Minnesota Department of Health Environmental Health Tracking and Biomonitoring Advisory Panel Meeting June 8, 2010 1:00 p.m. – 4:00 p.m. Snelling Office Park Red River Room 1645 Energy Park Drive St. Paul, Minnesota ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING ADVISORY PANEL MEETING AGENDA Time Agenda item Presenter(s) 1:00 Welcome, introduction of new panel members and general introductions Beth Baker, Chair Item type/Anticipated outcome BIOMONITORING 1:05 East Metro PFC biomonitoring study: Evaluation survey results Michonne Bertrand Discussion item Jean Johnson Staff will present data from an evaluation survey mailed to participants in the PFC biomonitoring study. Panel members are invited to provide input on interpretation of the results. In particular, panel members are asked to respond to the following questions: What are the important lessons to be learned from this evaluation? How can biomonitoring projects in similar exposed communities be improved? Based on this survey, can we draw any conclusions regarding necessary changes in state protocols or guidelines for conducting biomonitoring in exposed communities? Are there additional questions that should be asked of participants or communities to learn more about best practices for biomonitoring communications? 1:35 East Metro PFC biomonitoring study: Follow-up study protocol Jean Johnson Discussion item Staff will present a draft study protocol for a PFC follow-up study in the east metro area. Panel members are invited to make recommendations for strengthening the study protocol and for ensuring that the most meaningful results are obtained. In particular, panel members are asked to respond to the following questions: i Time Agenda item Presenter(s) Item type/Anticipated outcome 2:20 Break 2:35 Riverside prenatal biomonitoring study 3:20 Jean Johnson Carin Huset Are there any parts of the protocol that need further clarification? Are eligibility, enrollment and the expectations of participants clearly described? Should past study participants who have moved from the area be included or excluded? If included, what level of effort should be made to locate and obtain a specimen from individuals who have moved out of the area? Are the plans for data collection and analysis appropriate for meeting the study objectives? Are there questions that should be added to or removed from the exposure questionnaire? Discussion item Staff will present preliminary results from the Riverside prenatal biomonitoring study and will describe plans for disseminating the results. Panel members are invited to provide feedback on the analyses; to make recommendations for communicating the findings; and to make recommendations for further action based on pilot study results. In particular, panel members are asked to respond to the following questions: What are the most important findings? Are there methodological limitations that should be emphasized? Are there additional analyses of the data that should be pursued? What specific methods would you recommend for effectively communicating these results to the community and to the general public? Biomonitoring updates Lake Superior mercury biomonitoring study East Metro PFC Biomonitoring Study Information sharing. No formal presentations will be made on these topics. Panel members are invited to ask questions or provide input on any of the biomonitoring updates included in the meeting materials. ii Time Agenda item Presenter(s) Item type/Anticipated outcome Strategic planning for biomonitoring TRACKING 3:25 Tracking updates MN EPHT webbased information system EPHTN collaborations MN EPHT communications and outreach MN EPHT data submission to CDC New tracking indicators Information sharing No formal presentations will be made on these topics. Panel members are invited to ask questions or provide input on any of the tracking updates included in the meeting materials. OTHER 3:30 National Children’s Study Pat McGovern, Principal investigator, National Children’s Study iii Information sharing Pat will provide an overview of the National Children’s Study and a pilot recruitment study for the Ramsey County site. Panel members are invited to ask questions or provide input on this topic. In particular, panel members are asked to respond to the following questions: What aspect of the NCS is likely to be of most interest to Minnesotans—for professionals and the public? What questions might participants have? What questions will public health and health care professionals have? What challenges might we encounter when conducting the study, in particular, in regards to collecting biospecimens? How might we best address these challenges? What opportunities exist for collaborative Time Agenda item Presenter(s) Item type/Anticipated outcome projects between MN EPHT and NCS? 3:55 New business Beth Baker Discussion item The chair will invite panel members to suggest topics for future discussion. 4:00 Adjourn Beth Baker Next meeting: Tuesday, September 14, 2010, 1-4 p.m. Red River Room, Snelling Office Park iv TABLE OF CONTENTS Agenda ................................................................................................................................... i Table of contents ..................................................................................................................v Materials related to specific agenda items East metro PFC biomonitoring study: Evaluation survey results Section overview: East metro PFC biomonitoring study: Evaluation survey results .......1 Preliminary results of the evaluation survey of east metro PFC biomonitoring study participants..................................................................................................................3 East metro PFC biomonitoring study: Follow-up study protocol Section overview: East metro PFC biomonitoring study: Follow-up study protocol.....15 East metro community biomonitoring follow-up for measuring change in exposure to perfluorochemicals: Draft protocol...........................................................................17 Riverside prenatal biomonitoring study Section overview: Riverside prenatal biomonitoring study............................................27 Riverside prenatal biomonitoring study: Results to date ................................................29 Riverside prenatal biomonitoring study: Specimen analysis update ..............................33 Biomonitoring and tracking updates Section overview: Biomonitoring and tracking updates.................................................35 Status update on the Lake Superior mercury biomonitoring study.................................37 Status update on the East Metro PFC biomonitoring study............................................38 Status update on strategic planning for biomonitoring ...................................................39 Status update on the MN EPHT web-based information system....................................40 Status update on EPHTN collaborations.........................................................................41 Status update on MN EPHT communications and outreach...........................................42 Status update on MN EPHT data submission to CDC....................................................44 Status update on new tracking indicators........................................................................45 National Children’s Study Section overview: National Children’s Study.................................................................47 National Children’s Study: Ramsey County Location Frequently Asked Questions .....49 Other information Section overview: Other information....................................................................................51 Minnesota Environmental Public Health Tracking & Biomonitoring presentations, posters and publications............................................................................................53 Local, national and global biomonitoring and tracking news…...........................................55 EHTB advisory panel meeting summary (for March 9, 2010) .............................................57 v This page intentionally left blank. vi SECTION OVERVIEW: EAST METRO PFC BIOMONITORING STUDY: EVALUATION SURVEY RESULTS In late February and early March a survey was mailed to all 196 participants of the East Metro PFC Biomonitoring Study, asking them a series of questions evaluating the project, with emphasis on all MDH written and verbal communications with participants. The purpose of the survey was to provide valuable feedback regarding the materials and communications utilized in the PFC biomonitoring pilot project. Minnesota Statutes 144.997 (Biomonitoring Pilot Program) requires that “participants shall be provided with information and fact sheets about the program’s activities and its findings” and that “individual participants shall, if requested receive their complete results” subject to the Department IRB’s protocols and guidelines. All 196 participants in the project elected to receive their individual results. The law further directs the Minnesota Department of Health to “work with the advisory panel to assess the pilot program, including but not limited to the validity and accuracy of the analytical measurements and the adequacy of the guidelines and protocols.” Numerous communications were developed and implemented with participants in the PFC biomonitoring project that included: Introductory recruitment letters and consent forms Household and individual questionnaires Written and verbal instructions for completing the blood draw Letters with individual results and a booklet interpreting the result Telephone communication with a study coordinator and medical consultant Letters with a summary of the community results and booklet, and invitation to community meetings Three community meetings to present summary results and respond to questions The information gathered in the survey will be used to help in assessing the adequacy of the guidelines and protocols used in this project and in making recommendations for future biomonitoring in the state. At the June advisory panel meeting, MN EPHT staff will provide an overview of the survey and preliminary results. The following item is included in this section of the meeting materials: Preliminary results of the evaluation survey of East Metro PFC Biomonitoring Study 1 ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on this topic during the designated time on the meeting agenda. In particular, panel members are asked to respond to the following questions: What are the important lessons to be learned from this evaluation? How can biomonitoring projects in similar exposed communities be improved? Based on this survey, can we draw any conclusions regarding necessary changes in state protocols or guidelines for conducting biomonitoring in exposed communities? Are there additional questions that should be asked of participants or communities to learn more about best practices for biomonitoring communications? 2 Preliminary results of the evaluation survey of east metro PFC biomonitoring study participants Background In late February to early March a survey was mailed to all 196 participants of the East Metro Perfluorochemical Biomonitoring Study, asking them a series of questions evaluating the project, with emphasis on our communications with participants. The purpose of the survey was to provide valuable feedback regarding the materials and communications utilized in the PFC biomonitoring pilot project. The survey results have been reviewed and summarized below. All recruitment was completed through the mail. If a survey was not returned within three weeks of being mailed out a second survey was mailed to the participant. The first section of the survey addressed issues surrounding the introductory materials, including the consent and consent letter, as to how clear and informative these materials were. The second section asked for feedback on people’s feelings and understanding of the results letter and booklet they received. The following section asked people to provide their interpretation of how their blood PFC levels compared to that of the national average. The next two sections asked participants about their information sources as well as whom they had shared their PFC blood level results with. The final section asked the participants about their feelings about the benefits of the biomonitoring information to themselves as participants and to the community, and solicited open-ended feedback about the project as a whole. Results A total of 119 of the 196 participants responded to the mailed survey (61% of all participants), including 54 responses from the private water group and 65 responses from the municipal water group. A total of 53 males and 66 females responded. The average age of respondents was 55 years, with an average length of residency of 19 years. Those that chose to respond had slightly (though not significantly) higher geometric mean blood levels than the entire study population. 3 Table 1. Questions about the introductory biomonitoring materials Question 4 I understood the purpose of the biomonitoring project The objectives of the biomonitoring project were explained well in the materials I received in the mail The clinic location was convenient The clinic hours were satisfactory The introductory letter and consent form provided clear information on what I was being asked to do as a participant Strongly Agree (%) Agree (%) Neutral (%) 58 (48.7) 49 (41.2) 55 (46.2) No Response/ Multiple Responses (%) Disagree (%) Strongly Disagree (%) Not Sure (%) 7 (6) 1 (.8) 1 (.8) 1 (.8) 2 (1.7) 50 (42) 7 (6) 2 (1.7) 0 (0) 3 (2.5) 2 (1.7) 72 (61) 65 (54.6) 43 (36) 45 (37.8) 2 (1.7) 3 (2.5) 1 (.8) 4 (3.4) 0 (0) 0 (0) 0 (0) 1 (.8) 1 (.8) 1 (.8) 64 (53.8) 51 (42.9) 3 (2.5) 0 (0) 0 (0) 0 (0) 1 (.8) Table 2. Questions about access to staff Question Yes (%) No (%) I knew who to contact if I had questions about the project I contacted someone with questions 93 (78.2) 29 (24.4) 3 (2.5) 41 (34.5) I did not have any questions (%) 18 (15.1) 25 (21) No Response/ Multiple Responses (%) 5 (4.2) 24 (20.2) Table 3. Questions about the results letter and booklet Question 5 My questions were answered in a timely manner The information in the results letter was easy to understand The information in the results letter was accurate The information in the results letter was helpful The information in the results letter was reassuring The information in the results letter was cause for concern about my health The information in the results booklet was easy to understand The information in the results booklet was accurate The information in the results booklet was helpful The information in the results booklet was reassuring The information in the results booklet was a cause for concern about my health The information in the results booklet was a cause for concern about my family’s health Strongly Agree (%) Agree (%) Neutral (%) Disagree (%) Strongly Disagree (%) Not Sure (%) No Response/ Multiple Responses (%) 23 (19.3) 12 (10.1) 2 (1.7) 1 (.8) 0 (0) 0 (0) 81 (68) 24 (20.2) 58 (48.7) 21 (17.6) 9 (7.6) 0 (0) 0 (0) 7 (5.9) 16 (13.4) 37 (31.1) 27 (22.7) 2 (1.7) 0 (0) 23 (19.3) 14 (11.8) 20 (16.8) 55 (46.2) 29 (24.4) 5 (4.2) 0 (0) 3 (2.5) 7 (5.9) 8 (6.7) 25 (21) 41 (34.5) 15 (12.6) 11 (9.2) 9 (7.6) 10 (8.4) 24 (20.2) 25 (21) 31 (26.1) 10 (8.4) 8 (6.7) 10 (8.4) 11 (9.2) 21 (17.6) 51 (42.9) 21 (17.6) 8 (6.7) 0 (0) 4 (3.4) 14 (11.8) 18 (15.1) 35 (29.4) 29 (24.4) 2 (1.7) 1 (.8) 22 (18.5) 12 (10.1) 15 (12.6) 43 (36.1) 34 (28.6) 3 (2.5) 1 (.8) 9 (7.6) 14 (11.8) 11 (9.2) 22 (18.5) 42 (35.3) 13 (10.9) 8 (6.7) 9 (7.6) 14 (11.8) 21 (17.6) 26 (21.9) 32 (26.9) 11 (9.2) 4 (3.4) 11 (9.2) 14 (11.8) 26 (21.9) 20 (16.8) 32 (26.9) 8 (6.7) 4 (3.4) 13 (10.9) 16 (13.4) Table 4. Questions about health concerns based upon information in the results letter and booklet My concerns I was more I was less concerned concerned remained the (%) same (%) Question (%) After reading the results letter and booklet my concerns for/ about my health: After reading the results letter and booklet my concerns for/about my family’s health: Not Sure (%) No Response/ Multiple Responses (%) 38 (31.9) 7 (5.9) 60 (50.4) 9 (7.6) 5 (4.2) 43 (36.1) 7 (5.9) 52 (43.7) 9 (7.6) 8 (6.7) Table 5. Questions about the comprehension of comparing their levels to those in NHANES 6 Question Based on NHANES results, I understand that the levels of PFOA in my body were. Based on NHANES results, I understand that the levels of PFOS in my body were. Greater than most (%) About the same (%) Less than most (%) Not sure (%) No Response/ Multiple Responses (%) 73 (61.3) 16 (13.4) 7 (5.9) 19 (15.9) 4 (3.4) 71 (59.7) 17 (14.3) 5 (4.2) 21 (17.6) 5 (4.2) Yes (%) No (%) Not Sure (%) No Response/ Multiple Responses (%) 20 (16.8) 91 (76.5) 2 (1.7) 6 (5) Table 6. Question about meeting attendance Question In July 2009, I attended one of the PFC results community meetings where the Minnesota Department of Health presented the pilot project results. Table 7. Question about meeting non-attendance Question If you did attend a PFC results community meeting in July 2009. The PFC results community meeting was helpful in answering my questions. Strongly Agree Agree Neutral Disagree Strongly Disagree 0 (0) 10 (8.4) 6 (5) 2 (1.7) 2 (1.7) Table 8. Question about non-attendance reasoning Question 7 If you did not attend a PFC results community meeting in July 2009. Please tell us if any of the following are reasons you did not attend a PFC results community meeting in July 2009 where the Minnesota Department of Health presented the pilot project results. Didn’t Had to be somewhere know about the else (%) meeting (%) Didn’t feel the meeting offered anything new (%) Don’t remember why (%) Multiple Reponses (%) Other (%) 27 (22.7) 30 (25.2) 25 (21) 3 (2.5) 1 (.8) 9 (7.6) Table 9. Questions about PFC information sources Question 8 How helpful have your friends and community members been to you in understanding your exposure to PFCs and what it may mean to your health? How helpful has your doctor(s) or other healthcare providers been to you in understanding your exposure to PFCs and what it may mean to your health? How helpful were alternative medicine specialists to you in understanding your exposure to PFCs and what it may mean to your health? How helpful was the internet to you in understanding your exposure to PFCs and what it may mean to your health? How helpful was the newspaper, radio, or TV coverage to you in understanding your exposure to PFCs and what it may mean to your health? How helpful were other information sources to you in understanding your exposure to PFCs and what it may mean to your health? No Response/ Multiple Responses (%) Very Helpful (%) Somewhat Helpful (%) Not Helpful (%) Not Applicable (%) 5 (4.2) 44 (36.9) 37 (31.1) 22 (18.5) 11 (9.2) 4 (3.4) 29 (24.4) 37 (31.1) 34 (28.6) 15 (12.6) 2 (1.7) 3 (2.5) 27 (22.7) 69 (57.9) 18 (15.1) 5 (4.2) 37 (31.1) 24 (20.2) 41 (34.5) 12 (10.1) 6 (5) 41 (34.5) 40 (33.6) 24 (20.2) 8 (6.7) 4 (3.4) 4 (3.4) 16 (13.5) 39 (32.8) 56 (47.1) Table 10. Questions about behaviors Question I shared my results with my doctor I shared my results with my family I shared my results with others in my community Other members of my family had their PFC levels tested** I changed my drinking water source I stopped using products containing PFCs I made a change to my diet and/or vitamin regimen I had other medical tests done because of my exposure to PFCs I looked for information on alternative treatments to remove PFCs from my body Other actions or changes Yes (%) 28 (23.5) 91 (76.5) 53 (44.5) 19 (15.9) 39 (32.8) 25 (21) 12 (10.1) 2 (1.7) 2 (1.7) 5 (4.2) No Response/ Multiple Responses (%) 6 (5) 3 (2.5) 5 (4.2) 10 (8.4) 16 (13.4) 30 (25.2) 14 (11.8) 12 (10.1) 14 (11.8) 70 (58.8) No (%) 85 (71.4) 25 (21) 61 (51.3) 90 (75.6) 64 (53.7) 64 (53.8) 93 (78.2) 105 (88.2) 103 (86.6) 44 (36.9) 9 Table 11. Questions about feelings towards biomonitoring Question I’m glad that my PFC levels were measured, because a person should have that information. I would rather not have known about my PFC levels. Participating in the PFC biomonitoring project was beneficial to me and my family The PFC biomonitoring project was beneficial to my community Table 12. Question about health Question How would you describe your current health? Strongly Agree (%) Agree (%) Neutral (%) Disagree (%) Strongly Agree (%) No Response/ Multiple Responses (%) 54 (45.4) 46 (38.7) 12 (10.1) 0 (0) 0 (0) 7 (5.9) 2 (1.7) 2 (1.7) 12 (10.1) 48 (40.3) 44 (36.9) 11 (9.2) 32 (26.9) 42 (35.3) 32 (26.9) 3 (2.5) 2 (1.7) 8 (6.7) 41 (34.5) 44 (36.9) 19 (15.9) 2 (1.7) 3 (2.5) 10 (8.4) Very Good(%) Good (%) Bad (%) Very Bad (%) 40 (33.6) 67 (56.3) 3 (2.5) 0 (0) No Response/ Multiple Responses (%) 9 (7.6) Table 13. Comparison of PFC blood levels between the evaluation groups and the total study group. Eval Geometic Lower Upper Total Geometric Lower Analyte N Mean Limit Limit N Mean Limit (CI 95%) (CI 95%) (CI%) PFOA 119 16.2 13.8 19.1 196 15.4 13.6 PFOS 119 37.8 32.9 43.4 196 35.9 32.2 PFHxS 119 8.9 .. 10.4 196 8.4 7.3 Upper Limit (CI%) 17.4 40.1 9.7 10 Comments from open-ended responses “Follow up needs to be done. Additional blood levels for myself and family members” “The children who were born here, their little bodies grew up with this contaminated water. Shouldn’t there be a test group comprised of their age group?” “Follow up to see if higher rates of cancer, etc. due to exposure” “Specific health issues related to chemical exposure levels. Continue follow up” “Everyone in this study should be checked yearly. I also think a yearly letter should be sent to everyone in this study, to let them know if the people in the study are having higher or lower readings of PFCs this could be done on a percentage rating.” “We are worried these chemicals cause immune problems which manifest into cancers, lupus, thyroid problems. There was no test for children who had this water in their bottles as newborns. Very scary how they are to be affected by that.” “Follow up with individuals who were not able to attend the community meetings” “How to get 3M to stop burning garbage and toxins that also cause cancer into the air” “If I have a health issue and I asked whether it was related to PFCs I don’t think anyone could confirm nor deny whether there is a link…” “It is very clear to me that 3M has the data regarding the safety of PFC’s. However they have demonstrated to me that they prefer corporate profits over doing the right thing.” “Kids should be tested” “None, happy to put this behind us, problem has been resolved and my family can now brush teeth out of the sink and make out own frozen ice cubes.” “Stop the charade, make 3M take responsible actions. Enough is enough” “Washington County turned a water-filled gravel pit into a dump. Then they allowed household and 3M industrial trash to be dumped in it. Then (surprise) it leaked! Then the state took over the Lake Jane Landfill in Lake Elmo and further spread the water pollution by pumping and aerating the leachate to remove VOCs….” “What if any property value decrease have I experienced due to PFOA/PFCs in my (our) water?” “I wish more was known that we could get rid of the chemicals in our bodies. 3M supposedly installed a filter to help for the future. I’m all for being tested again in a year or so to see if results are better. I would also like to know what diseases, etc…….I wish more was known on this for long term health effects on us. I do want to thank all of you at MDH for your involvement and help regarding this and the meetings to try to explain this. You were all so professional and polite and tried to do your very best in all aspects of this difficult and scary ‘issue.’” “Each time I see the doctor regarding something I have and they don’t find or don’t know something I always wonder if these chemicals in my blood can be a cause.” “Ways to help remove the PFCs from my body” “My family has been exposed to PFC more than I have and are having more health problems than me.” 11 “I had some high levels but I was not overly concerned.” “The people were very helpful and patient” “Provide specific health issues related to chemical exposure levels” When asked to comment on what would have made the results letter and community meetings more helpful, several commented that opportunity for a more personal communication was needed. Comments included the following: “A one on one talk with one of the biomonitoring staff.” “I would like a letter explaining what the results mean personally to me, and what steps I should take, if any.” Regarding the community meeting, they suggested a “more personal Q & A session.” Results interpretation and discussion Overall, project participants expressed satisfaction with the introductory materials, including introductory letters, consents, factsheets and instructions. Most participants agreed that the information in the project results letters and booklets was easy to understand and helpful. Some were unsure about the whether the information was accurate and a majority of respondents were either neutral or disagreed that the information was reassuring. Most agreed that the information was cause for concern about their health. Most participants (n=91) reported that they did not attend the public community meeting where results were presented. When asked about other sources of information about PFCs, participants were divided on whether friends and family members, the internet, the media and health care providers were helpful or not helpful. Most (n=85) had not shared their results with their doctor but most (n=91) did share their results with family members. When asked about actions taken since receiving their results, 19 reported that other family members had been tested. This number likely includes the 7 families with more than one participant in the study that responded to the survey. Some reported that they changed their drinking water source (n=39), stopped using products containing PFCs (n=25), or changed their diet or vitamin regimen (n=12). Very few reported that they had other medical tests done because of their exposures to PFCs (n=2) and looked for alternative treatments to remove PFCs (n=2). Most participants (n=100) were glad that their PFC levels were measured. Very few (n=4) agreed that they would rather not have known about their PFC levels. (These same 4 people also agreed that they were glad to have their biomonitoring results.) Most agreed that the project was beneficial to them and their family (n=74) and to their community (n=85). An analysis of the PFC levels in the PFC survey respondents was compared to the total PFC biomonitoring population to see whether people with higher concentrations were 12 more likely to respond to the survey. Geometric mean concentrations of PFCs were slightly higher among survey respondents but not significantly different. Although participant responses to survey questions were generally favorable, participant comments did reveal frustration and concern about the lack of information on health effects, and their belief that more follow-up needs to be done to study the problem. Residents continue to express their anger about the contamination as noted in the final comments section. Future biomonitoring results communications should provide more opportunity for individual health education or medical counseling for those who request it. 13 This page intentionally left blank. 14 SECTION OVERVIEW: EAST METRO PFC BIOMONITORING STUDY: FOLLOW-UP STUDY PROTOCOL In response to recommendations from the advisory panel, EHTB program staff have developed a project protocol for a follow-up biomonitoring project in the East Metro community. The project is designed to repeat the same PFC measurements as the prior project which collected blood samples from 196 individuals in the fall of 2008. The purpose will be to estimate the rate of change in blood serum levels in the population over the 2-year time interval for PFOA, PFOS and PFHxS. Blood levels are expected to decline due to the alternative water supplies and filtration systems that currently have removed PFC contamination from household drinking water supplies. Levels of PFCs in the general US population are also declining. There were 186 participants who agreed to be contacted for future studies and will be invited to participate in this follow-up project. An exposure questionnaire is also under development. If the project is further recommended and approved by the EHTB steering committee, all project materials may be submitted with application to the MDH IRB for approval in July or August of 2010. Project staff can then begin contacting participants for specimen collection beginning in September 2010, two years from the first project specimen collection. At the June advisory panel meeting, staff will provide a brief overview of the project protocol. The following item is included in this section of the meeting materials: East metro community biomonitoring follow-up for measuring change in exposure to perfluorochemicals: Draft protocol ACTION NEEDED: At this time, no formal action is needed by the advisory panel. Panel members are invited to make recommendations for strengthening the study protocol and for ensuring that the most meaningful results are obtained. In particular, panel members are asked to respond to the following questions: Are there any parts of the protocol that need further clarification? Are eligibility, enrollment and the expectations of participants clearly described? Should past study participants who have moved from the area be included or excluded? If included, what level of effort should be made to locate and obtain a specimen from individuals who have moved out of the area? Are the plans for data collection and analysis appropriate for meeting the study objectives? Are there questions that should be removed from the exposure questionnaire? 15 This page intentionally left blank. 16 East metro community biomonitoring follow-up for measuring change in exposure to perfluorochemicals: Draft protocol May 2010 Purpose The primary purpose of the follow-up project is to measure the change over a 2-year period in exposure levels to PFCs, including PFOA, PFOS and PFBA measured in blood sera of East Metro PFC Biomonitoring Study participants with past exposure to these chemicals in drinking water, and to compare these results with national survey data and other exposed community studies. A secondary purpose is to identify and qualitatively assess population characteristics and exposure sources (such as occupations and foods) that may help to explain elevated exposures in the community. This project will also serve to provide public health officials with an evaluation of the efficacy of public health actions that have been take to remove drinking water exposure in the study communities and will further demonstrate the value of biomonitoring in public health practice. Background In 2007 the Minnesota Legislature enacted legislation that created the Environmental Public Health Tracking and Biomonitoring (EHTB) program at the Minnesota Department of Health (MDH) and directed MDH to conduct 4 biomonitoring pilot projects. The purpose of these projects was to build state capacity for biomonitoring and to provide a basis for establishing an ongoing biomonitoring program in the state. One of these projects was to investigate the range and distribution of perfluorinated chemicals (PFCs) in each of two communities likely to be exposed, specifically to PFOA, PFOS, and PFBA. MDH selected two Washington County East Metro communities to conduct the East Metro PFC Biomonitoring Pilot Project. MDH defined these communities by drinking water source as follows: 1. People currently living in households in Lake Elmo and Cottage Grove with a private well with PFOA and /or PFOS contamination above trace levels (>0.01 ppb) in at least one well water sample, and 2. People currently living in households served by the Oakdale Municipal Water Supply. Contamination of drinking water supplies with PFCs in the east metro area was first discovered in 2004. Further investigation by the Minnesota Pollution Control Agency (MPCA) and MDH revealed widespread contamination of ground water that supplied drinking water to the City of Oakdale and surrounding communities. In Lake Elmo, maximum levels of PFOA, PFOS and PFBA detected in private wells were 2.4, 3.5 and 12 ppb, respectively. In late 2006 and early 2007 levels above 1 ppb of PFBA were observed in water supply wells in Cottage Grove and St. Paul Park. 17 All households with PFC values above health based values have been provided with safe alternative drinking water sources. The Lake Elmo public water supply was extended to serve some of the residences previously depending upon private wells. Other residences were supplied with whole-house granular activated carbon (GAC) systems. In October 2006 a large granular activated carbon (GAC) system was installed on the two most contaminated wells in the Oakdale Municipal Water System, and these wells were then used preferentially. With these interventions, drinking water exposure in these communities has been reduced to below established health-based values for PFOA, PFOS and PFBA. Current post-treatment levels of PFBA in Oakdale are at about 2 ppb. The East Metro PFC Biomonitoring Project was designed and conducted by the EHTB program at MDH with input from the EHTB Advisory Panel. A total of 98 individuals from each of the two communities gave their informed consent and were enrolled. In order to ensure that persons most likely to be exposed were enrolled, participation was limited to adults 20 years or older who had lived in their current home prior to January 1, 2005. From August through December, 2008, 196 blood serum specimens were collected from participants for analysis by the MDH public health laboratory. Specimens were analyzed for seven PFC compounds including: PFOA, PFOA, PFBA, PFBS, PFPeA, PFHxS and PFHxA. A complete description of methods for sample selection, recruitment, specimen collection, analysis and results can be found at http://www.health.state.mn.us/divs/eh/tracking/ Results of the analysis were presented to the EHTB Advisory Panel in June 2009 and to the community in July 2009. We found measurable levels of PFOA, PFOS, and PFHxS in all 196 participants. PFOA had a geometric mean of 15.4 ng/mL, PFOS had a geometric mean of 35.9 mg/mL, and the geometric mean concentration of PFHxS was 8.4 ng/mL. Levels did not differ significantly between the two communities. Levels were higher in males and increased with age. These values were found to be elevated when compared to the geometric mean concentrations found in samples collected from the general population in 2003-2004 for PFOA, PFOS, and PFHxS which are 3.9 ng/mL, 20.7 ng/mL, 1.9 ng/mL respectively (Calafat, 2007b). Measurable levels of PFBA and PFBS were detected in a proportion of the participants, 28% and 3% respectively, while PFPeA and PFHxA were below the limit of detection (0.1) ng/mL for all 196 specimens. The EHTB Advisory Panel recommended on June 2, 2009, after viewing the project results, follow-up biomonitoring to be conducted at a later date with these same communities to measure change in levels over time. Blood levels of PFCs are expected to decline due to the actions that have been taken to remove PFCs from the drinking water. A subsequent analysis of the variance of the PFC blood levels with data collected on drinking water well levels among study participants in the well water community has demonstrated a strong relationship (partial r2 = .30), further supporting the prediction that blood levels in these communities will decline to approach population background levels over time. 18 It is not known how quickly this decline may occur due to the uncertainties about other sources of exposure or population differences that may still be contributing to elevations in this community. PFOA and PFOS or related chemicals have been used in consumer products and various industrial processes, and are known contaminants in foods, food packaging, outdoor air, indoor air, household dust, surface waters and fish (Fromme et al. 2009). According to recent literature reports (Tittlemeir et al. 2007, Fromme et al. 2009) primary sources in the general population are dietary (from foods or food packaging). However, contaminated local fish and drinking water in populations living near point sources are likely sources for elevated body burdens. PFOA and PFOS have long half-lives (3.8 and 5.4 years, respectively) (Olsen et al., 2007). However, a recent study completed by a research group in West Virginia found a shorter half life for PFOA (2.3 years) (Bartell, 2010). Rate of decline has been measured in Arnsberg, Germany where 40,000 residents were exposed to PFOA contaminated water. Biomonitoring with 355 residents in 2006 found elevated PFOA levels. Repeat testing conducted a year later after installation of water filtration found a 10% decline in men and a 17% decline in women (Holzer et al., 2009). PFC levels are also declining in the US general population (Calafat et al., 2007b), since the cessation of PFC (C8 compounds) use in products by 3M in 2002. Hypothesis This study will test the hypothesis that geometric mean blood levels for PFOS, PFOA, and PFHxS have declined among the East Metro Biomonitoring project participants in the two years between initial specimen collection in 2008 and the follow-up specimen collection in 2010. Based on current literature, we would expect to see a decline in the blood levels of at least 10%. The percent detection of PFBA and PFBS in blood is not expected to decline from levels measured in 2008. Change is far less predictable due to the short half life of these compounds and may vary with fluctuations in concentrations of PFBA that have been observed in the Oakdale drinking water supply with changes in the filtration. Study design and methods Study population: The study population is defined as all project participants from the two communities in Washington County identified in the East Metro Biomonitoring Project with exposure to PFCs in drinking water. The two communities were defined by their drinking water source. Participants in Oakdale were selected through a randomized sampling strategy to represent the population of adults living in homes served by the Oakdale Municipal Water Supply prior to Jan. 1, 2005. Participants from Lake Elmo and Cottage Grove were selected to represent the population of adults living in 169 homes served by contaminated private drinking water wells prior to Jan. 1, 2005, with PFOA and/or PFOS detected above trace levels (>0.1 ppb) in at least one sample of their well water prior to January 1, 2008. 19 Eligibility All individuals who were full participants in the original East Metro Perfluorochemical Biomonitoring Study and consented to contact for future research studies are eligible. A total of 186 individuals are eligible. Participant recruitment and informed consent Each eligible participant will be mailed a letter explaining the purpose of the follow-up study and inviting them to participate. The letter will also include the study consent forms. The consent will detail what will be expected of the individual if they choose to participate as well as the risks and benefits associated with the study. Included in the study consent form will also be a section detailing the storage of the participant’s biological specimen for future non-genetic research. The storage of samples for future research will be optional. Those that do not return the consent materials will receive a follow-up phone call by a trained interviewer to again invite their participation. If they refuse to participate in the specimen collection, the interviewer will invite them to complete a short interview using a subset of questions from the questionnaire to measure differences among nonparticipants that might impact the outcome (change in PFC exposure). Participants who refuse the questionnaire and specimen collection will be asked to describe the reason(s) for their refusal. Participants who agree to participate and return the signed consent form to MDH will be provided with the study questionnaire to complete on their own. Once the questionnaire has been returned it will be checked for completeness and if necessary a follow up phone call may be made to address any concerns, or collect missing information on the questionnaire. A phone call will be made to each enrolled participant detailing how and where to make their blood draw appointment. Study participants will be asked to contact the clinic for appointment times. The study participants will also be provided with written instructions on how to make the blood draw appointment as well as the labels to be applied to their sample, they will be asked to bring these with them to their blood draw appointment. A reminder postcard will be included with the letter so that the participant can note the date and time of their clinic appointment. Population characteristics and exposure questionnaire A self-administered questionnaire will be mailed to the home and participants will be asked to complete it and return it using a postage paid envelope provided. The questionnaire was developed using questions from the US Census (demographic factors) and the National Health Interview Survey (dietary factors) to measure and compare study population characteristics with the state and US population. Table 1 describes the factors to be measured in the questionnaire. 20 Table 1. PFC Biomonitoring Follow-up Questionnaire Demographic factors age gender education body mass index (height and weight) Residential Water Consumption History Current residence and years lived at current address Years lived at any address in the city of Oakdale Years lived at any address in the East metro study communities* and dates of water treatment or bottled water use in the home Time since cessation of drinking contaminated water Consumer Product Exposure Dietary History (in the past 2 years) Frequency of consumption: home grown fruits and vegetables fast food microwave popcorn pre-packaged snacks milk eggs potatoes red meat soft drinks coffee, including take-out local fish and game non-local fish, seafood Occupational and Military Health History History (in the past 2 years) Current employer and years general health status Use of stain-resistant carpet employed blood donations or fabric treatments in the Current work activities and surgeries home or car exposure to chemicals at blood transfusions work elevated total cholesterol Dates of current or past use of medications to control employment in specific elevated cholesterol occupations with potential elevated blood pressure PFC exposure use of medications to control Current or past employment elevated blood pressure with 3M Dates of service in the armed forces *East Metro study area is defined as the communities of Oakdale, Landfall , Lake Elmo, Cottage Grove, and St. Paul Park. 21 Blood sample collection, storage and transport A health clinic under contract with MDH and located in close proximity to the study communities will collect blood samples by venipuncture from study participants. The study participants will be provided with the labels to be applied to their blood sample. This lab will have only a study identification number applied thereby limiting any health information that would be available to the clinic and MDH lab. Only the study coordinator will have the key for identification of an individual from a study id number. Blood samples will be stored at the clinic, and then transported by MDH staff to the MDH Public Health Laboratory, where they will be stored at -70°C until analysis. Samples that have been designated for storage for future research will be kept at the MDH Public Health Laboratory; all samples where the participant did not give their permission for storage will be destroyed. Laboratory analysis methods Samples will be analyzed using the method developed by MDH PHL in 2008. This method was adapted from the CDC reference method for the determination of PFCs in serum and includes the analytes PFBA, PFPeA, PFHxA, PFOA, PFBS, PFHxS and PFOS. The sample preparation utilizes solid-phase extraction and analysis is performed on a high performance liquid chromatography –tandem mass spectrometry (LC-MS/MS) system. The report level for this method is 0.1 ng/mL. Data management and analysis Individual analytical results identified only by the unique study ID will be sent by the MDH laboratory to the MDH Biomonitoring Study Coordinator for entry into a secure database. The database will be housed on a secure server and on a secure floor of the MDH building. All physical copies of study data will be filed and kept by the study coordinator in a locked file cabinet on a secure floor. A descriptive analysis of the aggregated sample results will be conducted to include the percent detection, mean, median, and distribution of all seven PFCs. These findings will be compared to the most recent published serum sample results from NHANES for the US population. Data analysis will also compare the distribution of 2010 blood levels for PFOA, PFOS, and PFHxS with levels found in 2008 specimens and calculate the overall percent decline in the PFC blood levels of this population. For PFBA and PFBS, the percent of detection in the population will be determined and compared to previous detection percentage. A paired t-test will be utilized initially to determine whether a statistically significant change in exposure has occurred. A regression analysis will also be completed to include significant predictors of PFC blood levels, age and gender. The regression analysis will also test the associations with drinking water consumption habits and the time since PFC water exposure ceased. These analyses will be incorporated to control for possible confounding or modifying factors. 22 The data provided by the questionnaire will be used to identify differences in exposure sources and characteristics for individuals with elevated PFC blood levels when compared to the rest of the study group, defined as equal to or above the 90th percentile of exposure for PFOA, PFOS, or PFHxS log transformed variables. We will also compare study population demographic and exposure characteristics with general population characteristics available through the census and the National Health Interview Survey (NHIS). Due to the limited study sample size, the analysis will most likely be unable to provide a quantitative analysis of exposure pathways. Communication of biomonitoring results to participants Biomonitoring results for each individual participant will be provided to all participants who elect to receive them along with a letter explaining the comparison of their results to national studies as well as to their initial PFC blood levels. General information about drinking water quality, health risks, actions to prevent exposure to PFCs, and additional resources will also be provided. Participants will also be offered the opportunity to receive private individual counseling regarding their results by telephone with an MDH medical consultant. For the Oakdale, Lake Elmo and Cottage Grove communities, communication of the summarized (aggregated) study results, the community’s PFC level distribution, will be provided to the study participants in a written report and will also be presented at a community meeting. The meeting will be utilized not only to inform the community about the results of the project but also to respond to questions and seek input regarding the need for additional public health information or action. Data privacy All information about individual participants collected by MDH in this study will be private and will be protected in accordance with the Minnesota Government Data Practices Act and federal laws. No individuals will be identified in any reports or publications. Only summary information which does not identify individuals will be public. Limitations This study will not measure health outcomes related to the exposure, nor will it identify or measure all the possible PFC exposure pathways in the population. The questionnaire will be limited in length and content. Small study population size will limit the statistical power and precision of the analytical outcomes for assessing significant differences in exposure sources measured in the questionnaire that may potentially be related to blood levels. Comparisons of study population results to the general population are limited by differing population characteristics that are not well quantified and differences in the time periods for specimen collection which are known to affect population levels of exposure measured through biomonitoring. 23 Risks and benefits The risks to the participant include the possibility of bruising, bleeding, discomfort, and pain from the blood draw. Risk is greater for individuals with bleeding disorders, such as aplastic anemia, and for persons on blood thinning medications (e.g., Coumadin), and other therapies. It will be recommended to all participants that they consult with their health care provider if they have any of these conditions prior to visiting the clinic. Participants who elect to receive their individual biomonitoring results will receive analytical results of the measured concentrations of PFCs in their blood and a comparison to national reference values. The tests will be done at no expense to the participant. Some participants may have increased anxiety about chemicals detected in the body for which only very limited information is known about health effects, particularly for those whose results may exceed the national reference range values. Participants will have the opportunity to speak with an MDH medical consultant on the project (physician) about their results. References 3M 2007b. Estimation of the Half-life of Serum Elimination of Perfluorobutyrate (PFBA) in Four 3M Male Employees. Medical Department, 3M Company, St. Paul, MN 55144. July 18, 2007. Bartell, S., Calafat, A., Lyu, C., Kato, K., Ryan, P., and Steenland, K. Rate of Decline in Serum PFOA Concentrations after Granular Activated Carbon Filtration at Two Public Water Systems in Ohio and West Virginia. Environmental Health Perspectives 118:222228, Feb 2010. Bilott, R. 2007. Perfluorochemical exposure data for Washington County, Minnesota. Correspondence from Robert A. Bilott, Taft, Stettinius & Hollister LLP to EPA, MDH, and MPCA staff. February 2, 2007. Calafat, A.M., Kuklenyik, Z., Reidy, J.A., Caudill, S., Tully, J.S., and Needham, L.L. 2007a. Serum concentrations of 11 polyfluoroalkyl compounds in the U.S. population: data from the National Health and Nutrition Examination Survey (NHANES) 1999-2000. Environmental Science and Technology 41: 2237-2242. Calafat, A.M., Wong, L-Y., Kuklenyik, Z., Reidy, J.A., and Needham, L.L. 2007b. Polyfluoroalkyl chemicals in the U.S. population: data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004 and comparisons to NHANES 1999-2000. Environmental Health Perspectives, published online on August 29, 2007. doi:10.1289/ehp.10598. Fromme, H, Tittlemier, SA, Volkel, W, Wilhelm, M, Twardella, D. 2009. Perfluoronated compounds- exposure assessment for the general population in western countries. Int. J. Hygiene Environmental Health 212: 239-270. 24 Halldorsson, TI, Fei, C, Olsen, J, Lipworth, L, McLaughlin, JK, Olsen, S. 2008. Dietary Predictors of Perfluorinated Chemicals: A study from the Danish National Birth Cohort. Environ. Sci. Technol. 42 (23): 8971-7,. Holzer J, Goen T, Rauchfuss, K, Kraft M, Angerer J, Kleeschulte, P, Wilhelm M (2009) One year follow-up of perfluorinated compounds in plasma of German residents from Arnsberg formerly exposed to PFOA-conatminated drinking water. Int. J. Hyg. Environ Health 212: 499-504. Olsen, G.W., Burris, J.M., Ehresman, D.J., Froehlich, J.W., Seacat, A.M., Butenhoff, J.L., and Zobel, L.R. 2007a. Half-life of serum elimination of perfluorooctanesulfonate, perfluorohexanesulfonate, and perfluorooctanoate in retired fluorochemical production workers. Environmental Health Perspectives online, published June 12, 2007. Tittlemier, SA, Pepper, K et al., 2007. Dietary exposure of Canadians to perfluorinated carboxylates and perfluorooctane sulfonate via consumption of meat, fish, fast foods, and food items prepared in their packaging. J Agric Food Chem 55: 3203-3210. 25 This page intentionally left blank. 26 SECTION OVERVIEW: RIVERSIDE PRENATAL BIOMONITORING STUDY The Riverside Prenatal Biomonitoring Study has finished recruitment and sample collection. Specimen analysis for cotinine has been completed; analysis for environmental phenols is underway. At the June advisory panel meeting, staff will provide an update on specimen analysis for environmental phenols. Staff will also present preliminary results related to cotinine and for environmental phenols, if available by the time of the meeting. In accordance with Minnesota Statutes144.996, the advisory panel is asked to make recommendations related to interpreting the results, communicating findings to the public and planning ensuring stages of biomonitoring work (if any). The following item is included in this section of the meeting materials: Riverside prenatal biomonitoring study: Results to date Riverside prenatal biomonitoring study: Specimen analysis update ACTION NEEDED: At this time, no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on this topic during the designated time on the meeting agenda. In particular, panel members are asked to respond to the following questions: Considering the limitations in study size and the available data presented, what conclusions can be drawn and what, if any, additional analyses are recommended? Given the limited information presented in Table 1 (attached), MDH staff recommend that data not be analyzed by race/ethnicity. However, analysis by income category may be of interest. Would analysis by income be recommended, given the range of incomes shown in the table? MDH is planning for future communication of project results with community groups that may be interested in this project. What community groups or organizations should be approached or contacted about the findings of this project? 27 This page intentionally left blank. 28 RIVERSIDE PRENATAL BIOMONITORING STUDY: RESULTS TO DATE May 15, 2010 Recruitment and sample collection Recruitment and sample collection for the Riverside Prenatal Biomonitoring Pilot Project was completed on April 1, 2010. A total of 66 pregnant women agreed to participate and completed the study requirements which included a study questionnaire (part of the UM Riverside Birth Study) and urine specimen. Table 1 presents the study group characteristics for the 66 women who chose to participate. Table 1. Study Group Characteristics Total participants 66 Age 18-25 26-35 36-45 Race/Ethnicity Asian Black/African American East Indian Hispanic/Latino Other (Eastern European, South African, Russian Jewish) White Count (%) 12 (18.2) 44 (66.67) 10 (15.2) 4 (6.1) 8 (12.1) 1 (1.5) 4 (6.1) 3 (4.6) 46 (69.7) Birthplace US Born Born outside the US 56 (84.8) 10 (15.2) Years in Minnesota 1-5 6-10 11-20 >20 13 (19.7) 10 (15.2) 16 (24.2) 27 (40.9) 62 inches (1.5748 meters) 151.5 pounds (68.7204 kilos) 27.54 Height (mean) Weight *(mean) BMI (mean) 29 Annual Household Income Up to $10,000 10 (15.2) More than $10,000 up to $20,000 6 (9.09) More than $20,000 up to $40,000 9 (13.6) More than $40,000 up to $60,000 8 (13.6) More than $60,000 up to $80,000 6 (9.1) More than $80,000 up to $100,000 11 (16.7) More than $100,000 16 (24.2) *Weight is based on self-report of participant’s weight at the time she became pregnant. The recruitment goal for this project had been to enroll an ethnically diverse population of 90 pregnant women (30 white non-Hispanic, 30 black non-Hispanic, and 30 Hispanic) and to examine exposure differences by race/ethnicity. However, recruitment for this project was dependent on enrollment and recruitment in the larger Riverside Birth Study at the University of Minnesota. Although a special effort was made to enroll Somali women during part of the recruitment period, the study did not recruit a large enough group of Hispanic or Black non-Hispanic women to meet the intended goal. Results Analytical results for cotinine and questionnaire data on smoking are presented below in Table 2 for review and discussion by the advisory panel. Urine specimens were received by the MDH Laboratory and an aliquot of the sample was analyzed for cotinine by a contract laboratory, MedTox. The analysis is performed with an immunoassay screen followed by extraction and gas chromatography with nitrogen phosphorus detection (GCNPD). Ten of the 66 women had detectable levels of cotinine in their urine. Among 10 participants with detectable levels of cotinine in their urine, the presence of nicotine or cotinine, 9 reported on the questionnaire that they were smokers early in their pregnancy (before they knew they were pregnant), 5 continued to smoke during pregnancy (current at the time of questionnaire completion), and 3 stated that they currently were exposed to smoke from someone in their home. It is important to note that the date of urine collection generally followed the date of questionnaire completion so it is not known if women were currently smoking at the time that they provided the urine specimen. MedTox laboratory classifies people as “positive” for active use of a nicotine containing product (tobacco or smoking cessation product) if the combined total of urine nicotine and cotinine concentrations are greater than 200 ng/mL. Urine concentrations less than 200 ng/mL (total for nicotine and cotinine) could be considered consistent with passive exposure to tobacco smoke. By this definition, 9 of the 10 who tested positive for cotinine would be classified as actively using a nicotine product, and one would be classified as passively exposed to tobacco. Among the 56 participants with no detectable level of cotinine in their urine, 6 reported smoking early in their pregnancy but none reported current smoking (at the time of the questionnaire completion), 9 reported being exposed at home and 2 were exposed at work. All would be classified by MedTox as not exposed to tobacco smoke. 30 Table 2. Riverside Prenatal Biomonitoring Project: Cotinine Detections and Smoking Status (N=66 participants) Participants with Cotinine Detections 31 1* 2 3 4 5 6 7 8 9 10 “Non‐ Detects” 56 Participants Cotinine Conc. ng/mL Nicotine Conc. ng/mL Have you ever smoked cigarettes on a regular basis, that is, more than 20 cigarettes in your lifetime? In the 3 months before you became pregnant, did you smoke any cigarettes? Did you smoke in early pregnancy, before you knew you were pregnant? Did you smoke from the time you found out you were pregnant until now? During the time you were pregnant, were you exposed to cigarette smoke from anyone at home? During the time you were pregnant, were you exposed to cigarette smoke from anyone at work? 129 204 259 412 455 470 562 1217 1288 1405.3 <50 139 <50 129 82 155 <50 753 >1250 506.5 Yes Yes Yes Yes Yes No Yes Yes Yes Yes Counts Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes No No No No No Yes Yes No No Yes Yes Yes No No No No No No No No No No No No No No No 19 (Yes) 37 (No) 7 (Yes) 15 (No) 34 (No response) 6 (Yes) 0 (Yes) 9 (Yes) 18 (No) 24 (No) 47 (No) 32 (No response) 32 (No response) <10 <50 2 (Yes) 54 (No) *MedTox classifies people as “positive” for active use of a nicotine containing product (Tobacco or smoking cessation product) if the combined total of urine nicotine and cotinine concentrations are greater than 200 ng/mL. Urine concentrations less than 200 ng/mL (total for nicotine and cotinine) could be considered consistent with passive exposure to tobacco smoke. This page intentionally left blank. 32 Riverside prenatal biomonitoring study: Specimen analysis update Analysis for environmental phenols by the MDH public health laboratory is ongoing. The lab has done an initial analysis on all 66 urine samples received for the seven environmental phenols: methyl paraben, ethyl paraben, propyl paraben, butyl paraben, bisphenol A, benzophenone-3, and triclosan. In order to evaluate both the free and conjugated species present in the samples, two aliquots of urine are analyzed. The first aliquot is analyzed after the addition of stable isotope labeled internal standards to yield the levels of “free” environmental phenols present. The second aliquot is analyzed after an incubation period with glucuronidase and sulfatase enzymes as well as stable isotope labeled internal standards and a compound to track the extent of the enzymatic cleavage. The analysis of these deconjugated samples gives the total environmental phenols (free species + conjugated species). After analyzing these 66 samples for both free and conjugated species, the lab has encountered some problems with the matrix that are worse than any problems observed during method development. There are interferences present in some samples that result in very low internal standard recoveries. With low internal standard recoveries, the quantitative accuracy of the method is reduced, so right now the lab cannot report these values. The lab has begun testing alternative sample preparation methods to reduce the interferences, but does not have the results available at press time. If available, results will be presented at the June panel meeting. 33 This page intentionally left blank. 34 SECTION OVERVIEW: BIOMONITORING AND TRACKING UPDATES Given the limited time available for advisory panel meetings, updates on some items will be provided to the panel as information items only. This information is intended to keep panel members apprised of progress being made in program areas that are not a featured part of the current meeting’s agenda and/or to alert panel members to items that will need to be discussed in greater depth at a future meeting. Included in this section of the meeting packet are status updates on the following: Lake Superior mercury biomonitoring study East Metro PFC biomonitoring study Strategic planning for biomonitoring MN EPHT web-based information system EPHTN collaborations MN EPHT communications and outreach MN EPHT data submission to CDC Minnesota-specific tracking indicators Developmental tracking indicators: Pesticides ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on any of these topics during the designated time on the meeting agenda. 35 This page intentionally left blank. 36 Status update on the Lake Superior Mercury Biomonitoring Study Participant recruitment MDH will collect names for recruiting participants through May 14. We anticipate this will provide us the number of participants needed for Minnesota enrollment. Michigan may be able to participate in the study but will not know until after their IRM meets in July. EPA is considering a project extension in order to include Michigan results. Specimen analysis To date, 347 bloodspot samples have been analyzed: 147 from Wisconsin and 200 from Minnesota. However, due to a loss of instrument sensitivity, further sample analyses have been suspended. A plan for continued analysis is being developed. 37 Status update on the east metro PFC biomonitoring study Water-blood analysis A fact sheet (in the form of a community brief) describing the results of the analysis conducted to examine the relationship between levels of PFCs in the drinking water and blood was released at the end of April. Program staff responded to one media inquiry about the report. Given the amount of contact the program has already had with participants (e.g., the evaluation survey) and the likelihood of needing to contact participants in the near future regarding the follow-up study, the decision was made not to mail the fact sheet to participants at this time. The fact sheet may be included in a future mailing to participants. PFC oversight committee Jean Johnson, EHTB program director, testified before the Minnesota State Legislature PFC oversight committee on May 3. In particular she described the analysis measuring the correlation between past levels of PFCs in the drinking water and PFC levels in the blood as well as the planning that is underway to conduct a follow-up study to measure the change in PFC blood levels in the east metro area. Members of the committee continue to be interested in conducting a study of the health effects of PFCs in east metro residents and inquired whether MDH had spoken with researchers at the University of Minnesota or elsewhere (e.g., Mayo Clinic) about pursuing this possibility. CDC evaluation project The Environmental Health Laboratory at the CDC is planning to conduct a formative evaluation study to learn more about communicating biomonitoring information to target audiences that use, interpret, or communicate about biomonitoring data. One audience that they are particularly interested in learning from is members of “affected communities” and they have expressed an interest in conducting a study in the east metro biomonitoring study community. MDH staff in the EHTB program and the Site Assessment and Consultation unit (in the Environmental Health Division) are collaborating with CDC in designing the study, which is intended to gather information that will benefit MDH/Minnesota as well as CDC. We will continue to keep the advisory panel apprised as the project moves forward. 38 Status update on strategic planning for biomonitoring Based on guidance received from the EHTB steering committee, program staff are proceeding with developing several products related to strategic planning for biomonitoring. 1. A summary of lessons learned specific to each of the four biomonitoring pilot studies. 2. A biomonitoring framework, which will describe the benefits and limitations of several biomonitoring approaches (e.g., special investigations in exposed communities, targeted population exposure tracking, and statewide population exposure tracking) and will make recommendations about “critical to quality” issues for each approach. 3. A longer-term strategic plan for incorporating targeted community exposure tracking (biomonitoring) into the tracking program. The first two items will be incorporated into the program’s legislative report, which is due on January 15, 2011. The third item will likely be developed over a longer time period. The advisory panel will be asked to provide further input on these documents at future meetings. 39 Status update on MN EPHT web-based information system MDH is actively working to develop and implement the State Tracking Network (aka IBIS, public portal) by September 2010. This portal is being designed to allow web users to view static data graphs and charts, as well as conduct customized queries on the MDH web site. MN EPHT and IT staff are currently working to: Develop recommendations for the information architecture (page design, layout, navigation) Prepare best practices for securely handling data files (with input from MDH information security staff) Evaluate state/MDH web and accessibility standards Prepare to conduct usability testing with external stakeholders, including local public health professionals Develop a work plan for a new position (query technician) who will focus on customization and integration of the query module into the Liferay content management system (new hire will start June 1). Continue to actively participate in collaborative work groups with other states and the CDC. MDH is designing the public portal so that it will allow for future integration of a broad set of public health data sets – beyond MN EPHT. This plan is similar to the approach being taken by several other grantees in the National Tracking Network (including states using IBIS). Integration of data sets into the public portal will depend on several factors, including cost, available resources, time, and evaluation criteria developed by the technical team and EHTB advisory panel. The overall development and implementation of the IBIS public portal is guided by the IBIS steering committee, which meets monthly. For questions or more information about this project or the steering committee, please contact Michelle Demist (IBIS Project Manager) or Chuck Stroebel (MN EPHT Program Manager). 40 Status update on EPHTN collaborations MN EPHT continues to work with five other states (CT, ME, WI, NY, UT) and the University of Medicine and Dentistry of New Jersey (UMDNJ; Dr. Dan Wartenburg, PI) on a collaborative project to develop methods for measuring associations between air quality and birth outcomes using data available through the EPHT network. The exposures that are being studied are PM2.5 and ozone. Air quality data – hierarchical bayesian (HB) modeled data to cover the entire state – have been provided by the CDC EPHT and the EPA to all states in the EPHT network for this and other projects. The two birth outcomes of interest are pre-term birth and low birth weight. Data have been obtained from the National Center for Health Statistics and state birth registries. Preliminary analyses for this project were presented at a CDC EPHT workshop in April, 2010 by the investigators. To date, EPHT staff have conducted preliminary county level analyses using statistical procedures developed by UMDNJ investigators. Birth outcomes from Minnesota birth registry data have been linked to the HB county level air PM2.5 and ozone for one year of data in Minnesota. MN EPHT staff will present a summary of this work at a future advisory panel meeting. Results from other data linkage projects were reported at the CDC EPHT workshop by each of the academic centers funded by the CDC as Academic Partners of Excellence for the national EPHT network. The projects include the following: University of California, Berkeley has developed a Heat Vulnerability Index (HVI) and is linking daily heat-related hospitalizations and mortality (at the ZIP code level) with several parameters of maximum temperature. University of Pittsburgh, with EPHT states Kansas, Missouri and Florida, is measuring the impact of environmental lead exposure (non-residential, using National Air Toxics Data and Toxic Release Inventory Data) with childhood blood lead levels Tulane University is working with several states to conduct linkages of ambient PM and Ozone monitoring data with daily hospitalizations for asthma. 41 Status update on MN EPHT communications and outreach Brown bag seminars On April 12, the EHTB program launched a quarterly brown bag seminar series with a presentation on the development of environmental health outcome indicators for climate change. Sixty people attended the presentation. The audience included staff from MDH as well as other Minnesota state agencies, including the Department of Agriculture and the Pollution Control Agency. The next brown bag seminar, scheduled for July 8, will address biomonitoring in a public health context. MN EPHT data reports Four tracking reports are now available on the MN EPHT website at www.health.state.mn.us/tracking: The most recent report, released in April 2010, is Lead Poisoning – Childhood Blood Data and Measures Birth Years 2000 – 2004. This data report joins the following data reports released earlier: Carbon Monoxide Data and Measures (2000-2007) Drinking Water Quality – Community Water Data and Measures (1999-2007): Hospitalizations: Asthma, Heart Attack and COPD Data and Measures (1999-2007): Additional reports in the series that will be released include data and measures for air quality, birth defects, reproductive outcomes and cancer. Hard copies of the four reports are available upon request. Advisory panel members who would like copies of the reports may request individual copies or a binder containing the full set of reports (beginning with the four currently available reports). To place a request, please email Mary Jeanne Levitt at [email protected]. Other MN EPHT outreach efforts Several marketing and outreach items are under development: a revision of the MN EPHT website; a program brochure; a notepad to accompany the MN EPHT pens; and a fact sheet required by the national tracking program. We have applied to present a session on the MN EPHT system at the Community Health Conference to be held in late September 2010. The conference is sponsored by the State Community Health Services Advisory Committee and the Minnesota Department of Health’s Office of Public Health Practice. 42 As we did last year, MN EPHT will staff the MDH booth at the Minnesota State Fair and provide information about the program. CDC email list The National Environmental Public Health Tracking Network sends out program announcements to an email list service. If you are interested in keeping abreast of major developments at the national level (e.g., new data sets added to the national network) and would like to be added to the CDC’s email list, please email Mary Jeanne Levitt at [email protected]. 43 Status update on MN EPHT data submission to CDC In May the MN EPHT Program successfully completed its first data submission to CDC for the National Tracking Network. In this submission CDC requested data for two core content areas: drinking water quality (1999-2009) and birth defects (2006-2007). CDC currently is preparing these data for display on the National Network (estimated by the fall 2010). Several steps were necessary for MN EPHT to submit these data sets to CDC, including: (1) preparation of data use agreements with data stewards, (2) development of SAS code and XML data sets, (3) validation of XML data sets, and (4) secure transfer of the data sets to CDC. Successful implementation of these steps was made possible with the support of several staff in the MDH Environmental Health Division, Information Systems and Technology Management Division, and Health Promotion and Chronic Disease Division (MN EPHT Program). MDH, along with other grantees in the National Network, are expected to submit data to CDC in the spring and fall of each year. Content areas and the dates for each submission window are determined by CDC. The next data submission window will occur in October 2010. MN EPHT already is preparing the data sets for the next anticipated window in October 2010. For more information or questions about the data submissions to CDC, please contact Chuck Stroebel, MN EPHT Program Manager, (651) 201-5662 or [email protected]. 44 Status update on new tracking indicators Selection criteria and selection process Staff continue to refine the process and criteria for selecting new content areas to be incorporated into MN EPHT. The current thinking is that the selection process will occur throughout the year and for individual content areas to be considered qualitatively on their own merits rather than rated quantitatively against each other, as long as staffing resources do not limit the number of options that can feasibly be pursued. The EPHT technical team will play a vital role in moving this process forward. A revised set of criteria has been developed, which splits up the criteria to be applied at several different phases of indicator development: Pre-initiation (at which point an initial feasibility check is done), initiation (at which point a rationale that addresses the public health importance of the issue is developed and potential data sources are identified), exploration (when indicators are piloted in order to fully assess feasibility and usefulness) and recommendation (when a final decision is made to adopt or not adopt a new content area). At any of these stages a decision may be made to continue or discontinue developing a potential new content area. The EHTB advisory panel may be asked for input at various points, including considering staff recommendations not to proceed with further development of a new content area; making recommendations for adoption of a new content area; making recommendations for strengthening data sources that are not currently adequate for tracking a high priority content area; and making recommendations for gathering new data in high priority areas where no current data exist. Technical team members are currently in the early stages of exploring the following potential new MN EPHT content areas: Residential radon (described below) Pesticides (described below; also a national EPHT content area) Secondhand smoke As the selection process and criteria are piloted with this initial set of potential new content areas, we will continue to make changes based on what is working well and what is not. Residential radon Staff are continuing to explore the potential for adding residential radon as a new, Minnesota-specific tracking content area. Based on a preliminary assessment of available data sources and a consideration of the public health importance of the issue, the technical team recommended further exploring this potential new content area. A next step is to evaluate data quality issues. For example, in the available radon data set 45 (managed by the MDH Indoor Air Unit), the lowest level of geographic specificity is ZIP code. Although “side-by-side” results are often averaged together by labs prior to reporting results to MDH, within-home results from multiple tests (e.g., tests on different floors or within and across years) cannot be identified. To determine if multiple/repeat tests introduce bias when reporting aggregated results by sampling area, a sensitivity analysis will be conducted using Minnesota data from one major lab which was able to provide MDH with the physical address for each test result (~100,000 results over 10 years). Pesticides During the past year, the CDC’s national pesticide content workgroup has focused on identifying potential hazard, exposure and health outcome data sources that could be used to create national pesticide indicators. At the last national EPHT content workgroup meeting, a suggestion was made to try to narrow the scope of the universe in order to focus on a few pesticides or pesticide classes. The team identified triazines and pyrethroids as two classes of interest. The team co-leads will examine these chemicals further and report back to the group during the next conference call, scheduled for June. In Minnesota, staff continue to explore potential Minnesota-specific data sets for possible incorporation into MN EPHT. Out of several Minnesota-specific data sources on pesticides, three data sources were selected for further investigation. Ambient groundwater data (Indicator of potential drinking water exposure from private wells). Household pesticide collection and disposal data (Indicator of pesticide use in the residential environment). Applicator licensure data (Indicator of potential occupational exposure and the types of applications occurring throughout the state). The merits and limitations of these data sources for use in the development of potential indicators will be discussed at an upcoming MN EPHT technical team meeting. Consideration of pesticide sales data is tabled until the new agricultural pesticide sales reporting system is implemented next year. Sales data are currently only available at the state-level but will soon be collected at the dealership-level, allowing for greater geographic resolution. 46 SECTION OVERVIEW: NATIONAL CHILDREN’S STUDY The National Children’s Study (NCS) is the largest and most comprehensive study of infant, child and youth health ever conducted in the United States. It will include a representative sample of 100,000 children and will follow them from before birth or early fetal life to 21 years of age. The purpose of the NCS is to examine how environmental, biologic, behavioral, and genetic factors are associated with the health of infants, children, adolescents, and young adults. The study is designed to better understand the prevention and treatment of important childhood conditions, such as asthma, birth defects and other pregnancy outcomes, injuries, diabetes, obesity, physical development, autism and other behavioral/mental health conditions. The University of Minnesota will initiate a pilot recruitment study for the National Children’s Study in the summer of 2010 in Ramsey County. University researchers will enroll 300 pregnant women and those highly likely to become pregnant in the near future and their husbands or partners, and their infants and will follow their offspring for 21 years. Data collection will involve questionnaires, physical measures, biospecimens and environmental samples. At the June advisory panel meeting, Pat McGovern, principal investigator for the National Children’s Study Center and professor at the University of Minnesota’s School of Public Health will give a presentation on the Ramsey County pilot recruitment study and will ask for input from advisory panel members. The following item is included in this section of the meeting materials: ACTION NEEDED: No formal action is needed by the advisory panel. Panel members are invited to ask questions or provide input on this topic. In particular, panel members are asked to respond to the following questions: What aspect of the NCS is likely to be of most interest to Minnesotans—for professionals and the public? What questions might participants have? What questions will public health and health care professionals have? What challenges might we encounter when conducting the study, in particular, in regards to collecting biospecimens? How might we best address these challenges? What opportunities exist for collaborative projects between MN EPHT and NCS? 47 This page intentionally left blank. 48 National Children’s Study: Ramsey County Location Frequently Asked Questions May 2010 The University of Minnesota has been selected as a Study Center for the National Children's Study (NCS). The University will conduct the study in Ramsey County. WHAT IS THE NATIONAL CHILDREN’S STUDY? The NCS is the largest and most comprehensive study of infant, child and youth health ever conducted in the United States. It will include a representative sample of 100,000 children and will follow them from before birth or early fetal life to 21 years of age. The purpose of the NCS is to examine how environmental, biologic, behavioral, and genetic factors are associated with the health of infants, children, adolescents, and young adults. The study is specifically designed to better understand the prevention and treatment of important childhood conditions, such as asthma, birth defects and other pregnancy outcomes, injuries, diabetes, obesity, physical development, autism and other behavioral/mental health conditions. HOW IS THE UNIVERSITY OF MINNESOTA INVOLVED? The University of Minnesota (UM) was awarded a contract to conduct the study, based on its expertise in pregnancy, infant, child, and youth health and its experience conducting large studies. A pilot recruitment study will begin in the summer of 2010. University researchers will enroll pregnant women and those highly likely to become pregnant in the near future. The pilot study will enroll 300 Ramsey County women, their husbands or partners, and their infants and to follow their offspring for 21 years. Data collection will initially involve questionnaires administered online, by mail or telephone, or in person with women in their homes, selected clinics, and at the hospitals at which they deliver their babies. Subsequently, a random selection of participants will also be asked to provide data involving biospecimens and environmental samples. WHY AND HOW IS RAMSEY COUNTY INVOLVED? The national planners for the NCS identified 105 locations (mostly counties) around the country using a probability method, based on geography, demographics, number of births, birth outcomes, and other relevant data. Only these 105 locations are eligible for study participation. Each location was carefully selected to ensure that collectively they provide an accurate snapshot of all of America's children. Ramsey County was one of those locations. WHO ARE THE PARTNERS IN THE UNIVERSITY OF MINNESOTA'S RAMSEY COUNTY NCS LOCATION? The University's large team of investigators -- from the School of Public Health, the Medical School, and the Institute of Child Development -- has formal partnerships with St. Paul - Ramsey County Department of Public Health, the Minnesota Department of Health, and HealthPartners Research Foundation. The NCS team is also developing formal partnerships with hospitals and clinics that provide services to Ramsey County residents. The NCS has a Community Advisory Board that includes representation from local public health leaders, health care providers, legislators, and maternal and child health professionals. A high priority for the NCS team is to meet with local community agencies, schools, faith-based organizations, and other entities that are important to the health and well-being of Ramsey County residents. 49 WHO WILL THE STUDY PARTICIPANTS BE? The current plan is to conduct the study in two phases in Ramsey County: 1. A pilot phase, beginning in summer 2010, will involve 300 women and their offspring. 2. The Main Study, involving Ramsey County and each of the other 104 locations or counties nationwide, will enroll 1,000 mothers and their infants over a 4-5 year period beginning in 2012. Mothers-to-be will be identified primarily through a house-to-house survey conducted by survey professionals, with some identified through prenatal clinics or health plans. Initially, three groups of women will be recruited: (1) pregnant women; (2) women who are planning a pregnancy; and (3) women who are fertile, but are not planning a pregnancy. People will be enrolled prior to pregnancy or early in pregnancy to monitor the earliest possible influences on later infant, child, and youth health. Ultimately, participants of the study will be the offspring of the three groups of pre-pregnant/pregnant women. Researchers will follow the offspring (from the pilot phase and the Main Study) from fetal life (i.e., during their mothers' pregnancies) until they are 21 years old. Not all Ramsey County residents will be involved in the study. Neighborhoods were selected using probability sampling to assure a non-biased and representative sample. Only women residing in the randomly selected neighborhoods will be eligible for participation. Women and their offspring will be encouraged to remain in the study even if they move away from their original neighborhood after the infant is born. HOW WILL DATA BE COLLECTED? Women and their offspring will answer questionnaire data and some will provide blood and other samples at various intervals throughout the study. At all times, they will be asked for permission to collect data. Data collection may be conducted in-person, by a trained data collector (or nurse) at the participant’s home, or by phone, by web, or by mail. At no time will the investigators reveal the locations of the randomly selected neighborhoods or the identities of the individual participants in the NCS. HOW WILL DATA BE USED? All data collected for the NCS will be examined in aggregate (i.e., in a pool with the data from many other individuals) and at no time will data be examined or presented in a way that could reveal the participant’s identity. Because participant confidentiality is so important, individual participants will not routinely receive feedback on the data they provide (e.g., blood analyses if they provide a blood sample to the study). The most common way data will likely be disseminated is by combining data from multiple locations throughout the U.S. for data reports, presentations, and articles that can be used by health-care program developers and policymakers. FURTHER INFORMATION The national NCS website, http://www.nationalchildrensstudy.gov provides study details, study locations, research hypotheses, and background on key risk and protective factors, as well as health outcomes, that will be examined during the study. For information on the University of Minnesota’s Study Center please contact Laurie Ukestad, MS, Associate Study Coordinator: [email protected] or 612-626-3289. NCS-FAQ_public_Ramsey_2010May.doc 50 SECTION OVERVIEW: OTHER INFORMATION These documents are included in this meeting packet as items that may be of interest to panel members: Minnesota Environmental Public Health Tracking and Biomonitoring presentations, posters and publications Local, national and global biomonitoring and tracking news EHTB advisory panel meeting summary (from March 9, 2010) Additional reference materials, such as the advisory panel roster and EHTB statute, are available online at www.health.state.mn.us/tracking/. 51 This page intentionally left blank. 52 Minnesota Environmental Public Health Tracking & Biomonitoring Presentations, Posters and Publications March Panel discussion at the "Emerging Issues and Controversies in Occupational Health and Safety” program through the Continuing Education Program of the Midwest Center for Occupational Health Safety. Held at the University of Minnesota’s Continuing Education and Conference Center on the St. Paul Campus. One-day continuing education program for an interdisciplinary audience of students, faculty, alumni and professionals in occupational health and safety. The day's sessions addressed emerging and controversial issues in workplace research and science, policy and practice. Presenter: Jean Johnson, Geary Olsen, Tannie Eshenaur Attendance: Date: March 4, 2010 Building Blocks of Tracking: Building Capacity without Funding Presented as part of a NACCHO webinar series to help local public health and environmental health professionals become more familiar with the benefits of the EPHT network. Presenter: Michonne Bertrand Attendance: 70 Date: March 19, 2010 April Overview of MN EPHT Presented at M-Clean (Minnesota Collaborative Lead Education and Assessment Network) Spring meeting Presenter: Jean Johnson Attendance: 29 Date: April 6th, 2010 Developing Environmental Health Indicators for Climate Change Presented as part of the EHTB brown bag seminar series Presenters: Chuck Stroebel, Wendy Brunner, Paula Lindgren Attendance: 60 Date: April 12, 2010 53 Developing Environmental Health Indicators for Climate Change Presented at the University of Minnesota School of Public Health ERUPT series of monthly lectures. Presenter: Chuck Stroebel Attendance: 9 (includes students and faculty) Date: April 14, 2010 Introduction to MN EPHT Presented at the Metro Data Planners (local public health professionals from local public health agencies in the 7 county metro area) at the State Office Building in St. Paul Presenter: Chuck Stroebel Attendance: 10 Date: April 21, 2010 54 Local, national and global biomonitoring and tracking news Biomonitoring The release of MDH’s community brief describing the analysis of PFCs in the blood and past levels in the drinking water was briefly covered by MPR on April 28. The story can be found online at http://minnesota.publicradio.org/display/web/2010/04/28/pfc-water/. A literature review on the epidemiological evidence on the health effects of PFOA appeared in Environmental Health Perspectives online on April 27, 2010. The paper, which was authored by the investigators of the C8 study in the Mid-Ohio Valley, can be viewed online at http://dx.doi.org/ by entering the doi code: 10.1289/ehp.0901827. The Minnesota Pollution Control Agency recently determined that a metal plating company in St. Louis Park is a likely source for the PFCs in Lake Calhoun. MPR’s coverage of this story can be found online at http://minnesota.publicradio.org/display/web/2010/04/08/pfoa-lake-calhoun/. The U.S. EPA is holding “PFAA Days III” June 8-10. Jean Johnson and several other MDH staff will be attending. Information about PFAA days can be found online at http://www.epa.gov/nheerl/pfaa_days_3/index.html. A study in Environmental Science and Technology found that children playing on pressuretreated wood have nearly the same arsenic concentrations as children playing on non-treated structures. The paper can be viewed online at http://pubs.acs.org/doi/abs/10.1021/es101119b. Tracking The President’s Cancer Panel recently released a report titled, “Reducing Environmental Cancer Risk: What We Can Do Now.” The report summarizes the President’s Cancer Panel’s assessment of the “state of environmental cancer research, policy and programs addressing known and potential effects of environmental exposures on cancer” and includes recommendations for steps that individuals, industry, governments and others can take to reduce cancer risks associated with environmental contaminants. The report can be found online at http://deainfo.nci.nih.gov/advisory/pcp/pcp08-09rpt/PCP_Report_08-09_508.pdf. 55 The National Institutes of Environmental Health Sciences recently released a report titled, “A Human Health Perspective on Climate Change: A report outlining the research needs on the human health effects of climate change.” The report discusses eleven health categories: Asthma, respiratory allergies and airway diseases Cancer Cardiovascular disease and stroke Foodborne diseases and nutrition Heat-related morbidity and mortality Human developmental effects Mental health and stress-related disorders Neurological diseases and disorders Vectorborne and zoonotic diseases Waterborne diseases Weather-related morbidity and mortality The report can be found online at http://www.niehs.nih.gov/health/docs/climatereport2010.pdf. The U.S. Environmental Protection Agency published a report, “Climate Change Indicators in the United States,” that presents information on 24 climate change indicators falling in five categories: Greenhouse gases; weather and climate;.oceans; snow and ice; and society and ecosystems. The report can be found online at: http://www.epa.gov/climatechange/indicators/pdfs/ClimateIndicators_full.pdf. 56 Summary of the Minnesota Department of Health (MDH) Environmental Health Tracking & Biomonitoring Advisory Panel Meeting March 9, 2010, 1-4 p.m. Advisory panel members – Present: Bruce Alexander, Beth Baker (chair), Alan Bender, Jill Heins Nesvold, Cathi Lyman-Onkka, Debra McGovern, Pat McGovern, Geary Olsen, Greg Pratt, Dan Stoddard, Lisa Yost Advisory panel members – Regrets: Fred Anderson, Samuel Yamin Welcome and introductions Beth Baker, chair, convened the meeting. Climate change Chuck Stroebel, EPHT program manager, described work taking place on the national level to develop indicators of climate change. According to the Intergovernmental Panel on Climate Change, climate change is likely to affect the health status of millions of people in the world, particularly those with low adaptive capacity. Potential health effects of climate change may stem from extreme weather events (including heat waves, floods and hurricanes), vector-borne and zoonotic diseases, aero-allergens, changes in air quality, and water- and food-borne diseases. Climate change may also cause mental health effects and other indirect health effects. The State Environmental Health Indicators Collaborative (SEHIC) is a voluntary project working to develop environmental health indicators, including indicators for climate change. SEHIC’s work on climate change indicators was summarized in the November 2009 issue of Environmental Health Perspectives and is available online. Climate change was recently adopted as a core developmental content area by the national Environmental Public Health Tracking program. Minnesota is participating in national efforts to develop climate change indicators. Tracking staff are also exploring potential Minnesota-specific indicators for climate change. Collaborations with many entities at the national and local levels (e.g., SEHIC, CDC, US EPA, ASTHO, MPCA, DNR, U of M Extension, and local public health agencies) will be key to the success of this project. 57 Chuck highlighted one potential indicator that could be tracked, vector-borne diseases. He displayed a map showing the expansion of high-risk areas for tick-borne disease since 2004. He also stated that there has been an emergence of new ticks that carry disease. These changes could be due to climate change or some other factor, such as changes in land use. Paula Lindgren, statistician with the EPHT program, presented pilot data on extreme heat events, which is another potential indicator for climate change. Potential health effects related to extreme heat events include heat stroke, heat exhaustion, acute dehydration, and secondary effects, such as cardiovascular disease, heart attack, kidney failure and respiratory illness. Minnesota is one of twelve states piloting the extreme heat indicators. The pilot indicators look at mortality and morbidity during a period of extreme heat, which is tentatively defined as a heat index of more than 105 degrees for two or more days, compared to mortality and morbidity during a referent period. In Minnesota, the initial piloting showed that the increase in all-cause mortality during the selected heat event was not statistically significant. The piloting process revealed that finding a national indicator that is meaningful for all states is challenging. For example, some states don’t have qualifying heat events, either because the temperature doesn’t get high enough or because there’s very little humidity. Wendy Brunner, epidemiologist with the MDH asthma program and the EPHT program, discussed the development of potential pollen indicators for climate change. Climate change may lead to increases in pollen loads, changes in pollen types, and a lengthening of the pollen season. Potential data sources include the National Allergy Bureau, which operates 78 pollen monitoring stations across the country, satellite imagery, and the National Phenology Network. Limitations of the pollen monitoring data include the limited number of monitors. The EPHT program will be sponsoring a brown bag seminar on climate change indicators on April 12 from 1-2 p.m. in room B145 of the Freeman Building. Panel members were invited to make comments and ask questions. Alan Bender suggested that the indicators should be evaluated to determine how well the heat-related mortality constructs perform at random times throughout the year (i.e., what is the intrinsic variability of the constructs). Debra McGovern urged EPHT staff to consider multiple explanations for changes observed in the data over time; changes in ticks could be due to differences in land use and not climate change. Jill Heins-Nesvold inquired whether data from Wisconsin showed a similar increase in high-risk tick areas. Chuck replied that he had not seen data from Wisconsin yet. Geary Olsen asked why none of the high heat states (except for Louisiana) were included in piloting the extreme heat indicators. Chuck and Paula replied that it was a voluntary process and other states, such as Florida and New Mexico, had not volunteered yet. Hot weather states may see a greater impact on mortality from extreme heat or they may have more adaptive capacity and show less of an impact. Bruce Alexander suggested that in selecting Minnesota-specific indicators for climate change the specific ways that Minnesota is most likely to be affected by climate change be considered. 58 Criteria for selecting Minnesota-specific content areas, data and measures Jean Johnson, EHTB program director, explained that the tracking program is thinking ahead to setting priorities for Minnesota-specific content areas and data. Up to now, work has focused on the eight core national tracking content areas: air quality, drinking water, lead poisoning, hospitalizations, birth defects, birth outcomes, selected cancers and carbon monoxide poisonings. The Minnesota tracking program has analyzed data in each of these areas and is in the process of releasing reports on each area. Three reports are currently available on the MDH tracking website: drinking water, hospitalizations, and carbon monoxide poisonings. Additional reports will follow. When hard copies of the reports are printed they will be provided to advisory panel members. As mentioned previously, two new content areas have been added to the national program and Minnesota is participating in the development of those content areas. In future years, there will be resources available for developing Minnesota-specific tracking priorities. Some new content areas that have been suggested by staff include environmental tobacco smoke, radon and developmental disabilities. In addition, new measures could be developed in existing content areas; some possibilities include arsenic in private wells, alpha emitters in drinking water, modeled data on particulate matter, and pesticides in groundwater. Staff are developing a process for selecting Minnesota-specific priorities. Ideas for new content areas and measures could come from a variety of sources, including staff and advisory panel members. The advisory panel will be asked to make recommendations once staff have compiled information on potential content areas and measures. Jean reviewed a set of draft criteria for evaluating potential content areas and measures (pages 28-29 of the meeting materials). Then she applied the criteria to the existing content area of carbon monoxide poisonings as an example. She invited panel members to comment on the selection criteria. Greg Pratt suggested that the potential severity of an effect be considered, not just the prevalence. In comparing two effects, such as two diseases, the one with more severity should rank higher. Dan Stoddard suggested that the concept of risk – which includes exposure and potential hazard – be considered and should be a high priority. Criteria 1 (degree of prevalence), 3 (causality), and 6 (high priority hazard) might be related to this concept; . He stated that the highest priority be given to items with significant risk that we can take action on. The ability to link the data (#11) to is also important. Consideration of exposure should go beyond the levels in the body to include physical exposure. Debra McGovern stated that criteria 1, 3 and 6 were top priorities for her. Geary Olsen suggested that population attributable risk (PAR) be made a formal part of the assessment process; PAR could be its own bullet point or a sub-bullet under one of the other constructs. As written, the criteria are listed as independent events, but they’re not independent and PAR attempts to deal with that. Bruce Alexander asked whether the tracking program would focus on data that are already available or on developing methods to track important issues. There are a lot of data available, but they are not necessarily the data the program needs. For example, no surveillance system currently exists for Parkinson’s disease, Alzheimer’s, or autism. Jean stated that this was an issue 59 for the panel to make recommendations on. Currently the tracking program only uses data that are already being collected by other programs, but there may be opportunities to form partnerships with other programs to develop new tracking data. For example, there is a low-level effort underway to explore developing an autism surveillance system. One of the things the panel will be asked to consider is whether to focus on “low hanging fruit” (i.e., data that are already available) or looking at data gaps. Jill Heins-Nesvold asked how many new content areas the program has the capacity to add. Jean responded that one or two content areas might be feasible for next year, but other areas could be added in future years. The feasibility of adding new measures and content areas partly depends on how much work needs to be done to develop the measures. Jill suggested adding a criterion related to the balance of indicators related to different age groups. For example, radon would focus mainly on effects in adults and seniors; environmental tobacco smoke might focus more on effects in children. Jill requested that the wording of criterion 7a be changed to acknowledge that programs outside of state agencies, such as the American Lung Association, are positioned to take action on health issues. Pat McGovern asked who the program stakeholders are. Michonne Bertrand, program coordinator, replied that the stakeholder list is very broad, including local public health agencies, legislators, environmental advocacy and public health groups, and the general public. Bruce stated that the stakeholders are really the whole state of Minnesota. Pat suggested that a broader term be used to cover the concept of public health impact as an important criterion. This would incorporate both the issue of prevalence and severity, but also consider economic impact. For example, the long-term economic impact of autism is significant when considering the effects on the affected child’s family and the medical and school systems. Public health issues that are “high impact” are priorities for actionability. Alan Bender suggested that there are standard formulas that we could use to weight the factors related to disease impact; for example, the impact of a disease at a young age is often considered greater than the impact at an old age. These formulas would allow us to put different issues on the same scale. Bruce stated that criterion four (potential for information building and research application) was important. In particular, he advised that MDH would be wise to look in depth at existing data sets (e.g., emergency department visits and hospitalizations data) to mine them for as much information as possible. Because hospitalizations data are so complicated, MDH should focus on learning how to use those data well (e.g., by looking at a number of different health outcomes to refine methods). Alan Bender cautioned that hospitalization data are limited in their usefulness without identifiers to get at unique events, which are currently unavailable to MDH. Bruce stated that that kind of issue is what needs to be explored further (e.g., how to get at unique events). Jean stated that the only information currently available from hospitalization records is ICD9 code and ZIP code. 60 Michonne asked panel members what information they will need to be able to make recommendations about priority content areas in the future. Pat said it would be helpful to walk the examples through the criteria in the future. Panel members could participate in that conversation based on their own knowledge. Tracking updates Michonne Bertrand invited questions and comments on the written tracking program updates that were provided in the meeting packet. There were none. Biomonitoring lessons learned Michonne Bertrand explained that program staff are conducting an informal process evaluation of the biomonitoring pilot program in order to meet statutory requirements. All staff who were involved in the planning or implementation of the pilot projects were asked to provide input on what worked well and what could be improved about a wide range of topics related to study design and conduct. This evaluation process is separate from, but related to biomonitoring strategic planning efforts that took place in 2008 and 2009. Michonne stated that the panel was being asked to comment on one specific component of the pilot program at this time: community selection. The arsenic and PFC projects could be considered special investigations. Each project was centered on a community with a specific contamination issue. Michonne reviewed the feedback received through the evaluation related to the strengths and challenges of working in communities with known contamination issues. (Pages 50-51 of the panel materials.) Panel members were asked to break into small groups to discuss the following discussion questions: Is there anything else you’d add to the list of what worked well and what didn’t work well related to community selection? Based on what worked well and didn’t work well, what recommendations would you make with regard to community selection if Minnesota were to continue to conduct biomonitoring in communities with known contamination concerns? When is biomonitoring an appropriate response to community concerns about environmental contaminants and when is it not? If Minnesota were to continue using a community response approach to biomonitoring, how should requests from concerned communities, public health officials and elected representatives be prioritized? What factors should be considered? Thinking beyond the issue of community selection, in what ways would you say these two projects were most successful? Key recommendations included the following: NEED FOR SCIENTIFIC RIGOR There is a need to apply scientific rigor in biomonitoring studies. (Group 1) 61 Ongoing biomonitoring should not be legislatively driven but should be driven by scientific input. Scientific method should not be micromanaged. (Group 2) Staff need to articulate the best scientific position for biomonitoring, because the issue will be politicized as it moves up the chain of command. As a public health agency, the emphasis should be on conducting and executing biomonitoring studies that best serve the public health, not those that are conducted for political reasons or those that are better suited for an academic setting. (Group 3) NEED FOR ADEQUATE FUNDING AND TIME Sufficient funding is needed to answer scientific questions. (Group 2) The expense to do biomonitoring well needs to be factored into planning any future biomonitoring activity. To conduct biomonitoring on an ongoing basis the program would need to be handsomely funded. (Group 3) It is difficult and time-consuming to do community-based biomonitoring studies well. It takes a great deal of time to establish community relationships and to learn how to appropriately communicate within each community; it is the familiarity of the specific people/faces that builds trust – an agency in name only can’t build trust as it is the people who represent the agency in the community that build the trust; this one-on-one approach to the community takes time. (Group 3) BIOMONITORING SHOULD LEAD TO IMPROVED PUBLIC HEALTH Biomonitoring should be undertaken only when an actionable outcome is anticipated. Biomonitoring should serve to protect public health. Biomonitoring should be conducted only when there is a strong suspicion of the potential for harm. (Group 1) MDH is not a research organization. (Groups 1 &3) Biomonitoring as an approach should help MDH make risk management decisions and not be used to simply characterize risk and/or to sidestep decisions about risk management. (Group 3) BIOMONITORING NEEDS TO BE RESPONSIVE TO COMMUNITY NEEDS There is a need to know at the beginning of the project how the data will be interpreted. You need to know what the value means to the person (and the community) you just measured it in. (Group 3) With a community-based approach to biomonitoring, building a baseline of data is not a legitimate reason for conducting biomonitoring from the community members’ perspective. (Group 3) FUTURE PROJECTS SHOULD BE PRIORITIZED ACCORDING TO SELECTION CRITERIA Priority for future projects should be based on the same kinds of criteria that were discussed in the earlier part of the meeting. Key factors to consider are 1) that biomonitoring should be conducted to address a risk to public health (the greater the risk, the higher the priority); and 2) the outcomes should be actionable. (Group 1) Another factor is whether appropriate reference values for results are available. (Group 1) Biomonitoring is useful for responding to community concerns but there is a need for selection criteria by professionals. (Group 2) 62 THE SELECTION OF FUTURE PROJECTS SHOULD BE BASED ON BROADER INPUT MDH should seek input from a wide variety of stakeholders before selecting other communities for biomonitoring. One option for identifying community response needs would be to implement the “listening post” concept employed by local public health agencies. A more formal process is needed to collect information throughout the state to identify potential needs; this is preferable to waiting for communities to contact MDH with their requests. (Group 2) Other observations about the biomonitoring pilot projects included the following: Communications by MDH were very good, even if some people were not happy with outcomes. (Group 1) The studies did address the desire for a study by legislators and their concerns. (Group 1) If there was a major health concern, the pilot studies probably would have found it. A negative finding provides value, although if we expected a non-actionable outcome it may not be worth the cost. (Group 1) A positive outcome of the pilot program was that MDH increased their experience, knowledge and capacity to do biomonitoring. (Groups1 and 2) Biomonitoring projects present considerable communication challenges in terms of communicating things that are unknown. (Group 3) Biomonitoring updates Jean Johnson provided a brief update on the Riverside Prenatal Biomonitoring Study. The decision was made to cut off participant recruitment for the study as of March 1. Attention will be paid in March to getting in any remaining urine kits. Sample collection will end as of April 1. Sixty-one urine samples have been received so far. Though the project was hoping to recruit 90 women (30 each in three racial/ethnic groups), the participants have mostly been white. Because this pilot project was conducted as an ancillary study to another study, we had little control over recruitment efforts. There were no questions or comments on any of the other updates. New business Beth Baker asked panel members whether there were any suggestions for future agenda items. Pat McGovern offered to present some information on the National Children’s Study and plans for a pilot study. Geary Olsen suggested that MDH submit at least one poster on the PFC biomonitoring study for presentation at EPA’s PFFA days, June 8-10. Beth Baker adjourned the meeting. Drafted 3/11/10; finalized 3/29/10 63 This page intentionally left blank. 64
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