Summary of the Minnesota Department of Health (MDH) Environmental Health Tracking & Biomonitoring Advisory Panel Meeting March 8, 2011 1-4 p.m. Advisory panel members – Present: Greg Pratt, (chair), Fred Anderson, Alan Bender, Pat McGovern, Cathy Villas-Horns. Advisory panel members – Regrets: Bruce H. Alexander, Jill Heins Nesvold, Beth Baker, Cathi Lyman-Onkka, Thomas Hawkinson, Geary Olsen, Lisa Yost. Welcome and Introductions Greg Pratt, serving as chair for Beth Baker, convened the meeting. Jean Johnson introduced Barbara Scott Murdock, who will serve as program planner, replacing Michonne Bertrand. Tracking Update Chuck Stroebel and David Stewart reviewed the development of the MN DATA secure portal. Chuck framed his discussion of the development of the portal in terms of four questions: What are the key audiences for the Secure DATA system? What features, data or services, would make this system most useful? What are the key challenges, concerns or issues with its implementation? What uses would key audiences likely have for custom data sets? Goals are To provide secure access to EPHT data for authorized users; To meet a July 31 deliverable to CDC To develop and pilot a system for sharing data among authorized EPHT users. Target audiences for the secure portal include Public health professionals in the EPHT network Researchers and public health professionals in state and local agencies Researchers at universities Issues and challenges CDC requirements are poorly defined Few states have secure portals State standards for identity management are in development The timeline for Phase 1 is tight (July 31, 2011) 1 Phase 1 includes developing standards, procedures, and data dictionaries that allow users to look at available data and request access. Finally, it involves evaluating what users want in the way of tools and access to data. Phases 2 and 3 will use the information collected above to enhance and expand the portal.. Dave Stewart demonstrated the draft portal design on MDH’s web-test server. The login is on the right side of the screen; users must establish a valid need for access. The data steward also must approve the user’s access to the requested data in accordance with applicable laws that govern data use and practices. MN EPHT is developing an internal process and criteria for vetting such requests. Access agreement with data users. Hard copy would be submitted with terms & conditions for users. For now, the focus is on gathering information from potential users to see what they need and want. MN EPHT will evaluate resource constraints and need for access to determine whether it can meet data requests. Security is the key element; Chuck and Dave are working with ISTM and the MDH Chief Information Security Officer on password policies; permission settings at file level (users will be allowed access only to certain files); and tracking of users’ activities for audits. In addition, MN EPHT will work with ISTM to plan implementation of the anticipated state standards for identity management. Local public health staff in the Metro area who work with datasets will meet with Chuck & Dave to identify their needs and wishes. CDC will evaluate the system in 2011-12. Alan Bender questioned the use of the word ―secure,‖ concerned that the term suggests that private information would be on the website. Further discussion about how portal users could get data on the secure portal clarified the issue. Staff anticipate that professional users (researchers or state or local health professionals) may want to request unsuppressed data from MN EPHT and the data steward for research or public health practice purposes. Unsuppressed data is private data, subject to the MN Government Data Practices Act, and could contain information that might identify an individual. Staff noted that the MDH Legal Unit is reviewing a terms and practices document that is intended to serve as a contract, and that users would know what their responsibilities and obligations are for protecting the data in accordance with the law. Each user given access would be limited to the dataset requested and could gain access to other datasets only by requesting another dataset and signing another contract. Preparing custom data sets for the secure portal could become burdensome to MN EPHT. Pat McGovern suggested assessing the burden in the pilot phases. Because students might be interested in using the data for field projects, she suggested that enabling students to use the data would build an audience of professionals over time. User fees might be reasonable. Chuck stated that MN EPHT would follow the current model at MDH, in which MDH asks the data stewards to answer requests that MN EPHT is unable to fulfill. Greg Pratt 2 asked about the CDC’s secure portal. The presenters said that only approved staff can see and review their own state data on CDC’s portal. Wisconsin and Missouri also have secure portals. The term secure is CDC’s use. Pat McGovern suggested developing a list of key terms and their definitions. Environmental Tobacco Smoke Exposure as a New Content Area for Tracking Jeannette Sample reviewed the criteria and selection process used to identify new content areas for Tracking in Minnesota (pp 9-11) and Blair Sevcik presented Phase III of the selection process for ETS Exposure as a new content area (pp 15-22). The data sources used were the Youth Tobacco Survey (YTS) and the Adult Tobacco Survey (ATS). The advisory panel first considered the questions for consideration list on page 7. Alan Bender noted that the first two questions are related: Whether the data are informative at only the state-level depends on what inferences you want to draw. One can point out what the limits are in the data, and you want precision of estimates to support inferences. If users want county-level or metro vs. non-metro information, the statewide data won’t support that. For other questions, these data will suffice. The panel agreed that having state-level data only, as long as it was reliable and representative, was a good place to start. Pat McGovern asked whether the datasets gave any idea of how long people were exposed and whether one can get a sense of a dose-response relationship. Blair answered that the Youth Tobacco Survey questions do include an estimated of the number of days in the past week that the respondent was exposed to ETS but that the Adult Tobacco Survey questions are yes/no questions and would not allow an ―exposure-response‖ association to be calculated. Greg Pratt asked whether these surveys were randomly sampled and representative, and whether the data were weighted. Pete Rode (Center for Health Statistics, MDH), representing the data steward, responded that the data come from randomly sampled populations in Minnesota and that both data sources were population-based and randomly sampled. Moreover, the CDC questions for the Youth Tobacco Survey have been reviewed, and the Center for Health Statistics is confident that the questions are reliable. The questions from the Adult Tobacco Survey expand on a core bank of CDC questions and draw from Behavioral Risk Factor Surveillance System (BRFSS) questions, although no special reliability studies have been done. Pete is confident of the ATS data because he is confident of the survey contractor (Westat) but no special studies have been done on reliability or validity. Although the surveys ask what county people live in, Pete doesn’t think we have sufficient data to be confident of smoking rates within a county, but probably can be confident about adult smoking rates within a region. The project has surveyed the metro area vs. non-metro. 3 Fred Anderson asked about the intent behind tracking these measures, given that ETS exposure is trending downward and that we have public initiatives to reduce smoking. Pat McGovern noted that because laws can change (e.g., can be repealed), it would be good to have monitoring data to track the effects of any changes. Greg asked what the prevalence of active smoking is in these groups and whether that should be included as a measure in this new content area. In response to panel discussion, Pete noted that tracking ETS exposure in nonsmokers could determine whether declining exposure in nonsmokers reflects declining prevalence of smoking (already documented in tobacco reports) or whether it is related to new policies designed to reduce exposure in nonsmokers. He added that it would be informative for the Tracking program to look at this subpopulation of nonsmokers rather than behavioral risk factors, such as smoking status. Pete Rode pointed out that we have data on the prevalence of smoking and on ETS exposure among smokers, already published by the Center for Health Statistics and the Tobacco Prevention and Control Program, both at MDH. Jeannette noted that the CDC national EPHT program wants to add behavioral risk factors from Behavioral Risk Factor Surveillance System (BRFSS) survey data. The group considered a motion to recommend the new content, but had no quorum, so Pat McGovern moved to query everyone by email, Al Bender seconded the motion, and all agreed. The group then amended the motion to ask everyone to vote for or against recommendation to the Commissioner of Health that ETS Exposure be adopted as a new content area for Tracking in Minnesota by email by March 22.1 Jean Johnson then asked whether the panel had any comments on the process of selection. One panel member asked what would happen if the Advisory Panel did not recommend this content area. Jean and Jeannette responded that MDH would write up the reasons why the panel did not recommend a new content area be adopted and would send the report to the Steering Committee, who would make the final decision. Al Bender also pointed out that staff will not terminate a content area without consulting the Advisory Panel. Section Overview: Project Year 3 Proposal for Tracking and Biomonitoring Jean Johnson reviewed the program goals: 1. Develop a strong environmental public health tracking system based on the collection and analysis of high-quality data. 2. Ensure that environmental public health data are accessible and used. 3. Build awareness, knowledge and skills among potential data users related to environmental public health tracking in order to inform actions to improve public health. 4. Build collaborations that enhance environmental public health tracking in Minnesota. 1 Later, because of a question from a panel member and a question from a member of the Chamber of Commerce, staff conferred with panel chair Beth Baker, and the decision about the ETS content area was postponed to the June 7 meeting, when more panel members would be present to confer and vote. 4 She then showed a PowerPoint that listed content for new measures added. Plan to propose new areas to add to the tracking list ETS if the Advisory Panel so recommends; Important covariates include behavioral risks (e.g., smoking prevalence data) and population demographics. Having these will allow MDH staff to look at trends and demographic factors, such as poverty, that put people at risk. Asthma and chronic obstructive pulmonary disease (COPD) Additional cancers (15 cancers have been added in the portal), and the program proposes to add all 36 cancers for which data are routinely published by the state cancer registry. Air quality data: particulate monitoring data (air quality) & are working with the PCA on the use of continuous monitoring air quality data New drinking water & blood lead measures will be added as the CDC adds them Climate change measures, as adopted by CDC Possible new data sources National Air Toxics Assessment (NATA) data Pesticide sales data, NHANES biomonitoring data, pesticide poisonings (Poison Control Center data) Radon in homes Child health Chuck Stroebel reported on proposed activities for goals 2 and 3. For goal 2, the EPHT program supplies metadata in reports. Staff are enhancing the program’s portal, adding new or updated data to existing data, and will add maps for cancer (MN cancer surveillance) and demographic information. The staff plan to add blood lead and asthma maps in July, to evaluate GIS platforms, and to develop a glossary of terms and a users’ guide. For the secure portal, they will implement enhancements based on what the CDC requires in a secure portal and add custom data sets. For goal 3, the staff offer portal demonstrations for groups, presentations and displays at conferences, and a brown bag seminar series for state agency staff on such topics as the health effects of climate change, air quality, and other environmental issues. They will expand presentations to broader areas as available. The program website will offer updates and webinars. Staff will evaluate EPHT communications and program activities to see if people are in fact using the portal and the data. Jean Johnson updated progress toward goal 4. The EPHT program plans to continue current collaborations with the following groups: The American Lung Association (COPD & asthma outcomes), The University of Illinois-Chicago research collaboration, The Hennepin County EPA Care Grant to study the Hiawatha Light Rail corridor for contamination and health issues, 5 The Center for Occupational Health grant (CDC/NIOSH funded) to develop occupational parameters for dissemination over the MN DATA portal. The local Public Health Association of MN, The MDH climate change committee, and The MPCA air monitoring division. In addition, the program proposes to collaborate in the future with Wisconsin and Iowa on tracking radon, private well monitoring, and, possibly, biomonitoring, with the MDH Office of Statewide Health Improvement, which studies obesity & tobacco use, & with the Child Health Initiative to look at sources to track child health. Discussion Jean asked the panel whether they had any other priorities to suggest and ideas for how MN might supplement CDC’s work. Greg asked Chuck Stroebel about how much of the portal is public, and how much of it will be secure. Chuck explained that the primary emphasis has been on the public portal, to make as much data public as possible. Staff will limit effort on the secure portal until they can get advice and feedback from potential users of the secure portal about applications and content, which would determine the final proportions. Pat McGovern suggested a possible collaboration on the child health initiative. The National Children’s Study (NCS) in Ramsey County is in the pilot phase. As it moves into the main phase in 2012, it would be interesting if some of the MN child health outcomes followed are the same as the NCS outcomes of interest. Doing this might add value and cost efficiency for both groups. Al Bender noted that the last two years of the project call for strong epidemiologic input and involvement, as there will be pressure from users to correlate findings from the exposure side with the disease side, which could have severe consequences for the state. He observed that the recommendation of the Pew Report was to examine ecologic associations and to increase the dialog about the role of the environment in disease burden. This approach has the potential to consume a lot of energy on issues that have little or no plausibility—and this will increase the time and resources burden [on health departments]. Jean noted that MN EPHT is currently engaged in two ―linkage‖ projects: one with the University of Illinois (linking agrichemicals in drinking water with child health outcomes) and the other is linking MPCA air pollution data with monitoring of respiratory and cardiovascular disease outcomes. Al Bender noted that linkages can be of two kinds: ecological correlation and the kind of studies that follow a group of people and link their individual outcomes to other datasets. The first is much more prone to the ecological fallacy. It’s important to draw a distinction between the two kinds of correlations. Chuck noted that the linkage of health outcome data with demographic data is a useful one for examining health disparities. 6 Fond du Lac (FDL) Biomonitoring Project (ATSDR-funded 3-year study) David Jones and Rita Messing (MDH) presented the project, described on pp 39-43 in the background book. The project is funded by the CDC/Agency for Toxic Substances and Disease Registry. The focus is on looking at the body burden of contaminants in the Great Lakes in populations near Areas of Concern (AOCs). The ATSDR is funding three state agencies: MDH, the MI Dept of Community Health, and the NY Dept of Health. The objectives are to see which contaminants people are exposed to, to compare these with other populations (NHANES data), and to determine pathways of exposure. The analytes include a list of chemicals specified by ATSDR, plus chemicals of local concern to Minnesota’s study group. MDH chose the FDL tribe of Native Americans as a highly exposed population of interest in MN, because members of the group eat traditional diets, use more foods from the region, have vulnerable community members, and assign a greater cultural value to their traditional foods. Ultimately, the goal is to develop a public health action plan at the end of the study. MDH will include omega-3 fatty acids to quantify the benefits of fish consumption. The PIs will also measure some clinical parameters, in part to offer participants some direct benefit (for identifying diabetes, for example). They plan to measure height, weight, and blood pressure as part of the physical to get a sense of participants’ risk for CVD and diabetes and will also get the participants’ lipid content and triglycerides to offer some direct benefit to the participants. Rita Messing noted that the study is not research; it is meant only to characterize exposures in this population and not to contribute to generalizable knowledge. If the biomonitoring results show high levels of lead, cadmium, mercury or arsenic, MDH staff know how to interpret these results and will tell the participants about them. Because people are concerned about risks from eating traditional foods, if we find that the exposures are low, that will be a benefit to the community. MDH will work with the FDL health services and will share the project report with the community and with the advice committee in the community. This public health action plan is unique to the project and will give something back to the community. Discussion Al Bender said that he understood why the project is taking clinical information, but that taking clinical information raises a number of issues. Relevant questions include: What are the implications of offering clinical findings? What this will mean for the Tennessen warning given to participants? Who will review the results? What does one say about MDH’s responsibility if the study found something bad? Will the results be reported to the participant’s physician or to the participant? Is a physician involved in the study to help people understand their results? What does one say to a participant about MDH’s responsibility, once one has clinical information about an individual? Do all participants have access to the Indian Health Service? 7 Rita Messing referred to the slide that described how the study participants will be chosen: they must be members or descendents of members of an Indian tribe, a designation that, according to local sources, appears to cover nearly everyone in the FDL community. FDL human services are available to almost all of the people in the community through a clinic in Cloquet or Duluth. She said that individual results will probably be reported to the individual. And, although project procedures are still in development, the PIs will probably structure the informed consent procedure to specify that, if clinically relevant results for metals or other clinical information are found in the samples, they will contact the individuals and make medical advice available. The PIs will put a system in place for early notification and physician consultation about any exposures above health guidelines, as they learn about them. They will try to get the participant to get to the physician. Al Bender noted that this issue must be considered carefully because it is MDH’s responsibility to get information back consistent with the Tennessen warning. Al Bender asked whether anyone is helping to choose the clinical parameters, since markers such as liver enzymes can be helpful. Rita Messing said that the investigators had decided the parameters themselves (cholesterols and triglycerides). The project includes no parameters related to alcohol or drug consumption, but the investigators would try to get someone to a physician if they found evidence of problems. Pat McGovern suggested contacting Jean Forester at UMN, who has worked with the FDL; Pat would be willing to facilitate the contact. She also suggested snowball recruiting if the PIs have trouble recruiting. Asked whether the investigators planned surveys to find out how much fish people eat and other variables, the investigators replied that they are developing the questions now, and will discuss the survey with the project’s Advice Council (in Fond du Lac) to learn about consumption of fish and other traditional foods, basic demographics, and other characteristics, including occupational histories. There are actually two contaminated sites near the community. The major contaminants of concern to ATSDR at those sites are the polyaromatic hydrocarbons (PAHs), so the study is measuring 1, hydroxypyrene, an indicator of PAH exposure, a major concern in the superfund sites in the AOC. The PIs will also measure cotinine to estimate tobacco use. They plan to speciate Hg (to see whether it is elemental or methyl Hg) so they can better understand its sources and toxicity. They will also measure Se, Cd, PFCs, phenols (partly because of a plan to treat pilings with phenols), and toxaphene, which is of concern in Lake Superior. They do not plan to measure dioxins and furans because one needs too much blood for analysis. Because fish advisories are based on total PCBs, the project will measure total PCBs. In response to a question from Pat McGovern, the PIs said that, because the study is not a research study, it has no control population, but the data will be compared to the NHANES dataset and with the other study populations (MI, NY). Greg asked about the difficulty of recruiting. Rita answered that participants will get an incentive – probably of $50, but the PIs are debating a 2nd $50 incentive because the survey is getting long, and the study may ask for 7 tubes of blood from each person. 8 Al Bender inquired about the cost of the lab work. Rita Messing estimated that the study has about $1.5 million for lab work for 500 people (about $3000/person); the project will do only one blood draw per person. The PIs do not intend to save the serum. They will destroy the samples when they’re through with them, because they believe the tribe will not want to have their samples saved. The study will keep the personal identifiers so the PIs can go back to the people for more, if necessary. East Metro PFC Biomonitoring Follow-up Project (PFC2) Update Jessica Nelson and Carin Huset presented a brief update on the PFC2 project. Jessica reviewed the goals of the project and reported on participant recruitment and sample collection, which are now complete. Of the 186 participants contacted for PFC2, 164 gave a blood sample; this participation rate is 88% of those contacted, and 84% of participants in the 2008 study (10 of whom declined contact for future studies). The 22 non-participants fell into different categories: three returned the consent and questionnaire but did not give a blood sample; seven declined to participate in PFC2 but were willing to answer a short phone survey re: residential, water use, and occupational history; 12 did not respond. Carin discussed an issue that arose with the serum samples received from the clinic. She showed a series of photos documenting that, while most serum tubes were yellow in color, in some cases, tubes from the same individual were different colors (i.e. three yellow and one orange/pink tube). This indicates that hemolysis occurred during sample preparation. In a more limited number of cases, all tubes from an individual were pink or orange, indicating hemolysis during blood collection or sample preparation. Carin reexamined samples from 2008, which displayed a similar range of colors; the difference was that all tubes from an individual were the same color. Carin contacted different sources for input. Antonia Calafat (CDC) said they have not observed problems with method performance due to pink samples, though no systematic study has been done. Based on the photos Carin sent, Charles Dodson (CDC) said that, based on the colors observed, the quality of samples would not be a problem. Nathan Kendrick (MDH PHL) said that there does not appear to have been significant hemolysis and that the samples would still be usable for their purposes. Carin thus concludes that the samples are usable. She will analyze only the yellow tubes when an individual’s samples have multiple colors. But the multiple-color tubes offer an opportunity to do an analysis comparing PFC concentrations in yellow v. orange/pink serum samples from the same individuals. Carin and Jessica asked the Panel for feedback on whether staff have addressed this concern sufficiently or if there are outstanding questions. Jessica added that staff received an email from Panel member Geary Olsen, who could not attend the meeting. He commented that the serum color issue is likely related to hemolysis, and that it would be useful to consider if differences were a function of clinic, medical technician/phlebotomist, or amount of time from blood collection to storage in a freezer. Jessica stated that only one clinic was used in this project (in contrast to the 2 clinics used in 2008), that information was not collected on technician/phlebotomist, and that staff assume that the clinic followed the standard protocol re: sample processing and freezing. Alan Bender recommended that staff write up the issue thoroughly, but that it seems to 9 have been reported with due diligence. Greg Pratt recommended re-analyzing samples from 2008 as a quality control check. Carin responded that this is something to consider, though she is confident of the QA/QC measures in place. Still, if there were a difference in results, it would not be clear which were correct. Updates Panel members had no questions about the updates on biomonitoring and tracking projects in the background book. The meeting was adjourned. Finalized May 13, 2011 10
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