Minnesota Department of Health Environmental Health Tracking and Biomonitoring Advisory Panel Meeting June 3, 2008 1:00 p.m. – 4:00 p.m. Snelling Office Park Red River Room 1645 Energy Park Drive St. Paul, Minnesota Meeting agenda Minnesota Department of Health Environmental Health Tracking and Biomonitoring Advisory Panel Meeting June 3, 2008 1:00 p.m. – 4:00 p.m. Red River Room at Snelling Office Park 1645 Energy Park Drive, St. Paul, MN Time Agenda item Presenter Item type/Anticipated outcome 1:00 Welcome and introductions Beth Baker, chair 1:05 Environmental health tracking: Background Jean Johnson Information sharing. 1:15 Environmental health tracking: Indicator updates Jean Johnson, Wendy Brunner, Mia Jewell, Kari Palmer, Jeannette Sample, Deanna Scher Discussion item. Discussion item. 2:30 Break 2:45 Environmental health tracking: Next steps and planning Jean Johnson, Michonne Bertrand Chemical selection criteria Michonne Bertrand 3:15 The panel is invited to provide comments and ask questions on the piloting of the tracking indicators. The panel is invited to provide input on the following issues related to the future directions of the Minnesota Environmental Health Tracking System: o Submitting Minnesota data to the national EPHT Network o Continuing to develop nationally consistent indicators for the near term o Exploring other priorities for tracking in Minnesota as part of a longer-term strategic planning effort Discussion item. The panel is invited to comment on any aspect of the revised version of the chemical selection criteria and the process proposed for soliciting, scoring and prioritizing chemicals. 3:30 Project status updates Information sharing. The panel is invited to ask questions or provide input on any of these items. 4:00 Adjourn Next meeting: Tuesday, September 9, 1-4 pm, Minnesota Room, Snelling Office Park i This page intentionally left blank. ii Meeting Materials for June 3, 2008 Environmental Health Tracking & Biomonitoring Advisory Panel Table of Contents Agenda........................................................................................................................................... i Table of contents ...................................................................................................................... iii Materials related to specific agenda items Environmental health tracking Section overview: Environmental health tracking.....................................................................1 Environmental health tracking background ...............................................................................3 Minnesota Environmental Health Tracking System (MEHTS) indicator updates: Air quality ............................................................................................................................7 Water quality......................................................................................................................21 Childhood lead ...................................................................................................................29 Respiratory disease (asthma hospitalizations) ...................................................................31 Respiratory disease (CLRD and asthma mortality) ...........................................................35 Myocardial infarctions .......................................................................................................37 Cancer ................................................................................................................................39 Carbon monoxide poisonings ............................................................................................43 Birth defects .......................................................................................................................53 Birth outcomes ...................................................................................................................57 Environmental health tracking next steps & planning.............................................................59 Chemical selection Section overview: Chemical selection .....................................................................................63 Revised criteria for selecting chemicals for biomonitoring.....................................................65 Chemical selection process and timeline .................................................................................67 Project status updates Section overview: Project status updates.................................................................................69 Arsenic biomonitoring .............................................................................................................71 PFC biomonitoring...................................................................................................................72 Mercury biomonitoring............................................................................................................73 Biomonitoring for a fourth chemical .......................................................................................74 General reference materials Section overview: General reference materials .............................................................................75 NEW: New PFC citations (added since March 11, 2008)..............................................................77 NEW: National and global tracking and biomonitoring news .......................................................87 NEW: California Biomonitoring Program chemical selection survey...........................................89 iii NEW: EHTB advisory panel meeting summary (from March 11, 2008) ......................................97 EHTB advisory panel roster.........................................................................................................105 Biographical sketches of advisory panel members......................................................................107 EHTB advisory panel operating procedures ................................................................................111 EHTB steering committee roster .................................................................................................117 EHTB inter-agency workgroup roster............................................................................................118 Glossary of terms used in environmental health tracking and biomonitoring .............................119 Acronyms used in environmental health tracking and biomonitoring.........................................123 EHTB statute (Minn. Statutes 144.995-144.998)........................................................................................125 iv Section overview: Environmental health tracking The tracking program has made significant progress toward piloting indicators for the eight content areas that were identified as the first priority for program development. This section of the meeting packet contains the following items: • Environmental health tracking background. This information is provided to remind panel members about the gaps that environmental health tracking programs are designed to fill; the short-term and long-term goals for tracking programs, both in Minnesota and at the federal level; the framework for tracking; the limitations and challenges of tracking; and the workplan that the Minnesota program is pursuing. • Minnesota Environmental Health Tracking Systems (MEHTS) indicator updates. This information is included to provide panel members with an update on the piloting of each indicator. Where available, preliminary data are also included along with a discussion of the limitations of each indicator and suggestions for possible future refinements of the indicator for use in Minnesota. These content areas, which were selected to be consistent with the CDC’s Environmental Public Health Tracking Program and the State Environmental Health Indicators Collaborative are: • • • • • • • • • • Air quality Water quality Childhood lead Respiratory disease Myocardial infarctions Cancer Carbon monoxide poisonings Birth defects Birth outcomes Next steps for MEHTS development. This information is included to describe program staff’s preliminary ideas for the next stages of building the tracking program. This includes ideas for additional indicators to be developed and other elements of the program’s work plan. 1 ACTION NEEDED: Panel members are invited to ask questions and provide comments on each of the indicators being reported on. In addition, the panel is asked to provide input on the following issues related to the future directions of the Minnesota Environmental Health Tracking System: o Submitting Minnesota data to the national EPHT Network o Continuing to develop nationally consistent indicators for the near term o Exploring other priorities for tracking in Minnesota as part of a longer-term strategic planning effort No formal vote is anticipated. 2 Environmental health tracking background Origins of the national Environmental Public Health Tracking program In 2000 the Pew Environmental Health Commission issued a report calling for systematic, coordinated public health surveillance of environmental hazards, exposures and disease. The report described information gaps and data “silos” in government programs that preclude epidemiologists and other scientists from fully understanding relationships between environmental exposures and disease. The Commission proposed that a nationwide network be developed for the collection, integration, and dissemination of environmental and health data. [Note: A copy of the Pew report, America's Environmental Health Gap: Why the Country Needs a Nationwide Health Tracking Network, can be found at healthyamericans.org/reports/pew/.] In 2002, Congress appropriated funds to the CDC to establish a National Environmental Public Health Tracking Network. From 2002-2006, twenty six states and cities were awarded grants for program planning and pilot projects. In 2006, the CDC awarded grants to 16 states, 1 city, and 4 academic centers to begin implementation of a web based, secure electronic network for the collection, integration and dissemination of nationally consistent health and environmental data and measures. This new network is anticipated to launch, providing data access to the public and researchers, in September of 2008. Goals of Environmental Health Tracking programs Environmental health tracking (EHT) is defined in the Minnesota legislation as the “the ongoing collection, integration, analysis, and dissemination of data on human exposure to hazardous chemicals in the environment and on diseases potentially caused or aggravated by those chemicals.” EHT is designed to meet basic surveillance goals, that is: to determine impacts and trends; recognize patterns and outbreaks; identify populations most affected or most vulnerable; and to identify opportunities for research and/or public health intervention. A primary goal of EHT is to prioritize public health actions for policy makers and track progress of environmental programs in addressing environmental hazards, population exposures, and environmentally-related disease outcomes. As depicted in the graphic below, public health action is a vital component of any surveillance system. 3 Surveillance model Public Health Action Data Collection Research Mitigation/ Intervention Policy Hazard Exposure Disease Intervention Dissemination of Information Data Integration Reports Data Displays Data Access Communication Management Description Analysis Some of the specific long-term goals for EHT identified by the national program include the following: • Develop and implement a sustainable approach for national surveillance. • Identify geographic and temporal trends in the data. • Identify demographic or geographic disparities in health data (communities at risk). • Identify priority issues and contaminants. • Target high-risk populations for environmental and public health interventions. • Provide data to assist in evaluating environmental and public health interventions. • Develop surveillance measures that are consistent with national Healthy People 2010 and EPA program goals where feasible. • Improve the availability and accessibility of quality data for identifying emerging issues and/or assessing public health impacts. • Identify current gaps in data and information and develop recommendations for improved data collection. • Standardize methodology for routine and disaster-related surveillance including the development of case definitions and standard measures. While surveillance methods are commonly practiced by epidemiologists working with infectious and chronic disease data, EHT has been described as a “sea change” in the way experts view environmental data that is typically gathered for regulatory purposes. One of the outcomes of hazard indicator development at the national level has been to transform environmental monitoring data (air and water) into measures that can be used to track population level exposures over time and be 4 “linkable” to disease surveillance data. This generally means incorporating population data from the U.S. Census into geographically based environmental monitoring data. In the short term, the national tracking program has incorporated improvements in technology and increased accessibility to data analysis tools, thus increasing capacity of staff scientists to collect and analyze a wide variety of data and to examine relationships in the available data. As with any surveillance system, EHT will be built gradually over time. It may take years before the long-term goals are met and the true utility of EHT is known. EHT indicators Environmental Public Health Indicators were first described by the CDC/CSTE Environmental Health Indicators project in 2000. Indicators are descriptive, summary measures derived from data gathered by existing programs. They are tools for surveillance which, when integrated together, enhance the accessibility and utility of information for decision-making. They may stand alone or be combined to describe relationships between different measures. They identify areas for intervention and evaluate the efficacy of programs and actions. They also serve as communication tools for making environmental health information understandable to stakeholders. At the national level, EHT indicators are intended to provide standardized methods for comparing public health and environmental data across multiple states and for building a comprehensive national public health surveillance system. The national tracking program and the State Environmental Health Indicator Collaborative (SEHIC) have identified nine content areas as a priority for indicator development. These content areas include: Air quality Water quality Childhood lead Respiratory disease Myocardial infarctions Cancer Carbon monoxide poisoning Birth defects Birth outcomes At the October 2007 meeting, the EHTB Advisory Panel, approved a proposed workplan for tracking that identified a basic set of priorities for years one and two of program development. In year one, priority was given to evaluating and reporting on a set of core indicators utilizing data available to MDH and consistent with methods being developed by the National EPHT program and/or the Council of State and Territorial Epidemiologists (CSTE) State Environmental Health Indicator Collaborative (SEHIC). This was done so that Minnesota’s program is consistent with programs in other states, and Minnesota data can potentially be disseminated through the national network. This approach also positions Minnesota as a contributor to the national effort and a competitive applicant for future CDC funding to states. 5 Piloting EHT indicators in Minnesota Core indicators in the nine content areas are currently being piloted and evaluated, first to determine whether Minnesota has all of the data necessary to produce the indicators, and to identify their limitations. At the June meeting of the EHTB advisory panel, EHTB staff and members of our Indicator Development Team will describe their progress to date. Piloting these measures has helped to inform our understanding of the various data sources and their limitations, an important first step in developing an overall strategic plan. Many of the issues identified have also challenged other states and Minnesota is participating in multi-state workgroups working to resolve these issues and improve the data quality. While each indicator has unique limitations due to the variety of data sets in use, some of the challenges commonly encountered are: • Geographic scope is variable across data sets. Some data sets do not cover the entire state but may cover only certain counties, or certain segments of the population. This will present a challenge to integrating certain data sets together. • For most health data, address and demographic information are incomplete. Information on race, ethnicity and socioeconomic status, for example, are often not available or not reliable. Analyses based on these factors will be limited unless other supplemental sources of data are identified. • Differences in state practice and policies affect state to state comparisons. In some cases such comparisons are not recommended. Improved consistency in data collection practices is needed for some indicators to achieve national program goals. 6 Content area: Air quality Indicators National EPHT air quality indicators currently include short-term exposure to ozone and PM2.5 and long-term exposure to PM2.5. Specific data measures for these indicators include the following: • Short term exposure to ozone o Number of days with maximum 8-hour average ozone concentrations over the National Ambient Air Quality Standards (NAAQS) (.075 ppm) o Person-days with maximum 8-hour average ozone concentrations over the NAAQS (.075 ppm) • Short-term exposure to PM2.5 o Number of days with maximum 8-hour average PM2.5 concentrations over the NAAQS (35 ug/m3) o Person-days with maximum 8-hour average PM2.5 concentrations over the NAAQS (35 ug/m3) • Long-term exposure to PM2.5 o Annual average (based on seasonal averages and daily measurements) for ambient PM2.5 concentrations o Percent of the population living in areas that exceed the annual concentration NAAQS (15 ug/m3) [Note: Due to the fact that all monitored counties in Minnesota met current NAAQS for annual PM 2.5 concentrations, this measure is not necessary and is not reported on.] Data are reported by county and Metropolitan Statistical Area (MSA). Rationale High levels of ozone and PM2.5 (particulate matter less than 2.5 microns in aerodynamic diameter [fine particulate matter]) are the main known cause of poor air quality in much of the country. Both have been strongly linked with respiratory and cardiovascular health effects. Data source The source of data for this indicator is EPA Air Quality System monitoring data for ozone and PM2.5. Monitoring data are available only for counties and MSAs where monitors are located. For many Minnesota counties, monitoring data are unavailable as shown in Figures 1 and 4 below. 7 Preliminary data: Short-term exposure to ozone Monitored MSAs: • Duluth-Superior: St. Louis, Douglas (WI), Carlton (‘06Present) • Fargo-Moorhead: Cass (ND), Clay • Minneapolis-St. Paul: Anoka, Carver, Chisago, Dakota, Hennepin, Isanti, Ramsey, Scott, Sherburne, Washington, Wright, Pierce (WI), St. Croix (WI) • Rochester: Olmsted, Dodge (‘06-Present), Wabasha (’06Present) • St. Cloud: Benton, Stearns Figure 1. Minnesota Counties included in ozone exposure person-days estimates. Monitored Non-MSA Counties: • Becker (’05) • Crow Wing (’04) • Goodhue (’03) • Lake (’97), • Lyon (’05 only) • Mille Lacs (’99) Data Requirements: A threshold of 75% of in-season monitoring days is required for data to be validated. While the EPA lists Minnesota’s ozone monitoring season as April 1 – October 31, state practice reduces that season to April 1 – September 30, for a total of 183 monitoring days. Note: MSA Person-Day calculations include non-Minnesota counties. Calculation Method: All dates with readings above the NAAQS are considered a single exposure day, so long as the yearly monitoring threshold has been met. In MSAs or non-MSA counties with multiple monitors, if more than one monitor exceeds the NAAQS on the same day, that date will only be counted once. However, if multiple MSAs or non-MSA counties exceed the NAAQS on the same date, each exceedance will be counted in the overall exposure-days total. To calculate person-days the total number of exceedances are multiplied by the population estimate for the given year, per MSA or non-MSA county. 8 Figure 2. Number of Days with Maximum Daily 8-Hour Average Ozone Concentrations Exceeding the NAAQS Yearly Totals in Monitored MSAs and Non-MSA Counties 1997-2007 17 18 16 14 Days Above NAAQS 14 13 12 12 10 10 8 8 6 5 5 5 4 4 2 0 0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year Figure 3. Person-Days for Maximum Daily 8-Hour Average Ozone Concentrations Exceeding NAAQS Yearly Totals For Monitored MSAs and Non-MSA Counties 1997-2007 30,000,000 26,188,342 25,000,000 21,792,178 21,277,779 Person-Days 20,000,000 17,822,969 16,469,744 15,000,000 14,461,334 12,246,125 11,558,327 10,000,000 6,441,503 6,261,591 5,000,000 0 0 1997 1998 1999 2000 2001 2002 Year 9 2003 2004 2005 2006 2007 Table 1. Number of Days with Maximum Daily 8-Hour Average Ozone Concentrations Exceeding the NAAQS by monitored Metropolitan Statistical Areas (MSA) and non-MSA Counties, 1997-2007. DuluthSuperior MinneapolisSt. Paul 2 1 2 1 0 0 0 0 2 0 0 5 4 6 2 7 4 7 0 8 2 5 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Rochester 1 0 2 0 0 St. Cloud Crow Wing County Becker County 0 0 0 0 1 0 0 0 0 0 Goodhue County 0 1 0 1 Lake County 0 1 1 2 Lyon County 1 0 1 0 1 0 0 0 0 0 1 Mille Lacs County 5 1 4 1 2 0 3 2 3 0 Table 2. Person-Days for Maximum Daily 8-Hour Average Ozone Concentrations Exceeding NAAQS by Monitored MSAs and non-MSA Counties, 1997-2007. 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 DuluthSuperior 475,542 236,591 472,800 275,584 0 0 0 0 548,596 0 0 Minneapolis-St. Paul 13,975,120 11,321,736 17,232,654 5,963,558 21,175,007 12,222,476 21,571,585 0 25,105,448 6,344,024 16,041,060 Rochester 171,993 0 352,680 0 0 St. Cloud 0 0 0 0 185,555 Becker County Crow Wing County 0 0 0 0 0 0 59,763 0 61,648 Goodhue County 0 45,298 45,481 91,678 Lake County 10,672 0 10,765 0 11,116 0 0 0 0 0 10,741 Lyon County Mille Lacs County 0 106,750 22,449 91,656 23,649 48,600 0 76,557 51,998 79,062 Note: Blank cells indicate that no monitoring data is available for the given location and year. Zeros indicate that monitoring data is available, but 10 there are no NAAQS exceedances. Table 3. Number of Days with Maximum Daily 8-Hour Average Ozone Concentrations Exceeding the NAAQS by County, 1997-2007 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Anoka 4 4 4 2 5 4 3 0 5 0 2 Becker Carlton Crow Wing 0 0 0 0 0 0 0 0 0 0 1 0 1 Dakota 2 2 0 0 1 1 1 0 0 1 1 Goodhue 0 1 1 2 Lake Mille Lacs Lyon 1 0 1 0 1 0 0 0 0 0 1 Olmsted 5 1 4 1 2 0 3 2 3 0 1 0 2 0 0 Saint Louis 2 1 2 1 0 0 0 0 2 0 0 Scott 1 0 2 0 0 Stearns Washington Wright 0 0 0 0 1 4 4 1 4 3 3 0 1 1 4 0 0 2 1 4 Table 4. Person-Days for Maximum Daily 8-Hour Average Ozone Concentrations Exceeding NAAQS by County, 1997-2007 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Anoka 1,146,584 1,169,296 1,195,792 599,508 1,524,920 1,236,264 936,666 0 1,603,130 0 652,504 Becker 0 0 0 Carlton 0 0 0 0 0 0 Crow Wing 0 59,763 0 61,648 Dakota 669,544 684,118 0 0 363,610 368,275 372,100 0 0 45,298 45,481 Goodhue 0 45,298 45,481 91,678 Lake 10,672 0 10,765 0 11,116 0 0 0 0 0 10,741 Lyon 0 Mille Lacs 106,750 22,449 91,656 23,649 48,600 0 76,557 51,998 79,062 Olmsted 131,367 0 270,526 0 0 Saint Louis 389,374 193,463 386,866 200,479 0 0 0 0 393,420 0 0 Scott 108,025 0 237,258 0 0 Stearns Washington 0 0 0 0 146,051 786,700 810,424 202,537 826,692 627,789 637,275 0 217,609 222,009 905,900 Wright 0 0 219,442 113,906 469,488 Note: Blank cells indicate that no monitoring data is available for the given county and year. Zeros indicate that monitoring data is available, but there are no NAAQS exceedances. 11 Preliminary data: Short-term exposure to PM 2.5 Monitored MSAs: • Duluth-Superior: St. Louis, Douglas (WI), Carlton (‘06Present) • Fargo-Moorhead: Cass (ND), Clay • Minneapolis-St. Paul: Anoka, Carver, Chisago, Dakota, Hennepin, Isanti, Ramsey, Scott, Sherburne, Washington, Wright, Pierce (WI), St. Croix (WI) • Rochester: Olmsted, Dodge (‘06Present), Wabasha (’06-Present) • St. Cloud: Benton, Stearns Monitored Non-MSA Counties: • Mille Lacs (’02) Data Requirements: Daily PM 2.5 monitors typically operate on a 1:3 or 1:6 day cycle. For the purpose of this indicator, a county must have monitoring data for 75% of a 1:3 day monitoring cycle, or 90 of 120 days. Calculation Method: Due to the typical 1:3 day monitoring schedule it is not appropriate to describe NAAQS exceedances by day; rather this indicator considers the percent of days exceeding the NAAQS. To achieve Note: MSA Person-Day calculations include non-Minnesota counties. this measure first calculate the percentage of days monitored that exceed the NAAQS, and then multiply that percentage by 365 to estimate the yearly total. To calculate the total person-days multiply percent-days above the NAAQS by the given year’s population estimate, per county or MSA. 12 Figure 5. Person-Days for 24-Hour Average PM 2.5 Concentrations Exceeding NAAQS Yearly Total Including Monitored MSAs and Non-MSA Counties 2001-2007 35000000 32681554.29 30000000 27037653.1 Person-Days 25000000 20000000 15000000 11820851.72 10051235.86 10000000 9045190.469 10936132.63 3699168.305 5000000 0 2001 2002 2003 2004 2005 2006 2007 Year Figure 6. Percent-Days 24-Hour Average PM 2.5 Concentrations Exceed NAAQS Yearly Totals for Monitored MSAs and Non-MSA Counties 20 18 18.7 17.1 16 Percent-Days 14 12.8 12 10 8.7 7.7 8 6.0 6 4 2.9 2 0 2001 2002 2003 2004 Year 13 2005 2006 2007 Table 5. Percent-days 24-hour average PM 2.5 concentrations exceed NAAQS by monitored MSAs and nonMSA counties, 2001 – 2007. DuluthSuperior FargoMorehead Minneapolis-St. Paul Rochester St. Cloud Mille Lacs County 2001 0 3.1 10.4 3.5 0.0 2002 0 0.0 1.0 0.0 3.3 3.4 2003 3.016529 0.0 3.0 0.0 0.0 0.0 2004 0 0.0 8.7 0.0 0.0 0.0 2005 3.016529 0.0 2.9 3.3 6.0 3.4 2006 0 0.0 2.9 0.0 0.0 0.0 2007 0 0.0 3.0 3.2 3.2 3.4 Table 6. Person-days for 24-hour average PM 2.5 concentrations exceeding NAAQS by monitored MSAs and non-MSA counties, 2001 – 2007. DuluthSuperior FargoMorehead Minneapolis-St. Paul Rochester Mille Lacs County St. Cloud 2001 0 550,024 31,546,439 585,091 0 2002 0 0 3,055,619 0 570,720 72,829 2003 831,530 0 9,219,706 0 0 0 2004 0 0 27,037,653 0 0 0 2005 827,428 0 9,237,388 579,857 1,094,747 81,433 2006 0 0 9,045,190 0 0 0 2007 0 0 9,677,664 584,911 588,935 84,622 Note: Blank cells indicate that no monitoring data is available for the given location and year. Zeros indicate that monitoring data is available, but there are no NAAQS exceedances. 14 Table 7. Percent-days 24-hour average PM 2.5 concentrations exceed NAAQS by monitored counties, 2001 – 2007. Dakota Hennepin Mille Lacs Olmsted Ramsey Saint Louis Scott Stearns 2001 0 5.812102 2002 2.991803 1.045845 3.41 0.00 1.06 0.00 3.17 3.26 2003 0 0 0.00 0.00 3.02 3.02 0.00 0.00 2004 0 0 0.00 0.00 8.98 0.00 0.00 0.00 2005 3.119658 2.991803 3.44 3.29 2.99 3.02 3.41 6.03 2006 0 0 0.00 0.00 0.00 0.00 0.00 2007 3.146552 3.016529 3.41 3.02 0.00 3.12 3.17 3.23 Table 8. Person-days for 24-hour average PM 2.5 concentrations exceeding NAAQS by monitored counties, 2001-2007. Dakota Hennepin Mille Lacs Olmsted Ramsey Saint Louis Scott Stearns 2001 0 6,542,160 2002 1,101,806 1,176,263 0 0 542,406 0 327,567 450,909 2003 0 0 0 0 1,527,742 600,144 0 0 2004 0 0 0 0 4,504,659 0 0 0 2005 1,190,486 3,365,578 81,433 444,784 1,491,022 593,381 404,669 861,442 2006 0 0 0 0 0 0 0 0 2007 1,228,659 3,428,584 84,622 451,395 1,507,936 395,080 463,553 Note: Blank cells indicate that no monitoring data is available for the given location and year. Zeros indicate that monitoring data is available, but there are no NAAQS exceedances. 15 Preliminary data: Long-term exposure to PM 2.5 Monitored counties (Start Date): Dakota (’01), Hennepin (’01), Mille Lacs (’02), Olmsted (’02), Ramsey (’02), Saint Louis (’02), Scott (’02), and Stearns (’02). Figure 7. Maximum Weighted Arithmetic Mean for Annual Ambient Concentrations of PM 2.5 2001-2007 - by County 16 Standard 14 Dakota 12 Hennepin ug/m3 Mille Lacs Olmsted 10 Ramsey Saint Louis Scott 8 Stearns Standard 6 4 2001 2002 2003 2004 Year 16 2005 2006 2007 Table 9. Annual average PM 2.5 concentrations (ug/m3) by monitored counties, 2001-2007. Dakota 2001 2002 2003 2004 2005 2006 2007 10.6 9.82 9.35 8.15 10.32 8.78 9.57 Hennepin Mille Lacs Olmsted Ramsey Saint Louis Scott 11.93 7.32 13.02 13.02 8.81 10.48 7.03 10.43 11.33 7.91 10.17 6.88 10.14 12.02 8.28 8.98 5.77 8.91 10.76 6.63 10.28 6.96 11.35 12.24 7.78 9.16 6.51 10.55 7.65 10.16 6.56 10.29 10.86 7.44 17 Stearns 10.81 9.8 9.12 8.36 9.62 8.5 9.36 10.79 9.24 8.94 8.17 9.31 7.86 8.32 Figure 8: Comparison between Federal Reference Method and Continuous PM2.5 Methods in Calculating Indicators. Days Exceeding Daily PM 2.5 NAAQS Federal Reference Method (FRM) v. Continuous (BAM) Monitors January 1, 2007- December 31, 2007 10 9 8 7 6 6 5 5 5 5 4 4 4 3 3 3.1 3.4 3.0 3.2 3.2 3.1 3.0 FRM BAM 3 2 2 1 1 ht rig W rn s St ea tL ou is y Sa in R am se O lm st ed cs La on M ille Ly pi n ne ot a D ak H en C ro w W in g k C oo r ke Be c ka An o ot t 0.0 0 0 Sc Percent-days (FRM)/Days (BAM) 9 County FRM: Federal Reference Method. A filter method of monitoring PM 2.5 that results in a 24-hour average concentration. BAM: Beta Attenuation Mass. A continuous method of monitoring PM2.5 that gives on-going hourly averages. The national indicators use only FRM data. This graphic shows a comparison with BAM data which MPCA also collects. The BAM data is available every day while FRM data is available only one day out of three. The BAM data is also available in more counties than the FRM data. 18 Limitations and challenges There are several limitations associated with using the national indicator for air quality in Minnesota: • The national indicator does not track concentrations below the national air quality standards yet these standards for ozone and fine particulate have not been definitively shown to be health protective. • The national indicator considers only federal register method data for fine particulate and ozone. It does not effectively use other available monitoring data such as continuous fine particulate, data for other pollutants with standards and air toxics data for pollutants such as benzene, formaldehyde and metals. (See figure 8 for a comparison between the federal register method and continuous fine particulate data). • The national indicator is inconsistent with other indicators the MPCA reports such as the Air Quality Index (AQI). • The national indicator does not take into account personal exposure for individuals who get the bulk of their exposure indoors and in micro-environments. • The national indicator only considers the risks in counties which have monitors. This practice ignores exposure in the majority of counties. • The national indicator does not consider available emissions and modeling data which could help fill in the monitoring data gaps. • The national indicators are unlikely to be tracked internally at the MPCA due to the concerns listed above. Recommendations and next steps for indicator development The national indicators may be tracked in order to be consistent with the national EPHT program. The national measures are easy to calculate and the data is readily accessible. However, the indicators are likely to underestimate the health concerns due to air quality since they track a limited number of pollutants (although likely the ones of greatest concern); do not consider health risks below standards; ignore personal exposure; and do not consider counties where monitoring data is not available. The MPCA recommends that the EHTB program consider adding additional indicators which may balance this underestimation of exposure. The national EPHT program is considering methods for measuring the health impact of chronic and acute PM2.5 exposure and ozone exposure as well as susceptibility to PM2.5 by linking air quality measures with respiratory and cardiovascular disease indicators. MDH, through an EPAfunded, grant is also developing and piloting similar data linkage methods. 19 This page intentionally left blank. 20 Content area: Drinking water quality Indicators The national EPHT program is currently developing three indicators related to drinking water: • Public Water Use Index, which is designed to measure the number and percent of people served by community water systems1 (CWS) by state and county. • Levels of Contaminants in Finished Drinking Water, which is designed to measure the number and percent of CWS which had violations of water quality standards and the number/percent of CWS by specified water quality level (i.e., contaminant concentration). In both cases, the unit of observation is the CWS. The proportion of systems meeting water quality regulations and goals can be a measure of the effectiveness of prevention efforts, as well as a measure of hazard. • Potential Population Exposure to Contaminants in Finished Drinking Water, which is designed to measure the number and percent of people served whose CWS had violations of water quality standards and the number/percent and/or distribution of number of people served by specified water quality level (i.e., contaminant concentration). In both cases, the unit of observation is the person. The proportion of a population or demographic group receiving water of a certain quality is a measure of population exposure. The specific drinking water contaminants that are the initial focus of these indicators are disinfection byproducts (TTHM, HAA5, individual THMs and HAAs), arsenic, lead, and nitrate. Different contaminants have different sources, methods for regulation, and potential for causing adverse health effects at differing concentration levels. Therefore, measures were developed to specifically address the unique characteristics of each contaminant. The contaminant-specific measures are derivatives of the general indicators described above. The national drinking water content workgroup (DW CWG) selected 1999 as the start year for drinking water tracking. Specific measures for each indicator are as follows: Public Water Use Index A. Number and % of people served by CWS (state required, county optional) B. Distribution of size of population across CWS 1 The Safe Drinking Water Act requires collection of data for a number of different types of public water systems of which community water systems (CWS) are a sub-set. CWS represent non-transient public water systems that serve year-round community residents and are the focus of the initial indicators. 21 Level of contaminant in finished drinking water [Note: The underlying unit of observation is the CWS.] A. Disinfection byproducts (DBP) 1. Number and % of CWS with any DBP maximum contaminant level violation, by year 2. Number and % of CWS with any DBP MCL violation, by quarter 3. Number and % of CWS with each of 0,1,2,..8 DBP MCL violations, by year B. Arsenic 1. Number and % of CWS with any arsenic MCL violation, by year 2. Distribution of mean arsenic concentrations across CWS, by 3-year compliance (sampling) period (cut-points: <3, 5, 10, 15, >15 ppb) C. Lead [Note: No measure is recommended by the national EPHT program for lead at this time] D. Nitrate 1. Number and % of CWS with any nitrate MCL violation, by year 2. Distribution of mean nitrate concentration across CWS, by year (cut points: <=1, 3, 5, 10, 20, >20 mg/L nitrate-nitrogen) 3. Distribution of maximum nitrate concentration across CWS, by year (cut points: <=1, 3, 5, 10, 20, >20 mg/L nitrate-nitrogen) Potential population exposure to contaminants in finished drinking water [Note: The underling unit of observation is the person. ‘Population’ refers to the number of people served by CWS.] A. Disinfection byproducts 1. Number and % of people served by CWS with any DBP MCL violation, by year 2. Number and % of people served by CWS with any DBP MCL violation, by quarter 3. Number and % of people receiving water from CWS with each of 0, 1, 2, ,.., 8 DBP MCL violations per year 4. Percent of ‘person-months’ for which no DBP violation occurred, by year 5. Number and % of people receiving water from CWS with a mean DBP concentration greater than specific reference levels. Reference levels will be the 50th, 75th, 90th and 95th percentiles of the distribution of mean DBP levels in 2005. 6. Distribution of number of people by mean DBP concentration, by quarter and year (cumulative frequency distributions) B. Arsenic 1. Number and % of people served by CWS with any arsenic MCL violation, by year 2. Distribution of number of people by mean arsenic concentration, by 3-year compliance (sampling) period (cumulative frequency distribution). C. Lead [Note: No measure is recommended by the national EPHT program for lead at this time. 22 D. Nitrate 1. Number and % of people served by CWS with any nitrate MCL violation, by year 2. Mean concentration 3. Distribution of number of people by mean nitrate concentration of finished water, by year (cut points: <=1, 3, 5, 10, 20, >20 mg/L nitrate-nitrogen) 4. Distribution of number of people by maximum nitrate concentration of finished water, by year (cut points: <=1, 3, 5, 10, 20, >20 mg/L nitrate-nitrogen) Rationale The specific contaminants that are the initial focus for these indicators were selected by consensus of the national EPHT Drinking Water Content Work Group (DW CWG). The primary factors considered were a) the epidemiologic and toxicological evidence supporting an environmental exposure-health link and b) the representativeness in terms of how data are collected on a national level. Data sources Contaminant-level and violations data are extracted from MDH’s Minnesota Drinking Water Information System (MNDWIS). U.S. census data are used to establish the percent of the population served by CWS. Preliminary data The indicators have been piloted using Minnesota data; however, all data and measures are preliminary and will change. The DW CWG has recently developed a set of tools (i.e., SAS programs) to assist state tracking programs in calculating the nationally consistent data and measures. However, the DW CWG has not addressed certain issues that affect the quality and interpretation of the data and measures. Further, the DW CWG has not finalized how the measures should be “displayed.” The DW CWG plans to address data quality issues in June/July 2008, modify the tools accordingly, and will then instruct all states participating in the national network to re-create the data and measures. The following tables and graphs are examples of how measures may ultimately be displayed. They were created using SAS code provided by the DW CWG and Minnesota-specific data. 23 Table 1. Number and percent of CWS with any DBP MCL violation, by quarter1. 1 Prior to 2004, only surface water systems using disinfectant and serving > 10,000 people were required to sample for DBPs. TTHM MCL=80 ppb. HAA5 MCL=60 ppb. Table 2. Number and percent of population served by CWS with arsenic MCL violation, by year1. 1 Starting January 2006, the MCL was enforced at 10 ppb (previously 50 ppb). 24 Figure 1. Percent of CWS by maximum nitrate concentration in 20051 1 In this display, CWS with no sample results were placed in the “< or = 1” category. Figure 2. Cumulative population by mean total trihalomethane concentration in 20021 1 Those served by CWS with no data were assigned a concentration of zero in this display. TTHM values are rounded to next highest integer. Values of zero are classed to 1 so that the class labeled 1 has all 0 - 1 results. The tables are violation-based measures while the figures are concentration-based measures. Both CWS-based and population-based measures are represented in these examples. As shown in Tables 1 and 2, temporal differences in the measures (in this case, yearly versus quarterly) are seen depending on the contaminant’s sampling frequency and unique characteristics (e.g., DBP levels fluctuate seasonally). Figures 1 and 2 demonstrate how different descriptive statistics (in 25 this case, mean versus max) may be used based on the contaminant. For example, maximum values are presented for nitrate due to an acute health risk (methemogobinemia). As evidenced by the footnotes for Tables 1 and 2, data-specific “messaging” is necessary for the reader to properly interpret the data. The footnotes for Figures 1 and 2 are intended to highlight issues surrounding the display of missing data. No measures have been developed for lead. Limitations and challenges There are several general limitations to the data and measures. Some examples include: • Only CWS are included (not NTNCWS or TNCWS); private well data are lacking. • CWS have unique spatial boundaries which do not necessarily match other geographic units (e.g., census block). This makes it difficult to analyze drinking water quality data in terms of other types of exposure/health information. • Sampling requirements differ across CWS. For example, one system may sample quarterly for arsenic while another may sample once every 9 years. • The public health significance of the violations-based measures is uncertain since MCLs may be based on engineering and cost considerations as well as human health risk. • Population-based indicators are incomplete measures of exposure (i.e., do not account for water consumption, bathing, and other human behaviors). Several data analysis issues still need to be addressed before the data and measures can be finalized. Some examples include: 1) Results < MDL (method detection limit) This issue is unresolved. Currently, censored values are set to zero for DBPs while for nitrate and arsenic, they are set to ½ MDL. 2) Changes in water system activity status The DW CWG instructs that only currently active systems such be included in the data and measures. In Minnesota, sampling results and violations data from 56 currently inactive systems, which were active at some point between 1999-present, are currently excluded. 3) Consecutive systems CWS that purchase water from other systems generally are not required to conduct their own sampling. The DW CWG plans to substitute sampling results from systems that sell water for systems that purchase water. Currently, 75 systems (representing 6% population served) have no data because they purchase water. 4) Predicting levels between sampling dates Sampling waivers granted by the state result in data gaps. For example, some DBP measures are based on quarterly averages. In Minnesota, only 3% of disinfecting systems are currently sampling quarterly. 78% of CWS only sample once every 3 years. The DW CWG will be working to address this issue over the next few months. Performing some type of imputation is one possibility. At minimum, missing data must be acknowledged in tables 26 or figures. Excluding systems with missing data (mainly systems with waivers), may result in positively biased measures, since waivers are justified by monitoring data showing low/no contamination potential. 5) Accuracy of system population estimates The population-based measures depend on an accurate estimate of the number of people served. These estimates come directly from the systems themselves. Although the systems are believed to have fairly reliable information on number of connections, “population served” estimates are of unknown accuracy and reliability. Further, system population is a current estimate, so population-based estimates for years past may be inaccurate. Historical information is not available. Recommendations and next steps for indicator development Making a decision about whether to follow the national network’s guidelines on how to create the drinking water data and measures should depend on the outcome of DW CWG decisionmaking on data quality issues. This will take place over the next few months. The Minnesota tracking program will continue to be an active participant in all DW CWG discussions. 27 Acronym µg µg/L CDC CWS DBP DNR DW DW CWG EPA EPHT GW HAA5 HAA MCL MDA MDH MDL mg mg/L MGS MNDWIS NGO NTNCWS PCA ppb PWS SDWA SW THM TNCWS TTHM Description Microgram, one-millionth of a gram Micrograms per liter Centers for Disease Control Community Water System Disinfection byproduct Department of Natural Resources (Minnesota) Drinking water Drinking water Content workgroup. The DW CWG is charged with developing DW indicators, data, and measures for the national EPHT network U.S. Environmental Protection Agency Environmental Public Health Tracking (CDC’s National Program) Groundwater Total haloacetic acids, the sum of five haloacetic acids. An MCL for HAA5 is established under SDWA. Haloactic acids, one class of halogenated organic DBPs Maximum Contaminant Level Minnesota Department of Agriculture Minnesota Departmentof Health Method detection limit Milligram, one-thousandth of a gram Milligrams per liter Minnesota Geological Survey Minnesota Drinking Water Information System Non-governmental organization Nontransient Noncommunity Water System Pollution Control Agency (Minnesota) Parts per billion Public Water System Safe Drinking Water Act Surface water Trihalomethanes, one class of halogenated organic DBPs Transient Noncommunity Water System Total Trihalomethanes, the sum of four trihalomethanes. An MCL for TTHM is established under SDWA 28 Content area: Childhood lead Indicators Indicators related to childhood lead include childhood blood lead testing penetration and housing risk. Indicators for childhood lead include the following: • Percent of children tested for lead poisoning prior to 36 months of age (by ZIP code). • “Housing Risk,” defined as the percent of pre-1950 housing (by ZIP code). • Percent of children tested for lead poisoning prior to 36 months of age by housing risk category. The national EPHT program recommends using a birth cohort to determine how many children born in a specific year were tested before the age of 36 months. These indicators can be used to identify populations that are not being adequately tested and improve testing; help parents determine if their community is at risk; and allow health care providers to identify children who should be tested for lead. Rationale Elevated blood lead levels (BLL) in young children have been associated with adverse health effects ranging from learning impairment and behavioral problems to death. Because children may have elevated BLLs and not have any specific symptoms, CDC recommends a blood lead test for young children at risk for lead poisoning. One risk factor identified in the National Health and Nutrition Examination Surveys (NHANES) is living in housing built before 1950, especially in deteriorating condition. Other risk factors identified include being African American and living in a family in poverty. Data sources The National EPHT program plans to calculate these indicators from data acquired from: • State-specific childhood blood lead surveillance systems. • Birth data available from the National Center for Health Statistics. • U.S Census Bureau Summary File 3, total number of housing units and number of pre-1950 units. Preliminary data These indicators have not yet been piloted in Minnesota. EHTB staff met with lead program staff to discuss data sources, usefulness of the indicator, and data limitations. 29 Limitations and challenges There are challenges associated with each of the data sources to be used for this indicator: • • • Childhood blood lead surveillance data are not randomly sampled or representative of the population Census Bureau housing data uses ZIP Code Tabulation Areas (ZCTAs) which may not match lead ZIP code data A child’s address on a birth certificate may be different than address at lead test. Recommendations and next steps for indicator development The national EPHT program plans to develop additional nationally consistent data and measures for childhood lead, including indicators on at-risk groups and percent of children with high blood lead levels. MDH EHTB staff will continue to be involved in the national workgroup to refine these indicators. Staff will also continue meeting with MDH Childhood Lead Poisoning Prevention Program staff to discuss ways to use existing data sources that might be useful for Minnesota. 30 Content area: Respiratory disease (asthma hospitalizations) Indicators Indicators related to respiratory disease that are currently being piloted are several measures of asthma hospitalizations. The asthma hospitalization indicators are: • the annual number of hospital admissions due to asthma • the average number of hospital admissions per day, per month • the minimum and maximum daily number of hospital admissions • the annual rate for asthma hospitalizations • the annual age-adjusted rate for asthma hospitalizations Rationale In 2006, there were more than 4,200 hospitalizations for asthma in Minnesota. Asthma hospitalizations have been associated with exposure to both particulate matter and ozone. Increases in respiratory-related hospitalizations of 5-20% per 50µg/m3 of PM10 and 5-15% per 25µg/m3 of PM2.5 or PM10-2.5 have been observed, with the largest effect observed in asthma hospitalizations.1-3 In studies from the U.S. and Canada, increases in respiratory hospitalizations associated with warm season ozone ranged from 2-30% per 20 ppb (24 hours), 30 ppb (8-hours) or 40 ppb (1-hour) increase in the level of ozone.4 Data sources The source of data for the asthma hospitalization indicator is the Minnesota Hospital Association (MHA). Hospitals report their claims to MHA on a voluntary basis. Currently 96% of hospitals, covering 98% of licensed beds in the state, report their claims to MHA. Available data elements include age, sex, ZIP code of residence, date of admission and date of discharge. Denominators for the rates are from the 2000 U.S. Census. Preliminary data The data presented here are based on the asthma hospitalization indicator as developed by the State Environmental Health Indicators Collaborative (SEHIC). A similar indicator, with slightly different measures, was developed by the CDC EPHT program. The CDC indicator includes measures by county, age group and sex. For the purposes of piloting the indicator, one year of data (2006) is presented here. 31 Annual number of hospital admissions due to asthma 4,173 Number Average number of hospital admissions due to asthma per day, per month 20 18 16 14 12 10 8 6 4 2 0 17.2 11 11 14.1 13.4 13.2 11.8 10.9 7 Jan Feb Mar Apr May Jun 7.9 Jul 10.8 8.7 Aug Sep Oct Nov Dec Minimum and maximum daily numbers of hospital admissions due to asthma Minimum Maximum 2 30 Annual rate of hospital admissions per 10,000 residents 8.1 Annual age-adjusted rate of hospital admissions per 10,000 residents 8.1 Interpretation There are many risk factors for asthma hospitalizations. The most common are asthma severity (in many cases related to co-morbid conditions and reflected in previous hospitalizations) and inadequate asthma management (related to medication use and regular primary care). The graph of asthma admissions by month shows a consistent trend of a peak in the fall, with a smaller peak in the spring. The fall peak is thought to be due in part to students returning to school with an associated increase in respiratory infections, a known trigger of asthma attacks for many people with asthma. Asthma hospitalization data can be used to identify vulnerable populations and target public health interventions. 32 Limitations and challenges This indicator is only based on those asthma events that are serious enough to result in a hospitalization. Risk factors other than air quality may have a greater impact on asthma hospitalization rates. This indicator does not account for indoor air exposures, including environmental tobacco smoke which is a known trigger of asthma exacerbations. The hospital discharge data records zip code of patient residence, which may not be the location where the individual was hospitalized. Admissions to Veteran’s Administration, Indian Health Service and institutional (prison) facilities are not included. Recommendations and next steps for indicator development MDH EHTB staff will continue to pilot and evaluate the CDC program indicators using Minnesota data, and will explore methods for presenting county level data with data suppression rules applied to protect individual privacy. In addition, we are working with SEHIC to develop and refine an indicator of asthma emergency department visits using hospital outpatient data. These data are not available in all states however. MDH is also conducting an EPA-funded research study to develop methods for utilizing respiratory disease indicators together with air quality indicators to measure the impacts of pollution reduction strategies. References 1. US Environmental Protection Agency, October 2004. Air Quality Criteria for Particulate Matter (Volumes I & II), EPA/600/P-99/002aF. 2. Jorres RA, Magnussen H. Atmospheric pollutants. In PJ Barnes, IW Rodger and NC Thomson (Eds.), Asthma: Basic Mechanisms and Clinical Management (3rd Ed.). London: Academic Press, 1998, pp. 589-596. 3. Trasande L, Thurston GD, The role of air pollution in asthma and other pediatric morbidities. J Allergy Clin Immunol 2005; 115: 689-99. 4. US Environmental Protection Agency, February 2006. Air Quality Criteria for Ozone and Related Photochemical Oxidants (Volumes I-III), EPA/600/R-05/004aF. 33 This page intentionally left blank. 34 Content area: Respiratory disease (CLRD & asthma mortality) Indicators Indicators related to respiratory disease that are currently being piloted include chronic lower respiratory disease (CLRD) and asthma mortality. These indicators were developed by the State Environmental Health Indicators Collaborative; they are not currently national EPHT indicators. The CLRD and asthma mortality indicator measures are: • the annual number of CLRD deaths • the annual CLRD mortality rate • the annual, age-standardized mortality rate; • the annual number of asthma deaths Rationale CLRD includes the following conditions: asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. Each is characterized by impaired lung function. In 2006, there were 1,770 deaths due to CLRD among Minnesota residents. Epidemiologic studies have demonstrated associations between short-term exposures to increased levels ambient air particulate matter with increased rates of CLRD mortality, particularly in those 65 and older1-3. Data sources The source of data for the CLRD and asthma mortality indicators is death records, which will be obtained from the Minnesota Center for Health Statistics at the Minnesota Department of Health. Denominators for the rates are from the 2000 U.S. Census. Preliminary data These indicators have not yet been piloted for the EHTB program. Recommendations and next steps for indicator development MDH EHTB staff will continue to pilot and evaluate these indicators using Minnesota data, and will explore methods for presenting county level data with data suppression rules applied to protect individual privacy. MDH is also conducting an EPA-funded research study to develop methods for utilizing respiratory disease indicators together with air quality indicators to measure the impacts of pollution reduction strategies. 35 References 1. Fairley D, (2003). Mortality and air pollution for Santa Clara County, California, 1989-1996. In: Revised Analysis of Time-Series Studies of Air Pollution and Health. Special Report. Boston, MA: Health Effects Institute: pp. 97-106. Available: http://www.healtheffects.org/Pubs/TimeSeries.pdf [18 Oct., 2004] 2. Ito, K (2003). Associations of Particulate matter components with daily mortality and morbidity in Detroit, Michigan. In: Revised Analysis of Time-Series Studies of Air Pollution and Health. Special Report. Boston, MA: Health Effects Institute: pp. 97-106. Available: http://www.healtheffects.org/Pubs/TimeSeries.pdf [18 Oct., 2004] 3. Moolgavkar, SH (2003) Air Pollution and Daily Deaths and Hospital Admissions in Los Angeles and Cook Counties. In: Revised Analysis of Time Series Studies of Air Pollution and Health. Special Report. Boston, MA: Health Effects Institute: pp. 97-106. Available: http://www.healtheffects.org/Pubs/TimeSeries.pdf [18 Oct., 2004] 36 Content area: Myocardial infarctions Indicators The indicator related to myocardial infarctions (MI) that will soon be piloted is hospitalizations for MI. The MI indicator measures will include: • the annual number of hospital admissions due to acute MI, by age, gender, race/ethnicity, and geography • the average number of hospital admissions per month • the minimum and maximum daily number of hospital admissions • the annual rate for acute MI hospitalizations, by gender, race/ethnicity, and geography • the annual age-adjusted rate for acute MI hospitalizations, by gender, race/ethnicity, and geography • the annual age-adjusted rate for acute MI hospitalizations, for ages 35 and older, by gender, race/ethnicity and geography Rationale In 2007, the American Heart Association estimated 565,000 new attacks and 300,000 recurrent attacks of MI annually. Increasingly, research has shown significant relationships between air pollutants (ozone, PM10, CO, PM2.5, SO2) and increased risk of acute MI and other forms of coronary heart disease. Data sources The source of data for the MI hospitalization indicator is the Minnesota Hospital Association (MHA). Hospitals report their claims to MHA on a voluntary basis. Currently 96% of hospitals, covering 98% of licensed beds in the state, report their claims to MHA. Available data elements include age, sex, ZIP code of residence, date of admission and date of discharge. Denominators for the rates are from the 2000 U.S. Census. Preliminary data EHTB staff have access to MHA data and will pilot the indicator soon. Limitations and challenges Hospitalization data for acute MIs omits individuals who do not receive medical care or who are not hospitalized, including those who die in emergency rooms, in nursing homes, or at home without being admitted to a hospital, and those treated in outpatient settings. 37 The hospital discharge data records ZIP code of patient residence, which may not be the location where the individual was hospitalized. Admissions to Veteran’s Administration, Indian Health Service and institutional (prison) facilities are not included. Recommendations and next steps for indicator development EHTB staff will pilot and evaluate these indicators using Minnesota data and in consultation with epidemiologists in the Heart Disease and Stroke Prevention unit at MDH. We will explore methods for presenting county level data with data suppression rules applied to protect individual privacy. In addition, we will examine State Ambulance Reporting (STAR) data as another source of data for measuring acute MI events. 38 Content area: Cancer Indicators The cancer indicators currently being developed consist of counts and incidence rates of selected cancers. The specific indicators that will be calculated include: • Annual counts of selected cancers by age group, sex, and race/ethnicity. • Age-adjusted incidence rates for selected cancers by age group, sex, and race/ethnicity per 100,000 population or per 1,000,000 for childhood cancers (<15 & <20 years of age). Rates will be age-adjusted to 2000 U.S. standard population. Selected cancers include: • Breast cancer (females)1 o <50 years1 o 50+ years1 • Cancer of the lung and bronchus1 • Bladder cancer (including in situ)1 • Cancers of the brain and other nervous system (ONS)1 • Cancers of the brain and central nervous system (children)2 • Thyroid cancer1 • Non-Hodgkin lymphoma1 • Leukemias1 o Chronic lymphocytic leukemia2 o Acute myeloid leukemia2 • Leukemias (children)2 o Acute lymphoblastic leukemia2 o Acute myeloid leukemia2 1 2 Currently available in State Cancer Profiles, http://statecancerprofiles.cancer.gov/. Not currently available in State Cancer Profiles Rationale The National Cancer Institute (NCI) estimated that in January 2003, there were approximately 10.3 million living Americans with a history of cancer. Cancer, a diverse group of diseases characterized by the uncontrolled growth and spread of abnormal cells, is believed to be caused by both external and internal risk factors. Major risk factors for cancer include tobacco use, diet, exercise, and sun exposure. Researchers have also identified genetic risks for cancer. However, the etiology of many cancer types is not well established. The physical environment (air quality, chemical pollution, and water quality) 39 remains a source of great public concern, but few community-level environmental exposures have been well-studied. One way to assess cancer burden is to study geographic variation. All of the cancers for these indicators were chosen by the National EPHT program because of possible environmental etiology. Some examples include: • PAHs (poly aromatic hydrocarbons), benzene, organic solvents, and passive smoking have been implicated in the cause of breast cancer, but the evidence is weak and more research is needed1,2,3. • Environmental tobacco smoke (ETS) is a recognized causal factor for lung cancer. Diet, family history, and genetic factors also appear to play a role in causality. Occupational agents categorized by International Agency for Research on Cancer (IARC) as known lung carcinogens include arsenic, asbestos, bischloromethlyl ether, chromium, nickel, polycyclic aromatic compounds, radon and vinyl chloride.4 The impact of ambient air pollution on lung cancer is undergoing study. • Cigarette smoking is well established as a cause of bladder cancer. Excess risk has been associated with various occupations including truck drivers and other workers exposed to motor exhaust, working with textiles and leather dyes containing azo compounds, and aromatic amine manufacturing. • Specific exposures that have been linked to brain/other nervous system cancers in adults include ionizing radiation, n-hexane, organometallics, amines (other than nitrosamines), formaldehyde, vinyl chloride, and acrylonitrile5; and, to a limited degree, agricultural and occupational exposure to pesticides6,7. • Research suggests that children are at risk of developing brain/other nervous system cancers during fetal development and in early life, which has been linked to pesticide exposure and other chemical toxicants in the environment8,9. • The excess risk of thyroid cancer associated with exposure to external ionizing radiation has been well established. No other environmental chemicals or physical agents have been associated with this cancer. • The causes of non-Hodgkin’s lymphomas are mostly unknown and exposures to pesticides, solvents and sun exposure are under investigation. • For leukemias, exposures to ionizing radiation, benzene, parental exposure to pesticides and other chemicals may increase risk. 1 Brody JG, Rudel RA. Environmental Pollutants and Breast Cancer. Environ Health Perspect 2003; 111:1007-1019. Coyle YM. The Effect of Environment on Breast Cancer Risk. Breast Cancer Research and treatment 2004; 84:273-288. 3 Wolff MS, Weston A. Breast Cancer Risk and Environmental Exposures. Environ Health Perspect 1997; 105 (suppl 4):891-896. 4 International Agency for Research on Cancer: http://www.iarc.fr/. 5 National Cancer Institute: http://www.nci.nih.gov/cancertopics/wyntk/brain/page8. 6 Lee WJ, Colt JS, et al. Agricultural pesticide use and risk of glioma in Nebraska, United States. Occup Environ Med. 2005 Nov;62(11):786-92. 7 Provost D, Cantagrel A, et al. Brain tumours and exposure to pesticides: a case-control study in southwestern France. Occup Environ Med. 2007 Aug;64(8):509-14. 8 Infante-Rivard C and Weichenthal S (2007). Pesticides and childhood cancer: An update of Zahm and Ward’s 1998 review. Journal of Toxicology and Environmental Health-Part B-Critical Reviews 10(1-2): 81-99. 9 Suk WA, Murray AK, et al. Environmental hazards to children’s health in the modern world. Mutat Res 2003 Nov;544(2-3):235-42. 2 40 Data sources Incident cancer data are originally collected by State and Regional Cancer Registries. The National EPHT program has proposed that data for the network be obtained from the NCI and CDC joint venture, State Cancer Profiles. The network will not have county rates available for Minnesota because Minnesota’s Cancer Surveillance System (MCSS) submits data on a state level to the State Cancer Profile. Preliminary data This indicator has not yet been piloted in Minnesota. The National EPHT program plans to calculate these indicators from data acquired from Minnesota’s State Cancer Profile (available online at http://statecancerprofiles.cancer.gov). The Minnesota Cancer Surveillance System does not report county-level data to State Cancer Profiles, therefore the indicator can only be calculated using this data source at the geographical scale of the state. EHTB staff met with Minnesota Cancer Surveillance System staff to discuss sources, usefulness of the indicator, and data limitations. Limitations and challenges The challenges associated with these indicators include: • No personal exposure information will be available, including smoking history, diet, lifestyle, occupation or history of cancer. • Cancer indicators will be available only on the level of the state on the National EPHT network. Recommendations and next steps for indicator development State-specific data are available on a secure MCSS server and EHTB staff have been given a tutorial on the statistical program “SEER-Stat.” Summary data with suppression rules will be generated. Future plans include continuing involvement in the national workgroup to refine these indicators, working on a Minnesota-specific output format for the indicators, and exploring other datasets for linkage such as occupational or exposure cohorts for certain cancers. 41 This page intentionally left blank. 42 Content area: Carbon monoxide poisoning Indicators Indicators for carbon monoxide poisoning include the following: • Annual number of hospitalizations from carbon monoxide (CO) poisoning • Annual crude and age-adjusted CO poisoning hospitalization rate • Annual number of emergency department (ED) visits from CO poisoning • Annual crude and age-adjusted rate of ED visits for CO poisoning • Annual number of deaths from CO poisoning • Annual CO poisoning crude and age-adjusted death rate • Annual number and rate of cases of CO exposure reported to the states’s Poison Control Center Rationale Carbon monoxide (CO) poisoning resulting in illness or death is a significant, but often overlooked, public health problem in the United States. Unintentional exposure to CO commonly occurs from the incomplete combustion of fossil fuels that are burned by improperly installed, maintained, or operating household appliances1. Certain types of occupational or recreational activities may also result in CO exposure such as the operation of forklift trucks in enclosed spaces2 and the accidental inhalation of boat exhaust,3,4 respectively. The occurrence of natural disasters resulting in large-scale power outages has also been associated with an increased frequency of CO poisoning due to the inadequate ventilation of gasoline-powered generators5. Many of these sources of CO exposure are completely preventable through the proper installation, maintenance, ventilation, and use of devices that burn fossil fuels coupled with public health education regarding the importance of household CO detector use to prevent CO poisoning. Data sources Measures of carbon monoxide exposure and/or poisoning from five data sources have been fully developed by the National EPHT program and three are still under development. Four of the five data sources that are available in Minnesota are hospital discharge data, emergency department (ED) data, death certificate data, and Poison Control Center data (extracted from the Toxicall database). The Behavioral Risk Factor Surveillance System (BRFSS) data, necessary for calculation of one of the indicators, cannot be utilized for the purposes of CO surveillance in the state of Minnesota since the state has not incorporated the Indoor Air Pollution Module that includes CO-related questions as a part of the survey. 43 Preliminary data All of the indicators with available data have been piloted. Preliminary data on carbon monoxide poisoning are currently part of a master’s degree thesis by a University of Minnesota public health student who has been working with the EHTB staff. Presented here are some of the highlights from the piloting of these indicators. Figure 1. 5-year rate of unintentional carbon monoxide poisonings resulting in death among Minnesotaresidents by fire-relatedness and age Rate/100,000ths 2 1.5 Nonfire 1 Fire 0.5 0 0-17 18-34 35-64 65+ Age Figure 2. Rate/100,000 aths 5-year rate of unintentional carbon monoxide poisonings resulting in death among Minnesotaresidents by fire-relatedness and gender 0.6 0.5 0.4 Nonfire 0.3 Fire 0.2 0.1 0 Male Female Gender As shown in Figures 1 and 2, the rate of unintentional, fire-related deaths in the 35-64 age group is significantly higher than the youngest two age groups and there are no age-specific trends in the non-fire category. The rate of unintentional, non-fire related deaths are significantly higher for men than women for this same outcome, but there is no difference between males and females in the fire-related category. The cause for a significantly higher rate of fire-related deaths in the 35-64 age group is unknown and requires further investigation. However, the gender-related difference in deaths is not unusual since males often engage in higher-risk activities compared to females, causing men to be more predisposed to carbon monoxide exposure. 44 Figure 3. Rate/100,000 000 5-year rate of unintentional carbon monoxide poisonings resulting in hospitalization among Minnesotaresidents by fire-relatedness and age 2.5 2 1.5 Nonfire Fire 1 0.5 0 0-17 18-34 35-64 65+ Age Figure 4. 5-year rate of unintentional carbon monoxide poisonings resulting in hospitalizations among Minnesota residents by fire-relatedness and gender Rate/100,0000 1.2 1 0.8 Nonfire 0.6 Fire 0.4 0.2 0 Male Female Gender For unintentional, non-fire related hospitalizations (figures 3 and 4), the rate for the 65+ age group is significantly greater than the youngest three age categories and the rate for the 0-17 age group is significantly lower than the oldest three age groups. The rate of hospitalization among men is significantly higher than the rate for women in the non-fire related category. The higher rate of non-fire related hospitalizations in males is most likely due to higher risk activities that men participate in at a higher frequency than women. The substantially higher rate of hospitalizations in the elderly is expected due to the increased rate of susceptibility to severe poisoning upon CO exposure as a result of the decline in the overall general health in older individuals. It is also possible that they may not be able to respond to CO detector alarms due to physical and hearing limitations. 45 Figure 5. isits 7 Rate/100,000 5-year rate of unintentional carbon monoxide poisonings resulting in avisit to the emergency department (ED) among Minnesotaresidents by firerelatedness and age 5 6 4 Nonfire 3 Fire 2 1 0 0-17 18-34 35-64 65+ Age *The fire-related rate was not calculated for the 65+ age group due to a numerator <5. Figure 6. sits 5-year rate of unintentional carbon monoxide poisonings resulting in avisit to the emergency department (ED) among Minnesota residents by firerelatedness and gender 6 Rate/100,000 5 4 Nonfire 3 Fire 2 1 0 Male Female Gender The rates of unintentional, non-fire related CO poisoning resulting in a visit to the ED are significantly higher in males and in the youngest three age groups (figures 5 and 6). The genderrelated difference in the rates of death and hospitalizations is consistent with the gender-related differences observed in the rates of ED visits. Also, since the 65+ age group is more susceptible to severe CO poisoning, it may be likely that this age group is more often treated as a hospitalized case rather than in the ED. However, the limitations to this assumption are that the severity of a CO poisoning cannot be determined from the ED dataset6 and hospitalized cases are not necessarily mutually exclusive from the ED cases. The highest rate of unintentional, non-fire related ED visits is among the 18-34 age group and the second and third highest rates are in the 0-17 and 35-64 age groups, respectively. Since the youngest two age groups have the highest rates of CO poisoning resulting in a visit to the ED, it is plausible that this is related to the highrisk behaviors that are common to younger individuals. The rates observed in the fire-related category for visits to the ED demonstrate that there are no clear differences between the age and gender-related demographics. 46 Figure 7. 5-year rate of unintentional, nonfire related carbon monoxide poisonings resulting in hospitalization among Minnesota residents by month b 0.25 Rate/100,000 0.2 0.15 0.1 0.05 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Month *The rate for August was not calculated due to a numerator of <5. Figure 8. visits 5-year rate of unintentional, non-fire related carbon monoxide poisonings resulting in a visit to the emergency department (ED) among Minnesota residents by month 1 0.9 Rate/100,000 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Month The seasonal trends of unintentional, non-fire related CO poisoning observed in Minnesota are consistent with the trends documented in published literature7. The highest rate of CO poisoning occurs in the winter months, particularly in January and December, while the lowest rates occur in the summer months of June, July, and August (figures 7 and 8). Fuel burning appliances such as furnaces, boilers, and supplemental sources of heat are operated at a much higher frequency during winter months than summer months, resulting in a higher rate of CO poisoning during this time of high frequency use. Seasonal trends for unintentional, non-fire related deaths and firerelated events for all clinical outcomes could not be determined due to the small number of events for each stratum. 47 Figure 9. b 5-year age-adjusted rate of unintentional, non-fire related carbon monoxide poisonings resulting in death among Minnesota residents by region of residence Rate/100,000 0.6 0.5 0.4 0.3 0.2 0.1 0.0 Non-metro Metro Region kjhfd0 Figure 10. 5-year age-adjusted rate of unintentional, non-fire related carbon monoxide poisonings resulting in hospitalization among Minnesota residents by region of residence Rate/100,000 1 0.8 0.6 0.4 0.2 0 Non-metro Metro Region Figure 11. 5-year age-adjusted rate of unintentional, non-fire related carbon monoxide poisonings resulting in a visit to the emergency department (ED) among Minnesota residents by region of residence Rate/100,000 bkj 6 5 4 3 2 1 0 Non-metro Metro Region The spatial trends observed for unintentional, non-fire related CO poisoning are displayed in figures 9 through 11 and in table 4. These figures compare CO poisoning in the metro (includes the sevencounty metro area) and non-metro (excludes the seven-county metro area) regions of Minnesota and they illustrate that there are higher rates of non-fire related CO poisoning associated with the non-metro areas of the state, which is a phenomenon that has been documented in other epidemiological studies8. This spatially-related difference was only statistically significant, however, for unintentional, non-fire related CO poisonings resulting in a visit to the ED (figure 9). One potential explanation for higher rates of non-fire related CO poisoning in Greater Minnesota is that the residents of this region may not be as likely to get their fuel-burning appliances professionally serviced on a regular basis. However, there are likely to be other explanations for the presence of this relationship. Fire-related rates were not calculated by region due to future prevention efforts targeted toward non-fire related events. 48 Figure 12. Rate of probable unintentional carbon monoxide exposure cases reported to the Hennepin County Poison Control Center by year 7 Rate/100,000 6 5 4 3 2 1 0 2002 2003 2004 2005 2006 Year Figure 13. b Rate of probable unintentional carbon monoxide exposure reported to the Hennepin County Poison Control Center showing a health effect (none, any, or unknown) by year Rate/100,000 4 3 Health effect 2 No health effect Unknown health effect 1 0 2002 2003 2004 2005 2006 Year Figure 14. Percent of probable unintentional carbon monoxide exposure cases reported to the Hennepin County Poison Control Center having a known health effect that were treated in a healthcare facility by year Percent 90% 80% 70% 60% 50% 40% 30% Treated cases 20% 10% 0% 2002 2003 2004 2005 2006 Year Finally, the national recommendations also provide analytical methods for examining the numbers and rates of CO exposure reported to the local County Poison Control Center. Therefore, an analysis of the CO exposure calls received by the Hennepin County Poison Control Center (PCC) has been conducted (table 6 and figures 12 through 14). The results indicate that the rate of the total unintentional CO exposure calls by year are stable, except for the year 2006, which is significantly lower than the rates for 2002 and 2004. The rates of unintentional CO exposure calls with a known health effect are similar for the years of 2002-2004. Then these rates declined significantly in 2005 and 2006. Of the cases identified as having a known health effect, only a percentage are treated in a health care facility (HCF). The percentage of treated cases were consistent across the 5-year period, except for the significantly higher percentage treated in 2004. The rates of unintentional exposures reported to the Hennepin County PCC with no known health effect were very consistent from 2002 through 2006. However, the rates for 49 calls received by the PCC with an unknown health effect were similar for the years 2002, 2004, and 2005 but were significantly lower in 2003 and 2006. Furthermore, the relative proportion of calls reported with a known health effect, an unknown health effect, and no known health effect is different across the five-year period. In 2002, 2004, 2005, and 2006, unknown health effects were reported at a significantly higher rate than those with a known or no known effects. In 2003 and 2004, the rates of calls received with a known health effect and with no known health effect were significantly different from each other. This was not the case for 2002, 2005, and 2006. Limitations and challenges Some limitations unique to hospital discharge and ED data include: • Variations in ICD-9-CM coding practices between states in terms of the quality and completeness of E-coding, the number of diagnostic fields available to specify cause of injury, and whether E-codes are state mandated. State-to-state comparison of the acute CO exposure and poisoning trends may not be practical. • Symptoms of CO poisoning are non-specific and often mimic symptoms of food poisoning, the flu, or other illnesses. Consequently, misdiagnosed cases are not included in these datasets. Cases that were treated in Veteran’s hospitals and other federal facilities or cases that occurred among residents out of state are not included in the data either. Limitations of death certificate data include: • Some medical examiners, coroners, or physicians may not be as inclined to classify a death as intentional, resulting in a higher rate of unintentional deaths in a particular jurisdiction, or deaths may simply be misclassified and attributed to other causes. • The length and comprehensiveness of death investigations may vary by jurisdiction causing further potential misclassification of some deaths. Poison Control Center data is also subject to certain limitations: • Patient state and ZIP code is not consistently collected and caller state and ZIP code must often be used as a surrogate measure to assign patient residency. This is a concern since the caller is not always in the same ZIP code or even state as the patient. • Exposure status reported by the caller should not be considered confirmed since this is often a personal account of the event that occurred. • The data contained in the PCC database does not capture all CO exposures and the subsequent outcomes since patients, witnesses to the event, and/or health care providers may not always notify the PCC of the exposure or poisoning. • Data obtained from the local PCC may not be reflective of the national PCC’s dataset. The reason for this discrepancy is that when local PCC’s are overloaded with calls, the calls are rerouted to a PCC in another state. The re-routed calls are then identified and are adjusted for in the national dataset. 50 Recommendations and next steps for indicator development The assessment of a single data source in isolation will underestimate the true burden of acute CO exposure and poisoning across the state. More effort is required, at both the national and state levels, to obtain a consistent understanding of the nuances of the data. MDH will develop guidance for interpreting the results of these suggested analyses. References 1. Graber JM, MacDonald SC, Kass DE, et al. Carbon Monoxide: The Case for Environmental Public Health Surveillance. Public Health Reports. 2007. 122:138-44. 2. Centers for Disease Control and Prevention. Carbon Monoxide Poisoning Associated with Use of LPG-Powered (Propane) Forklifts in Industrial Settings -- Iowa, 1998. MMWR. 1999. 48(49):1121-4. 3. Centers for Disease Control and Prevention. Houseboat-Associated Carbon Monoxide Poisonings on Lake Powell --- Arizona and Utah, 2000. MMWR. 2000. 49(49):1105-8. 4. Centers for Disease Control and Prevention. Carbon-Monoxide Poisoning Resulting from Exposure to Ski-Boat Exhaust --- Georgia, June 2002. MMWR. 2002. 51(37):829-30. 5. Centers for Disease Control and Prevention. Carbon Monoxide Poisonings After Two Major Hurricanes --- Alabama and Texas, August--October 2005. MMWR. 2006. 55(09):236-9. 6. Graber J, Wheeler K. Carbon Monoxide Team Recommendations for Nationally Consistent Data and Measures. Part I: Recommended Indicators and Measures. 2007. Unpublished. 7. Centers for Disease Control and Prevention. Unintentional Non--Fire-Related Carbon Monoxide Exposures --- United States, 2001-2003. MMWR. 2005. 54(02):36-9. 8. Wilson RC, Saunders PJ, Smith G. An epidemiological study of acute carbon monoxide poisoning in the West Midlands. Occup Environ Med. 1998. 55:723–728. 51 This page intentionally left blank. 52 Content area: Birth defects Indicators The indicator for birth defects is prevalence at birth of select birth defects. The incidence of birth defects would be the ideal measure for birth defects but it cannot be determined as it requires information that is difficult to determine, such as the number of conceptions and the number of cases “lost” through spontaneous abortions, terminations, and fetal losses. The measure for the birth defects indicator is: • Prevalence rates of 12 selected birth defects per 10,000 live births. The following 12 birth defects have been selected by the national EPHT program: Central Nervous System 1. Anencephaly: Congenital absence of the skull, with cerebral hemispheres completely missing or reduced to small masses attached to the base of the skull. Anencephaly is not compatible with life. 2. Spina Bifida (without anencephaly): A neural tube defect resulting from failure of the spinal neural tube to close. The spinal cord and/or meninges may or may not protrude. This usually results in damage to the spinal cord with paralysis of the involved limbs. Cardiovascular 3. Hypoplastic Left Heart Syndrome: Atresia, or marked hypoplasia, of the aortic opening or valve, with hypoplasia of the ascending aorta and defective development of the left ventricle (with mitral valve atresia). This condition can be surgically repaired in a series of three procedures over a period of one year. Transplantation is also a treatment. This condition is usually fatal in the first month of life if not treated. 4. Tetralogy of Fallot: A congenital cardiac anomaly consisting of four defects: ventricular septal defect, pulmonary valve stenosis or atresia, displacement of the aorta to the right, and hypertrophy of right ventricle. The condition is corrected surgically. 5. Transposition of Great Arteries: A congenital malformation in which the aorta arises from the right ventricle and the pulmonary artery from the left ventricle (opposite of normal), so that the venous return from the peripheral circulation is recirculated without being oxygenated in the lungs. Immediate surgical correction is needed. The condition is corrected surgically. Orofacial 6. Cleft Lip: The congenital failure of the fetal components of the lip to fuse or join, forming a groove or fissure in the lip. Infants with this condition can have difficulty feeding, and may use assistive devices for feeding. This condition is corrected when the infant can tolerate surgery. 53 7. Cleft Palate Alone: The congenital failure of the palate to fuse properly, forming a grooved depression or fissure in the roof of the mouth. This defect varies in degree of severity. The fissure can extend into the hard and soft palate and into the nasal cavities. Infants with this condition have difficulty feeding, and may use assistive devices for feeding. Surgical correction is begun as soon as possible. Children with cleft palates are at high risk for hearing problems due to ear infections. Musculoskeletal 8. Gastroschisis: A congenital opening of the abdominal wall with protrusion of the intestines. This condition is surgically treated. 9. Upper Limb Deficiencies: The congenital absence of a portion of the upper limb. There are two general types of defect, transverse and longitudinal. Transverse defects appear like amputations, or like missing segments of the limb. Longitudinal defects are missing rays of the limb (for example, a missing radius and thumb). 10. Lower Limb Deficiencies: The congenital absence of a portion of the lower limb. There are two general types of defect, transverse and longitudinal. Transverse defects appear like amputations, or like missing segments of the limb. Longitudinal defects are missing rays of the limb (for example, a missing tibia and great toe). Genitourinary 11. Hypospadias: A congenital defect in which the urinary meatus (urinary outlet) is on the underside of the penis or on the perineum (area between the genitals and the anus). The urinary sphincters are not defective so incontinence does not occur. The condition may be surgically corrected if needed for cosmetic, urologic, or reproductive reasons. The corresponding defect in females (epispadias) is rare. Chromosomal 12. Trisomy 21 'Down Syndrome': The chromosomal abnormality characterized by an extra copy of chromosome 21. Down syndrome is characterized by moderate to severe mental retardation, sloping forehead, small ear canals, flat bridged nose and short fingers and toes. One third of infants have congenital heart disease, and one third have duodenal atresia. (Both can be present in the same infant.) Affected people can survive to middle or old age. There is an increased incidence of Alzheimer disease in adults with Down syndrome. Rationale Birth defects pose a significant public health problem. One in 33 babies is born with a structural birth defect in the United States. Birth defects are a leading cause of infant mortality and responsible for considerable morbidity and disability with enormous economic and social costs. A lifetime of medical care and special education for a single child can cost over $500,000. Approximately 60% of birth defects are of unknown etiology. The ambient environment remains a source of great public concern, but few environmental exposures have been well-studied. Most birth defects will likely be explained by a complex interaction between genetic predispositions and environmental factors. These specific birth defects were selected because of possible 54 environmental teratogenicity, severity, and relatively consistent and good quality ascertainment regardless of the surveillance system. Data sources The data for this indicator will be drawn from the Minnesota Birth Defects Information System (BDIS) to generate counts of the defects selected by the national EPHT program. BDIS collects information on 45 defects from birthing hospitals in Hennepin and Ramsey Counties. BDIS data will be linked to Minnesota birth certificate data to ascertain maternal county of residence at birth. BDIS is a new program at MDH and has not yet submitted or published data, therefore the National EPHT program will not be able to pilot this indicator for Minnesota. Preliminary data One hundred seventy-four cases in BDIS were born in 2006 to a mother living in Hennepin or Ramsey County and diagnosed with ≥ 1 of the selected defects. An additional 24 BDIS cases diagnosed with ≥ 1 of the selected defects have been excluded from the analysis because the case could not be matched to a Minnesota birth certificate. This match is necessary in order to obtain information on maternal residence at birth. Efforts are underway to resolve the issue related to missing residence data so that the pilot can be completed. Limitations and challenges The challenges associated with these indicators include: • In Minnesota, an “opt-out” clause that allows a parent to exclude their child from the system and remove any personally identifying information on that child from the system makes it difficult to generate population-based measures. • There is significant variability between existing state surveillance systems, including ascertainment method and coding system. Recommendations and next steps for indicator development MDH tracking staff will continue to work with MDH birth defects staff to develop high quality birth defects prevalence data for which the geospatial and temporal patterns and distributions can be monitored. In the near future, this will involve work on issues regarding maternal county of residence at birth. Plans for the birth defects indicator could include further classification of cases diagnosed with more than one defect into more homogeneous groups, which would be useful for etiologic investigations. This classification of birth defect cases into “syndromic,” “isolated” or “multiple congenital anomalies” recognizes that a diagnosis can be accompanied by other related or unrelated birth defects. Multiple congenital anomalies are considered sentinel defects: the birth prevalence will tend to increase in the presence of environmental (or other) teratogens. The national EPHT network may pilot an automated classification system based on CDC/British Pediatric Association (CDC/BPA) codes. Alternatively, Minnesota could classify the 65 cases in BDIS eligible for further classification with assistance from BDIS consulting physicians. 55 This page intentionally left blank. 56 Content area: Birth outcomes Indicators Indicators related to birth outcomes include: • • • • • Percent of births that are preterm/very preterm Percent of births that are low/very low birth weight Infant/neonatal/postneonatal/perinatal mortality rate per 1,000 live births Total fertility rate (average number of births to a hypothetical cohort of 1,000 women if they experienced the age-specific birth rates observed in a given year) Sex ratio at birth Rationale There are critical windows of development during pregnancy where environmental exposures could damage growth and function of a fetus. Preterm birth (birth at less than 37 completed weeks of gestation) affects more than 500,000 or 12.5% of live births in the US and is a leading cause of infant mortality, morbidity, and longterm disability. The preterm birth rate has risen 18% between 1990 and 2004 (from 10.6% in 1990 to 12.5% in 2004) and over 30% since 1981 (from 9.4%). Preterm birth rates may be associated with maternal characteristics. Increases in risk of prematurity or preterm delivery have also been related to exposures during pregnancy to air pollution, lead, some solvents, the pesticide DDT, and di-ethylhexyl phthalate (DEHP). Compared to infants of normal weight (2,500 through 3,999 grams or 5.9 to 8.7 pounds), low birth weight (LBW, <2,500 grams) infants may be at increased risk of perinatal morbidity, infections, and the longer-term consequences of impaired development, such as delayed motor and social development or learning disabilities. The risk of dying in the first year of life is estimated to be about 100 times higher for very low birth weight (VLBW, <1,500 grams) infants than for normal weight infants. The percentage of infants born LBW has been increasing steadily over time and it reached 8.2% of all births in 2005, which is the highest level reported since 1968. The 2005 rate is 22% higher than the 1984 low (6.7%). Meaures of low birth weight combine two conditions: growth retardation and prematurity. A low birth weight baby can be born too small, too early, or both. Increases in very low birthweight in the past 20 years could be due to improvements in maintaining fetal health. Reductions in birth weight or increases in low birth weight have been associated with exposure during pregnancy to lead, solvents, pesticides, polycyclic aromatic hydrocarbons (PAHs), and air pollution. Infant mortality was 685.7 per 100,000 live births in 2002-2004; neonatal mortality in 2002-2004 was 460.8 per 100,000 live born infants. Causes of infant/neonatal/perinatal/postneonatal mortality include access to and quality of health care, competency in childcare and understanding 57 injury prevention. Compared to low concentrations of particulate matter (PM10), high concentrations of PM10 were associated with 10% increase in early post-neonatal mortality in a study of 4 million infants born in the U.S. between 1989 and 1991. Fertility rates during the past decade have stayed close to the natural replacement rate (about 2.1 births per woman). However, according to data from the National Survey of Family Growth, 12% of U.S. couples had impaired fecundity in 2002, up 20% from 1995. Fertility measures are influenced by choices for reproduction, maternal age, use of contraception and infertility treatments leading to multiple births. Approximately 10% of problems with fertility are unknown and environmental contaminants including endocrine disruptors have been hypothesized as major contributors. Exposures to endocrine disruptors have also been suggested as affecting sex determination mechanisms and how many males are born. For all races in the United States, the sex ratio decreased from 1.055 in 1970 to a low of 1.046 in 2001. The decrease in sex ratio at birth was found only among Whites in the U.S., and not among African-Americans. Decreases in male births are affected by parental smoking, parental age, and birth order. Data sources The data for this indicator will be drawn from the Minnesota Vital Statistics system, including birth certificates and death certificates. The national EPHT program plans to calculate these measures from data acquired from the National Center for Health Statistics for all states. Preliminary data This indicator has not yet been piloted in Minnesota. EHTB staff met with staff from MDHVital Statistics and have been granted access to Minnesota birth certificate data for 2001-2006; the indicator will be piloted soon. Limitations and challenges There are several challenges at both the national and state levels associated with these measures: • Place of residence during pregnancy (and, with infant death, residence during first year of life) may not be represented by maternal residence at time of birth (or death). • Some births/deaths may be excluded because of the difficulty in distinguishing a death shortly after birth as a live birth; a death soon after birth might be reported as a fetal death rather than live birth and infant death. • In Minnesota, rate break-down by race and age of mother, sex of infant is problematic due to small counts and lack of comparison data. • Recommendations and next steps for indicator development MDH EHTB staff will continue to pilot and evaluate these indicators using Minnesota data; and will be involved in the national workgroup to refine these indicators. 58 Environmental health tracking: Next steps and planning Complete the piloting of EHT indicators EHTB staff will continue to pilot the complete set of core indicators consistent with the national program where the necessary data are available. In addition, staff will develop a process for evaluating each of the indicators and make recommendations for further refinement and inclusion in the ongoing surveillance program. The CSTE State Environmental Health Indicator Collaborative (CSTE/SEHIC) is also exploring methods for indicator evaluation. SEHIC has previously identified the following list of attributes useful for evaluating a set of indicators: • • • • • • • • • • Timely Reliable Valid Sensitive to changes in underlying factors Accessible at different levels (e.g., state, county, local) Based on demonstrated links between environment and health Useful and understood by diverse populations Informative to the public and to responsible agencies Tied to public health objectives Action-oriented Determine whether Minnesota data will be submitted to the national network In order to submit data to the national program for inclusion in the national network, Minnesota data would need to be consistent with the national indicators. In piloting the core indicators, staff have had many discussions about the advantages and drawbacks of maintaining this consistency. Advantages of staying consistent with the national program include the following: o Allows for consistent comparisons between states to meet program goals, where appropriate. o Allows for Minnesota programs to evaluate and respond to questions from the public and policy makers about data available on the national network. o Some disease outcomes, such as certain cancers, occur on such a rare basis that data suppression rules restrict the availability of small counts and rates in local populations. Data may be more useful for learning about correlations with the environment if examined nationally in large, aggregate data sets. o Minnesota will better prepared to compete for future funding from the CDC if we maintain a program that is consistent with the national surveillance program. o Minnesota’s program will benefit from future national efforts to evaluate, modify, grow and improve the system over time. 59 Disadvantages of staying consistent with the national program include the following: o Requiring that all data measures be nationally consistent limits the process for developing indicators using data collected locally that may be uniquely available in Minnesota, more timely and/or of higher quality than the national indicator data. o Maintaining nationally consistent data measures may overlook other content areas and measures that affect priorities and emerging issues important to Minnesota. o The national program is limited by a lack of exposure data (with exception of the childhood blood lead) and does not incorporate data from national or state biomonitoring programs. Minnesota may choose to recommend the integration of an ongoing state-level biomonitoring program to enhance the development of the tracking program for environmental public health surveillance. o The national program is limited by the focus on national measures which has necessitated a lack of program activity for addressing local, community-based concerns and providing data at a local level. If resources allow, a combination of being consistent with the national program and developing Minnesota-specific indicators in other areas may be considered in the future. Develop priorities for future indicator development As part of an overall strategic planning process described in the statute, EHTB staff will begin to identify and prioritize new content areas for developing indicators in the future. Depending on guidance received from the EHTB advisory panel and other stakeholders, these priority areas may be consistent with national program directions and/or may address areas of specific concern to Minnesota. CSTE/SEHIC has recently identified a set of indicators for a new content area: climate change. As proposed, this content area will include a set of health outcome indicators addressing morbidity and mortality due to extreme heat and cold events, infectious disease cases (e.g., Lyme, West Nile), and indicators of population vulnerability to extreme weather-related events. SEHIC also has plans to develop new measures for hazardous air pollutants (HAPS) and traffic exposure as additional measures in the area of Air Quality. As members of SEHIC, EHTB program staff will participate in developing and piloting these new measures for future consideration and possible inclusion in Minnesota’s Tracking program. Develop communications strategies and engage stakeholders We will develop a plan for communicating about the data and making data sets accessible to stakeholders. This process will include providing important messages with the data and conveying them in a variety of formats, and will explore feasibility issues related to portal development or other web-based data access. Finally, we will continue to build relationships with data stewards to enhance future data collection efforts, and with environmental and health program managers and policy makers who may be able to provide important feedback on the program and its potential impact on public health actions. 60 MDH staff in the Community and Family Health Division are planning to conduct a pilot study to assess the feasibility of developing a surveillance program for autism spectrum disorders in Minnesota. In accordance with the EHTB legislation, which directs the MDH to include developmental disorders in the tracking program, the EHTB program will be providing limited staff and financial support to this effort over the next year. Building this relationship and promoting the development of a new disease surveillance method is a necessary first step towards data collection for development disorders in Minnesota. 61 This page intentionally left blank. 62 Section overview: Chemical selection Selection criteria Included in this section is a revised set of selection criteria, incorporating changes recommended by the advisory panel and additional changes recommended by the EHTB workgroup. The workgroup recommended these changes based on a pilot process in which several sample chemicals were scored using the selection criteria. As a result of this piloting, workgroup members noted that there were some items that needed revision in order to improve the clarity and usefulness of the criteria. Aside from minor wordsmithing and reordering of the sections, the following changes were made: Degree of exposure: • Changed wording from exposure to a chemical at a level of “known or potential health significance” to just “known health significance.” (Rationale: Scoring according to a criterion with an “or” in it was confusing. With the new wording, an exposure level with known impacts would score highest, something with potential significance would score a bit lower, something with no known or potential significance would score low.) Seriousness of health effects: • Changed wording from seriousness of “known or suspected human health effects” to “known human health effects.” (Rationale: Same as above.) • Consolidated the two original health effects criteria. (Rationale: The two criteria were perceived as redundant.) Interpretability: • Deleted the criterion related to information known about sources of exposure (Rationale: This criterion seemed to be getting at the same concept as another criterion already included in the actionability section of the criteria.) Potential for information building: • Deleted the criterion related to building lab capacity for biomonitoring (Rationale: At this time, all chemicals/biomonitoring projects would build lab capacity. This criterion might make more sense to include in the future.) The revised criteria have also been assigned weights. In accordance with advice provided by the advisory panel in March, the majority of the points are assigned to the criteria related to degree of exposure and seriousness of health effects. In developing and piloting the selection criteria, several insights were gleaned. Workgroup members noted that the criteria chosen, and the weights assigned to them, tend to give preference to chemicals about which more information is known rather than to newly emerging chemicals (because of the weight assigned to seriousness of health effects and degree of exposure at levels 63 of significance). At this stage in the biomonitoring program’s development, workgroup members felt this was an appropriate focus, though that could change over time. As noted at a previous advisory panel meeting, there is a critical need to define the long-term vision and goals for biomonitoring in Minnesota. This need was reinforced through the process of choosing and weighting the selection criteria. Workgroup members acknowledged that the selection criteria would likely change depending on the purpose of a biomonitoring program. [Note: Program staff are moving forward with processes to articulate the vision and goals for biomonitoring. One step has been to engage in discussions with numerous other states about the role(s) that states play in biomonitoring. We expect to engage the advisory panel in this discussion at an upcoming meeting.] Finally, workgroup members noted that the scoring of nominated chemicals, while helpful for comparing multiple chemicals, would likely be just one component of the chemical selection process and that the final selection of chemicals – now or in the future – would also be influenced by additional factors, including advisory panel recommendations and a further consideration of feasibility issues within MDH. Chemical nominations, scoring and prioritization Also included in this section is a brief description of the process the EHTB program plans to use for soliciting, scoring and prioritizing chemicals for biomonitoring. Advisory panel members are asked to keep in mind that the intention of the proposed chemical selection process is not specifically to identify one top chemical to be studied in a fourth biomonitoring pilot project, though program staff continue to explore possibilities for conducting a fourth project. Instead, the purpose of the process is for the EHTB advisory panel to make recommendations about a set of high priority chemicals for biomonitoring in general. ACTION NEEDED: The advisory panel is invited to comment on any aspect of the revised version of the chemical selection criteria and the process proposed for soliciting, scoring and prioritizing chemicals. No formal vote is anticipated. 64 Revised criteria for selecting chemicals for biomonitoring CRITERIA SCORE (1-5; 1 is low) WEIGHT Degree of exposure in the population • Proportion of the state population likely to be exposed to the chemical at a level of known health significance 15 • Degree to which a sub-population of interest, such as an occupational group or vulnerable population, is likely to be exposed to the chemical at a level of known health significance 12 Seriousness of health effects • 22 Seriousness of known health effects resulting from exposure (based on peerreviewed health data, chemical structure, or the toxicology of chemically related compounds) Adequacy of method • Availability of analytical methods to detect the chemical or its metabolites with adequate accuracy, precision, sensitivity (i.e., ability to detect the chemical at low enough levels), specificity, and speed 5 • Availability of adequate biospecimen samples (i.e., existence and ease of collecting a biospecimen in which the chemical or its metabolites can be measured) 5 • Degree to which the chemical stays in the body long enough to be measured 5 65 WEIGHTED SCORE (Score x Weight) CRITERIA SCORE (1-5; 1 is low) WEIGHT WEIGHTED SCORE (Score x Weight) Interpretability of the result • Availability of appropriate values against which individual and community biomonitoring results can be compared 5 • Degree of information known about what levels in the body are considered safe and what levels are associated with human health effects 5 Actionability • Degree of potential for public health action or policy to be implemented based on biomonitoring results (i.e., steps can be taken to stop the exposure for the whole population or a sub-population of interest) 5 • Degree to which repeat measures of the chemical will assess the efficacy of public health actions that are taking place to reduce exposure in the population as a whole or a sub-population of interest 5 Feasibility • Cost of laboratory analysis (time and dollars) 5 • Degree to which laboratory capacity (e.g., equipment, expertise) exists (at the MDH laboratory or other laboratories) to perform the analysis 5 Potential for information building • Degree to which studying the chemical selected would add significantly to the existing knowledge base about chemical exposures 3 • Degree to which the public or a specific sub-population is concerned about a specific chemical 3 TOTAL WEIGHTED SCORE: ______________ 66 Chemical selection process and timeline At the request of the advisory panel in March, the EHTB workgroup has developed a pilot process for soliciting, scoring and prioritizing chemicals for biomonitoring. This pilot process will provide the EHTB program with a set of recommendations for biomonitoring in the near term and, just as importantly, will provide the EHTB program the opportunity to learn lessons about how to conduct similar processes in the future. Should additional funding be received for an ongoing biomonitoring program in the future, the process and the list of priority chemicals will likely need to be revisited. The intention of the pilot process for chemical selection is not specifically to identify one top chemical to be studied in a fourth biomonitoring pilot project. Rather, the purpose is for the EHTB advisory panel to make recommendations about a set of high priority chemicals for biomonitoring in general. The key elements of the chemical selection pilot process are described below: June: EHTB staff will notify the public about opportunities for providing input on chemicals. As part of this effort, staff will be clear that though the public is invited to provide suggestions, chemicals will not be selected based on public voting, per se. Public input is sought to get a glimpse of what issues are important to the citizens of Minnesota. The level of public concern about chemicals is one element of the selection criteria. July: Accept public nominations for chemicals via the MDH website, email, etc. Members of the advisory panel and workgroup are invited to submit nominations as well. August: Workgroup members and invited experts will score the nominated chemicals using the selection criteria. The scoring system alone is not intended to dictate decisions made about chemicals for study, but to serve as background information to guide recommendations. Workgroup members will categorize nominated chemicals according to priority levels. The results of the scoring and categorization process will be documented and provided to the EHTB advisory panel. September: EHTB advisory panel will develop a set of recommendations for priority chemicals for biomonitoring to be submitted to the commissioner of health. These recommendations may be based in part on the scores received by the nominated chemicals, but may also be based on other factors that panel members want to consider. In the future, as funding allows: EHTB program staff, in consultation with the commissioner of health, will make final decisions about which chemicals will be studied. This decision will be influenced by the feasibility of conducting any particular study (costs, available timeframe, etc.) as well as other factors the commissioner wishes to consider. 67 This page intentionally left blank. 68 Section overview: Project status 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 updates on the following items: • Arsenic biomonitoring • PFC biomonitoring • Mercury biomonitoring • Biomonitoring for a fourth chemical 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. 69 This page intentionally left blank. 70 Status update on arsenic biomonitoring The arsenic pilot project received final approval from the MDH IRB. The US EPA shared its soil testing records with MDH, which allowed us to identify the properties eligible for the study. Because the EPA list only identified property owners, a considerable amount of effort was needed in order to identify current residents’ names and additional addresses associated with each property (i.e., number of living units at each property). In mid May, an introductory postcard was mailed to each of the 894 eligible households. In the last week of May the introductory letter and survey to identify eligible children will be mailed to each of the households. A Spanish speaking field worker has been hired on contract and will be trained for door-to-door and phone recruitment and follow-up. Project staff are in the process of meeting with representatives from various community-based organizations to find ways to inform the community, especially non-English speaking residents, about the project. Sample collection is expected to begin in mid June. All individual results are expected to be provided to participants’ parents by early September. 71 Status update on PFC biomonitoring The PFC project protocol has been submitted to the MDH IRB and has gone to expedited review. Project staff have contracted with two HealthEast clinics to serve as sites where participants can go to have their blood drawn. This requires that the project protocol also be submitted to the HealthEast IRB, which will review the application in early June. Recruitment of the 200 participants is expected to begin by mid to late July, with sample collection beginning in early August and continuing through September. The MDH lab will complete analysis of the blood for 7 PFCs, including PFOS, PFOA and PFBA. Individual results will be sent to participants within three months of sample collection, with an expected end date in December. 72 Status update on mercury biomonitoring At the December 2007 EHTB advisory panel meeting, MDH staff described a study being conducted by the Environmental Health Division at MDH, “Mercury Levels in Blood from Newborns in the Lake Superior Basin” (hereafter referred to as the Minnesota Lake Superior Basin study – MN LSB). At that time, one option the EHTB workgroup was considering was whether providing support to the MN LSB study could serve in lieu of conducting a separate pilot biomonitoring project for mercury. At the March 2008 EHTB advisory panel meeting, panel members were informed that a decision about any possible contribution by the EHTB program to the MN LSB study was on hold until the Minnesota legislature made a decision related to the storage and use of residual newborn screening blood spots. This spring, the Minnesota legislature passed a bill that would explicitly authorize MDH to use residual blood spots for research purposes, by providing parents the chance to opt out of (as opposed to opting into) having the newborn screening blood spot stored and used for public health studies and research. After the legislative session adjourned in May, the governor vetoed the bill. In his letter, Governor Pawlenty stated that “I believe that written informed consent should be obtained for the long-term storage or use of the blood samples for non-screening research.” This raised new questions about how the MN LSB study will proceed and what role the EHTB program might play in supporting the study. Thus, at this time, staff are not in a position to present a specific proposal for mercury biomonitoring for the panel’s consideration as had originally been anticipated. Staff will continue to explore various options and it is possible that staff will be able to present an update or a specific proposal at the June panel meeting. 73 Status update on biomonitoring for a fourth chemical Program staff continue to explore the feasibility of conducting a fourth biomonitoring pilot project. Given time and staffing constraints, one option that we are pursuing is the possibility of collaborating with an ongoing research project that already collects and stores biospecimens. This could benefit Minnesota’s biomonitoring program in a number of ways: • • • We would pilot an additional method for conducting biomonitoring studies, which would help inform recommendations for ongoing biomonitoring in Minnesota We could potentially develop laboratory capacity for measuring an additional chemical We would deepen relationships with researchers outside of MDH If a promising opportunity for this type of collaboration is uncovered, program staff will develop a draft study proposal to be presented to the advisory panel at an upcoming meeting. It is likely that if a fourth project is pursued, the chemical proposed for study will be selected based on issues of feasibility and compatibility with the goals of the ongoing research project. A fourth project/fourth chemical, therefore, may ultimately be based on opportunity rather than the identification of a single highest priority chemical for study in Minnesota. 74 Section overview: General reference materials A number of new documents are included in this meeting packet as items that may be of interest to panel members: • New PFC citations (added since March 11, 2008) • National and global tracking and biomonitoring news • California Biomonitoring Program chemical selection survey • EHTB advisory panel meeting summary (from March 11, 2008) In addition, the following items are included in each meeting packet as reference materials: • EHTB advisory panel roster • Biographical sketches of advisory panel members • EHTB steering committee roster • EHTB inter-agency workgroup roster • Glossary of terms used in environmental health tracking and biomonitoring • Acronyms used in environmental health tracking and biomonitoring • EHTB statute (Minn. Statutes 144.995-144.998) 75 This page intentionally left blank. 76 New PFC Citations (added since March 11, 2008) The following articles and reports have recently been added to the EHTB program’s PFC citation list, which is updated on an ongoing basis. This list is not intended to be comprehensive and reflects only a small portion of the available research on PFCs. Note that not all citations on this list have been published in peer-reviewed journals. A study’s inclusion on this list does not imply endorsement by the EHTB program. 3M Company. (2007) “Descriptive Analysis of Perfluorobutyrate (PFBA) and Perfluorobutanesulfonate (PFBS) in Sera Collected in 2006 from 3M Cordova Electronic Materials Factory Employees.” 3M Company, St Paul MN 55114. Alexander BH and Olsen GW. (2007) “Bladder cancer in perfluorooctanesulfonyl fluoride manufacturing workers.” Ann Epidemiol. Jun;17(6):471-8. PURPOSE: To determine whether bladder cancer is associated with exposure to perfluorooctane sulfonate (PFOS) in an occupational cohort. METHODS: Incidence of bladder cancer was ascertained by postal questionnaire to all living current and former employees of the facility (N = 1895) and death certificates for deceased workers (N = 188). Exposure to PFOS was estimated with work history records and weighted with biological monitoring data. Standardized incidence ratios (SIRs) were estimated using U.S. population-based rates as a reference. Bladder cancer risk within the cohort was evaluated using Poisson regression by cumulative PFOS exposure. RESULTS: Questionnaires were returned by 1,400 of the 1,895 cohort members presumed alive. Eleven cases of primary bladder cancer were identified from the surveys (n = 6) and death certificates (n = 5). The SIRs were 1.28 (95% confidence interval [CI] = 0.64-2.29) for the entire cohort and 1.74 (95% CI = 0.64-3.79) for those ever working in a high exposed job. Compared with employees in the lowest cumulative exposure category, the relative risk of bladder cancer was 0.83 (95% CI = 0.15-4.65), 1.92 (95% CI = 0.30-12.06), and 1.52 (95% CI = 0.21-10.99). CONCLUSIONS: The results offer little support for an association between bladder cancer and PFOS exposure, but the limited size of the population prohibits a conclusive exposure response analysis. Auer CM (2003) Letter to Scott A Masten and Proposal for Perfluorinated Compounds Class Study. US EPA Washington DC 20460 Colscher P et al. “Examination of Community Concerns about Water Contamination with Perfluorooctanic Acid and Related Chemical Using Population-based Cancer Registry Data.” Division of Surveillance and Disease Control, West Virginia Department of Health. Emmett E et al. (2006) “Community exposure to perfluorooctanoate: relationships between serum levels and certain health parameters.” J Occup Environ Med. Aug;48(8):771-9. OBJECTIVE: The objective of this study was to determine whether certain biomarkers of toxicity and/or a past diagnosis of liver or thyroid disease were associated with serum perfluorooctanoate concentrations (PFOA) in a community with longstanding environmental exposure to PFOA. METHODS: Serum (PFOA), hematologic and biochemical biomarkers, and a questionnaire were administered to 371 residents selected by stratified random sampling and a lottery among volunteers. Median PFOA was 354 ng/mL (interquartile range, 181-571 ng/mL). RESULTS: No significant positive relationships between serum (PFOA) and liver or renal function tests, cholesterol, thyroidstimulating hormone, or with red cell indices, white cell, or platelet counts. Mean serum (PFOA) 77 was not increased in those with a history of liver or thyroid disease. CONCLUSIONS: No toxicity from PFOA was demonstrated using the measured end points; other end points need to be addressed. Environmental Working Group (2002) “Perfluorinated chemicals: Justification for inclusion of this Chemical Class in the National Report on Human Exposure to Environmental Chemicals” Fromme H et al. “Exposure of an adult population to perfluorinated substances using duplicate diet portions and biomonitoring data.” (2007) Environ Sci Technol. Nov 15;41(22):7928-33. Because dietary intake is supposed to be an important route of human exposure we quantified the dietary intake of perfluorooctane sulfonate (PFOS), perfluorooctanoate (PFOA), perfluorohexane sulfonate (PFHxS), perfluorohexanoate (PFHxA), and perfluorooctane sulfonamide (PFOSA) using 214 duplicate diet samples. The study was carried out with a study population of 15 female and 16 male healthy subjects aged 16-45 years. The participants collected daily duplicate diet samples over seven consecutive days in 2005. Duplicate samples were homogenized and their ultrasonic extracts were cleaned up by SPE and subjected to HPLC-ESI-MS/MS. In addition, individual intakes were estimated based on blood levels of PFOS and PFOA using a pharmacokinetic model. Blood samples were collected once during the sampling period. The median (90th percentile) daily dietary intake of PFOS and PFOA was 1.4 ng/kg b.w. (3.8 ng/kg b.w.) and 2.9 ng/kg b.w. (8.4 ng/kg b.w.), respectively. PFHxS and PFHxA could be detected only in some samples above detection limit with median (maximum) daily intakes of 2.0 ng/kg b.w. (4.0 ng/kg b.w.) and 4.3 ng/kg b.w. (9.2 ng/kg b.w.), respectively. Because PFOSA could not be detected above the limit of detection of 0.2 ng/g f.w. this indirect route of exposure seems to be of less significance. Overall, the results of this study demonstrate that the German population is exposed to PFOS and PFOA, but the median dietary intake did not reach the recommended tolerable daily intake by far. Biomonitoring data predict an exposure in a comparable range. We suppose that, normally, food intake is the main source of exposure of the general population to PFOS and PFOA. Fromme H et al. “Occurrence of perfluorinated substances in an adult German population in southern Bavaria.” Int Arch Occup Environ Health. 2007 Feb;80(4):313-9. Epub 2006 Aug 17. OBJECTIVES: Perfluorinated compounds (PFCs) are a large group of chemicals produced for several decades and widely used for many industrial and consumer applications. Because of their global occurrence in different environmental media, their persistence, and their potential to bioaccumulate in organisms they are of toxicological and public concern. METHODS: In the present study, the internal exposure to perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) in 356 human plasma samples collected from an adult population in Germany in 2005 is quantified. RESULTS: We were able to detect the target analytes in all plasma samples and observed a significant correlation between the PFOS and PFOA concentrations. In female participants, the levels of PFOS and PFOA ranged between 2.5-30.7 (median: 10.9 microg/l) and 1.5-16.2 microg/l (median: 4.8 microg/l), respectively. In males we observed concentrations from 2.1 to 55.0 microg/l (median: 13.7 microg/l) for PFOS and from 0.5 to 19.1 microg/l (median: 5.7 microg/l) for PFOA. A significant correlation between both PFOS and PFOA concentrations and gender was observed. We also found increased levels of the PFCs with increasing age of the participants, but this association reached statistical significance among females only. CONCLUSIONS: Our data agree well with results of other recent studies in Europe and suggest that the current exposure of the adult German population is lower than the exposure of the US and Canadian population. The sources of human exposure are currently not well understood. Toxicological implications are restricted to animal studies and occupational investigations not adequate for quantitative risk assessment in humans. Overall, more scientific research is necessary to characterize the body burden of PFCs (especially for 78 relevant subsets of the population) and the main sources and routes, which are responsible for human exposure and possible health implications of these compounds. Gilliland FD, Mandel JS. (1993) Mortality among employees of a perfluorooctanoic acid production plant. J Occup Med. Sep; 35(9):950-4. Perfluorooctanoic acid (PFOA) has been found at low levels (10 to 100 parts per billion) in sera of the general population and at higher levels in occupationally exposed workers. Although PFOA has been reported to be a promoter of rodent hepatocarcinogenesis and to alter reproductive hormones in humans and rodents, there is little information on human health effects associated with PFOA exposure. The present study examined the relationship between PFOA and mortality using a retrospective cohort mortality design. The cohort consisted of 2788 male and 749 female workers employed between 1947 and 1983 at a plant that produced PFOA. The all-causes standardized mortality ratio was .75 (95% confidence interval [CI], .56 to .99) for women and .77 (95% CI, .69 to .86) for men. Among men the cardiovascular standardized mortality rate was .68 (95% CI, .58 to .80) and the all-gastrointestinal diseases was .57 (95% CI, .29 to .99). There was no significantly increased cause-specific standardized mortality ratio for either men or women. Ten years of employment in exposed jobs was associated with a 3.3-fold increase (95% CI, 1.02 to 10.6) in prostate cancer mortality compared to no employment in PFOA production. There were only six prostate cancer deaths overall and four among the exposed workers; thus, the results must be interpreted cautiously. If prostate cancer mortality is related to PFOA, PFOA may increase prostate cancer mortality by altering reproductive hormones in male workers. Grice et al. “Self-reported medical conditions in perfluorooctanesulfonyl fluoride manufacturing workers.” (2007) J Occup Environ Med. Jul;49(7):722-9. OBJECTIVE: To evaluate whether some cancers, other conditions, and pregnancy outcomes were related to occupational perfluorooctane sulfonate (PFOS) exposure. METHODS: We surveyed current and former employees of a perfluorooctanesulfonyl fluoride production facility, using a selfadministered questionnaire to ascertain several cancers and health conditions. Female cohort members also completed a brief pregnancy history. We requested medical records to validate reported melanoma, breast, prostate, and colon cancers. PFOS exposure was estimated based on a job exposure matrix up to the year of the diagnosis of the condition. RESULTS: Of the 1,895 eligible participants, 1,400 questionnaires were returned. No association was observed between working in a PFOS-exposed job and the risk of any of the surveyed conditions. CONCLUSION: We observed no association between working in a PFOS-exposed job and several cancers, common health conditions, and birth weight. Holzer J et al (2008) “Biomonitoring of Perfluorinated Compounds in Children and Adults Exposed to Perfluorooctanoate (PFOA)-contaminated Drinking Water” Environmental Health Perspectives Online 20 February 2008. Objective: 40,000 residents in Arnsberg, Germany, had been exposed to drinking water contaminated with perfluorinated compounds (PFC). Internal exposure of Ansberg’s residents to 6 PFC was assessed in comparison to reference areas. Design, participants: 170 children (5-6 years old), 317 mothers (23-49 years) and 204 men (18-69 years) took part in the cross-sectional study. Measurements: Individual consumption of drinking water and personal characateristics were assessed by questionnaire and interview. Perfluorooctanoate (PFOA), perfluorooctantes ulfonate (PFOS), perfluorohexan oate (PFHxA), perfluorohexanesulfonate (PDHxS), perfluoropentanoate (PFPA) and perfluorobutanes ulfonate (PFBS) in blood plasma and PFOA/PFOS in drinking water samples were measured by solid phase extraction, HPLC and MS/MS detection. Results: Of the various perfluorinated compounds, PFOA was the main compound found in drinking water (500-600 79 ng/L). PFOA levels in blood plasma of residents living in Arnsberg were 4.5-8.3 times higher compared to the reference population (arithmetic means Arnsberg/controls: children 24.6/5.2 µg/L, mothers 26.7/3.2. µg/L, men 28.5/6.4 µg/L). Consumption of tap water at home was a significant predictor of PFOA –blood-concentrations in Arnsberg. PFHxS concentrations were significantly increased in Arnsberg compared to controls (P < 0.05). PFBS was detected in 33% (4%, 13%) of the children (women, men) in Arnsberg compared to 5% (0.7%, 3%) in the reference areas (<0.05). Regression analysis: age and male gender were significant predictors of PFOS, PFOA, PFHxS; associations of other regressors (diet, body-mass index) varied between PFC. Conclusions: PFCconcentrations in blood plasma of children and adults exposed to PFC-contaminated drinking water were 4-8 fold increased compared to controls. Leonard RC et al. (2008) “Retrospective cohort mortality study of workers in a polymer production plant including a reference population of regional workers.” Ann Epidemiol Jan;18(1):15-22. PURPOSE: Based on previous reports of increased serum lipid levels in workers at a U.S. polymer manufacturing facility, the study objective was to investigate ischemic heart disease (IHD) mortality as well as a broad range of mortality causes for an occupational cohort at the facility. METHODS: The cohort comprised 6,027 men and women who had worked at the facility between 1948 and 2002; these years delimit the mortality follow-up period. Standardized mortality ratios (SMR) were estimated to compare observed numbers of deaths to expected numbers derived from mortality rates for 3 reference populations: the U.S. population, the West Virginia state population, and an 8-state regional employee population from the same company. RESULTS: Most SMR estimates based on U.S. and state populations were below 100. Comparison to the employee population also resulted in many SMR estimates at or near a no-effect level. Relative to the regional worker population, a nonsignificant elevation for IHD mortality was observed (SMR = 109, 95% confidence interval [CI]: 96, 124). Mortality associated with diabetes was significantly increased compared to the regional worker population (SMR = 197, 95% CI: 123, 298). A corresponding increase in the SMR for IHD and diabetes mortality was not detected for comparisons with the two general populations. CONCLUSIONS: The results reported herein show little evidence of increased cause-specific mortality risks for workers at the plant. This study demonstrates the utility of comparing occupational cohorts with a similar worker reference population in order to reduce bias associated with the healthy worker effect. Lundin JI and Alexander BH. (2007) “Mortality of Employees at an Ammonium Perfluorooctanoate Production Facility.” Division of Environmental Health Sciences, University of Minnesota, School of Public Health. Midasch O et al. (2006) “Pilot study on the perfluorooctanesulfonate and perfluorooctanoate exposure of the German general population.” Int J Hyg Environ Health.Nov;209(6):489-96 Perfluorinated chemicals (PFCs) are used in a wide variety of consumer products. Major fields of application include surfactants, surface protection (e.g., for textiles, carpets, and upholstery), paper treatment (e.g., for food packages), and lubricants. Perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA) are raw materials or manufacturing aids for some PFCs and can be released of those by biotic and/or metabolic decomposition. Due to their widespread use, persistence and bioaccumulative properties they are taken up by the general population from different sources. This might be a problem for environmental medicine because in animal studies PFOS and PFOA provoked various types of cancer and showed developmental toxic potential besides other adverse health effects. We determined the PFOS and PFOA plasma concentrations of 105 non-smokers out of the German general population as a first estimate of the exposure situation in Germany. We employed an analytical method based on serum protein precipitation followed by HPLC with 80 MS/MS-detection. The median plasma concentrations of all participants were 22.3 and 6.8microg/l, the 95th percentiles 54.3 and 14.6microg/l for PFOS and PFOA, respectively. These values are comparable with those of other biomonitoring studies. In our study, men were higher burdened both with PFOS (median: 27.1 vs. 19.9microg/l) and PFOA (median: 8.3 vs. 5.8microg/l) than women. No significant influence of age on PFOS and PFOA plasma concentrations could be observed. A strong correlation (r=0.82) between PFOS and PFOA plasma levels indicates the same exposure sources. The ubiquitous internal exposure of the general population to PFOS and PFOA must lead to further activities primarily regarding clarification of sources, metabolism, pharmacokinetics, and health effects. Minnesota Cancer Surveillance System (2007) Cancer Incidence in Dakota and Washington Counties Chronic Disease and Environmental Epidemiology, Minnesota Department of Health. Miyake et al. (2007) Trace analysis of total fluorine in human blood using combustion ion chromatography for fluorine: A mass balance approach for the determination of known and unknown organofluorine compounds. Journal of Chromatography A, 1154: 214–221 The number of perfluorochemicals (PFCs) that have been found in biological and environmental matrices is increasing as analytical standards and methods evolve. Perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) constitute only a fraction of the total suite of PFCs found in environmental and biological matrices. A robust method and approach is needed to evaluate the mass of fluorinated compounds in biological matrices. In this study, we developed a method to measure total fluorine (TF) and organic fluorine (TOF) in human blood matrices using combustion ion chromatography (CIC). Blood matrices (whole blood, serum, and plasma) were analyzed in bulk to determine TF. An aliquot of the blood was also extracted with organic solvents such as methyltert-butyl ether (MTBE) and hexane, and organic and aqueous extracts were separated, to fractionate organofluorines from inorganic fluorine. The organic layer was analyzed for TF by CIC, and for known PFCs by high performance liquid chromatography-tandem mass spectrometry (HPLCMS/MS). PFCs measured by HPLC-MS/MS accounted for >80% of the TF in the organic fraction. The aqueous fraction contained inorganic fluorine and other non-extractable organofluorines. However, in the bulk sample, fluoride and non-extractable organofluorines accounted for >70% of the TF in blood samples from the general population. In occupationally exposed individuals, known organofluorines accounted for a major proportion of the TF. These results suggest the existence of yet uncharacterized fluorine fraction in human blood. Further studies are needed to characterize the aqueous fraction that contains inorganic fluorine and non- extractable forms of fluorine. New York State Department of Health “Biomonitoring of Perfluorochemical Exposures in Newborn Infants from New York State Using Blood Spots: 1997 to 2004” Albany NY 12201-0509. Olsen GW et al. (2003) An occupational exposure assessment of a perfluorooctanesulfonyl fluoride production site: biomonitoring.” AIHA J (Fairfax, Va). 2003 Sep-Oct;64(5):651-9. This investigation randomly sampled a fluorochemical manufacturing employee population to determine the distribution of serum fluorochemical levels according to employees' jobs and work areas. Previous analyses of medical surveillance data have not shown significant associations between fluorochemical production employees' clinical chemistry and hematology tests and their serum PFOS and perfluorooctanoate (PFOA, C(7)F(15)COO(-)) concentrations, but may have been subject to nonparticipation bias. A random sample of the on-site film plant employee population, where fluorochemicals are not produced, determined their serum concentrations also. Of the 232 employees randomly selected for serum sampling, 186 (80%) employees participated (n=126 chemical plant; n=60 film plant). Sera samples were extracted using an ion-pairing extraction 81 procedure and were quantitatively analyzed for seven fluorochemicals using high-pressure liquid chromatography electrospray tandem mass spectrometry methods. Geometric means (in parts per million) and 95% confidence intervals (in parentheses) of the random sample of 126 chemical plant employees were: PFOS 0.941 (0.787-1.126); PFOA 0.899 (0.722-1.120); perfluorohexanesulfonate 0.180 (0.145-0.223); N-ethyl perfluorooctanesulfonamidoacetate 0.008 (0.006-0.011); N-methyl perfluorooctanesulfonamidoacetate 0.081 (0.067-0.098); perfluorooctanesulfonamide 0.013 (0.0090.018); and perfluorooctanesulfonamidoacetate 0.022 (0.018-0.029). These geometric means were approximately one order of magnitude higher than those observed for the film plant employees. Olsen GW et al. (2004) “Analysis of episodes of care in a perfluorooctanesulfonyl fluoride production facility.” J Occup Environ Med. 46:837-46. The observed to expected episodes of care experience of 652 employees at a fluorochemical (perfluorooctanesulfonyl fluoride) production facility was compared with 659 film plant (nonfluorochemical) employees at the same site (Decatur, AL). Episodes of care were defined by a hierarchical analysis of health claims data from 1993 through 1998. The age- and sex-adjusted expected number of episodes of care was calculated from the company's U.S. manufacturing workforce. For a priori interests, the observed to expected episodes of care ratios were comparable for fluorochemical and film plant employees for liver tumors or diseases, bladder cancer, thyroid and lipid metabolism disorders, and reproductive, pregnancy, and perinatal disorders and higher for biliary tract disorders and cystitis recurrence. Non-a priori associations among the fluorochemical plant workers included benign colon polyps, malignant colorectal tumors, and malignant melanoma. Olsen GW et al. (2003) “Epidemiologic assessment of worker serum perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) concentrations and medical surveillance examinations.” J Occup Environ Med. Mar;45(3):260-70. Perfluorooctanesulfonyl fluoride (POSF, C8F17SO2F) is used to create applications for surfactants and paper, packaging, and surface (e.g., carpets, textiles) protectants. Such POSF-based products or their residuals may degrade or metabolize to PFOS (C8F17SO3-). PFOS concentrates in liver and serum and results in hypolipidemia as an early effect of cumulative dosages. Male and female employees of two perfluorooctanyl-manufacturing locations (Antwerp, Belgium and Decatur, Alabama) participated in a periodic medical surveillance program that included hematology, clinical chemistry, thyroid hormone, and urinalysis testing. Serum concentrations of PFOS and perfluorooctanoate (PFOA, C7F15CO2-, used as a fluoropolymer emulsifier) were measured via mass spectrometry methods. The mean serum PFOS and PFOA concentrations for 263 Decatur employees were 1.32 parts per million (ppm; geometric mean 0.91, range 0.06-10.06 ppm) and 1.78 ppm (geometric mean 1.13, range 0.04-12.70 ppm), respectively. Mean concentrations were approximately 50% lower among 255 Antwerp workers. Adjusting for potential confounding factors, there were no substantial changes in hematological, lipid, hepatic, thyroid, or urinary parameters consistent with the known toxicological effects of PFOS or PFOA in cross-sectional or longitudinal analyses of the workers' measured serum fluorochemical concentrations. Paustenbach DJ et al. (2006) “A methodology for estimating human exposure to perfluorooctanoic acid (PFOA): a retrospective exposure assessment of a community (1951-2003).” J Toxicol Environ Health A. 2007 Jan;70(1):28-57. Perfluorooctanoic acid (PFOA) is a persistent chemical that was recently shown to be widely distributed in the ambient environment. Because of concerns about the possible adverse health effects on persons exposed to PFOA, a retrospective exposure assessment was conducted for a population of about 50,000 persons who reside near one of the facilities where this chemical was used. No similar study of any chemical with the properties of PFOA had ever been performed; thus, 82 several novel methods were developed and applied in this analysis. Historical records of the emissions from the facility were the basis for the estimates of the potential intake of (PFOA) by residents over the past 53 yr. Various well-accepted environmental models were dynamically combined in order to estimate the concentrations in all relevant environmental media including ambient air, surface soil, drinking water, and homegrown vegetables. Following considerable analyses, particulate deposition from facility air emissions to soil and the subsequent transfer of the chemical through the soil was determined to be the most likely source of PFOA that was detected in groundwater. The highest off-site environmental concentrations were predicted to occur about 1 mile away. For this approximately square mile area, during the time period 1951-2003, the modelestimated average air concentration was 0.2 microg/m3, the estimated surface soil concentration was 11 microg/kg, and the estimated drinking water concentration was 4 microg/L. Similar data were generated for 20 additional geographical areas around the facility. Comparison of measured PFOA concentrations in groundwater in the various water districts indicated that the models appeared to overpredict recent groundwater concentrations by a factor of 3 to 5. The predicted historical lifetime and average daily estimates of PFOA intake by persons who lived within 5 miles of the plant over the past 50 yr were about 10,000-fold less than the intake of the chemical not considered as a health risk by an independent panel of scientists who recently studied PFOA. Peden-Adams M et al. (2008) Suppression of humoral immunity in mice following exposure to perfluorooctane sulfonate (PFOS). Toxicological Sciences. Mar 20 [Epub ahead of print]. doi:10.1093/toxsci/kfn059 Adult male and female B6C3F1 mice were exposed to perfluorooctane sulfonate (PFOS) daily via gavage for 28 days (0, 0.005, 0.05, 0.1, 0.5, 1 or 5 mg/kg total administered dose [TAD]). Following exposure, various immune parameters were assessed and serum PFOS concentrations were determined. Lymphocyte proliferation was not altered in either gender. NK-cell activity was increased compared to control at 0.5, 1, and 5 mg/kg TAD in male mice but was not altered in female mice. At these treatment levels, splenic T-cell immunophenotypes were minimally altered in females, but all T-cell subpopulations were significantly modulated in males beginning at 0.1 mg/kg TAD. The sheep red blood cell (SRBC) plaque-forming cell response (PFC) was suppressed in male mice beginning at 0.05 mg/kg TAD and in females at 0.5 mg/kg TAD. Serum TNP-specific IgM titers were also decreased by PFOS after TNP-LPS challenge suggesting that the humoral immune effects may be attributed to the B-cell rather than T-cell since both T-dependent (SRBC) and Tindependent (TNP-LPS) antigens result in suppressed IgM production. Based on the PFC response, the LOEL for males was 0.05 mg/kg TAD [ED(50) = 0.021 mg/kg TAD] and for females was 0.5 mg/kg TAD [ED(50) = 0.59 mg/kg TAD]. Measured PFOS serum concentrations at these dose levels were 91.5 + 22.2 ng/g and 666 + 108 ng/g (mean + SD), respectively. The male LOEL serum level was approximately 14-fold lower than reported mean blood levels from occupationally exposed humans and fell in the upper range of concentrations reported for the general population. Overall, this study provides a profile of PFOS immunotoxicity showing effects at levels reported in humans and identifies the B-cell as a potential target. Skutlarek D et al. (2006) “Perfluorinated Surfactants in Surface and Drinking Waters” Environ Sci Pollut Res Int. Sep;13(5):299-307. GOAL, SCOPE AND BACKGROUND: In this paper recent results are provided of an investigation on the discovery of 12 perfluorinated surfactants (PS) in different surface and drinking waters (Skutlarek et al. 2006 a, Skutlarek et al. 2006 b). In the last years, many studies have reported ubiquitous distribution of this group of perfluorinated chemicals, especially perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) in the environment, particularly in wildlife animal and human samples (Giesy and Kannan 2001, Houde et al. 2006, Prevedouros et al. 2006). 83 Perfluorinated surfactants (e.g. PFOS and PFOA) have shown different potentials for reproductory interference and carcinogenity in animal experiments as well as partly long half-lives in humans (Guruge et al. 2006, FSA UK 2006a, FSA UK 2006b, 3M 2005, OECD 2002, Yao and Zhong 2005). They possess compound-dependent extreme recalcitrance against microbiological and chemical degradation and, in addition, they show variable potentials for bioaccumulation in animals and humans (Houde et al. 2006). METHODS: Surface and drinking water samples were collected from different sampling sites: Surface waters: samples taken from the rivers Rhine, Ruhr, Moehne and some of their tributaries. Further samples were taken from the Rhine-Herne-Canal and the WeselDatteln-Canal. Drinking waters: samples taken in public buildings of the Rhine-Ruhr area. After sample clean-up and concentration by solid-phase extraction, the perfluorinated surfactants were determined using HPLC-MS/MS. RESULTS: All measured concentrations (sum of seven mainly detected components) in the Rhine river and its main tributaries (mouths) were determined below 100 ng/L. The Ruhr river (tributary of the Rhine) showed the highest concentration (94 ng/L), but with a completely different pattern of components (PFOA as major component), as compared with the other tributaries and the Rhine river. Further investigations along the Ruhr river showed remarkably high concentrations of PS in the upper reaches of the Ruhr river and the Moehne river (tributary of the Ruhr) (Ruhr: up to 446 ng/L, Moehne: up to 4385 ng/L). The maximum concentration of all drinking water samples taken in the Rhine-Ruhr area was determined at 598 ng/L with the major component PFOA (519 ng/L). DISCUSSION: The surface water contaminations most likely stem from contaminated inorganic and organic waste materials (so-called 'Abfallgemisch'). This waste material was legally applied to several agricultural areas on the upper reaches of the Moehne. Perfluorinated surfactants could be detected in some suchlike soil samples. They contaminated the river and the reservoir belonging to it, likely by superficial run-off over several months or probably years. Downstream, dilution effects are held responsible for decreasing concentrations of PS in surface waters of the Moehne and the Ruhr river. In analogy to the surface water samples, PS (major component PFOA) can be determined in many drinking water samples of the Rhine-Ruhr area where the water supplies are mainly based on bank filtration and artificial recharge. CONCLUSIONS: The concentrations found in drinking waters decreased with the concentrations of the corresponding raw water samples along the flow direction of the Ruhr river (from east to west) and were not significantly different from surface water concentrations. This indicates that perfluorinated surfactants are at present not successfully removed by water treatment steps. RECOMMENDATIONS AND PERSPECTIVES: Because of their different problematic properties (persistence, mobility, toxicity, bioaccumulation), the concentrations of specific perfluorinated surfactants and their precursors in drinking waters and food have to be minimised. Therefore, it is of utmost importance to take the initiative to establish suitable legal regulations (limitations/ban) concerning the production and use of these surfactants and their precursors. Furthermore, it is indispensable to protect water resources from these compounds. A discussion on appropriate limit values in drinking water and foodstuffs is urgently needed. Concerning the assumed soil contamination, the corresponding regulation (Bioabfall-Verordnung 1998--Regulation on Organic Waste 1998) should be extended to allow the control of relevant organic pollutants. Tao et al. (2008) Perfluorinated Compounds in Human Milk from Massachusetts, U.S.A. Environmental Science & Technology. Article in Press. Perfluorinated compounds (PFCs), notably perfluorooctanesulfonate (PFOS) and perfluorooctanoic acid (PFOA), have been reported in human blood. Furthermore, the occurrence of PFCs in the blood of newborn babies, coupled with the need to study the potential association of PFC exposure with birth outcomes in neonates, suggests the need for determining the sources and magnitude of exposure in infants. In this study, nine PFCs were measured in 45 human breast milk samples collected in 2004 from Massachusetts, U.S.A. PFOS and PFOA were the predominant PFCs found at 84 mean concentrations of 131 and 43.8 pg/mL, respectively. Comparison of the ratio of PFOS to PFOA in human milk with the ratios published for human serum from the U.S. female population suggested preferential partitioning of PFOA to milk. Concentrations of PFOA were significantly higher in the milk of mothers nursing for the first time (n ) 34) than in the milk of mothers who have previously nursed (n ) 8). Based on the estimated body weight and milk intake, the average and highest daily intakes of total PFCs by infants were 23.5 and 87.1 ng/kg bw, respectively. We found that the daily ingestion rates of PFOS and PFOA did not exceed the tolerable daily intake recommended by the U.K. Food Standards Agency. This is the first study to measure the occurrence of PFCs in human milk from the U.S.A. US Department of Health and Human Services (2005) “3M Chemolite Perfluorochemical Releases at the 3M – Cottage Grove Facility, City of Cottage Grove, Washington County, MN.” Public Health Service ATSDR, Atlanta GA 30333. US Environmental Protection Agency (2003) Preliminary Risk Assessment of the Developmental Toxicity Associated with Exposure to Perfluorooctanoic Acid Office of Pollution Prevention and Toxics Risk Assessment Division. 85 This page intentionally left blank. 86 National and global tracking and biomonitoring news California survey on biomonitoring During May, California’s biomonitoring program conducted an online survey to solicit public input on chemicals to be selected for biomonitoring. A copy of the survey is included in the meeting packet. California biomonitoring staff also conducted public input workshops and conference calls to discuss the biomonitoring program and the chemical selection process. Materials from the public workshop are available at www.oehha.ca.gov/multimedia/biomon/index.html. On June 9th the program will hold a public workshop on biomonitoring, featuring representatives from biomonitoring programs in Germany, Canada, and the United States. California’s Scientific Guidance Panel will meet on June 10th to discuss chemical selection issues. North Dakota biomonitoring study on lead The North Dakota Department of Health is conducting a study measuring the risk, if any, of consuming wild game harvested with lead bullets. The study will test the blood of 680 people of all ages and will compare blood lead levels of people who eat wild game with the lead levels of those who don't. For more information, go to www.ndhealth.gov/lead/venison/. C8 Health Project preliminary results released Preliminary blood level data from the C8 Health Study in Ohio and West Virginia were recently released. The preliminary data of 24,000 of the 65,000 people whose blood was drawn show that people in the communities near the DuPont plant have a median PFOA level of 28 ppb compared to a national median of 5 ppb. Residents of the Little Hocking Water District in Ohio, which is believed to be the most polluted with PFOA, had a median PFOA level of 132 ppb. The preliminary results, including PFOA levels be age, gender, water district, income, and education, can be viewed at: www.hsc.wvu.edu/som/cmed/c8/results/C8AndPFCLevels/index.asp. Proposed California PFC ban The California legislature is considering a proposal to ban “food contact substances” containing more than 10 ppb of PFCs. The most recent version (as of May 15, 2008) of Senate Bill 1313, can be viewed at www.leginfo.ca.gov/pub/07-08/bill/sen/sb_13011350/sb_1313_bill_20080429_amended_sen_v96.html. German biomonitoring report on children The German Environmental Surveys (GerES) provide reliable data on the exposure of Germany’s population to environmental pollutants. GerES IV is the first survey solely for children and was conducted from 2003 to 2006. The study included 1,790 children aged 3 to 14 years old. Chemicals tested in the children’s urine and blood include lead, cadmium, mercury and nickel; organochlorine 87 compounds including PCB; nicotine and cotinine; organophosphate metabolites; PCP and other chlorophenols; PAH metabolites; and pyrethroid metabolites. The executive summary and full report are now available at Germany’s Federal Environmental Agency website at www.umweltbundesamt.de/index-e.htm. Biomonitoring segment on Dateline NBC A recent episode of Dateline NBC featured a segment comparing biomonitoring results for two families – the “Greens,” who strive to live a chemical-free lifestyle and the “Browns,” who are described as an average American family. Family members were tested for phthalates, fire retardants, PFCs, triclosan, bisphenol A, parabens, mercury and lead. To view the episode, or read the transcript, go to www.msnbc.msn.com/id/24230246/from/ET/. Report on Water Quality in Domestic Wells The US Geological Survey, in collaboration with the Centers for Disease Control and Prevention (CDC), has released an online report on the occurrence of 11 priority water-quality constituents of possible health concern in domestic wells located in the 16 states that are part of the CDC’s Environmental Public Health Tracking Program. The 11 water-quality constituents selected for the pilot study (primarily on the basis of expected occurrence and potential human health impacts) included arsenic, atrazine, benzene, deethylatrazine, manganese, nitrate, perchloroethene (PCE), radon, strontium, trichloroethene (TCE), and uranium. USGS samples were collected using nationally consistent field and analytical methodology. Radon, arsenic, manganese, nitrate, strontium, and uranium had the largest percentages of samples with concentrations greater than their human-health benchmarks. In contrast, organic compounds (pesticides and volatile organic compounds) had the lowest percentages of samples with concentrations greater than human-health benchmarks. The overall purpose of the study is to demonstrate through a pilot effort how USGS water-quality, water-use, and associated geospatial data can be integrated in the CDC EPHT network. The report, and state-by-state summaries, can be viewed at pubs.usgs.gov/sir/2007/5213/. Great Lakes Area of Concern Report ATSDR recently released a draft report on the effect of chemical exposures on human health in 26 Great Lakes Areas of Concern. According to the report, scientists still do not have enough information to link health consequences to environmental exposures. The report offers five major conclusions: • There is evidence of environmental pollution in the Great Lakes region, and data reveal ongoing releases of pollutants in or near almost every Area of Concern. • Available information on environmental pollution in the Great Lakes region is limited or incomplete. Some data sources exclude important sources of pollutants, and information about many sources or pathways of exposure – such as food, air, consumer products – is not captured by available databases. • The available data about environmental pollution does not tell enough about people’s exposure to pollutants. • Since available health data are not well-matched to exposure data, they cannot be used to help assess whether environmental exposures have adverse health consequences. • More and better data are needed to provide useful information about health outcomes. The report may be viewed at www.atsdr.cdc.gov/greatlakes. 88 California Biomonitoring Program chemical selection survey California’s new biomonitoring program is intended to track and evaluate toxic environmental chemicals in California residents. The program will measure environmental chemicals in biological samples, such as blood and urine. This program is just getting underway and we would like you to tell us which chemicals or types of chemicals you think the program should measure in the future. Because there are many more environmental chemicals than the program will be able to measure, we are also asking you to tell us what should influence the choice of which chemicals the program should measure. Opinions provided by people responding to this survey about chemicals and program priorities will be shared in summary form with the program’s Scientific Guidance Panel, which will recommend chemicals to measure. (The Panel is a group of outside experts that, by law, provides advice on the state biomonitoring program.) Panel members and program staff are very interested in receiving public input on these issues. The survey asks you to rank priorities and to answer a number of multiple-choice questions, but also has space for you to provide additional comments and suggestions. This survey will take about 20 minutes to complete. 89 PART 1 1. Because the California Biomonitoring Program will be able to analyze only a limited number of chemicals, we need to set priorities among the different chemicals and groups of chemicals that could be included in the program. According to the law that established the program, priority chemicals for biomonitoring are based on: - the extent of exposure to the chemical (by the public or specific subgroups); - the likelihood that the chemical is toxic - the ability of laboratories to detect the chemical at low levels in people - other criteria that the Scientific Guidance Panel recommends. The following table lists some possible additional criteria or ways that priority chemicals might be selected. Please rank the top four items from the table below that you believe are most important for the Scientific Guidance Panel and the program to consider by checking 1, 2, 3, or 4 in the columns to the right of the priority list; 1 is the most important topic, 4 is less important. You can only choose your top four items. The program should give priority to: 1 a) Measuring chemicals that are widely used throughout California. b) Measuring chemicals that will help government decide whether environmental laws are working. c) Measuring new, emerging chemicals, or other chemicals, that are now becoming widely used. d) Measuring chemicals that Californians come into contact with at work. e) Measuring chemicals that are studied nationally so that we can compare California with the rest of the country. f) Measuring chemicals that are not studied nationally so that we can find out about chemical exposures that the federal government is not investigating. g) Measuring chemicals expected to be higher in Californians because of specific activities or regulations in the state - for example, gold mining, oil refining, farming, or strict flammability standards for furniture. h) Measuring chemicals to which pregnant women, fetuses and young children are likely to be especially sensitive. i) Measuring chemicals that persist in the environment and can accumulate in people's bodies over time. j) Measuring chemicals in communities where people may come into contact with more pollutants than the general population - for example, near factories, ports, oil refineries or farms k) Don't know 2. Should the program consider other issues in selecting priority chemicals? Yes No If yes, please describe: 90 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 PART 2 There are thousands of environmental chemicals. However, we will not be able to measure more than a limited number. Depending on the program’s budget, we hope to add additional chemicals to our list every couple of years. Please tell us whether you think the following chemicals or chemical groups are important for the program to measure by checking one of the following responses: Important - Somewhat Important - Not Important – Don't know. You have the option of naming specific chemicals to measure after each question. 1. Metals, such as those sometimes found in food, toys and drinking water – For example: mercury, lead, chromium, arsenic. Important Somewhat important Not important Don't know If you answered Important or Somewhat Important, you may list or describe below any specific metals that you think the program should measure. [NOTE: The online survey included an open-ended box such as this one for each category of chemicals; the boxes are omitted from this sample simply to save space.] 2. Pesticides or other chemicals used in farming to control weeds, insects, rodents or fungi that affect crops, including fruits, grains, vegetables or cotton. Important Somewhat important Not important Don't know 3. Pesticides used in or around homes or schools - for example, to control fleas, ticks, weeds or insects in the home or yard. Important Somewhat important Not important Don't know 91 4. Chemicals found in plastics, such as those in packaging and consumer products, including water bottles and children's toys. Important Somewhat important Not important Don't know 5. Flame or fire retardants, such as those found in furniture and electronics. Important Somewhat important Not important Don't know 6. Chemicals found in personal care products - for example, cosmetics, nail polish and shampoo. Important Somewhat important Not important Don't know 7. Chemicals found in cleaning supplies - for example, window, floor, and bathroom cleaners. Important Somewhat important Not important Don't know 8. Chemicals found in workplaces. There are many thousands of chemicals used in workplaces; a few examples include chemicals used to manufacture household appliances and electronics, solvents (such as metalworking fluids, paint thinner or nail polish remover), or gases that can be irritating to breathe. Important Somewhat important Not important Don't know 92 9. Chemicals that result from burning trash, plastic, tires and other discarded materials. Important Somewhat important Not important Don't know 10. Chemicals that result from burning oil, gasoline, diesel or coal - for example, from power plants, ships at port, cars, buses or trucks. Important Somewhat important Not important Don't know 11. Chemicals from industrial plants or hazardous waste sites. Important Somewhat important Not important Don't know 12. Chemicals that may contaminate drinking water - for example, prescription drugs, petroleum products, and chlorine disinfection byproducts. Important Somewhat important Not important Don't know 13. Chemicals found in food - for example, pesticide residues, fungal toxins, byproducts formed during cooking, or chemicals in packaging that migrate into food. Important Somewhat important Not important Don't know 14. Are there other chemicals that you think the program should measure? If so, please list or describe them below. 93 15. The table below lists the chemical categories from the previous questions in the left-hand column. Please tell us your four most important categories of chemicals that the program should measure by checking one of the circles under number 1, 2, 3, or 4 to the right of your choice. You can check each number only once. 1 2 3 4 Metals 1 2 3 4 Farm pesticides 1 2 3 4 Home or school pesticides 1 2 3 4 Chemicals in plastic 1 2 3 4 Fire retardants 1 2 3 4 Chemicals in personal care products 1 2 3 4 Chemicals in cleaning supplies 1 2 3 4 Chemicals in the workplace 1 2 3 4 Chemicals from burning trash 1 2 3 4 Chemicals from burning coal, oil or gasoline 1 2 3 4 Chemicals in drinking water 1 2 3 4 Chemicals from industrial plants or hazardous waste sites 1 2 3 4 Chemicals in food 1 2 3 4 Other chemicals you listed PART 3 1. Is there a specific community where people may come into contact with more pollutants than the general population that you would like us to know about? Please describe it. Yes No If yes, please describe it: 2. Is there a specific group of workers exposed to chemicals that you would like us to know about? Please describe it. Yes No If yes, please describe it: 3. Please provide any additional comments you may have regarding the questions above, including any additional suggestions regarding chemicals the California Biomonitoring Program should measure. 94 PART 4 We are interested in knowing who you are. The following information is optional. Name: Organization: Address: Phone number: Fax number: Email address: Web address: Please indicate your primary affiliation. Nonprofit/Community-Based Organization Government Business Tribal Individual Other (please specify) Non-Profit Organization (NGO)/Community-Based Organization (CBO)- please indicate below type of NGO/CBO. Community-based Environmental Organization Community-based - Environmental Justice Organization Health Outcome (e.g., cancer, autism, asthma) Homeowner/Neighborhood Association Worker Health and Safety Other Other organization (please specify) Government - please indicate below type of government agency. Local government Regional government State government Federal government Jurisdiction: 95 Business - please indicate below type of business. Small business National business or industry International business or industry Other What business do you represent? Tribal - please specify: Have you attended any of the following public participation activities hosted by the California Environmental Contaminant Biomonitoring Program? Please check all that apply. Yes – a workshop in Los Angeles, Oakland or Fresno Yes - a telephone conference call No 96 EHTB advisory panel meeting summary Summary of the Minnesota Department of Health (MDH) Environmental Health Tracking and Biomonitoring Advisory Panel Meeting March 11, 2008 1:00 p.m.-4:00 p.m. Advisory Panel Members - Present John Adgate Cecilia Martinez Bruce Alexander Geary Olsen Beth Baker, Chair Susan Palchick Alan Bender Daniel Stoddard David Wallinga Samuel Yamin Lisa Yost Advisory Panel Members – Regrets Debra McGovern, Gregory Pratt Welcome and introductions Beth Baker, chair of the Environmental Health Tracking and Biomonitoring (EHTB) Advisory Panel, welcomed participants to the meeting. Jean Johnson, director of the EHTB program, introduced new staff members, viz. Adrienne Kari, Carin Huset, Jeannette Sample, and Deanna Scher. Operating procedures and conflicts of interest Michonne Bertrand, the staff liaison between the EHTB program and the advisory panel, referred the panel members to the operating procedures contained in the background book. At the December meeting, the panel adopted all of these operating procedures except for a description of conflicts of interest. At that December meeting, panel members had offered revised language, and Beth Baker had instructed staff to present this revised text that describes conflicts of interest at this March meeting. In response to a motion regarding this revision, The panel members unanimously voted “yes” to accepting the revised description of conflicts of interest, thereby adopting the operating procedures in their entirety. At the December meeting, panel members had suggested two different procedures for declaring conflicts of interest. The first option would require panel members to sign an affirmation indicating that they agree to disclose any conflicts of interest as they arise. The second option would require panel members to list in writing any known conflicts of interest. The panel affirmed its expectations for declaring conflicts orally as they arise during panel discussions; these would be reflected in the meeting summaries. After a motion and clarification, page 1 of 8 97 With one abstention, the panel members voted “yes” to adopting the “Affirmations Referring to Conflicts of Interest Form”, presented on page 9 of the background book. Sharing relevant journal articles with panel members Michonne Bertrand reported that several panel members have contacted EHTB program staff to alert colleagues and the EHTB staff regarding journal articles pertinent to EHTB activities. On behalf of the EHTB staff, she welcomed the panel’s input to deepen the expertise of program staff. She noted that the MDH policy on copyrighted material prevents the staff from distributing full-text articles outside of MDH without purchasing reprints. At present, the mechanism for disseminating relevant journal articles is to assemble a list of citations, with abstracts; this list included in the current background book. She invited comments regarding this mechanism. David Wallinga expressed his appreciation for striking a reasonable balance, in which the panel members have a mechanism for distribution, but which is not burdensome. Al Bender cautioned the readers to note if articles were published in peer-reviewed journals. Geary Olsen advised that the lists of citations should include a note to explicitly describe that these citations are not intended to be comprehensive, as they capture only a small portion of the relevant literature. Beth Baker instructed the EHTB program staff to incorporate such a note. Biomonitoring pilot program guidelines Jean Johnson facilitated a review of the draft biomonitoring pilot program guidelines, presented in the background book. She introduced David Orren, MDH chief legal counsel, to help in facilitating discussions germane to genetic information and data privacy. She reported that, since the December panel meeting, a task force (comprising four panel members and supported by EHTB program staff) had met once to initiate discussions on prospective guidelines. The task force identified components such as purpose, informed consent, communication of results, and follow-up counseling. Jean explained that the MN Statutes require the EHTB program, in consultation with the advisory panel, to develop biomonitoring program guidelines. In examining other resources, she learned that the guidelines for the CDC NHANES program are not written, although they have been vetted thoroughly. Indeed, she received prompt responses to her questions during phone conversations with NHANES program staff. Beth Baker asked the panel to provide comments on each section of the draft guidelines. While no comments were received on the “introduction” section, many comments were made regarding the “purpose” section. Susan Palchick observed that, as these are guidelines specific to the pilot program which has a limited scope, the drafted purpose might be too ambitious. Al Bender reinforced that care should be exercised so that community expectations are aligned with the nature of a pilot program. David Wallinga advised that “purpose” and value” should not be used interchangeably. Dan Stoddard questioned if the guidelines should address the pilot program specifically or if they should address biomonitoring studies generally. He suggested that the purpose could be stated broadly, followed by caveats for a pilot program. Samuel Yamin expressed his page 2 of 8 98 satisfaction with the balance portrayed between the potential and the limitations of biomonitoring. John Adgate and Susan Palchick suggested that the phrase “Another fundamental value of the pilot projects hinges on their ability to build capacity …” be changed to “Another goal of the pilot projects is to build capacity…” Cecilia Martinez recommended that the statements should reflect different perspectives between the intent and spirit of biomonitoring studies and diverse community expectations. John Adgate, Bruce Alexander, and Al Bender suggested that the guidelines could acknowledge that public expectations are very high and, in parallel, the guidelines could be forthright about the aims and achievable products. David Wallinga reinforced that the panel and the community may have different expectations for the pilot projects. Dan Stoddard suggested that a stand-alone “vision” section could be added to the guidelines. Lisa Yost advised that the “vision” section could describe both short-term goals and long-terms goals. It was agreed that the fourth paragraph in the “purpose” section should be moved to the “vision” section. In response to a query, Beth Baker instructed MDH staff to write this section and present it to the advisory panel for feedback at an upcoming meeting. Michonne Bertrand thanked the panel for thoughtful input and noted that this would be instructive as the EHTB program evaluates candidates for the third and fourth pilot projects. Panel members deliberated on whether the cautious language in the “purpose” section would be viewed as hedging or too vague. Suggestions were voiced to include phrases such as: objectives will be; designed to determine; will not be able to conclude; what is possible to ascertain; information to be gained will include insights in how to engage the community. In reviewing the “privacy of information” section, the panel focused on the phrase “individual health data”. Geary Olsen advised that “individual exposure data” would be a better expression, particularly in communicating expectations forthrightly. David Orren explained that, in the legal context, “individual health data” refers to MDH’s ability to protect the study results as non-public data. The panel agreed that a revised text should clarify this by conveying that: (a) biomonitoring involves the collection of information about the levels of chemicals or their metabolites in the body and does not, on its own, infer health status; and (b) nonetheless, this type of information is interpreted legally to be health data and is subject to the legal protections afforded to health data. The panel advised that the “informed consent” section should acknowledge the role of institutional review boards (IRBs). It should also recognize that the federal regulations for IRBs are established for federally funded research, and that the state legislature is empowered to establish its own criteria for the protection of human subjects involved in state-funded research. David Orren suggested rewording the phrase “assuming that a legal consent” to become “verifying that a legal consent”. Lisa Yost suggested that the use of the term “participant” be expanded to include legal guardians and adult caregivers. page 3 of 8 99 Geary Olsen recommended that the “laboratory quality assurance” section include quality assurance for the sample containers, and David Orren suggested an additional statement to assure data privacy. In response to a query by Susan Palchick on the “laboratory approval program” section, MDH staff clarified that certification and accreditation are available for regulated methods, such as environmental compliance monitoring and clinical diagnostic tests. However, biomonitoring studies are not regulated. Thus, the phrase “laboratory approval program” is a better descriptor than “laboratory certification program”. Bruce Alexander recommended that the “storage of specimens” section be revised so that the guidelines would be for participants to opt-out, rather than opt-in, for storage of specimens for future research. David Orren reported that current Minnesota statutes would allow for future research of chemicals and metabolites but not for genetic markers unless informed consent were renewed annually. Geary Olsen asked if the specimen donors (or their adult care-givers) would need to furnish renewed informed consent if MDH wanted to conduct future research to measure additional chemicals on residual specimens. Jean Johnson replied that, if the original consent explicitly gave permission for use of the specimen for future research on other chemicals, then no additional consent would be required. Geary Olsen cautioned that requests for secondary use of specimens for measuring illegal drugs should be addressed. It was acknowledged that, although MDH might be within its legal authority to analyze for illegal drugs, such studies would undoubtedly fall short of acceptable criteria for secondary use of residual specimens. Cecilia Martinez asked if a two-tiered informed consent (one for participation in the biomonitoring pilot study, and one for specimen storage for future research) would introduce bias and affect the participation rate. Bruce Alexander responded that, generally, prospective participants find the specimen collection to be the larger barrier and they are not dissuaded from participating by a question regarding specimen storage. The “communication of results” section focused on the appropriate use of “information” and “results”. Susan Palchick recommended that “results” should be substituted for “information” in the statement that MDH has an ethical obligation to make information available to the participants. Samuel Yamin advised that the obligation extends to helping participants or the community interpret these results. He endorsed the final sentence in this section, which explains that communication efforts are to be appropriate and effective. Al Bender cautioned that, if future biomonitoring pilot projects were to measure occupational exposures, then the guidelines would need to acknowledge pertinent federal laws. In the “follow-up counseling” section, Lisa Yost pointed out that many participants may choose to not avail themselves of counseling services. Therefore, the phrase “providing an appropriate level of follow-up counseling” should be re-worded as “providing an opportunity for an appropriate level of follow-up counseling”. Jean Johnson thanked the panel for constructive suggestions. These will be incorporated into the next draft. EHTB program staff will be adding text soon for the headings currently designated as placeholders as well as for a new “vision” section. page 4 of 8 100 Selection of chemicals for biomonitoring studies Adrienne Kari, EHTB program staff member, facilitated a discussion of criteria that could be used when considering which chemicals to recommend for inclusion in the biomonitoring program. She asked the panel to focus its discussion on the criteria and the process, rather than on the merits of specific chemicals. Samuel initiated the discussion by asking if these criteria would be used for selecting a fourth chemical for a pilot project to be launched in this two-year period. Michonne Bertrand replied that, at the December meeting, the panel voted to bring forward a recommendation for a designated chemical within a reasonable timeframe. The EHTB program staff members are moving this process forward. At the same time, the program recognizes that resources (such as time and funding) are limiting. John Adgate recommended that the discussion of criteria should encompass both a prospective fourth biomonitoring pilot project as well as an ongoing biomonitoring program. Dan Stoddard expressed his satisfaction with the approach used by CDC for selection of NHANES chemicals. He recognized that the EHTB program would probably not have sufficient time to mirror CDC’s vetting process for our pilot projects, but it would be a sound process for future biomonitoring studies. While admiring CDC’s approach, Dan emphasized that he believed “health risk” should be Minnesota’s highest priority in a weighted scoring system. Beth Baker referred the panel to pp. 47–49 in the background book, in which the EHTB program staff presented possible criteria for selecting chemicals for biomonitoring. Lisa Yost concurred with the “public health impact” criterion and appreciated the risk assessment captured in the first bulleted item, “degree of exposures in the population”. Cecilia Martinez expressed her appreciation for the next bullet under “public health impact”, as it explicitly recognizes vulnerable populations. Bruce Alexander suggested that the third bullet in “other factors”, namely “degree to which studying a chemical is likely to create interest in and funding for future biomonitoring efforts” should not be a deciding factor. He recommended moving the second bullet, “degree to which studying the chemical selected would add new information to the existing knowledge base about chemical exposures” to the “public health impact” criterion. Panel members considered the dilemma of reporting biomonitoring data if no remediation is possible. In the past, CDC and others recommended against reporting data that would generate anxiety without making a positive contribution. Current ethical considerations tend to favor informing the public even if an individual’s future exposures cannot be prevented, reduced, or managed. Lisa Yost concurred with the “actionability” criterion, whereby prospective studies that have a high potential for mitigating exposure would receive a higher priority score than studies which have a low potential for mitigation. In addition to reviewing the criteria for chemical selection, the panel discussed the scoring system to be used. In response to a question about how to build a Minnesotacentric viewpoint into the scoring system, Dan Stoddard noted that the selection criteria page 5 of 8 101 would be specific to Minnesota’s program. He liked the NHANES approach of a weighted scoring system but would replace the NHANES-specific categories with ones to be articulated by this advisory panel. Panel members commented on other aspects of chemical selection. Beth Baker supported the “feasibility” criterion, which includes the availability of analytical methods and the cost of laboratory analysis. She also supported the “interpretability” criterion, which rests on the availability of a normal range of values in the general population. Lisa Yost reflected on the adequacy of available analytical methods and their ability to distinguish safe ranges or abnormal ranges. Bruce Alexander noted that, in some cases, occupational exposures are documented but normal ranges in the general population are not. Michonne Bertrand observed that NHANES data are for the general population. Dan Stoddard suggested that higher priority should be given to measurements of chemical candidates that are not duplicative or redundant. Michonne Bertrand and Jean Johnson asked the panel to evaluate the intent of the selection process. For example, would this inform the selection of a pilot project of a yetto-be designated chemical, to be completed in this two-year period? Would this process be used for a request to the legislature to fund an ongoing biomonitoring program? How should the EHTB program solicit opinions from the public? Beth Baker suggested that the MDH website could be used to post a 30-day public comment period. Michonne Bertrand reported that, for successive rounds of the NHANES program, CDC has put the onus on the nominators to support chemical candidates by documenting their justification. The website could announce the criteria and weighted scoring system for the chemical selection process, and nominators could respond to as many of the criteria as they wished. The solicitation should clarify resource limitations; for example, if this process is for the two-year pilot period, it should announce the time-frame and the available funds. Michonne Bertrand reported that, at the October panel meeting, a $67,000 budget was predicted to remain after budgeting for the arsenic and PFCs pilots. This figure is being adjusted to reflect the continuing refinements to these first two biomonitoring pilots. The panel considered alternative approaches to scoring chemical candidates. One approach would be that each panel member scores the chemicals based directly on the nominators’ documentation. Consensus was reached for an alternative approach, in which the EHTB program staff would supplement the nominators’ documentation with its own findings from the literature and other sources, and then the panel members would score the candidates. The panel agreed that all panel members and MDH staff are eligible (and encouraged) to join in the nomination process. Samuel Yamin observed that the panel’s identification of a designated chemical is time-sensitive, particularly if this study will be incorporated into the biomonitoring pilot program. Staff noted that the EHTB program has already received communications naming three chemical candidates, viz. atrazine, pesticides, and vinyl chloride. page 6 of 8 102 Project status update: Perfluorochemicals biomonitoring Michonne Bertrand referred the panel to pp. 61-99 of the background book, which includes communications from various stakeholders regarding the proposed perfluorochemicals (PFCs) biomonitoring pilot project. She noted that the biggest concern expressed by the affected community is that the proposed study would exclude children. Although the EHTB program staff reiterated the rationale for selecting adult participants, some parents and advocacy groups remain dissatisfied. Project status update: Mercury biomonitoring Louise Liao, manager of the environmental laboratory section in the MDH Public Health Laboratory, reported on the status of an EPA-funded study to measure mercury in newborn infants born in the Lake Superior Basin. The study has not been implemented yet, as MDH is considering two alternatives for implementing the study. One approach is to seek informed, written consent from parents to enroll residual, newborn specimens in the study. Another approach is to present a proposal to the state legislature that would explicitly permit MDH to use residual newborn specimens for research and permit parents to decline to have the specimens used for research. She reported that the legislature is considering this proposal during the month of March. A description was provided of activities in the MDH Public Health Laboratory to prepare for the EPA-funded mercury biomonitoring study. In addition to the quality control measures for the analytical method that were outlined in the background book, Louise Liao described progress toward building a laboratory approval program, particularly for external validation of the accuracy and precision of the reported data.. The MDH Public Health Laboratory already participates in a CDC-sponsored validation program for mercury in whole blood and is exploring inter-laboratory comparisons for mercury in dried blood spots on filter paper. On a related note, MDH staff members have been encouraging a nationally accredited provider of proficiency testing studies to offer an external validation program for perfluorochemicals. Its first offering is expected to be for PFBA, PFOA, and PFOS in water. Louise Liao invited panel members to tour the MDH Public Health Laboratory. She encouraged members to contact her for a visit. Project status update: Environmental Health Tracking Jean Johnson referred panel members to pp. 105-107 of the background book, which describes efforts underway to develop indicators for water quality, carbon monoxide poisoning, air quality, hospitalizations for asthma and myocardial infarctions, and birth defects. She reported that the upcoming June meeting would probably focus on the Minnesota Environmental Health Tracking System. page 7 of 8 103 Project status update: Arsenic biomonitoring Adrienne Kari, EHTB biomonitoring project coordinator, informed the panel that the study design for the arsenic biomonitoring pilot project had been submitted to the MDH Institutional Review Board (IRB), which will review the application shortly. She reported that the EHTB program staff had slightly altered the study design, such that it no longer includes a hair sample. It does include first-morning urine samples to be collected on two consecutive days and then combined for laboratory analysis. The “do it yourself” collection method was the chief reason for abandoning the hair analysis, as described on p. 109 of the background book. Closure Beth Baker thanked the panel for its constructive advice. Michonne Bertrand noted that the next scheduled meeting will be on Tuesday, June 3, 2008 from 1:00 to 4:00 at Snelling Office Park in Saint Paul. She noted that the date has changed from the June 10th date that was announced last summer. On June 3rd, the panel will meet in the Red River Room, which is down the hallway from the Mississippi Room. She invited the panel members to contact her with any feedback or input for upcoming meetings. Finalized April 7, 2008 page 8 of 8 104 EHTB advisory panel roster Cecilia Martinez, PhD Center for Energy and Environmental Policy University of Delaware Newark, Delaware 19716 302-831-8405 John L. Adgate, PhD University of Minnesota School of Public Health Environmental Health Sciences Division MMC 807 Mayo 420 Delaware Street SE Minneapolis, Minnesota 55455 612-624-2601 [email protected] University of Minnesota representative Local office: Inver Grove Heights, Minnesota 651-470-5945 [email protected] [email protected] Nongovernmental organization representative Bruce H. Alexander, PhD University of Minnesota School of Public Health Environmental Health Sciences Division MMC 807 Mayo 420 Delaware Street SE Minneapolis, Minnesota 55455 612-625-7934 [email protected] Minnesota House of Representatives appointee Debra McGovern Minnesota Steel Industries, LLC Environmental & Regulatory Affairs 2550 University Avenue, Suite 244S St Paul, Minnesota 55114 651-209-7707 [email protected] Statewide business organization representative Beth Baker, MD, MPH Specialists in Occupational and Environmental Medicine Fort Road Medical Building 360 Sherman Street, Suite 470 St. Paul, MN 55102 952-270-5335 [email protected] At-large representative Geary Olsen, DVM, PhD 3M Medical Department Corporate Occupational Medicine MS 220-6W-08 St. Paul, Minnesota 55144-1000 651-737-8569 [email protected] Statewide business organization representative Alan Bender, DVM, PhD Minnesota Department of Health Health Promotion and Chronic Disease Division 85 East 7th Place PO Box 64882 Saint Paul, MN 55164-0882 651-201-5882 [email protected] MDH appointee Susan Palchick, PhD, MPH Hennepin County Human Services and Public Health Department Public Health Protection 1011 South 1st Street, Suite 215 Hopkins, Minnesota 55343 612-543-5205 [email protected] At-large representative 105 Gregory Pratt, PhD Minnesota Pollution Control Agency Environmental Analysis and Outcomes Division 520 Lafayette Road St. Paul, MN 55155-4194 651-296-7664 [email protected] MPCA appointee Samuel Yamin, MPH Minnesota Center for Environmental Advocacy 26 E. Exchange St., Ste. 206 St. Paul, MN 55101 (651) 223-5969 [email protected] Minnesota Senate appointee Daniel Stoddard, MS, PG Minnesota Department of Agriculture Pesticide and Fertilizer Management Division 625 Robert Street North St. Paul, Minnesota 55155-2538 651-201-6291 [email protected] MDA appointee Lisa Yost, MPH, DABT Exponent, Inc. 15375 SE 30th Pl, Ste 250 Bellevue, Washington 98007 Local office St. Paul, Minnesota 651-225-1592 [email protected] At-large representative David Wallinga, MD, MPA Institute for Agriculture & Trade Policy Food and Health Program 2105 First Avenue South Minneapolis, Minnesota 55404 612-870-3418 [email protected] Nongovernmental organization representative Rev. February 20, 2008 Please submit corrections to [email protected] 106 Biographical sketches of advisory panel members John L. Adgate is an Associate Professor in the Division of Environmental Health Sciences at the University of Minnesota School of Public Health. His research focuses on improving exposure assessment in epidemiologic studies by documenting the magnitude and variability of human exposure to air pollutants, pesticides, metals, and allergens using various measurement and modeling techniques, including biomonitoring. He has written numerous articles and book chapters on exposure assessment, risk analysis, and children’s environmental health. He has also served on multiple U.S. EPA Science Advisory Panels exploring technical and policy issues related to residential exposure to pesticides, metals, and implementation of the Food Quality Protection Act of 1996, and was a member of the Institute of Medicine’s Committee on Research Ethics in Housing Related Health Hazard Research in Children. Bruce H. Alexander is an Associate Professor in the Division of Environmental Health Sciences at the University of Minnesota School of Public Health. Dr. Alexander is an environmental and occupational epidemiologist with expertise in cancer, reproductive health, respiratory disease, injury, exposure assessment, and use of biological markers in public health applications. Beth Baker is Medical Director of Employee Health at Regions Hospital and a staff physician at the HealthPartners. She is President of Medical and Toxicology Consulting Services, Ltd. Dr. Baker is an Assistant Professor in the Medical School and Adjunct Assistant Professor in the School of Public Health at the University of Minnesota. She is board certified in internal medicine, occupational medicine and medical toxicology. Dr. Baker is a member of the Board of Trustees for the Minnesota Medical Association and is on the Board of Directors of the American College of Occupational and Environmental Medicine. Alan Bender is the Section Chief of Chronic Disease and Environmental Epidemiology at the Minnesota Department of Health. He holds a Doctor of Veterinary Medicine degree from the University of Minnesota and a PhD in Epidemiology from Ohio State University. His work has focused on developing statewide surveillance systems, including cancer and occupational health, and exploring the links between occupational and environmental exposures and chronic disease and mortality. Cecilia Martinez has a B.S. degree from Stanford University and a Ph.D from the University of Delaware. She is an Adjunct Faculty at the Center for Energy and Environmental Policy where she leads projects on environmental mapping and community health. Her research interests include environmental policy, indigenous rights and the environment, and sustainable development. Dr. Martinez has numerous publications including Environmental Justice: Discourses in International Political Economy with John Byrne and Leigh Glover. Her interests include policy research on sustainable energy and environmental policy. Debra McGovern has more than 28 years of environmental experience. She has 15 years of experience in Minnesota governmental regulation and 13 years of experience in heavy process industry, and is well versed in Minnesota’s regulatory requirements. Ms. McGovern has created and implemented numerous environmental programs and is active in many organizations. Ms. McGovern is the former Environmental Policy Committee Chairperson for the Minnesota Chamber of Commerce, and currently serves on the Board of Directors for the Minnesota Environmental Initiative (MEI). 107 Geary Olsen is a staff scientist in the Medical Department of the 3M Company. He obtained a Doctor of Veterinary Medicine (DVM) degree from the University of Illinois and a Master of Public Health (MPH) in veterinary public health and PhD in epidemiology from the University of Minnesota. For 22 years he has been engaged in a variety of occupational and environmental epidemiology research studies while employed at Dow Chemical and, since 1995, at 3M. His primary research activities at 3M have involved the epidemiology, biomonitoring (occupational and general population), and pharmacokinetics of perfluorochemicals. Recently, he completed a 3-year appointment on the Board of Scientific Counselors for the U.S. Centers for Disease Control and Prevention (CDC) ATSDR/NCEH. Susan Palchick is the Administrative Manager for Epidemiology, Environmental Health, Assessment and Public Health Emergency Preparedness at Hennepin County Human Services and Public Health Department. She has been with Hennepin County for 11 years and also serves as the Environmental Health Director for Hennepin County. Prior to coming to Hennepin County, Susan was the program manager for the Metropolitan Mosquito Control District (MMCD) for 10 years. Susan is on the National Association of County and City Health Officials (NACCHO) environmental health essential services committee. She is the principal investigator for an Advanced Practice Center (APC) grant from NACCHO which focuses on environmental health emergency preparedness. Susan received her Ph.D. in Medical Entomology from the University of California-Davis; Master of Public Health in Epidemiology from the University of California-Berkeley; M.S. in Entomology from University of Wisconsin-Madison; and B.S. (with honors) in Agricultural Journalism-Natural Science from the University of Wisconsin-Madison. Greg Pratt is a research scientist at the Minnesota Pollution Control Agency. He holds a Ph.D. from the University of Minnesota in Plant Physiology where he worked on the effects of air pollution on vegetation. Since 1984 he has worked for the MPCA on a wide variety of issues including acid deposition, stratospheric ozone depletion, climate change, atmospheric fate and dispersion of air pollution, monitoring and occurrence of air pollution, statewide modeling of air pollution risks, and personal exposure to air pollution. He is presently cooperating with the Minnesota Department of Health on a research project on the Development of Environmental Health Outcome Indicators: Air Quality Improvements and Community Health Impacts. Daniel Stoddard is the Assistant Director for Environmental Programs for the Pesticide and Fertilizer Management Division at the Minnesota Department of Agriculture (MDA). He holds a master’s degree in Management of Technology which focuses on the management of multi-disciplinary technical organizations and projects, and he is a licensed Professional Geologist. He currently administers the MDA’s non-point source programs for pesticides and inorganic fertilizer. These include: monitoring surface water and groundwater for pesticides; monitoring pesticide use; registering pesticide products; developing and promoting voluntary best management practices; developing regulatory options; and, responding to local contamination problems. He previously worked in or managed a variety of other environmental and regulatory programs at the MDA and the Minnesota Pollution Control Agency, and as an environmental consultant. David Wallinga is Director of the Food and Health Program at the Institute for Agriculture and Trade Policy. Dr. Wallinga applies a systems perspective to the intersection of public health, agriculture, food and the environment. His expertise includes the impacts of food contamination and the means of food production on human health, including impacts on obesity and ecological health impacts from the 108 inappropriate use of antibiotics and arsenic in livestock and poultry. Dr. Wallinga also has for several years researched and advocated around the impacts on fetuses, children and adults of early-life exposures to neurotoxins—including many found in fish and other foods—on brain and nervous system function in children and adults, developing brains and other organs in fetuses and children. Dr. Wallinga authored “Playing Chicken: Avoiding Arsenic in Your Meat,” “Poultry on Antibiotics: Hazards to Human Health,” as well as “Putting Children First: Making Pesticide Levels in Food Safer for Infants & Children.” He is a co-author of “In Harm’s Way: Toxic Threats to Child Development” and co-developer of the Pediatric Environmental Health Toolkit. He received a medical degree from the University of Minnesota Medical School, a Masters degree from Princeton University, and a Bachelors from Dartmouth College. Samuel Yamin is the Public Health Scientist for the Minnesota Center for Environmental Advocacy. Before joining MCEA, Samuel worked as a toxicologist for the New Hampshire Bureau of Environmental and Occupational Health, and prior to that as an environmental epidemiologist for the Delaware Division of Public Health. While working for those agencies, his responsibilities included exposure assessment, risk analysis and hazard communication for pollutants in water, air, soils and indoor environments. Samuel has also worked extensively on the subject of environmental carcinogens and the potential impacts on public health. Samuel’s experience in hazardous materials management and environmental regulatory programs also includes two years of work with the Environmental Health and Safety Department at Ionics, Inc., a Massachusetts-based manufacturer of drinking water purification technology. Samuel holds a Master of Public Health in Environmental Health Sciences from Tufts University School of Medicine and a Bachelor of Science in Environmental Health and Safety from Oregon State University. Lisa Yost is a Managing Scientist at Exponent Inc., a national consulting firm, in their Health Sciences Group and she is based in Saint Paul, Minnesota. Ms. Yost completed her training at the University of Michigan School of Public Health and is a board-certified toxicologist with expertise in evaluating human health risks associated with substances in soil, water, and the food chain. She has conducted or supervised risk assessments under CERCLA, RCRA, or state-led regulatory contexts involving a wide range of chemicals and exposure situations. Her particular areas of specialization include exposure and risk assessment, risk communication, and the toxicology of chemicals such as PCDDs and PCDFs, PCBs, pentachlorophenol (PCP), trichloroethylene (TCE), mercury, and arsenic. Ms. Yost is a recognized expert in risk assessment and has collaborated in original research on exposure issues including background dietary intake of inorganic arsenic. She is currently assisting in a number of projects including a complex multi-pathway risk assessment for PDDD/Fs that will integrate extensive biomonitoring data collected by the University of Michigan. Ms. Yost is also an Adjunct Instructor at the University of Minnesota, School of Public Health. Rev. November 30, 2007 Please submit additions and corrections to [email protected] 109 This page intentionally left blank. 110 EHTB advisory panel operating procedures Panel Name, Membership, Function, and Objectives This advisory panel is known as the Environmental Health Tracking and Biomonitoring (EHTB) Advisory Panel. This panel and its membership, functions, and objectives are described in Minnesota Statute section 144.998. Charge The advisory panel is intended to function in an advisory capacity to the MDH program managers in environmental health tracking and biomonitoring and, ultimately, to the Commissioner of Health. This panel is to extend and supplement the range of expertise of MDH’s scientific staff, and to advise in setting priorities for, designing, and evaluating the environmental health tracking and biomonitoring projects. It is not intended that the advisory panel become involved in the day-to-day operational and administrative aspects of program resources, program management, or personnel matters. Reimbursement Members of the panel shall serve without compensation but shall be reimbursed for travel and other necessary expenses incurred through performance of their duties. Terms of Appointment 1. Members appointed by the Commissioner are appointed for a three-year term and may be reappointed. Legislative appointees serve at the pleasure of the appointing authority. 2. Each member will receive notification of the expiration of his or her term at least sixty days prior to the termination date. Notification will also be sent to the chair of the advisory panel. 3. Members should communicate their intent to resign in writing to the appropriate appointing authority and to the chair of the advisory panel. If the Commissioner of Health is not the appointing authority, then the member should also notify the Commissioner of Health. The appropriate appointing authority will appoint a new member to serve the remainder of the term if needed to maintain membership from each of the representative groups listed in Minnesota Statute 144.998. 4. A member may be removed by the appointing authority at any time, at the discretion of the appointing authority. 111 Responsibilities and Expectations of Advisory Panel Members In accepting appointments to the advisory panel, members are expected to: 1. Attend advisory panel meetings and other assigned meetings. Any member missing two consecutive full advisory panel meetings may be notified in writing that missing a third consecutive meeting may result in the member’s removal from the advisory panel. 2. Serve on committees, work groups, and other task forces as requested by the chair. 3. Prepare for active participation in discussions and decision-making by reviewing meeting materials prior to the meeting dates. 4. Act as a liaison when appropriate between constituent groups and the advisory panel. 5. Inform the represented constituent groups of advisory panel activities, actions, and issues. 6. Declare any actual or apparent conflicts of interest and abstain from voting on advisory panel matters that create an actual conflict of interest. A conflict of interest is a situation in which an advisory panel member, her/his organization, or a family member would personally benefit based on the outcome of a particular decision, endorsement, or action taken by the advisory panel. A conflict of interest exists if one of the following conditions applies: a. The member’s organization has a direct financial or organizational interest in the matter under consideration. Note that employees of large organizations may have little or no personal knowledge about certain financial interests of their employers. In those cases, members are required to declare only conflicts for which they have direct knowledge. They are not required to inquire about further details from their employers. In some situations, members may hold a position in which they exercise some authority with respect to projects in which they are not personally involved. In those cases, inquiry into additional information about the interest could be helpful in preventing unintentional conflicts of interests or appearances of impropriety. b. The member or a family member has a financial or personal interest in the matter under consideration and is not so free from personal bias, prejudice, or preconceived notion as to make it possible for her/him to objectively consider the evidence presented and base her/his decision solely on the evidence. c. The member has placed her/himself in a position where she/he finds it difficult, if not impossible, to devote her/himself to a consideration of the matter with complete energy, loyalty, and singleness of purpose to the general public interest. It should be noted that many members of the advisory panel will have exceptional professional or personal experience with environmental health tracking or biomonitoring. These qualities, by themselves, do not constitute a conflict of interest. Informed decision-making will benefit from personal experiences; however, personal interests should not distract from objective decision-making for the public good. 112 Advisory Panel Chair The Commissioner of Health shall appoint a chair from the advisory panel’s membership. The term of office is three years. The duties of the chair are to: 1. Preside at all full advisory panel meetings. 2. At the request of the Commissioner, be the spokesperson and representative for the advisory panel. 3. Establish work groups as needed to carry out the advisory panel’s recommended actions, consulting with staff to assure staff support will be available as needed. Meetings 1. The advisory panel shall meet as often as it deems necessary but, at a minimum, on a quarterly basis. Meetings will be held in Minneapolis or Saint Paul during the regular business day. The number and scheduling of meetings will depend on the timing and urgency of particular issues being addressed. Any work groups will meet outside of regularly scheduled meetings of the full advisory panel. 2. The advisory panel and work groups can meet more frequently, as requested by the chair or other advisory panel members. 3. Meetings of the advisory panel and work groups may be cancelled and rescheduled by the Commissioner in consultation with the chair. Advisory panel members and work group members will be notified of cancellations in as timely a manner as possible. 4. All meetings are open to the public for observation. Attendance 1. Attendance at each meeting is critical to the productivity of the advisory panel. While it is ideal to have all members of the advisory panel present at meetings, this is not always feasible. Members for whom travel time and distance are prohibitive may connect to meetings by telephone. Members who make arrangements for telephone connections are strongly encouraged to attend at least two meetings each year in person. 2. If a member cannot attend a meeting, she/he is to contact the advisory panel’s MDH staff liaison prior to the meeting. Panel members are encouraged to speak to the staff liaison before and/or after any meetings they are unable to attend to stay informed about panel deliberations and to share any comments. Absent members may also send a colleague to the meeting, either as an observer or as a formal alternate. Alternates do not have decision-making or voting privileges. Also, because discussions will often span several meetings, it may be difficult for alternates to understand the context of or participate in panel proceedings. Alternates must meet the same eligibility criteria as panel members (e.g., they may not be registered lobbyists). 113 Quorum and Voting It is anticipated that many issues considered by the panel will not result in a formal vote, but rather in a general exploration of the range of panel members’ opinions and advice. In some cases, program staff may ask the panel to conduct a formal vote. Items that would prompt a formal vote include those explicitly required by statute (e.g., the selection of the specific chemicals to study requires the agreement of nine panel members) and those that require program staff to operate outside of statutory requirements. During the course of panel meetings, panel members and program staff may request additional votes regarding issues under discussion. 1. Whenever possible, decisions requiring a vote by the advisory panel will be indicated in the meeting agenda, which will be distributed to panel members prior to the meeting. 2. A majority (51%) of the membership must be present at a given meeting. Decisions can be made when a majority of voting members present reach agreement on a given matter. 3. The panel will operate using a relaxed version of Robert’s Rules of Order. As such, items for which a vote is sought will require a motion, a second, discussion of the motion, and then a vote. Voting will normally be recorded as the number of ayes, number of nays, and number of abstentions. When specifically requested by a member of the advisory panel, the chair will take a roll call, and individual votes will be recorded. 4. Votes by members attending the meeting by telephone are acceptable. 5. As described in Minnesota Statute section 144.998, one representative each shall be appointed by the commissioners of the Pollution Control Agency, the Department of Agriculture, and the Department of Health. All other state employees are ex-officio participants. With this status, the ex-officio participants are allowed to participate but do not have decision-making or voting privileges. These exofficio participants are not appointed to the formal advisory panel membership. 6. Voting privileges for absent members are as follows: a. Members participating by telephone are allowed to vote. b. When an item requiring a vote is known in advance, members may submit absentee ballots by email, fax, or U.S. mail. Ballots must be received by the EHTB program staff at least one day prior to the meeting. c. When an item requiring a vote is known in advance, absent members may submit proxy votes to the chair or another panel member beforehand. The proxy statement will declare her/his approval or rejection of the issue that will be under discussion. d. Alternately, the proxy statement will declare that a specific member, who must be present, serves as the absent member’s delegate and has full authority to vote on a particular issue. e. Absent members are not allowed to submit proxy votes or appoint a delegate for issues or votes arising during meetings. 114 Communications Advisory panel members are expected to refrain from writing letters or engaging in other kinds of communication in the name of the advisory panel unless such communication has been specifically approved by the advisory panel or the Commissioner of Health. Decision-Making Process The following summarizes the key steps involved in the EHTB program’s decision-making process: 1. MDH staff members prepare background and supporting materials for advisory panel review. a. MDH staff members may enlist work groups, task forces, or other external experts to study complex issues. b. Usually the information is provided to the advisory panel in written form, supplemented by staff presentation, comments, and responses to questions during meeting discussions. c. During this stage, MDH staff members begin to identify options and assess their relative merits. 2. The advisory panel provides advice to EHTB program staff and, in some cases, develops formal recommendations. a. Advisory panel members discuss and debate matters as ideas are formulated. b. Discussions by the advisory panel members provide an important opportunity to test MDH staff members’ reactions to ideas and, as appropriate, recommend alternative approaches. c. In some cases, the advisory panel formalizes its advice and recommendations. Recommendations may be recorded as a consensus opinion or by a formal vote. Upon request, voice reports of the majority and minority opinions may be prepared. 3. MDH staff members prepare specific recommendations. a. Advisory panel advice and recommendations are considered carefully in light of alternative options. In many cases, EHTB program staff will need to weigh advisory panel recommendations along with feedback received from other stakeholders (such as community members). The relative merits of each option are examined thoroughly. b. Specific staff recommendations are developed; justification is documented. 4. The Commissioner of Health reviews recommendations and makes final decisions. a. MDH staff members present the advisory panel recommendations via written or verbal report to the Commissioner or the Commissioner’s representative (e.g., EHTB Steering Committee). Reports will include a summary of the issue, background, process, recommendations, and outcome of discussion and voting on recommendations (including other motions, as appropriate). b. MDH staff members present the staff recommendations, as well. These may support or enhance the advisory panel’s recommendations; alternatively, they may present contrary perspectives. 115 c. If substantial differences exist between advisory panel and MDH staff recommendations, the advisory panel chair is invited to meet with the Commissioner of Health or the Commissioner’s representative to provide further information concerning the rationale for the advisory panel recommendations. d. The Commissioner of Health or the Commissioner’s representative makes the final decision based on consideration of information and recommendations received. Adopted March 11, 2008 116 EHTB steering committee roster Mary Manning, RD, MBA Division Director Health Promotion and Chronic Disease Division Minnesota Department of Health PO Box 64882 St. Paul, Minnesota 55164-0882 651-201-3601 [email protected] Norman Crouch, PhD (chair) Assistant Commissioner Minnesota Department of Health PO Box 64975 St Paul, Minnesota 55164-0975 651-201-5063 [email protected] Joanne Bartkus, PhD Division Director Public Health Laboratory Division Minnesota Department of Health PO Box 64899 St Paul, Minnesota 55164-0899 651-201-5256 [email protected] John Linc Stine Division Director Environmental Health Division Minnesota Department of Health PO Box 64975 St Paul, Minnesota 55164-0975 651-201-4675 [email protected] Rev. February 19, 2008 117 EHTB inter-agency workgroup roster Rita Messing, PhD Site Assessment & Consultation Environmental Health Division Minnesota Department of Health PO Box 64975 St Paul, Minnesota 55164-0899 651-201-4916 [email protected] Michonne Bertrand, MPH Chronic Disease & Environmental Epidemiology Health Promotion and Chronic Disease Division Minnesota Department of Health PO Box 64882 St. Paul, Minnesota 55164-0882 651-201-3661 [email protected] Pam Shubat, PhD Health Risk Assessment Environmental Health Division Minnesota Department of Health PO Box 64975 St Paul, Minnesota 55164-0899 651-201-4925 [email protected] Jean Johnson, PhD Chronic Disease & Environmental Epidemiology Health Promotion and Chronic Disease Division Minnesota Department of Health PO Box 64882 St. Paul, Minnesota 55164-0882 651-201-5902 [email protected] Allan Williams, MPH, PhD Chronic Disease & Environmental Epidemiology Health Promotion and Chronic Disease Division Minnesota Department of Health PO Box 64882 St. Paul, Minnesota 55164-0882 651-201-5905 [email protected] Frank Kohlasch, JD Environmental Data Management Unit Environmental Analysis & Outcomes Division Minnesota Pollution Control Agency 520 Lafayette Road N St. Paul, Minnesota 55155-4194 651-205-4581 [email protected] Joe Zachmann, PhD Pesticide & Fertilizer Management Division Minnesota Department of Agriculture 625 Robert Street North St. Paul, Minnesota 55155-2538 651-201-6588 [email protected] Louise Liao, PhD Environmental Laboratory Public Health Laboratory Division Minnesota Department of Health PO Box 64899 St Paul, Minnesota 55164-0899 651-201-5303 [email protected] Rev. October 8, 2007 118 Glossary of terms used in environmental health tracking and biomonitoring Biomarker: According to the National Research Council (NRC), a biomarker is an indicator of a change or an event in a human biological system. The NRC defines three types of biomarkers in environmental health, those that indicate exposure, effect, and susceptibility. Biomarker of exposure: An exogenous substance, its metabolites, or the product of an interaction between the substance and some target molecule or cell that can be measured in an organism. Biomarker of effect: A measurable change (biological, physiological, etc.) within the body that may indicate an actual or potential health impairment or disease. Biomarker of susceptibility: An indicator that an organism is especially sensitive to exposure to a specific external substance. Biomonitoring: As defined by Minnesota Statute 144.995, biomonitoring is the process by which chemicals and their metabolites are identified and measured within a biospecimen. Biomonitoring data are collected by analyzing blood, urine, milk or other tissue samples in the laboratory. These samples can provide physical evidence of current or past exposure to a particular chemical. Biospecimen: As defined by Minnesota Statute 144.995, biospecimen means a sample of human fluid, serum, or tissue that is reasonably available as a medium to measure the presence and concentration of chemicals or their metabolites in a human body. Community: As defined by Minnesota Statute 144.995, community means geographically or nongeographically based populations that may participate in the biomonitoring program. A nongeographical community includes, but is not limited to, populations that may share a common chemical exposure through similar occupations; populations experiencing a common health outcome that may be linked to chemical exposures; populations that may experience similar chemical exposures because of comparable consumption, lifestyle, product use; and subpopulations that share ethnicity, age, or gender. Designated chemicals: As defined by Minnesota Statute 144.995, designated chemicals are those chemicals that are known to, or strongly suspected of, adversely impacting human health or development, based upon scientific, peer-reviewed animal, human, or in vitro studies, and baseline human exposure data. They consist of chemical families or metabolites that are included in the federal Centers for Disease Control and Prevention studies that are known collectively as the National Reports on Human Exposure to Environmental Chemicals Program and any substances specified by the commissioner after receiving recommendations from the advisory panel in accordance with the criteria specified in statute for the selection of specific chemicals to study. Environmental data: Concentrations of chemicals or other substances in the land, water, or air. Also, information about events or facilities that release chemicals or other substances into the land, water, or air. 119 Environmental epidemiology: According to the National Research Council, environmental epidemiology is the study of the effect on human health of physical, biologic, and chemical factors in the external environment. By examining specific populations or communities exposed to different ambient environments, environmental epidemiology seeks to clarify the relation between physical, biologic, and chemical factors and human health. Environmental hazard: As defined by Minnesota Statute 144.995, an environmental hazard is a chemical or other substance for which scientific, peer-reviewed studies of humans, animals, or cells have demonstrated that the chemical is known or reasonably anticipated to adversely impact human health. People can be exposed to physical, chemical, or biological agents from various environmental sources through air, water, soil, and food. For EPHT, environmental hazards include biological toxins, but do not include infectious agents (e.g. E. coli in drinking water is not included). Environmental health indicators: Environmental health indicators or environmental public health indicators are descriptive summary measures that identify and communicate information about a population’s health status with respect to environmental factors. Within the environmental public health indicators framework, indicators are categorized as hazard indicators, exposure indicators, health effect indicators, and intervention indicators. See www.cste.org/OH/SEHIC.asp and www.cdc.gov/nceh/indicators/introduction.htm for more information. Environmental justice: The fair treatment and meaningful involvement of all people regardless of race, national origin, color or income when developing, implementing and enforcing environmental laws, regulations and policies. Fair treatment means that no group of people, including a racial, ethnic, or socioeconomic group, should bear more than its share of negative environmental impacts. Environmental health tracking: As defined in Minnesota Statute 144.995, environmental health tracking is the collection, integration, integration, analysis, and dissemination of data on human exposures to chemicals in the environment and on diseases potentially caused or aggravated by those chemicals. Environmental health tracking is synonymous with environmental public health tracking. Environmental public health surveillance: Environmental public health surveillance is public health surveillance of health effects integrated with surveillance of environmental exposures and hazards. Environmental Public Health Tracking Network: The National Environmental Public Health Tracking Network is a Web-based, secure network of standardized health and environmental data. The Tracking Network draws data and information from state and local tracking networks as well as national-level and other data systems. It will provide the means to identify, access, and organize hazard, exposure, and health data from these various sources and to examine and analyze those data on the basis of their spatial and temporal characteristics. The network is being developed by the Centers for Disease Control and Prevention (CDC) in collaboration with a wide range of stakeholders. See www.cdc.gov/nceh/tracking/network.htm for more information. Environmental Public Health Tracking Program: The Congressionally-mandated national initiative that will establish a network that will enable the ongoing collection, integration, analysis, and interpretation of data about the following factors: (1) environmental hazards, (2) exposure to environmental hazards, and (3) health effects potentially related to exposure to environmental hazards. Visit www.cdc.gov/nceh/tracking/ for more information. 120 Epidemiology: The study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to the control of health problems. Exposure: Contact with a contaminant (by breathing, ingestion, or touching) in such a way that the contaminant may get in or on the body and harmful effects may occur. Exposure indicator: According to the Council of State and Territorial Epidemiologists (CSTE), an exposure indicator is a biological marker in tissue or fluid that identifies the presence of a substance or combination of substances that may potentially harm the individual. Geographic Information Systems (GIS): Software technology that enables the integration of multiple sources of data and displaying data in time and space. Hazard: A factor that may adversely affect health. Hazard indicator: A condition or activity that identifies the potential for exposure to a contaminant or hazardous condition. Health effects: Chronic or acute health conditions that affect the well-being of an individual or community. Health effect indicator: The disease or health problem itself, such as asthma attacks or birth defects, that affect the well-being of an individual or community. Health effects are measured in terms of illness and death and may be chronic or acute health conditions. Incidence: The number of new events (e.g., new cases of a disease in a defined population) within a specified period of time. Institutional Review Board: An Institutional Review Board (IRB) is a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. IRBs check to see that research projects are well designed, legal, ethical, do not involve unnecessary risks, and include safeguards for participants. Intervention: Taking actions in public health so as to reduce adverse health effects, regulatory, and prevention strategies. Intervention indicator: Programs or official policies that minimize or prevent an environmental hazard, exposure or health effect. National Health and Nutrition Examination Survey (NHANES): A continuous survey, conducted by CDC, of the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations. Since 1970, children in the survey were biomonitored for lead poisoning, and since 1999, an increasing number of environmental contaminants has been included in the survey. Visit www.cdc.gov/exposurereport/report.htm for more information. 121 National Human Exposure Assessment Survey (NHEXAS): An EPA survey designed to evaluate comprehensive human exposure to multiple chemicals on a community and regional scale. The study was carried out in EPA Region V, of which Minnesota is a part. Individual households from four Minnesota Counties were included in the survey. Visit www.epa.gov/heasd/edrb/nhexas.htm for more information. Persistent chemicals: Chemical substances that persist in the environment, bioaccumulate through the food web, and pose a risk of causing adverse effects to human health and the environment. Population-based approach: A population-based approach uses a defined population or community as the organizing principle for targeting the broad distribution of diseases and health determinants. A population-based approach attempts to measure or shape a community’s overall health status profile, seeking to affect the determinants of disease within an entire community rather than simply those of single individuals. Prevalence: The number of events (e.g., instances of a given health effect or other condition) in a given population at a designated time. Public health surveillance: The ongoing, systematic collection, analysis, and interpretation of outcome-specific data used to plan, implement, and evaluate public health practice. Standard: Something that serves as a basis for comparison. A technical specification or written report drawn up by experts based on the consolidated results of scientific study, technology, and experience; aimed at optimum benefits; and approved by a recognized and representative body. Revised October 10, 2007 Please submit additions and changes to [email protected] 122 Acronyms used in environmental health tracking and biomonitoring ACGIH American Conference of Governmental Industrial Hygienists ATSDR Agency for Toxic Substances and Disease Registry, DHHS CDC Centers for Disease Control and Prevention, DHHS CERCLA Comprehensive Environmental Response; Compensation and Liability Act (Superfund) CSTE Council of State and Territorial Epidemiologists DHHS US Department of Health and Human Services, including the US Public Health Service, which includes the CDC, ATSDR, NIH and other agencies EPA US Environmental Protection Agency EHTB Environmental Health Tracking and Biomonitoring (the name of Minnesota Statutes 144.995-144.998 and the program established therein) EPHI Environmental Public Health Indicators ICD International Classification of Diseases IRB Institutional Review Board MARS Minnesota Arsenic Study, conducted by MDH in 1998-1999 MDA Minnesota Department of Agriculture MDH Minnesota Department of Health MEHTS Minnesota Environmental Health Tracking System MNPHIN Minnesota Public Health Information Network, MDH MPCA Minnesota Pollution Control Agency NCEH National Center for Environmental Health, CDC NCHS National Center for Health Statistics 123 NGO Non-governmental organization NHANES National Health and Nutrition Examination Survey, National Center for Health Statistics (NCHS) in the CDC NHEXAS National Human Exposure Assessment Survey, EPA NIOSH National Institute for Occupational Safety and Health, CDC NIEHS National Institute of Environmental Health Sciences, NIH NIH National Institutes of Health, DHHS NLM National Library of Medicine, NIH NPL National Priorities List (Superfund) NTP National Toxicology Program, NIEHS, NIH PFBA Perfluorobutanoic acid PFC Perfluorochemicals, including PFBA, PFOA and PFOS PFOA Perfluorooctanoic acid PFOS Perfluorooctane sulfonate PHL Public Health Laboratory, MDH PHIN Public Health Information Network, CDC POP Persistent organic pollutant SEHIC State Environmental Health Indicators Collaborative Revised October 10, 2007 Please submit additions and changes to [email protected] 124 EHTB statute: Minn. Statutes 144.995-144.998 Minnesota: Environmental Health Tracking and Biomonitoring $1,000,000 each year is for environmental health tracking and biomonitoring. Of this amount, $900,000 each year is for transfer to the Minnesota Department of Health. The base appropriation for this program for fiscal year 2010 and later is $500,000. (i) "Environmental hazard" means a chemical or other substance for which scientific, peer-reviewed studies of humans, animals, or cells have demonstrated that the chemical is known or reasonably anticipated to adversely impact human health. (j) "Environmental health tracking" means collection, integration, analysis, and dissemination of data on human exposures to chemicals in the environment and on diseases potentially caused or aggravated by those chemicals. 144.995 DEFINITIONS; ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING. (a) For purposes of sections 144.995 to 144.998, the terms in this section have the meanings given. (b) "Advisory panel" means the Environmental Health Tracking and Biomonitoring Advisory Panel established under section 144.998. (c) "Biomonitoring" means the process by which chemicals and their metabolites are identified and measured within a biospecimen. (d) "Biospecimen" means a sample of human fluid, serum, or tissue that is reasonably available as a medium to measure the presence and concentration of chemicals or their metabolites in a human body. (e) "Commissioner" means the commissioner of the Department of Health. (f) "Community" means geographically or nongeographically based populations that may participate in the biomonitoring program. A "nongeographical community" includes, but is not limited to, populations that may share a common chemical exposure through similar occupations, populations experiencing a common health outcome that may be linked to chemical exposures, populations that may experience similar chemical exposures because of comparable consumption, lifestyle, product use, and subpopulations that share ethnicity, age, or gender. (g) "Department" means the Department of Health. (h) "Designated chemicals" means those chemicals that are known to, or strongly suspected of, adversely impacting human health or development, based upon scientific, peer-reviewed animal, human, or in vitro studies, and baseline human exposure data, and consists of chemical families or metabolites that are included in the federal Centers for Disease Control and Prevention studies that are known collectively as the National Reports on Human Exposure to Environmental Chemicals Program and any substances specified by the commissioner after receiving recommendations under section 144.998, subdivision 3, clause (6). 144.996 ENVIRONMENTAL HEALTH TRACKING; BIOMONITORING. Subdivision 1. Environmental health tracking. In cooperation with the commissioner of the Pollution Control Agency, the commissioner shall establish an environmental health tracking program to: (1) coordinate data collection with the Pollution Control Agency, Department of Agriculture, University of Minnesota, and any other relevant state agency and work to promote the sharing of and access to health and environmental databases to develop an environmental health tracking system for Minnesota, consistent with applicable data practices laws; (2) facilitate the dissemination of aggregate public health tracking data to the public and researchers in accessible format; (3) develop a strategic plan that includes a mission statement, the identification of core priorities for research and epidemiologic surveillance, and the identification of internal and external stakeholders, and a work plan describing future program development and addressing issues having to do with compatibility with the Centers for Disease Control and Prevention's National Environmental Public Health Tracking Program; (4) develop written data sharing agreements as needed with the Pollution Control Agency, Department of Agriculture, and other relevant state agencies and organizations, and develop additional procedures as needed to protect individual privacy; 125 stages of biomonitoring work; and (5) submit a biennial report to the chairs and ranking members of the committees with jurisdiction over environment and health by January 15, beginning January 15, 2009, on the status of the biomonitoring program and any recommendations for improvement. Subd. 3. Health data. Data collected under the biomonitoring program are health data under section 13.3805. (5) organize, analyze, and interpret available data, in order to: (i) characterize statewide and localized trends and geographic patterns of population-based measures of chronic diseases including, but not limited to, cancer, respiratory diseases, reproductive problems, birth defects, neurologic diseases, and developmental disorders; (ii) characterize statewide and localized trends and geographic patterns in the occurrence of environmental hazards and exposures; (iii) assess the feasibility of integrating disease rate data with indicators of exposure to the selected environmental hazards such as biomonitoring data, and other health and environmental data; (iv) incorporate newly collected and existing health tracking and biomonitoring data into efforts to identify communities with elevated rates of chronic disease, higher likelihood of exposure to environmental hazards, or both; (v) analyze occurrence of environmental hazards, exposures, and diseases with relation to socioeconomic status, race, and ethnicity; (vi) develop and implement targeted plans to conduct more intensive health tracking and biomonitoring among communities; and (vii) work with the Pollution Control Agency, the Department of Agriculture, and other relevant state agency personnel and organizations to develop, implement, and evaluate preventive measures to reduce elevated rates of diseases and exposures identified through activities performed under sections 144.995 to 144.998; and (6) submit a biennial report to the chairs and ranking members of the committees with jurisdiction over environment and health by January 15, beginning January 15, 2009, on the status of environmental health tracking activities and related research programs, with recommendations for a comprehensive environmental public health tracking program. Subd. 2. Biomonitoring. The commissioner shall: (1) conduct biomonitoring of communities on a voluntary basis by collecting and analyzing biospecimens, as appropriate, to assess environmental exposures to designated chemicals; (2) conduct biomonitoring of pregnant women and minors on a voluntary basis, when scientifically appropriate; (3) communicate findings to the public, and plan ensuing stages of biomonitoring and disease tracking work to further develop and refine the integrated analysis; (4) share analytical results with the advisory panel and work with the panel to interpret results, communicate findings to the public, and plan ensuing 144.997 BIOMONITORING PILOT PROGRAM. Subdivision 1. Pilot program. With advice from the advisory panel, and after the program guidelines in subdivision 4 are developed, the commissioner shall implement a biomonitoring pilot program. The program shall collect one biospecimen from each of the voluntary participants. The biospecimen selected must be the biospecimen that most accurately represents body concentration of the chemical of interest. Each biospecimen from the voluntary participants must be analyzed for one type or class of related chemicals. The commissioner shall determine the chemical or class of chemicals to which community members were most likely exposed. The program shall collect and assess biospecimens in accordance with the following: (1) 30 voluntary participants from each of three communities that the commissioner identifies as likely to have been exposed to a designated chemical; (2) 100 voluntary participants from each of two communities: (i) that the commissioner identifies as likely to have been exposed to arsenic; and (ii) that the commissioner identifies as likely to have been exposed to mercury; and (3) 100 voluntary participants from each of two communities that the commissioner identifies as likely to have been exposed to perfluorinated chemicals, including perfluorobutanoic acid. Subd. 2. Base program. (a) By January 15, 2008, the commissioner shall submit a report on the results of the biomonitoring pilot program to the chairs and ranking members of the committees with jurisdiction over health and environment. (b) Following the conclusion of the pilot program, the commissioner shall: (1) work with the advisory panel to assess the usefulness of continuing biomonitoring among members of communities assessed during the pilot program and to identify other communities and other designated chemicals to be assessed via biomonitoring; (2) work with the advisory panel to assess the pilot program, including but not limited to the validity and 126 to the development of materials specifically designed to ensure that parents are informed about all of the benefits of breastfeeding so that the program does not result in an unjustified fear of toxins in breast milk, which might inadvertently lead parents to avoid breastfeeding. The materials shall communicate relevant scientific findings; data on the accumulation of pollutants to community health; and the required responses by local, state, and other governmental entities in regulating toxicant exposures; (4) a training program that is culturally sensitive specifically for health care providers, health educators, and other program administrators; (5) a designation process for state and private laboratories that are qualified to analyze biospecimens and report the findings; and (6) a method for informing affected communities and local governments representing those communities concerning biomonitoring activities and for receiving comments from citizens concerning those activities. (b) The commissioner may enter into contractual agreements with health clinics, community-based organizations, or experts in a particular field to perform any of the activities described under this section. accuracy of the analytical measurements and adequacy of the guidelines and protocols; (3) communicate the results of the pilot program to the public; and (4) after consideration of the findings and recommendations in clauses (1) and (2), and within the appropriations available, develop and implement a base program. Subd. 3. Participation. (a) Participation in the biomonitoring program by providing biospecimens is voluntary and requires written, informed consent. Minors may participate in the program if a written consent is signed by the minor's parent or legal guardian. The written consent must include the information required to be provided under this subdivision to all voluntary participants. (b) All participants shall be evaluated for the presence of the designated chemical of interest as a component of the biomonitoring process. Participants shall be provided with information and fact sheets about the program's activities and its findings. Individual participants shall, if requested, receive their complete results. Any results provided to participants shall be subject to the Department of Health Institutional Review Board protocols and guidelines. When either physiological or chemical data obtained from a participant indicate a significant known health risk, program staff experienced in communicating biomonitoring results shall consult with the individual and recommend follow-up steps, as appropriate. Program administrators shall receive training in administering the program in an ethical, culturally sensitive, participatory, and communitybased manner. Subd. 4. Program guidelines. (a) The commissioner, in consultation with the advisory panel, shall develop: (1) protocols or program guidelines that address the science and practice of biomonitoring to be utilized and procedures for changing those protocols to incorporate new and more accurate or efficient technologies as they become available. The commissioner and the advisory panel shall be guided by protocols and guidelines developed by the Centers for Disease Control and Prevention and the National Biomonitoring Program; (2) guidelines for ensuring the privacy of information; informed consent; follow-up counseling and support; and communicating findings to participants, communities, and the general public. The informed consent used for the program must meet the informed consent protocols developed by the National Institutes of Health; (3) educational and outreach materials that are culturally appropriate for dissemination to program participants and communities. Priority shall be given 144.998 ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING ADVISORY PANEL. Subdivision 1. Creation. The commissioner shall establish the Environmental Health Tracking and Biomonitoring Advisory Panel. The commissioner shall appoint, from the panel's membership, a chair. The panel shall meet as often as it deems necessary but, at a minimum, on a quarterly basis. Members of the panel shall serve without compensation but shall be reimbursed for travel and other necessary expenses incurred through performance of their duties. Members appointed by the commissioner are appointed for a three-year term and may be reappointed. Legislative appointees serve at the pleasure of the appointing authority. Subd. 2. Members. (a) The commissioner shall appoint eight members, none of whom may be lobbyists registered under chapter 10A, who have backgrounds or training in designing, implementing, and interpreting health tracking and biomonitoring studies or in related fields of science, including epidemiology, biostatistics, environmental health, laboratory sciences, occupational health, industrial hygiene, toxicology, and public health, including: (1) at least two scientists representative of each of the following: (i) nongovernmental organizations with a focus on environmental health, environmental justice, 127 (viii) the availability of adequate biospecimen samples; or (ix) other criteria that the panel may agree to; and (7) other aspects of the design, implementation, and evaluation of the environmental health tracking and biomonitoring system, including, but not limited to: (i) identifying possible community partners and sources of additional public or private funding; (ii) developing outreach and educational methods and materials; and (iii) disseminating environmental health tracking and biomonitoring findings to the public. Subd. 4. Liability. No member of the panel shall be held civilly or criminally liable for an act or omission by that person if the act or omission was in good faith and within the scope of the member's responsibilities under sections 144.995 to 144.998. children's health, or on specific chronic diseases; and (ii) statewide business organizations; and (2) at least one scientist who is a representative of the University of Minnesota. (b) Two citizen panel members meeting the scientific qualifications in paragraph (a) shall be appointed, one by the speaker of the house and one by the senate majority leader. (c) In addition, one representative each shall be appointed by the commissioners of the Pollution Control Agency and the Department of Agriculture, and by the commissioner of health to represent the department's Health Promotion and Chronic Disease Division. Subd. 3. Duties. The advisory panel shall make recommendations to the commissioner and the legislature on: (1) priorities for health tracking; (2) priorities for biomonitoring that are based on sound science and practice, and that will advance the state of public health in Minnesota; (3) specific chronic diseases to study under the environmental health tracking system; (4) specific environmental hazard exposures to study under the environmental health tracking system, with the agreement of at least nine of the advisory panel members; (5) specific communities and geographic areas on which to focus environmental health tracking and biomonitoring efforts; (6) specific chemicals to study under the biomonitoring program, with the agreement of at least nine of the advisory panel members; in making these recommendations, the panel may consider the following criteria: (i) the degree of potential exposure to the public or specific subgroups, including, but not limited to, occupational; (ii) the likelihood of a chemical being a carcinogen or toxicant based on peer-reviewed health data, the chemical structure, or the toxicology of chemically related compounds; (iii) the limits of laboratory detection for the chemical, including the ability to detect the chemical at low enough levels that could be expected in the general population; (iv) exposure or potential exposure to the public or specific subgroups; (v) the known or suspected health effects resulting from the same level of exposure based on peerreviewed scientific studies; (vi) the need to assess the efficacy of public health actions to reduce exposure to a chemical; (vii) the availability of a biomonitoring analytical method with adequate accuracy, precision, sensitivity, specificity, and speed; INFORMATION SHARING. On or before August 1, 2007, the commissioner of health, the Pollution Control Agency, and the University of Minnesota are requested to jointly develop and sign a memorandum of understanding declaring their intent to share new and existing environmental hazard, exposure, and health outcome data, within applicable data privacy laws, and to cooperate and communicate effectively to ensure sufficient clarity and understanding of the data by divisions and offices within both departments. The signed memorandum of understanding shall be reported to the chairs and ranking members of the senate and house of representatives committees having jurisdiction over judiciary, environment, and health and human services. Effective date: July 1, 2007 This document contains Minnesota Statutes, sections 144.995 to 144.998, as these sections were adopted in Minnesota Session Laws 2007, chapter 57, article 1, sections 143 to 146. The appropriation related to these statutes is in chapter 57, article 1, section 3, subdivision 4. The paragraph about information sharing is in chapter 57, article 1, section 169. The following is a link to chapter 57: http://ros.leg.mn/bin/getpub.php?type=law&year=20 07&sn=0&num=57 128
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