Environmental Health Tracking and Biomonitoring Program Advisory Panel Meeting Agenda for February 11, 2014: 1:00 – 4:00 pm at The American Lung Association in Minnesota 490 Concordia Avenue, St. Paul, Minnesota Time Agenda Items Presenters Description/expected outcome 1:00 Welcome & Introductions Patricia McGovern, Chair Panel members & audience are invited to introduce themselves 1:05 Tracking Updates Jean Johnson Chuck Stroebel Information item: Jean will give a brief review of MN Tracking program updates. Panel members are invited to ask questions or comment on updates. Chuck Stroebel Discussion Item: MDH will present an overview of the agency’s health equity initiative. Chuck will highlight data on the portal that reveals health disparities and sub-county level data. Governor’s award New portal content CDC projects update 1:10 Advancing Health Equity and Portal Data Demonstration 1:30 Discussion Questions for the panel: 1:50 1 New Pesticide Poisoning Data Demonstration Tess Konen Over the next 3-5 yrs, how could data on the portal be enhanced to inform actions that advance health equity? Over the next 3-5 yrs, what could the biomonitoring program be doing to inform actions that advance health equity and environmental justice? Information item: Tess will give a brief preview of new Tracking pesticide poisoning data. Panel members are invited to ask questions or provide comment. Time Agenda Items Presenters Description/expected outcome 2:05 Refreshments 2:15 East Metro PFC3 Biomonitoring Project Update Christina Rosebush Information item: Christy will present the status of the PFC3 project. Panel members are invited to ask questions or comment. 2:25 Biomonitoring Updates Paul Moyer, Public Health Laboratory Jessica Nelson Information item: Jessica and Paul will briefly describe recent status of metals projects and laboratory. Panel members are invited to ask questions or comment. 2:40 Newborns’ Biomonitoring Protocol: Community Selection Jessica Nelson Discussion Item: Jessica will review the draft protocol and rationale for the community selection and consent process that is proposed. 3:00 Discussion Questions to the panel: 3:30 Sustaining Minnesota Biomonitoring: Workgroup Progress Report Kristin Van Amber Does the panel agree with the proposed clinic-based community selected for this project? How might we might best engage the community, and recruit participants? Should enrollment be open to all women seen for prenatal care in the community clinics, or should eligibility be further limited by race/ethnicity? Given that urine is a better biomarker for inorganic mercury found in skinlightening creams, should we also collect a maternal urine sample? Discussion item: Kristin will report on the first 2 meetings of the Sustaining Minnesota Biomonitoring Workgroup, draft charter and work plan. 2 Time Agenda Items 3:40 Discussion Presenters Description/expected outcome Questions to the panel: 3:50 New Business 3:55 Audience Questions 4:00 Motion to adjourn Does the charter and plan fit with your understanding of the group’s charge? What suggestions do you have to assist them in developing an action plan for sustaining Minnesota Biomonitoring? Note to audience: The panel asks that audience members hold comments and questions on discussion items until the end of the meeting, when the chair will invite questions from the audience. Audience members are asked to identify themselves when they speak, and to please record their names and affiliations on the list at the sign-in table. Meetings are recorded on audiotape. 3 Table of Contents Section Overview: Advancing Health Equity and Portal Data Demonstration ............................................ 8 Section Overview: New Pesticide Poisoning Data Demonstration............................................................ 14 Section Overview: East Metro PFC3 Biomonitoring Project Update ........................................................ 18 Section Overview: Biomonitoring Updates ................................................................................................ 21 Section Overview: Newborns’ Biomonitoring Protocol ............................................................................. 24 Section Overview: Sustaining Minnesota Biomonitoring: Workgroup Progress Report ........................... 31 Section Overview: Other Information........................................................................................................ 36 4 Section Overview: Environmental Public Health Tracking Updates Jean will give a brief review of MN Environmental Public Health Tracking program updates and respond to questions. This section includes status reports on the following projects: MN Tracking portal team receives Governor’s award New portal content CDC projects update Information Item: After this presentation, panel members are invited to comment and ask questions. 5 Tracking Updates MN Tracking Portal Team Receives Governor's Award In December 2013, the Minnesota Tracking Program’s data portal team received a Governor's Award for Continuous Improvement, which recognizes outstanding achievement in reforming state government and saving taxpayers' dollars. Honored at a reception at the State Capitol, this team from the Minnesota Department of Health (MDH) was one of just six throughout Minnesota's state government agencies to receive this award. At the reception, Governor Mark Dayton acknowledged the "tremendous efforts to improve the quality of services provided to Minnesotans." The award recognizes work that increases productivity and enhances the efficiency of state government services. The portal team is honored that their work to make public health data available and accessible to Minnesotans is helping to fulfill Governor Dayton’s mission of "Better Government for a Better Minnesota." By relying on best practices in usability, plain language, and web design, the portal provides public health information that is user-friendly and widely accessible, and that uses costeffective strategies to communicate health information that is actionable. MDH has developed estimates of costs avoidance and savings provided through the MN Tracking Program’s data access portal, as well as improvements in government services. Cost avoidance in handling data requests: $3.6 million/year Improved timeliness in access to data: 24/7 on the portal web site Cost savings in IT architecture: scalable to integrate broad public health data sets Currently the portal has data on 18 topics with approximately 2000 unique visitors per month. Chuck Stroebel, Minnesota’s Tracking Program Manager, estimates that costs avoided are substantial given the staff time and handoffs associated with handling individual data requests, one-by-one. Furthermore, with the IT infrastructure and standards for data now in place for tracking, MDH can efficiently integrate new data into the MN Tracking data portal. Several MDH programs have approached the MN Tracking Program to explore requirements to integrate data into the portal. Agency and IT programs are viewing the portal as a win-win to avoid duplication and rework required for maintaining multiple, independent on-line systems. For more, see the Governor’s blog: Governor Dayton Recognizes State Employees for Reforming State Government. New Portal Content New Private Well Data Launched In January 2014 the MN Tracking Program added new data for private wells (arsenic) to the data access portal, including interactive maps and charts. These data were developed in collaboration with the MDH Well Management Section, and through MDH participation in two CDC National Tracking Network project teams charged to develop and evaluate data on private wells. MDH currently is working to promote the availability of these new maps through conferences, newsletters, and other media channels. Minnesota is one of a handful of grantees in the CDC National Tracking Network who were able to successfully develop and launch data on private wells. Portal data are limited arsenic; however, 6 data on additional contaminants may be considered in the future if additional resources become available. View Arsenic in Private Wells: Facts & Figures Updated Air Quality Data Launched In December, the MN Tracking Program launched updated air quality data for fine particles and ozone. These data were developed by the Minnesota Pollution Control Agency, in collaboration with the MN Tracking Program. These data include monitored and modeled values, using the US EPA Downscaler model. In the spring of 2014, the MN Tracking Program and MPCA will initiate development of a new Air Quality Index indicator. View the updated air quality data CDC National Tracking Network – Update and Renewal Opportunity The MN Tracking Program continues to participate in four national CDC Tracking Project Teams that are working to demonstrate use of state/national tracking data. The next Advisory Panel meeting will include additional information about Minnesota’s involvement and products of these teams, and their work is expected to conclude in March-April 2014. MDH’s current award (Year 5) from the CDC National Tracking Network concludes in July 2014, and we will be applying for competitive renewal for our cooperative agreement in spring 2014. Panel members are encouraged to contact Jean Johnson or Chuck Stroebel for questions or to share ideas for our renewal application. 7 Section Overview: Advancing Health Equity and Portal Data Demonstration MDH will present a brief overview of the agency’s broad health equity initiative. Chuck will highlight data on the portal that reveals health disparities and opportunities for presenting sub-county level data. Questions for the panel: Over the next 3-5 years, how could data on the portal be enhanced to inform actions that advance health equity? Over the next 3-5 years, what could the biomonitoring program be doing to inform actions that advance health equity and environmental justice? 8 Advancing Health Equity Background Minnesota is one of the healthiest states in the country. However, a statewide assessment has found that not all Minnesotans have the same chances to be healthy. Those with less money, and populations of color and American Indians, consistently have less opportunity for health and experience worse health outcomes. The Minnesota Legislature in 2013 directed the Minnesota Department of Health (MDH) and its partners to complete a report about advancing health equity (AHE) in Minnesota. The report assesses Minnesota’s health disparities and recommends best practices, policies, processes, data strategies, and other steps that will promote health equity for all Minnesotans. The project officially launched October 22, 2013. The report was due to the Legislature February 1, 2014. A summary of key principals from the report is provided below. A copy of the complete final report can be found on the MDH website here: Advancing Health Equity Advancing Health Equity in Minnesota: Report to the Legislature Recommendations for Advancing Health Equity Principles guiding the recommendations An initial analysis of the nearly 200 pages of inquiry responses and an overview of research related to health equity have yielded six key principles that helped to guide the development of a set of recommendations for advancing health equity in Minnesota. The ideas encompassed in the principles are directed toward MDH as well as toward local government and community partners, other state agencies, health plans and health care providers, and organizations in many sectors across Minnesota. Please note that neither these principles nor the recommendations are presented in any intentional priority order. Principal 1. The importance of examining all policies for structural inequities and health equity. The inquiry responses indicated that health equity could not be advanced without a deliberate and concerted effort toward developing public policies that support health and address the structural inequities, including structural racism, evident in many arenas. Examples included were land use, transportation planning, education, health care, and the environment. Suggestions included establishing criteria and routinely conducting health equity impact assessments for policy, systems, and environmental decisions, when deemed appropriate. Emphasis was also placed on the need to make an analysis of structural racism and other structural inequities key elements of health policy and health equity discussions. Principle 2: The value of pulling people together and collaborating to advance health equity. In the inquiry responses, frequent references were made to the importance of bringing a variety of sectors and actors to the discussion table to expand understanding among decision makers and get 9 health equity to a central place in policy development. Particular emphasis was given to the role of the commissioner of MDH in convening cabinet-level discussions and decisions to advance health equity. Principle 3: The need for strong community relationships and shared decision-making to make a real difference. Inquiry respondents frequently noted that MDH and local public health leaders re primarily white/European, and that most MDH advisory councils also are primarily composed of white practitioners. Concern was expressed that there are unrealistic expectations for the few persons of color present on these councils to speak for entire racial/ethnic communities, and that communities of color and American Indians often have been used as a means to an end (e.g., to gather research data), rather than as entities with their own ideas and solutions. Respondents recommended that, in addition to addressing disparities in the workforce, MDH must take the time needed and develop stronger relationships with the American Indian, African American, Hispanic/Latino, Asian-Pacific Islander, and other racial/ethnic/cultural communities, including new immigrants and refugees. Additional responses were to provide payment as a means of facilitating participation of community members, as not everyone is paid by their employers to attend meetings. Many noted that new initiatives fail to seek community input at the very beginning, and/or do not assure adequate representation of the communities that will be most affected by the initiative or program on task forces and work groups, thus the solutions, policy development, or decisions are not as effective as they should be. Building relationships in the community is the first step toward sharing power in decision making. Principle 4: That health equity must become an integral aspect of all efforts, not just a focused effort in one area. Comments made in the inquiry responses noted that if health equity is to be advanced, it has to become the responsibility of all parts of the department (similar to the idea of interagency or cross-sector work). Historically, however, some people both inside and outside of MDH have assumed that eliminating health disparities and advancing health equity are the sole responsibility of the Office of Minority and Multicultural Health (OMMH). This narrow view of health equity needs to be overcome by explicit efforts to institutionalize the concept and activities throughout MDH. The many workforce issues identified in the inquiry include both workforce development and the cultural competence of MDH staff. The inquiry responses frequently identified a lack of racial/ethnic diversity among MDH leadership and professional staff. This lack of diversity in these positions reflects many different issues, including structural racism in educational and degree-development processes, financial and cultural barriers to post-high school education, and state hiring processes (including webbased applications, resume development, job requirements that give priority to degrees over experience, and more). MDH faces many difficulties in recruiting, developing, promoting and retaining employees that represent the populations served by MDH and the state. In addition to workforce development, a numberof comments emphasized the daily stress faced by some employees in the workplace environment at MDH, in part due to the lack of racial and ethnic diversity and cultural sensitivity noted above. And while many in MDH recognize the importance and need to look at their work through both a structural racism and a health equity lens, not all agree. 10 Some inquiry responses noted that a number of health occupations (especially some para-professional fields, e.g., dieticians) are white (and often female) dominated areas, thus the values and expectations these professionals bring to their work reflect the white middle class, affecting the working environment of the profession, the standards they develop, and the ways in which each profession interacts with communities that have a different culture and different values. It also affects who is attracted to these professions, learns about them or has the opportunity to see them at work, or views these professions as valuable and relevant to their communities’ needs. Principle 5: The need to acknowledge and support the capacity of Minnesota communities to create health. Frequent reference was made in the inquiry responses to the need for MDH to understand and respond to the differing capacities of community organizations who seek any competitive grants from the department. A number of structural issues, such as financial requirements for grantees, result in advantages being giving to larger, established and well-resourced organizations rather than emerging organizations from the communities most affected by health disparities. Throughout the inquiry responses, comments were made about the importance of early and meaningful engagement of stakeholders in decisions that affect them. Principle 6: The need to improve the collection, analysis, and use of data for health equity. Responses in the inquiry to questions about data for health equity included: That data should be disaggregated into more racial, ethnic and linguistic groups to more accurately reveal what is happening (e.g., broad categories of race do not advance understanding of the significant differences among ethnic subgroups). That more data and greater expertise in analysis are needed on sexual orientation and gender identity (including statewide demographic data as well as provider data). That the community needs to receive training and be involved in every phase, including planning and the actual processes of data collection and analysis. That data need to be analyzed from community (i.e., not just MDH professional) perspectives, and that all those who will be analyzing the data need cultural competence. A specific concern was expressed regarding the need for the involvement of investigators from the community to be included in the interpretation and analysis of data collected from and about their community. A number of responses also commented on the great value of qualitative data and collecting stories from the community to help understand the quantitative data. Links to other reports on this topic: Wilder Foundation of MN: The unequal distribution of health in the Twin Cities This report by the Blue Cross and Blue Shield of Minnesota Foundation and Wilder Research finds that health and life expectancy are strongly connected to median area income, neighborhood conditions, education and race. 11 CDC Chronic Disease Prevention and Health Promotion: Health Equity This website provides links to various reports and resources on health disparities, social determinants of health and heath equities from a national perspective. Report to the Minnesota Legislature: Collection of Racial and Ethnic Health Data by the Minnesota Departments of Health and Human Services (2011) This report finds that only 60% of MDH datasets that include data on individuals include data on race, ethnicity or language. How can Tracking and Biomonitoring Inform MDH’s work: Advancing Health Equity? Biomonitoring Shows Disparities in Chemical Exposures Data collected nationally and in other states show some striking disparities by race/ethnicity and socioeconomic factors in exposure to chemicals, such as mercury and lead. Figure 1 shows that, nationally, exposure to mercury is highest in women of child-bearing age who identified themselves as "other race" (which includes Asian, Native American, Pacific Islander, and Caribbean). Nearly 16% of women in the “other race” group had mercury in blood above a level of health concern, compared to under 5% for non-Hispanic white women. Mercury is a potent neurotoxin that is especially harmful to a developing fetus. Figure 1: Percent of U.S. women aged 16-49 with mercury above a level of health concern (>5.8 g/L of blood), by race/ethnicity Source: National Health and Nutrition Examination Survey 1999-2004. For more information on mercury levels in the U.S. population, see Mercury: Facts and Figures [link to: https://apps.health.state.mn.us/mndata/biomonitoring_mercury] at MN Public Health Data Access. In Minnesota, we do not know whether certain populations, such as African Americans or Asians, bear an unequal burden of exposure to toxic metals and other chemicals, though there is good reason to 12 think that these disparities exist. The Minnesota Biomonitoring Program at MDH is working to fill this gap by providing data that will inform decisions and evaluate actions for protecting the next generation. For more information about Minnesota’s strategic plan for biomonitoring to address health disparities, see MDH’s Framework for an Ongoing Biomonitoring Program Environmental Public Health Tracking Data Portal Informs Actions to Eliminate Disparities Access to public health data helps MN communities, agencies, and others to identify priorities, and to evaluate the effectiveness of actions to eliminate health disparities. MDH is working to improve access to data that are actionable and highlight areas where we can work together to advance health equity. In 2011, for example, the MDH Tracking Program launched a new data portal that provides public access to interactive charts, maps, and queries on the department’s web site. Data are available on over 18 health and environment topics, including poverty and income, health insurance (coverage), asthma, cancer, lead poisoning, and chronic obstructive pulmonary disease (COPD). Data on this portal may be used to evaluate trends for health disparities by race/ethnicity, age, gender, income and other factors. For example, COPD, which includes emphysema and chronic bronchitis, is the fifth leading cause of death in Minnesota. An estimated 4.1% (164,000) of Minnesotans report ever being diagnosed with COPD (BRFSS, 2011). Figure 2 shows some striking disparities for COPD in Minnesota by race with high rates of death for American Indians compared to people who are white, black or Asian. Figure 2: Chronic Obstructive Pulmonary Disease (COPD) Mortality in MN by Race Source: Minnesota Center for Health Statistics (2001-2010). By using these and other data to inform public health actions for COPD in Minnesota, MDH and our partners, such as the American Lung Association of MN, are able to identify areas to eliminate health disparities, and to evaluate the effectiveness of initiatives to protect health. For more information about COPD and other data topics available on the portal, visit Minnesota Public Health Data Access 13 Section Overview: New Pesticide Poisoning Data Demonstration MN Tracking staff will give a brief preview of new Tracking pesticide poisoning data and measures. Information Item: After this presentation, panel members are invited to comment and ask questions. 14 New Pesticide Poisoning Data Demonstration The MN Tracking Program has developed new indicators to better understand and track the nature of unintentional, non-occupational pesticide poisonings in Minnesota. These indiicators are: pesticide poisoning emergency department (ED) visits, pesticide poisoning hospitalizations, and pesticide exposure calls to the MN Poison Control Center. These indicators will be added as a new topic area on the data access portal this spring. The hospitalization and ED visits indicators were created using the Minnesota Hospitalization Discharge Data (MNHDD), for the years 2000-2011. Rates of pesticide poisoning hospitalizations and ED visits were calculated, and differences by sex, age, seasonal variation, and geographic location were assessed (see sample charts). We found that males are more likely to be hospitalized for pesticide poisoning than females in almost every age group. While males, aged 15-34 are more likely to be hospitalized, children under four years of age have a much higher rate of ED visits than other age groups. There is a seasonal pattern to pesticide poisoning ED visits, with increased visits in the summer and fall probably due to the increased use of pesticides for pest management. The indicator for pesticide poisoning calls was created using pesticide exposure calls from the MN Poison Control Center for the years 2005-2012. The number of poison control center calls was calculated for possible unintentional, non-occupational pesticide exposures by month, pesticide type, gender, and age group. A seasonal pattern was detected in the number of pesticide calls, with more calls occurring during the summer months. For pesticide exposure calls there are two vulnerable groups, children under four and adults aged 20-64 years. Symptoms of pesticide poisoning often mimic symptoms of colds or the flu. Therefore, pesticide poisonings are often misdiagnosed and under-reported. Immediate symptoms may not be severe enough to urge an individual to seek medical attention, or a doctor might not think to ask about pesticide exposure. This may result in uncounted hospitalizations or ED visits and an underestimation of pesticide poisonings. Some limitations of these data are the underestimation of rates for counties in which residents are likely to cross state lines for healthcare, multiple hospital or emergency department admissions by the same patient cannot be identified, and only those who sought care for their pesticide poisoning symptoms are represented. The main limitation to poison control center calls are that they are a voluntary reporting of data verified only by follow-up phone calls by poison center specialists. These calls represent suspected exposures from pesticides and serve as a proxy for the actual burden of pesticide poisonings. An actual poisoning event can only be verified through medical outcome. Additionally, data acquired by telephone are limited to those who have access to telephones and knowledge of the poison center service. An unknown number of pesticide exposure events may occur for which no call was made. Previously, data on pesticide poisonings in Minnesota were difficult to access. The data can be used to inform prevention guidelines and for targeting public awareness & prevention campaigns during peak times of accidental poisoning. With the access to Minnesota-specific data, MDH, the MN Department of Agriculture, and others may use these data to inform poisoning prevention programs and initiatives. 15 The following are examples of charts developed for the data access portal. For questions, or more information on charts that will be placed on the data access portal, contact Tess Konen— epidemiologist—at [email protected]. 0.8 Age-adjusted Rates per 100,000 0.7 Pesticide poisoning hospitalizations in Minnesota by age and sex 0.6 0.5 0.4 0.3 Males 0.2 Females 0.1 0 0-4 years* 5-14 years* 15-34 years 35-64 years 65+ years Age Categories Source: Minnesota Hospital Association, 2002-2011. *Unstable rates due to some counts less than 20. 16 Pesticide poisoning ED visits in Minnesota by age and sex Age-specific ED Rate per 100,000 8 7 6 5 4 3 2 1 0 0-4 years 5-14 years 15-34 years 35-64 years 65+ years Age Males females Source:Minnesota Hospital Association, 2007-2011. Pesticide poisoning calls in Minnesota by month Total Number of Pesticide Calls 2500 2000 1500 1000 COUNT 500 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Month Source: MN Poison Control Center, 2005-2012. 17 Section Overview: East Metro PFC3 Biomonitoring Project Update This section provides a summary of current progress of the East Metro PFC3 Biomonitoring Project and includes the following: Project overview IRB approval Outreach to communities Participant recruitment o Original Cohort o New Residents Timeline Information Item: After this presentation, panel members are invited to comment and ask questions. 18 East Metro PFC3 Biomonitoring Project Update Christy Rosebush, MPH Project overview The East Metro PFC3 Biomonitoring Project will measure blood levels of PFCs in residents of the East Metro to check that measures put in place to reduce PFC exposures through drinking water are working. We will measure PFCs in participants of the 2008 and 2010 PFC biomonitoring projects to verify that PFC levels have continued to decline in this group. Additionally, we will measure PFCs in Oakdale residents who moved to the city after the installation of a filtration system on the city water supply and compare PFC levels to those seen in the U.S. general population. All participants will be asked to donate a blood sample and complete a questionnaire about factors that may be related to their PFC levels. IRB approval The project received initial approval from the MDH and HealthEast IRBs in November 2013. Study protocols and documents were amended based on MDH and HealthEast IRB stipulations and suggestions, and on revised thinking about the project timeline. Amended protocols and documents were resubmitted in December and subsequently approved by both IRBs. Outreach to communities Project staff have been working to inform local public health departments and legislators about the project. Meetings have been conducted with officials from Washington County, Oakdale, and Cottage Grove. Lake Elmo was informed of the project by phone. Outreach to legislators has also been initiated. Media efforts to inform East Metro communities about the project will begin approximately February 12th, one week before recruitment materials are mailed. Participant recruitment Original Cohort: The 183 participants from the 2008 and 2010 projects who agreed to future contact will be mailed a letter inviting their participation in the project, consent forms, and a questionnaire around February 19th. Phone calls will be made to those who do not return the materials to ensure they have received the mailing and understand the project. New Residents: At least 500 Oakdale households that began municipal water service after October 2006 will be sent an introductory letter, factsheet, and household survey to identify eligible adults around February 19th. After recipients have had sufficient time to respond, a list of eligible adults will be compiled. We will stratify this list into 2-3 groups based on length of residence before randomly selecting a total of 200 individuals. These individuals will be mailed a second letter inviting their participation in the project, consent forms, and a questionnaire. Phone calls will be made to those who do not return the materials to ensure they have received the mailing and understand the project. Replacement individuals will be randomly selected for those who decline to participate. Timeline The first mailing to the original cohort and new residents is scheduled for February 19th. Beginning the week of February 24th, we expect to begin receiving full study materials (letter, consent forms, 19 questionnaire) from the original cohort and household surveys from new residents. It may take up to one month to collect household survey data and select potential new resident participants. The mailing with full study materials is expected to go out to new residents in mid-March. Once participants return their materials, they will receive a phone call from study staff thanking them, clarifying questionnaire responses, and providing instructions for making their blood draw appointment at the HealthEast Oakdale clinic. Clinic information will also be sent in the mail. Participants will likely begin scheduling their appointments with the clinic in early March. Study staff will collect blood samples from HealthEast Oakdale on a weekly basis and deliver them to the MDH PHL. Blood collection is tentatively scheduled for March through June, though flexibility has been built into HealthEast Oakdale’s contract due to the large number of participants. Update on East Metro Cancer Report MN Tracking and the Minnesota Cancer Surveillance System (MCSS) will soon release a report that details cancer rates among residents of Dakota and Washington Counties between 2000 and 2009. This report is an update to a 2007 report released by MCSS. It will provide Standardized Incidence Ratios for select types of cancer and for all cancers combined down to the zip code level for 8 communities where PFCs have raised health concerns. The data analysis phase is complete, and the full report will soon enter the MDH review process. We anticipate that it will be released in winter 2014. 20 Section Overview: Biomonitoring Updates This section contains status reports on the following projects: Public Health Lab Recovering from Water Damage Pregnancy and Newborns Exposure Study NCS Newborn Mercury Biomarker Validation Supplemental Methodological Study Riverside Newborn Mercury Project Information Item: After this presentation, panel members are invited to comment and ask questions. 21 Biomonitoring Updates Public Health Lab Recovering from Water Damage The Minnesota Department of Health (MDH) Public Health Laboratory suspended some of its laboratory operations in January after the heating system failed on January 6, leading some building systems to freeze and causing significant water leaks on several floors of the building. Crews from MDH and the Minnesota Department of Administration’s Plant Management worked hard to protect equipment, samples and supplies, and to remove equipment from affected areas. Crews stopped the leaks and are now engaged in repair and recovery of the affected work and office areas. Laboratory Director Joanne Bartkus has reported that several major pieces of equipment sustained significant damage, including the instruments used to test metals, and the cost of the total damage could exceed $1 million. MDH lab officials will decide how quickly they will be able to resume operations. If necessary, Minnesota can call on neighboring states to help with some laboratory testing. Damage to the metals laboratory and time needed for recovery will impact current and future biomonitoring projects Pregnancy and Newborns Exposure Study Staff presented results on the relationship between mercury levels in paired newborn bloodspot and cord blood samples at the October 2013 Advisory Panel meeting. Since the meeting, we submitted a manuscript as a “Report from the Field” to Environmental Research; unfortunately, the paper was not accepted for publication. The issues cited by the editor for the rejection include the large number of non-detect values, which they felt questioned “the utility of this method for studying effects at low exposures as well as the strength of your comparisons of the two biomarkers.” They also raised two laboratory method issues: the fact that analyses were not done on split samples from the same blood sample, and questions about how we expressed the concentration of mercury in a dried bloodspot sample without truly knowing the volume of blood involved. We are currently assessing whether to resubmit this manuscript to another journal. The MDH Public Health Laboratory still plans to investigate whether the higher mercury levels found in cord compared to spot blood could be related to the lab method. Cord blood samples with mercury levels >1 g/L will also be analyzed for speciated mercury. Once these analyses are complete, we will summarize the results and post them on the web site. The timeline for this project will likely be impacted by damage to the metals laboratory caused by the water leakage described above. NCS Newborn Mercury Biomarker Validation Supplemental Methodological Study The status of this project has not changed since the October 2013 Advisory Panel meeting but will likely be delayed due to damage in the metals laboratory. The project will measure mercury and other metals in matched cord blood, newborn bloodspot, and maternal blood samples from National Children’s Study participants enrolled by South Dakota State University’s Original Vanguard Center serving Brookings SD, and Yellow Medicine, Pipestone, and Lincoln Counties, MN. All samples (83 pairs of matched newborn bloodspot and cord blood samples, with maternal blood samples at birth from 49 of these mothers) have been received by the MDH Public Health Laboratory. Samples will be analyzed for total mercury and cord blood will also be analyzed for speciated mercury, lead, and cadmium. Staff are still finalizing Data Use Agreements with the NCS. 22 Riverside Newborn Mercury Project The status of this project has not changed since the October 2013 Advisory Panel meeting. The MDH Public Health Laboratory has received 160 newborn bloodspot samples collected from participants in the Riverside Birth Study. Lab analysis for total mercury was expected to begin this fall but may be further delayed due to damage sustained in the metals laboratory. 23 Section Overview: Newborns’ Biomonitoring Protocol Staff will review the project rationale and draft protocol, and will give an overview of the community selection and consent processes that are proposed. Panel members are invited to ask questions or provide comment on any aspect of the proposal. The proposed project will use a clinic-based approach to recruit women during their 2nd or 3rd trimester of pregnancy and obtain consent at that time for MDH to test their baby’s newborn screening blood spot for total mercury. In addition, for a subset of the study population, we propose to obtain a cord blood sample for further analyses including mercury speciation, additional metals (lead and cadmium), and comparison to the blood spot results. Staff are currently in the planning stages of the project and have begun to identify and meet with specific clinics that serve the communities of interest for this project. We have met with a number of colleagues at MDH and other organizations such as St. Paul-Ramsey County Public Health and the MN Council of Health Plans to determine possible clinics and how best to approach them. Questions to the panel: Does the panel agree with the proposed staff recommendations for community selection, based on prior recommendations that MDH target communities of greatest concern? Does the panel have advice for how we might best engage the community, and recruit participants? Does it make sense to narrow our focus to just the specific ethnic populations of concern, or should enrollment be open to all women served by the selected clinics? Exposure to inorganic mercury through skin-lightening creams has emerged as a key concern. Given that urine is a better biomarker for inorganic mercury, should we also collect a maternal urine sample? 24 Newborns’ Biomonitoring Protocol Jessica Nelson, PhD Draft Partial Protocol: Minnesota Family Environmental Exposure Tracking (MN FEET) Minnesota Biomonitoring: Chemicals in People Introduction Fetal exposure to mercury is of great public health concern because even small amounts of mercury can damage the developing infant’s brain and nervous system (NRC, 2000). Mercury exposure may affect future learning abilities, memory, and attention, and lead to learning and behavioral problems later in life (NRC, 2000). In utero and early life exposure to other metals, such as lead, can also have neurodevelopmental effects. The Minnesota Department of Health’s Mercury in Newborns in the Lake Superior Basin pilot study measured mercury in newborns born in the Lake Superior region of the state by testing a leftover portion of the dried newborn bloodspot routinely collected from infants at birth. The study found that 10% of Minnesota babies tested had mercury exposure above a level of health concern (MDH, 2011). This pilot study raised important public health questions, including whether other groups of Minnesotans, beyond those in the Lake Superior region, have elevated mercury exposures. Studies of newborns in other parts of the country have found marked disparities by race/ethnicity in exposure to mercury; certain groups, such as some Asian populations and African Americans, have been shown to have higher exposures than white newborns (King et al., 2013; Lederman et al., 2008). Beyond the Lake Superior mercury results, information on newborn mercury exposures in Minnesota is limited to one small MDH study of newborns born to primarily white, affluent, urban mothers. The sample size (n=48) limited conclusions we can draw from the study, but only 2% of participants had exposures above a level of health concern. No other information on Minnesota newborn mercury exposures is available, and we do not know whether disparities in exposure exist in our state population. The EHTB Advisory Panel recommended that Minnesota Biomonitoring conduct additional mercury biomonitoring to find out whether newborns in regions outside of the Lake Superior Basin are also exposed to harmful levels of mercury during prenatal development and to identify the sources of those exposures where possible. The Panel further recommended that MDH continue biomonitoring of newborn bloodspots and, again where possible, expand our evaluation of the bloodspot method as a way of measuring newborn exposure to mercury. This work is part of a larger effort, based on our strategic plan, to track exposures to chemicals in vulnerable Minnesota populations with a focus on pregnant women, children, and disadvantaged communities. Results will inform decisions and evaluate actions for protecting future generations. 25 Rationale and goals To address these questions, Minnesota Biomonitoring proposes to measure mercury (and other metals, if possible) in bloodspots from approximately 6001 newborns in Minnesota. We also hope to measure mercury and other metals in a smaller number of paired cord blood samples. Because we do not have the resources to do a state-wide sample, we will focus instead on targeted populations that may be at risk for higher mercury exposures. Populations of interest in Minnesota include urban newborns from certain racial/ethnic backgrounds, including Somali, Hmong, and African American newborns. In a future phase of the project, we are also interested in testing newborns from a non-Metro area of the state. Minnesota is home to the largest Somali population in the U.S., with an estimated 50,000 Somali people living in the state (A. Adawe, personal communication, January 24, 2014). A particularly high concentration of Somali people live in the Minneapolis-St. Paul Metro area. Concern about mercury exposure in this population has grown in recent years as information has emerged about the use of skinlightening creams by Somali women (Adawe and Oberg, 2013). Though cosmetic products containing mercury are illegal in Minnesota, they are still widely available for purchase. The St. Paul-Ramsey County Public Health Department, MDH, and the Minnesota Pollution Control Agency tested skin-lightening creams purchased locally and found that 11 out of 27 products contained mercury, some at levels up to 33,000 ppm (Adawe and Oberg, 2013). Interviews with Somali women found that they commonly apply the products to their entire body, sometimes multiple times a day, including when they are pregnant and breastfeeding. No data are available on mercury exposures in Minnesota Somali women or newborns. Biomonitoring studies in different parts of the U.S. have found elevated urinary mercury levels in women who used skin-lightening creams, including Dominican women in New York City and Hispanic women in Arizona, California, New Mexico, and Texas (McKelvey et al., 2011; Weldon et al., 2000).2 A large Hmong population has also settled in Minnesota; over 66,000 Hmong people now live in the state, with the greatest concentration (over 29,000 people) living in St. Paul (Hmong American Partnership). Mercury exposures are a concern in this population for multiple reasons. Anecdotally, the use of skin-lightening creams may be prevalent in Hmong women, and folk remedies and medicines used by Hmong people may contain metals (CDC, 1984). Mercury exposure through fish consumption is 1 The final number of bloodspots tested will depend on the budget and the other specimen types collected. 2 Urine is the preferred biomarker for measuring exposure to inorganic mercury, the form most commonly found in skin-lightening creams. Inorganic mercury is present in blood, but has a short halflife (4 or 5 days), compared to 45 days in urine (Sin et al., 2003). Speciating blood mercury helps better understand inorganic mercury exposure, but blood levels of inorganic mercury reflect very recent exposure only. 26 also a concern as local fishing is common in this community and some may rely on subsistence fishing. A study in Green Bay, WI found that 60% of Hmong households fished (Hutchison and Kraft, 1994), though a biomonitoring study in the same community did not find particularly elevated mercury levels (Schantz S.L. et al., 2010). Other biomonitoring studies have consistently found Asian populations to have higher mercury levels than other groups. In New York City, babies born to China-born Asian women had geometric mean cord blood mercury concentrations of 12.6 µg/L compared to 4.4 µg/L for the rest of the population (Lederman et al., 2008). No biomonitoring data are available on mercury exposures in Hmong or other Asian populations in Minnesota. Another group that may be at higher risk for mercury exposure is African Americans. In Rhode Island, infants born to African American mothers had geometric mean cord blood mercury concentrations of 2.1 µg/L, compared to 0.5 µg/L for the population as a whole (King et al., 2013). This study did not look at exposure sources so it is not entirely clear why this elevation occurred; it could be related to diet or use of personal care products that contain mercury. Again, no biomonitoring data exists on mercury exposures in Minnesota African Americans. MN FEET proposes to measure mercury in the residual portion of newborn bloodspots collected for the MDH Newborn Screening Program. Biomonitoring for metals using newborn bloodspots is a relatively new approach and involves a novel laboratory method. A small MDH project determined that mercury levels in newborn bloodspots were strongly correlated with levels in paired cord blood, a more standard measure of fetal exposure to mercury, but that bloodspot measurements may underestimate mercury exposure compared to cord blood measures. The EHTB Advisory Panel recommended that MDH continue with mercury biomonitoring using bloodspots, but that we also investigate further the methodological question of whether newborn bloodspots are a reliable measure of newborn exposure to mercury. Thus, MN FEET also proposes to collect paired cord blood samples from a subset of newborns and compare mercury levels in the two specimen types. MN FEET will provide an evidence-base for targeting available resources and public health actions to reduce mercury exposures. For newborns whose results indicate elevated exposures, we will partner with St. Paul-Ramsey County Public Health, other local public health agencies, and our collaborating health clinics to be sure that appropriate follow-up is available. In addition, materials for advising women about safe fish consumption are available through MDH’s Fish Consumption Advisory Program. MN FEET has the following goals: 1. 2. 3. 4. Characterize mercury exposures in Minnesota newborns from certain targeted groups and identify disparities that may exist. Determine the proportion of babies with mercury exposures above a level of health concern and initiate a public health response for these families. Investigate sources of mercury exposure using survey data. Establish an infrastructure for ongoing biomonitoring surveillance of newborn exposures in Minnesota. If resources permit, MN FEET will also address these goals: 27 1. 2. Measure mercury in paired cord blood from a subset of newborns to continue investigation of the relationship between mercury levels in spot v. cord blood. Investigate sources of exposure using mercury speciation of cord blood samples. 3. Characterize exposure to other metals (lead, cadmium) in cord blood. Study Design Study population and eligibility The study population will comprise newborns born to pregnant women receiving prenatal care at 3-4 Metro-area clinics that focus on serving the populations of interest described above. We will enroll 200250 families from each clinic. Eligibility will be open to all women seen at that clinic for prenatal care during their 2nd or 3rd trimester. Enrollment will place special emphasis on outreach and communication with Asian, Somali, and African American women. Eligible women must be receiving prenatal care at one of the participating clinics and plan to allow the collection of newborn bloodspots for the MDH Newborn Screening Program. Clinic collaborations For this phase of the project, we hope to partner with three or four Metro-area clinics that serve the above-mentioned populations. Possible clinics include: East Side Clinic, part of West Side Community Health Center, serving a large Hmong population HealthPartners Riverside, Midway, and/or Brooklyn Park Clinics or Smiley’s and Cook Clinic (both University of Minnesota Physicians clinics), serving a large Somali population Northpoint or Broadway Clinics, serving a large African American population We may also explore other avenues of participant recruitment, including working with the WIC and family home visiting programs. Participant recruitment and informed consent Many logistics still need to be determined with participating clinics, but the plan is that trained clinic staff will introduce the project to patients during a 2nd or 3rd trimester visit, possibly when education about the MDH Newborn Screening Program is initiated. Staff will give the families background on the project and answer any questions. Fliers on the project will also be posted in clinic waiting and exam rooms. Information will be available in different languages. An advantage of working through the clinics is that they have interpreters and community health workers on staff who can assist with the project. If the family feels they have enough information and do not have questions, clinic staff will ask for consent. If they have questions, they can contact MDH and choose to participate in the study at a later visit. In tandem with clinic recruitment, we will do outreach to the communities of interest with the help of local public health agencies and their community health workers. This will include meetings with community leaders and the use of appropriate media to reach women in our target populations (radio, TV, and web sites). 28 Informed consent will ask for permission to use a portion of the newborn bloodspot already being collected for the MDH Newborn Screening Program for mercury testing. Participants will also be asked to answer a short set of questions about possible mercury exposure sources. For a subset of participants (most likely all women recruited at one clinic, 200-250 participants), the consent will also allow for the collection of a cord blood sample at the time of the infant’s delivery. For all biospecimens collected, the consent will ask whether or not the family wants to receive their individual results. Participants will be informed that they will receive a small gift as compensation for their involvement. [Sections of the protocol that still need to be completed] Study methods Exposure questionnaire Obtaining bloodspot samples from the Newborn Screening Program Cord blood sample collection, storage and transport Laboratory analysis methods Data management and analysis Communication of biomonitoring results to participants Data privacy Limitations Risks and benefits --------------------------------------References Adawe, A., Oberg, C., 2013. Skin-lightening practices and mercury exposure in the Somali community. Minn Med. 96, 48-9. CDC, 1984. Nonfatal Arsenic Poisoning in Three Hmong Patients -- Minnesota. MMWR. 33, 347-9. Hutchison, R., Kraft, C. E., 1994. Hmong fishing activity and fish consumption. Journal of Great Lakes Research. 20, 471-478. King, E., et al., 2013. Mercury, lead, and cadmium in umbilical cord blood. J Environ Health. 75, 38-43. Lederman, S. A., et al., 2008. Relation between cord blood mercury levels and early child development in a World Trade Center cohort. Environ Health Perspect. 116, 1085-91. 29 McKelvey, W., et al., 2011. Population-based inorganic mercury biomonitoring and the identification of skin care products as a source of exposure in New York City. Environ Health Perspect. 119, 203-9. MDH, Mercury Levels in Blood from Newborns in the Lake Superior Basin. Vol. EPA GLNPO ID 2007-942, 2011. NRC, Toxicological Effects of Methylmercury. National Academy Press, Washington, DC, 2000. Hmong American Partnership, 2010 Census Hmong and Southeast Asian Americans Data. Schantz S.L., et al., 2010. Contaminant profiles in Southeast Asian immigrants consuming fish from polluted waters in northeastern Wisconsin. Environ Res. 110, 33-9. Sin, K. W., Tsang, H. F., 2003. Large-scale mercury exposure due to a cream cosmetic: community-wide case series. Hong Kong Med J. 9, 329-34. Weldon, M. M., et al., 2000. Mercury poisoning associated with a Mexican beauty cream. West J Med. 173, 15-8; discussion 19. 30 Section Overview: Sustaining Minnesota Biomonitoring: Workgroup Progress Report Kristin Van Amber will report on the first two meetings of the Sustaining Minnesota Biomonitoring Workgroup. The workgroup has developed a draft charter and work plan included here for your review prior to discussion of the questions below. Panel members are invited to ask questions and comment on these materials. Questions to the Panel: How does the charter and work plan as presented at the meeting fit with your understanding of the workgroup’s charge? What recommendations do you have to assist them in achieving their goal of developing an action plan for sustaining Minnesota Biomonitoring? 31 Sustaining Minnesota Biomonitoring: Workgroup Progress Report Sustaining Minnesota Biomonitoring Workgroup Charter 1.27.14 Workgroup Purpose This group will explore potential funding sources for an ongoing biomonitoring program in Minnesota and guide MDH in developing an action plan to ensure the long-term sustainability of the program. An ongoing biomonitoring program will track exposures to chemicals in vulnerable Minnesota populations with a focus on pregnant women, children, and disadvantaged communities. Led by an expert Advisory Panel and strategic plan, the program will do systematic, repeated biomonitoring in targeted Minnesota communities for chemicals that are a concern in the state because of our natural environment, industries, and diverse people. Gathering this information will allow us to track trends over time, identify groups that are highly exposed to chemicals, and, ultimately, inform decisions and evaluate actions for protecting future generations. Workgroup Scope Help MDH staff develop a sustainable funding action plan, which identifies the steps we need to take to put the program in the best position to secure longer-term funding. What’s in: Identifying customers of our information, and future funding strategies,; working with MDH to identify and prioritize action steps. Actions to be recommended may include identifying grant funding sources, working with local foundations, and/or best methods for informing or engaging state legislators and advocacy organizations. What’s out: The scope will not include developing a communications or marketing plan. A separate communications plan is being developed and implemented to supplement the work of this group. Workgroup Roles and Responsibilities: Program Champion: Workgroup Leader: Facilitator: Kris Van Amber (Management Analysis Division) Prepares meeting agenda, notes, and documents, facilitates discussion. MDH program staff responsibilities: Support Team Leader in meeting preparation and logistics Attend meetings, provide timely information to the workgroup as requested. Implement action plan steps and report back to the Task Force. 32 Workgroup members: Alan Bender, MDH David DeGroote, St. Cloud State University Melanie Ferris, Wilder Foundation, Jill Heins-Nesvold, American Lung Association Lisa Yost, Environ International Deb Hendricks, University of Minnesota Mary Manning, MDH Workgroup member responsibilities: Participate in approximately 5-6 meetings to advise and recommend to staff a sustainable funding action plan, review implementation and report to the full MN Tracking Advisory Panel. Level of Agreement: Group consensus Duration: One year, December 2013- Dec.2014. (may be extended per group decision) 33 DRAFT Work Plan for Sustaining Minnesota Biomonitoring Workgroup Revised January 24, 2014 Activity Goal Who When 1. Customer conversation and SWOT analysis Identify the customers and how to engage them in this conversation. Workgroup Jan 2014 Product: Targeted (vulnerable populations & chemical) data to inform the protection of future generations. Assess the current state of biomonitoring funding activities by identifying the current strengths, weaknesses, opportunities and threats 2. Report to EHTB Advisory Panel Report on activities to date and request input Workgroup Feb 2014 3. Cost Estimate the annual operational cost of an effective, sustained biomonitoring program MDH staff March 2014 4. Funding strategies Expand thinking about funding and consider strategies that may provide funding for years to come. MDH staff research alternative funding approaches and provide information for workgroup April 2014 5. Prioritize alternative funding strategies Develop criteria and Identify best Workgroup strategies to move forward. May 2014 6. Report to EHTB Advisory Panel Report on activities to date and request input Workgroup June 2014 7. Action Plan Recommendation: operationalize the strategies Identify and prioritize action steps and resources that are crucial to sustaining biomonitoring in MN. Workgroup July 2014 34 8. Operationalize the Plan Begin to implement the action plan as recommended and report progress. MDH staff August 2014 Activity Goal Who Whe n Identify the customers a nd how to engage the m in this conversation. Workgroup Jan 2014 Feb 2014 9. Customer conversation and SW OT analysis Product: Targete d (vul nerable populations & chemi cal) data to infor m the pr otection of future ge nerations. Assess the current state of biomonitoring funding activities by identi fying the current strengths, weakness es, opportunities and thr eats 10. Report on activities to date and reque st input Workgroup Estimate the annual operational cost of a n effe ctive, sustaine d biomonitoring progra m MDH staff 11. Expand thinking about funding and consider strategies that may provide funding for years to come. MDH staff re search alternative funding approaches and provide information for workgroup 12. Develop criteria and I denti fy best strategies to move forward. Workgroup 13. Report on activities to date and reque st input Workgroup 14. Identify and prioritize acti on step s and re sour ces that are cr ucial to s ustaining bi omonitoring in M N. Workgroup Begin to imple ment the acti on plan a s recommen ded and rep ort progress. MDH staff 15. Operationali ze the Plan August 2014 Work Product: An Action Plan for Sustaining Minnesota Biomonitoring at MDH. Funding approach Strategies Action steps Who When Resources needed Strategies Action steps Who Whe n Resour ces needed State funding National funding Foundation funding Other Fundi ng approa ch State funding National fundi ng Foundation fundi ng Other 35 Section Overview: Other Information This section contains documents that may be of interest to panel members. 2014 Upcoming Advisory Panel Meeting dates October 8, 2013 Advisory Panel Meeting Summary Advisory Panel Roster Biographical Sketches of Advisory Panel Members Biographical Sketches of Staff Environmental Health Tracking and Biomonitoring Legislation 36 2014 Advisory Panel Meetings Tuesday, June 10 1–4 pm Tuesday, October 14 1-4 pm All meetings for 2014 will take place at The American Lung Association of Minnesota 490 Concordia Avenue St. Paul, Minnesota 37 Environmental Health Tracking & Biomonitoring Program Summary: October 8, 2013 Advisory Panel Meeting Advisory Panel: Bruce Alexander, Alan Bender, David De Groote, Jill Heins Nesvold, Pat McGovern, Geary Olsen, Cathy Villas-Horns, Lisa Yost MDH staff: Betsy Edhlund, Tess Gallagher, Jean Johnson, Jim Kelly, Mary Jeanne Levitt, Aggie Leitheiser, Mary Manning, Pat McCann, Matthew Montesano, Paul Moyer, Barbara Scott Murdock, Jessica Nelson, Christina Rosebush, Chuck Stroebel, Paul Swedenborg, Janis Taramelli MAD consultants: Barbara Deming, Kris Van Amber Welcome and introductions Patricia McGovern, chair, welcomed the attendees and invited the panel members and audience to introduce themselves. Agenda Overview Jean Johnson briefly reviewed the topics and discussion items. Explaining that the first half of the meeting would focus on mercury in newborns, she asked the panel to consider the material presented in the first three presentations and then, given the program’s limited funding, to consider how best to move forward with future mercury projects. She asked panel members to discuss and vote on the best blood specimen (cord blood or newborn spots). Pregnancy and Newborn Exposure Study: Data Analysis Jessica Nelson reported on the cord blood to newborn bloodspot (NBS) comparison project carried out in collaboration with Dr. Ruby Nguyen, principal investigator for the University of Minnesota’s arm of The Infant Development and Exposure Study (TIDES). The project measured mercury in 48 paired newborn bloodspot–cord blood samples and found detectable mercury in both cord and newborn bloodspots in 16 paired samples. Among these 16 paired samples, mercury levels were slightly higher in cord blood: the average cord-to-NBS ratio was 1.3 + 0.4, ranging from 0.5 to 2.1. Mercury levels in the two sample types were moderately correlated using the Spearman test. Using information reported by the mothers during their first trimester, mercury levels in cord blood were associated with seafood meals per week. This Advisory Panel presentation explored the finding that cord blood mercury levels were 30% higher on average than NBS mercury levels. Given that cord blood is fetal blood and that NBS are collected within two days of birth and should be very similar, Jessica said that the divergence required an explanation. Did it arise from the differing analytical methods used to measure the two sample types in the laboratory, or did it reflect a biological difference? Jessica reviewed possible reasons why laboratory methods might explain the disparity: The laboratory must use different analytical methods for the two sample types. One method is used to extract mercury from whole cord blood. The other must extract mercury from small spots of blood dried on filter paper, an overnight process. This difference may lead to lower recoveries in bloodspots compared to cord blood. Recoveries of the standard reference materials (SRMs) were acceptable, but the SRMs were not comparable to the low mercury concentrations seen in this study. 38 She then considered the possible biological explanations for the disparity. Both specimen types are newborn blood collected within 24-48 hours of each other. The halflife of methylmercury in blood is ~50 days, so it’s unlikely that the mercury could decrease so quickly. Mercury levels in cord blood and newborn spots should be very similar. So staff explored the idea of whether hematocrit—the percent of red blood cells in a unit of blood—could be involved. The higher mercury concentrations seen in cord blood compared to maternal blood have been attributed to the fact that hematocrit is higher in the developing fetus than the mother, so we hypothesized that this could be involved here as well. Staff assessed the hematocrit in a sample of cord blood from each infant. Staff then compared the hematocrit with mercury levels in the cord blood and bloodspots gathered from the 16 infants with detectable mercury. Hematocrit was not correlated either with cord mercury or with the cord-NBS mercury ratio. A comparison of samples with low v. high hematocrit showed that the correlation between cord and NBS mercury was similar when tested using Pearson correlations on log-transformed values. (Spearman correlations were different, but Jessica said staff decided to primarily use Pearson results because these met the statistical assumptions, and the test has greater power.) In regression models of cord v. spot mercury, adding hematocrit to the model did not appreciably change the estimate or the R2 value, nor was hematocrit a significant predictor of cord mercury. These results, Jessica said, are limited by the small sample size. We don’t know for sure whether hematocrit may explain the higher mercury levels in cord blood because we don’t have hematocrit measurements in spot blood and cannot make this direct comparison. Hematocrit may explain the variability of mercury levels in cord blood v. newborn bloodspots, but this project did not see evidence for this. More work is necessary to resolve the question. Jessica gave a few other updates about the statistical analysis. Results using data from questionnaires administered during the mothers’ third trimester were similar to those using data from first trimester questionnaires: reported number of seafood meals per week was positively associated with cord mercury. Jessica also discussed the correlation statistic used, and said that, after more exploration, staff decided to use the Pearson test on log-transformed values; other papers in the literature use this approach, and the test has greater power. The overall correlation is stronger using this approach than the Spearman test (r=0.82 compared to 0.58). Because the main message from these findings is that measuring mercury in NBS may underestimate fetal exposure (as measured by cord blood), staff decided to flip the cord-to-NBS ratio to present the NBS-to-cord ratio instead in preparing the manuscript. The NBS-to-cord ratio is 0.85, compared to the cord-to-NBS ratio of 1.3. Finally, Jessica showed a slide that put these cord blood mercury results in the context of other studies (Table 1). The slide summarized the results of 7 studies in the US and Canada, including the MDH-UMN project. The MDH-UMN project’s small population primarily comprised well educated Caucasian women, and only one child had a mercury level above the 5.8 µg/L reference limit. Our results were similar to studies in Rhode Island and Quebec, but lower than studies in a number of other places, including New York City and Hawaii, where much higher percentages of participants had levels above 5.8 µg/L. Results of the other studies indicated that higher cord blood mercury levels occurred more often among babies of women of minority or foreign birth, including African American and China-born Asian women. 39 Table 1. Hg in cord blood: other studies Study Population n MDL % ND GM (µg/L) 95th %> Median Max %ile 5.8 (µg/L) (µg/L) (µg/L) µg/L MDH 2012 Women receiving prenatal care at a clinic in Minneapolis 52 0.3 35% 0.6 0.7 Rhode Island Women giving birth at a community hospital in Pawtucket, RI 538 0.2 43% 0.5 African American participants 46 Women giving birth at 3 hospitals within 2 miles of the WTC site 280 China-born Asian participants 83 Baltimore 2004-05 Births at Johns Hopkins Hospital (70% African American) 294 0.3 Quebec Women receiving prenatal care at a clinic in SW Quebec 92 0.2 Brooklyn 2007-09 Women receiving prenatal care at a clinic in Brooklyn (41% Caribbean/ West Indian, 43% African American) 78 0.2 Hawaii 200405 Women giving birth at hospital in Honolulu (8% white) 188 NYC 2001 Study Population n MDL % ND GM (µg/L) Media n (µg/L) 95th %ile (µg/L) Max (µg/L) % > 5.8 µg/L MDH 2012 Wome n receiving pre natal care at a clinic in Minne apolis 52 0.3 35% 0.6 0.7 3.5 8.3 2% Rhode Isla nd Wome n giving birth at a community hospital in Pawtucket, RI 538 0.2 43% 0.5 39. 9 7% Africa n American participa nts 46 Wome n giving birth at 3 hospitals within 2 miles of the WTC site 280 63 32% NYC 2001 3.5 8.3 2% 39.9 7% 32% 2.1 0.2 0.3% 2.4% 4.4 4.3 63 12.6 15.8 63 1.4 1.4 3.0 (90th) 0.6 1.6 2.1 4.8 (mean) 16.5 9.2 2% 16% 20 28% 2.1 0.2 0.3% 2.4% China- born Asia n participa nts 83 Baltimore 2004-05 Births at Johns Hopkins Hospital (70% Africa n American) 294 0.3 Que bec Wome n receiving pre natal care at a clinic in SW Que bec 92 0.2 Brookly n 2007- 09 Wome n receiving pre natal care at a clinic in Brookly n (41% Caribbean/ West India n, 43% Africa n American) 78 0.2 Hawaii 2004- 05 Wome n giving birth at hospital in Honol ul u (8% white) 188 4.4 4.3 12. 6 15. 8 1.4 1.4 3.0 ( 90t h) 0.6 1.6 2.1 4.8 (mea n) 63 16. 5 9.2 2% 16% 20 28% 40 MDH 2012 Wome n receiv ing pre natal care at a clinic in Minnea pol is 52 0.3 35% 0.6 Rhode Isla nd Wome n giv ing birt h at a community hospital in Pawt ucket, RI 538 0.2 43% 0.5 Africa n American participa nts 46 Wome n giv ing birt h at 3 hospita ls w ithin 2 mile s of t he WTC site 280 China- born A sia n pa rticipant s 83 Baltimore 2004-05 Births at Johns Hopk ins Hospital ( 70% A frica n American) 294 0.3 Que bec Wome n receiv ing pre natal care at a clinic in SW Que bec 92 0.2 Brookly n 2007- 09 Wome n receiv ing pre natal care at a clinic in Brookl yn ( 41% Caribbe an/ West India n, 43% A frican American) 78 0.2 Hawaii 2004- 05 Wome n giv ing birt h at hospital in Honol ul u (8% w hite) 188 NYC 2001 0.7 3.5 8.3 39. 9 7% 32% 2.1 0.2 0.3% 2.4% 4.4 4.3 63 12. 6 15. 8 63 1.4 1.4 3.0 ( 90t h) 0.6 1.6 2.1 4.8 (mean) 16. 5 9.2 2% 16% 20 28% 41 42 The project’s next steps include Submitting a manuscript to the journal, Environmental Research, as a “Report from the Field.” Learning more about laboratory investigation of spot v. cord differences in mercury analyses. Speciating a subset of the cord blood samples to identify the proportion of methylmercury (from fish) and the proportion of inorganic mercury (from other sources, such as metallic mercury or mercury in skin lightening creams). Eventually, a summary of the project results will be placed on the MN Tracking website. Jessica then asked panel members to consider the following questions: Can the panel suggest other ideas about why mercury levels were higher in cord blood than in NBS? Have we adequately explored the role of hematocrit or other factors in this relationship? Discussion The discussion was short, to provide more time for a joint discussion of all of the mercury presentations together. Bruce Alexander asked whether laboratory staff could create a blood spot with cord blood, and laboratory chemist Betsy Edhlund said that they could. Bruce added that hematocrit might be a red herring, but that we need to know whether the blood spot can characterize the mercury in the cord blood. MDH Assistant Commissioner Aggie Leitheiser asked whether “seafood” in the survey applied to fish in general. Jessica explained that the survey was designed before the joint project existed and asked only one general question about seafood.3 She added that the lack of specificity about the meaning of the term, seafood, is a limitation in the collaborative study. During her presentation, Jessica had mentioned that delayed cord clamping during cord blood collection might affect hematocrit. Pat McGovern asked Jessica to tell the group more about this. Jessica explained that, until recently, the standard of care in a birth was to clamp and cut the umbilical cord immediately after the birth. Some clinicians are now waiting longer before clamping the cord to allow more blood to flow into the infant. Waiting even 2 minutes or more can raise the iron level in the baby.4 3 Exact wording for the question was: “At how many meals [in a typical week since you became pregnant] did you consume seafood?” Respondents answered with the number of meals per week. 4 JAMA. 2007;297(11):1241-1252 (original report). The placenta and umbilical cord can contain up to 200 ml of blood, which contains hematopoietic stem cells as well as important reserves of iron for the infant. According to the Journal of the American Medical Association, roughly 20-40 ml of blood can 43 Pat McCann asked, is cord mercury actually higher than spot mercury, given the strong Pearson correlation results? Jessica answered that the two blood measures are strongly correlated, but that doesn’t mean they reflect the same absolute amount. These findings are preliminary, but it looks as though the two measures are strongly correlated, and cord mercury is higher than spot mercury (this difference is statistically significant). Pat McGovern then commented that the key to the question is for the laboratory to test cord bloodspots. A recruitment protocol for pregnant women and their newborns Ruby Nguyen, collaborator and UMN principal investigator in the MDH-UMN Pregnancy and Newborn Exposure Study, reviewed key elements of the way The Infant Development and Environment Study (TIDES) protocol was adapted to recruiting and obtaining consent from pregnant women in the MDHUMN study (Note: the full TIDES Recruitment Protocol is in both the June and October 2013 Advisory Panel books). The MDH-UMN study was an add-on to the original Minnesota TIDES. The participants had been in TIDES since their first trimester of pregnancy and knew the TIDES staff. Thus, when TIDES staff met with the study participants at their third trimester clinic and TIDES visit, the women knew and trusted the staff and were willing to learn about the new study and to sign consents for themselves and their babies. In addition, TIDES staff already had developed good relationships with the hospital staff. TIDES study staff prepared and delivered all of the MDH-UMN study specimen collection kits. Delivering clinicians collected the cord blood, and hospital staff who collect newborn screening spots collected extra spots for the study. TIDES staff also provided gift cards as compensation to participants. New studies in other hospitals and clinics would have to develop these relationships from the start. Ruby identified several potential barriers to recruiting pregnant women that could affect future studies of the distribution of mercury exposure in Minnesota’s newborns. She listed five factors in the TIDES effort that made the MDH-UMN collaboration work well and then listed likely hurdles that could arise in new studies. Table 2. Important Factors in Recruitment and Consent in Studies of Pregnant Women TIDES • • Future Studies Relationship with women Relationship with clinic and hospital • • “Cold contact” New relationship with clinics and hospital ‘pulse’ from the placenta to the newborn during birth. Current industry benchmarks for cord blood collections are a minimum of 50 ml of blood. Given the amount of blood likely to flow out of the placenta at the time of birth, there is typically plenty to be stored for later use. Retrieved 12/9/13; Source: Delayed Clamping and Cord Blood Banking: A Parent’s Guide 44 TIDES Future Studies • • • Population generally willing to participate Access to birth records in real-time On-going contact for notification of results • • • • • Relations hip with women Relations hip with cli nic and hospital Population generally willing to participate Acces s to birth records in real -time On-g oing contact for notification of results TIDES • • • Population of unknown willingness to participate Multiple birth records system Address at time of consent for notification • • • • • “Col d contact” New relationshi p with clini cs and hos pital Population of unknow n willingnes s to participate Multiple birth records syste m Address at time of cons ent for notifi cation Future Studies Future studies of interest to EHTB would seek more diverse populations than those in TIDES. To find diverse populations, MDH staff would have to contact and build relationships with hospitals and clinics in the Metro and outstate. Noting that recruiting populations that are not predominantly highly educated Caucasians can be difficult, Ruby said that some populations of minority and disadvantaged women might not be willing to participate. She also pointed out that different hospitals often use different systems for birth records; having no access to real-time birth records makes it difficult for staff to prepare effectively for the cord blood collection and also means that the record does not provide an extra check on the correct number of samples. Moreover, because people in disadvantaged populations often change addresses, the address a participant gave at the time of consent might not be valid when staff send out the results. To ensure that the addresses are current, staff would need to keep in close contact with the participants. Ruby suggested that MDH approach multiple clinics. In the Metro, she recommended approaching Hennepin County Medical Center and Allina physicians who are tied closely to UMN research programs. Discussion Pat McGovern asked, if a cord blood study involved several different hospitals, could the women themselves be empowered to request the attending physicians to collect cord blood at the birth? Ruby Nguyen replied that, in TIDES, some women who were in labor were sent to other hospitals because the birthing rooms at the study hospital were full. In that case, she explained, even if we sent a collection kit for the cord and newborn spots, we could not know whether the other hospital could handle the cord blood properly. The biggest problem would be in storing the cord blood sample at – 20oC, rather than the blood collection itself. Bruce Alexander wondered whether women in labor might forget to bring the kit in their haste to reach the hospital. Ruby replied that, before they go into labor, women often pack a travel bag to bring to the hospital when labor begins. Studies could give the women a bag with the study logo, a cord blood collection kit, and instructions for specimen collection and handling. In the MDH-UMN study, Bruce asked, how much time elapsed between the time the blood was collected and the time the study staff could send the results to the mothers? Ruby replied that the study looked at babies born between June and January. The results were sent in batches and the time interval ranged from three to nine months. Bruce said that he was concerned that someone else might be at the address a participant had given when she entered the study. He suggested staff should track the addresses to ensure that the participants receive the results. Jessica Nelson said, this issue is the same for all biomonitoring results, and suggested that using something like certified mail might add an extra layer of security. 45 Pat McGovern asked how much the study used social media technology to communicate with the participants. Ruby replied that TIDES did not use much because they saw the participants frequently, but the study did use email to let potential participants know about the meetings. Public Health Laboratory Progress Report Metals chemist Betsy Edhlund briefly described the MDH Public Health Laboratory’s responsibilities and progress in developing and validating methods for measuring mercury and other metals in newborn blood spots and in cord blood. The PHL is a Level 1 laboratory in the federal Emergency Response Network. In this role, the PHL’s metals laboratory has been adding more metals to its list of analysis methods and is taking part in emergency response exercises that require the lab to analyze 500 samples in as short a time period as possible (hours, rather than days). The laboratory also participates in proficiency tests (PTs) three times per year. The laboratory also provides the metals analyses in both blood and urine for MDH biomonitoring projects. 46 Table 3. Current MDH PHL Metals Laboratory Responsibilities • • • Laboratory Response Network • Blood Metals, Urine Metals, Arsenic Speciation • 3 PTs/year • Emergency Response and biomonitoring EH • GLRI – 6 analyses in house (more than 20 analytes) • Fish are Important for Superior Health – blood metals, fatty acids EHTB • TIDES • National Children’s Study (Supplemental Methodological Study: Newborn Mercury Biomarker Validation) • Riverside bloodspots • Future projects • • 1 Currently, the laboratory has only one instrument for analyzing metals in blood and urine, and the instrument is used for both biomonitoring and emergency response. But the lab has updated and validated metals methods for blood and urine for both uses and has expanded the urine method to 16 metals. The laboratory has been awarded an Association of Public Health Laboratories (APHL) fellowship. This person will assist with clinical testing and biomonitoring support over the term of the fellowship. The lab may also obtain another instrument for metals analysis. Both of these will greatly enhance the laboratory’s capacity for metals analysis. In comparing the advantages and disadvantages of analyzing mercury—and possibly other metals—in cord blood versus newborn blood spots, Betsy reviewed the following factors: Table 4. Advantages and Disadvantages of Cord Blood and Newborn Blood Spots Whole blood Gives sufficient amount to measure Hg, Cd, Pb Standard reference materials (SRMs) are available Standard network-wide method Regular PTs Simpler method Homogeneous sample Blood spots In MN, lab now can do Hg only, but Utah also does Cd & Pb Chemists must assume the amount & homogeneity in the very small blood sample Less efficient sample throughput More complicated extraction process 47 Whole blood Blood spots Requires more storage space Easier to store (require little storage space) The bottom line, Betsy said, is that blood spots take more preparation and data analysis time. Discussion Pat McGovern asked Betsy to list the metals that the lab can measure. They are: Table 5. Current PHL Metals Suite 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Antimony Arsenic Barium Beryllium Cadmium Cesium Cobalt Lead Manganese Mercury Molybdenum Strontium Thallium Tin Tungsten Uranium Currently, staff are halfway through the methods validation of all these metals and expect to finish all of them in the next few weeks. 48 Table 6. Comparison of Newborn Specimens for Ongoing Mercury Biomonitoring NBS (Newborn Screening Bloodspots) Umbilical Cord Blood Advantage: Specimens from a statewide MN population. Low cost. Bloodspots stored for 71 days, but with informed consent, may be stored & used for research for up to 18 years. Disadvantage: Cord blood is collected in hospitals/ birthing centers with advance informed consent. Higher cost: contracts with hospitals, staff training, collection kits, collection & transport protocols. Disadvantage: Spot blood volume is limited. Lab analysis can determine total mercury only. Quality control is limited. Advantage: Large volume of whole blood allows more analyses; e.g., a metals suite (Pb, Hg, Cd). Disadvantage: NBS have a small blood volume. Detection limits for mercury are less sensitive than those for cord blood. Only the highest exposures (e.g., 75th or 95th percentile) can be reported. Advantage: A more sensitive detection limit for mercury allows staff to describe a wider range of exposures, from low to high. Disadvantage: Spots have a small blood volume, so staff cannot distinguish methylmercury (from fish) from inorganic sources of mercury (e.g., skinlightening creams) Advantage: Greater blood volume & lower detection limit allow staff to analyze methyl- & inorganic mercury to identify exposure sources. MDH can work to prevent exposure. Neutral: Difficult to achieve a representative sample from the population. Spots are collected for nearly all births, so MDH could contact mothers by mail to ask consent for testing, but participation is low. Hospital/clinic consent may improve participation. Neutral: Difficult to achieve a population-based sample. Participation rates for consent obtained prenatally in hospitals/clinics vary; the National Children’s Study Alternative Recruitment Study obtained nearly 80% participation through hospitals/clinics. Problems during delivery may prevent hospital staff from collecting cord blood. Disadvantage: NBS analysis method at MDH is not yet a published method. Advantage: Published and externally validated methods. Disadvantage: No reference level for total mercury exposure in newborn bloodspots has been established to date. Advantage: Exposure measured with cord blood specimens can be compared to published reference levels. 49 NBS (Newborn Screening Bloodspots) Umbilical Cord Blood NBS (Newbor n Scree ning Bloods pots ) Umbili cal Cor d Blood Advantage : Speci men s from a statewide M N population. Low cost. Bloodspots stored for 7 1 days, but with infor med co nsent, may be store d & used for resear ch for up to 18 years. Disadva ntage: Cord bl ood is colle cted in hos pitals/ birthing centers with adva nce infor med consent. Hig her cost: contracts with hospitals, staff traini ng, colle ction kits, collection & transport pr otocols. Disadva ntage: Spot blood volume is limite d. Lab a nalysis ca n determi ne total mer cury only. Quality control is limited. Advantage : Large volume of whole blood allows more analyse s; e.g., a metals suite (Pb, Hg, Cd). Disadva ntage: N BS have a s mall blood volume. Dete ction li mits for mercury are less sen sitive than thos e for cord blood. Only the highest e xposures (e.g., 7 5th or 95th perce ntile) can be re ported. Advantage : A more se nsitive dete ction limit for mer cury allows sta ff to des cribe a wider range of e xposures, from low to hig h. Disadva ntage: Spots have a s mall blood volume, so staff cannot disting uish methylmercury (from fi sh) from inorga nic s ources of mer cury (e.g. , skin-lighte ning crea ms ) Advantage : Greater blood volume & lower dete ction limit allow sta ff to a nalyze met hyl- & i norgani c mer cury to ide ntify expos ure sources . MDH ca n work to prevent e xposure. Neutral: Di ffi cult to achieve a represe ntative sample from the population. Spot s are colle cted for nearly all births, s o MDH could contact mothers by mail to ask consent for testing, but participation is low. Hospital/cli nic consent may i mprove parti cipation. Neutral: Di ffi cult to achieve a population -ba sed sa mple . Participation rates for consent obtained prenatally in hos pitals/cli nics vary; the National Chil dren’s Study Alternative Recruit ment Study obtained nearly 80% participation throug h hospitals/ clinics. Proble ms during delivery may prevent hospital staff from colle cting cord blood. Disadva ntage: N BS analysis method at MDH is not yet a publishe d met hod. Advantage : Publi shed a nd e xternally validated met hods. Disadva ntage: N o refer ence level for total mercury e xposure in newbor n bloods pots ha s bee n establis hed to date. Advantage : Exposur e meas ured with cord blood spe cimens can be compare d to publishe d refere nce levels . Choice of Mercury Specimens: Bloodspots v. Cord Blood Jean Johnson reviewed the advantages and disadvantages of both newborn bloodspots (NBS) and cord blood for measuring mercury and other metals in newborn blood (Table 6). A more detailed table is in the Advisory Panel background book for the October 8, 2013 meeting. She asked for the panel’s recommendation for the specimen type that best meets the criteria in Minnesota Statutes5 for a biospecimen “that most accurately represents body [prenatal or newborn] concentration of the chemical of interest.” She asked panel members to consider the availability of each specimen (cord and newborn spot blood), ease and cost of collection, the ability to compare and interpret results with other studies and reference groups, the capacity to conduct additional analyses with the same specimen, and laboratory quality assurance and validity issues. Jean then asked the panel to take a vote in the following question: Which specimen type should MDH collect for ongoing biomonitoring of mercury in newborns to meet the public health goals below? 5 To measure the extent to which newborns in different parts of the state are exposed to potentially harmful levels of mercury during prenatal development, To determine whether some groups are more exposed than others, and Minn. Stats. 144-995-144-998. 50 To identify what sources, in addition to fish consumption, contribute to the exposure In funding EHTB’s biomonitoring program in 2013-14, she explained, the Minnesota legislature’s intent was for MDH to follow up on the findings of the Mercury in Newborns in the Lake Superior Basin6 project to learn whether other populations were similarly exposed in other parts of the state. Newborn bloodspots analyzed in the Lake Superior project indicated that 10% of Minnesota newborns tested in the study had total mercury levels over 5.8µg/L, the Environmental Protection Agency’s reference limit for methylmercury exposure. In addition, the high levels peaked in the summer months, which suggested that the source was probably methylmercury in fish that the mothers had eaten. Jean also reminded panel members of a new barrier to using newborn bloodspots in similar studies. Under recent legislation in Minnesota, storing and using newborn bloodspots for any purpose other than newborn screening now requires the mother’s consent within 71 days of the birth. Discussion The panel’s discussion revolved around the issues below: Ability to obtain consent from participants Ability to report results to parents, crucial for newborns with elevated mercury levels Ability to collect and analyze specimens with limited finances Potential to contribute to better scientific understanding Potential for public health assessment of exposure (to measure the extent to which newborns in different parts of the state are exposed to potentially harmful levels of mercury during prenatal development) Ability to obtain consent from participants Panel members discussed Minnesota’s data practices requirements first, turning to Assistant Commissioner Aggie Leitheiser to learn more about the 2006 legislation and its effects on public health practice. Aggie explained that MDH’s newborn screening program tests newborn bloodspots to identify congenital disorders that could pose health and developmental challenges if they are not addressed early in a child’s life. The 2006 law followed a lawsuit that claimed that MDH was collecting newborn spots and using them for research without consent. This legislation has raised barriers to using newborn spots for such projects as tracking mercury exposure in newborns. The requirements allow the newborn spots to be stored for 71 days, after which they are destroyed. During the 71 day period, the spots cannot be used for any purpose other than newborn screening, except with special consent. Test results can be stored for two years before they 6 Mercury in Newborns in the Lake Superior Basin, conducted by MDH’s Fish Consumption Advisory Program and funded by the Environmental Protection Agency (EPA), with additional support from MDH’s Environmental Health Tracking and Biomonitoring (EHTB) Program. 51 are destroyed. Spots retained with consent to allow research may be retained for 18 years or “until I request otherwise,” but to date, few mothers (< 1%) have been approached for consent and agreed to that long period of time. Jean Johnson suggested that staff could obtain consent prenatally, or that staff could send out letters shortly after births to obtain consent within the 71-day period. Jean wasn’t optimistic about the likelihood of getting consents within that window of time and meeting recruitment goals. Pat McCann, principal investigator of the Mercury in Newborns in the Lake Superior Basin project, said that the Lake Superior Basin study’s requests for consent to use newborn spots were returned about five weeks after the consent request (or 8 weeks after the birth). Lisa Yost asked whether some event had occasioned this lawsuit, but Aggie answered, no. MDH complies with federal definitions of public health surveillance v. research, she said, but a group of people, concerned that babies’ genetic information could be used inappropriately by the government, filed the lawsuit. Obtaining consent can be expensive and difficult, Aggie commented. Alan Bender noted that requiring consent for collecting public health data on the population could make it difficult to do effective surveillance. Currently, MDH is writing a report arguing for longer storage and research options in future newborn screening spots, and expects to need informed consent from the mothers for these options. Ability to report results to parents Bruce Alexander asked whether MDH would be able to contact parents of babies who were found to have high mercury exposures. If we measure mercury in cord or newborn bloodspots, he said, we will find high mercury levels in some babies. Would that concern influence the decision to choose cord blood v. newborn spots? Aggie Leitheiser replied that MDH tests newborn spots in routine newborn screening now and has a protocol for contacting parents. Ruby Nguyen said that the MDH-UMN study reported the cord blood results to the parents and also enabled parents concerned about their child’s exposure to consult with MDH’s environmental health physician. Jean Johnson added that, so far, MDH has not reported any newborn blood spot results to the parents. Lisa Yost asked, isn’t that because you found only one baby with a high mercury level in the MDH-UMN study? Yes, said Jean, but 10% of the babies tested in the Lake Superior Basin project had high mercury levels in their newborn spots. Because the Lake Superior study anonymized the spots,7 MDH was unable to contact the parents of babies born with high mercury levels. Lisa noted that part of the reason for anonymizing the spots was that, at the time, we didn’t know what the laboratory report might mean. Utah’s state health department is doing a surveillance study of cadmium, lead, and mercury levels in newborn bloodspots, Jean said, but MDH does not know whether the department is sending the results to the parents. But in any future project, whether in newborn spots or in cord blood, MDH would notify 7 The laboratory technique for mercury in newborn spots was considered experimental at the time. 52 the parents. Any baby with a mercury level of 5.8µg/L and above should have follow up. Alan Bender agreed, saying that it’s hard to believe that MDH would conduct a public health assessment of exposure in newborns without contacting the parents if we identified a problem. If you find an elevated reading, he added, aren’t the results from either of the two specimens just indicators for further follow up with the participants? In either case, finding an elevated mercury level in a newborn requires follow up. Ability to collect and analyze specimens with limited finances Both David DeGroote and Jill Heins-Nesvold asked about the differences in cost between cord blood collection and analysis v. newborn spot collection and analysis. MDH will have to consider both costs. Pat McGovern noted that the cost of cord blood collection would depend on whether hospitals bill for the collection. Sometimes, she said, hospitals interested in doing research will collect the cord blood as an in-kind contribution to a study; others may not. Betsy Edhlund said that it is cheaper to measure metals in cord blood than in spots. Speciating mercury8 in the cord blood raises the analysis cost, but the longer time to prepare and run bloodspots through the lab instrument costs more than measuring metals in whole blood (cord blood). Overall, however, she thinks the two analyses may be fairly comparable in cost. Aggie Leitheiser asked, how many mercury projects do you envision? Jean Johnson replied that EHTB has $268,000 each year for mercury assessment for Fiscal Years 2014—2015. Assessing mercury exposure in Minnesota newborns is only one project, but will need to be carried out in multiple sites. David asked whether staff had any sense of the number of samples needed to address the question of newborn spots versus cord blood samples. Jean replied that the program had budgeted for 600 newborn spots. Potential for better scientific understanding v. public health assessment The discussion then turned to the scientific and public health value that each kind of specimen offered. Pat McGovern urged the staff to keep pushing the science to determine whether the newborn spots provide a robust, valid, reliable index. She said that more research with matched cord blood: newborn spot pairs would help to clarify this question. Bruce Alexander argued for using newborn bloodspots to assess mercury exposure in newborns across Minnesota. Long-term, this would build a framework for tracking routine measurements of mercury exposure in Minnesota newborns. In the end, the decision hinged on the purpose of the project and on the populations of interest. Arguments for cord blood focused on two factors. 8 First, hospital staff can collect 4 to 40 ml of cord blood. The amount of blood is enough to allow the laboratory to speciate mercury, measure other analytes, such as cadmium, lead, and manganese, and to use the blood to further test the results found in the MDH-UMN study. Speciation identifies the proportion of methylmercury v. inorganic mercury. 53 Second, cord blood has been used to assess mercury in many studies of newborns, so MDH can compare its results with those of published results. Lisa Yost suggested that cord blood might be more reliable for a targeted study of vulnerable populations. Alan Bender agreed that cord blood is the standard. If the program must choose, and if we are unsure of what the data mean, he said, the specimen should be cord blood. Lisa advised the program to look at other studies and to decide which of the two specimens to use based on which populations would be more willing to consent to one specimen or the other. Pat McGovern suggested that the program could go forward with cord blood in the Metro and then address the question of the relationship between cord v. newborn spots in two years. Lisa suggested that staff focus on groups that are likely to be exposed. Although cord blood is more reliable, she said, if we ask for consent, we may be able to get both cord blood and newborn bloodspots. Jean Johnson said that, with Ruby Nguyen’s help, we can reach diverse populations in the Metro area to determine which are being exposed. Pat added, given the health disparities in minority and disadvantaged populations, this is important. Geary Olsen asked, what target populations would be recruited in these projects, and how would EHTB staff recruit them? Jean said that staff would present target populations at the next Advisory Panel meeting, in February. In the meantime, staff would talk with hospital staff and find out where we would have viable partners. Geary also asked for clarification on the question the project would address. Jean said to answer the legislature’s question: Are newborns being exposed to mercury in regions of Minnesota other than the Lake Superior Basin? Alan Bender rminded panel members of legislative intent— to determine whether mercury is a problem in Minnesota with the best use of the resources you have. Arguments for newborn bloodspots depended on four major factors clarified in the discussion: First, newborn screening bloodspots are collected from almost all babies in Minnesota. Second, both the Public Health Laboratory’s experience and the results of the MDH-UMN project indicate that newborn bloodspots give reliable results at and above the EPA reference limit for methylmercury, 5.8µg/L of blood. Third, although MDH must obtain consent for collecting either cord blood or newborn bloodspots, the newborn spot collection is a routine request and less expensive. Last, the legislature funded MDH to assess mercury exposure in Minnesota to learn whether mercury is a problem in parts of the state other than the Lake Superior Basin. Twice during the earlier discussions, both Jean Johnson and Mary Manning, assistant director of the Health Promotion & Chronic Disease division, had turned to the Public Health Laboratory to ask about their confidence in the results of mercury measurements in newborn bloodspots. Both times, the laboratory staff affirmed that they were confident of the validity of the newborn blood spot results. These answers, plus the close correlation between cord blood mercury and newborn spot mercury seen in the MDH-UMN study, led panel members to return to considering the role of newborn bloodspots. Bruce Alexander pointed out that MDH already has a system for collecting newborn bloodspots. He asked: Can MDH make use of this newborn screening system for routine public health surveillance? Are 54 we setting up a surveillance system across the state that would be able to detect and report high mercury levels in newborns? Is this [a decision] for a long-term plan? Pat McGovern suggested that the question of interest might determine the specimen: surveillance v. targeted study, with cord blood in some populations, newborn spots in others. David DeGroote said the issue is a question of analytics—should we use cord blood because it offers better science v. how can we best answer the legislature’s question: Is mercury a problem in Minnesota? David encouraged the panel to think beyond the Metro area. He pointed out that St. Cloud is near the state’s largest coal-fired power plant, the Sherco Generating Plant, which in the past released much more mercury than the other, smaller, coal-fired plants in Minnesota. [Note: The Sherco Plant is reducing its mercury emissions in cooperation with the Minnesota Pollution Control Agency.] St. Cloud Hospital has a strong research arm and serves a large population of Somali and Hmong residents who may be affected by mercury, he added, so staff might want to contact St. Cloud Hospital. Bruce Alexander concurred with the need for a more statewide sample. Newborn bloodspots, rather than cord blood, may be a better way to answer the legislators’ question: Are newborns exposed to high levels of mercury exposure in other regions of Minnesota? Spots could give a more efficient sample from a larger portion of the state. Even given the hurdle of having to obtain informed consent, he said, I still think the legislature’s question about the distribution of high mercury exposure in Minnesota will be answered better by measuring newborn bloodspots. Collecting cord blood would involve far more work, from recruiting and consent to collection, storage, and shipping from outstate Minnesota. Lisa Yost asked, am I right that the spots have a detection limit that’s adequate to detect 5.8 µg/L and above? Jean Johnson answered that bloodspots reliably identify newborn exposure at the 5.8 µg/L limit and above, and results above 5.8 µg/L should have follow up. In that case, Lisa said, the spots serve the purpose of identifying babies with a mercury problem. A wider distribution of data may not be needed for this purpose. In addition, both cord blood and newborn spot samples involve a consent issue, but if what you want to get a better picture of the overall state population, the availability of the bloodspots is very attractive. Ruby Nguyen suggested that new projects could use either leftover newborn screening spots or ask for consent to collect an extra spot with the standard newborn screening spots. In the MDH-UMN collaboration, staff asked pregnant women to consent to the collection of an extra blood spot on special filter paper. The advantage was that the collection was done through the normal newborn screening process, with the addition of an extra spot. She also noted that some leftover spots might be on contaminated filter paper. Geary Olsen suggested that the best access to cord blood is [likely to be] local and suggested that the program collect and analyze cord blood locally and newborn bloodspots statewide. Pat McGovern suggested that the program might collect cord blood in a subsection of the newborn spot study to answer the scientific question at the same time. But Bruce Alexander disagreed, saying that adding cord blood to the 600 newborn spot samples would likely be too expensive. Lisa Yost joined Bruce in arguing for using newborn bloodspots. With either specimen, she said, you need to spend the funds to get consents that are representative of Minnesota populations. I think we know that bloodspots are good enough to use [for a statewide study]. The real barrier is the consent. 55 The bloodspots under-predict the exposure, but not dramatically, and bloodspots are both valid and cheaper. Moreover, Alan Bender pointed out, if the project limits the inferences it can draw, the data would be sound for the purpose. After first asking panel members which specimen they thought would best answer the legislature’s question, Pat McGovern asked panel members for a motion and a vote. Bruce Alexander proposed the motion: Staff should pursue the use of newborn bloodspots to answer the legislature’s question: Is mercury exposure in newborns a problem in Minnesota [outside of the Lake Superior Basin]? Pat McGovern seconded it, and the vote was unanimous in favor. After the vote, Bruce proposed that it would be useful to pursue the cord blood: newborn bloodspot validation in some arena. Pat seconded that motion, saying that the program could look for external resources with the support of the panel. She asked for a vote on the motion, If resources exist, the program should further explore the cord: newborn blood spot correlation in a new study. This vote, too, was unanimous in favor. Biomonitoring Summit—Reflection & Next Steps for Sustainability In June, MDH partnered with Wilder Research to sponsor a State Biomonitoring Summit, held at the Dakota Lodge in St. Paul. Nearly 100 participants attended, representing state and local government agencies, academic institutions, private and non-profit businesses, health laboratories, advocacy groups and the Minnesota Legislature, along with leaders from state biomonitoring programs in California, Washington, and Wisconsin. The Summit provided a platform for sharing the program’s accomplishments since Minnesota’s EHTB program began in 2007, and for learning from other states’ experiences and envisioning the future. In the afternoon sessions, participants were asked to consider questions about the sustainability of Minnesota’s Biomonitoring Program. The 2007 legislation that created the EHTB program had based the program’s funding on an ongoing appropriation. In 2011 and again in 2013, the legislature changed that appropriation to funding for specific, limited projects over each two-year period (FY 2011-12 and FY 2014-15), with no assurance for continuing state support beyond FY 2015. As speakers from other states made clear in their own presentations, this situation is not unusual. Barbara Deming, a consultant from Minnesota Management and Budget’s Management Analysis Division, reported on the outcomes of the Summit and on EHTB’s proposed sustainability planning. She noted that the 2007 legislation that established the program had directed MDH to plan and implement an ongoing biomonitoring program for the state of Minnesota. The program’s 2013 Report to the Legislature (EHTB 2013 Report to the Legislature) put forward a vision and strategies (see p. 32, AP background book) that included protecting future generations by focusing resources on biomonitoring populations that are most vulnerable to chemical exposures, including pregnant women, their babies, children, and disadvantaged communities. At the Summit, Barbara reported, participants demonstrated a high level of interest, both in the state and among other states. Participants said that the Summit showed the value of biomonitoring through progress in identifying exposures and addressing public health concerns. They saw biomonitoring as a tool to be used in identifying and understanding health disparities and social determinants of health, and as a tool to help us understand where to focus our public health interventions. The overall message 56 from participants was that the program meets a need in public health and needs to develop financial sustainability. Barbara then presented the next steps: a three-part plan for addressing the program’s sustainability: 1. Funding strategy: In accordance with the “duties of the advisory panel” as described in the Minnesota’s legislation, form a task force to explore potential funding for an ongoing biomonitoring program, including federal, state, foundation, and business sources. 2. Evaluation strategy: Evaluate and describe the impact of biomonitoring as a tool for health improvement in Minnesota. 3. Communication (marketing/PR) strategy: Develop multiple approaches to raising the visibility and promoting understanding of the public health value of a state biomonitoring program. Barbara introduced Kris Van Amber, another consultant from MAD who will work closely with staff and will lead the biomonitoring task force. Kris said her role is to work with a task force from the panel to identify funding and develop strategies to sustain the program. Panel members were invited to discuss and comment on the Summit Report and recommended strategies, and to consider these questions: Which strategies are likely to be most successful for sustaining a state biomonitoring program? Would you be willing to serve on a task force to provide additional guidance to staff as we explore potential new funding sources? Discussion Pat McGovern applauded the strategy, saying that the three tasks—funding, evaluation, and communication are right. “I think you nailed it with these three issues.” The funding is the key factor, but knowing how to frame your message with strong communications must have a role. Alan Bender’s view was that some of these strategies are out of our hands. We need to capture people’s imagination. Stories will help keep the program going—stories capture people’s imagination. Jill Heins-Nesvold said, I think the question is too big – it starts with, what’s the plan for addressing sustainability. Sustainability of what? Are we talking about the data portal, special research projects, or are we looking at public health surveillance? I think we’re looking at too large a question. We need to break it down into sub-questions and then determine what the strategies are to sustain the program’s components. Kris Van Amber answered that the work of this group will be doing some of that discovery, understanding what kind of financially sustainable programs and models are out there. Also, is this a specific issue of funding? Part of this is exploring sources of funding, but we also need to understand who the stakeholders are. Bruce Alexander said that the funding strategy would be huge, so the program will have to develop it piecemeal. But the communications, public relations, and marketing—getting resources for that – may be the way to begin. Think about the process for getting consent, for example. If health providers aren’t aware of this program and why it is valuable, and if they don’t know why they should advise their patients to consent, we need to educate them. We should do that by using Alan’s good stories… why 57 biomonitoring is important to individuals. A good story is better able to communicate importance than a long report with data and statistics. Jean Johnson replied that Mary Jeanne Levitt, who handles communications and marketing for the tracking program, will also be working with the biomonitoring program. Before this, we’ve never taken a marketing approach with biomonitoring. Pat McGovern wondered whether the program could identify a family or person or community whose health behaviors or health changed because of biomonitoring. Lisa Yost suggested that the program might create something interesting and accessible. She suggested that staff might make a UTube video explaining public health tracking and biomonitoring. Kris Van Amber agreed, saying you need to show the intrinsic benefit. But we will also need to be looking at other funding as well. Pat McGovern asked about the demands on time and the amount of work for panel members who would work on the task force. Kris Van Amber said that, initially, task force members would come together to look at the process, assess what the time demands might be, define the goals, and suggest ways to accomplish them. Barbara Deming added, we could ask staff to do some research and bring ideas and possibilities to the meetings, so more work could be done outside of the meetings for staff, but not for panel members. Jean Johnson summed up the dilemma: our vision is long-term surveillance, and our funding is for a short-term project. The other states with biomonitoring programs have the same problem. Everyone is just kind of piecing it together. PFC3: Draft Protocol for East Metro PFC Biomonitoring III After the 2004 discovery of contamination of East Metro drinking water supplies with PFCs, MDH and the MPCA carried out public health interventions to reduce residents’ exposure to PFCs in their drinking water. MDH then carried out two biomonitoring projects, in 2008 and 2010, to assess PFC exposure in long-term residents in the area. The first round of biomonitoring documented that the residents had higher body burdens of the PFCs compared to the general U.S. population; the second (PFC Follow-Up Project) documented declines in the PFCs in the same group. In September 2012, the EHTB Advisory Panel recommended that MDH continue biomonitoring for PFCs in the East Metro. Their recommendation involved two parts: 1. Collect a third blood sample from participants in the original cohort to ensure that levels are continuing to decline in this population, and 2. Expand the sample in the East Metro so that more people, including new residents, are represented. Measuring PFC levels in new residents will help answer the question of whether people who moved to the community after the public health intervention are being exposed to elevated levels of PFCs. Christina Rosebush and Jessica Nelson presented a draft protocol for the third round of PFC biomonitoring. The study will test two hypotheses, said Christina. • Blood levels of PFOS, PFOA, and PFHxS will have declined from 2010 - 2014 in the original cohort. 58 • Blood levels of PFOS, PFOA, and PFHxS in new Oakdale residents will not be significantly different than PFC levels in the US general population. The study populations will include two different groups: one is the original group of adults whose blood was measured for PFCs; 183 people are eligible. The second group will be 200 newer adult residents who moved to Oakdale after the municipal water was treated to reduce PFC contamination. These people are eligible if they moved to Oakdale and started their water service on or after November 1, 2006. In the original group of people, the PFC analysis will measure the same 7 PFCs of interest in the original pilot project, plus PFNA. The 2014 blood levels will be compared to the earlier levels seen in 2008 and 2010. In the new residents, MDH will compare the participants’ PFC blood levels to those seen in the general population as measured in the Centers for Disease Control’s National Health and Nutrition Examination Survey (NHANES). Christina also reviewed the proposed questionnaire topics that the PFC3 project will use to learn more about participants’ exposure to PFCs. The questionnaire will ask about a range of possible exposures, including drinking water, diet, occupation, and product use. Then, Jessica Nelson listed the limitations of the study of new residents: We can’t compare new residents to the original cohort. The original participants were longterm residents, and they are older (mean, 60 years) than the new residents. Greater age is associated with higher levels of PFCs. The new sample does not include private well users, Cottage Grove/Lake Elmo residents, or additional long-term residents in Oakdale. While NHANES provides a very valuable U.S. reference population, there are some limitations. One is timing: we will have NHANES data from samples collected in 2011-2012, while the MDH samples will be collected in 2014. As levels of some PFCs are declining in the general population, this time lag could affect the comparison. Sociodemographic and other differences between people studied in NHANES and the new resident population studied in the East Metro may also be an issue. In NHANES, PFCs are positively associated with higher income, and it is likely that the East Metro population differs from the NHANES population in this respect. The proposed protocol was the approach we thought would give the clearest answer to the key questions that people have about PFC exposures in the East Metro. Then Jessica described two alternative approaches that staff had considered and rejected (Table 7, below) 59 Table 7. Alternative Approaches Approach Pro Stratified random sample of Oakdale residents by length of residence (n=100 new residents and n=100 long-term residents) Con Will be sure to get sufficient number of new residents Age match will enable valid comparison between new and long-term residents Random sample of new Oakdale residents (n=100) and new residents of a reference East Metro community (n=100) Can compare new Oakdale residents to similar MN reference population w/o exposure history Avoid limitations of NHANES comparison Approach Pro Stratified random sa mple of Oakdale re sident s by length of reside nce (n= 100 new resident s and n=100 long-ter m reside nts) Will be sure to get sufficient number of new resi dents Age match will enabl e valid comparis on betwe en new a nd long -term re sident s Random sa mpl e of new Oakdale re sidents (n= 100 ) and new reside nts of a re feren ce East Metro community (n=100 ) Can compare new Oak dale reside nts to si milar MN refere nce population w/ o expos ure history Avoid limitations of NHA NES comparis on Recruiting more long-term residents not a priority; have answered the question of more PFCs associated with longer residence Will be hard to recruit older new residents More complicated to explain to public Given need for minimum residency requirement, new resident window of eligibility very narrow (~3 years) If we have no minimum residency requirement, may not have power to look at length of residence in Oakdale residents Con Recruiting more l ong-ter m residents not a priority; have answere d the question of more PF Cs ass ociated with l onger residence Will be hard to re cruit older new reside nts More compli cated to e xplain to publi c Given need for mini mum reside ncy req uireme nt, new resident window of eligi bility very narrow (~3 years) If we have no mini mum residency re quire ment, may not have pow er to look at length of reside nce in Oakdale re sidents Christina then asked the panel members to consider the following questions: • • Is the proposed sampling strategy the best for answering our key questions about PFC exposures in the East Metro? Can panel members suggest how best to recruit new residents in the East Metro, who are less familiar with, and likely less motivated by the topic? Discussion David DeGroote asked about the proposed size of the new resident population. Do you know how many people have moved here since November 1, 2006? Christina Rosebush responded that the Oakdale population is around 20,000 adults, and in any given year, about 10% of residents are new to their home. We will know more about the size of the Oakdale new resident pool when we get water records from the city. 60 You plan to send out 500 letters to get 200 participants, David continued. Will that size of population be enough—is this a good statistical sample size? Christina answered, yes, our power calculations show that 200 people will be sufficient to answer our primary question: Are PFC levels in the new resident population different from those in the US general population? Bruce Alexander said there is an issue about people moving into and out of Oakdale and other parts of the East Metro and then moving into Oakdale again. Are there ways to track those people who might have lived there before? Christina said that “no residence in Oakdale before 11/1/06” is an eligibility requirement, and we will be sure to ask this in the household survey. We will also ask about all past East Metro addresses in the questionnaire, so we will have residential history information for other towns as well. Bruce asked, why did you exclude Cottage Grove residents on private wells? Christina answered that it would be difficult to get a representative sample of Cottage Grove residents who are both municipal water and private well users. Jessica Nelson added that focusing on the Oakdale population answers the question most directly because so many people are on city water, and there is one clear intervention date when the city water filters were changed. Private wells are complicated because they may be treated with different kinds of filters. Geary Olsen added that many people in Lake Elmo are now on municipal water, so new residents there might be available for a larger population. Geary Olsen then asked, why are you measuring PFPeA and PFHxA again? They weren’t detected in the earlier projects, so do we need to keep testing for them? PFHxA has a halflife of 30 days, and the 4carbon chain PFBA has a halflife of 3 days, so PFPeA will likely have a halflife between 30 days and 3 days. It may be reasonable to keep PFHxA, as this is the chemistry that companies are now using, but it’s not going to be in the water and will be coming from other sources. Levels in the water have not been changing. Christina responded that staff will think more about this in the next phase of planning. Geary also noted that the NHANES 2011-2012 sample included participants from Washington County. Because that may affect the overall results, he suggested that MDH may want to check with NHANES to see if they will provide information on the number of people involved. Jessica said she thought that this will be important to check. Jean Johnson said that the NHANES Washington County data would be a very useful reference to have. Next, Geary referred to two sentences in the October Advisory Panel background book that read “Although PFC levels in Oakdale city water are below health-based limits, low levels of PFCs are still present in some water samples. This study will seek to determine whether this low-level exposure results in elevated PFC blood levels.” He asked, why is MDH trying to correlate exposure to PFCs in water to blood levels in people? The water levels are below the Health Risk Limits (HRLs), and MDH says they’re safe for drinking for a lifetime. And when water levels are very low, ambient environmental exposures—non-water source exposures—can become more important. Jessica Nelson answered that we see our mandate as a question about new residents’ exposures—are there any water exposures that might be accumulating in the body? Geary then asked how the variation in water levels over time will be taken into account. Jessica explained that we are using length of residence as a proxy for low-level exposure; we are not actually using water values in any models. Low-level exposure means living in a community for 61 a longer time and presumably drinking water that has varying levels while you live there. Bruce pointed out that there are limitations to this, e.g., you assume that everybody drinks water in the same amount and from the same source. David added, I assume the questionnaire gets at those questions and that you will analyze those variables along with the laboratory data. Jessica agreed that the assumption that everyone is getting the same water all the time is a big one. Jean said that staff will change the wording in the project protocol to clarify that the analysis will not involve water concentrations, but will use length of residence as a proxy for water exposure. Geary commented that the decline we saw in blood levels from 2008 to 2010 followed the pharmacokinetic data well, and that the third time point should do the same. For each individual in the original cohort, he suggested that staff predict ahead of time what blood values will be in 2014 based on pharmacokinetic data. Then, when we have the results, we can compare these predictions to the actual measured values. If past water exposure is still the main source, you should be able to predict the participants’ levels closely. Pat McGovern pointed out that the time was up, and suggested that the discussion could continue by email or phone. But staff asked the panel to agree that, on the whole, with the small changes noted above, the project can move forward. Panel members agreed. Biomonitoring Updates Members had no questions or comments. Administrative Item Because time was limited, Pat McGovern moved on to the next item: request for applications from panel members whose terms end on December 31, 2013. Barbara Scott Murdock named those whose terms would end on that date and handed out copies of the requirements for applications to the Office of the Secretary of State (OSS). The OSS will post the open positions on the panel on November 4; applications should be submitted by November 26, 2013. Tracking Updates Matthew Montesano gave a short presentation of new work on the data portal—Community Environmental Health Profiles. This new web function will offer users an overview of environmental health issues in their community (e.g., data by location for multiple indicators on the state/grantee/national portals). It would allow users, such as local public health officials, to see all the county-level data, compare the data to statewide averages, and use it for making graphs and tables. Data users are now asking for community-level data, saying that county-level data are nice, but we need more detailed community data, so MDH staff are beginning to develop a system for these data as well. After giving a brief demonstration of examples, Matthew concluded by noting that the project is underway and a little ahead of CDC. Discussion Bruce Alexander asked, are you able to export data broken out by other categories? Matthew replied that people can integrate the data with other queries, carry out a more in-depth query, and crunch the data by smaller categories. 62 Adjournment Pat McGovern adjourned the meeting. The next Advisory Panel meeting will be held on February 11, 2014, from 1:00–4:00 PM, at the American Lung Association. 63 Environmental Health Tracking & Biomonitoring Advisory Panel Roster As of January 2014 Bruce Alexander, PhD University of Minnesota School of Public Health Environmental Health Sciences Division MMC 807 Mayo 420 Delaware Street SE Minneapolis, Minnesota 55455 612-625-7934 [email protected] At-large representative 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 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 David DeGroote, PhD St. Cloud State University 840 4th Street South St. Cloud, MN 56301 320-308-2192 [email protected] Minnesota House of Representatives appointee Melanie Ferris Wilder Foundation 451 Lexington Parkway N St. Paul, MN 55104 651-280-2660 [email protected] Nongovernmental organization representative Thomas Hawkinson, MS, CIH, CSP Toro Company 8111 Lyndale Avenue S Bloomington, MN 55420 [email protected] 952-887-8080 Statewide business org representative Jill Heins Nesvold, MS American Lung Association of Minnesota 490 Concordia Avenue St. Paul, Minnesota 55103 651-223-9578 [email protected] Nongovernmental organization representative Patricia 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 64 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 Gregory Pratt, PhD Minnesota Pollution Control Agency Environmental Analysis & Outcomes Division 520 Lafayette Road St. Paul, MN 55155-4194 651-757-2655 [email protected] MPCA appointee Cathy Villas-Horns, MS, PG Minnesota Department of Agriculture Pesticide and Fertilizer Management Division 625 Robert Street North St. Paul, Minnesota 55155-2538 651-201-6291 [email protected] MDA appointee Lisa Yost, MPH, DABT ENVIRON International Corporation 333 West Wacker Drive, Suite 2700 Chicago, IL 60606 Local office 886 Osceola Avenue St. Paul, Minnesota 55105 Phone: 651-225-1592 Cell: 651-470-9284 [email protected] At-large representative Vacant Minnesota Senate appointee 61 Biographical sketches of advisory panel members Bruce H. Alexander is a Professor in the Division of Environmental Health Sciences at the University of Minnesota’s 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’s 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. 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. David DeGroote is a Professor of Biological Sciences at St. Cloud State University. He has been at St. Cloud State University since 1985, initially as an Assistant Professor in Biological Sciences. He served as Department Chair from 1996 to 2003 and Dean of the College of Science and Engineering until June 2013. As Dean, he focused on providing up-to-date academic programming and facilities to serve the needs of Minnesota employers in the health sciences, engineering, computing, biosciences, and STEM education. He is currently a special advisor to the Provost for industrial collaboration and curriculum alignment with workforce needs. Melanie Ferris is a Research Scientist at Wilder Research, a nonprofit research organization based in St. Paul, Minnesota. She conducts a variety of program evaluation and applied research projects focused primarily in the areas of public health and mental health. She has worked on a number of recent projects that focus on identifying disparities across populations and using existing data sources to develop meaningful indicators of health and wellness. Examples of these projects include a study of health inequities in the Twin Cities region related to income, race, and place, development of a dashboard of mental health and wellness indicators for youth living in Hennepin County, and work on local community health needs assessments. She has a Master’s of Public Health degree in Community Health Education from the University of Minnesota’s School of Public Health. Tom Hawkinson is the Corporate Environmental, Health, and Safety Manager for the Toro Company in Bloomington, MN. He completed his MS in Public Health at the University of Minnesota, with a specialization in industrial hygiene. He is certified in the comprehensive practice of industrial hygiene and a certified safety professional. He has worked in EHS management at a number of Twin Cities based companies, conducting industrial hygiene investigations of workplace contaminants and done environmental investigations of subsurface contamination both in the United States and Europe. He has taught statistics and mathematics at both graduate and undergraduate levels as an adjunct, and is on the faculty at the Midwest Center for Occupational Health and Safety A NIOSH-Sponsored Education and Research Center School of Public Health, University of Minnesota. 62 Jill Heins Nesvold serves as the Director of the Respiratory Health Division for the American Lung Association in Iowa, 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 master’s degree in health management and a short-course master’s degree in business administration. Jill has published extensively in a variety of public health areas. 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 corporate 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 27 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. Gregory Pratt is a research scientist at the Minnesota Pollution Control Agency. He holds a Ph.D. in Plant Physiology from the University of Minnesota, 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. Cathy Villas Horns is the Hydrologist Supervisor of the Incident Response Unit (IRU) within the Pesticide and Fertilizer Management Unit of the Minnesota Department of Agriculture. Cathy holds a Master of Science in Geology from the University of Delaware and a Bachelor of Science in Geology from Carleton College and is a licensed Professional Geologist in MN. The IRU oversees or conducts the investigation and cleanup of point source releases of agricultural chemicals (fertilizers and pesticides including herbicides, insecticides, fungicides, etc. as well as wood treatment chemicals) through several different programs. Cathy has worked on complex sites with Minnesota Department of Health and MPCA staff, and continues to work with interagency committees on contaminant issues. She previously worked as a senior hydrogeologist within the IRU, and as a hydrogeologist at the Minnesota Pollution Control Agency and an environmental consulting firm. Lisa Yost is a Principal Consultant at ENVIRON, an international consulting firm. She is in their Health Sciences Group, and is based in Saint Paul, Minnesota. Ms. Yost completed her training at the University of Michigan’s 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 areas of specialization include exposure and risk 63 assessment, risk communication, and the toxicology of such chemicals 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’s School of Public Health. 64 Staff Biosketches Wendy Brunner, PhD, serves as surveillance epidemiologist for the MDH Asthma Program since 2002, and joined Minnesota’s Environmental Public Health Tracking and Biomonitoring Program (MN Tracking) program on a part-time basis in fall 2009. Previously, she worked on occupational respiratory disease studies for MDH. She has a masters degree in Science and Technology Studies from Rensselaer Polytechnic Institute and a masters degree in Environmental and Occupational Health from the University of Minnesota. She received her doctorate in the Division of Epidemiology and Community Health at the University of Minnesota. Betsy Edhlund, PhD, is a research scientist in the Environmental Section of the Public Health Laboratory at the Minnesota Department of Health. She works in the metals laboratory developing methods and analyzing samples for both biomonitoring programs and emergency response. Betsy received her PhD in chemistry from the University of Minnesota where her research focused on the photochemistry of natural waters. Jean Johnson, PhD, MS, is Program Director/Principal Investigator for MN Tracking. Dr. Johnson received her Ph.D. and M.S. degrees from the University of Minnesota, School of Public Health in Environmental Health and has 25 years of experience working with the state of Minnesota in the environmental health field. As an environmental epidemiologist at MDH, her work has focused on special investigations of population exposure and health, including studies of chronic diseases related to air pollution and asbestos exposure, and exposure to drinking water contaminants. She is currently the Principal Investigator on an EPA grant to develop methods for measuring the public health impacts of population exposure to particulate matter (PM) in air. She is also an adjunct faculty member at the University of Minnesota School of Public Health. Tess Konen, MPH, graduated from the University of Michigan’s School of Public Health with a master’s in Occupational Environmental Epidemiology. She completed her thesis on the effects of heat on hospitalizations in Michigan. She currently is a CSTE/CDC Epidemiology Fellow in MN Tracking working on birth defects, pesticides, climate change, and a follow-up study of the Northeast Minneapolis Community Vermiculite Investigation cohort. Mary Jeanne Levitt, MBC, is the communications coordinator with MN Tracking. She has a Masters in Business Communications and has worked for over 20 years in both the public and non-profit sector in project management of research and training grants, communications and marketing strategies, focus groups and evaluations of educational needs of public health professionals. She serves on 3 institutional review boards which specialize in academic research, oncology research, and overall clinical research. Paula Lindgren, MS, received her Masters of Science degree in Biostatistics from the University of Minnesota. She works for the Minnesota Department of Health as a biostatistician, and provides statistical and technical support MN Tracking for data reports, publications, web-based portal dissemination and presentations in the Chronic Disease and Environmental Epidemiology section. Ms. Lindgren has also received training in the area of GIS for chronic disease mapping and analysis. In addition to her work for MN Tracking, she works for various programs within Chronic Disease and Environmental Epidemiology including the Asthma program, Center for Occupation Health and Safety, Minnesota Cancer Surveillance System, and Cancer Control section. 65 Jessica Nelson, PhD, is an epidemiologist with MN Tracking, working primarily on design, coordination, and analysis of biomonitoring projects. Jessica received her PhD and MPH in Environmental Health from the Boston University School of Public Health where her research involved the epidemiologic analysis of biomonitoring data on perfluorochemicals. Jessica was the coordinator of the Boston Consensus Conference on Biomonitoring, a project that gathered input and recommendations on the practice and uses of biomonitoring from a group of Boston-area lay people. Christina Rosebush, MPH, is an epidemiologist with MN Tracking. Her work includes the development and coordination of biomonitoring projects that assess perfluorochemicals (PFCs) and mercury in Minnesota communities. She also works on collection and statistical analysis of public health surveillance data for MN Tracking, with a focus on behavioral risk factors. Christina received her Masters degree in epidemiology from the University of Minnesota’s School of Public Health, completing research in PFC biomonitoring for the Minnesota Department of Health in partial fulfillment of her degree. Jeannette M. Sample, MPH, is an epidemiologist with MN Tracking at the Minnesota Department of Health, working primarily with the collection and statistical analysis of public health surveillance data for MN Tracking. She also works on research collaborations with academic partners relating to reproductive outcomes and birth defects. Prior to joining MN Tracking, she was a CSTE/CDC Applied Epidemiology Fellow with the MDH Birth Defect Information System. Jeannette received her Masters degree in epidemiology and biostatistics from The George Washington University in Washington, DC. Blair Sevcik, MPH, is an epidemiologist with MN Tracking at the Minnesota Department of Health, where she works on the collection and statistical analysis of public health surveillance data for .MN Tracking. Prior to joining MN Tracking in January 2009, she was a student worker with the MDH Asthma Program. She received her Master of Public Health degree in epidemiology from University of Minnesota School of Public Health in December 2010. Chuck Stroebel, MSPH, is the MN Tracking Program Manager. He provides day-to-day direction for program activities, including: 1) development and implementation of the state network, 2) development and transport of NCDMs and metadata for the national network, and 3) collaboration and communication with key EPHT partners and stakeholders. Chuck received a Masters of Public Health in Environmental Health Sciences from the University of North Carolina (Chapel Hill). He has over 15 years of expertise in environmental health, including areas of air quality, pesticides, climate change, risk assessment, and toxicology. Chuck also played a key role in early initiatives to build tracking capacity at the Minnesota Department of Health. Currently, he is a member of the IBIS Steering Committee (state network), the MDH ASTHO Grant Steering Committee (climate change), and the Northland Society of Toxicology. He also serves on the Minnesota EPHT Technical and Communications Teams. Janis Taramelli, TTS, is the Community Outreach Coordinator for MN Tracking, responsible for communications with the MN Tracking Advisory Panel and study participants. A tobacco treatment specialist, she has 20 years of experience working on research studies, surveys, group facilitation, and one-on-one counseling in both the public and private sectors. Her background includes development and coordination of statewide QUITPLAN at Work programs, metro area QUITPLAN centers, and piloting tobacco cessation and heart healthy programs for Minnesota’s Sage (Breast and Cervical Cancer Screening) and SagePlus (Heart Health Screening) programs, funded by the Centers for Disease Control. Allan N. Williams, MPH, PhD, is an environmental and occupational epidemiologist in the Chronic Disease and Environmental Epidemiology Section at the Minnesota Department of Health. He is the 66 supervisor for the MDH Center for Occupational Health and Safety. For over 25 years, he has worked on issues relating to environmental and occupational cancer, cancer clusters, work-related respiratory diseases, and the surveillance and prevention of work-related injuries among adolescents. He has served as the PI on two NIOSH R01 grants, as a co-investigator on four other federally-funded studies in environmental or occupational health, and is an adjunct faculty member in the University of Minnesota’s School of Public Health. He received an MA in Biology from Indiana University, an MPH in Environmental Health and Epidemiology from the University of Minnesota, and a PhD in Environmental and Occupational Health from the University of Minnesota. 67 Environmental Health Tracking and Biomonitoring Statute $1,000,000 each year is for environmental health tracking and biomonitoring. Of this amount, $900,000 each year is for transfer to the Minnesota Department of Health. The base appropriation for this program for fiscal year 2010 and later is $500,000. 144.995 DEFINITIONS; ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING. (a) For purposes of sections 144.995 to 144.998, the terms in this section have the meanings given. (b) "Advisory panel" means the Environmental Health Tracking and Biomonitoring Advisory Panel established under section 144.998. (c) "Biomonitoring" means the process by which chemicals and their metabolites are identified and measured within a biospecimen. (d) "Biospecimen" means a sample of human fluid, serum, or tissue that is reasonably available as a medium to measure the presence and concentration of chemicals or their metabolites in a human body. (e) "Commissioner" means the commissioner of the Department of Health. (f) "Community" means geographically or nongeographically based populations that may participate in the biomonitoring program. A "nongeographical community" includes, but is not limited to, populations that may share a common chemical exposure through similar occupations, populations experiencing a common health outcome that may be linked to chemical exposures, populations that may experience similar chemical exposures because of comparable consumption, lifestyle, product use, and subpopulations that share ethnicity, age, or gender. (g) "Department" means the Department of Health. (h) "Designated chemicals" means those chemicals that are known to, or strongly suspected of, adversely impacting human health or development, based upon scientific, peer-reviewed animal, human, or in vitro studies, and baseline human exposure data, and consists of chemical families or metabolites that are included in the federal Centers for Disease Control and Prevention studies that are known collectively as the National Reports on Human Exposure to Environmental Chemicals Program and any substances specified by the commissioner after receiving recommendations under section 144.998, subdivision 3, clause (6). (i) "Environmental hazard" means a chemical or other substance for which scientific, peerreviewed studies of humans, animals, or cells have demonstrated that the chemical is known or reasonably anticipated to adversely impact human health. (j) "Environmental health tracking" means collection, integration, analysis, and dissemination of data on human exposures to chemicals in the environment and on diseases potentially caused or aggravated by those chemicals. 68 144.996 ENVIRONMENTAL HEALTH TRACKING; BIOMONITORING. Subdivision 1. Environmental health tracking. In cooperation with the commissioner of the Pollution Control Agency, the commissioner shall establish an environmental health tracking program to: (1) coordinate data collection with the Pollution Control Agency, Department of Agriculture, University of Minnesota, and any other relevant state agency and work to promote the sharing of and access to health and environmental databases to develop an environmental health tracking system for Minnesota, consistent with applicable data practices laws; (2) facilitate the dissemination of aggregate public health tracking data to the public and researchers in accessible format; (3) develop a strategic plan that includes a mission statement, the identification of core priorities for research and epidemiologic surveillance, and the identification of internal and external stakeholders, and a work plan describing future program development and addressing issues having to do with compatibility with the Centers for Disease Control and Prevention's National Environmental Public Health Tracking Program; (4) develop written data sharing agreements as needed with the Pollution Control Agency, Department of Agriculture, and other relevant state agencies and organizations, and develop additional procedures as needed to protect individual privacy; (5) organize, analyze, and interpret available data, in order to: (i) characterize statewide and localized trends and geographic patterns of population-based measures of chronic diseases including, but not limited to, cancer, respiratory diseases, reproductive problems, birth defects, neurologic diseases, and developmental disorders; (ii) characterize statewide and localized trends and geographic patterns in the occurrence of environmental hazards and exposures; (iii) assess the feasibility of integrating disease rate data with indicators of exposure to the selected environmental hazards such as biomonitoring data, and other health and environmental data; (iv) incorporate newly collected and existing health tracking and biomonitoring data into efforts to identify communities with elevated rates of chronic disease, higher likelihood of exposure to environmental hazards, or both; (v) analyze occurrence of environmental hazards, exposures, and diseases with relation to socioeconomic status, race, and ethnicity; (vi) develop and implement targeted plans to conduct more intensive health tracking and biomonitoring among communities; and (vii) work with the Pollution Control Agency, the Department of Agriculture, and other relevant state agency personnel and organizations to develop, implement, and evaluate preventive measures to 69 reduce elevated rates of diseases and exposures identified through activities performed under sections 144.995 to 144.998; and (6) submit a biennial report to the chairs and ranking members of the committees with jurisdiction over environment and health by January 15, beginning January 15, 2009, on the status of environmental health tracking activities and related research programs, with recommendations for a comprehensive environmental public health tracking program. Subd. 2. Biomonitoring. The commissioner shall: (1) conduct biomonitoring of communities on a voluntary basis by collecting and analyzing biospecimens, as appropriate, to assess environmental exposures to designated chemicals; (2) conduct biomonitoring of pregnant women and minors on a voluntary basis, when scientifically appropriate; (3) communicate findings to the public, and plan ensuing stages of biomonitoring and disease tracking work to further develop and refine the integrated analysis; (4) share analytical results with the advisory panel and work with the panel to interpret results, communicate findings to the public, and plan ensuing stages of biomonitoring work; and (5) submit a biennial report to the chairs and ranking members of the committees with jurisdiction over environment and health by January 15, beginning January 15, 2009, on the status of the biomonitoring program and any recommendations for improvement. Subd. 3. Health data. Data collected under the biomonitoring program are health data under section 13.3805. 144.997 BIOMONITORING PILOT PROGRAM. Subdivision 1. Pilot program. With advice from the advisory panel, and after the program guidelines in subdivision 4 are developed, the commissioner shall implement a biomonitoring pilot program. The program shall collect one biospecimen from each of the voluntary participants. The biospecimen selected must be the biospecimen that most accurately represents body concentration of the chemical of interest. Each biospecimen from the voluntary participants must be analyzed for one type or class of related chemicals. The commissioner shall determine the chemical or class of chemicals to which community members were most likely exposed. The program shall collect and assess biospecimens in accordance with the following: (1) 30 voluntary participants from each of three communities that the commissioner identifies as likely to have been exposed to a designated chemical; (2) 100 voluntary participants from each of two communities: (i) that the commissioner identifies as likely to have been exposed to arsenic; and (ii) that the commissioner identifies as likely to have been exposed to mercury; and 70 (3) 100 voluntary participants from each of two communities that the commissioner identifies as likely to have been exposed to perfluorinated chemicals, including perfluorobutanoic acid. Subd. 2. Base program. (a) By January 15, 2008, the commissioner shall submit a report on the results of the biomonitoring pilot program to the chairs and ranking members of the committees with jurisdiction over health and environment. (b) Following the conclusion of the pilot program, the commissioner shall: (1) work with the advisory panel to assess the usefulness of continuing biomonitoring among members of communities assessed during the pilot program and to identify other communities and other designated chemicals to be assessed via biomonitoring; (2) work with the advisory panel to assess the pilot program, including but not limited to the validity and accuracy of the analytical measurements and adequacy of the guidelines and protocols; (3) communicate the results of the pilot program to the public; and (4) after consideration of the findings and recommendations in clauses (1) and (2), and within the appropriations available, develop and implement a base program. Subd. 3. Participation. (a) Participation in the biomonitoring program by providing biospecimens is voluntary and requires written, informed consent. Minors may participate in the program if a written consent is signed by the minor's parent or legal guardian. The written consent must include the information required to be provided under this subdivision to all voluntary participants. (b) All participants shall be evaluated for the presence of the designated chemical of interest as a component of the biomonitoring process. Participants shall be provided with information and fact sheets about the program's activities and its findings. Individual participants shall, if requested, receive their complete results. Any results provided to participants shall be subject to the Department of Health Institutional Review Board protocols and guidelines. When either physiological or chemical data obtained from a participant indicate a significant known health risk, program staff experienced in communicating biomonitoring results shall consult with the individual and recommend follow-up steps, as appropriate. Program administrators shall receive training in administering the program in an ethical, culturally sensitive, participatory, and community-based manner. Subd. 4. Program guidelines. (a) The commissioner, in consultation with the advisory panel, shall develop: (1) protocols or program guidelines that address the science and practice of biomonitoring to be utilized and procedures for changing those protocols to incorporate new and more accurate or efficient technologies as they become available. The commissioner and the advisory panel shall be guided by protocols and guidelines developed by the Centers for Disease Control and Prevention and the National Biomonitoring Program; 71 (2) guidelines for ensuring the privacy of information; informed consent; follow-up counseling and support; and communicating findings to participants, communities, and the general public. The informed consent used for the program must meet the informed consent protocols developed by the National Institutes of Health; (3) educational and outreach materials that are culturally appropriate for dissemination to program participants and communities. Priority shall be given to the development of materials specifically designed to ensure that parents are informed about all of the benefits of breastfeeding so that the program does not result in an unjustified fear of toxins in breast milk, which might inadvertently lead parents to avoid breastfeeding. The materials shall communicate relevant scientific findings; data on the accumulation of pollutants to community health; and the required responses by local, state, and other governmental entities in regulating toxicant exposures; (4) a training program that is culturally sensitive specifically for health care providers, health educators, and other program administrators; (5) a designation process for state and private laboratories that are qualified to analyze biospecimens and report the findings; and (6) a method for informing affected communities and local governments representing those communities concerning biomonitoring activities and for receiving comments from citizens concerning those activities. (b) The commissioner may enter into contractual agreements with health clinics, communitybased organizations, or experts in a particular field to perform any of the activities described under this section. 144.998 ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING ADVISORY PANEL. Subdivision 1. Creation. The commissioner shall establish the Environmental Health Tracking and Biomonitoring Advisory Panel. The commissioner shall appoint, from the panel's membership, a chair. The panel shall meet as often as it deems necessary but, at a minimum, on a quarterly basis. Members of the panel shall serve without compensation but shall be reimbursed for travel and other necessary expenses incurred through performance of their duties. Members appointed by the commissioner are appointed for a three-year term and may be reappointed. Legislative appointees serve at the pleasure of the appointing authority. Subd. 2. Members. (a) The commissioner shall appoint eight members, none of whom may be lobbyists registered under chapter 10A, who have backgrounds or training in designing, implementing, and interpreting health tracking and biomonitoring studies or in related fields of science, including epidemiology, biostatistics, environmental health, laboratory sciences, occupational health, industrial hygiene, toxicology, and public health, including: (1) at least two scientists representative of each of the following: (i) nongovernmental organizations with a focus on environmental health, environmental justice, children's health, or on specific chronic diseases; and 72 (ii) statewide business organizations; and (2) at least one scientist who is a representative of the University of Minnesota. (b) Two citizen panel members meeting the scientific qualifications in paragraph (a) shall be appointed, one by the speaker of the house and one by the senate majority leader. (c) In addition, one representative each shall be appointed by the commissioners of the Pollution Control Agency and the Department of Agriculture, and by the commissioner of health to represent the department's Health Promotion and Chronic Disease Division. Subd. 3. Duties. The advisory panel shall make recommendations to the commissioner and the legislature on: (1) priorities for health tracking; (2) priorities for biomonitoring that are based on sound science and practice, and that will advance the state of public health in Minnesota; (3) specific chronic diseases to study under the environmental health tracking system; (4) specific environmental hazard exposures to study under the environmental health tracking system, with the agreement of at least nine of the advisory panel members; (5) specific communities and geographic areas on which to focus environmental health tracking and biomonitoring efforts; (6) specific chemicals to study under the biomonitoring program, with the agreement of at least nine of the advisory panel members; in making these recommendations, the panel may consider the following criteria: (i) the degree of potential exposure to the public or specific subgroups, including, but not limited to, occupational; (ii) the likelihood of a chemical being a carcinogen or toxicant based on peer-reviewed health data, the chemical structure, or the toxicology of chemically related compounds; (iii) the limits of laboratory detection for the chemical, including the ability to detect the chemical at low enough levels that could be expected in the general population; (iv) exposure or potential exposure to the public or specific subgroups; (v) the known or suspected health effects resulting from the same level of exposure based on peer-reviewed scientific studies; (vi) the need to assess the efficacy of public health actions to reduce exposure to a chemical; (vii) the availability of a biomonitoring analytical method with adequate accuracy, precision, sensitivity, specificity, and speed; 73 (viii) the availability of adequate biospecimen samples; or (ix) other criteria that the panel may agree to; and (7) other aspects of the design, implementation, and evaluation of the environmental health tracking and biomonitoring system, including, but not limited to: (i) identifying possible community partners and sources of additional public or private funding; (ii) developing outreach and educational methods and materials; and (iii) disseminating environmental health tracking and biomonitoring findings to the public. Subd. 4. Liability. No member of the panel shall be held civilly or criminally liable for an act or omission by that person if the act or omission was in good faith and within the scope of the member's responsibilities under sections 144.995 to 144.998. INFORMATION SHARING. On or before August 1, 2007, the commissioner of health, the Pollution Control Agency, and the University of Minnesota are requested to jointly develop and sign a memorandum of understanding declaring their intent to share new and existing environmental hazard, exposure, and health outcome data, within applicable data privacy laws, and to cooperate and communicate effectively to ensure sufficient clarity and understanding of the data by divisions and offices within both departments. The signed memorandum of understanding shall be reported to the chairs and ranking members of the senate and house of representatives committees having jurisdiction over judiciary, environment, and health and human services. Effective date: July 1, 2007 This document contains Minnesota Statutes, sections 144.995 to 144.998, as these sections were adopted in Minnesota Session Laws 2007, chapter 57, article 1, sections 143 to 146. The appropriation related to these statutes is in chapter 57, article 1, section 3, subdivision 4. The paragraph about information sharing is in chapter 57, article 1, section 169. The following is a link to chapter 57: MN Session Laws, Chapter 57 Current Appropriation for EHTB (see bolded text on page 75) Office of the Revisor of Statutes 88th Legislature, 2013, Regular Session, Chapter 114 Minnesota Session Laws Subd. 2.Water 25,453,000 25,454,000 3,737,000 3,737,000 Appropriations by Fund General 74 State Government Special Revenue Environmental 75,000 75,000 21,641,000 21,642,000 $1,959,000 the first year and $1,959,000 the second year are for grants to delegated counties to administer the county feedlot program under Minnesota Statutes, section 116.0711, subdivisions 2 and 3. By January 15, 2016, the commissioner shall submit a report detailing the results achieved with this appropriation to the chairs and ranking minority members at the senate and house of representatives committees and divisions with jurisdiction over environment and natural resources policy and finance. Money remaining after the first year is available for the second year. $740,000 the first year and $740,000 the second year are from the environmental fund to address the need for continued increased activity in the areas of new technology review, technical assistance for local governments, and enforcement under Minnesota Statutes, sections 115.55 to 115.58, and to complete the requirements of Laws 2003, chapter 128, article 1, section 165. $400,000 the first year and $400,000 the second year are for the clean water partnership program. Any unexpended balance in the first year does not cancel but is available in the second year. Priority shall be given to projects preventing impairments and degradation of lakes, rivers, streams, and groundwater according to Minnesota Statutes, section 114D.20, subdivision 2, clause (4). $664,000 the first year and $664,000 the second year are from the environmental fund for subsurface sewage treatment system (SSTS) program administration and community technical assistance and education, including grants and technical assistance to communities for water quality protection. Of this amount, $129,000 each year is for assistance to counties through grants for SSTS program administration. A county receiving a grant from this appropriation shall submit the resultsachieved with the grant to the commissioner as part of its annual SSTS report. Any unexpended balance in the first year does not cancel but is available in the second year.$105,000 the first year and $105,000 the second year are from the environmental fund for registration of wastewater laboratories. $913,000 the first year and $913,000 the second year are from the environmental fund to continue perfluorochemical biomonitoring in eastern metropolitan communities, as recommended by the Environmental Health Tracking and Biomonitoring Advisory Panel, and address other environmental health risks, including air quality. Of this amount, $812,000 the first year and $812,000 the second year are for transfer to the Department of Health. Notwithstanding Minnesota Statutes, section 16A.28, the appropriations encumbered on or before June 30, 2015, as grants or contracts for SSTS's, surface water and groundwater assessments, total maximum daily loads, storm water, and water quality protection in this subdivision are available until June 30, 2018. 75
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