonitoring study if the chemical is new. Epidemiologists will need to develop a unique design, protocols and materials, and obtain approvals for each project to meet community-based objectives and needs. It is also necessary for proposed investigations to be reviewed and prioritized in accordance with defined criteria before they are planned and implemented. Local public health agency officials would be particularly helpful in representing the concerns of their communities. This would be preferable to waiting for local communities to request that biomonitoring be done. Per Minnesota statute, the EHTB advisory panel has a clear role in prioritizing and recommending to the MDH commissioner populations and chemicals for biomonitoring. Although all biomonitoring can be unduly influenced by politics, community-based biomonitoring investigations are particularly vulnerable to the influence of local politics and inaccurate perceptions of risk. Program managers and Advisory Panel members will need to have well documented protocols and guidelines in place for making decisions about chemical and community priorities in the face of political pressures. Biomonitoring alone – except in the rare cases– is unable to answer questions about harm or about how people are exposed. It is possible to combine biomonitoring with other tools to gather more information to answer these questions. However this additional data collection adds expense and time to the project, and it may not be possible to arrive at satisfactory answers to the questions community members want answered. Managing expectations with frequent, open and honest communication is essential to the success of community-based investigations. 48 Overall Promise of Biomonitoring in Public Health When used appropriately, biomonitoring has the potential for providing data that can inform the development of future public health interventions and to help evaluate past public health actions. When integrated with exposure and disease data, biomonitoring has great potential to support future research and reveal new knowledge about the relationships between population characteristics, chemical exposure and chronic disease. But significant challenges lie ahead for implementation of state programs. Laboratory method development for biomonitoring can be a significant undertaking; even when laboratory methods are published, there can be significant difficulties implementing these methods. Standards for calibration and quality control materials may not be available for the contaminant and matrix of interest. [lack of proficiency testing] This results in additional work for method validation to ensure high levels of precision and accuracy. Published methods may rely on specialized sample preparation equipment which may not be available. [Extra matrix effects] Biomonitoring is just one tool for learning about the relationships between exposure and health and it is not useful in all situations. Some stakeholders have cautioned that biomonitoring not be done “for biomonitoring’s sake.” Biomonitoring is expensive and requires careful planning and execution to ensure wise use of resources. Lessons learned from the MDH pilot program will provide valuable insight and direction for future planning. In order to be successful, a biomonitoring program must start with a clear understanding of the purpose and objectives, adequate planning, involvement of stakeholders and scientific rigor. Population selection, chemical selection, sampling protocols, laboratory method development, ethics and communications are just a few of the issues to be addressed in program planning. But the overarching decision for a biomonitoring approach, among those presented in this document, will be the first step to move the program forward in reaching its goal. Recommended Approach Given the strengths and limitations of each of the approaches, MDH staff supports and recommends the following for consideration by the Advisory Panel: 1. Continued planning for an ongoing biomonitoring program focusing on a targeted population exposure tracking approach is supported. Given current fiscal realities in the state budget, costly implementation of the full model to include the statewide exposure tracking approach is unrealistic. The targeted approach is fiscally responsible and can best be aligned with agency priorities and programs. It can be integrated with EPHT, and has the greatest promise for advancing both the science and practice of biomonitoring in public health. This approach best maintains and strengthens state capacity for the future and can be expanded as resources allow. Planning should include efforts to seek broader stakeholder input for selecting a targeted population that is in line with agency priorities for addressing children’s health and health disparities in the population. 2. Coordinated pursuit of external funding for special investigations in the state conducted in collaboration with the state EHTB program is also recommended. External collaborations with 49 researchers in other programs, agencies, or the University of Minnesota offer opportunities to build the science and practice of biomonitoring and are complimentary to the goals of a sustained state-funded program. Such collaborative investigations will help the state in addressing special needs of local communities where appropriate, while leveraging resources wisely. Likely sources of such external funding include several CDC programs (ATSDR, EPHT, NIOSH and the Public Health Laboratory) as well as research programs (NIH, NIEHS, and EPA Office of Research) With this two-tiered approach, MDH will have the best chance at successfully achieving the vision and goal of healthy Minnesotans living is safe environments. References: National Conference of State Legislators ,“Biomonitoring: A Best Practices Report for State Legislators,” July 2010. Available online at: http://www.ncsl.org/default.aspx?TabId=20829. Association of Public Health Laboratories report 50 SECTION OVERVIEW: OTHER INFORMATION These documents are included in this meeting packet as items that may be of interest to panel members: Public inquiry to the panel Local, national and global biomonitoring and tracking news EHTB advisory panel meeting summary (from June 8, 2010) Additional reference materials, such as the advisory panel roster and EHTB statute, are available online at www.health.state.mn.us/tracking/. 51 This page intentionally left blank. 52 Public inquiry to the panel In June, the following letter was received by the EHTB program. Given that the letter arrived nearly three full months before the next scheduled meeting of the EHTB advisory panel and that the request is beyond the scope of the panel, the letter was forwarded to John Soler, an epidemiologist with the Minnesota Cancer Surveillance System, to respond to. Dear panel: I am being housed at the Minnesota Correctional Facility – Oak Park Heights, which is in very close proximity to some of those tall, high-powered electrical towers. I have read many reputable reports from the EPA, NIH, etc. that living too close to these towers causes cancer. I believe we, at this prison, are living too close to these towers. There is an unusually high rate of malignancy, or various types of cancers, including brain tumors, bone cancers, etc. at this prison. Please let me know if there is any validity to those tall, high-powered electrical towers causing cancer in people living too close to them. If so, what can be done to correct it? If you don’t fully know, then please give me the contact information to a state or federal agency that is familiar with this subject. 53 This page intentionally left blank. 54 Local, national and global biomonitoring and tracking news Biomonitoring The National Conference of State Legislators released a report, “Biomonitoring: A Best Practices Report for State Legislators,” in late July. The report includes several references to Minnesota’s biomonitoring program and legislation. The report is available online at: http://www.ncsl.org/default.aspx?TabId=20829. The Centers for Disease Control and Prevention (CDC) has posted updated data tables for the National Report on Human Exposure to Environmental Chemicals. The Exposure Report, Updated Tables, July 2010 presents exposure data from the National Health and Nutrition Examination Survey for the civilian, non-institutionalized U.S. population over a two-year survey period of 2005–2006. In addition to presenting data from 2005–2006, these updated tables include the data from 1999–2000, 2001–2002, 2003–2004 as reported in the Second, Third, and Fourth National Report on Human Exposure to Environmental Chemicals. The updated tables can be found at http://www.cdc.gov/exposurereport/. Other ATSDR & CDC, along with other partners, are sponsoring the “National Conversation on Public Health and Chemical Exposures.” The goal of the national conversation is to develop an action agenda “that can help government agencies and other organizations strengthen their efforts to protect the public from harmful chemical exposures.” Through the process ATSDR and CDC have sought to engage a wide range of groups and individuals. John Stine and Linda Bruemmer, EHTB steering committee members, have been participating in the conversation’s workgroups. EHTB panel member Cathi Lyman-Onkka has also participated in the process as a convener of one of the community conversations. For more information about the national conversation, visit http://www.atsdr.cdc.gov/nationalconversation/index.html. 55 This page intentionally left blank. 56 Summary of the Minnesota Department of Health (MDH) Environmental Health Tracking & Biomonitoring Advisory Panel Meeting June 8, 2010, 1-4 p.m. Advisory panel members – Present: Bruce Alexander, Fred Anderson, Beth Baker (chair), Alan Bender, Jill Heins Nesvold, Cathi Lyman-Onkka, Pat McGovern, Greg Pratt, Lisa Yost Advisory panel members – Regrets: Debra McGovern, Geary Olsen, Dan Stoddard, Samuel Yamin Welcome and introductions Beth Baker, chair, convened the meeting. East Metro PFC Biomonitoring Study: Evaluation results Jean Johnson, EHTB program director, described an evaluation that was conducted in late February and early March of the East Metro PFC Biomonitoring Study. A survey was mailed to all 196 participants in the study in order to evaluate written and verbal communications related to the study. One hundred nineteen responses were received; Jean reviewed participant characteristics including gender, age, and length of residency. (Complete results can be found on pages 3-13 of the meeting materials.) Jean highlighted participants’ responses to some of the survey questions. Nearly all participants agreed that the introductory study materials were clear and that they understood the purpose of the study. Participants were asked to compare their own PFC levels with those of the general population (i.e., NHANES levels); most agreed that their levels were greater than most people’s levels. Bruce Alexander suggested that these responses be compared to participants’ actual results to test the accuracy of participants’ assessment. Participants were asked about how helpful a variety of sources of information were to them in understanding PFCs; for most sources of information (e.g., friends, doctor, Internet, media) participants were split in their opinions. Jean pointed out that relatively few participants discussed their PFC levels with their doctors. Beth Baker wondered whether some participants had been tested before or had spoken with their doctors before they got their test results. Greg Pratt stated that he wouldn’t expect a doctor to know about specific chemicals. Cathi LymanOnkka stated that some participants may not have shared the information with their doctors out of concern that the information be put in their medical record. Bruce stated that these kinds of studies often offer participants the advice to consult their physician, but that most physicians will not have very good information on the topic. Lisa Yost stated that in some biomonitoring studies, specific doctors are prepared with comprehensive information for responding to patients’ 57 concerns. Beth pointed out that some education was done with medical providers. Bruce suggested that CME credit be offered as an incentive for participation in the future. Most participants indicated that they were glad to know their PFC levels and felt the project was beneficial. Jean stated that this was reassuring information because there are some ethical concerns that biomonitoring has the potential to cause harm especially when there is very little concrete information about health effects of certain chemicals. Alan Bender wondered whether it was a Minnesota-specific phenomenon for people to be agreeable on surveys. Beth pointed out that for other questions there were more negative responses (e.g., participants reported that they did not find the results letter or booklet reassuring). Jean added that participants also expressed frustration in the open-ended comments section of the survey. Lisa stated that it was interesting that participants didn’t find the information reassuring and that it was cause for concern, yet were still glad to have participated. Jill Heins-Nesvold asked whether information on education was collected and stated that it would be interesting to compare responses across education levels if the sample size was big enough. Jean replied that demographic information was collected and would be included in the next report. Jean reviewed some of the comments that participants provided. Several respondents identified a desire for follow-up actions, including repeat testing, testing for other family members, ongoing medical follow-up. Lisa asked whether participants’ levels were compared to any benchmarks for health effects; Jean replied that there are no known benchmarks. Greg commented that even when there are no known health effects, people object to chemicals being in their bodies (i.e., chemical trespass). Only two participants indicated that they had looked into alternative treatments for removing PFCs from the body. This was a concern after the public meeting where someone was marketing a detoxifying product by attaching flyers on windshields. People may be vulnerable to these kinds of marketers. Bruce suggested that the MDH website include information on the fact that there are no such treatments available. Jean reviewed a summary of how the evaluation group’s results compared to the complete study group; the PFC levels were similar. Bruce suggested that a comparison be made instead of those that participated in the evaluation with those that did not. Jean asked the panel members what lessons were learned through the evaluation and whether any changes should be made for future projects. Alan stated that the results point out that the community supports the idea of a follow-up study and that he was encouraged to note that the study seemed to build a level of trust between the community and MDH. Bruce commented that the results reflect positively on the outreach that was conducted and show that staff did a good job communicating complex information. Lisa suggested that in the future more one-on-one consultation could be offered. Jean stated that this was planned for the follow-up study. Alan suggested that a pre- and post-test design to assess knowledge may have been ideal. 58 Fred Anderson asked whether there seemed to be a strong sense of community around the PFC issue. Michonne Bertrand replied that she wasn’t sure, but that that didn’t seem to be the case. Jean announced that the CDC’s public health laboratory is also interested in evaluating biomonitoring communications and will be conducting interviews in the east metro study communities as part of a research project they are doing. Jill asked what the plans were for ongoing communication with the community around this issue. Jean replied that in addition to planning the follow-up study, MDH has made a commitment to provide community members with ongoing updates. John Stine stated that the Environmental Health Division maintains an email list of approximately 1600 names and sends out updates about PFC-related issues. Some of the information is at a technical level, but the updates also include general information. Greg pointed out that Europe’s response to the lack of information about the health effects of chemicals was to enact legislation (called REACH) requiring the government and industry to develop databases about health effects information. That type of recommendation could also stem from this program’s work. East Metro PFC Biomonitoring Study: Follow-up study protocol Jean Johnson, EHTB program director, described plans for a follow-up study to re-measure PFC levels in the original participants. One hundred eight-six participants agreed to be contacted again for future research. The purpose of the follow-up study will be to measure how much PFC levels have changed in two years. Bruce Alexander asked what the protocol for the blood draw was. Jean stated that participants would be directed to specific clinics. Bruce suggested that it might be possible to send participants a blood draw kit to take to their own clinic if they’ve moved away from the area in order to increase the response rate; he acknowledged that this would involve more effort, especially since the blood needs to be processed at the clinic before it is shipped to MDH. Greg Pratt stated that he was glad to see that the follow-up study questionnaire was going to include more questions about potential exposure pathways. He asked whether any additional consumer products would be asked about besides stain resistant carpet and fabric treatments, such as non-stick pans. Lisa suggested figuring out whether this is really a source of PFC exposure before adding it to the survey, as including it could lead to spurious conclusions. Jean stated that she had spoken separately with Geary Olsen, who was unable to attend the advisory panel meeting, about the study protocol. Geary suggested removing the question about high cholesterol from the survey because, even though it is not intended as a measure of health effects of PFCs, it may be misinterpreted as such. Also, a recent theory that PFCs might bind with cholesterol (suggesting that high cholesterol would precede high PFC levels) was not supported in a recent study. It appears that for the general population a main source of exposure to PFCs is diet, with exposure coming through the packaging as well as bioaccumulation in foods. Thus, the observed relationship between PFCs and cholesterol in the general population may be confounded by diet. Bruce stated that because cholesterol information would not include actual cholesterol levels, it would be difficult to interpret. Cathi Lyman-Onkka and Lisa Yost 59 agreed. Beth pointed out that given the relatively high average age of participants, many would be likely to report high cholesterol (and high blood pressure), which would also decrease the usefulness of the information. Advisory panel members supported removing the questions about cholesterol levels and high blood pressure from the questionnaire. Jill Heins-Nesvold suggested that MDH should try to get a good estimate of when people made changes their water usage that would have resulted in eliminating their exposure. Jean stated that an attempt was made to estimate this in the first study and additional questions would be asked in the follow-up study. Based on the results from the first study, the average time between people changing their water source and having their first blood draw was about 2 years. Alan stated that the individual questions on the survey themselves were unlikely to be useful, but that grouped together into several indicators they might be able to help provide an explanation if PFC levels are not falling as fast as expected. Bruce stated that there would likely not be enough power to detect differences in exposure related to participants’ PFC levels but that it was useful to collect some information. Greg stated that collecting information on exposures could help identify alternative hypotheses related to exposure. Lisa cautioned that MDH be careful not to create an expectation that anyone’s PFC level would ever reach zero. Jill asked what was unique about the follow-up study and suggested that if there were nothing unique being contributed to the scientific literature that work not continue. Bruce stated that it is not intended as a scientific study and that the purpose is to evaluate whether a public health intervention is working. Jean stated that the study would contribute because there are very few studies that have estimated the rate of decline in a community setting. Pat McGovern stated that learning about people’s response to biomonitoring is also an important contribution to the field. In terms of health history, Beth suggested adding dialysis to the list of questions. Jean stated that Geary had also suggested asking about recent childbirth because there would be considerable blood loss. Greg suggested adding a question about breastfeeding. Alan asked whether the samples were tested to determine how dehydrated someone was because that might influence the concentration of PFCs in the blood. Beth stated that a person would need to be extremely dehydrated to make a difference. Bruce suggested that EHTB staff speak with researchers at the University of Minnesota who regularly assess dietary histories through surveys (e.g., John Himes, Mary Story, Jamie Stang). Jill Heins-Nesvold suggested looking at other PFC studies’ survey instruments for questions on health and dietary histories. Jean stated that most of the survey questions related to dietary history were taken directly from the National Health Interview Survey. Bruce cautioned that staff should think about how the survey data would be analyzed, as the survey will result in a lot of data for a small sample size. Alan agreed that the survey was gathering a lot of information and recommended paring it down to only those items that are most likely to be useful. Jean stated that most of the data would likely be used to try to compare the 60 participants whose PFC levels are in the upper 10th percentile to the rest of the sample to try to account for the difference in levels. Alan suggested that each of the variables on its own would be unlikely to be useful, but that clumped together into a few indicators they may be useful. Riverside Prenatal Biomonitoring Study Jean Johnson, EHTB program director, presented data on participant characteristics and cotinine levels. (Information on environmental phenols levels will be presented at the September advisory panel meeting.) The original goal was to recruit 30 women in each of three racial/ethnic categories. Because this project was conducted as an ancillary study to a study at the University of Minnesota, recruitment was dependent on the pool of participants being recruited through the other study. In addition, EHTB project staff were not allowed to have any direct contact with participants. Sixtysix women were ultimately recruited into the biomonitoring study; 46 of them were white, so an analysis by racial/ethnic group is not feasible. As depicted in Table 1 of the meeting materials, participants reported a fairly even spread of incomes, so analysis could potentially be conducted using income as a variable. Bruce Alexander asked whether information on education level was available; Jean replied that is not. Jill Heins-Nesvold suggested looking at the data on the U of M study to see if the biomonitoring study participants were significantly different than the participants in the U of M study. Jean reported that the lab that ran the cotinine analysis classifies anyone with a combined nicotine and cotinine level of greater than 200 ng/mL to be an active smoker. Levels less than that could be considered to be exposed to secondhand smoke. Of the 66 participants, only 10 had levels above the limit of detection. Nine of these appear to be active smokers, though five of them reported that they had not smoked since they found out they were pregnant. Alan Bender suggested talking to tobacco researchers at the University of Minnesota or elsewhere, as they are probably familiar with the apparent contradictions in the data (e.g., people stating that they do not smoke). Beth Baker suggested that the discrepancy could be because women might feel a stigma about smoking during pregnancy and therefore misrepresent their smoking status on the survey. Lisa and Alan agreed. Bruce asked how sensitive the urinary cotinine analysis is and whether the study might have missed people who are exposed to secondhand smoke. Jean agreed that it was curious that there was only one person whose result indicated exposure to secondhand smoke. Beth stated that one conclusion to be drawn from the results is that most women did not have a detectable level of cotinine in their bodies. Cathi Lyman-Onkka supported the idea of analyzing the data by income level. Lisa Yost asked what the likely routes of exposure were for the environmental phenols. Jean replied that it varied by chemical and included sunscreen, anti-bacterial soaps, fragrances added to toiletries, and plastics. Beth stated that exposure might be related to income. Jean stated that staff are planning on sharing the results of the study with Healthy Legacy (which has an interest in pregnant women and children) as well as city and county public health officials. She asked whether there were other groups that may be interested in the results. Cathi 61 suggested meeting with maternal and child health nurses at the county and state levels. Jill suggested presenting cotinine results to the tobacco prevention advocacy community. Carin Huset from MDH’s environmental health laboratory described methods for analyzing environmental phenols. After exposure to environmental phenols, the chemicals are excreted as free and conjugated analytes. Because there are no internal standards available for conjugated species, they need to be cleaved before they are measured. The lab encountered a number of problems during the analysis. During the method validation stage, there were issues with carryover from sample to sample, with recovery of the specimen and with maximizing cleavage. In addition, there are no internal standards available for two of the analytes. During the analysis phase, there were problems with signal reduction in about 80% of the samples resulting in the need to re-analyze those samples. Preliminary results for detections of environmental phenols in the 66 samples are as follows: % detections (free and conjugated species) by MDH % detections (free and conjugated species) by CDC MePB EtPB PrPB BuPB BPA 100% 36.4% 74.2% 10.6% 39.4% 89.4% 86.4% >96% 58% 75% >96% 69% 93% BZP-3 97% TCS CDC results are from 2004, which could account for some of the differences observed. Some of the compounds (e.g., BPA) are being phased out of some consumer products. Beth asked whether these chemicals have been measured in other studies of pregnant women. Carin said she had not seen any such studies. Alan asked what the program was planning to say about these data. Jean replied that, as with PFCs, the program can report the numbers but cannot provide any specific information about what level of exposure, if any, might be associated with health effects. The program can also provide some information about steps people can take to reduce their exposure if they are concerned. Biomonitoring of Great Lakes populations Pam Shubat from MDH’s Environmental Health (EH) Division described a funding opportunity through the Great Lakes Restoration Initiative (GLRI) that MDH is applying for. The GLRI provides funding for many topics; the current funding opportunity is for human biomonitoring where fish consumption is a likely pathway of exposure to various priority contaminants. All funded states would be required to biomonitoring for a set of chemicals; additional chemicals can be added by each state. The funding is for projects looking at “areas of concern” and “highly exposed populations.” For Minnesota’s portion of Lake Superior, the area of concern is the St. Louis River drainage area. One potential highly exposed population is members of the Fond du Lac reservation who fish. 62 Another potential population is the Central Hillside area of Duluth where residents may also be likely to fish. EH staff (including Rita Messing, Pat McCann, Deanna Scher & Tannie Eshenaur) are speaking with representatives from Fond du Lac reservation to try to secure the reservation’s collaboration in the project. Lisa Yost asked whether information on fish tissue concentrations was available in order to guide selection of chemicals. Pam replied that there has been a great deal of testing of many kinds of biota in the areas of concern. Pam stated that one substance that Minnesota is proposing to measure is Omega-3 fatty acids. This would test whether people who have low levels of contaminants also have low levels of healthy fatty acids. Results could help inform the fish advice that is offered by MDH. Lisa asked whether MDH had an existing partner at the Fond du Lac reservation. Pam replied that MDH has partnered with Fond du Lac for many years. Tracking and biomonitoring updates Beth Baker invited questions and comments on the written tracking and biomonitoring program updates that were provided in the meeting packet. There were none. National Children’s Study Pat McGovern, EHTB advisory panel member and principal investigator for the Ramsey County site of the National Children’s Study (NCS) presented an overview of the vision of the NCS. The nationwide study hopes to enroll 100,000 children and their parents, beginning prenatally or even before conception, and follow the children for 21 years from their births. The study’s goal is to identify root causes of diseases that have increased in prevalence and are hypothesized to be influenced by a gene-environment interaction, such as asthma, allergies, diabetes, autism and obesity. The study will examine the physical environment, chemical exposures, the biological environment, genetics and psycho-social factors. It will include an assessment of indoor and outdoor air, house dust, drinking water, soil and noise. Biomonitoring will be conducted on the mother, father and child using a wide variety of biospecimens. The study will examine multiple outcomes and hypotheses. The Ramsey County site is one of 105 anticipated study sites. Because the original prediction of the number of expected births was higher than actual births in the first seven Vanguard or pilot study sites, recruitment has been slow and the study is now piloting three recruitment methods in 30 additional study centers to try to improve the recruitment rate. The Ramsey County site is piloting a method called high- intensity/low-intensity recruitment. This recruitment method will test whether reducing data collection demands increases the participation rate. Women will initially be enrolled into a low-intensity option, which will involve providing survey data at various points in time. About one-third of the women will eventually be asked to move into the high-intensity option, which will involve home visits and biological and environmental sampling. 63 Women will be recruited from 36 neighborhoods in Ramsey County. Recruitment will begin in early fall with a goal of recruiting 300 women from about 47,000 households (assuming there is a response rate of about 50%) within 12 months. The first step will be to conduct an enumeration to identify age-eligible women in the selected neighborhoods. Women will be screened to determine whether they are pregnant already or likely to become pregnant in the near future. Women who are age-eligible and not medically sterile will be invited to enroll in the study and provide informed consent for the low-intensity data collection. Subsequently, women who are pregnant or likely to become pregnant in a few months and live in selected neighborhoods will be invited to enroll in the high-intensity study. Beth Baker asked whether the women consent to participation for 21 years; Pat replied that consent is sought in stages. The first phase of consent for the low-intensity study, the second phase is for those women invited into the high-intensity study, the additional stages of consent are only for the women in the high-intensity study and occurs with birth of the child and when the child is seven years old.. Mary Manning asked whether there was any concern about the mobility of the population affecting retention; Pat replied that the area contained a highly mobile population and that for the pilot, participants were invited to continue to participate in the study as long as they remained within 50 miles of their original address. Both cash and non-cash incentives will be offered to participants. The pilot is also testing whether the chance to be entered in a drawing for a savings bond is an effective incentive. Noncash retention strategies include relationships with staff, ongoing communications about the study, and the availability of faculty and students to potentially conduct research that the community requests. Alan Bender pointed out that the U of M IRB has had issues in the past with active (e.g., face-to-face) recruitment strategies and incentives, because it views these as coercive. Pat replied that the recruitment protocol had been approved at many other study sites and that participation includes incentives but the actual consent phase does not. Retention at the initial seven Vanguard sites was good. At this time, the plan is that most biospecimens collected for the study will not be analyzed immediately, but stored for several years. Other researchers will be able to propose using the samples; and they will need to seek external research funding to support the cost of analysis of the specimens. However, there is some formative research underway to evaluate if real time local or regional analysis of selected biospecimens would be feasible and cost effective. Jean Johnson asked what the process was for researchers to propose an adjunct study; Pat replied that researchers would present their ideas to the PI of the closest site, who would match the researcher with one of the study investigators. However, adjunct research proposals will not be accepted until the full study begins in 2012. For details see the national website: http://www.nationalchildrensstudy.gov/research/adjunctstudies/Pages/default.aspx Study results will typically only be reported to participants if they are actionable. Physical measures and drinking water results will be reported to participants. The pilot group will be followed for the full 21 years and will serve as a test group for the development of new measures and data collection processes throughout the course of the study. 64 A staff person responsible for community engagement efforts will be starting in July. Pat invited panel members and others to offer suggestions for specific contacts and or methods of community engagement. Beth stated that she is interested to see what the participation rate is for Hmong and Somali women, and recommended Dr. Pat Walker at the University of Minnesota as a good contact for working with immigrant populations. Greg Pratt asked whether recruitment varied across ethnic groups; Pat replied that that information was not yet available. Alan suggested meeting with Minnesota State Representative Karen Clark, who could be an advocate for the study. Lisa Yost suggested using community members (as volunteers or employees) to assist with recruitment. Beth Baker adjourned the meeting. Drafted 6/10/10; finalized 7/6/10 65 This page intentionally left blank. 66
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