Minnesota Department of Health
Environmental Health Tracking and Biomonitoring
Advisory Panel Meeting
March 13, 2012 1:00 p.m. – 4:00 p.m. American Lung Association 490 Concordia Avenue St. Paul, Minnesota ENVIRONMENTALHEALTHTRACKINGANDBIOMONITORING
ADVISORYPANEL
MEETINGAGENDA
March13,2012
Time Agenda item Presenters 1:00 Welcome and introductions East Metro PFC follow‐
up laboratory analysis Bruce Alexander Chair Carin Huset 1:20 Laboratory method for Hg in newborn blood spots: assessment and recommendations Betsy Edhlund, Jeff Brenner 1:55 Specific Aims, Part 1: umbilical cord: newborn blood spot comparison study Barbara Scott Murdock 2:25 Break 1:05 Description/anticipated outcome Members and audience members are invited to introduce themselves. Discussion item Panel members are invited to ask questions and provide comment. i
Discussion item Questions to the Panel 1. 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? 2. Should the EHTB support further improvements to this method for biomonitoring in Minnesota? Action item: Motion Questions to the Panel 1) Have panel members 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? Refreshments 2:35 3:00 3:05 3:25 Specific Aims, Part 2: Determining sources and extent of mercury exposure in MN newborns. Jean Johnson Biomonitoring Updates (no presentation)  East Metro PFC Follow‐up  Great Lakes Initiative Jean Johnson Biomonitoring as new content for tracking: evaluation of content and rationale CDC Tracking data on developmental disabilities Blair Sevcik Action item: Motion. Questions to the Panel 1) Have panel members suggestions for changes or clarifications to the Specific Aims? 2) Are we ready to develop a proposal based on these Specific Aims? 3) Since the study must include a wide range of maternal characteristics and potential exposure sources, what population selection criteria should we use for this project? Information item Updates on these biomonitoring topics are in the meeting materials. Panel members are invited to ask questions about these topics. 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 item. 1. What concerns do you have about the data sources? 2. Should we evaluate Developmental Disabilities as a new content area in Minnesota? 3. If we implement this content area in MN, what data sources would you suggest we evaluate with our selection process? ii
3:40 3:45 3:55 4:00 Tracking updates  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 Legislative Update New business Motion to adjourn (no presentation) Aggie Leitheiser Bruce Alexander Bruce Alexander Information item Panel members are invited to ask questions and offer comments. Information item. The Assistant Commissioner will review recent action on EHTB legislation. Request for new topics for future discussion. Request for a motion to adjourn. Next meeting: Tuesday, June 12, 2012, 1‐4 p.m. Red River Room, Snelling Office Park St. Paul iii
TableofContents
Contents
ETHB Advisory Panel Meeting Agenda.............................................................................. i Table of Contents ............................................................................................................... iv Section Overview: East Metro PFC Follow-up Laboratory Analysis ............................... 2 Section Overview: Review of Methods & Quality Controls for Analyzing Mercury in
Residual Dried Blood Spots ................................................................................................ 4 Section Overview: Specific Aims for Follow-up Monitoring Mercury in Newborns
(Parts 1 & 2) ...................................................................................................................... 12 Section Overview: Biomonitoring Updates ..................................................................... 22 Section Overview: New CDC Content Area ................................................................... 32 Section Overview: Tracking Updates .............................................................................. 36 Section Overview: Other Information ............................................................................. 44 iv
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SectionOverview:EastMetroPFCFollow‐upLaboratoryAnalysis
The East Metro PFC Biomonitoring Follow‐up Project measured the concentration of perfluorochemicals (PFCs) in serum of residents of the East Metro who participated in MDH’s 2008 pilot project. The primary purpose of the project is to assess whether efforts to reduce drinking water exposure to PFCs have been successful in reducing body burden in the population. Because some individuals’ samples in 2010 had large percent increases in PFC levels, but still below the geometric mean for the 2010 follow‐up project, the Advisory Panel suggested that the laboratory re‐analyze specimens from 2008 and specimens from the same people in 2010 to make sure the measurements were comparable. Public Health Laboratory chemist Carin Huset will discuss results of her re‐analysis of samples with the largest percent changes (both increases and decreases) between the first round of biomonitoring in 2008 and the follow‐up biomonitoring project in 2010. ACTION NEEDED: No action need be taken at this time. Panel members are invited to ask questions and comment on the findings. 2
Re‐AnalysesofPFCSampleswithLargePercentChanges(2008to2010)
Submitted by Carin Huset, PhD, MDH Public Health Laboratory At the October 2011 Advisory Panel Meeting, the Public Health Laboratory presented the data for the PFC Follow‐Up study. Panel members had some concern about large percent increases in individual samples between 2008 and 2010 (some examples showed a 200%, 400%, and 1100% increase). Because some analytical uncertainty is inherent in the method, and the laboratory was comparing samples analyzed in two different years, the Advisory Panel suggested we re‐analyze specimens from 2008 at the same time as the corresponding 2010 sample to make sure that the measurements are comparable. I looked at the data from 2008 and 2010 and found the samples with the largest percent changes (both increase and decrease). From these, I selected 5 pairs with increases and 5 pairs with decreases that represented the greatest changes for concentrations of PFHxS, PFOA and PFOS, and re‐extracted and re‐analyzed both specimens. The average relative duplicate precision for the 2008 specimens were 10%, 5% and 9% for PFHxS, PFOA, and PFOS, respectively. The average relative duplicate precision 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. Minnesota Pollution Control Agency guidance for PFCs in water and more complex matrices requires relative duplicate precision of 30% for water and 50% for other matrices. All of the samples reanalyzed for this experiment had relative duplicate precision of less than 50%, which is the recommendation for complex matrices. 3
SectionOverview:ReviewofMethods&QualityControlsfor
AnalyzingMercuryinResidualDriedBloodSpots The EHTB statute states that, following the conclusion of the pilot program, MDH shall work with the advisory panel to “assess the pilot program, including but not limited to the validity and accuracy of the analytical measurements and adequacy of the guidelines and protocols.” At the December 2011 meeting, Advisory Panel members were asked to consider and recommend next steps for the EHTB program in completing the assessment of the mercury biomonitoring pilot project. Next steps included an assessment of the feasibility and utility of a novel laboratory method that uses newborn blood spots for mercury biomonitoring. The MDH Public Health Laboratory developed the method for measuring mercury in dried blood spots for the Lake Superior Mercury in Newborns project. Staff recently presented it at the 2012 Winter Conference on Plasma Spectrochemistry, the poster won an outstanding poster prize. To date, the method has not been peer‐reviewed or validated by an outside laboratory. The method was challenging. Because of small sample size constraints, it was not always possible to reanalyze samples when quality control samples did not achieve the set criteria. This raised the number of reported results that needed qualification; in most other metal analyses, adequate sample volumes allow for reanalysis. Moreover, because this method is novel, its extraction efficiency and other performance characteristics were unknown before this study. In this presentation, staff will discuss the strengths and weaknesses of the method and present recommendations for improving the method and their assessment of the best applications for the method. Panel members are asked to consider recommending additional work that the EHTB program could do to improve and apply the method in Minnesota, and/or disseminate the method to other state laboratories.
ACTION NEEDED: We ask the panel to consider the following question for discussion and we welcome other comments and questions. 1. Should the EHTB program support the further improvements and documentation of the method by the MDH Public Health Laboratory for the purpose of disseminating the method to other laboratories? 2. Should the EHTB support further improvements to this method for biomonitoring in Minnesota? 4
ReviewofMethodsandQualityControlsforAnalyzingResidualDried
BloodSpotsintheLakeSuperiorMercuryinNewbornsStudy
Submitted by Betsy Edhlund, PhD., MDH Public Health Laboratory The method for measuring mercury in dried blood spots was developed for this project and was presented at the 2012 Winter Conference on Plasma Spectrochemistry, where the poster won an outstanding poster prize. The quality control acceptance rate is consistent with other metals analyses performed by MDH. Because of small sample size constraints, it was not always possible to reanalyze samples when quality control samples did not achieve the set criteria. This raised the number of reported results that needed qualification, whereas in most other metal analyses, adequate sample volumes allow for reanalysis. Moreover, because this method is novel, its extraction efficiency and other performance characteristics were unknown before this study. To date, the method has not been peer‐reviewed or validated by an outside laboratory Sample Collection Infant blood is spotted onto filter paper cards 24‐48 hours after birth for newborn screening for heritable or congenital disorders. The Newborn Screening (NBS) Programs in each state (MI, MN, WI) collected a sample from residual newborn blood specimens by punching disks from the dried blood spot on the submitted filter paper. Punches from each specimen were collected and stored in 96 well plates. Each well was labeled with a unique Study ID Number for each specimen. Punches from a blank area from each card were collected similarly and stored in separate wells on the plate containing the corresponding specimen. The blank served as a quality control measure to check for possible contamination in each specimen card. NBS Laboratories were supplied with pre‐populated chain‐of‐custody forms to track the unique identifiers assigned. The well plates were submitted to MDH PHL for mercury analysis. NBS cards were excluded from the study if the blood was judged ineligible or inadequate to produce representative results. The following exclusion criteria were established by MDH NBS: 



Specimens other than the initial specimen collected from an infant. Specimens collected at greater than 9 days from birth. Specimens from an infant identified as transfused on the specimen card. Specimens with more adult hemoglobin than fetal hemoglobin. Initially, eight disks were punched from each NBS card for mercury analysis, and many NBS cards were rejected because of insufficient blood. The method was modified to punch 4 disks per NBS card. Mercury Analysis Two 3‐mm filter paper disks containing dried blood were placed into a 96‐well filter plate; 0.15 ml of reagent water containing 0.05% 2‐mercaptoethanol, 0.001% L‐cysteine, 0.005% EDTA, 0.01% Triton X‐100, and 10 μg/L of Iridium (internal standard) was added, 5
followed by 0.15 ml of 2% hydrochloric acid. The covered filter plate was agitated for 30 minutes and stored overnight at room temperature. The filter plate was re‐agitated for 20 minutes and the contents filtered into a 96‐well plate and placed on ICP‐MS auto sampler for analysis against a 5‐ point aqueous standard calibration curve. The laboratory determined the method detection limit (MDL) before analyzing the patient samples. A filter card was spotted with human blood spiked with a mixture of methyl mercury and inorganic mercury, allowed to air dry overnight, and analyzed for total mercury concentration. Ten replicate samples were analyzed over a two‐day period, and the MDL was calculated from the precision of the replicates, using the Student’s t‐test value for nine degrees of freedom multiplied by the standard deviation of the ten replicate total mercury concentrations. The MDL was determined to be 0.70µg/L. The report level was set by multiplying the MDL by 3; for this study, the report level was 2.13µg/L, which is equal to the lowest calibration standard. Patient samples with a total mercury concentration between the MDL and report level were reported as estimated values. The report level was verified with each analytical run to demonstrate that the reporting level would be valid within the analytical run. In this project, defined limits for the reporting level verification (RLV) standard were not agreed upon in the quality assurance project plan (QAPP), but the laboratory has an established guideline that the percent recovery of the RLV standard must fall within ± 40% of the true value. Patient samples were reanalyzed in another batch or reported with a data qualifier whenever the RLV standard did not fall within the lower control limit (LCL) of 60% recovery and the upper control limit (UCL) of 140% recovery. Of the 1496 samples (including blind reference samples) analyzed, 98 samples (7% of all samples analyzed) were reported with a data qualifier as a result of a high recovery of the RLV standard and 80 samples (5% of all samples analyzed) were qualified similarly as a result of low recovery of the RLV standard. A calibration curve was generated for each batch of 20 samples. Every calibration curve was linear with an R2 value ranging from 0.999103 to 0.999998. Calibration verification standards (CVS) at three levels (low, medium, and high) were prepared from the same lots of standards as those used to prepare the calibration standards. Patient samples were bracketed by CVS pairs, and the average of the pairs was used to evaluate the on‐
going acceptability of the calibration. Aqueous blanks (AB) were used to assure that reagents were not contaminated with mercury, or that carryover of higher levels of mercury was not occurring between the highest calibration standard or laboratory control samples (LCS) and patient samples. Of the 78 batches of samples with reportable results, only one batch had an AB preceding a patient sample that exceeded the MDL. 6
For each patient sample punched from the blood specimen spotted onto a filter card, we also punched a blank area of the card to use as a method blank (MB). MBs were processed exactly the same way as the associated patient samples. Only one method blank was observed with mercury values over the reporting limit (RL). Sixteen method blanks (1% of blanks analyzed) were estimated to be between the MDL and the RL. Of the 16 method blanks with low levels of total mercury, only seven (less than 1% of samples analyzed) were observed with mercury values in the blank card punches while those of the accompanying patient sample had mercury concentrations below the MDL. Quality control samples (QCS), laboratory control samples (LCS), and reference samples (RS) were analyzed during each batch of patient samples, although not all batches contained an RS. All were made using National Institute of Standards and Technology (NIST) standard reference material (SRM) of bovine blood at a concentration of 31.4 ± 1.7 µg/L total mercury. The QCS was used to establish that mercury could be extracted from blood; it comprised whole blood diluted with the extraction solution and analyzed. The LCS was used to demonstrate that mercury could be extracted from dried blood spots; it consisted of the SRM spotted onto filter paper cards. When the project began, the laboratory had no experience with how well mercury could be extracted from whole blood or blood that had been spotted onto cards, dried, and then subjected to the entire analytical procedure. The average percent recovery for the QCS was 86% and for the LCS, 82%. QCS and LCS samples were analyzed three times in each analytical run, at the beginning, middle, and end of a batch. The acceptance criteria, published in the QAPP as 80‐120% recovery for both the QCS and LCS, were based on those in the EPA methods for metals in water matrices. Patient samples were reanalyzed in another batch or reported with a qualifier whenever the QCS standard did not fall within the lower control limit (LCL) of 80% recovery and the upper control limit (UCL) of 120% recovery. If insufficient sample remained to reanalyze the samples, the results were reported with a data qualifier. Once the laboratory finished sample analysis, the control limits were reassessed to reflect the true extraction efficiency of the method. Using all of the data collected, we found that the statistically derived 3‐sigma range for the QCS was 70%‐101%, and for the LCS was 64%‐98%. These limits reflect the average percent recovery ± 3 times the standard deviation. Overall, 17% of patient samples were reported with a data qualifier due to a recovery of the QCS outside the 80%‐120% acceptance limits and 60% of samples as a result of the LCS. The RS were prepared just as the LCS were, and distributed to the participating newborn screening laboratories. These samples were re‐submitted to the laboratory blind, as if they were authentic patient samples, and were used to assess the transport and storage of samples. Throughout the study, 26 blind RS were analyzed with an average percent recovery of 80%. 7
Three types of duplicate samples were analyzed with each batch: 1) The field duplicates (FD) consisted of spots punched in duplicate of patient samples. The well plates arrived at the laboratory with the duplicate samples in place. Eighty FD pairs were analyzed in the course of the project. One pair of FD failed the precision limit of 20% relative standard deviation (RSD) with its RSD calculated at 21%. The patient sample result was reported with a data qualifier. All other FD pairs met the criteria for precision. 2) The laboratory duplicate (LD) samples were two concentration levels of past proficiency testing of whole blood samples spotted onto filter paper cards. One level was analyzed at the beginning of the batch and the other at the end. The higher level, analyzed at the beginning of the batch, had an average RSD of 6.8% and the lower level had an average RSD of 8.8% throughout the study. 3) The LCS was also used as a duplicate to evaluate the variability of the analytical procedure. The average relative percent difference (RPD) of the LCS duplicate pairs was 6.4%; 3% of all samples analyzed were reported with a data qualifier due to the RSD of the LCS being greater than the acceptance limit of 20%. Recommendations for Method Improvement & Utility of this Method for Analysis of Dried Blood Spots This method has both weaknesses, with some areas for improvement, and strengths. One weakness was limited availability of standards, both the methyl mercury standard and a certified reference material in a suitable concentration range. Having only one vendor produce a methyl mercury standard led to a discrepancy in the reported concentration. Had more vendors been available, we would have used two different sources of materials, and thus would have discovered the discrepancy sooner and accounted for it from the beginning. More vendors are available now, so if the laboratory were to use this method, we would change the SOP to require the use of two separate sources of material and correct the vendor concentration to be that of methyl mercury, rather than methyl mercury chloride. We would also use a certified reference material with a mercury concentration closer to that of the expected sample concentrations. In this case, the available SRM from NIST had a mercury concentration of 31.4μg/L, well above the general concentrations seen in samples. Now, a new SRM from NIST is certified for a mercury concentration of 17.8 μg/L , with a reference value of 4.95 μg/L in another level. Although these levels are still higher than most seen in the study, they are much closer than the original SRM. The limited sample material available greatly affected the volume of sample that could be used for analysis. Currently, this method uses two bloodspot punches with a total blood volume of 6.2μL. If more sample blood were available, the volume could be increased. This would significantly reduce the method detection and reporting limits and allow more samples to be reported above the detection limit, and without having to be estimated below the reporting limit. 8
More available sample would also reduce the number of qualified samples. For this study, the laboratory received enough of each sample for two analyses. If a QA failure happened, the laboratory had only one chance to reanalyze. Moreover, all samples were analyzed within a batch in which the calibration standards, all QA samples, and patient samples were prepared together, allowed to sit overnight, and then analyzed. The benefit is that every sample is treated equally; they all sit in the same conditions and are filtered at the same time. The downside was that the whole batch had to be run without the ability to re‐inject a sample. Each prepared sample had only enough volume for one injection and could not be re‐prepared for analysis with the current batch. While it seems that this method produced a high number of qualified results, the results seem to be on‐par with other methods run by the laboratory. With other methods, however, the laboratory is able to reanalyze and resolve the QA issues. Although this method has its challenges, it is very consistent. Overall, the recoveries for the report level verification standards, QCS, LCS, and reference samples were all very consistent over the course of the study (about 1.5 years). Given the limited amount of sample, this method is not suited for characterizing the full range of population exposure. It may be better suited for a study that is designed only to look for elevated levels of mercury and is unconcerned with baseline population exposures. A follow‐up analysis could then collect a whole blood sample from the exposed individual to confirm the finding and identify the source of the exposure. 9
10
20
30
40
Total Mercury Concentration (µ
µg/L)
50
0.0E+00
Old PT sample on cards;
5.36 µg/L; n = 93
84%
92%
1.0E-02
Old PT sample on cards; 15.9 µg/L
Hg; n = 92
82%
86%
5.0E-03
SRM 966; 31.4 µg/L; n = 214
SRM 966 on cards; n = 219
91%
80%
Accuracy
Precision
Average of SRM 966 spotted on
cards duplicates
2.13 µg/L spotted on cards; n = 78
0.70 µg/L
2.13 µg/L
Method Performance
MDL
Report Level
Report Level
Verification
Blind Reference Samples, SRM 966
on cards; n = 26
0
y = 0.00107x + 0.00019
R² = 0.99997
Calibration Curve
1.5E-02
2.0E-02
2.5E-02
3.0E-02
3.5E-02
4.0E-02
4.5E-02
5.0E-02
• Two 3-mm punches placed in a 96-well
filter plate
• Added 0.15 mL 0.05% 2-mercaptoethanol,
0.001% L-cysteine,0.005% EDTA, 0.01%
Triton X-100, and 10 µg/L Iridium
• Followed by 0.15 mL 2% Hydrochloric acid
• 30 minutes of agitation and stored
overnight
• 20 minutes of re-agitation followed by
vacuum filtration
• Analyzed by ELAN DRC-II ICP-MS
equipped with a ESI SC-FAST autosampler
• 5-point aqueous calibration curve
containing a mixture of inorganic and
methylmercury
RSD = 8.8%
RSD = 6.8%
RPD = 6.4%
46
186103 3 1 3 1 3 3 1 1
0
12/3/2009
20
40
60
80
100
120
0
100
200
300
<MDL
11.8
400
1
2
111
Blind Reference Samples, SRM 966
5/2/2010
9/29/2010
2/26/2011
Date Analyzed
SRM 966 spotted on filter paper
SRM 966
QC Sample Recoveries
Total Mercury Concentration (µ
µg/L)
22.8
33.9
45.0
500
• 1465 infants, born 2008 – 2010
• MN = 1130, WI = 140, MI = 200
• 44% of samples < 0.70 µg/L (study MDL)
• Median = 0.83 µg/L
• Maximum concentration = 211 µg/L
• MN results suggest a seasonal exposure
pattern
56.0
67.1
600
Study Results
78.2
700 639
721
89.2
100.3
111.4
800
122.5
133.5
144.6
155.7
Mercury Analysis
Conclusions
Funding for this work was provided by the Great Lakes National Program Office under the United States
Environmental Protection Agency, grant number GLNPO 2007-942. Although the research described in this work has
been partly funded by the US EPA, it has not been subjected to the agency's required peer and policy review and
therefore does not necessarily reflect the views of the Agency and no official endorsement should be inferred.
Thank you to the MN, WI, and MI Newborn Screening Programs and the US EPA and
Minnesota State Legislature for funding support.
Information on any of the MN EHTB pilot projects can be found at:
http://www.health.state.mn.us/divs/eh/tracking/biomonitoringpilot.htm
Acknowledgments
SN, Butala S, Ball RW, Braniff CT, 2009. Pilot study for utilization of dried
blood spots for screen.doi:10.1038/jes.2008.19
1Chaudhuri
• Method Performance
• Reproducible, linear calibration curves
• ≥ 80% recoveries for a variety of control samples
• Very consistent percent recoveries over time
• Compares well to mercury in RDBS study conducted in UT1
• Similar MDLs (0.65 µg/L vs. 0.70 µg/L)
• Smaller RDBS punches and lower volumes than UT
• 8% of infants tested had mercury levels above the U.S. EPA
reference dose for methylmercury of 5.8 µg/L
• Supports the need for education on mercury exposure
and fish consumption to women of child-bearing age
• Due to limited availability of blood spots leftover after newborn
screening, only 2-3mm discs were used for mercury analysis
• Increased the MDL; limited characterization of low end of
exposure distribution
• Limits ability to re-analyze if QC issues
• Speciation- unlikely to consistently have enough residual
sample to speciate mercury
• Useful for characterizing high end of exposure distribution and
as a screen for follow-up
• However preference would be to screen mothers to
prevent exposure
• Uncertainty regarding future restrictions on use of RDBS for
public health research
• Correlation of bloodspot mercury with cord blood and maternal
blood would be an interesting follow-up study
Betsy L. Edhlund1, Jeffrey J. Brenner1, and Patricia J. McCann2, 1Public Health Laboratory, 2Environmental Health, Minnesota Department of Health
Determination of Total Mercury in Residual Dried Bloodspots of Newborns from the Lake Superior
Basin Region of Minnesota, Wisconsin, and Michigan
166.7
177.8
188.9
Introduction
A method was developed to determine the
concentration of total mercury in residual dried
bloodspots (RDBS). This method was used for the
analysis of total mercury in RDBS from 1465
infants born 2008 through 2010 to mothers
residing in the US portion of the Lake Superior
Basin. This study was conducted to determine the
range of mercury concentrations in these infants
and to assess the feasibility of using RDBS from
infants as an indicator of mercury exposure. The
level of mercury found
in the newborns’ blood
is indicative of the
mothers’ exposure to
mercury during pregnancy.
Net Intensity
Frequency
Percent Recovery
199.9
211.1
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SectionOverview:SpecificAimsforFollow‐upMonitoringMercury
inNewborns(Parts1&2)
At the December 2011 Advisory Panel meeting, Pat McCann, from the MDH Fish Consumption Advisory program, presented the findings of a study that measured total mercury levels in 1,126 Minnesota newborns from the Lake Superior Basin area. The study used a novel laboratory method developed by the MDH Public Health Laboratory for measuring mercury in newborn screening blood spots. The study found that 10% of newborns tested had total mercury levels that exceeded the EPA reference dose (5.8 micrograms per liter), and suggested that maternal consumption of locally caught fish during pregnancy may be a primary source of the exposure. Advisory Panel members considered several important questions raised by the findings and ultimately directed the MDH staff to develop specific aims for further study needed to help with interpretation of the findings. The specific aims were to address questions both in the short term and long term related to: 1. Comparability of blood spot measurements to cord blood measurements, necessary to establish whether use of the EPA reference dose (based on cord blood) for establishing a safe level in blood spots is recommended (short term objective). 2. Identify the type and sources of mercury exposure (inorganic vs. methylmercury), and the generalizability of the findings to newborns in other communities (long term objectives). In this section, staff will present draft specific aims in response to two motions passed at the December 2011 meeting. The aims are written to clarify the goals, hypotheses, and significance of proposed follow‐up studies, to meet these short and longer term aims. Panel members will be asked to make a recommendation on whether staff should modify the aims, and/or move forward with developing detailed proposals (methods and analysis plans) and budget estimates for follow‐up projects with these specific aims. The section provides a brief background, a review of the motions passed at the last Advisory Panel meeting, and specific aims in two parts for consideration and discussion by the panel. ACTION NEEDED: Panel members are invited to ask questions and provide comment on Specific Aims, Parts 1 and 2. In particular, we ask the panel to consider these questions: Questions to the Panel 1) Have panel members any suggestions for changes or clarifications to these specific aims? 2) Are we ready to further develop a proposal based on these specific aims? 3) What population selection criteria should we use for these projects (given the specific aims and any limitations noted)?
12
BiomonitoringFollow‐upProjectforMercuryinNewborns:SpecificAims
Background The MDH Lake Superior Mercury in Newborns biomonitoring project measured total mercury in residual newborn blood spots collected from 1,465 infants born to mothers in the US Lake Superior Basin (MN, WI, MI; 2008‐10). The project was jointly funded by the EPA and the State of Minnesota Environmental Public Health Tracking and Biomonitoring (EHTB) program, and served as one of the legislatively‐mandated EHTB pilot projects for monitoring mercury levels in an exposed community. Results of the project were reported to the EPA and to the EHTB Advisory Panel in December 2011. The EHTB goals of the original study were to:  Characterize exposure in a population of newborns in the Lake Superior Basin.  Assess the feasibility and validity of a novel method that uses newborn blood spots for mercury biomonitoring.  Assess the need for further biomonitoring in this population or other populations in the state. All specimens were obtained in collaboration with newborn screening programs in the three states. In Minnesota, mothers were contacted after the births to obtain written informed consent for the testing. All blood specimens that were sufficient for analysis were anonymized before testing by the MDH Public Health Laboratory for this study. Most infants were from Minnesota (n=1,126). Results of the study revealed that 10% of the Minnesota spots tested (representing 112 samples) had total mercury concentrations >5.8µg/L, the blood equivalent to the EPA Hg Reference Dose (RfD). The reference dose represents a daily oral exposure likely to be without adverse effects over a lifetime. [For more background on the EPA reference dose, see below]. Fourteen newborns had mercury levels above the EPA benchmark dose limit (>58 µg/L) the estimated dose that could affect neurobehavioral development in 5% of children exposed at this level. Average mercury concentrations in the Minnesota newborn blood spots were higher in summer, which suggests that the mothers may have been exposed by eating fish from local lakes. This in turn implies that the chemical form may be primarily methylmercury, rather than inorganic mercury. However, the form of mercury measured in the blood spots is unknown as the quantity of residual blood in the specimens was insufficient for the laboratory to conduct speciation. Methylmercury, a potent neurotoxin, is readily taken up by the brain and nervous system in rapidly developing fetuses and young children. Health effects include delayed cognitive and behavioral development. Inorganic mercury and vapor from metallic 13
mercury can affect the gastrointestinal tract, kidneys, and nervous system. Health effects vary according to the exposure level. Laboratory staff have a number of suggestions for improvements to the laboratory method for analyzing newborn blood spots. One of these would be a better understanding of the extraction efficiency of the inorganic and organic forms of mercury from dried blood spots. A better understanding of the individual forms could lead to an overall improvement in method extraction efficiency and improved standard recoveries; the current method’s standard recovery is about 80%. Derivation of the EPA Reference Dose for MeHg in Newborns’ Blood One goal of this project is to determine whether the EPA reference dose, which is based on cord blood, is an appropriate reference for interpreting biomonitoring data from dried newborn blood spots. The discussion below traces the development of the EPA reference dose. In 1999, the EPA asked the National Research Council, National Academies of Science, to convene a panel on the Toxicological Effects of Mercury to provide scientific guidance for deriving a prudent reference dose (RfD) for methylmercury. The panel defined the context as follows: Mercury (Hg) is widespread and persistent in the environment. Methylmercury (MeHg) accumulates up the food chain, leading to high concentrations in predatory fish. If humans eat these fish, the exposure raises the risk of adverse effects, such as neurodevelopmental delays, in highly exposed or sensitive populations. Hg‐contaminated fish are the major sources of human exposure to MeHg in the US.1, 2 The NRC chose the Faroe Islands study as the basis for the RfD because of its large population, use of both cord blood and hair mercury as measures of exposure, its documentation of poor neurodevelopmental outcomes associated with MeHg exposure, extensive peer review in the epidemiologic literature, and a re‐analysis in response to questions raised by outside experts. The panel chose umbilical cord blood Hg as biomarker because “[this measure] would be expected to correlate most closely with fetal‐brain Hg concentrations during late gestation… ”1, 2 The NRC panel calculated a benchmark dose level (BMDL), defined as “the lowest dose… expected to be associated with a small increase in incidence of adverse outcomes (… in the 1% to 10% range).” The adverse effects seen in the Faroe Islands study were best detected with cord blood as the biomarker; the lowest BMD for a neurobehavioral endpoint was the Boston Naming Test. On this basis, the panel estimated the BMDL as 58µg/L (58 ppb) of Hg in cord blood.1, 2 From that BMDL, which EPA identifies as a BMDL05, the EPA applied an uncertainty factor of 10 to derive an RfD of 5.8µg/L in maternal blood, which corresponds to a maternal intake of 0.1 µg of Hg/kg body weight/day.2 EPA also identified areas for greater clarification, noting that the ratio of cord:maternal blood and variability around 14
this ratio is highly relevant. EPA assumed that the cord: maternal blood ratio was 1.0, although the data available suggested that it was likely 1.5 to 2.0 cord:maternal blood.3 A Monte Carlo‐based meta‐analysis of 10 studies of the cord:maternal ratio resulted in a recommended central tendency estimate of 1.7, a coefficient of variation of 0.56, and a 95th percentile of 3.4.4 Although EPA has not changed the RfD to accommodate this, several recent studies argue for and/or use the 1.7 ratio to calculate a maternal RfD of 3.5 µg/L of blood.5,6,7 References 1. National Research Council (NRC). 2000. Toxicological Effects of Mercury. Executive Summary. pp. 1–12. Washington DC: National Academies Press. 2. National Research Council (NRC). 2006. Human Biomonitoring for Environmental Chemicals. Appendix B. Case Example of Biomonitoring Results Interpretation Based on Biomarker Effect Relationship Developed in Epidemiologic Studies: Methylmercury. pp. 265‐277. Washington DC: National Academies Press. 3. Rice DC, Schoeny R, Mahaffey K. 2003. Methods and Rationale for Derivation of a Reference Dose for Methylmercury by the U.S. EPA. Risk Analysis 23(1): 107–115 . 4. Stern AH, Smith AE. An Assessment of the Cord Blood:Maternal Blood Methylmercury Ratio: Implications for Risk Assessment. Environmental Health Perspectives 111(12): 1465–1470 5. Hightower JM, O’Hare A, Hernandez GT. 2006. Blood Mercury Reporting in NHANES: Identifying Asian, Pacific Islander, Native American, and Multiracial Groups. Environmental Health Perspectives 114(2): 173–175. 6. Mahaffey KA, Clickner RP, Jeffries RA. 2009. Adult Women’s Blood Mercury Concentrations Vary Regionally in the United States: Association with Patterns of Fish Consumption (NHANES 1999‐2004). Environmental Health Perspectives 117(1): 47–53. 7. Miranda ML, Edwards S, Maxson PJ. 2011. Mercury Levels in an Urban Pregnant Population in Durham County, North Carolina. Int. J. Res. Public Health 8: 698–712. Advisory Panel Recommends Next Steps In the December 2011 Advisory Panel meeting, results from the project were presented to the EHTB Advisory Panel, and members discussed next steps. Advisory Panel members commented on several key questions that remain for interpreting these results including the following: 
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The relationship between mercury levels measured in newborn blood spots and cord blood is unknown. This information is needed so we know whether comparison to the EPA reference dose (based on cord blood) is valid for interpreting the findings. Speciation is important and would help in identifying the sources of the exposure. High levels in the tail of the distribution, in particular, might reflect other sources of mercury exposure. It would be useful to compare these results with a different MN population to see if it’s a state problem or is unique to the Lake Superior region, and to identify 15
whether the seasonal peak in exposure is related to local or regional exposure differences. EHTB Advisory Panel members agreed that this pilot project’s results raise important public health questions that merit further investigation. More information about laboratory methods and the need for additional refinements would be presented at a future meeting. The panel requested that staff develop specific aims and proposals for future work on these questions and bring them back to the panel for further review. The panel passed two motions: Motion 1 (passed) Do a follow up study that would compare mercury levels in cord blood to mercury in newborn blood spots. The study would use paired samples of cord and newborn blood spots from each newborn in the study. The study would verify whether newborn blood spots accurately reflect the mercury levels in cord blood and enable the laboratory to identify the species of mercury. Motion 2 (passed) Down the road, the EHTB program should look for resources to investigate the sources of mercury exposure in other populations in the state. The long‐term objectives are to develop other [methods] to characterize exposure in broader populations of Minnesota to learn the [sources and] extent of the problem [identified in the Lake Superior pilot project]. 16
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SPECIFICAIMS:Part1,ResponsetoMotion1
Project to refine the laboratory method and measure the ratio of cord blood: blood spot total mercury concentration. Goals, Rationale, Hypotheses and Significance Goal 1 is to compare the total mercury content in paired umbilical cord blood and newborn blood spots from a sample of newborns (with parental consent) and obtain a measure of the average ratio of cord blood to blood spot mercury concentration. Goal 2 is to learn the relative concentrations of methylmercury and inorganic mercury in the specimens through speciation of the cord blood, and establish whether this is a significant co‐variate for determining the cord:blood spot ratio. Goal 3 is to further refine the MDH laboratory methods for measuring mercury exposure in newborns. Rationale. Pilot study findings measuring exposure to newborns from newborn blood spots suggest that a significant proportion (up to 10%) of fetuses and babies in the Lake Superior Basin and perhaps in other regions of Minnesota may be exposed during gestation to mercury levels that can harm cognitive development. This proportion is greater than expected based on other US studies of maternal and cord blood. At the same time, interpreting the results from a novel laboratory method involves uncertainties. If the results can be verified as being comparable to or predictive of exposure measured by standard methods in cord blood, MDH will be able to recommend the method for ongoing monitoring of newborn exposure over time and in other populations, and may have greater confidence in the interpretation of blood spot results using comparisons to the EPA reference dose, which is based on cord blood. Furthermore, the MDH Public Health Laboratory will be able to determine whether differences in mercury speciation affect extraction efficiencies from the blood spot and the cord:spot ratio. Hypothesis 1 (null): The ratio of total mercury concentration in the newborn blood spot: cord blood total mercury concentration will be equal to 1.0 (no difference). If this be true, the significance will be that the comparison of newborn blood spot concentrations to the EPA reference dose provides an appropriate assessment of health risk among the population of infants tested and may be used to inform further public health actions. Moreover, after further verification and methods development, future biomonitoring projects in Minnesota and in other states may be able to use this method (with parental consent) to measure and track newborn population exposure to total mercury, rather than having to obtain cord blood. Hypothesis 1 (alternative): The ratio of total mercury concentration in the newborn blood spot: cord blood total mercury concentration will be not be equal to 1.0 (a measured difference). If this be true, the significance will be that the comparison of newborn blood spot concentrations to the EPA reference dose requires an adjustment or correction factor for making an appropriate assessment of health risk among the population of infants tested and for informing further public health actions. 18
Hypothesis 2 (null): The ratio of total mercury concentration in the newborn blood spot: cord blood total mercury concentration is not changed by differences in the ratio of MeHg and I‐Hg measured in the cord blood sample. The significance is, if the total mercury content of paired cord and newborn blood spots correspond and the ratio is unchanged by mercury composition, it may be possible to estimate a newborn’s MeHg exposure and compare it directly to the reference dose, which is based on cord blood. Given the uncertainties about the novel laboratory method and specimen, we will need further verification to be confident about whether the proportions of the mercury species in newborn blood spots accurately reflect those in cord blood, and whether differences is mercury composition affects extraction efficiency in the laboratory. Specific Aims  Obtain paired cord blood and newborn blood spots from a small population of newborn infants.  Measure total mercury in both blood specimens for each pair; compare the results for each cord blood and newborn blood spot pair and calculate an average ratio.  Speciate the mercury in the cord blood sample for each pair; document the MeHg and I‐Hg for the cord blood in each pair.  Categorize paired specimens based on differences in the ratio and analyze how differences in mercury speciation results contribute to variability in the ratio  Analyze how differences in mercury speciation affect blood spot extraction efficiency. Questions to the Panel 1. Have panel members any suggested changes or clarifications to the Specific Aims? 2. Are we ready to further develop a proposal based on these Specific Aims? 3. Given that the study must be small enough to be conducted within limited resources, what population selection criteria should we use for this project? Suggested motion: I move that EHTB staff develop a project proposal (to include project design, methods, population selection, laboratory method, and data analysis plan) for accomplishing these specific aims (as above or as modified by the Panel) and that the proposal be submitted for consideration by the Advisory Panel at a future meeting. 19
SPECIFICAIMS:Part2,ResponsetoMotion2
Project to Measure the Sources and Extent of Mercury Exposure in Other Parts of the State Goals, Rationale, Hypotheses and Significance Goal 1 is to describe the range and distribution of total mercury in newborn blood spots from a sample of newborns (with parental consent) in Minnesota in one or more locations outside the Lake Superior Basin region. Goal 2 is to learn whether populations in other parts of the state have the same (or different) proportion of babies born with elevated mercury concentrations (exceeding the EPA reference dose) as those observed in the Lake Superior project. Goal 3 is to identify maternal risk factors that explain variations in the total mercury concentrations. Goal 4 is to further refine the MDH laboratory methods for measuring mercury exposure in newborns. Rationale. Pilot study findings measuring exposure to newborns from newborn blood spots suggest that a significant proportion (up to 10%) of fetuses and babies in the Lake Superior Basin and perhaps in other regions of Minnesota may be exposed during gestation to mercury levels that can harm cognitive development. This proportion is greater than expected based on other US studies of maternal and cord blood. Furthermore, a seasonal pattern was observed suggesting that local fish consumption may be a factor in the summer months. An important public health question is whether this observation is unique to babies in the Lake Superior region of the state or whether these patterns can be observed in other parts of the state. In addition, a maternal questionnaire will be administered to gather information on dietary exposure in pregnancy and other risk factors in order to further elucidate the source of the exposures. The information learned will help to inform public health actions throughout the state. Hypothesis 1 (null) [No regional differences]: The proportion of newborns with total mercury concentration that exceed the EPA reference dose (10%) will be consistent with those in the Lake Superior region when measured in populations outside the Lake Superior region (no difference). If this be true, the significance will be that further public health actions recommended for the Lake Superior region are applicable throughout the state and future biomonitoring should be extended to other populations. Hypothesis 1 (alternative) [Regional differences exist]: The proportion of newborns with total mercury concentration that exceed the EPA reference dose will be different when measured in populations outside the Lake Superior region (> or < 10%). If this be true, the significance will be that public health actions should be tailored to meet specific regional and population differences, and more study is needed to identify the 20
risk factors that predict under what conditions and locations these elevated exposures are likely to occur. Hypothesis 2 (null) [No exposure variable differences]: Total mercury concentration in the newborn blood spot does not vary significantly by differences in maternal risk factors such as income, education, race/ethnicity, age, reported tobacco use, or fish consumption frequency in pregnancy. The significance is, if these factors are not predictive of mercury exposure, then public health education and exposure prevention programs should not be targeted at these specific at‐risk populations but should be broadly applied to all women of child‐bearing age throughout the state. Hypothesis 2 (alternate) [Exposure variable differences exist]: Total mercury concentration in the newborn blood spot does varies significantly based on differences in maternal risk factors such as income, education, race/ethnicity, age, reported tobacco use, or fish consumption frequency in pregnancy. The significance is, if these factors are predictive of mercury exposure, then resources for public health education and exposure prevention programs should be targeted at these specific at‐risk populations, which can be identified through survey methods, to be most cost‐effective. Specific Aims  Obtain newborn blood spots from a sample of newborn infants (with parental consent) from a population (or populations) living in Minnesota but outside the Lake Superior basin region.  Measure total mercury in blood specimens for each pair; if possible obtain sufficient blood spot material for speciation (two whole spots).  Obtain questionnaire responses on maternal risk factors including age, education, income, race, ethnicity, any use of mercury during cultural practices, and diet, including fish consumption frequency in pregnancy.  Analyze the contribution of risk factors to variance in total and speciated blood mercury levels in newborns. Questions to the Panel 1) Do panel members have any suggestions for changes or clarifications to these Specific Aims? 2) Are we ready to further develop a proposal based on these Specific Aims? 3) Given that the study must be large enough to include a wide range of maternal characteristics and potential exposure sources, what population selection criteria should we use for this project? Suggested motion: I move that EHTB staff develop a project proposal (to include project design, methods, population selection, laboratory method, and data analysis plan) for accomplishing these specific aims (stated above or as modified by the Panel) and that the proposal be submitted for consideration by the Advisory Panel at a future meeting.
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SectionOverview:BiomonitoringUpdates
These updates are provided to let panel members know about progress in program areas that are not featured in the current meeting. This section contains status updates on the following: Biomonitoring Status Updates:  East Metro PFC Follow‐up  Great Lakes Initiative ACTION NEEDED: No action need be taken at this time. Panel members are invited to ask questions and offer comments on the project updates. 22
BiomonitoringUpdates
Status Update: The East Metro PFC Follow‐up Biomonitoring Project All communications about phase 1 of the project―assessing whether PFC blood levels have declined since 2008―are complete. Before releasing results, staff met with local public health officials in Washington County, Oakdale, and Cottage Grove to inform them of findings and our outreach plan. Participants were then mailed their individual results (the mailing included a letter, individual results in graphic and table form, a report to the community summarizing the findings, and a pre‐stamped postcard that they could return if they wanted to talk with an MDH physician about their results). Soon after, we issued a news release and held a telephone press briefing; a number of local and state‐wide media outlets covered the story. We held a community meeting in Oakdale, which 25‐30 people attended, and gave a presentation on results and implications for health care providers to a group of physicians at the HealthEast Oakdale clinic. Epidemiologist Jessica Nelson is expected to begin the phase 2 analysis of the project results in late May, when she returns from maternity leave. This next phase will include a detailed analysis of the data collected in the participant questionnaires and will explore the contribution of a range of co‐variates and other sources of exposure (dietary, consumer products, occupation, and drinking water history) to the variability in the blood levels. MDH staff will continue to monitor the developing PFC health literature, so that public officials and community members are informed about any new developments or findings. New findings from the C8 studies (West Virginia and Ohio communities) are anticipated in 2012. Status Update: The Great Lakes Initiative Biomonitoring Study Background This study has a non‐research public health focus on susceptible subpopulations with increased risk of exposure to persistent contaminants common to Great Lakes watersheds. Funding for the study originated from the Great Lakes Restoration Initiative and was provided through EPA to ATSDR, who funded cooperative agreements with public health agencies in Minnesota, Michigan, and New York to conduct human biomonitoring studies. In Minnesota, the Fond du Lac (FDL) Band of Lake Superior Chippewa Reservation is located in the Great Lakes Basin and within the St. Louis River Area of Concern (SLRAOC). The SLRAOC has been impacted by industrial activities over decades, resulting in contaminated sediments, abandoned hazardous waste sites, landfill and industrial discharges, and surface runoff. American Indians affiliated with FDL or other tribes, who 23
live in proximity to the SLRAOC (herein called the “FDL Community”), may experience greater exposure to contaminants as consumers of traditional foods from local aquatic environments, such as fish and waterfowl. Within the FDL Community, certain subgroups are also more sensitive to the effects of contaminants due to life stage, including elders and women of child‐bearing age. MDH and the FDL Human Services Division (HSD) are collaborating on the study. The overall strategy is to measure contaminant levels in, and to administer questionnaires to, a representative sample of 500 adults in the FDL Community. Study findings will be used by MDH and FDL to develop a public health action plan to prevent or reduce exposures to Great Lakes contaminants through targeted interventions. Timeline The project period is September 30, 2010 to September 29, 2013. MDH plans to request an additional one‐year, no‐cost extension. Recruitment and enrollment are anticipated to begin in summer 2012. Status Update FDL HSD study staff are leading the process to hire an on‐site study manager and two recruiters/interviewers. MDH study staff are writing the study operations manual, building IT infrastructure, and implementing revisions to the study protocol required by both the FDL IRB and the CDC Information Collection Review Office (ICRO). On January 12, the FDL IRB approved the study protocol contingent upon several required changes. MDH has addressed the FDL IRB’s concerns and is awaiting a final approval letter. At the federal level, ATSDR submitted a package to ICRO for review in mid‐February. ICRO coordinates clearance for CDC‐sponsored data collections regulated by the Office of Management and Budget (OMB). MDH is currently implementing ICRO‐recommended changes to the protocol prior to OMB submission later this month. OMB approval is expected by June 1st. 24
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SectionOverview:BiomonitoringasNewContentforTracking
Exposure:EvaluationofContentandRationale
In this section, staff will present a new Minnesota‐specific Tracking content area that is under development: Biomonitoring (Chemicals in People). Minnesota’s legislation directs us to integrate biomonitoring (exposure) data with state environmental health hazard and health outcome data. With the promotion of these data and measures, and accompanying messages, Minnesota will be the first state to feature biomonitoring data as content on its state EPHT (Tracking) data portal. These data have the potential to provide an important source of information for informing public health policy and disease prevention programs. For Minnesota, they serve as the primary reference for interpreting results from our community‐based projects. At the March 2012 advisory panel meeting, MN EPHT staff will provide an overview of the criteria used for exploring and evaluating the data and measures thus far, and will provide a preview of the proposed data display for the state data portal. We have selected two chemicals that are priority chemicals under our state legislation, PFCs and mercury, for piloting this new content. ACTION NEEDED: Panel members are invited to ask questions and provide input on Biomonitoring (Chemicals in People) as a new content area for Tracking. In particular, we ask the panel to consider the following questions: 1. Based on the portal demonstration, have you any suggestions for improving the content or messaging for biomonitoring data displays on the portal? 2. In addition to PFCs and mercury, what other important Minnesota priority chemicals should be included in data display in this content area? 26
SummaryofEvaluationCriteria
Biomonitoring:ChemicalsinPeople
DataSources:NationalHealthandNutritionExaminationSurvey
(NHANES)
PhaseI:Exploration
Resourcesavailable
Question Is there staff time/interest/expertise? Are there financial and technical resources available? Answer Yes. The data provide an important reference for targeted biomonitoring in the state and can be integrated with other MN EPHT hazard and health outcome data. Yes, MN EPHT supports an epidemiologist with expertise in analysis of NHANES biomonitoring data Prevalence
Question Is there a high estimated proportion of the population that is exposed? Answer We propose to add biomonitoring data on different environmental chemicals of public health interest in Minnesota in this new content area. We will start with data on mercury and perfluorochemicals (PFCs), which have been the focus of our state biomonitoring program. The estimated proportion of the population exposed will vary by chemical, and will be part of the criteria we use in determining which chemical data to add. Biomonitoring uses very sensitive lab methods that can detect concentrations of a chemical in peoples’ blood or urine at very low levels – usually in parts per billion. Most chemicals that we would propose to add to this content area will thus be widely detected in people. For example, the three most commonly detected PFCs are present in greater than 99% of people in the NHANES 2007‐2008 sample (source: Kato et al. ES&T 2011); in the NHANES 1999‐2000 sample, total mercury was detected in the blood of 81% of children aged 1‐5 years and 94% of women aged 16‐49 years (source: Schober et al. JAMA 2003). 27
Causality
Question Is there evidence that exposure is a component cause of adverse health outcomes? Answer This will again vary with the specific chemical in question, and will play a role in determining which chemical data to add. For some chemicals, such as mercury, enough research on possible health effects has been done that public health scientists have determined safe and unsafe levels in blood or urine. Outcomes of concern include neurodevelopment in babies and children, and kidney and nervous system damage in adults. For other chemicals, such as PFCs, we do not yet have enough information to determine safe or unsafe levels. However, concern about possible human health effects from exposure exists based on evidence from animal and toxicological studies. Human studies are under way. Actionability
Question Are there existing prevention or control programs at MDH or other Minnesota organizations for the exposure or its adverse health outcomes? Answer Yes. For many environmental chemicals of interest in Minnesota, some type of exposure reduction policy or program is in place. For mercury, MDH’s Fish Consumption Advisory Program provides statewide and site‐specific advice for safe fish consumption based in part on mercury levels; MDH also provides information and resources on other possible mercury exposures in the home. The MPCA provides regulatory control of mercury emissions and has implemented mercury emissions reduction strategies. For PFCs, MDH has established Health Risk Limits for two PFCs in drinking water. MDH has also conducted two biomonitoring pilot projects in Minnesota communities exposed to PFCs in contaminated drinking water to determine whether efforts to reduce drinking water exposure to PFCs were successful. The PFC example shows that biomonitoring data, a direct measure of exposure in people, uniquely provides important data about whether exposure reduction policies and programs have been effective. 28
Can the level of exposure or disease be modified through policy, regulatory, or personal actions? Is the exposure or disease tied to state or federal public health objectives? Can data and measures in this content area be used to develop new program initiatives? Yes. All chemicals for which we would propose to add biomonitoring data, exposure can be modified through a combination of these factors. It is a crucial part of our messaging around biomonitoring data to be clear about actions that can be taken to reduce exposure. When state or national policies on exposure are in place, we would highlight these, and we would also emphasize personal actions that individuals can take. Federal Healthy People 2020 objectives include biomonitoring measurements of 17 environmental chemicals or their metabolites, including separate objectives for reductions in total blood mercury in children and women of child‐bearing age. Currently. no Healthy People or state objectives specifically address reducing PFC levels in people. Objectives for ensuring clean, safe drinking water are applicable to reducing PFC exposure in exposed communities. Yes. Biomonitoring data are very useful in setting priorities for, and helping shape future program initiatives. They can help determine whether some populations, such as children or certain racial/ethnic groups, are more highly exposed to environmental chemicals than others, or whether they are exposed at levels that are above a health‐based standard. If such differences are found, these groups should be targeted in any program initiatives. PublicHealthImpact
Question Is the population attributable risk (PAR) or public health impact of exposure known or can it be estimated from available data? Answer For chemicals with more robust data on health outcomes, such as mercury, estimates of public health impact have been made. An analysis of NHANES data estimated that as many as 300,000 to 600,000 American children were born with elevated risk of neuro‐developmental disorders during 1999‐2000 due to chronic organic mercury exposure (>5.8µg/L in maternal blood).* For other chemicals (e.g., PFCs) whose human health impacts are less well understood, these estimates have not been made. 29
(Initial)Feasibility
Question Is there one or more data sources for exploration of trackable indicators? Does MDH have the legal authority to collect and use the data? Are private data classified and protected according to state and federal law? Answer Yes. The CDC's National Biomonitoring Program conducts biomonitoring for hundreds of chemicals in the blood and urine of a representative sample of the U.S. population. It does so through the National Health and Nutrition Examination Survey (NHANES), an ongoing survey of the non‐
institutionalized civilian U.S. population. Yes. NHANES data are publicly available, with free download from the internet. Yes. No private data are available through NHANES. *MahaffeyKr,ClicknerRp,BodurowCc(2004)BloodOrganicMercuryandDietaryMercuryIntake:National
HealthandNutritionExaminationSurvey,1999–2000.EnvironHealthPerspect112:562‐570.
PhaseII:DetailedFeasibility
Question What is the level of quality of the data? Is there continuity? Are the data timely? Are the data comparable [to similar data in other populations]? Is aggregation possible at different geographic and temporal levels? What is the cost to MDH to obtain data? Answer The data are:  US population‐based probability sample  Laboratory methods are assumed to be reliable and valid. Yes, there has been consistent data collection over time, the NHANES chemical biomonitoring reports are generated on 2‐
year cycles, starting in 1999‐2000 for most chemicals of interest. New chemicals have been added with each cycle. Refinements in biomonitoring methods in some cases have led to lower detection limits, which makes measures of percent detection not comparable across years. Yes with limitations. For most chemicals, datasets are typically available to the public within 2‐4 years of sample/specimen collection (2007‐2008 data are currently available). Yes with limitations. Other biomonitoring data collected may or may not use standard published laboratory methods that are comparable to CDC methods. Careful attention needs to be paid to specimen collection and study methods in comparing biomonitoring results. Data are available at the national level only. With special permission, some regional‐level analysis is possible. Aggregation is possible across 2‐year cycles. The cost to MDH to obtain data and staff time to complete these data steps is reasonable and not prohibitive. 30
PilotedData&Measures
PFCmeasures:populationmedianbloodlevelsforPFOS,PFOA,andPFHxS
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By year By gender By race/ethnicity By two exposed MN communities (compared to US)
Mercurymeasures:bloodmercurylevelintheUS
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Median and 95th percentile by age category (2007‐2008) 95th percentile blood mercury level in US children by 2‐year cycle (1999‐2008) Percent of US women of child‐bearing age with blood mercury above 5.8 µg.L o By 2‐year cycle (1999‐2004) o By race/ethnicity (aggregated 1999‐2004 **END OF PHASE II: FEASIBILITY**
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SectionOverview:NewCDCContentArea
In January 2012, the CDC launched a new content area that tracks data for seven developmental disabilities on the CDC Tracking data portal. The data come from the CDC and from the US Department of Education and differ in focus and in selection criteria. DISCUSSION Item: Panel members are invited to address questions and suggest ways to address the data limitations in Minnesota. Questions for Advisory Panel: 1. What concerns do you have about the data source(s)? Do you share concerns about IDEA? 2. Do you suggest we evaluate Developmental Disabilities as a new content area in Minnesota? 3. If we implement this content area in Minnesota, which Minnesota data sources on developmental disabilities would you recommend we evaluate through our selection process? 32
NewCDCContentArea:DevelopmentalDisabilities
The CDC launched this content area January 2012 on the CDC Tracking data portal at: http://ephtracking.cdc.gov/showDevelopmentalDisabilitiesLanding.action Data for seven developmental disabilities are available on the national portal: 
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Autism spectrum disorders (ASDs) Developmental delay Emotional disturbance Hearing impairment or hearing loss Intellectual disabilities Speech or language impairment Specific learning disability These data come from the CDC and from the US Department of Education. As the information below illustrates, the data differ in focus and in selection criteria. Indicator 1: autism Indicator 2: services for DD Prevalence of autism 
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Per 1000 children Age 8 By race/ethnicity and sex Data from ADDM – not available in Minnesota Number of children receiving services or interventions for developmental disabilities (DD) 
By age group (3‐17 years) Data from IDEA – available in Minnesota Data source 1: Autism and Developmental Disabilities Monitoring Network (ADDM)  From CDC  Sparse data (not available in Minnesota) Data source 2: Individuals with Disabilities Education Act (IDEA)  From the US Department of Education  Ensures that children with a range of developmental disabilities receive services in school  Good temporal and spatial data (available in Minnesota and at the state‐level in the US)  Limitations: o Cannot be used to estimate prevalence of any given disability, but only the number of children receiving services for selected disabilities. o Selection bias: There is systematic bias in who is “captured” in this data source; many children are captured at 3‐5 years old and then drop out of the system after receiving services or an intervention (artificially low data after 6 years of age). 33
o Not comparable across years or between states because programs and funding differ by state and over time. Not all children with disabilities receive services. If they do not receive services, they are not counted in IDEA data. DISCUSSION Item: Panel members are invited to address questions and suggest ways to address the data limitations in Minnesota. Questions for Advisory Panel: 1. What concerns do you have about the data source(s)? Do you share concerns about IDEA? 2. Do you suggest we evaluate Developmental Disabilities as a new content area in Minnesota? 3. If we implement this content area in Minnesota, which Minnesota data sources on developmental disabilities would you recommend we evaluate through our selection process? 34
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SectionOverview:TrackingUpdates
These tracking updates are provided to let panel members know about progress in program areas that are not featured in the current meeting. This section contains status updates on the following: 
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Childhood Lead Poisoning Environmental Tobacco Smoke Birth Defects New Interactive Cancer Incidence Maps New Nationally Consistent Data and Measures Developing and Evaluating New Arsenic Measures for Private Wells Communications and Outreach Update March 2012 ACTION NEEDED: No action need be taken at this time. Panel members are invited to ask questions and offer comments on the project updates. 36
TrackingUpdates
Childhood Lead Poisoning: CDC Funding Cut CDC’s funding for lead poisoning surveillance, prevention, and medical case management has been slashed—severely. Nationwide, funding for lead programs has been cut by 94% to $2 million. Although current CDC funding for Healthy Homes and Lead Poisoning Prevention in Minnesota will continue through August 30, 2012, it appears likely that the final two years of the three‐year cooperative agreement will not be funded. During the first year of the CDC award, two thirds of funding must be used to fund Healthy Homes grants to local agencies and organizations working on lead issues. The federal cuts have limited MDH’s capacity to sustain blood lead surveillance. For the MDH Lead Program and the MN Public Health Tracking Program, the reduced capacity has prevented staff from entering manually reported blood lead test results to the Blood Lead Information System (BLIS) database. As a result, about 10‐15% of total annual blood lead level tests are not being entered into the BLIS database. All electronically reported blood lead tests continue to be entered into the BLIS database. MDH is continuing to enforce lead poisoning prevention through environmental assessments in homes of children with blood lead levels ≥15 µg/dL, and hopes to continue assistance with medical case management for children with elevated blood lead levels (EBLLs). The effect of this data gap on surveillance is substantial. Minnesota currently tracks four measures under the Childhood Lead Poisoning content area. Three of the four measures depend on the denominator defined by the total number of children who are tested for EBLLs, regardless of the test result. If gaps in data entry continue, MN EPHT will be unable to track three of the four childhood lead measures: 1) the number and 2) percent of children tested, and 3) the percent of children with EBLLs among those tested. Without these measures, it will be impossible to track the proportion of children with an elevated result among those tested. Both the Lead Program and MNPHT are currently looking at ways to enter all data for 2011, so both programs will have a complete 2011 database for tracking all four childhood lead poisoning measures. Ironically, in January 2012, CDC’s Advisory Committee on Childhood Lead Poisoning Prevention recommended a new reference value based on the 97.5th percentile of the NHANES‐generated EBLL distribution in children 1‐5 years old (currently, 5 μg/dL). They based this recommendation on the weight of evidence from studies of large numbers and diverse groups of children who had low BLLs and associated IQ deficits, problematic attention‐related behaviors, and low academic achievement. This new reference level should be used to identify children with elevated blood lead levels. Currently, approximately 450,000 U.S. children have EBLLs above 5 µg/dL. EBLLS at this level, the Committee said, should trigger lead education, environmental investigations, and additional medical monitoring. In pediatric primary care, primary prevention must start with counseling – even prenatally when possible. Because the literature has shown no 37
safe threshold for lead exposure, it is important that CDC continue to support blood lead surveillance through Public Health Tracking and Healthy Homes/Lead Poisoning Prevention programs. Environmental Tobacco Smoke (ETS): New Topic Area! Webpages for the new Minnesota‐specific topic area of Environmental Tobacco Smoke (ETS) are now available at https://apps.health.state.mn.us/mndata/ets. Measures include the percentage of youths or adults who are nonsmokers and exposed to ETS in various settings in Minnesota. The data come from the Minnesota Youth Tobacco and Asthma Survey and the Minnesota Adult Tobacco Survey. These data can be used to inform the public about the proportion of nonsmokers exposed to ETS in Minnesota, the settings or locations in which exposure may occur, and disparities in ETS exposure. These data explore trends in the percentage of ETS exposure among nonsmokers and could be used for program planning and evaluation by state and local partners. New Tracking Report: Birth Defects A new Tracking Report is available for Birth Defects Data and Measures for 2006‐2008. This is the 5th Tracking Report in the series of reports published by MN EPHT since 2009. The report is available in hard copy (by request) or electronically on the MN EPHT website at: www.health.state.mn.us/divs/hpcd/tracking/pubs/birthdefreport.pdf New Interactive Maps (Cancer Incidence) MN EPHT is developing new interactive maps of cancer incidence data in collaboration with the MN Cancer Surveillance System at MDH. These maps, which will be available in mid‐March, include state and county‐level data for: 
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All cancer types (combined) Lung and bronchus Breast Mesothelioma (*region only) In 2012, MN EPHT also will develop and implement 8 newly adopted Nationally Consistent Data and Measures (NCDMs) for cancer. In addition, we will be expanding outreach and communications activities to state and local agencies, non‐profit organizations, and others to inform them about the availability of these data to inform assessment, planning, and policy. To view data currently available on the data portal, see Minnesota Public Health Data Access: https://apps.health.state.mn.us/mndata 38
New Nationally Consistent Data and Measures The CDC National Tracking Network has adopted new Nationally Consistent Data and Measures (NCDMs) for: 
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Cancer: kidney, liver, mesothelioma, melanoma (required); esophageal, pancreas, oral/pharynx, larynx (optional) Climate change: heat‐related hospitalizations and deaths Drinking water: community water system data (means, maximums) for atrazine, trichloroethylene, tetrachloroethylene, di(2‐ethylehexyl)phthalate, radium, uranium; also, location information for community water systems Childhood lead poisoning: by test year In 2012‐13 MN EPHT will be working with data stewards to develop data and messaging for displaying these new NCDMs on the tracking data portal (MN Public Health Data Access). NCDMs for climate change have already been posted on CDC’s National Tracking data portal, and data for the other NCDMs will be rolled out based on CDC’s schedule for data calls and portal updates in 2012‐2013. For more about the new NCDMs and timelines for data availability, please contact Chuck Stroebel, MN EPHT Program Manager, [email protected], 651/201‐5662. Developing and Evaluating New Measures for Private Wells MN EPHT is collaborating with MDH Well Management staff to develop and evaluate new hazard measures for private wells. This content area, still under development, is new to the Minnesota and National Tracking Networks. Both the state and national efforts have focused first on arsenic as a contaminant of interest. Facts  Nearly 37 million Americans obtain their drinking water from private wells or other small systems. In Minnesota, nearly 1 million people rely on private wells (approximately 20% of the State’s population).  In Minnesota, approximately 10.4% of the new private wells constructed since August 2008 exceed 10 micrograms of arsenic per liter of water (US EPA Maximum Contaminant Level). The percent of total MN private wells (new and existing statewide) that exceed 10 µg/L is likely higher than this estimate.  Arsenic (inorganic) is associated with several adverse health outcomes and is classified as a known human carcinogen by the US Department of Health and Human Services, US Environmental Protection Agency, and the International Agency for Research on Cancer.  Arsenic sample collection and analysis for all new water‐supply wells has been required by rule (Minnesota Rule, Chapter 4725) since August 2008 and will continue for the foreseeable future. The MDH Well Management Section maintains a database that currently contains over 15,000 new well records with arsenic analyses. 39
Data Limitations Many EPHT grantee states do not have a system or statute requiring ongoing collection and reporting of private well data to a central system or government agency. This raises questions about the feasibility of developing Nationally Consistent Data and Measures (NCDMs) for the National Tracking Network. Although MN is fortunate to have a rule that requires arsenic sample collection and analysis, these data are required only for new private wells. As a result, the data have significant limitations: 
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Testing and reporting to MDH is only available in areas of the State where new wells are being constructed. Much of the new well construction occurs in areas under development, although some new wells are replacement wells on existing developed property. No exposure information is required or available (e.g., frequency or amount of use of newly constructed wells, presence of water treatment to reduce arsenic exposure). In Minnesota many private wells are used only occasionally for drinking water or during the summer (cabins). MN statute requires well contractors to collect water samples, but MDH does not verify that the samples have been collected properly. In some cases, for example, sediment in the samples leads to artificially high measured arsenic concentrations. Evaluation Process The new measures for arsenic are currently in Phase 3 of MN EPHT’s evaluation process (the same process used to develop measures for environmental tobacco smoke or ETS). The evaluation applies a systematic set of criteria to assess scientific rationale for developing and adopting tracking data and measures. See MN EPHT’s evaluation criteria and template at: http://www.health.state.mn.us/divs/hpcd/tracking/evaluationprocess/index.html Next Steps MN EPHT and Well Management staff will continue to develop and evaluate (pilot) new tracking measures for arsenic in private wells. This effort will include a detailed analysis of feasibility and evaluating information about actionabililty (i.e., how new tracking measures for private wells may be used to inform public health actions at the state and local levels). In addition, MN EPHT and Well Management Section staff will continue to actively participate in national Private Well Task Force calls to keep informed about other state and national developments, and to evaluate other potential contaminants of public health interest in private wells (e.g., nitrate, manganese, pesticides). For more information about private well data and well regulations in Minnesota, contact Mike Convery, MDH Well Management Section, [email protected], 40
651/201‐4586, or Ed Schneider, MDH Well Management Section, [email protected], 651/201‐4595. For questions or updates about the MN EPHT evaluation process and timeline, contact Chuck Stroebel, [email protected], 651/201‐5662. Communications and Outreach March 2012 Overview MN EPHT communication activities currently focus on reaching staff throughout the Minnesota Department of Health (MDH), other Minnesota state agencies, and local public health agencies to introduce or update them about:  The MN EPHT program and the Minnesota Public Health Data Access (MNPH Data Access), the portal.  The MN EPHT partnership with CDC’s national tracking program;  The value of using MNPH Data Access and the CDC National Tracking Network. Our goal is to increase our target audience’s knowledge of tracking and its enhancements, such as mapping, and to promote the use of the portal in their work. Since October 2012 we have extended our outreach to include policy makers and research librarians. Since our last report in October 2011, MN EPHT staff have completed the following activities:  We hosted the MN EPHT exhibit booth and provided portal demonstrations at the School Nurses of Minnesota Conference, November 2011  We hosted the exhibit booth at the MDH Making It Better Conference, November 2011  And we hosted the exhibit booth and provided portal demonstrations at the Association of Minnesota Counties Conference, December 2011. Commissioners and county staff from 32 of Minnesota ‘s 87 counties visited our table to talk about the data portal and have a hands‐on experience using the portal to find information, mostly the interactive map pages for asthma and lead poisoning; we also had numerous requests to view the acute myocardial infarction and cancer data. Presentations
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MN EPHT Brownbag Seminar: Informing Public Health Planning and Assessment through Data Access (Portal Demonstration) October 2011 
Portal Demonstrations for MN Legislative Reference Librarians, MN House and Senate Research staff, and MN State Legislators Portal Demonstration and Introduction to MN EPHT for MDH School Nurse Coordinator working with school nurses October 2011 October 2011 
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Midwest Center for Occupational Health and Safety Graduate Student Seminar: Tracking Environmental Public Health in Minnesota: From Data to Action Representative Keith Ellison’s Air Quality/ Asthma forum ‐ Asthma presentation Minnesota Public Health Association Policy & Advocacy Committee: Minnesota’s Biomonitoring Program: Update and Next Steps October 2011 October 2011 November 2011 November 2011 
Portal Demonstration for MDH Public Health Nurse Consultants 
Portal Demonstration for MDH Health Promotion and Chronic Disease/Chronic Disease and Environmental Epidemiology staff November 2011 Portal Demonstration for Central Data Group (Local Health Dept. staff) December 2011 
MN EPHT Brownbag Seminar: Biomonitoring Towards Protecting Future Generations January 2012 
Portal Demonstration for MDH Drinking Water Protection management and staff February 2012 
MN EPHT collaboration with CDC national and state tracking outreach efforts MN EPHT communications staff serve on several CDC national tracking marketing workgroups/subcommittees that develop education and outreach materials to promote the national and state grantee tracking efforts. MN EPHT staff co‐chair the Public Health Environmental Practitioner workgroup, one of our important target audiences. Plans for 2012  Seminars available via webinar to a broader audience;  Development of user guides for the data portal;  Continued use of MDH social media resources for outreach;  Pilot tests of the on‐line EPHT survey to gather data from our data users about their use of the portal; this is a collaborative effort with other state tracking grantees. CDC email list The National Environmental Public Health Tracking Network sends program announcements to an email list service. To keep abreast of major developments at the national level (e.g., new data sets added to the national network) via the CDC’s email list, please go to http://ephtracking.cdc.gov/showAbout.action. In the right‐hand column under Resources, click on “Join our List‐serv.” 42
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SectionOverview:OtherInformation
These documents are included in this meeting packet as items that may be of interest to panel members:  December 2011 Meeting Summary  EHTB Advisory Panel 2012 meeting dates  EHTB Advisory Panel roster  EHTB Staff bios  EHTB statute  Recent PFC reports and publications Additional reference materials are available online at www.health.state.mn.us/tracking/ 44
December13,2011MeetingoftheEHTBAdvisoryPanel:Summary
Contents Designing MN Public Health Data Access to Meet Audience Needs ............................ 46 MN Environmental Public Health Tracking (MN EPHT) Updates .................................. 47 Lake Superior Mercury in Newborns: Project Results .................................................. 47 Discussion.................................................................................................................. 48 Lake Superior Mercury in Newborns Study: Questions and Next Steps for the EHTB . 49 Discussion.................................................................................................................. 50 Motion 1 .................................................................................................................... 52 Discussion of the motion. ......................................................................................... 53 Motion 2. ................................................................................................................... 53 Discussion of the motion. ......................................................................................... 54 Criteria for Selecting a Target Population ..................................................................... 54 The National Children’s Study: might the EHTB collaborate with the NCS? ................ 55 Biomonitoring Updates ................................................................................................. 57 East Metro PFC Biomonitoring Follow‐up (PFC2) Project Update ................................ 57 The Giigoonh Ogikendaan Biomonitoring Study (Great Lakes Restoration Initiative) . 57 45
December13,2011MeetingoftheEHTBAdvisoryPanel:Summary
Members present: Bruce Alexander, Fred Anderson, Alan Bender, David DeGroote, Jill Heins‐Nesvold, Cathi Lyman‐Onkka, Geary Olsen, Greg Pratt, Cathy Villas‐Horns, Pat McGovern, and Lisa Yost. EHTB Staff: Jean Johnson, Eric Hanson, Barbara Scott Murdock, Blair Sevcik, Dave Stewart, Chuck Stroebel Other attendees: Assistant Commissioners of Health Aggie Leitheiser and Jeanne Ayers; Public Health Laboratory staff Joanne Bartkus, Paul Moyer, Paul Swedenborg, Betsy Edhlund, and Jeff Brenner; Environmental Health staff Jeanne Carls, Sara Dunlap, Carl Herbrandson, Rita Messing, and Deanna Scher; Minnesota Department of Agriculture staff Joe Zachman; and Nate Mussell (lobbyist, Lockridge Grindal Nauen PLLP). Bruce Alexander welcomed everyone, invited members, staff, and audience members to introduce themselves, and called the meeting to order. DesigningMNPublicHealthDataAccesstoMeetAudienceNeeds
Dave Stewart gave a brief presentation about the ways in which staff have worked with different audiences to gather feedback for improving the public portal’s content and usability. To date, staff have tailored the portal primarily to meet the needs of local public health department staff through usability testing, interviews, and other formal and informal qualitative assessments. He showed examples to illustrate how audience suggestions have helped make the portal easier to use, both in finding and using data. He asked panel members to consider the three questions below and offer their feedback. In asking about other audiences, the goal is allow the staff to focus portal resources on these audiences, as well as local public health audiences. 1) What other audiences might be potential users of the portal? 2) What other state‐specific topic areas might be useful to our priority audiences? 3) What new data displays (e.g., map views, map overlays, zip code‐level data, etc.) might we investigate? During the discussion, panel members suggested the audiences below:  Healthcare providers (physicians, clinicians)  Environmental health departments in state universities in Minnesota  University students in environmental health  All educational levels, from K‐12 to graduate students  Hospitals  Healthcare professions, including school nurses  The Veterans’ Administration: Jill Heins said the VA frequently calls the American Lung Association for advice and information. 46
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Tribal colleges Suggestions for new topic areas and data displays were fewer, as time was limited. Panel members suggested mental health issues, particularly those related to developmental disabilities and autism. National data on these, Blair said, will likely be included in CDC’s National EPHT Network, described on page 8 in the December 13, 2011 Advisory Panel book. Measures include: (1) the prevalence of autism at age 8 (data source: Autism and Developmental Disabilities Monitoring Network), and (2) children receiving services or interventions for developmental disabilities (data source: Individuals with Disabilities Education Act). Pat McGovern suggested adding links from portal pages to other webpages with useful content. MNEnvironmentalPublicHealthTracking(MNEPHT)Updates
The panel had no questions about the updates to the content on the tracking portal. These include:  Cancer Query  Cancer Maps  National EPHT Network Launches New Content Area: Developmental Disabilities  Reproductive and Birth Outcomes Query  Air Quality Query LakeSuperiorMercuryinNewborns:ProjectResults
Patricia McCann presented the results of the study that measured total mercury (Hg) in newborn blood spots from 1465 infants born during 2008 through 2010 to mothers residing in the US portion of the Lake Superior Basin (Minnesota, Wisconsin, and Michigan included). The purpose of this study was to determine the range of mercury concentrations in these infants and to assess feasibility of using dried blood spots from infants as an indicator of mercury exposure. The study found that eight percent of the specimens analyzed were above 5.8 µg/l, the US EPA Reference Dose (RfD) for methylmercury (MeHg). About one percent (14 of 1465) of specimens were above 58 µg/l, the Benchmark Dose Limit (BMDL) used by EPA in developing the RfD. The BMDL is the lower 95th confidence interval of the estimated dose that would double the number of children that test in the lowest 5% of the population in subtle measures of neurobehavioral toxicity. Thirteen of the fourteen specimens above the BMDL were from MN. Overall, mercury concentrations were higher in the MN specimens than in Wisconsin and Michigan specimens, and were higher during the summer. The results suggest a seasonal exposure pattern, which supports a fish consumption exposure pathway. For a more detailed overview of the study, please look at the Advisory Panel book for December 13, 2011. 47
Pat asked panel members for suggestions for the best ways to communicate the results to the public and to health providers in the Lake Superior region. The study anonymized the specimens, so contacting the parents of children with high mercury results is not possible. For this reason, increased communications efforts and plans focus on local public health officials and on healthcare providers, so that physicians would be more likely to advise pregnant and potentially pregnant women to eat fish that are low in mercury. Patricia McGovern suggested reaching out to nurse‐midwives. Discussion. The study sparked a variety of questions. Because the study had used an experimental method, anonymized the specimens, and recruited participants by mail after the births, Alan Bender asked whether willingness to participate led to a bias in the kinds of people who agreed to give informed consent to having their baby’s newborn blood spots analyzed. Fred Anderson asked whether the study had data on race and ethnicity. In both cases, Pat replied that the study had no data on these issues. Because the laboratory method is experimental, Bruce asked, how confident are the laboratory scientists that the high concentrations are real? Jeff Brenner from the Public Health Laboratory (PHL) said that the laboratory staff are confident of their results. The PHL tested the paper used for the blood spot cards for any significant mercury contamination, ran standard mercury samples to test the instruments, and re‐analyzed the specimens with high mercury results to see if the results were consistent from one analysis to the next. To test their laboratory instruments and procedures, staff sent filter paper spotted with blood mercury standards to the Wisconsin and Michigan laboratories, which sent them back as blind samples for testing. The PHL did not send duplicate samples to other laboratories for independent analysis (i.e., no external validation); to date, aside from Utah, no other laboratory has a method for measuring metals in newborn blood spots. Bruce also asked whether Pat and other Environmental Health colleagues had tried to put the findings in a public health context: that is, from these results, did they estimate the total number of babies with elevated levels that are born each year in the Lake Superior basin and in Minnesota as a whole? Would these findings be representative of the population? Pat answered that this estimate has not been done. She added that it would be difficult to compare the findings with NHANES data because, given the increased level of mercury in cord blood versus maternal blood, data from newborn blood spots are not comparable with data from adult blood samples. Lisa Yost noted that the RfD is based on cord blood. Therefore, it’s important to establish the relationship between [residual dried] blood spots and cord blood so we can know what the spot means. It would be nice to be able to analyze a subset in which cord blood is available. Lisa also asked about the time needed to clear mercury from the body. Pat answered that, within the first 24 hours, blood mercury has a peak in concentration and then levels off and follows a one‐compartment model with a half‐life of about 50 days. Aggie Leitheiser then asked, if a mother had eaten a fish meal a day or 48
two before giving birth, would the baby show up as a peak in Hg level? Pat responded that if the mother hadn’t been eating fish at all, that peak would show up, but if she had been eating fish routinely, the peak would not affect the baby’s concentration. Cathi Villas‐Horns asked whether the fish advisory program is extending any outreach to men, but Pat answered that, although the program has reached out to men, men do not necessarily share fish advisory information with their families. Fred asked whether some portions of the fish body have higher levels of MeHg than others. Pat explained that methylmercury binds to sulfide groups in the meat, so there is no way to remove it. When the Fish Advisory program was new, Pat explained, we told people to remove the fat because of PCBs and similar compounds, and now everyone thinks that works for Hg, too. That, she said, is a myth. Aggie Leitheiser asked whether Pat had any speculations about sources of the very high concentrations. Pat answered that the Hg probably is methylmercury. It’s possible that Hg from a broken mercury thermometer or skin lightening creams or some other inorganic mercury (I‐Hg) source could have exposed the mothers of high mercury infants. Pat McGovern suggested that the March of Dimes might be a funding source for further research, or that foundations that serve the area might be interested in the regional issue. Pat said that they were interested in working with the NCS. LakeSuperiorMercuryinNewbornsStudy:QuestionsandNextStepsfor
theEHTB
Jean Johnson followed up on Pat McCann’s presentation by acknowledging that the study’s findings point directly to four sets of questions about…  Sources of exposure  Interpretation of the data  Validity and technical feasibility in the laboratory  Ethical concerns and informed consent First, the study clearly indicates that, although most newborn exposures are within a “safe” range, some exposures are occurring above accepted safe levels in a small subset of the population. The findings also demonstrate a seasonal pattern, which points towards fish consumption as probably the greatest contributor to the exposure. Given that the EHTB program adopted this program as its biomonitoring project in a vulnerable population, have we achieved the goals listed below? These EHTB goals for the mercury pilot project were to: 1) Characterize exposure in the population, and 49
2) Assess the feasibility and utility of a novel method that uses newborn blood spots for mercury biomonitoring. Jean said that follow‐up investigation is needed, both to build on this initial study so the EHTB program can meet the project goals, and, ultimately, to inform future mercury biomonitoring and exposure tracking. Finally, what action steps can we take to protect newborns other than fish consumption advisories? Discussion then focused on the questions below. 1) Sources of Exposure. Should further biomonitoring be conducted in this Lake Superior population to investigate the sources of exposures? 2) Interpretation of the Result. Should EHTB conduct or seek to collaborate with other interested partners in a follow‐up study of paired specimens to determine the ratio of total mercury in newborn blood spots to maternal and cord blood? 3) Interpretation of the Result. Should EHTB conduct biomonitoring using newborn blood spots in a comparison population? In a representative sample of all Minnesota newborns to serve as a reference population? 4) Laboratory Method. Should the EHTB program support the further assessment and documentation of the method by the MDH Public Health Laboratory for the purpose of disseminating the method or making a recommendation? 5) Informed Consent. Should the EHTB program seek to develop consensus on the best methods for obtaining informed consent for future use of newborn blood spots as a biomonitoring specimen? 6) Informed Consent. Given the informed consent requirements currently in law, should the EHTB program seek to inform elected representatives of the costs and benefits of biomonitoring for public health surveillance in order to inform future decision‐making? Discussion. Bruce Alexander suggested that the EHTB program should start with Question 2, what needs to be done in order to understand what newborn blood spots mean? But to answer questions about the interpretation of the data, he added, we need to start with questions about the validity and feasibility of the laboratory method. What needs to be done so we can interpret the data? The first step is to understand the laboratory method. The question is, what do the newborn blood spots mean? How can we interpret the level in the spots if we can’t compare them to the RfD [the reference dose, which is based on cord blood]. That is an important question to be answered. What else is known about infants’ exposure to Hg during pregnancy? 50
David DeGroote commented, that ties into question # 2 on p.22 of the AP book (Can we improve interpretation of the data from newborn spots?), as it derives from the methods. Lisa Yost agreed, asking, how comparable is a blood spot with cord blood? They should be the same, but we don’t know that. Alan: The issue of informed consent leads to a question about how generalizable these results are. Bruce agreed, but observed that this is another issue. If you have data that you are going to report, he said, what do we know about what [the mercury form and content] is in the cord blood? David asked, are there any standards about inorganic mercury (I‐Hg) and MeHg in blood & serum? Rita said that it depends on the individual and the exposure. Pat said that the form of mercury in fish is 95% methylmercury. Greg Pratt asked, does this piece of evidence raise a public health question that should be investigated further? If so, what steps should be taken? Bruce replied that, taken at face value, yes. If we compare these data to NHANES, which is all we have, this population appears to have higher levels of Hg in the summertime. So yes, this does appear to be an issue. It’s not a huge proportion of the population. The figure on p 18 [of the AP book] showed 8% of babies born across the year. The graph shows that babies born in the summer months are exposed above the level of concern. So children who are born or in utero in the summer months potentially have higher exposures. Aggie Leitheiser asked, if the next step is to see whether the blood spot is an accurate reflection of the exposure in the baby, what is the best comparison? Lisa Yost answered that cord blood would be the comparison. That’s the established standard. Speciation should be important, too. Pat McGovern commented that the solution seems to be a two‐fold path. If you want to replicate this in a population, you want to work with a healthcare provider to get the volume of babies and help with recruitment and informed consent. And if you feel this is a concern in the population, this same provider could educate women about fish consumption. Around Lake Superior, fish advisories are important for that population. Cathy Villas‐Horns suggested following up with families to find out if they eat fish. Lisa Yost agreed, saying that the high levels in the tail of the graph (in the McCann presentation) might mean that other sources of mercury might be relevant. Greg Pratt said that if exposure is coming from fish consumption in smaller lakes, then it is important to follow up in other places in Minnesota aside from Lake Superior. In addition, while it makes sense that the exposure is from fish consumption, the evidence is circumstantial. 51
Lisa wondered whether the very upper numbers in the population represent mercury exposures other than methyl mercury in fish. Would it be useful to compare these results with a different MN population, one that has less fish consumption or different fish consumption? It would be interesting to see if it’s a state problem, or just a problem in that region. Pat McCann said that focus groups with women of childbearing age along the north shore of Lake Superior do, anecdotally, appear to show that this population eats a lot of walleye and northern pike, fish that typically have higher mercury levels. Moreover, the literature supports the conclusion that, for most people, fish consumption is the primary source of mercury. Studies found very high levels in Japanese newborns at birth, but the infants were normal, with no clinical symptoms (see references at the end of Pat McCann’s AP book entry for Murata, K., M. Dakeishi, et al. (2007), plus Jean Johnson’s table in her AP book entry for other reports). Bruce asked whether the EHTB program would have the resources to do any study. To do a larger study or statewide study, would you have to find other resources? Jean answered that we have the resources to do a small pilot study of cord blood vs. newborn blood spots. But staff would like to have a recommendation for a larger study if we are asked by a legislator what priorities we have. Greg asked where the resources would be used if the program didn’t use them on the cord blood vs. newborn blood spots. Jean said, the legislation directs us to assess the need for further biomonitoring in this community, or other communities, and to assess the validity of the laboratory method. Alan said that Jean would like at least one recommendation if the EHTB program is to respond to the legislature and media inquiries about what to do next. Cathi Lyman‐Onkka commented that if you cannot correlate the data you have now with cord blood, you would need some method to compare matched cord blood to newborn blood spots for comparison to other populations. When Jean agreed, she asked how difficult that would be. Jean answered that it would not take a large number—perhaps 30 infant‐mother pairs—the program could recruit pairs of mothers & their newborns out of a hospital setting with little difficulty. This discussion led to two motions: Motion 1 Pat McGovern proposed, and Cathi Lyman‐Onkka seconded, a motion that the panel support a follow up study that would compare mercury levels in cord blood to mercury in newborn blood spots. The study would use paired samples of cord and newborn blood spots from each newborn in the study. Such a study would verify whether newborn 52
blood spots accurately reflect the mercury levels in cord blood and enable the laboratory to identify the species of Hg in the blood spots. Cord blood is assumed to reflect the mercury levels in newborn babies. Because the supply of cord blood is much greater than that in dried blood spots, cord blood enables the laboratory to speciate the mercury, thus answering uncertainties about the likely sources and chemistry of mercury in the blood spots. Pat also noted that such a study would not only be consistent with priorities of the legislation, the EHTB Advisory Panel, and other stakeholders, but that fishing and eating fish are culturally important in Minnesota. Discussion of the motion. Lisa Yost asked whether dried blood spots offered a methodological advantage over cord blood, or was this more opportunistic? Pat McCann answered that they were a convenient source of newborn blood at the time. Pat McGovern said that she understands, anecdotally, that collecting fetal blood in cord blood is challenging. You have to notify the hospital delivery suite ahead of time. Blood spots are easier to obtain. Bruce added that newborn blood spots are lower cost than cord blood collection, but Betsy Edhlund from the laboratory noted that cord blood is easier to analyze (and thus less expensive). Pat McCann suggested adding maternal blood to the study as well, to establish the relationship of maternal blood to cord blood to newborn blood spots. Jean said the staff would have to work out the details for the next Advisory Panel meeting and bring the proposal to the meeting. Bruce asked for a vote on the motion. The motion passed by voice vote, with no dissent. Discussion then focused on the next steps. Jean suggested that the laboratory staff discuss the laboratory methods in the next panel meeting, and that it would be useful to for Minnesota to know what to say to other states that are interested in the laboratory blood spot method. David suggested benchmarking the exposures seen in the Lake Superior basin by establishing a reference population for future population studies. Jean said that would require a larger population, a larger sample size, and more resources. Bruce added, if we identify this finding as a potential problem, it begs for follow up. Even if we don’t have the resources right now, that would be a reasonable activity for this program. Pat McGovern added that such a study should do an exposure assessment to validate that fish are the primary source of Hg, and not just assume that the exposure is methylmercury. Or, she suggested, maybe other validated data are available that the program can use. The cord blood to blood spots is a pilot validation of an instrument [for assessing exposure]. Motion 2. Greg Pratt proposed a motion that the EPHTB program look for resources to investigate down the road the sources of Hg exposure in other populations in the state. Pat McGovern seconded the motion. 53
Discussion of the motion. Geary Olsen commented that the motion was too broad, and Jean agreed. She asked whether the panel wanted staff to look at a broad reference population or a target population in one area, to test a smaller population that might have high Hg levels. Pat McCann said that, since blood spots are not useful for routine analysis, we should think about the media we should measure. Given that Hg is an important exposure, it might be better to look at women’s blood to prevent exposure because we can’t do anything about Hg levels by measuring blood spots. Returning to Greg’s motion, Bruce said that we don’t have a study design to react to, but this is one population in the state with some high levels. So monitoring newborn Hg levels is useful. I don’t know that we can get more specific than that. He acknowledged that the motion is broad, but added that it might be difficult to be more specific without first examining the issue in greater detail. Jean said that answering that question would require a broad statewide study. Greg added that the motion enables the program to develop a small study here and a small study there that would provide pieces to the puzzle. Lisa Yost commented that establishing the relationship of the newborn blood spot to maternal blood and to cord blood in a larger population could be much more helpful for understanding population exposure. Jill Heins‐Nesvold asked, which of the things we could study would make a difference in preventing mercury exposure to children? Bruce noted that this program is a biomonitoring and environmental tracking program. The question is, what can this group do to provide useful information about Hg exposure? The program can come back to us with specific ideas. Greg restated the motion: To enable MDH to keep on the table the idea of pursuing more studies as resources appear: 1) To what extent are other populations exposed, and 2) what are the sources of exposure? Pat McGovern proposed a friendly amendment to the motion: The workgroup should develop specific aims and long‐term objectives. The primary aim is to validate the newborn blood method by comparing cord blood to newborn blood spots. The long‐term objectives are to develop other long‐term research agendas to characterize exposure in broader portions of Minnesota—to learn the extent of the source of the problem. The program staff should come back to the panel with specific recommendations. The motion, as amended, passed unanimously with a voice vote. Criteria for Selecting a Target Population Barbara Scott Murdock reviewed the criteria for selecting a target population that had been discussed at the October meeting. She presented the four criteria and tested their efficacy against pregnant women as a proposed general target population. That population was chosen to enable the program to evaluate exposures to a priority target 54
population: “children, as young as possible,” based on stakeholder priorities identified in interviews. These criteria were…  Exposure  Demographic and geographic diversity  Public health policy impacts  Information potential for individual results interpretation Panel members then added and discussed others that should be considered:  Vulnerability  Feasibility  Fundability  Importance of health outcome  Likelihood that exposure at community levels could lead to the outcome  Policy opportunity for intervention  Value as target population: would it add information versus duplicating other efforts, such as the National Children’s Study (NCS). She then introduced the next speaker, Pat McGovern, principal investigator of the NCS study in Ramsey County, Bond Professor of Environmental and Occupational Health Policy at the UMN, and recipient of an award for outstanding leadership contributions to the National Children's Study at the NCS Expanded Steering Committee meeting. The National Children’s Study: Might the EHTB collaborate with the NCS? Pat explained that the NCS is a longitudinal study that will follow 100,000 children across the US from preconception or in utero to 21 years of age. It is the first large exposure and health study in children since the 1950s. Since then, exposures have changed in the environment and in diet. The study is looking at health outcomes that include such components as pre‐term birth, low birth weight, and birth defects. The Ramsey County study is just finishing recruitment, which began in 2011. The Ramsey Co study is testing a two‐tier high‐low intensity method, one of three recruitment strategies. In the low intensity recruitment strategy, once recruited, the women are called and interviewed by mail or phone every six months for 20 minutes at a time. The second group of women starts out with low intensity contact, but the women convert to high if they are interested and live in the right segment of the county. Because the full scale study involves a home exposure assessment, plus blood and urine samples, the researchers felt that was too much of a burden at first. What the researchers wanted to test was, if the recruitment started out at the low‐intensity level, would the participants convert to high intensity more easily? The purpose is to look at the yield and bias with each method, Pat explained. With the first method, we mailed an invitation and waited to see if they mailed us back. Then we added a $10 incentive, and the response grew by 70%. We have mailed to over 31,000 families, and some 2750 55
women responded. After the initial consent, the researchers do a high intensity interview and visit the home. Then they can move on to taking biological and environmental samples. Currently, the NCS is doing a pilot study of environmental chemicals and nutrition in 400 to 500 pregnant women and their infants in the NCS Vanguard phase of the NCS. The study is measuring a short list of analytes in maternal blood and breast milk. Analysis of the blood metals show that total mercury and lead levels in this NCS population are lower than in the 2007‐08 NHANES. Potentially, MDH can add value to the NCS by measuring and adding state‐specific population and analyte data for comparison with the NCS data. Pat then asked Barbara to describe a potential project in Minnesota. Barbara said that the discussion was in its early stages, but she and Jean have been meeting with Lea Foushée, who, with a University of Minnesota Environmental Health Sciences graduate student, conducted a study of diet and health in 200 White Earth Objibwe (Anishanaabeg) families in Mahnomen County. Lea’s findings indicate that these families eat fish as a mainstay of their diet. They raise walleye and lake sturgeon, stock the local lakes, and eat the fish. Their children have been increasingly found to have behavioral and cognitive problems in school, and the community is interested in a follow‐up biomonitoring study. Possible funders include an NIH FOA that focuses on Native American populations and the Blue Cross/Blue Shield Foundation, which helped fund Lea Foushée’s earlier study. Barbara then posed the following questions to the panel: 1) What do Panel members see as the strengths and weaknesses for the suggested collaboration between the EHTB, the NCS and the White Earth families? 2) Do Panel members have other suggestions related to a collaboration between the EHTB program, the NCS and members of the White Earth reservation? 3) What other projects might the EHTB program do that might complement the NCS or address other problems in Minnesota? Alan asked whether we had spoken to the head of the tribe, and the answer was no. Pat McGovern commented that, if staff were looking for mercury and other analyte data to complement the NCS data, that the tribe in Mahnomen County would be a Minnesota population that would be complementary to the NCS. Bruce said that this potential project falls under the motion earlier to explore mercury elsewhere and report back to the panel, with the idea that it might form an NCS comparison population. Greg said that Lea has been involved in environmental issues from way back. Lea and her husband are principals in the North American Water Organization and Lea is leader of the Indigenous Women’s Mercury Project. 56
Pat suggested that Jean and Barbara should work on a proposal to explore interest in the mercury project by discussing it with Lea and the tribe and then reporting back to the panel. Bruce agreed that we don’t have enough information now, but that this would be a very interesting population. He advised the earlier project and said that building on that is not a bad idea. Biomonitoring Updates East Metro PFC Biomonitoring Follow‐up (PFC2) Project Update Jean gave a brief update of follow up to the PFC2. 



Letters and stamped postcards for return have gone out to the participants A press release went out to the media, and staff (Jean, Jessica Nelson) held a telephone conference and met with media reporters. The Star Tribune, Pioneer Press, Oakdale and Stillwater newspapers all carried stories, and MPR also covered it. A successful community meeting took place in Oakdale on December 12. Mary Winnett, the physician who consults on the project, has received about 12 postcards from study participants who request consultation. Jessica and Mary will brief clinicians at the HealthEast Oakdale clinic. Paul Swedenborg gave a very brief update about Carin Huset’s repeat of samples from high PCF participants in the 2008 and 2010 PFC pilot studies. In short, her results for the repeated analyses confirmed the original findings. The Giigoonh Ogikendaan Biomonitoring Study (Great Lakes Restoration Initiative) Rita Messing, from the MDH Environmental Health Division, gave a brief update of this biomonitoring study in the Fond du Lac population. To date, staff have filed for and received exempt status from the MDH IRB. They are still waiting on the decision of the Fond du Lac IRB. Fond du Lac wants to ensure that the community will not be stigmatized by any of the exposure findings, so they are focusing on the subject protection and privacy aspects of the project. The tribe is looking for a coordinator to work with them, and the study staff hope to enroll participants beginning in Spring 2012. Alan asked whether participants would give a one‐time blood draw, and Rita affirmed that. Next, Bruce asked about New Business and, having heard none, asked for a motion to adjourn. The meeting was adjourned at 4:00 PM. 57
2012AdvisoryPanelMeetings
Tuesday, June 12 1‐4pm June meeting will take place in: The Red River Room Snelling Office Park 1645 Energy Park Drive St. Paul, Minnesota Tuesday, Sept. 11, 1 – 4pm Tuesday, Dec. 11 1‐4pm All meetings for the rest of 2012 will take place at MDH’s Snelling Office Park location at 1645 Energy Park Drive. 58
ENVIRONMENTAL HEALTH TRACKING AND
BIOMONITORING
ADVISORY PANEL ROSTER
As of April 2011
Thomas Hawkinson, MS, CIH, CSP
Toro Company
8111 Lyndale Avenue S
Bloomington, MN 55420
[email protected]
Statewide business org representative
Bruce Alexander, PhD
University of Minnesota School of Public
Health
Environmental Health Sciences Division
MMC 807 Mayo
420 Delaware Street SE
Minneapolis, Minnesota 55455
612-625-7934
[email protected]
At-large representative
Jill Heins Nesvold, MS
American Lung Association of Minnesota
490 Concordia Avenue
St. Paul, Minnesota 55103
651-223-9578
[email protected]
Nongovernmental organization
representative
Fred Anderson, MPH
Washington County
Department of Public Health and
Environment
14949 62nd St N
Stillwater MN 55082
651-430-6655
[email protected]
At-large representative
Cathi Lyman-Onkka, MA
Preventing Harm Minnesota
372 Macalester Street
St. Paul, MN 55105
Home office
651-647-9017
[email protected]
Nongovernmental organization
representative
Alan Bender, DVM, PhD
Minnesota Department of Health
Health Promotion and Chronic Disease
Division
85 East 7th Place
PO Box 64882
Saint Paul, MN 55164-0882
651-201-5882
[email protected]
MDH appointee
Pat McGovern, PhD, MPH
University of Minnesota School of Public
Health
Environmental Health Sciences Division
MMC Mayo 807
420 Delaware St SE
Minneapolis MN 55455
612-625-7429
[email protected]
University of Minnesota representative
David DeGroote, PhD
St. Cloud State University
740 4th Street South
St. Cloud, MN 56301
320-308-2192
[email protected]
Minnesota House of Representatives
appointee
59
Geary Olsen, DVM, PhD
3M Medical Department
Corporate Occupational Medicine
MS 220-6W-08
St. Paul, Minnesota 55144-1000
651-737-8569
[email protected]
Statewide business organization
representative
Cathy Villas-Horns, MS, PG
Minnesota Department of Agriculture
Pesticide and Fertilizer Management
Division
625 Robert Street North
St. Paul, Minnesota 55155-2538
651-201-6291
[email protected]
MDA appointee
Gregory Pratt, PhD
Minnesota Pollution Control Agency
Environmental Analysis and Outcomes
Division
520 Lafayette Road
St. Paul, MN 55155-4194
651-757-2655
[email protected]
MPCA appointee
Lisa Yost, MPH, DABT
ENVIRON International Corporation
333 West Wacker Drive, Suite 2700
Chicago, IL 60606
Local office
St. Paul, Minnesota
651-225-1592
[email protected]
At-large representative
Vacant
Minnesota Senate appointee
60
Staff Biosketches
Wendy Brunner, MS, serves as surveillance epidemiologist for the MDH Asthma
Program since 2002, and joined the MN EPHT program on a part-time basis in fall 2009.
Previously, she worked on occupational respiratory disease studies for MDH. She has a
masters degree in Science and Technology Studies from Rensselaer Polytechnic Institute
and a masters degree in Environmental and Occupational Health from the University of
Minnesota. She is currently a doctoral student in the Division of Epidemiology and
Community Health at the University of Minnesota.
Eric Hanson, MS, is an Information Technology Specialist with the Environmental
Public Health Tracking program. His work is focused in Geographic Information Systems
(GIS), application development, cartography, data visualization, data management and
providing GIS technical assistance. He has a Masters degree in Geographic Information
Systems (GIS) and Masters Minor in Public Health from the University of Minnesota.
Jean Johnson, PhD, MS, is Program Director/Principal Investigator for Minnesota’s
Environmental Public Health Tracking and Biomonitoring Program. Dr. Johnson
received her Ph.D. and M.S. degrees from the University of Minnesota, School of Public
Health in Environmental Health and has 25 years of experience working with the state of
Minnesota in the environmental health field. As an environmental epidemiologist at
MDH, her work has focused on special investigations of population exposure and health,
including studies of chronic diseases related to air pollution and asbestos exposure, and
exposure to drinking water contaminants. She is currently the Principal Investigator on an
EPA grant to develop methods for measuring the public health impacts of population
exposure to particulate matter (PM) in air. She is also an adjunct faculty member at the
University of Minnesota School of Public Heath.
Mary Jeanne Levitt, MBC, is the communications coordinator with the Minnesota
Environmental Public Health Tracking program. She has a Masters in Business
Communications and has worked for over 20 years in both the public and non-profit
sector in project management of research and training grants, communications and
marketing strategies, focus groups and evaluations of educational needs of public health
professionals. She serves on 3 institutional review boards which specialize in academic
research, oncology research, and overall clinical research.
Paula Lindgren, MS, received her Master of Science degree in Biostatistics from the
University of Minnesota. She works for the Minnesota Department of Health as a
biostatistician, and provides statistical and technical support to the MN EPHT and
Biomonitoring programs for data reports, publications, web-based portal dissemination
and presentations in the Chronic Disease and Environmental Epidemiology section. Ms.
Lindgren has also received training in the area of GIS for chronic disease mapping and
analysis. In addition to her work for MN EPHT, she works for various programs within
Chronic Disease and Environmental Epidemiology including the Asthma program,
Center for Occupation Health and Safety, Minnesota Cancer Surveillance System, and
Cancer Control section.
61
Barbara Scott Murdock, MPH, is the Program Planner for the state Environmental
Public Health Tracking and Biomonitoring (EHTB) program, responsible for leading
strategic planning and communications with stakeholders and the EHTB Advisory Panel.
She is a biologist and public health professional by training and has over 30 years of
experience in writing and editing professional publications. Recently a grants
coordinator/writer for social science faculty at the University of Minnesota, she also
served as the biomonitoring project manager at the Minnesota Department of Health
(2001-2003); senior research fellow in the Center for Environment & Health Policy,
UMN School of Public Health (1995-2001); director of water and health programs at the
Freshwater Foundation (1991-1992); and founding editor of the Health & Environment
Digest, a peer-reviewed publication for environmental health and management
professionals in the US and Canada (1986-1992). She holds a BS in biochemistry from
the University of Chicago, an MA in zoology from Duke University, and an MPH from
the University of Minnesota.
Jessica Nelson, PhD, is an epidemiologist with the Minnesota Environmental Public
Health Tracking and Biomonitoring Program, working primarily on design, coordination,
and analysis of biomonitoring projects. Jessica received her PhD and MPH in
Environmental Health from the Boston University School of Public Health where her
research involved the epidemiologic analysis of biomonitoring data on
perfluorochemicals. Jessica was the coordinator of the Boston Consensus Conference on
Biomonitoring, a project that gathered input and recommendations on the practice and
uses of biomonitoring from a group of Boston-area lay people.
Jeannette M. Sample, MPH, is an epidemiologist with the Minnesota Environmental
Public Health Tracking program at the Minnesota Department of Health, working
primarily with the collection and statistical analysis of public health surveillance data for
EPHT. She also works on research collaborations with academic partners relating to
reproductive outcomes and birth defects. Prior to joining EPHT, she was a CSTE/CDC
Applied Epidemiology Fellow with the MDH Birth Defect Information System. Jeannette
received her Masters degree in epidemiology and biostatistics from The George
Washington University in Washington, DC.
Blair Sevcik, MPH, is an epidemiologist with the Minnesota Environmental Public
Health Tracking (EPHT) program at the Minnesota Department of Health, where she
works on the collection and statistical analysis of public health surveillance data for
EPHT. Prior to joining EPHT in January 2009, she was a student worker with the MDH
Asthma Program. She received her Master of Public Health degree in epidemiology from
University of Minnesota School of Public Health in December 2010.
Naomi Shinoda, MSPH, is an epidemiologist at the Minnesota Department of Health,
where she works on surveillance of carbon monoxide poisonings and conducts analyses
relating air pollution and adverse respiratory and cardiovascular health outcomes. She has
international work experience, most notably from her Peace Corps service as a science
and environmental educator at the Palau Environmental Quality Protection Board in the
62
Republic of Palau. Ms. Shinoda holds a M.S.P.H. degree in epidemiology from Emory
University and a B.S. in molecular biology and music from Yale University.
Dave Stewart MPH, is the Program Consultant for MDH’s Environmental Public Health
Tracking Program, where he oversees content development, layout, and design for the
MPH Data Portal. He also develops and delivers demonstrations and trainings of the
Web Portal for key data users and stakeholders. Dave has a Master of Public Health
degree with a concentration in Health Behavior and Health Education. Prior to working
at MDH, Dave worked at the Suicide Prevention Resource Center, providing technical
assistance to Federal Suicide Prevention Grantees on developing comprehensive suicide
prevention programs. He has experience in web development, training design, and health
program planning. Dave is also working on a community level collaboration with
Hennepin County.
Chuck Stroebel, MPH, is the MN EPHT Program Manager. In this capacity, he
provides day-to-day direction for program activities, including: (i) development and
implementation of the state network, (ii) development and transport of NCDMs and
metadata for the national network, and (iii) collaboration and communication with key
EPHT partners and stakeholders. Chuck received a Masters of Public Health in
Environmental Health Sciences from the University of North Carolina (Chapel Hill). He
has over 15 years of expertise in environmental health, including areas of air quality,
pesticides, climate change, risk assessment, and toxicology. In addition, Chuck played a
key role in early initiatives to build tracking capacity at the Minnesota Department of
Health. Currently, Chuck is a member of the IBIS Steering Committee (state network),
the MDH ASTHO Grant Steering Committee (climate change), and the Northland
Society of Toxicology. He also serves on the MN EPHT Technical and Communications
Teams.
Allan N. Williams, MPH, PhD, is an environmental and occupational epidemiologist in
the Chronic Disease and Environmental Epidemiology Section at the Minnesota
Department of Health. He is the supervisor for the MDH Center for Occupational Health
and Safety, which currently includes both the state-funded and federally-funded
Environmental Public Health Tracking and Biomonitoring programs. For over 25 years,
he has worked on issues relating to environmental and occupational cancer, cancer
clusters, work-related respiratory diseases, and the surveillance and prevention of workrelated injuries among adolescents. He has served as the PI on two NIOSH R01 grants
and as a co-investigator on four other federally-funded studies in environmental or
occupational health. He is also an adjunct faculty member at the University of Minnesota
School of Public Heath. He received an MA degree in Biology from Indiana University
and an MPH degree in Environmental Health and Epidemiology from the University of
Minnesota, and his PhD in Environmental and Occupational Health from the University
of Minnesota
63
ENVIRONMENTAL HEALTH TRACKING AND
BIOMONITORING STATUTE
collectively as the National Reports on Human
Exposure to Environmental Chemicals Program
and any substances specified by the
commissioner after receiving recommendations
under section 144.998, subdivision 3, clause (6).
(i) "Environmental hazard" means a chemical
or other substance for which scientific, peerreviewed studies of humans, animals, or cells
have demonstrated that the chemical is known or
reasonably anticipated to adversely impact
human health.
(j) "Environmental health tracking" means
collection, integration, analysis, and
dissemination of data on human exposures to
chemicals in the environment and on diseases
potentially caused or aggravated by those
chemicals.
$1,000,000 each year is for environmental health
tracking and biomonitoring. Of this amount,
$900,000 each year is for transfer to the
Minnesota Department of Health. The base
appropriation for this program for fiscal year
2010 and later is $500,000.
144.995 DEFINITIONS;
ENVIRONMENTAL HEALTH TRACKING
AND BIOMONITORING.
(a) For purposes of sections 144.995 to
144.998, the terms in this section have the
meanings given.
(b) "Advisory panel" means the
Environmental Health Tracking and
Biomonitoring Advisory Panel established under
section 144.998.
(c) "Biomonitoring" means the process by
which chemicals and their metabolites are
identified and measured within a biospecimen.
(d) "Biospecimen" means a sample of human
fluid, serum, or tissue that is reasonably
available as a medium to measure the presence
and concentration of chemicals or their
metabolites in a human body.
(e) "Commissioner" means the commissioner
of the Department of Health.
(f) "Community" means geographically or
nongeographically based populations that may
participate in the biomonitoring program. A
"nongeographical community" includes, but is
not limited to, populations that may share a
common chemical exposure through similar
occupations, populations experiencing a
common health outcome that may be linked to
chemical exposures, populations that may
experience similar chemical exposures because
of comparable consumption, lifestyle, product
use, and subpopulations that share ethnicity, age,
or gender.
(g) "Department" means the Department of
Health.
(h) "Designated chemicals" means those
chemicals that are known to, or strongly
suspected of, adversely impacting human health
or development, based upon scientific, peerreviewed animal, human, or in vitro studies, and
baseline human exposure data, and consists of
chemical families or metabolites that are
included in the federal Centers for Disease
Control and Prevention studies that are known
144.996 ENVIRONMENTAL HEALTH
TRACKING; BIOMONITORING.
Subdivision 1. Environmental health
tracking. In cooperation with the commissioner
of the Pollution Control Agency, the
commissioner shall establish an environmental
health tracking program to:
(1) coordinate data collection with the
Pollution Control Agency, Department of
Agriculture, University of Minnesota, and any
other relevant state agency and work to promote
the sharing of and access to health and
environmental databases to develop an
environmental health tracking system for
Minnesota, consistent with applicable data
practices laws;
(2) facilitate the dissemination of aggregate
public health tracking data to the public and
researchers in accessible format;
(3) develop a strategic plan that includes a
mission statement, the identification of core
priorities for research and epidemiologic
surveillance, and the identification of internal
and external stakeholders, and a work plan
describing future program development and
addressing issues having to do with compatibility
with the Centers for Disease Control and
Prevention's National Environmental Public
Health Tracking Program;
(4) develop written data sharing agreements as
needed with the Pollution Control Agency,
Department of Agriculture, and other relevant
64
(3) communicate findings to the public, and
plan ensuing stages of biomonitoring and disease
tracking work to further develop and refine the
integrated analysis;
(4) share analytical results with the advisory
panel and work with the panel to interpret
results, communicate findings to the public, and
plan ensuing stages of biomonitoring work; and
(5) submit a biennial report to the chairs and
ranking members of the committees with
jurisdiction over environment and health by
January 15, beginning January 15, 2009, on the
status of the biomonitoring program and any
recommendations for improvement.
Subd. 3. Health data. Data collected under
the biomonitoring program are health data under
section 13.3805.
state agencies and organizations, and develop
additional procedures as needed to protect
individual privacy;
(5) organize, analyze, and interpret available
data, in order to:
(i) characterize statewide and localized trends
and geographic patterns of population-based
measures of chronic diseases including, but not
limited to, cancer, respiratory diseases,
reproductive problems, birth defects, neurologic
diseases, and developmental disorders;
(ii) characterize statewide and localized trends
and geographic patterns in the occurrence of
environmental hazards and exposures;
(iii) assess the feasibility of integrating disease
rate data with indicators of exposure to the
selected environmental hazards such as
biomonitoring data, and other health and
environmental data;
(iv) incorporate newly collected and existing
health tracking and biomonitoring data into
efforts to identify communities with elevated
rates of chronic disease, higher likelihood of
exposure to environmental hazards, or both;
(v) analyze occurrence of environmental
hazards, exposures, and diseases with relation to
socioeconomic status, race, and ethnicity;
(vi) develop and implement targeted plans to
conduct more intensive health tracking and
biomonitoring among communities; and
(vii) work with the Pollution Control Agency,
the Department of Agriculture, and other
relevant state agency personnel and
organizations to develop, implement, and
evaluate preventive measures to reduce elevated
rates of diseases and exposures identified
through activities performed under sections
144.995 to 144.998; and
(6) submit a biennial report to the chairs and
ranking members of the committees with
jurisdiction over environment and health by
January 15, beginning January 15, 2009, on the
status of environmental health tracking activities
and related research programs, with
recommendations for a comprehensive
environmental public health tracking program.
Subd. 2. Biomonitoring. The commissioner
shall:
(1) conduct biomonitoring of communities on
a voluntary basis by collecting and analyzing
biospecimens, as appropriate, to assess
environmental exposures to designated
chemicals;
(2) conduct biomonitoring of pregnant women
and minors on a voluntary basis, when
scientifically appropriate;
144.997 BIOMONITORING PILOT
PROGRAM.
Subdivision 1. Pilot program. With advice
from the advisory panel, and after the program
guidelines in subdivision 4 are developed, the
commissioner shall implement a biomonitoring
pilot program. The program shall collect one
biospecimen from each of the voluntary
participants. The biospecimen selected must be
the biospecimen that most accurately represents
body concentration of the chemical of interest.
Each biospecimen from the voluntary
participants must be analyzed for one type or
class of related chemicals. The commissioner
shall determine the chemical or class of
chemicals to which community members were
most likely exposed. The program shall collect
and assess biospecimens in accordance with the
following:
(1) 30 voluntary participants from each of
three communities that the commissioner
identifies as likely to have been exposed to a
designated chemical;
(2) 100 voluntary participants from each of
two communities:
(i) that the commissioner identifies as likely to
have been exposed to arsenic; and
(ii) that the commissioner identifies as likely
to have been exposed to mercury; and
(3) 100 voluntary participants from each of
two communities that the commissioner
identifies as likely to have been exposed to
perfluorinated chemicals, including
perfluorobutanoic acid.
Subd. 2. Base program. (a) By January 15,
2008, the commissioner shall submit a report on
the results of the biomonitoring pilot program to
the chairs and ranking members of the
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changing those protocols to incorporate new and
more accurate or efficient technologies as they
become available. The commissioner and the
advisory panel shall be guided by protocols and
guidelines developed by the Centers for Disease
Control and Prevention and the National
Biomonitoring Program;
(2) guidelines for ensuring the privacy of
information; informed consent; follow-up
counseling and support; and communicating
findings to participants, communities, and the
general public. The informed consent used for
the program must meet the informed consent
protocols developed by the National Institutes of
Health;
(3) educational and outreach materials that are
culturally appropriate for dissemination to
program participants and communities. Priority
shall be given to the development of materials
specifically designed to ensure that parents are
informed about all of the benefits of
breastfeeding so that the program does not result
in an unjustified fear of toxins in breast milk,
which might inadvertently lead parents to avoid
breastfeeding. The materials shall communicate
relevant scientific findings; data on the
accumulation of pollutants to community health;
and the required responses by local, state, and
other governmental entities in regulating toxicant
exposures;
(4) a training program that is culturally
sensitive specifically for health care providers,
health educators, and other program
administrators;
(5) a designation process for state and private
laboratories that are qualified to analyze
biospecimens and report the findings; and
(6) a method for informing affected
communities and local governments representing
those communities concerning biomonitoring
activities and for receiving comments from
citizens concerning those activities.
(b) The commissioner may enter into
contractual agreements with health clinics,
community-based organizations, or experts in a
particular field to perform any of the activities
described under this section.
committees with jurisdiction over health and
environment.
(b) Following the conclusion of the pilot
program, the commissioner shall:
(1) work with the advisory panel to assess the
usefulness of continuing biomonitoring among
members of communities assessed during the
pilot program and to identify other communities
and other designated chemicals to be assessed
via biomonitoring;
(2) work with the advisory panel to assess the
pilot program, including but not limited to the
validity and accuracy of the analytical
measurements and adequacy of the guidelines
and protocols;
(3) communicate the results of the pilot
program to the public; and
(4) after consideration of the findings and
recommendations in clauses (1) and (2), and
within the appropriations available, develop and
implement a base program.
Subd. 3. Participation. (a) Participation in the
biomonitoring program by providing
biospecimens is voluntary and requires written,
informed consent. Minors may participate in the
program if a written consent is signed by the
minor's parent or legal guardian. The written
consent must include the information required to
be provided under this subdivision to all
voluntary participants.
(b) All participants shall be evaluated for the
presence of the designated chemical of interest as
a component of the biomonitoring process.
Participants shall be provided with information
and fact sheets about the program's activities and
its findings. Individual participants shall, if
requested, receive their complete results. Any
results provided to participants shall be subject
to the Department of Health Institutional Review
Board protocols and guidelines. When either
physiological or chemical data obtained from a
participant indicate a significant known health
risk, program staff experienced in
communicating biomonitoring results shall
consult with the individual and recommend
follow-up steps, as appropriate. Program
administrators shall receive training in
administering the program in an ethical,
culturally sensitive, participatory, and
community-based manner.
Subd. 4. Program guidelines. (a) The
commissioner, in consultation with the advisory
panel, shall develop:
(1) protocols or program guidelines that
address the science and practice of
biomonitoring to be utilized and procedures for
144.998 ENVIRONMENTAL HEALTH
TRACKING AND BIOMONITORING
ADVISORY PANEL.
Subdivision 1. Creation. The commissioner
shall establish the Environmental Health
Tracking and Biomonitoring Advisory Panel.
The commissioner shall appoint, from the panel's
membership, a chair. The panel shall meet as
66
least nine of the advisory panel members; in
making these recommendations, the panel may
consider the following criteria:
(i) the degree of potential exposure to the
public or specific subgroups, including, but not
limited to, occupational;
(ii) the likelihood of a chemical being a
carcinogen or toxicant based on peer-reviewed
health data, the chemical structure, or the
toxicology of chemically related compounds;
(iii) the limits of laboratory detection for the
chemical, including the ability to detect the
chemical at low enough levels that could be
expected in the general population;
(iv) exposure or potential exposure to the
public or specific subgroups;
(v) the known or suspected health effects
resulting from the same level of exposure based
on peer-reviewed scientific studies;
(vi) the need to assess the efficacy of public
health actions to reduce exposure to a chemical;
(vii) the availability of a biomonitoring
analytical method with adequate accuracy,
precision, sensitivity, specificity, and speed;
(viii) the availability of adequate biospecimen
samples; or
(ix) other criteria that the panel may agree to;
and
(7) other aspects of the design,
implementation, and evaluation of the
environmental health tracking and biomonitoring
system, including, but not limited to:
(i) identifying possible community partners
and sources of additional public or private
funding;
(ii) developing outreach and educational
methods and materials; and
(iii) disseminating environmental health
tracking and biomonitoring findings to the
public.
Subd. 4. Liability. No member of the panel
shall be held civilly or criminally liable for an act
or omission by that person if the act or omission
was in good faith and within the scope of the
member's responsibilities under sections 144.995
to 144.998.
often as it deems necessary but, at a minimum,
on a quarterly basis. Members of the panel shall
serve without compensation but shall be
reimbursed for travel and other necessary
expenses incurred through performance of their
duties. Members appointed by the commissioner
are appointed for a three-year term and may be
reappointed. Legislative appointees serve at the
pleasure of the appointing authority.
Subd. 2. Members. (a) The commissioner
shall appoint eight members, none of whom may
be lobbyists registered under chapter 10A, who
have backgrounds or training in designing,
implementing, and interpreting health tracking
and biomonitoring studies or in related fields of
science, including epidemiology, biostatistics,
environmental health, laboratory sciences,
occupational health, industrial hygiene,
toxicology, and public health, including:
(1) at least two scientists representative of
each of the following:
(i) nongovernmental organizations with a
focus on environmental health, environmental
justice, children's health, or on specific chronic
diseases; and
(ii) statewide business organizations; and
(2) at least one scientist who is a
representative of the University of Minnesota.
(b) Two citizen panel members meeting the
scientific qualifications in paragraph (a) shall be
appointed, one by the speaker of the house and
one by the senate majority leader.
(c) In addition, one representative each shall
be appointed by the commissioners of the
Pollution Control Agency and the Department of
Agriculture, and by the commissioner of health
to represent the department's Health Promotion
and Chronic Disease Division.
Subd. 3. Duties. The advisory panel shall
make recommendations to the commissioner and
the legislature on:
(1) priorities for health tracking;
(2) priorities for biomonitoring that are based
on sound science and practice, and that will
advance the state of public health in Minnesota;
(3) specific chronic diseases to study under the
environmental health tracking system;
(4) specific environmental hazard exposures to
study under the environmental health tracking
system, with the agreement of at least nine of the
advisory panel members;
(5) specific communities and geographic areas
on which to focus environmental health tracking
and biomonitoring efforts;
(6) specific chemicals to study under the
biomonitoring program, with the agreement of at
INFORMATION SHARING.
On or before August 1, 2007, the
commissioner of health, the Pollution Control
Agency, and the University of Minnesota are
requested to jointly develop and sign a
memorandum of understanding declaring their
intent to share new and existing environmental
hazard, exposure, and health outcome data,
within applicable data privacy laws, and to
67
cooperate and communicate effectively to ensure
sufficient clarity and understanding of the data
by divisions and offices within both departments.
The signed memorandum of understanding shall
be reported to the chairs and ranking members of
the senate and house of representatives
committees having jurisdiction over judiciary,
environment, and health and human services.
Effective date: July 1, 2007
This document contains Minnesota Statutes,
sections 144.995 to 144.998, as these sections
were adopted in Minnesota Session Laws 2007,
chapter 57, article 1, sections 143 to 146. The
appropriation related to these statutes is in
chapter 57, article 1, section 3, subdivision 4.
The paragraph about information sharing is in
chapter 57, article 1, section 169. The following
is a link to chapter 57:
http://ros.leg.mn/bin/getpub.php?type=law&year
=2007&sn=0&num=57
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