Summary of the Minnesota Department of Health (MDH)
Environmental Health Tracking & Biomonitoring
Advisory Panel Meeting
December 7, 2010, 1 - 4 p.m.
Advisory panel members – Present:
Geary Olsen, Alan Bender, Cathi Lyman‐Onkka, Lisa Yost, Bruce Alexander, Greg Pratt, Thomas Hawkinson, Jill Heins Nesvold, Pat McGovern Advisory panel members – Regrets:
Beth Baker, Fred Anderson, Cathy Villas‐Horns Special guests:
Leslie Stayner, Karl Rockne, Judith Graber, Academic Partners at University of Illinois – Chicago Kristin Oehlke, Newborn Screening Program, MDH Public Health Laboratory Welcome and introductions
Lisa Yost, serving as chair for Beth Baker, convened the meeting. Following introductions, Jean Johnson, EHTB Program Director, announced several staff changes. MN DATA Demonstration and Update
Chuck Stroebel, Tracking program manager, demonstrated the MN DATA website that the Tracking program newly launched. A hard launch of the portal (e.g. press release, announcement) is planned for May 2011. David Stewart, Tracking program consultant, demonstrated some key features of the new MN DATA portal and reviewed recent usability testing. Chuck mentioned the future launch of a secure web portal, for example an unsuppressed dataset that could be used by authorized user. Geary Olsen asked what Chuck meant by “unsuppressed” data, regarding the secure portal. Chuck responded that “unsuppressed” meant the secure data may be identifiable via back calculation due to low counts. Chuck emphasized that enhancing the portal is an ongoing process, and that the Tracking program is continuing to add more data to the portal. Alan Bender asked for clarification whether the query module uses a static, pre‐calculated dataset. Chuck responded that the tables in the datasets consist of summary data that are pre‐calculated, but the user would be interacting with a database. Alan also asked how the portal would handle a high number of users at one time (e.g. 1,000 users). Michele DeMist, MN DATA project manager, responded that there is load testing planned to address that scenario. Jill Heins Nesvold asked about the example of asthma hospitalization data, mentioning that data from 2007 is up on MN DATA and how much of a lag is anticipated for adding data, since asthma hospitalization data from 2008 and 2009 is currently available. Chuck responded that there is a small lag and added that the portal will replace the static Data Reports published by the Tracking program. He pointed out that the dynamic data will be available in a more timely matter. Jill also asked about the plan for adding new topical datasets, such as adding data on asthma ED visits. Chuck responded that the Tracking program is focusing on national requirements now but is interested in expanding measures. Jill also commented that the American Lung Association (ALA) would be able to use Tracking program data in the future rather than duplicating analysis efforts. Geary asked what the Tracking program estimates for resources to handle user questions and data requests that result from the new portal. Chuck responded that estimated resources will be something that staff and managers need to consider and are already thinking about. Jean Johnson responded that partnerships will be key in responding to user questions. Alan added that the MDH interpretation will already be available for the static pages, and that the only issue will be if a user has questions or concerns about the query part of the portal. Academic Partners Research: University of Illinois – Chicago
Jean introduced the investigators from University of Illinois‐Chicago, who received a grant from CDC to conduct a study that would utilize Tracking Network data to link health outcome data in children and agrichemical water contamination in the Midwest. The Tracking program at MDH is collaborating with these investigators for the research project. Leslie Stayner, UIC principal investigator, and his colleagues, Karl Rockne and Judith Graber, reviewed their academic partner research project, entitled, “A Linkage Study of Health Outcome Data in Children and Agrichemical Water Contamination Data in the Midwest.” Leslie introduced their project topic and provided background information, and described three project objectives: 1) explore the potential associations between adverse health outcomes in children and exposure to atrazine and nitrate in drinking water; 2) to further enhance the methodology for linking water contaminant and health data, both for CDC EPHT and state Tracking programs; and 3) to develop a partnership with states in the Midwest region, especially EPHT states, to develop methods and studying health issues related to water contamination. The participating states include 4 EPHT‐funded states and 4 non‐tracking states, including Illinois. Leslie discussed the data source: SDWIS which has data on surface water in communities, and birth data from 2003‐2008. He also discussed the project phases. Phase 1 involves an ecological analysis of county‐
level data that is gender‐ and race‐specific, with a focus on monthly rates to study the seasonal associations with atrazine and nitrates. Phase 2 will also focus on reproductive outcomes that can be found on birth certificate data (e.g. low birth weight, sex ratio). Phase 2 will included an expanded list of health outcomes to include childhood cancers and birth defects. Phase 3 (if funded) would collect and analyze data on the individual level, like risk factor data found on birth certificates, and estimates of household‐level water contaminants. Q&A Geary referred to the National Cancer Institute’s Agricultural Health Study, being conducted in two major cohorts in Iowa and North Carolina. He asked how Leslie and his colleagues would compare the research questions their project will be asking, to the cohort studies of the Agricultural Health Study and the National Children’s Health Study. Leslie responded that their project will focus on children, as opposed to a focus on adult applicators in the Agricultural Health Study. He added that they are trying to meet with local investigators to discuss health outcomes of interest and that this project will focus on water contaminants rather than pesticide use, and that they will have a larger sample size than AHS, using data from eight states. Leslie also responded that this study will be pursuing a Tracking program objective and the goal to a linkage study, using state and county data. He added that they don’t expect 2
an “answer” after Phase I of the project, but perhaps after Phase III and that a theoretical Phase IV would involve a case‐control analysis. Alan added that it is a legitimate goal to determine what factors are and are not associated with some of these adverse health outcomes that are established problems. For example, there are a lot of conditions (e.g. leukemia and lymphoma) that have been elevated for 30‐40 years in dairy states, for which researchers don’t know the risk factors, so it’s worthwhile to study despite the possibility of a lack of conclusions. Michele asked how the researchers plan to manage expectations of the public or stakeholders. Leslie responded that the study’s funding sources are the stakeholders and Judith added that this research is looking across different layers of existing data, in direct response to the original PEW Commission’s vision for Tracking. Alan added that if something doesn’t work, that’s still a useful finding. Karl stated that the project will be taking existing data, so UIC researchers can utilize these data to test hypotheses, and he added that it is a much cheaper endeavor (compared to cohort studies). Pat McGovern asked about other funded projects, and whether UIC researchers plan to coordinate with the National Children’s Study sites because the studies might overlap and provide an opportunity for adjunct studies to look at specific outcomes. Leslie responded that in the project proposal, Phase 3 includes obtaining Biomonitoring data, such as atrazine data from the National Children’s Study. Judith pointed out that there is a research focus to their project, but it also aims to develop methodology and tools for Tracking programs to track outcomes and other data, among other benefits. Biomonitoring Pilots: Lessons Learned from the Lab
Jean introduced the final presentation in a series of three discussions of lessons learned from the Biomonitoring pilot project. This session deals specifically with lessons learned from the laboratory perspective. Carin Huset, research scientist at the MDH Public Health Laboratory (PHL), reviewed lessons learned from the biomonitoring pilot program concerning laboratory analytical procedures and methods, quality assurance, safety and safety equipment, resources and other topics. Previously at the PHL, Biomonitoring was limited – the lab primarily analyzed environmental samples, with some emergency response work. New lab methods had to be developed for all four pilot projects. Published/existing methods were available in some but not all cases. The CDC’s published methods did not include PFBA or speciated arsenic, and a method for analysis of blood spots was not available. New protocols had to be developed as well, including additional safety precautions (such as personal protective equipment), data privacy measures, new sample receiving and storage procedures, and adherence to CLIA standards that regulate clinical results (though samples were not used for diagnostic purposes, the standard still had to be met). Development of these new procedures went well, and no major issues arose. The PHL did encounter some hurdles in developing methods for new analytes. The CDC was a very helpful resource, but there were challenges that PHL staff had to deal with on their own. Proficiency tests were not available for all analytes, matrices, and concentration ranges of interest. This affected the 3
lab’s ability to compare results nation‐wide. Quality assurance and control were also an issue, as the EPA and CDC have different ways to evaluate them (recovery v. statistics and large‐scale validation), and communicating the expectations of analytical performance was difficult. More equipment maintenance was required with biomonitoring analyses than with other methods, and more than anticipated. In some cases, the monopolization of staff and instrument time by certain projects lead to back‐ups in others. Carin stated that overall the projects were successful. Collaboration within MDH worked well. Collaboration with other labs (CDC, IA, WI, CO) was also helpful. The lab successfully developed new methods for PFBA in serum (not done before by CDC), mercury in newborn blood spots, and arsenic speciation. Geary Olsen asked for clarification about whether methods for PFBA had been developed previously. Carin said they had hoped to be able to follow a CDC method so that results would be comparable to national data, but this method was not available. Geary stated that 3M had measured PFBA in serum before that time, reported in Chang et al. 2008. New Protocols for Research Use of Newborn Screening Specimens
Kristin Oehlke, genetic counselor for the Newborn Screening program at the PHL, presented the program’s new protocol developed for responding to requests for use of residual newborn blood spots for research purposes. Newborn Screening hopes to share this new process with others as a model for how these decisions can be made in an ethical, legal, and transparent way. This process was needed because decisions in the past on whether to allow researchers to access RDBS samples were made after an informal vetting process. RDBS are a valuable resource – they are population‐based, and can be linked to identifying information. But, they are also a limited resource, and MDH needs to ensure that only well‐designed studies that further public health knowledge are able to use them. MDH has a responsibility to legislators and the public to use these samples in a responsible way. The RDBS are private medical data, and there are ethical and legal implications for testing for purposes other than those for which they were collected. It is very important that MDH maintains the public trust in this program, as there have been challenges to it. In the first step of the application process, the applicant submits an abstract of their idea, which receives a quick review to determine whether it meets basic requirements. If the abstract is accepted, the applicant is asked to submit a full proposal. The proposal guidelines were developed using different well‐vetted examples (NIH, NSF, MDH). The applicant must explain how the study is consistent with MDH’s mission, its public health significance, the scientific methods used, how issues of confidentiality and data privacy will be addressed, the background and experience of the investigators, and whether there are any conflict of interest concerns. Three reviewers, at least one of whom is from outside of MDH, read each full proposal and submit comments via an on‐line form. The reviewer can recommend, recommend with major or minor revisions, or decline. The comments are summarized and passed up through management, with final determination by the Executive Office to accept or decline. The applicant is provided with reviewer comments once the process is complete. Once the application has been accepted, the study must get MDH IRB approval (even if it has approval from another institution), investigators must provide an abstract in everyday language to post on the MDH web site, investigators must sign an agreement to destroy or return any remaining samples, and the outcomes, once they are available, must be provided in summary form to post on the web site. 4
Four applications have been received since the new process was established. Two have completed review and have started their way up to PHL management. Alan Bender clarified that this is an MDH policy, not a state statute or administrative rule, and that it could be changed with each administration. Kristin agreed, and emphasized that this is currently in draft form. Leslie Stayner asked whether mothers have provided consent. Kristin replied that, if the specimen can be identified, informed consent must be obtained. If the specimen is truly anonymous, informed consent is not needed. Leslie said that the California program has passive consent – the mother has to opt out of research. Kristin replied that MN decided not to go this route; there is an opt out for the Newborn Screening program and they do not want people to choose to opt out based on the research issue. Michigan is developing a biobank of newborn blood spots and people have to opt in to the bank. So far, they have not seen that people are opting out of the screening program, but it will be interesting to watch how this develops over time. Jean asked whether internal MDH projects must go through the review process. Kristin responded that all research projects need to be reviewed. If the project is part of a public health effort, the answer is less clear. John Stine added that the program intends to proceed cautiously with this. Internal or external projects would need the same level of scrutiny. He noted that the distinction between surveillance and research is not meaningful to those outside the circle of public health. Jean pointed out that MDH now has stored specimens from biomonitoring projects that were set aside for possible future use. Due to this, Jean asserted that the biomonitoring program needs a similar review process. Kristin commented that she thinks the Newborn Screening program process could definitely be a starting place and that it could be improved. She would love to hear any thoughts about improvements that people have. Biomonitoring Updates
Jean introduced the new Biomonitoring program coordinator and epidemiologist, Jessica Nelson. There were several Biomonitoring project updates included in the meeting materials: East Metro PFC Follow‐
up Study, Lake Superior Mercury Project, and Riverside Prenatal Project. Geary asked the status of publishing results from the PFC biomonitoring pilot project. Jean replied that two draft manuscripts (one on the 1st PFC project, another on the arsenic pilot project) are undergoing internal review but have not been submitted. Al Williams commented that some journals do not want to publish data that has already been published as a technical report. Lisa added that her group often publishes things that were a report, although the publication would be very different from the report. Adrienne added that the journal would require MDH to remove the technical report from the web site if the article was accepted and replace it with a link to the published article, which is not ideal. Karl Rockne asked for a summary of the Lake Superior Mercury Biomonitoring Project. Pat McCann, research scientist in the Environmental Health Division, responded that the project is measuring total mercury in newborn blood spots from MN, WI, and MI. The project was initiated before the proposal review process just discussed. Informed consent was obtained from mothers in MN. Due to the small amount of blood left after screening, the original number of punches planned was reduced, and the feasibility of speciation of mercury is unclear. MI and WI provided punches to MDH, and the PHL did the analyses. Ken asked what the investigators hypothesized or hoped to find. Pat replied that the purpose 5
was to describe the reference range in the population. The original intent was to compare the results to NHANES, but there is not a very good comparison population. The project will describe mercury levels in the population and put it into a larger context. Administrative Details
Jean Johnson reviewed an outline of the Legislative Report and presented a summary of key successes of the Tracking program for Legislators. Al would like to discuss the topic of data privacy at a future meeting, specifically the consequences of an opt‐out provision for surveillance systems, such as the Minnesota Cancer Surveillance System (MCSS). MCSS does not currently have an opt‐out provision and Al argued that an opt‐out provision would have negatively impacted the collection of data on incidence of mesothelioma and health effects at the time when mesothelioma was an emerging issue. Jean said that this will be put on the March agenda. There was no other new business. Lisa Yost adjourned the meeting. Drafted 2/4/11 Finalized March 5, 2011 6