Summary:March13,2012MeetingoftheEHTBAdvisoryPanel
Attendees: Panel Members: Bruce Alexander, Alan Bender, Tom Hawkinson, Jill Heins‐
Nesvold, Cathi Lyman‐Onkka, Pat McGovern, Greg Pratt, Geary Olsen, Cathy Villas‐
Horns, Lisa Yost (by phone). Steering Committee: Aggie Leitheiser, Mary Manning. Other MDH divisions: Carin Huset, Eric Zabel, Pat McCann, Carl Herbrandson, Betsy Edhlund, Jeff Brenner. Staff: Jean Johnson, Barbara Scott Murdock, Blair Sevcik, Dave Stewart, Chuck Stroebel. Bruce Alexander welcomed everyone, invited panel members, staff, and members of the audience to introduce themselves, and called the meeting to order. EastMetroPFCFollow‐upLaboratoryAnalysis
Public Health Laboratory (PHL) chemist Carin Huset presented results of paired re‐
analyses of selected samples from the 2008 and 2010 East Metro PFC Biomonitoring Projects. The PHL originally presented the data for the 2010 East Metro PFC Biomonitoring Follow‐up Project at the October 2011 Advisory Panel meeting. The project had measured the concentration of perfluorochemicals (PFCs) in serum of residents of the East Metro who had participated in MDH’s 2008 pilot project to assess whether efforts to reduce drinking water exposure to PFCs had been successful in reducing body burden in the population. Because uncertainty is inherent in all analytical methods, and comparisons are being made between samples analyzed in two different years, the Advisory Panel suggested that the lab re‐analyze specimens from 2008 at the same time as the corresponding 2010 sample to make sure that the measurements were comparable. Carin chose paired 2008 and 2010 samples from five individuals in whom PFHxS, PFOA, and/or PFOS had increased by a large percent, and another five paired samples from people in whom one or more of these PFCs had declined by a large percent. She then re‐extracted and re‐analyzed both specimens in each pair. The average relative duplicate precisions (RDPs) for the 2008 specimens were 10%, 5% and 9% for PFHxS, PFOA, and PFOS, respectively. The average RDPs for the 2010 specimens were 7%, 15%, and 12% for PFHxS, PFOA, and PFOS, respectively. These precision values are within the range of analytical uncertainty for the method. The correlation coefficient of agreement was >0.99 in the 2008 data and >0.97 in the 2010 data. In short, Carin concluded, the analytical technique was not the source of differences in PFC concentrations seen in the specimens between 2008 and 2010. 1 The panel had no questions. Geary Olsen commented that he was comfortable with Carin’s analysis and conclusion. LaboratorymethodforHginNewbornBloodSpots:
AssessmentandRecommendations
Betsy Edhlund reviewed the methods and quality controls used in measuring mercury in the residual dried blood spots (RDBS) used in the Lake Superior Mercury in Newborns Study (March Advisory Panel book). She compared MDH’s methods with those reported by Utah’s Public Health Laboratory, which has published a similar method for measuring mercury and other metals in newborn blood spots (Chaudhuri et al., 2008). Although their methods differ somewhat, both laboratories had similar detection limits. The MDH method detection limit (MDL) was 0.7 µg/L; the Utah laboratory’s MDL was 0.65 µg/L. MDH laboratory staff noticed some high bias in medium and high levels of mercury measured in the blood spots, but so far, have not been able to explain it. They also established that different storage conditions for the dried blood spots did not seem to affect mercury extraction (for details, please see March 13, 2012 Advisory Panel book). Betsy noted that there is ample scope for improving the method. First, better calibration standards are needed. When the project was underway, the PHL was able to find only one vendor that could supply a methylmercury (MeHg) standard. Later, someone discovered that the concentration of the standard differed from what was reported in the certificate of analysis. This meant that the laboratory had to re‐calculate the RDBS results, reducing the minimum detection limit (MDL) and the reporting level for the mercury concentration results. Had the laboratory used two different sources of materials, which now are available, staff would have discovered the discrepancy sooner. In future, now that more vendors are available, the laboratory would change the standard operating procedure for the method to require two separate sources of material and correct the vendor concentration to MeHg, rather than MeHg chloride. Other improvements available now include better toxic metal standards in goat blood. These come in four different concentrations of total mercury, including one with a concentration below the MDL, one with a reference value of 4.95 µg/L, and one with certified concentrations for methyl mercury, inorganic mercury, and ethyl Hg, with a total mercury concentration of 17.8 µg/L. Although both levels are higher than most in the study, they are much closer to the concentration range found in the blood spots than the original standard reference material (SRM). Now that these standards are available, the laboratory staff would like to do a study of extraction efficiency measures in various mercury species. This study would enable the staff to have a better understanding of the extraction efficiency of the method and how that relates to the mercury recoveries for the patient samples. The preparation of calibration curve standards could then be optimized for the best method performance. The laboratory 2 would also like to analyze more RDBS, but would like to have more blood spots per newborn in case an analysis needs to be repeated, reducing the number of samples reported with a data qualifier. This could also reduce the MDL and the reporting level, and allow more samples to be reported above the detection limit. Overall, Betsy considers RDBS from newborn screening programs as unlikely to be useful for identifying the full range of population exposure, but as potentially useful for identifying the high end range of mercury exposure and as a screen for follow up. Overall, the method has proved to give very consistent results. Discussion Tom Hawkinson asked whether PHL staff had considered non‐destructive methods, such as X‐ray fluorescence spectrometry (XRF), for analyzing the blood spots and whether staff had considered inconsistencies in the volume of blood in the spots. It’s a big assumption to assume consistency. Betsy answered that, yes, staff had to consider that variation, but they did assume that the volume would be consistent across the RDBS and within a spot. Greg Pratt followed up, saying, if a spot is not homogeneous for mercury, it would be a problem for the SRM as well. Tom added that the detection limits of XRF analysis were not in the appropriate range for this type of sample and it doesn’t allow for speciation of the sample. SpecificAims1:UmbilicalCord:NewbornBloodSpotComparisonStudy Barbara Scott Murdock reviewed the Advisory Panel’s motion in the December meeting that staff develop specific aims for a cord blood: newborn blood spot comparison as a follow up to the Lake Superior Mercury in Newborns findings. The project found that 10% of the Minnesota newborns measured had mercury concentrations in the newborn blood spots above the Environmental Protection Agency (EPA) reference level (5.8 µg/L, a “safe” level) in umbilical cord blood. The EPA reference level was derived from a benchmark dose level (BMDL) established by a National Research Council study requested by the EPA (NRC 2000). The BMDL (58 µg/L) is based on a well established, long‐term study of prenatal methylmercury exposure and its neurological effects in a population in the Faroe Islands. It is “the lowest dose… expected to be associated with a small increase in incidence of adverse outcomes…” Moreover, the NRC committee chose to measure mercury in umbilical cord blood because “[this measure] would be expected to correlate most closely with fetal‐brain Hg concentrations during late gestation.”1, 2 That is, cord blood is fetal blood, and therefore, comparing total mercury in cord blood with total mercury in newborn blood spots is a way to establish whether or not the blood spots accurately reflect or predict mercury exposure to the fetus in the last trimester of pregnancy. (For more detail, please see the December 2011 Advisory Panel book). For these reasons, EHTB staff developed the following goals, rationale, hypotheses, and specific aims. Staff then posed the questions below to the panel; the questions address both the laboratory presentation and the specific aims presentation. 3 Goals • Goal 1: To compare total Hg content in paired cord blood: blood spots from sample of newborns to get a measure of the ratio. • Goal 2: To speciate the cord blood to obtain the MeHg: I‐Hg content. • Goal 3: To further refine the laboratory methods for measuring Hg exposure in newborns. Rationale • If newborn spots compare with or predict exposure measured in cord blood, then… • MDH can recommend the method for public health surveillance studies and compare the blood spot results to the EPA RfD (5.8µg/L) in cord blood. • The PHL can determine whether different ratios of organic‐Hg and I‐Hg in blood samples affect extraction efficiencies and the cord: blood spot ratio. Hypotheses • 1 (null) T‐Hg in blood spot: cord blood = 1 – Significance: comparing spot T‐Hg to the EPA RfD is appropriate for assessing health risk in a population of tested infants. • 1 (alt) T‐Hg in blood spot: cord blood ≠ 1 – Significance: if we use heel stick blood spots, we will need a correction factor to appropriately assess health risk in a population of tested infants. • 2 (null). Differences in the MeHg: I‐Hg ratio do not change the T‐Hg blood spot: cord blood ratio. – Significance: if the T‐Hg amounts in blood spot: cord blood pairs correspond and the Hg composition does not change the ratio, then we should be able to compare the MeHg exposure to the RfD and inform public health action. Specific Aims • Obtain paired cord blood & newborn blood spots from a small population of newborns. • Measure total mercury in both blood specimens for each pair; compare results for each pair and calculate an average ratio. • Speciate mercury in the cord blood sample for each pair; record cord MeHg & I‐Hg for each pair. • Categorize paired specimens based on differences in the ratio; analyze how different Hg species contribute to variability in the ratio • Analyze how differences in mercury speciation affect blood spot extraction efficiency. 4 Questions to the Panel 1) Have panel members any suggestions for changes or clarifications to the Specific Aims? 2) Are we ready to develop a proposal based on these Specific Aims? 3) Given that the study must be small and conducted within limited resources, what population selection criteria should we use for this project? 4) Should the EHTB program support efforts by the MDH’s Public Health Lab to further improve & document the method so it can be disseminated to other laboratories? 5) Should the EHTB support further improvements to this method for biomonitoring in Minnesota? Note: Questions 2 and 3 were tabled so as to allow more time for Dr. Ruby Nguyen to describe a possible collaboration with MDH. Discussion Pat McGovern said the project would be an interesting and important contribution to Minnesota and to the literature in the field. Bruce Alexander was skeptical of the alternative hypothesis 1, which suggests that we could identify a consistent, but unequal, relationship between cord and newborn spot that would allow us to calculate an adjustment or correction ratio. Both Greg Pratt and Bruce Alexander pointed out that the adjustment sounds simple, but is probably more complex than just applying a correction ratio. Alan Bender suggested that EHTB staff work with laboratory staff to identify a priori boundaries for accepting and rejecting hypothesis 1 before you start testing. Tom Hawkinson, however, suggested that that approach might be a pretty high standard for this method. Aggie Leitheiser asked whether we would do this project in a small population. Jean said that staff had done an n calculation that suggests that, at minimum, 50 cord: newborn spot pairs might be enough to determine a spot and cord blood geometric mean. It might take as many as 100. Tom asked whether EHTB staff had looked in the literature for other studies that have addressed these questions, such as partition of mercury species in maternal blood and in animal studies. Pat McCann answered that many studies have looked at this and are the source of the cord blood: maternal blood ratio of 1.7. But there are differences in species and how they partition, and a lot of variability in the ratio. She added, “I think there will be a lot of variability in these results.” Alan said that, given the variability, staff should do a sequential analysis, rather than setting a sample size first. [Alan explained later that the variability of the data may not be known before the start of the study. Sequential analysis starts with an initial sample, determines the variability of that sample, and estimates the number of additional samples required to meet stated goals (type 1 and type 2 errors). Then additional samples are taken, tested again, and when the goals are met, the study ends. This method allows for “on the fly” determination of variability and for the earliest termination of the study, adjusting for improving knowledge of the variability as the study progresses.] 5 Attention then turned to the laboratory question: Should EHTB financially support the PHL’s efforts to improve the RDBS method as Betsy described it in her presentation? Geary Olsen argued that the PHL should publish the method in an analytical journal to elicit the required critique of the method. You can get a good peer review that way, he said, although you may have to carry out this [cord: spot] step first. Pat McGovern asked whether the two processes, the [cord: spot] analysis and improvement of the method, could go on together. She suggested Betsy could turn her award‐winning poster into a publication. Pat McCann noted that her group, MDH Environmental Health (not EHTB), is working on publishing the original Lake Superior Mercury in Newborns study, and that Betsy is working to publish the laboratory method. Alan asked, what must be known about the method before CDC’s laboratory would adopt the laboratory method? Betsy replied that she had spoken with CDC staff at her poster presentation in January, and that CDC is interested in the method and in seeing it published, but she doesn’t know what their process for adopting it would entail. Jean asked whether it is a goal for the laboratory to disseminate the method to other laboratories for their use and reproduce its results (for external validation). Betsy agreed with that goal, and Jean explained that sharing with other laboratories is how a method can become a standard. Geary pointed out that people typically publish methods before establishing inter‐laboratory consensus. Getting the methods out will generate the enthusiasm of others to look, tweak, and challenge your methods. Bruce suggested that the panel propose a motion on the specific aims and a recommendation for publication. Pat McGovern proposed a motion that includes Greg’s amendment to the specific aims hypothesis 1 (alternative). I move that EHTB staff develop a project proposal the addresses the specific aims above with hypothesis 1(alternative) amended to read that if blood spot mercury is not equal to cord blood mercury, does not necessarily enable us to conclude that it is possible to derive a ratio for adjustment. Cathi Lyman‐Onkka seconded it. Vote: All in favor. Geary Olsen then framed a recommendation: to encourage MDH to ensure the publication of results when MDH is comfortable with releasing the work. Panel members variously emphasized that publication of good work not only is important to public health, but also enhances the reputation of MDH, its staff, and the state of Minnesota. Bruce suggested taking a voice vote that the panel members are in support of that. All said yes. 6 PotentialCollaborationwithTheInfantDevelopment&EnvironmentStudy
(TIDES)
Ruby Nguyen (UMN) Jean Johnson Jean introduced Dr. Ruby Nguyen and briefly reviewed the background for the next presentation. To find a source of cord blood and dried blood spots for the two mercury follow‐up studies, staff first contacted Dr. Logan Spector, who collaborated with the EHTB to carry out the Riverside Prenatal Biomonitoring Pilot Project as an ancillary to his Riverside Birth Study. Dr. Spector collected maternal blood, cord blood, and extra newborn blood spots for research, with informed consent. Unfortunately for the EHTB projects, Dr. Spector’s study kept the blood plasma, but discarded the red blood cells, which would have contained most of the methylmercury; the blood spots may still be useful to MDH in future. Dr. Spector recommended that the EHTB staff should talk with Ruby Nguyen, who is carrying out the Minnesota arm of The Infant Development and Environment Study (TIDES). Ruby explained that TIDES is a four‐year NIH‐funded project focused on four sites: Minnesota (Minneapolis), Washington (Seattle), New York State (Rochester), and California (San Francisco). The principal investigator is Dr. Shanna Swan, currently at Mt. Sinai School of Medicine in New York. The study’s primary focus is on learning more about the effects of phthalates and anti‐androgen receptors on infants during gestation. The study will measure such physical indicators as anal‐genital distance and other changes in estrogen‐responsive organs in the infant boys at one year. The study is beginning to look at infant girls as well. The study has been recruiting women at six to 10 weeks of pregnancy at all four sites. The study collects maternal blood in the first trimester and urine for all trimesters, and follows up with infant examinations at birth and at one year. Future plans for the project include looking at gender play in the children. The total number of babies is expected to be 800 to 900. At the Riverside clinic in Minneapolis, the study currently has enrolled nearly 100 women, English speakers only, and expects to enroll 220 by the end of recruitment in May or June 2012. Less than 10% of the women decline enrollment. Drs. Nguyen and Swan are very interested in collaborating with the EHTB. They propose to work with the obstetrics staff to add the collection of cord blood and extra newborn blood spots obtained by routine heel stick. They also propose to give MDH access to food frequency data in their questionnaire. These changes would require changes in the IRB (institutional review board) protocol, but because the addition of more blood spots would be minimally invasive, would involve no new procedure for the infant, and no effect on the mother, the investigators expect a quick approval from the IRB. The MDH IRB will also need to review the protocol. 7 Discussion Pat McGovern asked whether the proposed project could learn what kinds of fish that the women in the study might be eating. The work in the Lake Superior Mercury in Newborns study focused on women who lived in the Lake Superior basin, but this project would involve only women in the Twin Cities. Ruby said that the questionnaire asks only for the amount of fish that the women eat, not the type or origin. She added that the investigators do not yet have the ethnic identities of the women, but said that most are Caucasian. In response to Aggie Leitheiser’s concern about generalizability of the study, she said that TIDES is also sampling from other newborns in the nursery [infants whose mothers were not recruited during pregnancy] to increase the generalizability of the findings. The TIDES study will not provide the phthalate findings to the women because health effects from phthalate exposure have not been established in humans. Mercury results in the Minneapolis study, however, would be sent to the mothers because the health effects of mercury exposure are well understood. Pat McGovern observed that if the population is mostly Caucasian, the [cord: spot] study is another step forward, but maybe the next step [could involve] a more diverse population that would generate more generalizable data. Aggie agreed, saying this is an incremental process. But, Cathi Lyman‐Onkka noted, given that this first study is simply looking at the cord blood: heel stick ratio, it may not matter if the results of the paired samples are not generalizable. Bruce agreed that the ratio is the objective of this project. Saying that “it absolutely makes sense to go ahead with this study,” Greg Pratt argued that, although the study would not be generalizable [with respect to differences among demographic groups], it would provide valuable information about the method. The PHL staff raised questions about the amount of blood for laboratory analyses, particularly for blood spots. Ruby commented that Logan Spector (anecdotally) had some trouble with blood volume when his project was collecting blood spots. The first priority was to ensure enough blood for the newborn screening procedure, and then three spots were taken for the research project. Quantity was an issue. He considered a second heel stick for babies “who aren’t bleeders,” but to be collected only on a case‐
by‐case basis. Pat McCann asked whether that study followed quality control parameters for the extra three spots, especially with respect to the concern about the volume of blood mentioned earlier. She said the collection should make all of the spots meet the criteria used for newborn blood spots, since [uniformity of the sample] is important for mercury analysis. Pat also asked whether TIDES planned to get informed consent for additional newborn spots. Ruby said the study would add a supplemental consent form or, if the investigators decide to gather more blood with a second heel stick, they might use a new consent form. When Betsy asked whether the study would use the same filter paper as that used for the newborn blood spots, Ruby said the study would use the same filter paper if the laboratory recommended it. 8 Ruby asked about any concerns for processing cord blood, and Aggie asked whether any method had been established. Betsy answered that the PHL had an established method for processing whole blood. She had no recommendations for collecting and processing cord blood per se, but would research that. For speciating forms of mercury in whole blood, the laboratory would need 50 µg of blood. She speculated that the laboratory might develop speciation procedures for blood spots [if they had enough spots to provide the amount of blood necessary]. Pat McCann asked whether TIDES had an interest in mercury before. Ruby explained that, although mercury was not an initial focus, the TIDES investigators had discussed mercury as an environmental exposure. Thus, they are interested in collaborating with MDH. They would like to add lead and cadmium to the analysis and were willing to pay for those analytes, as they want to follow up on cognitive development in these children. Ruby asked for a recommendation on timeline. She said that protocols should go to the IRB quickly, as 10‐12 babies are being born each month, and TIDES plans to stop recruiting in May or June. Jean turned to the panel and, noting the time sensitivity of this project, asked, “How would the panel like to proceed?” Bruce suggested that EHTB staff draw up the methods and send them by email to the panel members for review and comment. Cathi Lyman‐Onkka said, “I move that MDH pursue collaboration with TIDES to compare mercury in cord blood to mercury in newborn blood spots in paired samples from newborns. Pat McGovern seconded the motion. All in favor, motion passed. BiomonitoringUpdates
East Metro PFC Follow‐up and the Great Lakes Initiative Although this section had no presentation scheduled, Jean Johnson noted that Jessica Nelson is on maternity leave but, on her return, would continue to follow the literature on PFCS and other material on biomonitoring, and resume Phase II of the PFC study by analyzing the PFC questionnaire data. ChemicalsinPeople
Biomonitoring as a Content Area for Tracking: Evaluation of Content and Rationale Jean Johnson explained that Minnesota’s legislation directs the EHTB program to integrate biomonitoring (exposure) data with state environmental health hazard and health outcome data. Minnesota will be the first state to feature biomonitoring data as content on its state EPHT (Tracking) data portal. The objective of this content area is to address the exposure category of the hazard  exposure health outcome paradigm. Most of the data will be drawn from CDC’s National Health and Nutrition Examination Survey (NHANES). The chemicals of interest will be vetted through the content area 9 process developed in the MN EPHT program: exploration, feasibility, and recommendation. Minnesota‐specific biomonitoring data may be added as available. Jean reviewed the feasibility criteria for using NHANES data sources and data from EHTB pilot projects to provide biomonitoring data on environmental chemicals of public health interest in Minnesota (for details, see March 2012 Advisory Panel book). She then demonstrated the new webpages, which highlight biomonitoring of PFCs and mercury both in NHANES data and in EHTB pilot project findings in Minnesota (Jessica Nelson prepared the text and graphics for the pages). And she asked panel members to respond to the questions below: Discussion item 1. Do panel members have suggestions for improving the content or messaging for biomonitoring data displays on the portal? 2. What other important Minnesota priority chemicals should be included in data display in this content area? Discussion The conversation first focused on question 1: content and messaging. Alan Bender asked, how do members of the public ask questions about the website? What is the feedback mechanism? Chuck Stroebel answered that the home page has a “contact us” link that leads people to Dave Stewart’s email address, so they can ask questions directly. During the website’s usability testing period, the home page also linked to a Vovici survey that allowed website users to provide feedback on the website’s content and ease of use. Jill Heins‐Nesvold suggested that the “About the Biomonitoring Data” link might be a good place to manage expectations and to inform policymakers that this is new, cutting‐
edge science, which develops incrementally. It’s a place to highlight progress and point to future research directions. Jean noted that the “What can these data not tell us?” section lists some of the limitations of biomonitoring data, but agreed that elaborating on this message might be helpful. Jill suggested that the messages might clarify that more research is necessary, that we are only beginning to learn about exposures in Minnesota, and that we need resources to gather data and identify problems. Jean pointed out that we have no state biomonitoring data on most chemicals—we miss pockets of high exposure. Alan agreed, saying that people often are shocked when they learn that MDH has such limited population‐based data on such illnesses as cardiac morbidity. When asked about other chemicals that the panel would like to see on the “Chemicals in People” webpage, Pat McGovern asked whether the program would need to find more funding if the panel proposed additional chemicals for the website. Jean clarified that we would not need more funding to promote the national data, as we would add only biomonitoring data from NHANES. Jean suggested EHTB could start with chemicals 10 selected for the EHTB program’s other pilot projects, which examined exposure to BPA, parabens, cotinine and arsenic. Jean added that the national tracking program (EPHT) Biomonitoring Task Force is working with CDC to integrate biomonitoring into tracking with 11 chemicals added to the national EPHT network portal. CDCTrackingDataofDevelopmentalDisabilities Blair Sevcik In January, CDC launched a new content area that tracks data for two indicators: (Indicator 1) prevalence of autism and (Indicator 2) children receiving services or interventions for a developmental disability. The data, which come from the CDC and from the US Department of Education (USDE), differ in focus and in selection criteria. As the first step in the evaluation process for adding new content to the MN EPHT data portal, Blair Sevcik discussed the two data sources for tracking developmental disabilities on CDC’s data portal: CDC’s Autism & Developmental Disabilities Monitoring (ADDM) and USDE’s Individuals with Disabilities Education Act (IDEA). ADDM collects data on the prevalence of autism spectrum disorders (ASDs) among children 8 years of age from network sites in 15 states. IDEA tracks the number of children who receive services or interventions for developmental disabilities. Blair pointed out that ADDM has data by year, gender, and race/ethnicity, but the data are not representative, and ADDM has no data for Minnesota. IDEA, on the other hand, has good temporal and spatial data at the state level across the US, but because it focuses on services, cannot be used to estimate the prevalence of any one disability. It has no prevalence data; the classification of disabilities is defined by the services needed; and the program and funding differ by state and over time as state funding for special education and other services fluctuates. Moreover, many children in IDEA are identified at ages 3‐5 years, but often drop out of the system after receiving a service or intervention. As a result, the data are artificially low for children over 6 years of age, according to MDH Maternal and Child Health Section staff who were consulted about the quality of this data source. The full IDEA dataset collects about a dozen types of developmental disabilities; CDC tracks seven of those among children aged 3‐17 years. Children are included in Indicator 2 (receiving services) if they a) are receiving services or interventions and b) are found to have one of the seven developmental disabilities, according to IDEA. Blair’s conclusion is that MN EPHT should look at other data sources, such as the National Survey of Children with Special Health Care Needs (NS‐CSHCN), if the program begins the evaluation process for developmental disabilities as a Minnesota‐specific content area. Phase 1 of this process includes determining what data sources could feasibly be used to develop new indicators. She asked the panel to address the following questions: 11 1. What concerns do you have about the data sources? Do you share concerns about IDEA? 2. Should we evaluate Developmental Disabilities as a new content area in Minnesota? 3. If we explore this content area, which Minnesota data sources would you recommend we evaluate? Tom Hawkinson commented that the diagnostic criteria for autism spectrum disorders (ASDs) are changing, and also differ by state. The higher bar for diagnosis means that fewer children might be receiving services in future. Blair responded that, in Minnesota, children can receive services for ASDs without a physician’s diagnosis, but it’s true that other states require a medical diagnosis of ASD prior to receiving services tracked by IDEA. Cathi indicated she agrees with the listed limitations for the IDEA data source. Alan suggested looking at data in Minnesota’s Department of Human Services (DHS), which has an extensive database for children receiving services, but Jill said that DHS would not have data on specific disabilities. In Minnesota, children are not eligible for services until they are either in 3rd grade or have fallen two years behind their peers. “I support this effort [to track developmental disabilities],” she added. Pat McGovern recommended that the MN EPHT program should look further at the strengths and weaknesses of the data sources and share their assessments with the panel. She commented that both services and disease prevention are important, but they shouldn’t be confused. Blair commented that Phase 2 of Minnesota’s evaluation process would examine the quality of potential data sources in more detail. Cathi asked whether it would be possible to partner with medical and healthcare systems to share data on developmental disabilities. Bruce pointed out that getting access to and interpreting data in medical databases might be challenging in terms of generalizability, but would be worth exploring. Jill has found that healthcare plans are willing to share data sets; Medica has shared data with the American Lung Association (ALA), and ALA and Medica have published some data jointly. Pat McGovern noted that working with healthcare plans can be fruitful, but warned that successful collaboration depends on their current leadership and priorities. Still, she said, keep the options on the table and explore them. Both Cathy Villas‐Horns and Cathi Lyman‐Onkka suggested looking at environmental ties to development disabilities. Blair said that CDC indicated the seven developmental disabilities included in Indicator 2 (from IDEA) were chosen “because evidence suggests environmental exposures may play a role in developing these conditions,” and that MN EPHT could explore those issues. Bruce recommended that MN EPHT should explore what the data sources are, and what they represent, and especially explore IDEA. Jill added that staff should also see how the data relate to the environment. Pat McGovern suggested that staff might want to look at the NRC report, Children’s Health, the Nation’s Wealth, both because it describes 12 a spectrum of what is normal, and because it includes a section on data sources. Pat also suggested that EHTB invite someone from Maternal and Child Health to speak at the Advisory Panel meeting [when it next addresses developmental disabilities]. In summary, members of the panel were supportive of MN EPHT’s suggestion to begin formally evaluating developmental disabilities, exploring Minnesota‐specific data sources. Staff plan to present Phase 1 at the June 2012 panel and consult the panel for next steps. Trackingupdates
Although this section had no scheduled presentation, the first update prompted a discussion about CDC’s cuts to programs to identify lead poisoning in children. The funding cut, said Assistant Commissioner Aggie Leitheiser, reduced CDC’s national budget for lead programs from $30 million to $2 million. EPA funds are focused on cleaning up lead hazards, but not on identifying children who are lead‐poisoned. In addition, the funding cut will severely hamper MDH’s ability to track lead poisoning cases in Minnesota. The tracking updates address:  Childhood Lead Poisoning  Environmental Tobacco Smoke  Birth Defects  Interactive Cancer Incidence Maps  Nationally Consistent Data and Measures  New Arsenic Measures for Private Wells  Communications and Outreach LegislativeUpdate
Aggie Leitheiser summarized several proposed bills. A bill introduced by Senator Sieben would fund more PFC work, but it has not had a hearing. Two bills focus on surveillance: One proposes that all data collected by MDH should be done with consent; it has not yet had a hearing. Another bill proposes that if MDH receives a grant that involves a surveillance program or a registry, the grant must undergo legislative review and approval. Pat McGovern commented that the latter bill raises questions of federal executive authority. The two bills MDH is working on respond to the [State] Supreme Court decision on newborn screening blood spots [these blood spots are tested for heritable or congenital disorders that can cause health‐ or life‐threatening problems that are treatable or avoidable if treated early]. The Court said that MDH has implied authority to collect newborn screening blood spots, but doesn’t have express authority in law to use and store the spots, or to disseminate data derived from the spots. MDH is proposing new language around the newborn screening program that would allow the department to keep spots and data for quality assurance & quality improvement for 71 days and keep 13 the data for two years for newborn studies. MDH is asking for language and an approach that would allow the department to ask parents for permission to keep their information and newborn spots for use in research in future. A current suit on the newborn screening program, plus two class action suits, is scheduled for trial for damages. For genetic information, MDH is now filing to modify language that refers to “biological specimens or genetic information,” which can be applied to almost everything, to limit the term to genetic tests of chromosomes and DNA. Aggie also noted that the governor has proposed a modest supplemental budget. Newbusiness
Bruce Alexander suggested a more complete discussion of sources for tracking developmental disabilities. Pat McGovern suggested that staff prepare a high level summary of EHTB biomonitoring pilot projects and a review of other chemicals that staff propose to add to the website so that panel members who have not been on the panel for all four years will have a better sense of the program’s accomplishments. Pat McGovern made a motion to adjourn; the motion was seconded, and the meeting was adjourned. 14