Minnesota Department of Health Environmental Health Tracking and Biomonitoring Advisory Panel Meeting March 9, 2010 1:00 p.m. – 4:00 p.m. Snelling Office Park Red River Room 1645 Energy Park Drive St. Paul, Minnesota ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING ADVISORY PANEL MEETING AGENDA Time Agenda item Presenter(s) 1:00 Welcome, introduction of new panel members and general introductions Beth Baker, Chair Item type/Anticipated outcome TRACKING 1:05 Climate change indicators Chuck Stroebel Wendy Brunner Information sharing Staff will provide preliminary information about national and state activities to develop environmental health outcome indicators for climate change. The presentation will include examples of current indicators being developed at the national and state levels and information on potential data sources and indicators of interest to Minnesota. Panel members are invited to ask questions or provide input on this topic. 1:45 Criteria for selecting Minnesota-specific tracking priorities Michonne Bertrand Jean Johnson Discussion item Staff will present a set of draft criteria for evaluating and selecting Minnesota-specific tracking priorities. Panel members are invited to provide input on the draft criteria. In particular, panel members are asked to respond to the following questions: What other criteria should be considered when weighing new content areas and/or measures? Which criteria are the most important? Which are less important? What information does the advisory panel need in order to effectively make recommendations about new content areas and/or measures? i Time Agenda item 2:25 Tracking updates MN EPHT webbased information system EPHTN collaborations Communications and outreach 2:40 Presenter(s) Item type/Anticipated outcome Information sharing Panel members are invited to ask questions or provide input on any of the tracking updates included in the meeting materials. Break BIOMONITORING 2:55 Lessons learned from biomonitoring pilot program: Selection of study communities Jean Johnson Andrea Baeder Michonne Bertrand Discussion item. Staff will share a draft document describing some of the lessons learned from the biomonitoring pilot program. The EHTB statute requires MDH to submit a report about the pilot biomonitoring program; these lessons learned will be further developed and summarized as part of that report. Panel members are invited to provide input on the summary of lessons learned from the biomonitoring pilot program. In particular, panel members are asked to respond to the following questions: The two pilot projects that have been completed so far (i.e., arsenic and PFCs) were special investigations designed to measure chemicals in communities in response to specific exposure concerns. If Minnesota were to continue using a special investigation approach to biomonitoring, what recommendations would you make with regard to community selection? When is biomonitoring an appropriate response to community concerns about exposures to environmental contaminants? When is it not an appropriate response? If Minnesota were to continue using a community-based investigation approach to biomonitoring, how should requests from concerned communities, public health officials ii Time Agenda item Presenter(s) Item type/Anticipated outcome 3:40 and elected representatives be prioritized? What factors should be considered? Thinking more broadly, in what ways were these two projects most successful? Information sharing. Biomonitoring updates Lake Superior mercury biomonitoring study Riverside prenatal biomonitoring study East Metro PFC biomonitoring study Panel members are invited to ask questions or provide input on any of the biomonitoring updates included in the meeting materials. OTHER 3:55 New business Beth Baker Discussion item. The chair will invite panel members to suggest topics for future discussion. 4:00 Adjourn Beth Baker Next meeting: Tuesday, June 8, 2010, 1-4 p.m. Red River Room, Snelling Office Park iii This page intentionally left blank iv TABLE OF CONTENTS Agenda ................................................................................................................................... i Table of contents ................................................................................................................v Materials related to specific agenda items Climate change indicators Section overview: Climate change indicators...................................................................1 Development of environmental health indicators for climate change ..............................3 Public health impacts of climate change...........................................................................7 Criteria for selecting Minnesota-specific tracking priorities Section overview: Criteria for selecting Minnesota-specific tracking priorities ............25 Draft criteria for selecting data content areas and measures for MN EPHT ..................27 Draft model for evaluating new content areas, data and measures.................................31 Tracking updates Section overview: Tracking updates...............................................................................33 Status update on the MN EPHT web-based information system....................................35 Status update on EPHTN collaborations.........................................................................36 Status update on communications and outreach .............................................................38 Lessons learned from biomonitoring pilot program Section overview: Lessons learned from biomonitoring pilot program .........................39 Background information on the MDH biomonitoring pilot program .............................41 Biomonitoring vision, purpose and approaches..............................................................45 Lessons learned from the biomonitoring pilot program: Selection of study communities (DRAFT) .............................................................................................49 Biomonitoring updates Section overview: Biomonitoring updates......................................................................53 Status update on the Lake Superior mercury biomonitoring study.................................55 Status update on the Riverside prenatal biomonitoring study ........................................56 Status update on the East Metro PFC biomonitoring study............................................57 v Other information Section overview: Other information....................................................................................59 Minnesota Environmental Public Health Tracking & Biomonitoring presentations, posters and publications............................................................................................61 Local, national and global biomonitoring and tracking news…...........................................63 EHTB advisory panel meeting summary (for December 8, 2009) .......................................65 EHTB advisory panel roster (revised) ..................................................................................75 Biographical sketches of advisory panel members (revised)................................................77 EHTB steering committee roster (revised) ...........................................................................81 EHTB governance structure (revised) ..................................................................................83 vi SECTION OVERVIEW: CLIMATE CHANGE INDICATORS As reported at the September 15, 2009, meeting of the EHTB advisory panel, the content area of climate change was recently added to the national EPHT network. MN EPHT staff have been participating in discussions about developing nationally consistent data and measures (NCDMs) related to this new content area. In addition, MN EPHT staff have been exploring potential data sources and indicators of interest to Minnesota. At the March advisory panel meeting, MN EPHT staff will provide an overview of the efforts underway to develop environmental health indicators for climate change, potential indicators, the strengths and limitations of potential data sets, and the next steps in the process. The following items are included in this section of the meeting materials: Development of environmental health indicators for climate change: This document summarizes preliminary efforts made by the national EPHT climate change team and MN EPHT staff to develop climate change indicators. Public health impacts of climate change: This document provides an overview of potential public health impacts of climate change and examples of public health responses to climate change. It is provided as background on the issue of climate change and includes resources for more information. ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on this topic during the designated time on the meeting agenda. 1 This page intentionally left blank. 2 Development of environmental health indicators for climate change National EPHT Network In 2009 the National Environmental Public Health Tracking Network adopted climate change as a core content area. Since October 2009, MDH and other EPHT grantees have been participating in monthly calls of the EPHT Climate Change Team. Initial activities of this team have focused on extreme heat events and methods for developing an indicator of heat-related mortality. Anticipated next steps include development of more sensitive (and specific) morbidity indicators, such as hospitalizations and emergency department visits from heat-related illnesses (e.g., heat stroke). SEHIC For some time MDH epidemiologists have been working with other states to develop environmental health indicators for climate change through a Council of State and Territorial Epidemiologists (CSTE) sponsored group called the State Environmental Health Indicators Collaborative (SEHIC). MDH participates in monthly calls with the SEHIC Climate Change Workgroup. This workgroup is developing a broad suite of indicators related to the environment, morbidity/mortality, vulnerability, adaptation, and policies related to climate change. The initial list of climate change indicators proposed by the SEHIC Climate Change Workgroup is included below. As the workgroup pilots the indicators, some of the indicators will drop off of the list due to data gaps, inconsistency of data across states, and/or other reasons. SEHIC’s Proposed Environmental Health Indicators for Climate Change Environmental Indicators Greenhouse Gas Emissions Air Mass Stagnation Events Ozone due to Climate Change Maximum and Minimum Temperatures/ Heat Index Increase in Heat Alerts/ Warnings Pollen Counts Frequency, Severity, Distribution, and Duration of Wildfires Droughts Harmful Algal Blooms Morbidity & Mortality Indicators Excess Mortality due to Extreme Heat Excess Morbidity due to Extreme Heat Number of Injuries/ Mortality from Extreme Weather Events 3 Human Cases of Infectious Disease/ Positive Test Results in Sentinels and Reservoirs Respiratory/ Allergic Disease and Mortality Related to Increased Air Pollution and Pollens Vulnerability Indicators Population Vulnerability or General Social Vulnerability Heat Vulnerability Flood Vulnerability Sea Level Rise Vulnerability Mitigation Indicators Energy Efficiencies Use of Renewable Energy Number of Vehicle Miles Traveled Adaptation Indicators Access to Cooling Centers Number of Heat Wave Early Warning Systems/ Heat Alerts Number of Municipal Heat Island Mitigation Plans Number of Health Surveillance Systems Related to Climate Change Public Health Workforce Available/ Trained in Climate Change Research, Surveillance, and Adaptation Policy Indicators Number of Cities/ Municipalities Covered by Kyoto Protocol Number of States/Cities Participating in Climate Change Initiatives A summary of SEHICs efforts was published in the November 2009 issue of Environmental Health Perspectives (available on-line at): http://ehsehplp03.niehs.nih.gov/article/fetchArticle.action?articleURI=info%3Adoi%2F1 0.1289%2Fehp.0900708. Through SEHIC, MDH epidemiologist, Wendy Brunner, has been working closely with other states to develop indicators for pollen that may be related to climate change and respiratory health outcomes (e.g., asthma). Indicators may provide a measure for different pollen types, loads, and the duration of the pollen season. SEHIC is currently working with the National Allergy Bureau to gain access to national pollen monitoring data; however, spatial coverage of these data is limited. This effort is highlighting a potentially important data gap for evaluating the impact of climate change on pollen, and subsequent impacts on respiratory diseases (e.g., exacerbation of asthma; emphysema and bronchitis). Members of SEHIC and the EPHT Climate Change Team are scheduled to hold a joint meeting at the April EPHT workshop. One primary objective of this meeting is to 4 facilitate coordination and communication between these two national efforts to develop climate change indicators. Related developments In December 2008 MDH completed a summary paper on the public health impacts of climate change (included in your materials). MDH developed this paper to provide: (1) a summary of information about potential health impacts of climate change in the US, (2) examples of public health responses to climate change, and (3) resources for more information. This paper has been used as a preliminary paper for MDH employees and senior management. In August 2009 MDH also received a grant from the Association of State and Territorial Health Officials (ASTHO) to build capacity for addressing the public health impacts of climate change. As a part of this grant, MDH conducted a needs assessment (electronic survey) of MDH employees regarding knowledge and awareness about climate change. MDH currently is developing training modules (webinars) on climate change topics, including population vulnerability, extreme heat events, and vector-borne diseases. MDH also expects to develop a 5-year strategic plan for addressing climate change impacts (on public health) in Minnesota. 5 This page intentionally left blank. 6 Public Health Impacts of Climate Change Minnesota Department of Health December 9, 2008 …the most important question we must ask ourselves is, “Are we being good ancestors?” Jonas Salk INTRODUCTION The following document provides: (1) a summary of information about potential public health impacts of climate change in the US, (2) examples of public health responses to climate change, and (3) resources for more information. This document was prepared by the Minnesota Department of Health (Health Risk Assessment Unit) to highlight areas where further evaluation is needed and to identify resources for additional information. This synthesis is based on a review of scientific journals, presentations, and other information from leading climate change and public health authorities, including the Intergovernmental Panel on Climate Change, Centers for Disease Control and Prevention, US Environmental Protection Agency, National Institute of Environmental Health Sciences, and the Institute of Medicine. This not a comprehensive review of all potential public health impacts from climate change, or potential public health responses; nor does this document address specific regional, state, or local impacts. BACKGROUND The scientific consensus is that the global climate is changing with rising surface temperatures, melting ice and snow, rising sea levels, and increasing climate variability (IPCC 2007; CDC 2008). These global phenomena are highly likely to cause wide fluctuations in climate variables (e.g., temperature, precipitation) at regional and local levels in the US. These changes are expected to have substantial impacts on public health, including increases in morbidity and mortality attributed to extreme heat events (e.g., heat waves), extreme weather events (e.g., floods, hurricanes), air pollution, and vector-borne and other infectious diseases. Uncertainty remains regarding the rate at which these impacts will occur, in part, because of the underlying complexities of physical and biological systems (e.g., variable adaptive responses of ecosystems and humans to the effects of climate change). Predictive models serve as useful tools to identify and evaluate potential climate and public health impacts. A coordinated, multi-disciplinary research strategy will be needed to address data gaps, reduce model uncertainty, and ultimately to better understand long-term climate change impacts (e.g., factors influencing the rate of temperature change; reversibility/ irreversibility of public health impacts). Public health impacts from climate change are expected to vary considerably by region and by demographic and individual factors associated with susceptibility. Population vulnerability assessments using GIS methodologies are emerging as useful tools for developing effective intervention and communication strategies (e.g., for state and local emergency preparedness planning). Populations likely to be at risk from climate change impacts include: children and the elderly; people of low socioeconomic status; people with underlying medical conditions; and people living in coastal or low lying lands. Additional populations may be at risk, depending on the climate impact. 7 Climate change is likely to increase the costs of health care, fuel, food, water and other resources. These increases are likely to widen the gap between low and high socioeconomic populations (i.e., perpetuate health disparities), and to impact an already burdened health care and public health systems. Frequent and severe weather events can cause displacement, disrupt social support systems and increase behavioral health issues including depression and post-traumatic stress disorder. While some climate impacts have a direct and immediate effect on human health (e.g., heat-related morbidity and mortality from heat waves); other impacts are indirect through the environment and ecosystems (e.g., vector-borne and water-borne diseases). There are known, effective public health responses to many of these impacts, but the scope, timeline, and complexity of climate change are unprecedented. Some of these impacts will require immediate public health actions (e.g., emergency response to a disaster); others will require longer-term, sustained actions (e.g., addressing gaps in public health infrastructure; disease surveillance, medical services). Public health responses will need to be multi-dimensional requiring the coordination of all levels of government, academia, the private sector, and non-government organizations. Responses to climate change are often described in terms of mitigation and adaptation. o Primary prevention corresponds to mitigation – efforts to slow, stabilize, or reverse climate change by reducing greenhouse gas emissions (Frumkin et al., 2008a). Mitigation efforts will occur mainly in sectors other than health, such as energy, transportation, and architecture. o Secondary and tertiary prevention corresponds to adaptation – efforts to anticipate and prepare for the effects of climate change, and thereby to reduce the associated health burden. Public health responses are likely to focus on adaptation. However, the health sector, as a large and energy intensive component of the US economy, has an opportunity to demonstrate leadership by promoting sustainable and health practices. From a policy perspective it is important to note that many responses to reduce future impacts of climate change offer co-benefits for health. If an action that addresses climate change –e.g., reducing greenhouse gas emissions, developing and deploying sustainable energy technologies, and/or adapting to climate change – yields multiple benefits, then that action may represent an exceptional opportunity to improve public health. Health professionals and others need to be alert to such opportunities (for case studies of cobenefits, see Frumkin et al., 2008b; Younger et al., 2008). PUBLIC HEALTH IMPACTS The following are anticipated public health impacts from climate change in the US. Extreme Heat Events (heat waves) Climate change is highly likely to increase the frequency, intensity, duration, and geographic distribution of heat waves, causing increases in heat-related illnesses (e.g., 8 2 morbidity and mortality from heat exhaustion and heat stroke). These events will be exacerbated by increasing urbanization and the aging US population. Heat waves currently cause more deaths than hurricanes, lightning, tornadoes, floods, and earthquakes combined (CDC 2008a). From 1999-2003, a total of 3,442 reported heatrelated deaths occurred, with an annual mean of 688 deaths (MMWR 2006). Cases of heat-related illnesses are thought to be substantially underreported because the cause of death is often attributed to other causes (e.g., death certificates may identify heat-related exposures as a contributing cause (as opposed to the primary cause) of death, or not list it at all). Some populations will be more affected by heat waves than others. For example, heat waves will impact urban areas more than rural areas because of the “urban heat island effect.” Also, cities with cooler climates tend to experience more heat-related deaths than those with warmer climates whose populations can better acclimatize to different levels of temperature (Haines et al., 2004). Populations especially vulnerable to heat waves include people living in homes without air conditioning, people with underlying medical conditions, the elderly, young, and homeless. Extreme Weather Events (hurricanes, floods, tornadoes, landslides) Climate change is very likely to increase the frequency and intensity of extreme weather events over the next century. For instance, future hurricanes will become more intense with higher peak wind speeds and heavier precipitation events (IPCC 2007). This is likely to increase event-related morbidity and mortality from injuries, drowning, and infectious diseases. Increases in the number of heavy precipitation events will likely result in flooding that overwhelms storm and waste water infrastructure. Extreme weather events also are likely to disrupt public health and medical services (e.g., requiring emergency preparedness and response, and medical services). Populations at risk from extreme weather events include people living in coastal areas; low-lying land dwellers; people with low socioeconomic status; children; and the elderly. Vector-Borne/Zoonotic Diseases Climate change is likely to alter the geographical distribution and incidence of US vectorborne diseases (e.g., diseases transmitted by mosquitoes and ticks) and other zoonotic diseases (i.e., diseases with animal reservoirs) (Gage et al., 2008). Risks associated with these diseases are likely to increase in some areas and decrease in others. Predictions about vector-borne and other disease impacts from climate change are uncertain because there are multiple contributing factors that influence disease risk, including temperature and precipitation patterns, movement of human and animal populations, vector and reservoir host survival, public health infrastructure, changes in land use, and the emergence of drug or pesticide resistance. Higher temperatures, in combination with favorable rainfall patterns, could enhance vector development in some locations where certain diseases already exist (e.g., West Nile Virus in Minnesota). In other locations, climate change may inhibit vector development or reduce survival. Climate variability also is likely to influence pathogen development (e.g., extrinsic incubation periods, pathogen concentrations with vectors and reservoir hosts). 9 3 Climate change also is likely to facilitate the emergence and establishment of vectorborne diseases that are currently endemic to the tropics or subtropics (e.g., malaria, dengue fever). Wetter conditions may increase numbers of ticks that transmit Lyme disease or fleas that transmit plague; dry conditions in other regions may reduce numbers (CDC 2008b). Population vulnerability is disease specific. Risks are expected to be higher in rural areas (compared to urban areas) for many vector-borne diseases. Air Pollution Higher temperatures and changing meteorology from climate change will likely worsen air pollution episodes in the US. This primarily is attributed to increases in ambient concentrations of ground-level ozone (i.e., higher temperatures hasten the chemical reactions that lead to ozone formation) (Kinney 2008). In addition, air emissions from power plants are likely to increase with heat waves, when air conditioning use peaks. Several areas in the US currently experience air pollution health alerts. Exposures to high levels of ozone are associated with increases in morbidity and mortality due to respiratory effects – particularly in vulnerable populations (e.g., people with asthma, emphysema, bronchitis). The impact of climate change on fine particle concentrations remains uncertain, with somewhat conflicting results from the few studies conducted to date (Kinney, 2008). However, climate change is likely to increase the risk of wildfires which are a major local and regional source of fine particles (see wildfires below). Allergens/Allergies Climate change is likely to influence the distribution and abundance of pollen and other airborne allergens with a corresponding increase in allergic responses (e.g., allergic asthma, hay fever, atopic dermatitis). Earlier onset of the pollen season due to higher temperatures and a longer growing season also is likely to increase the duration and intensity of allergic responses. Experimental studies also indicate that a rise in ambient levels of carbon dioxide itself also may cause increases in pollen levels (Kinney 2008). Elevated concentrations have been shown to increase pollen production and allergen potency (e.g., ragweed). Changes in temperatures and precipitation also may also influence the distribution and abundance of molds and other allergens (e.g., dust mites, animal dander, and cockroaches). Collectively, these changes suggest that future aeroallergen characteristics of our environment may change considerably as a result of climate change. Vulnerable populations include people with allergies; people with pre-existing respiratory diseases; children and the elderly. Wildfires Higher temperatures, decreased soil moisture, and extended periods of draught are likely to increase the risk of wildfires, particularly in the southwestern US. Wildfires are associated with increased risks of morbidity and mortality from physical injuries/trauma and smoke inhalation. In addition, increases in wildfires will require additional public health and medical services. 10 4 Wildfires are a significant source of local and regional air pollution, including fine particles and nitrogen oxides. These pollutants can travel long distances and have regional (and even global) impacts on air quality and visibility. Vulnerable populations include people living in low precipitation areas; people with preexisting respiratory and cardiovascular diseases; children; elderly; outdoor workers; athletes; and low socioeconomic populations Water-borne and Food-Borne Diseases Extremes of the hydrologic cycle will accompany climate change, causing precipitation intensity to increase, particularly in middle and high latitudes (e.g., Great Lakes Region) (Patz et al., 2008). These changes are likely to increase risks associated with flooding and water-borne disease outbreaks. Heavy precipitation events have been shown to lead to storm water discharges of sewage and contaminants into surface water bodies. The abundance and distribution of pathogens in water will depend on several factors influenced by climate change (e.g., sunlight, pH, currents, water temperatures). The Great Lakes serve as a primary drinking water source for more than 40 million people. In addition, rivers (e.g., Mississippi River) and reservoirs serve as a primary drinking water sources for a large percentage of the US population. Extreme precipitation events may overwhelm sewer systems and lead to overflow events that impact human health (and recreation). Heavy precipitation events and rising sea levels may cause flooding, resulting in contamination of drinking water (groundwater) wells and contamination (petroleum and other spills/leaks). Damage from flooding will increase the risks associated with mold exposures. A large proportion of the US population lives in coastal or low-lying areas that are likely to experience increased risks of flooding from climate change. Changes in water quality may also influence the proliferation of phytoplankton that release toxins causing illnesses through bathing or ingestion (e.g., when fish or shellfish are consumed). Thermal and hydrologic changes may affect the usability of recreational beaches. In addition, outbreaks associated with food-borne illnesses may increase because of conditions (e.g., rising temperatures) that are conducive to proliferation of food pathogens. Vulnerable populations include: children, elderly, people with underlying medical conditions (e.g., immunocompromised); people in low-lying or coastal lands; people whose primary drinking water source is surface water or a shallow aquifer. Water and Food Supplies Decreases in snow melt and spring stream flows coupled with increasing demand for water from a growing population and increasing average temperatures are likely to exacerbate water shortages, particularly in areas already facing shortages (e.g., western and southeastern US). Drinking water supplies along coastal areas may also be impacted by rising sea water (i.e., increasing salinization of groundwater used for drinking). Changes in the patterns of distribution of pests, parasites, and pathogens affecting wildlife, livestock, agriculture, forests, coastal marine organisms are likely to alter ecosystem composition and functions. This, in combination with changes in climate 11 5 (temperature, moisture), are likely to influence crop yields, pesticide use, and potentially the costs of food. Ocean acidification resulting from increased absorption of atmospheric carbon dioxide into the oceans, poses a severe threat to marine organisms. This could result in collapse of certain ocean ecosystems, severely compromising food supplies in costal communities dependent on seafood. Deterioration of coral reefs may cause the collapse of fisheries (and damage tourist economies) in some areas. Vulnerable populations include: populations in areas experiencing drought conditions and water shortages; coastal areas subject to salinization; and low socioeconomic populations (e.g., due to the increasing costs of food and water). Other Impacts Climate change impacts will burden an already taxed US health care system by placing greater demands on emergency preparedness and response programs (e.g., increasing needs associated with disaster relief and medical care following extreme weather events) and public health surveillance (e.g., increases need for disease surveillance; public health interventions and care for refugee populations globally from dislocation and conflicts). Climate change will result in disproportionate and severe impacts to other areas of the world (Africa, Southeast Asia). Climate change is highly likely to impact mental health (stress levels, post traumatic stress disorder) of affected populations (e.g., extreme weather events causing dislocations of populations; those with disrupted access to health care services). On a geologic scale and time frame, climate change is likely to result in extensive loss of species (i.e., extinctions). Generally, the stability of ecosystems depends on their biodiversity; and these systems could reach a tipping point and collapse (i.e., indirectly impacting public health). These changes also are highly likely to eliminate species that would be beneficial for future generations (e.g., pharmaceuticals, consumer products). PUBLIC HEALTH RESPONSES The tone of the debate has shifted from whether climate change impacts are occurring, to how we will deal with them. There is ongoing debate about public policies related to who will have to pay for adaptation and mitigation strategies; and what are the appropriate policies/roles for government (federal, state, local) and other sectors, such as industry; academia; health care professionals; environmental organizations and non-profit organizations. Public health responses to address climate change will vary at regional, state, and local levels. These actions may be viewed in the context of the standard 10 essential public health environmental services (CDC 2008c): 1. Monitor environmental and health status to identify and solve community environmental health problems 2. Diagnose and investigate environmental health problems and health hazards in the community 3. Inform, educate and empower people about environmental health issues 4. Mobilize community partnerships and actions to identify and solve environmental health problems 5. Develop policies and plans that support individual and community environmental health efforts 6. Enforce laws and regulations that protect environmental health and ensure safety 12 6 7. Link people to needed environmental health services and assure the provision of health care when otherwise unavailable 8. Assure a competent public health and personal health care workforce 9. Evaluate effectiveness, accessibility, and quality of personal and population-based environmental health services 10. Research for new insights and innovative solutions to environmental health problems Examples of public health responses include: Enhancing disease surveillance (tracking diseases and trends related to climate change) Investigating water-borne, food-borne, and vector-borne/zoonotic outbreaks Expanding emergency preparedness to include climate change impacts; incorporating climate change into response plans (e.g., city specific heat response plans for heat waves, see Excessive Heat Events Guidebook: http://www.epa.gov/heatisland/about/pdf/EHEguide_final.pdf Conducting population vulnerability assessments using GIS methods; and developing environmental health indicators (see highlights below). Vulnerable Populations Some populations (and geographic regions) are expected to be more vulnerable than others to the public health impacts of climate change. An important role for state and local public health will be to identify those populations and to develop and implement effective responses (e.g., communication/intervention strategies). For many impacts, the vulnerable populations are similar; therefore, strategies will benefit from an integrated approach (e.g., emergency preparedness planning). Emerging GIS tools (software) and census data are readily available to conduct population vulnerability assessments (see below). Building Public Health Capacity Public health agencies serve important roles related to preparedness for both immediate and long-term health threats (e.g., emergency preparedness and response functions for extreme weather events; public health infrastructure for disease surveillance). The anticipated increase in the frequency and intensity of extreme weather events is likely to challenge our existing capacity to prepare for and respond to public health emergencies. It is equally important to build capacity for core public health infrastructure activities that address the impacts from climate change. Promoting Effectiveness and Accountability Climate change, an environmental health hazard of unprecedented scale and complexity, requires health care professionals to develop new ways of thinking, communicating, and acting (Frumkin et al., 2008b). For example, thinking in a far longer time frame than has been customary for health planning, and a systems approach that extends well beyond the current boundaries of health sciences and the formal health sector. Communicating about the risks posed by climate change requires messages that motivate constructive engagement and support for wise policy decisions, rather than instilling fear or indifference. Actions or responses to address climate change also will need to be evaluated in the context of co-benefits that improve public health, as well as a range of environmental, economic, and social factors (e.g., smart growth and the built environment). Development of environmental health outcome indicators through environmental public health tracking will be an emerging and increasingly useful tool for tracking climate impacts on public health, and for ensuring accountability (e.g., evaluating whether our public 13 7 health interventions are effective). See below for development of environmental health outcome indicators for climate change. HIGHLIGHTS (topics, tools & resources): Conducting Population Vulnerability Assessments: Existing Geographical Information System (GIS) methodologies may be used to assess population vulnerability to a range of environmental health hazards (e.g., emergency preparedness for disasters; planning for extreme weather events). This approach uses widely available demographic data (e.g., at the census track level) to identify geographic areas and populations that are especially vulnerable to hazards. This type of analysis lends itself to applications across many different types of hazards, including climate change, for more targeted and effective state and local planning and risk communication (CDPH 2008). For an example assessment of heat-related illness and mortality from the California Department of Public Health, see: http://www.phi.org/pdflibrary/Heat_Vulnerability_2007.pdf Developing Environmental Health Outcome Indicators: The Council of State and Territorial Epidemiologists (CSTE) has formed the State Environmental Health Indicators Collaborative (SEHIC). The goal of SEHIC, which is composed primarily of state health and environmental agency representatives, is to develop and pilot test indicators which could be used by States to track trends in environmental health, including climate change. Existing working groups include: excess morbidity and mortality due to climate change, population vulnerabilities to climate change, air quality and respiratory morbidity, and vector-borne disease. Several states are developing indicators to establish a baseline and track trends of impacts over time. For more about SEHIC, see: http://www.cste.org/OH/SEHIC.asp MDH has prepared a table of environmental health outcome indicators, vulnerable populations, and public health responses, see Appendix (Table). The information in this table is intended to provide examples (not to be inclusive of all possible outcomes, measures, and responses). Promoting Sustainable and Healthy Practices (leadership by example) State and local government agencies and others in the health sector (e.g., hospitals) have an opportunity to lead by example by actively promoting sustainable and healthy practices (e.g., through the built environment, smart growth, healthy homes). Transportation systems and infrastructure, building construction and operation, and land use planning (e.g., landscaping, access to green spaces) serve as good examples of sustainable practices that offer co-benefits to both human health and environment. The health sector is a large and energy intensive component of the US economy, and can be an important partner in mitigation strategies (e.g., design and operation of hospitals and clinics that lower energy demand, reduce waste streams, and link with local transit systems) (Younger et al., 2008). Facilitating Cross-Disciplinary and Cross-Jurisdictional Interaction The keys to effective mitigation of and adaptation to climate change involve nearly all public health specialty areas, other disciplines, many state agencies, and all levels of government. State agencies and others can provide leadership by facilitating cross-disciplinary and crossjurisdictional interaction across diverse programs and disciplines. 14 8 RESOURCES Intergovernmental Panel on Climate Change (IPCC) IPCC was established by the World Meteorological Organization (WMO) and the United Nations Environment Program (UNEP) to assess scientific, technical and socio- economic information relevant for the understanding of climate change, its potential impacts and options for adaptation and mitigation. In November 2007 this panel published the fourth assessment report which represents the consensus of leading scientists on global climate change. http://www.ipcc.ch/ Centers for Disease Control and Prevention (CDC) CDC is leading efforts to anticipate the health effects of climate change, to assure that systems are in place to detect and track them, and to take steps to prepare for, respond to, and manage associated risks. CDC has adopted a policy and scientific framework on climate change, and is the lead federal health agency on this topic. http://www.cdc.gov/nceh/climatechange/ U.S. Environmental Protection Agency (US EPA) EPA's Climate Change Site offers comprehensive information on the issue of climate change for all parts of society – communities, individuals, business, states and localities, and governments. http://epa.gov/climatechange/index.html State Environmental Health Indicators Collaborative (SEHIC) CDC, the Counsel of State and Territorial Epidemiologists (CSTE), and state-level epidemiologists are working through the State Environmental Health Indicators Collaborative (SEHIC) to develop environmental health indicators for climate change. SEHIC has three active climate change working groups, and a there was a SEHIC climate change workshop in March 2008. There is strong potential for future indicator development projects related to climate change and public health. http://www.cste.org/OH/SEHIC.asp ADDITIONAL WEB LINKS US Climate Change Science Program The US Climate Change Science Program integrates federal research on climate and global change, as sponsored by thirteen federal agencies and overseen by the Office of Science and Technology Policy, the Council on Environmental Quality, the National Economic Council and the Office of Management and Budget. http://www.climatescience.gov/ Institute of Medicine (IOM) IOM sponsored a workshop on climate change and human health in September 2007, featuring many prominent scientists. This IOM web page includes the workshop agenda, speakers, and links to presentation on several topics related to climate change. http://www.iom.edu/?id=46445 15 9 National Institute of Environmental Health Sciences (NIEHS) NIEHS sponsors the Climate Change and Energy Project which includes articles, presentations, and other publications related to climate change and health. http://www.niehs.nih.gov/about/od/programs/climatechange/index.cfm Association of State and Territorial Health Officials (ASTHO) ASTHO is sponsoring a webinar series on the topic of climate change and human health. Two recent topics included climate change and heat stress, and climate change and changing vectors. http://www.astho.org/index.php?template=methamphetamine.html National Association of City and County Health Officials (NACCHO) NACCHO has developed a statement policy on the role of local public health in addressing climate change. Their web page provides links to some excellent resources, particularly topics and articles of interest to public health actions at the state and local levels. http://www.naccho.org/topics/environmental/climatechange.cfm World Health Organization (WHO) http://www.who.int/globalchange/climate/en/ REFERENCES CDC 2008a. Health Effects of Exposure to Extreme Heat, George Luber, Ph.D., National Center for Environmental Health, Centers for Disease Control and Prevention, March 17, 2008. ASTHO web site accessed on March 26, 2008. http://www.astho.org/pubs/ASTHOwebinarheatwaves-Luber.pdf CDC 2008b. Climate Change and Vector-Borne/Zoonotic Diseases, Kenneth L. Gage, National Center for Zoonotic, Vector-Borne and Enteric Diseases, Centers for Disease Control and Prevention, February 19, 2008. ASTHO web site accessed on March 26, 2008. http://www.astho.org/pubs/Gage_climate_ASTHO_Jan2008.pdf CDC 2008c. Ten Essential Environmental Health Services, Centers for Disease Control and Prevention. CDC web site accessed on March 26, 2008. http://www.cdc.gov/nceh/ehs/Home/HealthService.htm CDC 2008d, The Domestic Public Health Impact of Climate Change: US Perspective on Waterborne Disease Transmission, Michael J. Beach, Centers for Disease Control and Prevention, April 29, 2008. ASTHO web site accessed on November 19, 2008. http://www.astho.org/index.php?template=methamphetamine.html CDPH 2008, Public Health Impacts of Climate Change in California: Community Vulnerability Assessments and Adaptation Strategies, Report No. 1, Heat-Related Illness and Mortality, California Department of Public Health, 2008. CDPH web site accessed on November 19, 2008: http://www.phi.org/pdf-library/Heat_Vulnerability_2007.pdf Frumkin et. al.,2008a. Framing Public Health Matters, Climate Change: The Public Health Response, Howard Frumkin, MD, DrPH, Jeremy Hess, MD, MPH, George Luber, PhD, Josephine Malilay, PhD, MPH, and Michael McGeehin, PhD., MSPH, American Journal of Public Health, March 2008, Vol. 98, No. 3, pp 435-445. 16 10 Frumpkin et al., 2008b, Climate Change and Public Health, American Journal of Preventative Medicine, November 2008, Vol. 35(5), pp 403-410. Gage et al., 2008, Climate Change and Public Health, American Journal of Preventative Medicine, November 2008, Vol. 35(5), pp 436-450. Haines et al., 2004. Health Effects of Climate Change, Andy Haines, MD, Jonathan Patz, MD, Journal of the American Medical Association, January 7, 2004, Vol 291., No. 1, pp 99-103. IPCC 2007. Climate Change 2007: Synthesis Report, Intergovernmental Panel on Climate Change, November 12-17, 2007. http://www.ipcc.ch/ipccreports/ar4-syr.htm Jackson et al., 2008. Preparing the US Health Community for Climate Change, Richard Jackson, Kyra Naumoff Shields, Annual Review of Public Health, 2008, 29, pp. 25.1-25.17. Accessed on the NACCHO web site on 3-26-08: http://www.naccho.org/topics/environmental/documents/PrepUSHealthCllimateChange.pdf Kinney, Patrick L., Climate Change, Air Quality, and Human Health. American Journal of Preventative Medicine, November 2008, Vol. 35(5), pp 459-467. Luber et al., 2008. Climate Change and Extreme Heat Events. American Journal of Preventative Medicine, November 2008, Vol. 35(5), pp 429-435. MMWR 2006. Heat-Related Deaths – United States, 1999-2003, Morbidity and Mortality Weekly Report, July 28, 2006, 55 (29), pp 796-798. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5529a2.htm NACCHO, Environmental Defense Fund, George Mason University, Preparing for the Public Health Challenges of Climate Change, 2008. Accessed on the NACCHO web site on 11-192008: http://www.naccho.org/topics/environmental/climatechange/upload/Are-weready_14_view.pdf Paz et al., 2008, Climate Change and Waterborne Disease Risk in the Great Lakes Region of the US, American Journal of Preventative Medicine, November 2008, Vol., 35(5), pp 429-435. Younger et al., 2008, The Built Environment, Climate Change, and Health: Opportunities for CoBenefits, American Journal of Preventative Medicine, November 2008, Vol., 35(5), pp 517-526. 17 11 18 19 20 21 This page intentionally left blank. 22 23 24 SECTION OVERVIEW: CRITERIA FOR SELECTING MINNESOTA-SPECIFIC TRACKING PRIORITIES In order to guide future development of the tracking program, EPHT staff and members of the EPHT technical team are defining a process to identify and weigh various options for new data content and measures. Until now, the MN EPHT program has focused almost exclusively on the content areas and measures identified by the national EPHT network. In future years, we anticipate that staff will have time and resources to dedicate to developing some additional content areas and measures specific to Minnesota interests. Staff are very early in the process of articulating possible methods for identifying and weighing Minnesota-specific priorities. The first step has been to develop a set of draft criteria for evaluating new data content and measures. At the March advisory panel meeting, staff will provide an overview of the criteria and the possible processes that could be used to select new tracking program priorities. The following items are included in this section of the meeting materials: Draft criteria for selecting data content areas and measures for MN EPHT Draft model for evaluating new content areas, data and measures ACTION NEEDED: Panel members are invited to provide input on the draft criteria for selecting content areas and measures for MN EPHT. In particular, panel members are asked to respond to the following questions: What other criteria should be considered when weighing new content areas and/or measures? Which criteria are the most important? Which are less important? What information does the advisory panel need in order to effectively make recommendations about new content areas and/or measures? 25 This page intentionally left blank. 26 Draft criteria for selecting data content areas and measures for MN EPHT Definitions A content area is a broad category under which data and measures are organized. There are currently eight content areas in the national EPHT network: Hazards o Air quality o Water quality Exposures o Childhood lead poisoning Disease/Health Outcomes o Hospitalizations for asthma and heart attacks o Reproductive outcomes o Birth defects o Cancers o Carbon monoxide poisoning There are two additional content areas that are under development by the national network: Climate change (hazards, vulnerability, outcomes and mitigation) Pesticides (hazards, exposures and outcomes) Minnesota-specific content (not part of national tracking program) in our current EPHT data and measures reports include: Chronic Obstructive Pulmonary Disease Hospitalizations and Prevalence Childhood lead poisoning: Blood lead levels by test year Within each content area, specific data and measures are used to track a population's health status, their environment, and other factors. In the national program these are called “nationally consistent data and measures” or NCDMs. These specific measures are used to monitor trends, make comparisons between groups, and potentially can serve to promote research collaborations to explore associations between the environment and health. Each content area can include several sources of data and measures. For example, the content area of carbon monoxide poisoning includes the following data and measures: Annual number of hospitalizations for unintentional carbon monoxide (CO) poisoning Annual crude and age-adjusted rates of hospitalization for unintentional CO poisoning 27 Annual number of emergency department (ED) visits for unintentional CO poisoning Annual crude and age-adjusted rates of ED visits for unintentional CO poisoning Annual number of deaths from unintentional CO poisoning Annual crude and age-adjusted rates of CO poisoning deaths Annual number of unintentional CO poisonings reported to the poison control center (PCC) Annual crude and age-adjusted rates of unintentional CO poisoning reported to the PCC Draft criteria These criteria could be used to evaluate new content areas and/or new measures within existing or new content areas. The evaluation process could be largely qualitative (a narrative justifying how the new content areas or measures meet these criteria) or the process could be somewhat quantitative (with numeric scores assigned). The details of the process are still being developed. 1. Degree of prevalence a) High estimated prevalence of disease in the state or sub-populations. b) High estimated proportion of population in the state or sub-population potentially exposed to hazard within particular media. 2. Emerging issues a) Incidence or prevalence of disease is changing or perceived to be changing in population/sub-population. b) Degree or level of hazard is changing or perceived to be changing in population/sub-population. 3. Causality a) Evidence exists that the disease has an environmental component cause. b) Evidence exists that the hazard or exposure is a component cause of an adverse health outcome. 4. Potential for information building and research application a) Disease with unknown environmental etiology or unknown prevalence in the population/subpopulation. b) Hazard with unknown association to health outcomes or unknown proportion of the population/subpopulation exposed to the hazard. 5. Outside interest (public, local public health, other stakeholders) a) High concern regarding prevalence and etiology of disease. 28 b) High concern regarding proportion exposed to a hazard, hazard levels, or changes in level of hazard. 6. High priority hazard or disease previously identified by environmental health professionals (academic researchers, State Environmental Health Indicators Collaborative, Pew Report, ATSDR, WHO, EPHTN, NHANES, EPA, NACCHO, ASTHO, etc.). 7. Actionability a) Disease has existing prevention and control program (intervention, education, services) at MDH or other government agency, or is tied to public health objectives (e.g., CDC’s Healthy People 2020 goals and objectives) b) Level of hazard can be modified through public policy, regulatory actions or health education to address personal actions, or is tied to public health objectives. 8. High potential to inform the public about the environment and health in their communities, can be understood by diverse population/subpopulations, and can be used to take action or develop new program initiatives at a community or local level. 9. Feasibility a) Data exist for this content area necessary to develop “trackable” measures b) Data are available over a geographical scale (e.g., state, county, ZIP code level) and temporal scale (e.g., annual, monthly daily) that can be analyzed for geographic and temporal variation. c) Data quality and timeliness are acceptable. Data are representative of disease, hazard, exposure or intervention in the population Data have a high degree of reliability and validity Data are timely without significant time lags. d) Financial and technical resources exist to conduct the work, including availability of necessary staffing and expertise. e) Data are accessible and EPHT has legal authority to collect, analyze and disseminate the data and measures. 10. Balance between hazard/exposure and disease content areas 11. Linkability between health and environmental data Data can be aggregated and integrated with other data sets on a common geographical and temporal scale Data can be used to measure relationships across hazard and disease data sets. 29 This page intentionally left blank. 30 Draft model for evaluating new content areas, data and measures 31 This page intentionally left blank. 32 SECTION OVERVIEW: TRACKING UPDATES Given the limited time available for advisory panel meetings, updates on some items will be provided to the panel as information items only. This information is intended to keep panel members apprised of progress being made in program areas that are not a featured part of the current meeting’s agenda and/or to alert panel members to items that will need to be discussed in greater depth at a future meeting. Included in this section of the meeting packet are status updates on the following: MN EPHT web-based information system EPHTN collaborations Communications and outreach ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on any of these topics during the designated time on the meeting agenda. 33 This page intentionally left blank. 34 Status update on MN EPHT Web-Based Information System In January 2010 MDH established a steering committee to help guide the development of a web-based information system, or portal for the tracking program to provide public data access. As previously described, this system will be used to display state-specific data and measures of interest, as well as nationally consistent data and measures developed for Minnesota through the Tracking Network. While the original plan was to install IBIS 2.0 in its entirety, the MDH Information Systems and Technology Management Division (IS&TM) has recommended integrating the query module from IBIS with an open source content management system called Liferay. This will better ensure that project timelines in the first grant year are met and that the vision of MDH executive management for a department-wide portal solution is achieved. The public data access portal is expected to be operating by September 2010. In conjunction with developing and testing the IT components of this system (e.g., developing the application; ensuring security; complying with web/accessibility standards), MN EPHT staff are currently preparing the data, metadata, and messaging for eight content areas, consistent with the national data content areas. The project team is working to further refine the schedule and create communication, quality, and risk plans. The timeline for this project is ambitious, and it is likely that the initial system will be limited to critical features and those required by the grant. MN EPHT expects to evaluate and enhance the system in project year 2, based on input from data users and the public. 35 Status update on EPHTN collaborations Academic Partners of Excellence (APEX) Collaborations There are currently four academic centers funded by the CDC as Academic Partners of Excellence for the national EPHT network. The four APEXs are: University of California, Berkeley University of Pittsburgh University of Medicine and Dentistry of New Jersey Tulane University Each of the four centers is currently working with states to conduct data linkage project using data available on the CDC and state portals to demonstrate the utility of the Tracking portal data for epidemiological investigations to measure associations between environmental hazards, exposures, and chronic disease outcomes. Minnesota EPHT has joined with five other states (CT, ME, WI, NY, UT) and the University of Medicine and Dentistry of New Jersey (UMDNJ) on a collaborative project to measure associations between air quality and birth outcomes. The exposures that will be studied are PM2.5 and ozone. Air quality data (Hierarchical Bayesian modeled to cover the entire state) will be provided by the CDC EPHT and the EPA. The two birth outcomes of interest are pre-term birth and low birth weight. Data will be obtained from either the National Center for Health Statistics or state birth registries. There are several proposed levels of analysis for this project including: 1) county level analysis (ecological design), 2) individual level analysis, and 3) meta-analysis or pooled analysis. UMDNJ will provide SAS code for state EPHT staff to conduct county and individual level analyses that includes linkage of air and birth outcome data as well as statistical analyses. Results will be discussed during bi-weekly conference calls as well as during the upcoming EPHT national workshop in April, 2010. MN EPHT staff will present a summary of this work at a future Advisory Panel meeting. Renewal of APEXs Expected in Spring 2010 The APEXs are reaching the end of their current grant funding period. We recently received word that there will not be a new Request for Proposals (RFP) but rather that the CDC plans to use a contract approach for specific deliverables using a bidding process. We expect to hear more about this in the near future. It is unclear how this will affect ongoing collaborations. 36 New Geospatial Team Forming for the National EPHT Program In January 2010, a Spatial Analysis Tools and Methods Workshop was held in Miami, Florida, for grantees to share mapping applications, geospatial analysis methods, and other ideas for displaying data on the EPHT network. MN EPHT biostatistician, Paula Lindgren, attended. As a result of the presentations at this workshop, attendees (n=40) expressed the need for a cross-cutting team to discuss the use of geospatial tools, methods and software applications and provide recommendations that could be applied to the National and grantee portals. Given the extensive use of mapping on the National and grantee portals, there is an interest in sharing ideas, approaches, tools, and experience on best practices for managing and displaying geospatial data. Currently, a forum does not exist for discussing recommendations for geospatial applications on EPHT portals, and such a community of practice is clearly needed to optimize public communication on the portals using spatial tools like mapping. A new Geospatial Team would be made up of a cross-section of EPHT representatives, bringing expertise in GIS and geospatial data, Tracking Network content, user needs, and evolving approaches to mapping. Topics for Team discussion will be identified by members during the first few calls and are likely to include the following: Using maps to depict environmental hazards – informing with discretion Uniting maps, charts, and reports for intuitive display of EPHT data on web portals Disease incidence mapping, cluster detection, and public communication of results Mapping drinking water system boundaries on EPHT portals Leveraging GIS resources Identifying approaches for geocoding 37 Status update on communications and outreach Brown bag seminars The EHTB program will launch a quarterly brown bag seminar series with a discussion of the development of environmental health outcome indicators for climate change. The inaugural brown bag seminar is scheduled for April 12th from 12-1 p.m. in the Orville Freeman Building. The presenters include MDH staff from the MN EPHT program, the Environmental Health Division, and the Office of Emergency Preparedness. The seminar is an opportunity for state agency staff to learn more about national and state activities to develop environmental health outcome indicators for climate change. Examples of current indicators being developed at the national and state levels will be addressed, followed by a discussion about potential data sources and indicators of interest to Minnesota. This seminar also will provide an update about broader MDH efforts to build capacity for addressing the public health impacts of climate change. The second seminar will be held in July 2010; that seminar will focus on biomonitoring. MN EPHT data reports Three tracking reports are now available on the MN EPHT website at www.health.state.mn.us/tracking: Carbon Monoxide Data and Measures (2000-2007): This is a report on trends in unintentional carbon monoxide exposures and poisonings in Minnesota. Drinking Water Quality – Community Water Data and Measures (1999-2007): This is a report on trends in concentrations for arsenic, nitrate and disinfection byproducts in community water systems in Minnesota. Hospitalizations: Asthma, Heart Attack and COPD Data and Measures (19992007): This is a report on trends in hospitalizations for asthma, heart attacks, and chronic obstructive pulmonary disease (COPD) in Minnesota. These reports are the first in a series of eight publications that are planned for release by the MN EPHT program. Additional reports in the series include data and measures for childhood blood lead, air quality, birth defects, reproductive outcomes and cancer. Hard copies of the reports are available upon request. Advisory panel members who would like copies of the reports may request individual copies or a binder containing the full set of reports to be released in 2010 (beginning with the three currently available reports). To place a request, please email Mary Jeanne Levitt at [email protected]. 38 SECTION OVERVIEW: LESSONS LEARNED FROM BIOMONITORING PILOT PROGRAM The statute that created the EHTB program directs MDH to assess the pilot program and to make recommendations for future biomonitoring stemming from that assessment. Staff are in the process of gathering and compiling information about what worked well and what could be improved related to the biomonitoring pilot studies. From this information, recommendations for future biomonitoring efforts will be developed and included as part of the program’s legislative report due in January 2011. At the March advisory panel meeting, program staff will summarize the input gathered so far related to one specific aspect of the biomonitoring pilot program: Selection of study communities. At future panel meetings, it is anticipated that panel members will be asked to discuss lessons learned related to other elements of the biomonitoring pilot program. The following items are included in this section of the meeting materials: Background information on the MDH biomonitoring pilot program Biomonitoring vision, purpose and approaches Lessons learned from the biomonitoring pilot program: Selection of study communities ACTION NEEDED: Panel members are invited to provide input on the summary of lessons learned from the biomonitoring pilot program. In particular, panel members are asked to respond to the following questions: The two pilot projects that have been completed so far (i.e., arsenic and PFCs) were special investigations designed to measure chemicals in communities in response to specific exposure concerns. If Minnesota were to continue using a special investigation approach to biomonitoring, what recommendations would you make with regard to community selection? When is biomonitoring an appropriate response to community concerns about exposures to environmental contaminants? When is it not an appropriate response? If Minnesota were to continue using a community-based investigation approach to biomonitoring, how should requests from concerned communities, public health officials and elected representatives be prioritized? What factors should be considered? Thinking more broadly, in what ways were these two projects most successful? 39 This page intentionally left blank. 40 Background information on the MDH biomonitoring pilot program In 2007 the Minnesota State Legislature passed Minnesota Statutes 144.995 – 144.998, which established the Environmental Health Tracking and Biomonitoring (EHTB) program and directed the Minnesota Department of Health (MDH) to design and implement four pilot biomonitoring projects in communities “likely to be exposed”: 1. A project to measure arsenic in 100 voluntary participants likely to have been exposed to arsenic. 2. A project to measure PFCs in 100 voluntary participants from each of two communities likely to have been exposed to PFCs, including PFBA. 3. A project to measure mercury in 100 voluntary participants likely to have been exposed to mercury. 4. A project to measure a designated chemical (to be recommended by the advisory panel) in 30 voluntary participants in each of three communities. MDH was further directed to collect one biospecimen from each participant. Each biospecimen was to be analyzed for one type or class of related chemicals. By statute, community is defined as “geographically or nongeographically based populations that may participate in the biomonitoring program. A "nongeographical community" includes, but is not limited to, populations that may share a common chemical exposure through similar occupations, populations experiencing a common health outcome that may be linked to chemical exposures, populations that may experience similar chemical exposures because of comparable consumption, lifestyle, product use, and subpopulations that share ethnicity, age, or gender.” The four pilot studies are summarized in the table below. 41 Table: Comparison of four pilot projects Two of the projects (arsenic and PFCs) are completed. The remaining two (mercury and phenols/contine) are in the recruitment and specimen collection stage. Using the comprehensive model developed by program staff to depict the three biomonitoring approaches that could be combined to fulfill the broad statement of purpose identified for the biomonitoring program (see below), these pilot studies could be classified as “special investigations.” Minneapolis Children’s Arsenic Study The Minneapolis Children’s Arsenic Study was designed to measure the range and distribution of urinary arsenic levels in 100 children living in the South Minneapolis area, specifically within the Seward, Longfellow, Powderhorn, Phillips and Corcoran neighborhoods. Children in this community were identified as “likely to be exposed” due to elevated soil arsenic levels as identified through various federal and state agency investigations. 42 In 1994, elevated levels of arsenic in the soil were found along Hiawatha Avenue when a reconstruction project was begun. Further testing of the surrounding area occurred and the former CMC Heartland Partners Lite-Yard Site, a former pesticide manufacturer, was identified as a contributing source to the soil arsenic concentrations along Hiawatha Avenue. In 2001 MDH and the Minnesota Department of Agriculture (MDA) began an investigation of the residential area surrounding the site to evaluate possible contamination of the neighborhood with arsenic. Over 3,500 properties were tested by MDH, MDA, or the Environmental Protection Agency (EPA) between 2001 and 2006. Properties tested were within a ¾ mile radius from the CMC Heartland site, located at the corner of 28th Avenue and Hiawatha Avenue in Minneapolis. MDH and the Agency for Toxic Substances and Disease Registry (ATSDR) developed a soil action level of 95 ppm (parts per million of arsenic in soil). Properties that were found to have an arsenic soil concentration greater than 95 ppm were to have the soil removed by the EPA. A total of 197 properties were identified and by the time the biomonitoring study began recruitment, actions had already been initiated to remove the soil from the most contaminated properties. In 2007 the site was listed on the National Priorities List (Superfund) to facilitate the remediation of soil from properties that had an arsenic concentration of less than 95 ppm but greater than 25 ppm. Arsenic is rapidly cleared from the body. The half-life in urine is 1-3 days. Children were selected for this project because children are likely to have the greatest exposure to contaminants in residential soils from their outdoor play activities and greater potential for ingestion from frequent hand to mouth behaviors. The target sample size of 100 was specified in the legislation. For the report with complete results, please visit our website: www.health.state.mn.us/tracking. East Metro PFC Biomonitoring Study The East Metro PFC Biomonitoring Study was designed to measure the range and distribution of 7 types of perfluorinated chemicals (PFCs) in 100 individuals from each of two separate communities. Contamination of drinking water supplies with PFCs in the east metro was discovered in the summer of 2004. MPCA and MDH collected water samples from private well owners as well as the Oakdale Municipal supply to assess and define the extent of the contamination. Routine monitoring was established by MDH and MPCA and actions to stop drinking water exposure were taken, including the provision of bottled water, granular activated carbon (GAC) home filters, access to municipal water, and a water treatment plant that utilizes large GAC filters to remove PFCs for the Oakdale Municipal Water Supply. 43 With the implementation of these filtration practices, drinking water exposure in the community has been reduced to below established health-based values, and the plan for remediation of the contaminated waste facilities are currently underway which may further reduce the PFC exposure through drinking water. PFOA and PFOS (two of the PFCs included in the study) have long half-lives (3.8 and 5.4 years respectively). PFBA has a short half-life (less than 5 days). The target sample size of 100 individuals from each of two exposed communities was specified in the legislation. For the report with complete results, please visit our website: www.health.state.mn.us/tracking. 44 Biomonitoring vision, purpose and approaches The following language was developed based on discussions with advisory panel members, steering committee members and state agency staff during four meetings between November 2008 and June 2009. Vision statement Minnesota’s biomonitoring program will have the capacity to accurately and efficiently measure and track exposures in people from the environment, and to protect public health through improving the understanding of risk and disease so that Minnesotans will lead healthier lives and live in safer environments. Vision elements Biomonitoring data are collected and effectively used to protect public health Biomonitoring will protect the health of all Minnesotans by measuring and tracking the concentrations of chemicals that get in to people’s bodies from the environment. Knowing more about people’s exposure to chemicals will help state and local officials, advocacy groups, industry, decision makers better determine the health risk and take actions that can best help to reduce risk, promote health, and eliminate disparities. Risk and disease are better understood Biomonitoring will provide a base of information that will help public health scientists to study the connections between environmental hazards and disease. Public health officials will better understand and be able to share new information with the public, and will be better able to track progress in improving environmental public health. Minnesotans will know more about the risks of chemicals in their environment in order to make wise choices to promote their own health and the health of their communities. Adequate capacity and resources are maintained Minnesota’s biomonitoring program will have the capacity and expertise needed to measure environmental chemicals in people’s bodies accurately and efficiently. The program will be a resource for public health officials to use as needed for providing a scientifically grounded response to the public health concerns of communities in Minnesota. 45 Core purpose The core purpose of Minnesota’s biomonitoring program is to monitor and track trends over time in the distribution of exposure to designated chemicals among the general population of Minnesota and communities within the population in order to: identify exposure disparities; assess the need for public health interventions; evaluate the efficacy of interventions in reducing exposure; and assess the need for continued biomonitoring of a designated chemical. Other beneficial purposes Other important secondary purposes are anticipated and should be achieved as resources allow. These purposes can best be accomplished through collaborations with external and internal partners, and leveraging of supplemental resources: 1. Investigate sentinel exposure events, emerging contaminants, and highly exposed individuals identified by public health officials for targeted exposure assessments and interventions. 2. Provide information about exposures to local public health officials and community representatives in response to community concerns about chemicals in the environment. 3. Provide data about exposure distributions and trends to support research studies that measure the association of health outcomes with exposure and identify the sources of exposure. 4. Provide data about exposure distributions and trends to support the establishment of health-based criteria for regulating chemicals in the environment. Approaches Three primary biomonitoring approaches apply and can be combined in a single comprehensive program model (see the figure on the next page) to fulfill the core program purposes: 1. 2. 3. Statewide Population Exposure Tracking Targeted Population Exposure Tracking Community-based Special Investigations 46 Figure: Comprehensive program model for a state biomonitoring program 47 This page intentionally left blank 48 Lessons learned from the biomonitoring pilot program: Selection of study communities (DRAFT) Evaluation methods The EPHTB program is in the process of conducting a process evaluation of the biomonitoring pilot program. The goal of the evaluation is to develop recommendations for future biomonitoring efforts. The recommendations will be included in the program’s next report to the legislature (due in January 2011). The first step of the evaluation is to collect input on “lessons learned” from the four biomonitoring pilot studies. An open-ended survey was sent to MDH, MDA and MPCA staff who had been involved in the planning and/or implementation of any of the pilots. The survey asked for feedback on what worked well and what could be improved about various aspects of study design and implementation, ranging from hypothesis development and participant recruitment to conducting lab analyses and interpreting results. The amount of feedback and the level of detail varied a great deal across survey respondents. The number of people providing input on any specific survey question was small. The data are therefore not reflective of broad consensus so much as individual people’s observations. Program staff are working on summarizing the input gathered through the survey. Future steps in the evaluation are to solicit additional input from advisory panel members and steering committee members and greater detail from those who were invited to complete the original survey . The purpose of the summary below is to provide a foundation for a discussion of recommendations for selecting communities for biomonitoring studies. Results from other key areas of the evaluation survey will be presented for discussion at future meetings. 49 Preview of “lessons learned” for community selection: what worked and what could be improved for arsenic and PFC projects Working in exposed communities with a known source of contamination, which is the approach that was used for selecting study populations/communities for the arsenic and PFC biomonitoring studies, provided both benefits and challenges. Benefits (things that worked well): Focusing on communities with a known source of contamination and heightened public concern makes the selection process easier and faster, because there are only a limited number of sites in the state that meet this criterion. One benefit of working in exposed communities with a known source of contamination was that the biomonitoring staff were able to quickly establish relationships with local politicians, community groups and community leaders because of the relationships already developed by MDH site assessment and other programs working in the communities. The arsenic and PFC biomonitoring pilots were able to capitalize on the availability of existing environmental sampling data collected as part of the prior site investigation (EPA soil sampling data in South Minneapolis and MDH water sampling data in the East Metro) to enable the analysis of correlations between the biomonitoring data and the source sampling data. The arsenic and PFC pilots were able to capitalize on the expertise of department staff who worked previously in the community for developing background information and risk communication messages. Challenges (things that could be improved): Among several individual community members, staff encountered frustration over contamination and remediation efforts when biomonitoring pilots were initiated making it difficult for biomonitoring staff to develop credibility and trust within community. Community members were sometimes confused by multiple public meetings and other communications taking place simultaneously for biomonitoring, site/risk assessment, and site remediation activities, despite efforts to clearly identify the purpose of our communications. Managing expectations and clearly conveying the purpose and scope of the arsenic and PFC biomonitoring pilots was a challenge in working with communities with known contamination and where remediation activities were already underway. Focusing on exposure from one chemical of concern from a particular source of contamination (in contrast to a list of chemicals from multiple sources) may have raised 50 expectations in the community about the information biomonitoring results can provide about the source of exposure and/or health effects associated with that chemical. Clearly articulating that biomonitoring results alone cannot provide a link between exposure and disease was a constant challenge throughout both pilot studies. Some community members had an expectation that the biomonitoring result would provide a basis for additional action (e.g., remediation, legal compensation, health care services). Considerable staff time and resources were needed to achieve a high level of coordination across divisions and agencies involved in working with these communities so that messages were consistent, appropriate experts were consulted, and programs with related activities were fully informed. Focusing on communities with a known source of contamination requires MDH to operate in rapid response mode. The short timeframe available for developing these types of projects provides challenges in terms of the degree to which stakeholder engagement (state agency staff, community members, local decision makers, community groups, advisory panel members, etc.) can take place. The time constraints also affect other aspects of study development and implementation (e.g., materials development, participant recruitment, study design), particularly when coupled with limited staffing. 51 This page intentionally left blank 52 SECTION OVERVIEW: BIOMONITORING UPDATES Given the limited time available for advisory panel meetings, updates on some items will be provided to the panel as information items only. This information is intended to keep panel members apprised of progress being made in program areas that are not a featured part of the current meeting’s agenda and/or to alert panel members to items that will need to be discussed in greater depth at a future meeting. Included in this section of the meeting packet are status updates on three of the biomonitoring pilot projects: Lake Superior Mercury Biomonitoring Study Riverside Prenatal Biomonitoring Study East Metro PFC Biomonitoring Study ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on any of these topics during the designated time on the meeting agenda. 53 This page intentionally left blank. 54 Status Update on the Lake Superior Mercury Biomonitoring Study Participant recruitment Minnesota participants continue to be enrolled in the Lake Superior Mercury Biomonitoring Study. As of February 18, 2010, written informed consent has been received from 913 participants; approximately 10% of these were recruited through local public health staff. Enrollment in Wisconsin is complete and we have received all their samples. Wisconsin also provided information on percentages of their specimens that fall into the categories we excluded in Minnesota due to our informed consent. This will help us address the extent of bias we introduced by having those exclusions. Michigan participation in the study is on hold due to a change in their specimen storage system. Specimen analysis The MDH Public Health Lab has analyzed several batches of specimens and is currently reviewing quality control before proceeding with the rest of the samples. 55 Status update on the Riverside Prenatal Biomonitoring Study Participant recruitment As of February 10 MDH had received 56 urine specimens for the Riverside Prenatal Biomonitoring Study. The Riverside Birth Study at the University of Minnesota had reached 418 enrolled participants; it is anticipated that they will reach their enrollment goal of 500 women by the end of March. At this time the Riverside Birth Study is again enrolling all women and not selectively enrolling Somali women. Specimen analysis The lab has been working through a problem with background levels of methyl and ethyl paraben in the blanks. After talking to scientists at CDC about this, staff are ready for method validation and then sample analysis. Communications Staff anticipate providing health provider education in mid May at the two recruitment clinics. The two clinics are: Fairview Riverside Women’s Clinic 701 25th Ave. S. Minneapolis University Specialists in Women’s Health 2450 Riverside Ave. Minneapolis 56 Status Update on the East Metro PFC Biomonitoring Study Water-blood analysis The blood-to-water analysis is complete. Results have been written up as a factsheet that will be mailed to all participants with a cover letter and posted on the EPHT website. Evaluation A survey to evaluate the pilot study was sent to all 196 participants, soliciting feedback about their experience as a participant in the study, with a particular focus on the project communications (recruitment letters, consents, factsheets, results letters and public meetings). The survey was mailed out in early February and returned forms are being reviewed and entered in to a database. Follow-up study In response to recommendations from the advisory panel, a project team led by Jean Johnson and made up of epidemiologists from Chronic Disease and Environmental Epidemiology, chemists from the Public Health Laboratory, and toxicology/site assessment staff from Environmental Health has begun planning for a follow-up biomonitoring project in the East Metro community. Using the advice of panelists from the December advisory panel meeting, staff will be developing a project proposal, including the purpose and scope of the project, the data measures to be collected, project protocols and survey instruments (exposure questionnaire). The project will be designed to repeat the same PFC measurements as the prior project which collected blood samples from 196 individuals in the fall of 2008. The purpose will be to measure changes in blood serum levels in the population over time and to estimate a rate of decline or half-life for PFOA and PFOS. There were 186 participants who agreed to be contacted again for future studies. An exposure questionnaire now under development may include information on residential history in the East Metro area, drinking water consumption, occupational and military history (with special focus on occupations with potential PFC exposure), and other local/social history (income, education, consumption of local produce, fish and game). A project budget will be prepared and submitted to the Environmental Health Tracking & Biomonitoring Steering Committee for funding consideration in state fiscal year 2011. If funded, study materials will be submitted to the MDH IRB for approval in July of 2010. Project staff can then begin contacting participants in August and specimen collection could be conducted from September through December 2010, two years from the first project specimen collection. 57 This page intentionally left blank. 58 SECTION OVERVIEW: OTHER INFORMATION These documents are included in this meeting packet as items that may be of interest to panel members: Minnesota Environmental Public Health Tracking and Biomonitoring presentations, posters and publications Local, national and global biomonitoring and tracking news EHTB advisory panel meeting summary (from December 8, 2009) EHTB advisory panel roster (revised) Biographical sketches of advisory panel members (revised) EHTB steering committee roster (revised) EHTB organization chart (revised) Additional reference materials, such as the EHTB statute, are available online at www.health.state.mn.us/tracking/. 59 This page intentionally left blank. 60 Minnesota Environmental Public Health Tracking & Biomonitoring Presentations, Posters and Publications December “New Tools for Responding to Chemical Concerns in Your Community” Presented to State Community Health Services Advisory Committee (SCHSAC) Meeting Presenters: Jean Johnson & Lowell Johnson, Washington Co. Director of Public Health and Environment Attendance: approx 75 Date: 12/11/09 Overview of Minnesota’s EHTB Legislation and Policy Presented at the National Conference of State Legislatures meeting in San Diego Presenter: Representative Julie Bunn Date: 12/11/09 January Overview of Biomonitoring and Tracking activities Presented at the MDH Environmental Surveillance and Assessment Section meeting Presenters: Chuck Stroebel and Jean Johnson Attendance: approximately 35 Date: 1/29/10 February Tracking and Biomonitoring Update Presented to the Housing Policy and Finance and Public Health Finance Division of the Minnesota Legislature – House Presenter: Jean Johnson Attendance: 18 – 20 legislators; audience of approximately 40 Date: 2/910 “Arsenic Speciation in Urine: the Minneapolis Children’s Arsenic Study” Presented at the Mass Spectrometry: Applications to the Clinical Laboratory (MSACL) conference in San Diego Presenter: Betsy Edhlund Date: 2/9/10 61 “Human Biomonitoring of Perfluorochemicals in Communities with Contaminated Drinking Water in the East Metro of St. Paul, Minnesota” Presented at the Mass Spectrometry: Applications to the Clinical Laboratory (MSACL) conference in San Diego Presenter and session chair: Carin Huset Attendance: Approximately 50 Date: 2/10/10 “Human Biomonitoring of Perfluorochemicals in Communities with Contaminated Drinking Water in the East Metro of St. Paul, Minnesota” Presented at the Department of Toxic Substances Control Environmental Chemistry Lab’s seminar series in Berkeley Presenter: Carin Huset Attendance: Approximately 25 Date: 2/11/10 62 Local, national and global biomonitoring and tracking news Biomonitoring The Learning and Developmental Disabilities Initiative recently released a report titled, “Mind, Disrupted: How Toxic Chemicals May Change How We Think and Who We Are.” The report summarizes biomonitoring results for twelve leaders and advocates in the learning and developmental disabilities community. The report can be found online at: http://www.minddisrupted.org. In November, the CDC released its Fourth National Report on Human Exposure to Environmental Chemicals. The report can be found online at: http://www.cdc.gov/exposurereport/. In February, the New York Times published an article about biomonitoring’s impact on the debate over the Toxic Substances Control Act (TSCA). The article can be found online at: http://www.nytimes.com/gwire/2010/02/15/15greenwire-human-testing-at-heart-of-debate-overus-toxic-77544.html?emc=eta1 Tracking Safer Chemicals, Healthy Families, a coalition of agencies advocating the reform of the Toxic Substances Control Act (TSCA) released a report titled, “The Health Case for Reforming the Toxic Substances Control Act.” The report summarizes studies examining the relationship between exposure to environmental chemicals and disease. The report can be found online at: http://healthreport.saferchemicals.org/. In December the New York Times ran two articles on drinking water that were part of a series called, “Toxic Waters: A series about the worsening pollution in American waters and regulators’ response.” The complete series can be found online at: http://projects.nytimes.com/toxic-waters. Two of the MN EPHT data reports have received local coverage: Carbon monoxide: MDH released a news release on the carbon monoxide report on December 29, 2009, “Tis (still) the Season for carbon monoxide risks.” The report was subsequently covered by the following news outlets: 63 MPR, 12/29/09, Report Raises Concerns over Carbon Monoxide Poisoning: http://minnesota.publicradio.org/display/web/2009/12/29/carbon-monoxide-poisonings/ Rochester Post Bulletin, 12/31/09, Rochester Woman testifies about Carbon Monoxide Nightmare Star Tribune, 12/31/09, Carbon monoxide poisoned couple in critical condition http://www.startribune.com/local/stpaul/80318487.html Shakopee Valley News, 12/29/09, State issues report on carbon monoxide poisoning risks during winter http://www.shakopeenews.com/news/general_news/state_issues_report_carbon_monoxid e_poisoning_risks_during_winter-112 Hospitalizations: Thanks to efforts by the American Lung Association, the hospitalization report was covered by the PR Newswire: Minnesota Dept of Health Report: Nearly 6,000 Hospitalizations for COPD in 2007. http://www.prnewswire.com/news-releases/minnesota-department-of-health-report-nearly6000-hospitalizations-for-copd-in-2007-83920077.html 64 Summary of the Minnesota Department of Health (MDH) Environmental Health Tracking & Biomonitoring Advisory Panel Meeting December 8, 2009, 1-4 p.m. Advisory panel members – Present: Beth Baker (chair), Alan Bender, Cathi Lyman-Onkka, Deb McGovern, Geary Olsen, Greg Pratt, Dan Stoddard, Lisa Yost Advisory panel members – Regrets: Bruce Alexander, Jill Heins Nesvold, Samuel Yamin Welcome and introductions Beth Baker, chair, welcomed Cathi Lyman-Onkka to the EHTB advisory panel. Cathi fills the nongovernmental organization representative vacancy left by Cecilia Martinez. Cathi serves on the board of directors for Preventing Harm Minnesota and worked for 34 years at St. PaulRamsey County Public Health. Her areas of expertise include community involvement and health education. Deb McGovern announced that she is no longer employed with Essar Steel. East Metro PFC Biomonitoring Study Water-Blood Analysis Adrienne Kari, biomonitoring coordinator, presented preliminary results of an analysis of the relationship between PFC levels in water and PFC levels in serum. This analysis was conducted to determine the percent of variability in serum PFC levels that is accounted for by the PFC levels in the water. The results of the analysis are included in the meeting packet on pages 3-10 The follow-up analysis included 98 participants from 77 households. For the analysis, the PFC water levels were estimated based on well sampling data collected by the Minnesota Department of Health between 2005 and 2008. The analysis was restricted to PFOA and PFOS only. Because some wells had more test points than others, both the highest PFC level recorded and the average level were used in the analysis. The average PFC level measured in the water was more predictive of blood PFC levels than the highest level of PFCs measured in the water. Other variables that were part of the analysis include the following: Age: The average age of participants was 54, with a range of 20 to 86 years. 65 Gender: There were 44 males and 54 females included in the analysis. History of 3M employment: Ten participants indicated that they had worked for 3M. Length of residence: The average length of residence was 20 years, with a range of 4 to 60 years. “Cessation time” (which was a proxy for estimating the amount of time since the participants stopped drinking the contaminated water): The average cessation time was 27 months, with a range of 0 to 45 months. The initial regression analysis found that levels of PFCs in the drinking water alone accounted for 30% of the variability seen in people’s blood PFC levels. Additional variables were then examined and assessed for significance. The final PFOA model included age as a variable. Levels of PFOA in the drinking water combined with age accounted for 42% of the variability in people’s blood PFOA levels. The final PFOS model included age and gender. Levels of PFOS in the drinking water combined with age and gender accounted for 40% of the variability in people’s blood PFOS+ levels. Adrienne stated that, based on this analysis, we can predict that the steps taken to provide alternate water sources are likely to lead to decreases in PFC blood levels. Advisory panel members had several questions about the variables included in the model. Beth Baker asked whether the question about 3M employment included information on length of employment. Adrienne stated that there was a yes/no question about ever having worked at 3M which was followed up with a question about specific jobs that may have resulted in PFC exposure. There was considerable discussion about the variables of age and length of residence. Alan Bender asked whether the analysis checked for the covariance of age and residence, since those two variables are likely related. Adrienne responded that that analysis had indeed been done and that age was a better predictor of PFC levels than length of residence. Greg Pratt asked whether length of residence was tested without age. Adrienne replied that this was done and clarified that length of residence is predictive of PFC levels, but only when age is not included in the model as well. Greg suggested that it is not accurate to say that length of residence is not predictive. Lisa Yost suggested that age might be a better predictor because it accounts for exposure to PFCs through all sources, not just the water. Geary Olsen wondered whether age at time of first residence could be used to separate the age and residence variables in order to determine the independent contributions of those two variables. Adrienne replied that the survey only asked for length of residence at the current address, not any address in the study community. Geary agreed that without that information, the additional analysis would not be worthwhile. Alan suggested that a power analysis be conducted to test the model and determine what the model missed. The 66 fact that length of residence was not an independent predictor of PFC levels might be a function of the number of participants included in the study. Geary Olsen asked whether Adrienne had the r-squared values for each of the variables tested. Adrienne said she would follow up with an answer when she was back in the office. Deb McGovern suggested that program staff focus on articulating what happens next with this project and determining how to close the project out. Jean replied that the plan for closing the project is to submit the results to a peer-reviewed technical publication. Beth clarified that the cessation time variable was an estimate of the time since participants stopped using the contaminated water and suggested that this be made more explicit when the results are shared. Greg suggested clarifying that all of the variables are imperfect, that we are using them to try to calculate exposure. Geary stated that the word “log” could be removed from Figures 6 and 8 because the scales are already presented in log form. Lisa Yost suggested including information on serum levels found in NHANES in our final report to the community; even though this information was included in the first report, she felt it was important enough to carry it forward into the follow-up report. PFC follow-up study Jean Johnson reminded the advisory panel that they had previously recommended that MDH conduct a follow-up biomonitoring study to determine whether PFC levels were dropping in the community. The EHTB steering committee approved program staff proceeding with planning the follow-up, contingent on the continued availability of funding. With the goal of collecting specimens in a year, a project team is beginning to plan the follow-up study now and is seeking advice from the advisory panel on potential research questions. Some of the potential questions stem from inquiries that program staff continue to receive from community members and legislators. Pages 17-27 of the meeting packet lay out the six potential research questions that advisory panel members are being asked to comment on along with some background information on each question. Jean briefly described the six questions (below) and asked panel members to consider for each question whether it is feasible (i.e., do the methods exist to address the question and provide a conclusive answer); whether there is scientific value in addressing the question; and whether it is responsive to community needs. 1. What are current (2010) levels of PFOA, PFOS, and PFHxS in the study population and how do they compare to levels that were measured in 2008? (Note: PFOA, PFOS, and PFHxS are the only PFCs that were detected in all study participants.) 67 2. What is the rate of decline for PFOA, PFOS, and PFHxS blood levels in the study population? What is the half life of PFOA, PFOS, and PFHxS in this population? 3. In addition to the drinking water, what other sources of exposure help to explain the variability in the blood levels of PFOA, PFOS, and PFHxS? 4. What are the levels of other PFCs in the community, including those that have not been detected in the water? [Note: The MDH laboratory can measure approximately 16 PFCs using methods comparable to NHANES.] 5. Is there a relationship between blood cholesterol and PFC levels in this study group? Is the rate of decline for PFCs different for people with high vs. low blood cholesterol levels? 6. Are there long-term health effects (cardiovascular, cancer, reproductive, etc.) associated with PFC exposures: a. In this community? b. In the state? Jean stated that 185 of the original 196 study participants agreed to be contacted again for future studies. It is expected that some of these will have moved away or will decline to participate. Conducting a limited follow-up study (e.g., measuring the current levels of PFCs in the blood, calculating the rate of decline) with this group of participants would be feasible within the existing budget, as long as the existing funds remain available. Expanding the study’s scope to include additional research questions and/or other participants will require additional funding to be secured. Advisory panel members had a wide-ranging discussion about the potential research questions. Their comments are summarized according to each question. Question 1: What are current (2010) levels of PFOA, PFOS, and PFHxS in the study population and how do they compare to levels that were measured in 2008? (Note: PFOA, PFOS, and PFHxS are the only PFCs that were detected in all study participants.) Jean stated that the follow-up study would be designed to address this question; it is technically feasible, contributes to the scientific literature and responds to community concern. Question 2: What is the rate of decline for PFOA, PFOS, and PFHxS blood levels in the study population? What is the half life of PFOA, PFOS, and PFHxS in this population? Beth Baker inquired whether it was preferable to have more than two data points in order to calculate a half-life. Geary Olsen replied that because PFCs follow a first-order pharmaceutical curve at low levels (even though they technically follow a linear curve), having just two data points will be enough to provide assurance that there has been a decline. Alan Bender asked what program staff saw as the value in calculating a half-life. Jean replied that making this calculation would contribute to the scientific literature because there have been relatively few such calculations made; she speculated that community members might be less 68 interested in this research question. Geary suggested that the community may in fact be interested in seeing if the half-life is quicker than it is for 3M workers with occupational exposure; the C8 study of community members in West Virginia/Ohio saw a quicker half-life than for 3M workers. Question 3: In addition to the drinking water, what other sources of exposure help to explain the variability in the blood levels of PFOA, PFOS, and PFHxS? Jean explained that this question could be addressed through an expanded questionnaire or potentially through sampling (e.g., dust samples) in homes. Lisa Yost asked whether there would be any interview aspect in the follow-up study to determine possible sources of exposure. Jean replied that the scope of a questionnaire (e.g., the level of detail included) would need to be determined; consideration would be needed in terms of the amount of value that would be added. Greg Pratt suggested that if a decision is made to go back to participants with a questionnaire, attempts should be made to pin down as much as possible about exposures. Lisa added that the biggest cost in the study would be to find each person and that adding a questionnaire would constitute less of an additional cost. Jean stated that costs would depend in part on the length of the survey and whether the survey contained validated questions; it could take considerable time to develop. Geary Olsen stated that it would be unlikely for MDH to identify sources of exposure. This is a big area of investigation in the literature; if the exposures could be easily quantified this question would have already been answered by others. Instead, the study should focus on obtaining a better estimate of the role of the water in PFC levels; the questionnaire should be focused on local issues. Lisa suggested that the study could attempt to get better information on the cessation time variable discussed in the previous presentation. Question 4: What are the levels of other PFCs in the community, including those that have not been detected in the water? [Note: The MDH laboratory can measure approximately 16 PFCs using methods comparable to NHANES.] Beth Baker asked whether adding other PFCs could provide an indication of exposure to other products. Geary Olsen stated that none of the PFCs are exposure-specific compounds and that the shorter chain PFCs can actually be metabolites of other PFCs. Geary stated that, in his view, the unique question that we should focus on is what is the contribution of the water to the PFC blood levels. He suggested included PFBA in the list of analytes (in addition to PFOA, PFOS and PFHxS) even though it was found in a smaller number of participants. This would help confirm that the levels are no different than before and PFBA is of particular interest in Minnesota because of the exposure in the water. Louise Liao and Carin Huset from the MDH lab stated that adding PFBA would add minimally to the burden of the lab. Jim Kelly from the MDH environmental health division added that PFBA is still in the water in Oakdale at low levels, so some participants are still being exposed. 69 Deb McGovern stated that she supported the idea of measuring PFBA, but questioned the purpose of including other PFCs that were not found in the water, particularly because the messaging around those exposures would be more difficult. Lisa Yost, Beth Baker and Cathi Lyman-Onkka agreed that if a PFC is not related to the drinking water it should not be measured. In addition, Lisa stated that PFCs should only be measured if there are NHANES data available for comparison. Greg Pratt disagreed, saying that if the additional cost to measure other PFCs is minimal, more PFCs should be included in the follow-up analysis, even if the data are hard to interpret; such information could be useful in the future. Geary stated that for PFCs not found in the water, the study population would likely look like the general population. He stated that he was not opposed to including other chemicals, but that MDH should expect levels to be at background levels. He added that the biggest question in the study population is PFHxS levels, which are higher than levels found in other communities thought PFHxS was generally not detectable in the well water. He suggested that MDH could try to explore the relationship between the water levels and blood levels for PFHxS using the data on the Oakdale municipal water. Lisa stated that even if adding chemicals to the analysis introduces little cost, the downside of collecting information that can’t be interpreted is that it can become more expensive later in terms of addressing community concerns. Alan Bender stated that even if there were no additional cost created, the MDH study should not gather information that can’t be interpreted. His view is that MDH should be viewed as public health clinicians not public health academicians. While gathering information that can’t be interpreted may be appropriate for an academic setting, it’s not appropriate for MDH. Question 5: Is there a relationship between blood cholesterol and PFC levels in this study group? Is the rate of decline for PFCs different for people with high vs. low blood cholesterol levels? Question 6: Are there long-term health effects (cardiovascular, cancer, reproductive, etc.) associated with PFC exposures in this community or in the state? Jean stated that the studies looking at the relationship between blood cholesterol and PFC levels have been cross-sectional. An MDH study could be designed to explore whether the difference in PFC levels is associated with a difference in PFC rates of decline. Jean also stated that community members frequently request for MDH to conduct a health study, such as cancer, reproductive outcomes and thyroid. Greg Pratt suggested that, given that we know what the distribution of cholesterol levels are in the population and we know the rate of decline of PFCs, staff could conduct a power calculation to determine whether it would even be feasible to measure a cholesterol association. A similar calculation could be done for various health effects. Geary Olsen stated that new research on health effects and PFCs is coming out every day and that the expertise to advise such a study is not present on the current EHTB advisory panel. 70 Geary, in response to a question from Deb McGovern, then described the current research on PFCs and cholesterol levels. The response is different at community exposure levels from the response at occupational exposure levels. The increase in cholesterol at lower levels of exposure may be due to binding issues (e.g., PFCs binding to beta lipo-proteins and albumin) rather than to a causal relationship between PFCs and cholesterol. He stated that other researchers are looking at this issue and he is not sure that such a study at MDH could be adequately carried out within the constraints of the EHTB program. Deb McGovern stated that, based on Geary’s description, she did not support the MDH study addressing the questions of cholesterol levels and health effects. Beth Baker stated that, because community members are interested in information on health effects, MDH could consider looking at the cholesterol issue if the sample size is adequate. As long as blood is being drawn for the PFC levels, running a cholesterol test is inexpensive. Cathi Lyman-Onkka agreed, stating that the program needs to balance research with community expectations. Adding the cholesterol question to the project could help build credibility with the community by responding to their concerns. Lisa Yost stated that she would be reluctant to include a health endpoint in the study unless it can be done with an appropriate level of rigor. Additionally, she questioned whether exposures were high enough in this population to warrant looking at health effects. Geary stated that the current sample size is adequate for measuring PFC levels but not sufficient for looking at health effects (which would have required a different study design), and that MDH may not be able to add to what is already being learned elsewhere. Greg stated his opinion that the study should build in as much as is cost-effective and that the first four research questions seem more feasible in this regard. Alan Bender stated that there might be other tools available to answer the health-related research questions, such as using Minnesota Cancer Surveillance System data. On a more general level, Alan Bender suggested that in considering any new biomonitoring study there should be a discussion of the philosophical framework guiding the work. If money is spent on biomonitoring, it will mean that resources will not be available to do other work. A question for consideration is whether the priority should be to spend money on programs where there is a defined public health impact or on things like measuring PFCs, whose impact on health is unknown. His view is that the health department should focus on work with known health impacts and look to academic institutions and other researchers for guidance on PFCs as more research is carried out. 71 Biomonitoring Updates Mercury Pat McCann, the principal investigator for the Lake Superior Mercury Biomonitoring Study, provided an update on that project. An automated punch is now being used on the blood spots instead of a hand punch. The number of punches needed to run the analysis has been reduced which has resulted in an increase in the inclusion rate. Lab analysis is expected to begin in December. In terms of enrollment, Wisconsin has completed sample collection with 140 samples; Michigan’s participation is still on hold; and Minnesota, where informed consent is required for participation, has received 810 consents (out of the target of 1,160). Approximately 10% of the consents received to date have been obtained with the assistance of local public health agency staff. The participation rate in Minnesota is estimated to be about 48%. Enrollment in Minnesota is expected to be completed by February 2010. At an earlier advisory panel meeting, a recommendation was made to collect data in the other participating states to determine how Minnesota’s exclusion criteria might affect participation. This information is being collected. Pesticide indicator Joe Zachmann from the Minnesota Department of Agriculture, Deanna Scher from the environmental health division at the Minnesota Department of Health, and Naomi Shinoda from the health promotion and chronic disease division at the Minnesota Department of Health made a presentation on the progress made in developing nationally consistent data and measures related to pesticides. Joe reported that progress has been slow and that there is a lack of understanding among group members of the issues and terminology. Participating states are compiling potential data sources, which will be pooled and examined for commonalities across states. Five areas have been identified for possible indicator development: Product sales and use Needs for pesticides (e.g., pest trends) Exposures Health outcomes (acute and chronic) Interventions (e.g., regulatory actions) Deanna described national data sources being considered for inclusion. Joe described some of the Minnesota-specific data sources related to hazards. Naomi described Minnesota-specific data sources related to health outcomes. Further information about these data sources can be found in the meeting materials on pages 41-86 and in the attached Power Point handout. Panel members were invited to provide feedback in terms of establishing Minnesota-specific priorities and identifying data gaps. Geary Olsen asked about which health conditions are likely to be included under the category “suspected chronic” health conditions related to pesticide exposure. Naomi responded that she was not sure where the national program was heading but that she would urge caution within Minnesota in terms of incorporating this into the tracking program. 72 Alan Bender stated that the panel could provide recommendations about where Minnesota should diverge from the national program and could give advice to help form national priorities. Beth Baker commented that there are data gaps in terms of health outcomes. There is no information on occupational exposures and no information about chronic conditions. Tracking updates IBIS (portal development) Chuck Stroebel, EPHT program manager, described progress made in developing a web-based queriable information system for the tracking program. The target date for having the system up is September 2010. It is likely that the initial content will be somewhat limited, but that additional content and functionality will be added over time. Beth Baker adjourned the meeting. Drafted 12/30/09; finalized 1/21/10 73 This page intentionally left blank. 74 Environmental Health Tracking and Biomonitoring Advisory Panel Roster 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 Jill Heins Nesvold, MS American Lung Association of Minnesota 490 Concordia Avenue St. Paul, Minnesota 55103 651-223-9578 [email protected] Nongovernmental organization representative Cathi Lyman-Onkka, MA Preventing Harm Minnesota 372 Macalester Street St. Paul, MN 55105 Fred Anderson, MPH Washington County Department of Public Health and Environment 14949 62nd St N Stillwater MN 55082 651-430-6655 [email protected] At-large representative Home office 651-647-9017 [email protected] Nongovernmental organization representative Debra L. McGovern Minnesota Chamber of Commerce 400 Robert Street North, Suite 1500 St. Paul, Minnesota 55101-2098 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 Home office 651-488-9050 [email protected] Statewide business organization representative Pat McGovern, PhD, MPH University of Minnesota School of Public Health Environmental Health Sciences Division MMC Mayo 807 420 Delaware St SE Minneapolis MN 55455 612-625-7429 [email protected] University of Minnesota representative 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 75 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 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 Lisa Yost, MPH, DABT Exponent, Inc. 15375 SE 30th Pl, Ste 250 Bellevue, Washington 98007 Gregory Pratt, PhD Minnesota Pollution Control Agency Environmental Analysis and Outcomes Division 520 Lafayette Road St. Paul, MN 55155-4194 651-757-2655 [email protected] MPCA appointee Local office St. Paul, Minnesota 651-225-1592 [email protected] At-large representative 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 Rev. February 17, 2010 Please submit corrections to [email protected] 76 Biographical sketches of advisory panel members 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. Fred Anderson is an epidemiologist at the Washington County Department of Public Health and Environment and has over 30 years of public health experience. .He holds a Master of Public Health (MPH) in environmental and infectious disease epidemiology from the University of Minnesota and is a registered environmental health specialist. For over 20 years, he has led county-wide disease surveillance and intervention programs, including numerous multidisciplinary epidemiologic investigations. 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. Jill Heins Nesvold serves as the Director of the Respiratory Health Division for the American Lung Association of Minnesota, North Dakota, and South Dakota. Her responsibilities include program oversight and evaluation related to asthma, chronic obstructive lung disease (COPD), lung cancer, and influenza. Jill holds a masters degree in health management and a short-course masters of business administration. Jill is extensively published in a variety of public health areas. Cathi Lyman-Onkka worked in local public health with the Saint Paul – Ramsey County Department of Public Health for nearly 34 years, until her retirement in 2006. From 1997 through May 2006 she was supervisor of the Community Involvement Program in the Environmental Health Section. The Community Involvement Program provided community and professional education related to environmental health, administered the county Household Hazardous Waste Collection Program, and administered the county Waste Management Service Charge and its transition to the County Environmental Charge. Cathi has a B.A. in Biology with a concentration in Environmental Studies from Macalester College, Saint Paul, Minnesota, and a M.A. in Public Administration from Hamline University, Saint Paul, Minnesota. From 2002 to May 2006 Cathi was associated with Preventing Harm through her work for Ramsey County. She has been active on the Preventing Harm Board since November 2007. 77 Debra McGovern has more than 30 years of environmental experience. She has 15 years of experience in Minnesota governmental regulation and 15 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). Pat McGovern is a Professor in the Division of Environmental Health Sciences at the University of Minnesota’s School of Public Health. Dr. McGovern is a health services researcher and nurse with expertise in environmental and occupational health policy and health outcomes research. She serves as the Principal Investigator for the National Children’s Study (NCS) Center serving Ramsey County, one of 105 study locations nationwide. The NCS is the largest, long-term study of children’s health and development in the US and the assessment of environmental exposures will include data collection from surveys, biological specimens and environmental samples. 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. 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. 78 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. February 23, 2010 Please submit additions and corrections to [email protected] 79 This page intentionally left blank. 80 Environmental Health Tracking and Biomonitoring Steering Committee Roster John Linc Stine (chair) Assistant Commissioner Health Protection Bureau Minnesota Department of Health 651-201-5063 [email protected] Jim Golden Division Director Health Policy Division Minnesota Department of Health 651-201-4819 [email protected] Pat Adams Assistant Commissioner Community and Family Health Promotion Bureau Minnesota Department of Health 651-201-5809 [email protected] Mary Manning Division Director Health Promotion and Chronic Disease Division Minnesota Department of Health 651-201-3601 [email protected] Joanne Bartkus Division Director Public Health Laboratory Division Minnesota Department of Health 651-201-5256 [email protected] Wendy Nelson Division Director Information Systems and Technology Management Division Minnesota Department of Health 651-201-5010 [email protected] Linda Bruemmer Division Director Environmental Health Division Minnesota Department of Health 651-201-4739 [email protected] Mike Sandusky Division Director Environmental Analysis and Outcomes Division Minnesota Pollution Control Agency 651-757-2689 [email protected] Greg Buzicky Division Director Pesticide and Fertilizer Management Division Minnesota Department of Agriculture 651-201-6639 [email protected] Rev. January 12, 2010 81 This page intentionally left blank. 82 Environmental Health Tracking and Biomonitoring Governance Structure 83 This page intentionally left blank. 84
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