Minnesota Department of Health
Environmental Health Tracking and Biomonitoring
Advisory Panel Meeting
September 9, 2008
1:00 p.m. – 4:00 p.m.
Snelling Office Park
Minnesota Room
1645 Energy Park Drive
St. Paul, Minnesota
Meeting agenda
Minnesota Department of Health
Environmental Health Tracking and Biomonitoring Advisory Panel Meeting
September 9, 2008
1:00 p.m. – 4:00 p.m.
Minnesota Room at Snelling Office Park
1645 Energy Park Drive, St. Paul, MN
Item type/Anticipated outcome
Time
Agenda item
Presenter(s)
1:00
Welcome and
introductions
Beth Baker, chair
1:05
Project updates:
• Hospital data
• Chemical selection
process
• Biomonitoring
vision and purpose
• Arsenic
• PFCs
Norm Crouch
Information sharing.
Michonne Bertrand
Adrienne Kari
Panel members are invited to ask questions or
Louise Liao
provide input on either of these items.
1:15
Mercury biomonitoring
pilot project
John Stine
Pat McCann
Information sharing.
Panel members are invited to ask questions or
provide input on this item.
1:30
Fourth biomonitoring
pilot project
Jean Johnson
Adrienne Kari
Discussion and decision item.
Panel members are invited to provide
comments in order to strengthen the
biomonitoring proposal and to ensure that the
most meaningful results are obtained.
*VOTE NEEDED* In addition, the advisory
panel is asked to make a specific
recommendation for a chemical to be
measured in the fourth biomonitoring pilot
project.
(NOTE: By statute, any chemical
recommended for study must be agreed upon
by at least 9 of the 13 panel members. If you
cannot attend the meeting in person, please
contact Michonne Bertrand to make
arrangements to join the meeting by phone.
Or, in accordance with the advisory panel’s
i
Time
Agenda item
Presenter(s)
Item type/Anticipated outcome
operating procedures, you may make
arrangements to submit an absentee vote or to
vote by proxy.)
Suggested motion: I move that [x chemical] be
recommended for study in the Environmental
Health Tracking and Biomonitoring Program’s
fourth biomonitoring pilot project.
2:30
Break
2:45
Biomonitoring pilot
program guidelines
Jean Johnson
Discussion item.
Panel members are invited to provide
suggestions for revising and strengthening the
NEW PORTIONS of the draft biomonitoring
pilot program guidelines. (The other portions
of the guidelines were reviewed during the
advisory panel meeting on March 11.)
The new portions of the guidelines include the
following:
• Pilot project design
• Use of stored specimens for future
research
• Community acceptance and
participation
• Selecting appropriate reference
(comparison) values for data
interpretation
• Inclusion of children in biomonitoring
pilot projects
Staff are not seeking a vote to adopt the
program guidelines, but instead are seeking to
uncover the range of viewpoints held by panel
members.
3:15
Environmental health
tracking: Strategic plan
Michonne
Bertrand
Discussion item.
Panel members are invited to provide
comments in order to strengthen the draft
strategic plan for the environmental health
tracking program. In particular, the panel is
asked to provide input on the following
specific questions:
ii
Time
Agenda item
Presenter(s)
Item type/Anticipated outcome
•
•
•
•
Does the draft mission clearly describe
the purpose of the program? Does the
mission differentiate the program from
other programs operating in similar
areas?
Do the draft goals and objectives
reflect what the program must do to
achieve its mission? Are there goals
and objectives missing from the draft?
Are there groups of stakeholders for
the tracking program missing from the
list?
Thinking about the stakeholder groups
that you represent, do you have any
suggestions in terms of how
stakeholders should be involved in
providing input on the draft strategic
plan?
Staff are not seeking a vote on the strategic
plan, but instead are seeking to uncover the
range of viewpoints held by panel members,
who are valued stakeholders in the tracking
program.
4:00
Adjourn
Next EHTB advisory panel meeting:
Tuesday, December 9, 1-4 pm, Red River Room, Snelling Office Park
Mark your calendars – 2009 meeting dates
Tuesday, March 10
Tuesday, June 9
Tuesday, September 15
Tuesday, December 8
All meetings will be held from 1-4 pm and will take place at
MDH’s Snelling Office Park location at 1645 Energy Park Drive.
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Meeting Materials for September 9, 2008
Environmental Health Tracking & Biomonitoring Advisory Panel
Table of Contents
Agenda........................................................................................................................................... i
Table of contents ........................................................................................................................v
Materials related to specific agenda items
Project updates
Section overview: Biomonitoring project updates.....................................................................1
Status update on arsenic biomonitoring.....................................................................................3
Status update on PFC biomonitoring .........................................................................................4
Mercury biomonitoring pilot project
Section overview: Mercury biomonitoring pilot project ...........................................................5
Lake Superior mercury biomonitoring study.............................................................................7
Fourth biomonitoring pilot project
Section overview: Fourth biomonitoring pilot project.............................................................15
Draft project proposal for the fourth pilot................................................................................17
Possible chemicals to be measured in the fourth pilot.............................................................21
Criteria for selecting a chemical for the fourth pilot................................................................31
Biomonitoring pilot program guidelines
Section overview: Biomonitoring pilot program guidelines....................................................33
Draft Minnesota biomonitoring pilot program guidelines (FY 08-09)....................................35
Environmental health tracking strategic plan
Section overview: Environmental health tracking strategic plan ............................................51
Draft environmental health tracking strategic plan (2008-2012).............................................53
General reference materials
Section overview: General reference materials .............................................................................61
NEW: New PFC citations (added since June 3, 2008)...................................................................63
NEW: EHTB advisory panel meeting summary (from June 3, 2008) ...........................................69
REVISED: EHTB advisory panel roster.........................................................................................83
Biographical sketches of advisory panel members........................................................................85
EHTB advisory panel operating procedures ..................................................................................89
EHTB steering committee roster ...................................................................................................95
REVISED: EHTB inter-agency workgroup roster............................................................................97
Glossary of terms used in environmental health tracking and biomonitoring ...............................99
Acronyms used in environmental health tracking and biomonitoring.........................................103
EHTB statute (Minn. Statutes 144.995-144.998)..................................................................................... 105
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vi
Section overview: Project updates
Given the limited time available for advisory panel meetings, updates on some items will be
provided to the panel as information items only. This information is intended to keep panel
members apprised of progress being made in program areas that are not a featured part of the
current meeting’s agenda and/or to alert panel members to items that will need to be discussed in
greater depth at a future meeting. Included in this section of the meeting packet are updates on
the following items:
•
Arsenic biomonitoring
•
PFC biomonitoring
ACTION NEEDED: At this time, no formal action is needed by the advisory panel. Panel
members are invited to ask questions or provide input on any of these topics.
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2
Status update on arsenic biomonitoring
Laboratory:
Laboratory scientists have been analyzing internal quality control samples on the ICP-MS and
are completing external validation studies for the arsenic method, originally developed by CDC.
The MDH Public Health Laboratory has received CLIA certification from the U.S. Centers for
Medicare and Medicaid Services, which regulates all non-research, laboratory testing performed
on humans in the U.S. For the more sophisticated method to speciate arsenic (to distinguish
inorganic sources and dietary sources of arsenic), the laboratory’s metals research chemist has
scheduled a 3-day training session at the Colorado Department of Public Health and
Environment in September.
Recruitment and sample collection:
As of August 11, there were 65 children on our list of potential participants, representing 41
independent households. The list includes some Somali and Latino families. Recruitment has
been more difficult than anticipated. Each household on the list of 894 eligible households has
received two mailings and at least one in-person visit to date. Field staff are attempting to visit
each household three times as needed to obtain a response. Of the houses where contact has been
made and/or where all three in-person visits by field staff have been completed (618
households), only 83 households have children between the ages of 3 and 10.
Given the short timetable for completing recruitment and specimen collection (i.e., the need to
complete specimen collection during the summer when children are more likely to be playing in
their yards), and given the low proportion of households with eligible children in the defined
study area, two changes to the original study protocol are being made.
First, MDH will attempt to immediately enroll any children on our list of potential participants so
that we do not lose participants due to the passage of time. This is instead of waiting to compile
the list from all households and then randomizing participant selection. This means that more
than one child from each household will be enrolled in the study, which will require additional
statistical analysis.
Second, we will expand the number of properties from which participants will be recruited.
Information has been sent to the rest of the houses in the testing area (i.e., the households with
arsenic levels of 20 ppm or less) to recruit children for the remaining spots in the study. These
children will be enrolled on a first-come, first-served basis.
The contacts with whom MDH has been working in the city and neighborhoods have been
notified about these changes to the study.
Sample collection is underway and expected to be completed in September, slightly behind
schedule because of the additional time needed in the recruitment phase.
3
Status update on PFC biomonitoring
Laboratory:
An MDH research chemist skilled in PFCs analyses in environmental matrices has trained at the
CDC with Antonia Calafat on PFCs analyses in serum. A new LC-MS/MS instrument has been
assigned for blood work only; lab staff have participated in a week-long course hosted by the
vendor to learn how to optimize the instrument’s advanced features. The lab has completed a
NIST-certified proficiency testing study for PFCs in a water matrix and is enrolling in an
international proficiency testing study for PFCs in serum. The MDH Public Health Laboratory
method for the analysis of PFCs in serum is in the final stages of development/validation.
Recruitment and sample collection:
The initial recruitment mailing was sent on July 17 and we have received a good response in
both communities (i.e., Oakdale municipal water community and Lake Elmo/Cottage Grove
private wells community). For private wells, 168 homes were contacted; as of August 11 there
were 97 people (not households) on our list of potential participants. For Oakdale, 500 homes
were contacted; as of August 11 there were approximately 300 people (not households) on our
list. As originally proposed, the 200 participants for the study will be selected randomly from the
lists. The names of potential participants are collected on household surveys returned to MDH.
A study recruiter started with the project in August. She will be following up with people who
did not respond to the recruitment mailing and will be enrolling participants in the study. The
first focus will be to contact non-respondent households in Lake Elmo and Cottage Grove. Final
selection of participants is likely to occur in September, with sample collection beginning shortly
thereafter.
Physician education:
Beginning in September, MDH’s physician consultant will be providing physician education
sessions in the east metro area to notify medical providers of the biomonitoring project and to
share information on PFCs in general (uses, exposure sources, etc.) and the current research on
health effects of PFCs.
In response to questions we’ve received from community members, she is also looking into
options for private citizens to be tested for PFCs if they are not chosen to be part of the
biomonitoring project.
4
Section overview: Mercury biomonitoring pilot project
Provided in this section is a summary of a US EPA-funded study being conducted at MDH to
measure mercury in bloodspots. This study, called “Mercury Levels in Blood from Newborns in
the Lake Superior Basin” (hereafter referred to as the Lake Superior Mercury Biomonitoring
Study) was originally described for the panel in December 2007, with updates in March and June
of 2008. MDH plans to implement the study with the addition of written, informed consent from
the Minnesota mothers before enrolling the newborn specimens into an anonymized mercury
biomonitoring study.
The EHTB Steering Committee has chosen this study to serve as the mercury biomonitoring
requirement of the legislation. Staff resources and $50,000 of EHTB funds have been allocated
to support the Lake Superior Mercury Biomonitoring Study. This study is being presented to the
advisory panel for information and discussion.
The benefits of selecting the Lake Superior Mercury Biomonitoring Study to fulfill the mercury
biomonitoring requirement for the EHTB program include:
•
•
•
•
•
•
•
Guaranteeing that one pilot project measures mercury levels
Expanding existing biomonitoring efforts to a community outside of the Twin Cities
metropolitan area
Ensuring that at least one of the biomonitoring pilot projects focuses on infants
Capitalizing on existing projects to preserve limited resources for other uses, such as to
improve the arsenic and PFC studies and/or to explore a fourth pilot project
Exploring different ways of conducting biomonitoring projects, including using stored
specimens collected for other purposes
Developing laboratory capacity and piloting new laboratory methods for measuring toxins in
dried blood
Informing recommendations for an ongoing biomonitoring program in Minnesota
ACTION NEEDED: No formal action is needed by the advisory panel. Panel members are
invited to ask questions or provide input on this study.
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6
Lake Superior Mercury Biomonitoring Study
U.S. EPA-funded study, “Mercury levels in blood from newborns in the Lake Superior basin”
Purpose and objectives
As presented to the EHTB advisory panel in December 2007 (and updated in March and June of
2008), the purpose of the Lake Superior Mercury Biomonitoring Study is to measure mercury in
residual blood spots from newborns to assess population exposure to mercury. This information
will be used to assist local public health agencies and MDH in targeting exposure prevention
activities. This study will also serve as a demonstration and assessment of the technical
feasibility of a newly developed laboratory method for utilization of dried blood spots collected
by the Minnesota Newborn Screening Program for biomonitoring in Minnesota.
Background
The Lake Superior Mercury Biomonitoring Study is being conducted by MDH investigators in
collaboration with state newborn screening programs in Wisconsin and Michigan, with funding
from the U.S. EPA Great Lakes National Program Office. The principal investigator is Patricia
McCann with the MDH Division of Environmental Health, Fish Consumption Advisory
Program. This program evaluates data and provides information statewide on environmental
contaminant exposures through fish consumption. Although there are considerable data on the
levels of mercury in fish throughout the state, there exists only limited human biomonitoring data
and no data on the extent of exposure to newborns in utero.
Newborns can be exposed to mercury in utero from mothers who consume mercury during
pregnancy. Studies have identified a ratio of umbilical cord to maternal blood mercury
concentrations in the range of 1.5 to 2.0 (Rice et al., 2003, Stern and Smith, 2003). CDC has
established 58μg/l in cord blood as a concentration associated with adverse neurological effects
in the fetus (CDC, 2005). The National Research Council (NRC) recommended that U.S. EPA
use an uncertainty factor of 10 to calculate a reference dose (RfD) of 5.8μg/l due to uncertainties
in the exposure measures used in the studies, and individual response variability (National
Academy of Sciences, 2000; Schober et al., 2003).
The National Biomonitoring Program conducted by CDC measures total mercury in samples of
whole blood from a random sample of the U.S. population, including women of childbearing age
and children ages 1-5. For samples taken from 1999 to 2002 the geometric mean blood mercury
concentration for the U.S. population aged 1-5 was 0.33 (0.30-0.37) μg/l and the 95th percentile
concentration was 2.21 μg/l. The geometric mean blood mercury concentration for women of
childbearing age was 0.92 (0.82-1.02) μg/l; the 95th percentile concentration was 6.04 μg/l (CDC,
2004).
No data are available from the National Biomonitoring Program on mercury exposure in
newborns. Newborns are typically not included in biomonitoring studies due to difficulties in
7
obtaining samples (NRC, 2006). The purpose of this study is to establish a reference range for
mercury exposure in newborns in the Lake Superior basin using residual blood spots.
In Minnesota, a few drops of blood are collected from the heel of all newborns at 24-48 hours
after birth. The spot is collected onto filter paper, dried, and submitted to the MDH Public Health
Laboratory. The laboratory analyzes small samples of the spot for more than 50 heritable or
congenital disorders. The residual spots are stored at the MDH Public Health Laboratory.
The use of dried blood spots for monitoring mercury exposure is new. Dr. Zheng Yang, while a
research scientist with the MDH Public Health Laboratory, adapted CDC’s blood mercury
method. The modified method can characterize mercury species in dried blood and has improved
sensitivity. Further improvement of the method sensitivity are anticipated with the addition of an
auto-sampler. As specified in the Minn. Statutes for the EHTB program, laboratories must be
designated as competent to analyze biospecimens and report the findings. One expression of
competency is data validation, which measures the ability of a laboratory to report chemical
concentrations that match the "true value" of the chemical concentration. As with almost all
biomonitoring methods, this mercury method is not yet a mature, widely used method. Thus,
internal validation (by scientists within one laboratory) and external validation (by scientists
conducting independent studies in multiple laboratories) is key to measuring laboratory
competency. The MDH Public Health Laboratory has conducted rigorous internal validation of
this modified method, and its quality control steps meet or exceed those used in the CDC method
for mercury in whole blood. The MDH Public Health Laboratory is currently exploring options
for external validation of this new method. No proficiency testing studies are currently available
for mercury in dried blood spots.
A recent study by the Utah Department of Health used the MDH methodology to assess the
feasibility and methodology of using newborn screening dried blood spots for measuring
mercury exposure (Chaudhuri, 2008). Dried blood spots have the advantage over other specimen
types because they are readily available, stable and easy to transport and store. Concerns about
their use, particularly for lead measurements, include contamination of (unused) filter paper that
is variable across different lots of paper, the heterogeneous distribution of the contaminant
throughout the blood spot, and the effects of storage conditions and time on the sample. The
study by Chaudhuri et al. found that recoveries of commercial standards spotted onto filter paper
at concentrations of .71 and 2.6 μg/l ranged between 93% and 222% and were generally biased
high, whether analyzed after storage of only a few weeks or up to 9 months, and whether stored
at room temperature or under refrigeration. Therefore, the authors recommended pairwise
analysis of blank filter paper disks and dried blood spots from the same filter paper card. They
also recommended that abnormally high values be automatically re-analyzed to minimize false
positives. Overall, the method was found to be suitable for routine screening of mercury in
newborns.
The method protocols developed in the MDH Public Health Laboratory and the Utah Department
of Health incorporate rigorous controls to both minimize and measure variability due to storage
conditions, filter paper lots, heterogeneity across the spot and across the paper, the recovery of
mercury from the filter paper, and other sources of uncertainty. The accuracy and precision of
the measurements have been well characterized. However, until a novel method meets the
8
standards defined in federal regulations (CFR Title 42 part 493), including standards for
proficiency testing, verification of the procedure, and a defined clinical reference value, the
testing results can be used for research purposes only and not for medical management.
Community
The Lake Superior Mercury Biomonitoring Study will measure mercury levels in approximately
750 babies born to women living in northeastern Minnesota zip codes identified as within the
Minnesota portion of the Lake Superior Basin (MN LSB). At U.S. EPA’s request MDH has
applied for an amendment that would increase the project funding by $25,000. If awarded, blood
spots from an additional 400 babies in Minnesota would be included in the study. There are
approximately 2,700 births each year to mothers living in the MN LSB. The study also includes
approximately 100 samples from Wisconsin and 500 samples from Michigan.
Mercury exposure to pregnant women and newborns is believed to occur primarily through the
women’s fish consumption. All Minnesotans who consume fish, locally-caught or purchased, are
likely to be exposed to mercury. Newborns may be more susceptible because mercury is a known
neurotoxin and has been found to cause adverse effects on child development in populations that
consume fish as a regular part of the diet. At this time we have no data to indicate differences in
exposure to mercury between residents of the Lake Superior basin and the rest of the State.
Methods for recruitment and informed consent
This project depends on a close collaboration between the MDH Public Health Laboratory’s
metals analytical staff and newborn screening staff. Participation in the newborn screening
program by hospitals and other birth attendants is mandatory, and they must inform parents of
their right to decline. Parents have the right to decline the newborn screening testing and/or the
storage of residual specimens and data. Written objection is made part of the medical record. All
infants born in the Lake Superior Basin during the duration of the sample collection period,
expected to begin fall 2008, for whom a blood spot is shipped to the newborn screening program
at the MDH Public Health Laboratory will be selected for inclusion in the study. Exclusion
criteria for Minnesota infants include death, very low birth weight, or an abnormal screening
result, as well as a parent’s written directive to destroy the specimen and data.
Within weeks of receiving the blood spot, the MDH Public Health Laboratory will send a letter
to the mother with a consent form. The form will request her written consent for the MDH
Public Health Laboratory to use a portion of the newborn’s stored specimen for mercury
analysis.
Specimens collected for the study will be anonymized (stripped of personal identifiers). The
Newborn Screening Program will provide the principal investigator with the mother’s residence
defined as belonging to a particular zip code cluster, baby’s birth month and year, and the baby’s
gender for entry into a secure database. Each subject will be assigned a unique identifier (e.g.
MN-001), and the MDH metals laboratory will have access to only the specimen and its unique
identifier.
9
Laboratory analysis methods and quality assurance
This project will utilize the CDC method for measuring mercury in whole blood, as modified by
Dr. Zheng Yang for use with dried blood spots. The modified method permits lower detection
levels and can be readily extended for characterizing mercury species. Filter paper disks
(punches) will be treated with acidic reagents in a clean-room facility to release and recover total
mercury for analysis. Each analytical batch will include several types of quality control samples,
including those spiked with internal mercury standards. Specimens will be analyzed using
inductively coupled plasma mass spectrometry (ICP-MS).
The method detection limit is defined as the minimum concentration of a chemical that can be
measured and reported with 99% confidence that the concentration is greater than zero. The
MDH Public Health Laboratory uses nationally approved statistical formulas to compare data
from at least eight independent analyses. The method detection limit is determined at the
beginning of the project by each analyst on each instrument to establish the minimum
concentration above which sample values will be reported, i.e. the minimum reporting level.
Several types of quality control will be incorporated. All residual blood spot samples will be
accompanied by an equivalent number of punched spots taken from a part of the card near the
spot (blank filter paper). The background level of mercury in the specimen cards will be
subtracted from the mercury level in the blood spot.
Unique ID numbers will be assigned to each punching device, and the extent of variability in
punch sizes will be measured. Staff will assure that: spots that are improperly applied by the
birthing hospital will be rejected; repeat samples from any infant are eliminated; the punching
devices are sterilized; at least five punches from a cloth wiper are taken to eliminate crosscontamination between cards; specimens are stored at -20 degrees C before submitting; and
chain-of-custody forms accompany each delivery.
Blood spots containing human blood and spiked mercury from controlled specimen cards will be
prepared by the metals chemists in the MDH Public Health Laboratory and distributed as qualitycontrol samples to be punched, labeled, and randomly submitted by the Michigan, Minnesota and
Wisconsin newborn screening laboratories. These submitted quality control samples will be blind
to the MDH metals chemists.
Four extra blood spots will be punched on every 20th sample and analyzed for mercury. Precision
and accuracy will be determined for each batch of samples. A complete Quality Assurance
Project Plan (QAPP) has been submitted to the U.S. EPA. The QAPP will be approved by U.S.
EPA prior to MDH initiating sample collection and analysis.
Data analysis, interpretation and reporting of project results
Individual results will be expressed as a concentration of mercury in blood (ng/l or µg/l).
Summary analysis of the distribution of mercury levels in the population will include a
calculation of geometric means, standard deviations, and percentiles. The overall geometric
mean for the sample set and the proportion of the total sample above the U.S. EPA RfD of 5.8
μg/l will be compared to national survey data from the 2003-2004 National Health and Nutrition
10
Examination Survey (NHANES) using t-test comparisons. Analysis accounting for seasonality
and other stratified analyses may be limited due to small numbers.
Results of the mercury analysis to date of Minnesota newborns will be summarized (e.g. number
of samples analyzed, frequency of detection, range of detections) and provided as part of an
EHTB report to the Minnesota Legislature in January 2009. The legislative report will also
present a method for interpreting the preliminary findings and provide recommendations. Final
results of the complete study will be reported by the study investigators at a later date.
Methods for communicating results
The purpose of the study is to assess population exposure to mercury. All samples and analytical
data collected for this project will be irreversibly anonymized. MDH will not inform participants
of the individual findings, or of the anonymized, aggregate findings. Instead, MDH will generate
reports and other communications for scientific audiences and disseminate the anonymized
results in a non-targeted manner, such as a posting at the MDH website.
MDH staff has met with local, county, and tribal health officials in the MN LSB community to
inform them of the project and to solicit their input on developing a communication plan. The
plan will include: communication with health care providers to describe the study and the
impacts that it may have on them: such as calls from physicians who may be contacted by the
family or calls from concerned citizens. MDH will also distribute informational materials on
mercury exposure to citizens, health care providers and local public health for their use to discuss
the project and health effects of mercury and raise awareness of the fish advisory.
Risks and benefits to participants
There is no health risk or direct benefit to the individual participants in this project. Local health
officials and members of the community of the MN LSB will be provided with the aggregated
results of the project as well as information that may guide future exposure prevention and health
education activities.
Methods for protection of data privacy
Personal identifiers of the mothers who have provided written, informed consent for this study
are classified as private data and protected in accordance with the provisions of the Minnesota
Government Data Practices Act (Minn. Statutes Chapter 13).
All analytical data and specimens (punched filter paper samples submitted to the MDH Public
Health Laboratory metals analytical staff) collected for this project will be anonymized (will not
include information which may be used to identify individual mothers or infants). Anonymized
data is not private data on individuals under Minn. Stat. 13.
Sample storage
Specimens are stored in a secure location within the MDH Public Health Laboratory. The metals
chemists and their supervisor are responsible for the care and custody of the specimens once they
11
are in their possession. The metals chemists and their supervisor must be able to assert that the
specimens were in their possession and view, or locked in a secure area, from the time that they
received the specimens until the time that they returned the specimens to the appropriate secured
storage area. The date and time of return are recorded in the appropriate chain-of-custody log
book.
For each of the submitted specimens, four of the eight disks will be consumed in the initial
analysis. The other four disks will be held in reserve in case the equipment malfunctions or other
events lead to data that are outside the established quality control limits. Any residual specimens
kept beyond the study period will be available to monitor the behavior and recovery of mercury
in dried blood under long-term storage conditions. Unlike controls artificially spiked with
mercury standards, these specimens contain mercury in its physiological forms, sequestered
within the red blood cells. Thus, they are valuable indicators for sample integrity during longterm storage.
EHTB support of the Lake Superior Mercury Biomonitoring Study
The EHTB legislation directs MDH to conduct a pilot biomonitoring project to measure
exposure to mercury. In lieu of conducting a separate pilot project to measure exposure to
mercury, the MDH Steering Committee has chosen this study to serve as the mercury
biomonitoring requirement of the legislation.
The benefits of using the Lake Superior Mercury Biomonitoring Study to fulfill the mercury
biomonitoring requirement include:
•
•
•
•
•
•
•
•
Guaranteeing that one pilot project measures mercury levels
Expanding existing biomonitoring efforts to a community outside of the Twin Cities
metropolitan area
Ensuring that at least one of the biomonitoring pilot projects focuses on infants
Capitalizing on existing projects to preserve limited resources for other uses, such as to
improve the arsenic and PFC studies and/or to explore a fourth pilot project
Exploring different ways of conducting biomonitoring projects, including using stored
specimens collected for other purposes
Developing laboratory capacity and piloting new laboratory methods for measuring toxins in
dried blood
Piloting a different way of interpreting biomonitoring data than the other pilot projects (i.e.,
using a reference range approach)
Informing recommendations for an ongoing biomonitoring program in Minnesota
EHTB contribution to the study
EHTB staff resources and $50,000 of EHTB funds have been allocated to support the Lake
Superior Mercury Biomonitoring Study. This augments the $40,000 US EPA award and a
pending $25,000 US EPA amendment.
12
References
CDC, 2004. Blood Mercury Levels in Young Children and Childbearing-Aged Women-United
States, 1999-2002. MMWR Weekly 53(43):1018-1020.
CDC, 2005. Third National Report on Human Exposure to Environmental Chemicals. National
Center for Environmental Health, Division of Laboratory Sciences, Atlanta, Georgia. NCEH
Pub. No. 05-0570.
Chaudhuri SN, Butala SJM, Ball RW, Braniff CT, Rocky Mountain Biomonitoring Consortium,
2008. Pilot Study for Utilization of Dried Blood Spots for Screening of Lead, Mercury, and
Cadmium in Newborns. J. Exposure Science and Environmental Epidemiology, advance online
publication, doi:10.1038/jes.2008.19
Rice DC, Schoeny R, Mahaffey K, 2003. Methods and Rationale for the Derivation of a
Reference Dose for Methylmercury by the U.S. EPA. Risk Analysis. 23(1): 107-115.
Schober DJ, Sinks TH, Jones RL, Bolger PM, McDowell M, Osterloh J, et al. 2003. Blood
Mercury Levels in U.S. Children and Women of Childbearing Age 1999-2000. JAMA, 289(13):
1667-1674.
Stern AH and Smith AE, 2003. An Assessment of Cord Blood: Maternal Blood Methylmercury
Ratio: Implications for Risk Assessment. Environ. Health Perspect 111(12): 1465-1470.
National Academy of Sciences, 2000. Toxicological effects of methylmercury. Washington, DC:
National Research Council.
National Academy of Sciences, 2006. Human Biomonitoring for Environmental Chemicals.
Washington, DC: National Research Council.
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Section overview: Fourth biomonitoring pilot project
Included in this section are several documents related to the fourth pilot project:
1. Project proposal for the fourth pilot: Given limited time, staffing and financial resources,
the only feasible way to do a fourth pilot is to find a way to collaborate with another study
already in progress rather than developing an independent biomonitoring study. Program
staff have met with researchers involved in a number of research projects at the U of M to
determine whether there were any viable options for such a collaboration. One study emerged
as the most feasible option. This study, the Riverside Birth Study, and the EHTB program’s
proposal for collaborating with it, are described in this document. The proposed project will
address questions about exposure to pregnant women and will attempt to examine
demographic differences based on race/ethnicity. It demonstrates an alternate method for
recruiting participants from the population using a clinic-based approach, and builds
laboratory capacity for analyzing an emerging contaminant of public health concern.
2. Possible chemicals to be measured in the fourth pilot: The workgroup considered a range
of chemicals for inclusion in the fourth pilot project. After discussing each option in light of
a set of selection criteria (see below), the workgroup narrowed the list of potential chemicals
and/or chemical families to 4. The rationale for including the chemicals on this short list of
possibilities is summarized in this document, as well as the rationale for chemicals that were
omitted from the list.
3. Criteria for selecting a chemical for the fourth project: This set of criteria is adapted
slightly from the chemical selection criteria already reviewed by the advisory panel. Changes
were made to reflect specific aspects of the study we are proposing to collaborate with, such
as the time frame, the study population (pregnant women), and the specimen available
(urine). The workgroup used these criteria in discussing options for chemicals to be measured
in the fourth pilot project. The panel may also wish to consider these criteria in making its
recommendation for the chemical to be selected for study in the fourth pilot project.
In its discussion of the fourth pilot project, the panel is asked to keep in mind the following
requirements that are specified in the EHTB legislation in addition to the general limitations on
resources:
• The study must involve 30 voluntary participants from each of three communities that the
commissioner identifies as likely to have been exposed to a designated chemical (or class
of chemicals).
• We may collect one biospecimen.
• We may measure one chemical or class of chemicals
• 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.
• According to staff interpretation of the legislation, the pilot project must be completed
within the biennium, i.e., by June 30, 2009
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•
The goals of the pilot projects are limited to measuring exposure (the concentration of the
chemical in the body) in individuals and in the population as a whole. Pilot projects are
not health studies and are not designed to provide links to exposure sources or health
effects. Pilot projects also provide opportunity to demonstrate methodology and build
state capacity for conducting biomonitoring activities.
ACTION NEEDED: The advisory panel is asked to make a formal recommendation as to
which chemical should be studied in the fourth biomonitoring pilot project. This will require a
formal vote and the agreement of at least 9 of the 13 panel members. The panel’s vote will be
recorded as a recommendation; the commissioner of health will have final decision-making
authority of the chemical selected.
Suggested motion: I move that [x chemical] be recommended for study in the Environmental
Health Tracking and Biomonitoring Program’s fourth biomonitoring pilot project.
In addition, the panel is invited to provide comments and recommendations in order to
strengthen the biomonitoring proposal and to ensure that the most meaningful results are
obtained.
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Draft project proposal for the fourth pilot
Measuring Exposure [to a Designated Chemical] in Pregnant Women
Enrolled in the Riverside Birth Study
Objectives:
This project will collect and analyze biospecimens (urine) from an ethnically diverse sample of
pregnant women currently being enrolled in a study of maternal exposures during pregnancy, the
Riverside Birth Study conducted by the University of Minnesota. The aim of the EHTB pilot
project is to measure the distribution of a chemical exposure in the pilot study population, to
pilot a method for enrolling participants in a clinic setting, to build partnerships with University
of Minnesota researchers, and to build or identify laboratory capacity for monitoring an
emerging contaminant of public health concern.
Background:
Pregnancy is a time of vulnerability for in-utero exposures to environmental contaminants,
particularly for endocrine disrupters and neurotoxins which can affect fetal and child
development. In Minnesota, there is considerable public concern about exposures during
pregnancy and rates of developmental disabilities in children. Minnesota Statutes 144.996
directs MDH to conduct biomonitoring of pregnant women where scientifically appropriate. It
further directs MDH to collect specimens from 30 voluntary participants from each of three
communities identified as likely to have been exposed to a designated chemical.
The Riverside Birth Study (RBS) is being conducted by University of Minnesota investigators
Simona Ognjanovic, PhD, Logan G. Spector, PhD, and Julie A Ross, PhD from the Division of
Epidemiology/Clinical Research. The RBS study is designed to measure the correlation between
specific analytes in neonatal infant specimens and maternal exposures during pregnancy. The
study will enroll 500 pregnant women at prenatal clinics, beginning in the late summer 2008.
Women will complete questionnaires similar to those used in childhood cancer studies, and will
donate specimens (buccal cells and blood). When the infant is born, cord blood, meconium and
a heelstick spot will be collected.
For this project MDH EHTB investigators and study staff will partner with the U of M
investigators to add the collection of one spot urine sample at 3-8 months prepartum for 90
pregnant women enrolled. Basic demographic information such as age and ethnicity will be
collected by the RBS study; EHTB investigators also hope to collect information in regards to
length of time in the U.S., number of pregnancies, etc. (this will be dependent on the
questionnaire forms of the RBS).
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Community:
The community of study will consist of pregnant women who receive prenatal services and plan
to deliver at the University of Minnesota Medical Center (Riverside Campus) in Minneapolis.
The hospital and clinic are centrally located in the Minneapolis-St. Paul Area and draw patients
from a large and diverse urban area. Efforts will be made to enroll women in 3 ethnic/racial
communities: Hispanic (n=30), non-Hispanic black (n=30) and non-Hispanic white (n=30) for a
total of 90 participants. The area includes a large Somali population and all materials will be
translated into Spanish and Somali with trained bilingual staff available. Conducting this
project in a diverse community of pregnant women will provide valuable information to inform
our recommendations for an ongoing biomonitoring program in Minnesota, and will be
complimentary to the other biomonitoring pilot projects currently underway. These pilot project
results will provide data which will help to plan for the possibility of continuing the project in
the entire study cohort, and/or follow-up with the children.
Rationale for Selection of the Chemical:
[To be determined]
Methods for Recruitment:
Pregnant women receiving prenatal care at the study clinics will be identified by investigators
with the RBS. All women who consent to participate in the RBS, including agreement to be
contacted about participating in future studies, and complete the questionnaire for the RBS study
will be sent a postcard by RBS staff. The postcard will offer women the opportunity to
participate in the MDH pilot biomonitoring study for [to be determined] exposure. Women who
agree to participate will return their response to the RBS study staff. RBS staff will then mail the
women the urine collection kit, to be provided by MDH, with an RBS study ID label on the
specimen collection container. The women will then ship the completed urine collection to MDH
for laboratory analysis. MDH staff will not have any identifying information provided to them.
With the use of the study ID number from the sample, RBS staff will provide MDH staff with
de-identified demographic information from the questionnaire. The consent signed by the women
for participation in the RBS study will allow for future contact for further research and follow
up.
Laboratory Analysis
[To be determined.]
Methods for Communicating Results:
On the postcard form, pregnant women will have the option of receiving the results of the test.
The results letters from MDH will be provided to the RBS study with the assigned study ID
number to be mailed to the women. Individual results will be compared to the most recent
national sample results (NHANES). Women will also be provided with information about ways
to avoid exposure to [to be determined].
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Methods for Communicating with and Engaging the Community:
MDH staff will contact local and county health officials to inform them of the project and to
solicit their input. Community groups and organizations with a stake in the project will also be
contacted.
Risks and Benefits to Participants:
As a benefit, all participants will receive information about protecting the unborn child from
known environmental risks, including lead-based paints, and mercury exposure (fish
consumption advisories).
There is no health risk to participation. Pregnant women may become concerned or anxious
about the potential health risks. MDH will not be able to identify the source of the exposure but
will provide general recommendations for reducing future exposure. MDH will also not be able
to relate the result to current or future health outcomes. MDH will provide telephone numbers
and contacts where information and consultation about the health risks of [to be determined] can
be obtained, including a physician consultant available to consult with participants and the
medical community.
Statistical Analysis and Reporting of Pilot Project Results:
Results of the 90 sample pilot will be aggregated and a descriptive analysis summarizing the
distribution of exposure among pregnant women in the RBS community will be provided in the
project report.
Methods for Protection of Data Privacy:
All individual identifiers for the pregnant women and babies will be maintained in a secure
database at the University of Minnesota and will be accessible only to the study investigators at
the University of Minnesota. MDH will retain de-identified information directly related to this
study protocol, its questionnaire and lab analysis. Any information retained by MDH which may
be used to identify an individual will be classified as private health data under the Minnesota
Government Data Practices Act. Only summary results that do not identify individuals will be
available to the public.
Sample Storage and Future Use Research
As part of the consent process for the RBS study, the participants will be asked for their
permission to be contacted again for future research purposes. They will also be asked to
consent to the storage and use of any biologic specimen that is not consumed by the laboratory
analysis for this project. Use of the samples will be determined by the RBS study. The pilot
project samples will be stored under a study ID number that only the study coordinator in the
EHTB unit has access to. It is expected that urine samples collected by MDH will be consumed
in the laboratory analysis and no residual specimens will be stored by MDH beyond the study
end date.
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Possible chemicals to be measured in the fourth pilot
A list of chemicals to be explored for possible inclusion in the fourth biomonitoring pilot project was generated and evaluated using the chemical selection criteria by workgroup members and other agency staff. The list included chemicals of interest to staff and/or the public, as well as chemicals thought to be potentially relevant to the specific study population to be included in the pilot project. Of these, the advisory panel is asked to consider the following four chemicals/chemical families for possible inclusion in the fourth pilot project: 1. Environmental phenols, including the following: • Bisphenol A • Ethyl Paraben • Triclosan • Propyl Paraben • Benzophenone • Butyl Paraben • Methyl Paraben 2. Phthalates, including metabolites of the following: • diethyl phthalate • diethylhexyl phthalate • dibutyl phthalate • dioctyl phthalate • benzylbutyl phthalate 3. Pyrethroids, including the following metabolites: • cis‐3‐(2,2‐Dichlorovinyl)‐2,2‐dimethylcyclopropane carboxylic acid • trans‐3‐(2,2‐Dichlorovinyl)‐2,2‐dimethylcyclopropane carboxylic acid • 3‐Phenoxybenzoic acid • 4‐Fluoro‐3‐phenoxybenzoic acid • cis‐3‐(2,2‐Dibromovinyl)‐2,2‐dimethylcyclopropane carboxylic acid 4. Cotinine (a metabolite of nicotine and marker of exposure for tobacco smoke) Each of these chemicals/chemical families can be detected in urine. An adequate laboratory method exists to detect them, and the MDH laboratory has the capacity to measure these within the timeframe available. The workgroup eliminated an additional four chemicals/chemical families for reasons of feasibility: 1. DEET 2. PBDE 3. Siloxanes 4. Synthetic musks Brief summary information on each chemical/chemical family discussed by the workgroup is included below. Panel members will undoubtedly bring additional knowledge and expertise to the discussion. 21
Chemicals recommended for consideration by the advisory panel Chemical family: Environmental phenols Specific chemicals to be measured would likely include the following: • Bisphenol A (BPA) • Triclosan • Benzophenone (bp‐3) • Methyl Paraben • Ethyl Paraben • Propyl Paraben • Butyl Paraben Alkyl phenols (e.g., nonylphenol and octylphenol) and chlorophenols are less likely to be detected in the population. Also, nonylphenol and octylphenol may not be the best metabolites to monitor for alkyl phenolic surfactants as there is a potential for other metabolites to be formed. For these reasons, these specific environmental phenols will likely be excluded from lab analysis. Sources of exposure BPA is an industrial chemical used to make one type of polycarbonate plastic and certain types of epoxy resins. Polycarbonate plastic is used in many products such as refillable beverage containers, compact disks, some plastic eating utensils, and impact‐resistant safety and sports equipment. Epoxy resins containing BPA are used in dental composites and sealants, as coatings inside some food and beverage cans, and as corrosion‐resistant metal coatings. Triclosan is a chemical with antibacterial properties that has been used widely in many consumer products for at least the past 20 years. It is an ingredient in many detergents, soaps, skin cleansers, deodorants, lotions, creams, toothpastes, and dishwashing liquids. Triclosan is also added to various plastics (including toys and kitchenware) and to textiles such as underwear and socks. Bp‐3 is a uv‐filter and fragrance fixative that is widely used in sunscreens, moisturizers, lipstick, hairspray and other personal care products. It is used in consumer products such as cosmetics but also is approved for use in plastic coatings for food packaging. Parabens are commonly used as antimicrobial preservatives in a wide range of cosmetics, pharmaceuticals, and in food and beverage processing. The methyl and propyl parabens are the most commonly used parabens. Extent of exposure There is widespread exposure to BPA in the U.S. population (NHANES detected BPA in the urine of nearly 93% of the people tested. NHANES found that females had significantly higher levels of BPA in their urine than males. Non‐Hispanic blacks and non‐Hispanic whites had higher levels of BPA than Mexican‐Americans. People with the lowest household incomes had higher levels of BPA than people in the highest income bracket. Some data show an increase in BPA in urine during pregnancy. It is unclear whether exposure occurs at levels likely to cause health effects. 22
NHANES detected triclosan in the urine of nearly 75 percent of the people tested and bp‐3 in 97% of the people tested. No differences in Triclosan levels either by sex or race/ethnicity were found. Triclosan levels were greater among people in the highest income bracket than among those in either the middle or lower income bracket. Women had higher urinary concentrations of bp‐3 than men and non‐Hispanic whites had higher concentrations than non‐Hispanic blacks. A study of 100 adults conducted by CDC staff found methyl and n‐propyl parabens in 99% and 96% of the samples respectively. Other parent compounds, such as ethyl and butyl paraben, appeared in 58% and 69% of the samples. Potential health effects Generally speaking, environmental phenols are considered to be potentially estrogenic and/or carcinogenic. BPA CDC reports that when laboratory test animals are dosed during pregnancy, BPA has been shown to have hormone‐like effects on the developing reproductive system and neurobehavioral changes in the offspring. Scientists continue to debate whether effects could possibly occur in people who are exposed to low environmental levels of these chemicals. More research is needed to assess the human health effects of exposure to these chemicals. The National Toxicology Program (NTP) has issued a report stating that that there is some concern for neural and behavioral effects in fetuses, infants, and children at current human exposures to BPA. The NTP also has some concern for BPA exposure in these populations based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females. According to NTP, studies only provide limited evidence for adverse effects on development. However, because these effects in animals occur at BPA exposure levels similar to those experienced by humans, the possibility that BPA may alter human development cannot be dismissed. The NTP has negligible concern that exposure of pregnant women to BPA will result in fetal or neonatal mortality, birth defects or reduced birth weight and growth in their offspring. The NTP has negligible concern that exposure to BPA causes reproductive effects in non‐occupationally exposed adults and minimal concern for workers exposed to higher levels in occupational settings. Triclosan CDC reports that the health effects of triclosan in people are unknown. Few adverse effects are seen in animal studies. More research is needed to determine whether exposure to this chemical, especially at levels found in the U.S. population, actually affects human health. Bp‐3 CDC reports that the health effects of benzophenone‐3 in people are unknown. There is some evidence of estrogenic activity of BP‐3 in vitro and in vivo studies as well as antiandrogenic activity in vitro. The potential health effects of exposure to this chemical have not yet been determined. Parabens The toxic effects of parabens in people are mostly unknown. Parabens have demonstrated weak estrogenic activity in some in vitro and in vivo studies. Parabens have been shown to induce growth of MCF‐7 breast cancer cells and have been detected in human breast tumors. 23
Interpretability The 2003‐04 NHANES included analysis for BPA, Triclosan, and Benzophenone‐3, so pilot study results could be compared to a national average. A small biomonitoring study of 100 adults conducted by CDC staff determined the median concentrations of the four parabens mentioned above; no NHANES‐specific data exist for parabens. Actionability The ability to take steps to prevent exposure varies depending on the specific environmental phenol. Advice to individuals wishing to avoid exposure to BPA is more straightforward (e.g., avoid certain kinds of plastic; discontinue use of baby bottle containing BPA) than it is for other environmental phenols, which are found in many kinds of consumer products. Because so little is known about what are “acceptable” levels of exposure to environmental phenols and what the specific routes of exposure might be, it may be difficult to provide good advice. Degree of concern There is considerable public concern about BPA in particular, and in endocrine disruptors in general. Rationale and further considerations The workgroup recommends environmental phenols for consideration due to its known endocrine disrupting effects. While there is little known about human health effects, the NTP in a November 2007 review of BPA, indicated some concern for possible behavioral and neural effects from in‐utero exposure to the developing fetus making this chemical relevant to the study population of pregnant women. The recent release of the NTP report and the widespread exposure measured by NHANES have generated considerable public concern about BPA. Environmental phenols are also a chemical family of interest in environmental samples, such as wastewaters, surface waters, and drinking water, and as such the MDH Public Health Laboratory is interested in developing capacity in this area. The lack of NHANES comparison values for the parabens will make interpretation of these results difficult, and specific actions that individuals can take to prevent exposure to environmental phenols will likely not eliminate the exposure, nor will MDH be able to provide any assurance of reduced health risk from such actions. 24
Chemical family: Phthalates Specific chemicals to be measured would likely include metabolites of the following: • diethyl phthalate • dibutyl phthalate • benzylbutyl phthalate • diethylhexyl phthalate • dioctyl phthalate The metabolites of these phthalates are the ones that are most frequently detected. Sources of exposure Many consumer products contain phthalates, including vinyl flooring; adhesives; detergents; lubricating oils; solvents; automotive plastics; plastic clothing; and personal‐care products, such as soap, shampoo, deodorants, fragrances, hair spray, nail polish; children’s toys; garden hoses; and some medical pharmaceuticals. Extent of exposure According to NHANES data, the degree of exposure in the general population varies by specific phthalate, with some metabolites present in the majority of those sampled and others detected only at the 90th or 95th percentile. NHANES observed differences in concentrations of specific phthalate metabolites by age, gender, and race/ethnicity. Potential health effects CDC reports that the health effects of phthalates in people are not yet fully known. Although several studies in people have explored possible associations with developmental and reproductive outcomes (semen quality, genital development in boys, shortened pregnancy, and premature breast development in young girls), more research is needed. The National Toxicology Program has issued a report stating that for pregnant women not medically exposed to diethylhexyl phthalate (DEHP), available toxicity data and estimates of human exposure to DEHP lead to a conclusion of some concern for adverse effects on male offspring. Further, the NTP concludes that there is concern for adverse effects on male offspring of pregnant and breast‐feeding women undergoing certain medical procedures that may result in high levels of exposure to DEHP. Interpretability NHANES included analysis for 13 phthalate metabolites, so pilot project results could be compared to a national average. Actionability While it is possible to provide advice on reducing exposure to phthalates (e.g., avoid certain kinds of plastics), given their widespread use, it may be difficult for individuals to implement the recommended measures. Degree of concern There is considerable public concern about exposure to phthalates. 25
Rationale and further considerations The workgroup recommends that phthalates be considered for the fourth pilot due to their endocrine disrupting properties and possible associations with developmental and reproductive health outcomes, although these effects in humans are not yet known. The NTP report and the high degree of exposure measured in the U.S. population have raised public awareness and concern about phthalates, particularly among pregnant and breast‐feeding women. Results can be compared to the national averages established by NHANES. However, due to their widespread use in consumer products, specific actions that individuals can take to prevent exposure to phthalates will likely not eliminate the exposure, nor will MDH be able to provide any assurance of reduced health risk from such actions.
26
Chemical family: Pyrethroid compounds Specific metabolites to be measured would likely include the following: • cis‐3‐(2,2‐Dichlorovinyl)‐2,2‐dimethylcyclopropane carboxylic acid • trans‐3‐(2,2‐Dichlorovinyl)‐2,2‐dimethylcyclopropane carboxylic acid • 3‐Phenoxybenzoic acid • 4‐Fluoro‐3‐phenoxybenzoic acid • cis‐3‐(2,2‐Dibromovinyl)‐2,2‐dimethylcyclopropane carboxylic acid Most of these metabolites are non‐specific, meaning they are not linked to exposure to one specific pyrethroid. Because of this non‐specificity, however, it is not possible to say that they are metabolites of all pyrethroids, or to identify all specific pyrethroids to which they are linked. For example, 3‐Phenoxybenzoic acid has been identified as a metabolite of ten different pyrethroids (including cypermethrin, deltamethrin, permethrin, phenothrin, fepropathrin, cyhalothrin, fenvalerate, tralomethrin, flucythrinate and fluvalinate). The parent compounds associated with the metabolites listed above include permethrin, cypermethrin, cyfluthrin, cis‐permethrin, cis‐
cypermethrin, trans‐permethrin, trans‐cypermethrin, and deltamethrin. This contrasts with approximately 22 additional pyrethroids registered for use as insecticides in Minnesota for various purposes. Sources of exposure People may be exposed to pyrethroids by eating foods contaminated by these chemicals and using products that contain pyrethroids, such as household insecticides, pet sprays, specifically formulated shampoos used to treat head lice (regulated as medical treatments rather than as insecticides), and mosquito repellents that can be applied to clothing. Note that many of the pyrethroids used in various pest control applications (e.g., pet flea collars or agricultural pest control that could lead to residues on food) may not result in significant human exposure or be discernable in biomonitoring results. Extent of exposure In the most recent NHANES study, 3‐phenoxybenzoic acid, a common metabolite of several pyrethroid insecticides, was found in much of the U.S. population and suggests widespread exposure. For 3‐phenoxybenzoic acid, females had slightly higher levels than males. In addition, non‐
Hispanic blacks had slightly higher levels than Mexican Americans or non‐Hispanic whites. Two other pyrethroid metabolites (linked specifically to potential cyfluthrin or deltamethrin exposure) were not detected at the 95th percentile. A study in South Minneapolis has shown a higher incidence of cockroach allergen in apartment buildings vs. single family homes, which might lead to a higher potential for indoor pest control treatments in such buildings. In the same study, cockroach allergen concentrations were higher in Spanish‐ and Somali‐speaking households than in English‐speaking households. The Minnesota Children's Pesticide Exposure Study (MNCPES) showed that common pesticides found in air samples from urban and rural Minnesota homes included permethrin. Potential health effects CDC reports that compared with other older insecticides, pyrethroids are less hazardous to health. Accidental exposure to large amounts of pyrethroids for a short period causes dizziness, headache, 27
nausea, muscle twitching, reduced energy, changes in awareness, convulsions, or loss of consciousness. No evidence has been found that indicates pyrethroids cause cancer in people or in animals. Interpretability Five pyrethroid metabolites have been measured in NHANES; pilot results could be compared to a national average; however, among all pyrethroids registered for use in Minnesota, human exposure potential, especially among populations in the pilot project, may be dependent on the use pattern of specific pyrethroids, which may not be identifiable through the project participant surveys or through the biomonitoring results. Actionability A biomonitoring study will not be able to discern whether pyrethroid exposure is from diet versus residential exposure versus other exposures. Eliminating exposure to pyrethroids may not be feasible, particularly due to the public health benefits associated with their use (e.g., cockroach control), but some actions can be taken to reduce exposure. Degree of concern There is not a great deal of known concern among the general public about pyrethroids. Because of the increasing use of some pyrethroids, there is some interest among public health professionals in learning more about exposures. Rationale and further considerations The workgroup recommends that pyrethroids be considered for the fourth pilot due to their neurotoxic properties, but also due to their increasing use as replacements for more toxic compounds in a wide variety of commonly used household pesticide products. The pyrethroids have low toxicity and may be less of a concern to pregnant women. Test results may be difficult to interpret. Some of the metabolites of pyrethroids are non‐specific, or not associated with a specific chemical exposure or source. Therefore, it will not be possible to identify specific sources or provide specific advice on ways to avoid exposure. General advice on reducing pesticide exposure is possible but must be weighted against the health benefits of controlling pests in the home (particularly for controlling asthmagens). 28
Chemical name: Cotinine Sources of exposure Tobacco smoke Degree of exposure NHANES shows declining exposure in the U.S. population. The Third Report shows differences in cotinine levels among different groups of people. For example, non‐Hispanic blacks have levels twice as high as do Mexican Americans and non‐Hispanic whites. Potential health effects Secondhand smoke (SHS) exposure increases the risk for lung cancer and heart disease in adults who do not smoke. Because their lungs are not fully developed, young children are more susceptible to the effects of SHS. Exposure to SHS increases the risk for sudden infant death syndrome, asthma, bronchitis, and pneumonia in young children. Interpretability Cotinine was Included in the NHANES 2003 “Third Report.” However, NHANES measures cotinine in serum, not urine. It is likely that comparison values could be found elsewhere in the published literature. Actionability Advice could be provided to study participants about not smoking and not being around people who smoke. However, it is likely that these messages are already widely known. Degree of concern There is little known public concern about secondhand smoke exposure. Cotinine has been examined in depth in many studies and including it in the fourth pilot is unlikely to yield new information. Rationale and further considerations Of the four chemicals/chemical families on the list, it is likely that tobacco smoke is the most toxic, and therefore has the greatest known impact on public health. A project measuring cotinine also has the greatest potential for recommending action to reduce exposure and health risk. However, tobacco smoke and cotinine exposure have been studied extensively, which means there is likely little interest in studying it further and little chance that public health officials or the public will learn new information from the pilot. The workgroup also expressed concern that it may be undesirable to include a chemical in the pilot project for which exposure is entirely attributable to personal behavior (smoking) without an expressed interest from the community.
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Chemicals not recommended for further consideration by the advisory panel Chemical family: PBDEs Sources of exposure Brominated flame retardants are added to plastics and foam products to make it more difficult for them to burn. They are found in furniture foam; consumer electronics; wire insulation; back coatings for draperies and upholstery; and plastics for television cabinets, personal computers, and small appliances. Feasibility issues This category of chemicals was excluded from further consideration because it is measured in blood rather than urine. Chemical name: DEET (N,N‐Diethyl‐meta‐toluamide) Sources of exposure DEET is used in insect repellents. Feasibility issues This chemical was excluded from further consideration because it is unlikely to be detected in the study population. NHANES could measure DEET in only 5% of the population; this proportion may be even lower in the winter, when samples for the pilot project will be collected. Chemical family: Siloxanes and siloxane metabolites Sources of exposure Siloxanes are compounds made up of silicon, oxygen and methyl groups. The siloxanes are used in silicone products. Siloxanes are common components of personal care products as well as some pharmaceuticals. They are also used as lubricants and sealants in broad range of consumer products. Feasibility issues This chemical family was excluded from further consideration because no published laboratory method exists. Chemical family: Synthetic musks Sources of exposure Synthetic musks are used in consumer products to add fragrance. Feasibility issues This chemical family was excluded from further consideration because no published laboratory method exists for biomonitoring samples. 30
Criteria for selecting a chemical for the fourth pilot
PASS/FAIL CRITERIA
1. Adequacy of method
a) Availability of analytical methods to detect the chemical or its metabolites with adequate
accuracy, precision, sensitivity (i.e., ability to detect the chemical at low enough levels),
specificity, and speed
b) Availability of adequate biospecimen samples (i.e., this chemical can be detected in urine)
c) Degree to which the chemical stays in the body long enough to be measured during the study
time frame
2. Feasibility
a) Cost of laboratory analysis (time and dollars)
b) Degree to which laboratory capacity (e.g., equipment, expertise) exists or can be developed (at
the MDH laboratory or other laboratories) to perform the analysis within the study time frame
OTHER CRITERIA
3. Degree of exposure in the population
a) Proportion of the study population likely to be exposed to the chemical (at a level of known health
significance) [E.g., based on other exposure studies]
b) Degree to which study sub-populations are likely to be exposed to the chemical (at a level of
known health significance) [I.e., is this a special concern for pregnant women; are there likely to
be differences across race?]
4. Seriousness of health effects
a) Seriousness of known health effects resulting from exposure (based on peer-reviewed health
data, chemical structure, or the toxicology of chemically related compounds) [Are these health
effects of special concern for fetal development?]
5. Interpretability of the result
a) Availability of appropriate values against which individual and community biomonitoring results
can be compared
b) Degree of information known about what levels in the body are considered safe and what levels
are associated with human health effects
6. Actionability
a) Degree of potential for public health action or policy to be implemented based on biomonitoring
results (i.e., steps can be taken to stop the exposure for the whole population or a sub-population
of interest)
b) Degree to which repeat measures of the chemical will assess the efficacy of public health actions
that are taking place to reduce exposure in the population as a whole or a sub-population of
interest
7. Potential for information building
a) Degree to which studying the chemical selected would add significantly to the existing knowledge
base about chemical exposures
b) Degree to which the public or a specific sub-population is concerned about a specific chemical
*Modifications from the original selection criteria are underlined.
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Section overview: Biomonitoring pilot program guidelines
At its March 2008 meeting, the ETHB advisory panel discussed a draft set of biomonitoring pilot
program guidelines. Since that meeting, revisions have been made based on panel members’
comments and new sections have been added to the draft.
A revised draft of the biomonitoring pilot program guidelines is included in this section. The
advisory panel is asked to review the new sections of the program guidelines (which are noted as
such in the text).
The new portions of the guidelines include the following:
• Pilot project design
• Use of stored specimens for future research
• Community acceptance and participation
• Selecting appropriate reference (comparison) values for data interpretation
• Inclusion of children in biomonitoring pilot projects
As before, the goal of bringing the draft biomonitoring pilot program guidelines to the panel is
not a formal adoption of this document. Rather, staff are seeking the panel’s input and advice on
the creation of this document, and would like to uncover the range of viewpoints held by panel
members. This discussion will inform the further development of biomonitoring program
guidelines.
ACTION NEEDED: The panel is invited to provide suggestions for revising and strengthening
the new portions of the draft biomonitoring pilot program guidelines to ensure that the
guidelines reflect the appropriate values and will adequately guide decision making. No
formal vote is anticipated.
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Draft Minnesota biomonitoring pilot program guidelines (FY 08-09)
Introduction
0B
On a national and international level, biomonitoring is an area of rapid technological advancement. A
decade ago, only a few dozen chemicals in a limited number of biological matrices (e.g., serum,
urine, hair, or toenails) were the subject of biomonitoring research. Today, a few hundred chemicals
or their metabolites have been measured, albeit often only in preliminary studies, in a much wider
range of biospecimens. These numbers are dwarfed by the 75,000 chemical substances that are
included on the EPA’s Toxic Substances Control Act (TSCA) Chemical Substance Inventory.
As public health laboratory scientists have forged ahead with developing and validating analytical
methods to measure internal doses of chemicals, there has been a corresponding acceleration in
the number of health research studies that include biomonitoring. Public health research
institutions now incorporate biomonitoring into major epidemiological studies such as the National
Children’s Study being conducted by the National Institute of Child Health and Development.
In public health agencies, biomonitoring can potentially be applied in a number of ways. For
example, biomonitoring can be a tool for exposure assessment, with potential applications to risk
assessment, and the development of environmental standards. When measures are repeated over
time, biomonitoring can serve in a surveillance capacity to monitor population exposures and can
enable public health practitioners to track the progress and efficacy of public health actions
aimed at reducing exposures (e.g., lead). And in the environmental community, biomonitoring
has served to raise public awareness of the prevalence of chemical exposures, particularly for
emerging contaminants such as PFCs. Many advocates view biomonitoring as a tool for shaping
public policy around chemical regulation.
Biomonitoring poses unique challenges when performed in a public health context. According to
a recent publication of the National Research Council’s Committee on Human Biomonitoring for
Environmental Toxicants “the challenge for public health agencies is to understand the health
implications of the biomonitoring data and to craft appropriate public health responses” (NRC,
2006). It is imperative that we direct our limited resources for the four biomonitoring pilot
projects in Minnesota towards activities which will best enable us to meet this challenge.
These guidelines will help inform and guide decisions made about the design and conduct of the four
EHTB pilot projects. While we may not be able to adhere to all of these principles during the pilot
stage of the biomonitoring program, these statements should serve to set a standard for biomonitoring
projects in Minnesota that are scientifically sound, have community acceptance and address all
ethical and legal considerations for studies that involve human subjects. They should make us think
hard about any tradeoffs we make.
These guidelines are a work in progress, and will be reviewed, modified and built upon on an
ongoing basis. The development of these guidelines included the following steps:
35
1) MDH staff conducted a review of available publications, including the recent publication
of the National Research Council’s Committee on Human Biomonitoring for
Environmental Toxicants (NRC, 2006).
2) MDH staff contacted or reviewed other state and federal biomonitoring programs to
obtain copies of existing guidelines for biomonitoring. Staff conducted 3 telephone
conferences with staff at the National Biomonitoring/NHANES program and obtained
information about guidelines and procedures used in the national program.
3) MDH staff surveyed a subgroup of advisory anel members. Members were asked to rate
their agreement or disagreement with a series of policy and ethical statements regarding
biomonitoring and then discussed the statements.
4) Based on the survey and discussion of the advisory panel subgroup, and with additional
research of available literature (see references), guidelines were drafted by staff.
5) Guidelines were reviewed by the workgroup, and modified in accordance with
recommendations of the group.
6) Guidelines were presented to the full advisory panel for review and recommendations,
then modified in accordance with panel recommendations.
36
Biomonitoring program vision statement [Placeholder]
1B
This section will describe the long-term vision/goals of Minnesota’s base biomonitoring
program, which will be developed in consultation with stakeholders and will be reported to the
Legislature in January 2009. There are several models that could potentially serve as the basis for
a biomonitoring program in Minnesota, including laboratory-based research, state investigatorinitiated research, exposed community-based response/investigation, and population-based
surveillance.
Pilot program purpose
2B
Biomonitoring pilot projects should provide information to individuals and communities about the
prevalence and range of exposure to chemicals in the selected community and compare those
values to a reference range.
The primary purpose of the EHTB biomonitoring pilot projects is to answer questions about the
distributions and ranges of exposure to specific chemicals in the selected communities. Where
possible, projects will compare exposures in populations most vulnerable to the exposure to a
reference data set from the general population, and in so doing, may contribute to communitylevel health assessments.
A secondary purpose of the pilot projects is to build capacity in Minnesota for implementing an
ongoing biomonitoring program. To this end, careful attention will be paid to documenting and
applying lessons learned from the pilot projects in terms of protocol development, participant
recruitment, communication of results, community engagement, survey development, methods
for specimen collection, and other steps in conducting biomonitoring studies.
In addition, it is important to recognize that biomonitoring is an emerging laboratory science.
Analytical methods have not yet been developed to characterize many chemicals (and their
metabolites) in human specimens. Therefore, another secondary purpose of biomonitoring pilot
projects is to gain knowledge about the robustness and comparability of laboratory techniques,
precision and accuracy of laboratory data, detection limits of analytical methods, and the
integrity of aged biospecimens.
In selecting biomonitoring pilot projects, preference will be given to projects that fulfill more
than one of these purposes.
*new section* Pilot project design
3B
For each pilot project, a protocol document will be developed for review by the EHTB Advisory
Panel and the MDH Institutional Review Board to ensure the project is scientifically sound and
conducted in a manner that meets all ethical and legal requirements as stipulated by the EHTB
Statute, the biomonitoring program guidelines, and the Minnesota Government Data Practices
Act.
The protocol document will describe salient aspects of the project design, depicted in Figure 1
(attached), including but not limited to the following parts:
37
Project objectives
The objectives of the project will be consistent with the purposes of the pilot program as
described above.
U
Selection of communities
The specific community population will be defined and a clear rationale will be provided as to
why a chosen community is likely to be exposed, or is more vulnerable to exposure than the
general population. Any inclusion or exclusion criteria for determining participant eligibility will
be described.
U
Choice of biospecimen
The protocol will describe why the specific biospecimen was selected, including how the
biospecimen accurately represents the body concentration of the chemical of interest (in
accordance with the EHTB statute) and how the biospecimen will allow for interpretation and
comparison of results to the general population (e.g., consistency with specimens collected by
NHANES or other appropriate studies). Consideration will also be given to cost-effectiveness
and to choosing biospecimens that are less invasive or risky for participants.
U
Methods for participant selection, recruitment and consent
The protocol will describe how eligible participants will be identified and selected from the
chosen community, contacted, and invited to participate in the project. Where feasible,
participants should be selected using probablistic sampling methods (or in total) from a clearly
defined population within the selected community so that results are generalizable to the defined
population. Self-selection into the project prohibits any such generalization and is generally not
appropriate for the purposes of the pilot projects. A high degree of non-participation will also
limit generalizability, so methods used to assure a high rate of participation will be described.
Methods for obtaining informed consent will also be described.
U
Methods for collection and transport of specimens
Methods will describe the location (e.g., home, clinic, etc.) where samples will be collected, the
required weight or volume of sample needed, who will collect them (e.g., parent, clinician, etc.),
and the type of container needed for safe storage and transport (e.g., refrigeration temperature, if
needed).
U
Methods for laboratory analysis
The protocol will briefly describe the laboratory analytical methods to be used and any criteria
by which a sample may be rejected for analysis. The project protocol will ensure that a written
quality assurance plan and a standard operating protocol are available in the laboratory and that
these documents have successfully passed an external evaluation for scientific soundness.
Minimum requirements for a quality assurance plan and/or the standard operating procedure
(SOP) are described in a subsequent policy.
U
Methods for data management and statistical analysis
This section will describe any databases to be used or developed as well as the statistical
methods planned for describing, analyzing, and summarizing aggregate results, consistent with
the stated project objectives and design.
U
38
Data privacy
The protocol will describe the specific classification of all data collected for the project in
accordance with the Minnesota Government Data Practices Act, where and how data will be
stored, and methods used for ensuring data privacy and database security.
U
Limitations
The protocol will describe any important limitations in the project design that are expected to
impact the use or interpretation of project results.
U
Risks and benefits
The protocol will describe the specific risks and benefits that individual participants may receive
from participation. These will include not only risks or benefits to individual health, but also any
potential for discomfort, inconvenience, or cost the participant may incur. Any incentives will
also be described.
U
Communication of results and follow-up
The protocol will describe how results will be communicated to the individual participant and to
the community, and the available reference values for interpretation of the result. It will describe
specific actions to be taken if an individual result is elevated and conditions under which medical
follow-up may be needed. Methods for providing health education and medical counseling will
be described.
U
The MDH Institutional Review Board reviews all MDH research projects to ensure that projects
are consistent with laws and best ethical practices for the treatment of human subjects in
research. An application must be submitted for a determination of exemption (in the case of
some studies of minimal risk to participants), or full board review. Where a project involves
collaboration with other institutions, such as hospitals, universities, or other health agencies,
these institutions may require that a separate application be submitted to their IRB as well.
Privacy of information
4B
MDH data storage systems, in compliance with the Minnesota Government Data Practices Act,
provide adequate protection of data privacy; anonymization of samples and data collected by the
EHTB pilot program, which limits the potential uses of the data and the communication of
individual results, is not necessary to ensure data privacy.
Given that biomonitoring involves the collection of individual information about the levels of a
chemical or its metabolites in the body, the utmost care must be taken to protect the privacy of
this information. The Minnesota Department of Health is required by Minnesota Statutes Chapter
13 to classify individual biomonitoring data as private health data. This means that participants’
individual biomonitoring data may be released only to the participant (or the participant’s
parent/legal guardian). While permanently removing all identifying information from a specimen
and the analytical data is one way to protect participants’ privacy, such anonymization severely
limits the ability of scientists to use the data for other research purposes in the future (e.g., to
examine links between exposure and health information). Anonymization of the result also
39
restricts the possibility of contacting participants and communicating results, which is required
by the EHTB statute and is an important facet of the biomonitoring pilot program guidelines.
An exception to this policy may be appropriate where the primary purpose for a particular
biomonitoring pilot project is to assess the technical feasibility or the development of a
laboratory method. Objectives of technical feasibility studies might include an assessment of
variation in laboratory measurements due to: (a) relative integrity of the biospecimens during
transport and storage; (b) chemicals in the biospecimens or collection containers that interfere
with the analytical technique; and (c) uncontrolled, ephemeral factors that influence the
chemistry of the biospecimen. For such projects, where the analytical methods do not ensure that
the laboratory measurements have validity for reporting internal exposure levels on individuals
or for future studies, the use of anonymized specimens may be appropriate.
Informed consent
5B
Written informed consent will be obtained from each participant (or adult guardian of a
participating minor) who provides a biospecimen as part of EHTB biomonitoring pilot projects.
The consent document must meet informed consent requirements under federal rules and policy
developed by the Department of Health and Human Services and be accepted by the Institutional
Review Board (IRB) of MDH and any partnering institution.
During the collection of biomonitoring data, careful attention will be paid to the informed
consent process to ensure that participants (or adult parents or guardians for child participants)
understand the research goals, the risks and benefits of their participation, and how the data they
provide will be stored and used. The consent will provide information about the types of
chemicals and metabolites for which the specimen will be analyzed.
The specific processes for obtaining adequate informed consent will vary depending on the
situation. If new biospecimens are collected specifically for an EHTB project, participants will
be provided with information on the overall objectives of the research and specific information
about the chemicals being tested, and will be asked to provide written, informed consent. If a
biomonitoring project uses anonymized biospecimens collected by other researchers or
programs, obtaining project-specific informed consent is not possible. Such specimens will be
used only after verifying that a valid “blanket” informed consent has already been provided by
the participant, which allows for the future use of their individual specimens for other research
purposes.
Laboratory quality assurance
6B
Laboratories approved to provide biomonitoring data for the EHTB Program must fulfill many
criteria, including those listed herein. They must have a documented quality assurance plan and
must adhere to any required quality control procedures specified in an approved method. They
must ensure that the analytical data are scientifically valid and legally defensible. The data must
be of known and acceptable precision and accuracy, and data must be protected in accordance
with the Minnesota Government Data Practices Act.
Rigorous quality assurance/quality control procedures should be in place before a biomonitoring
project moves forward. This includes appropriate calibration of instruments, running standards
40
and blanks, reporting limits of detection, and other parameters. In addition, sample collection,
storage and transportation techniques must be specified in the project protocol to ensure the
integrity of the sample for analysis. Biospecimens must be stored at the proper temperature and
isolated from laboratory contaminants, standards, and highly contaminated specimens. Samples
must be assigned unique identification numbers and tracked from receipt by the laboratory
through analysis to long-term storage or disposal. Criteria must be specified for rejecting samples
that do not meet shipping, holding time, or preservation requirements.
The analytical method must describe the procedures for reducing, validating, reporting, and
verifying the data, as well as procedures for corrections or amended reports. At a minimum,
quality control parameters in the method should describe:
• Instrument performance check standards;
• Frequency and acceptability of calculations of the method detection limit;
• Frequency and acceptability of the demonstration of the minimum reporting limit;
• Criteria for specimen collection, preservation, transport, receipt and storage;
• Calibration, internal, and surrogate standards, including specimen collection
containers;
• Laboratory reagent blank and laboratory matrix spike replicates;
• External quality control samples and proficiency testing samples (when available);
• Initial and continuing demonstrations of method capability;
• Identification of contaminants or confounders;
The method should describe responses to obtaining unacceptable results from internal quality
control checks and describe how corrective actions are taken and documented.
The laboratory facilities must be adequate to ensure the security and integrity of the samples and
the data. The analytical chemists must have the appropriate level of education and experience in
the specific discipline. Data produced by analytical chemists during their apprenticeship are
acceptable only when reviewed and validated by a fully qualified analytical chemist or the
laboratory supervisor. Laboratory procedures and facilities to ensure the security and privacy of
individual data will be described in the quality assurance plan and/or standard operating
procedures.
Laboratory approval program
7B
The EHTB program will utilize only those laboratories that have provided assurance that systems
are in place to generate reliable data.
At a minimum, an approved laboratory must have the appropriate equipment, trained analytical
chemists, demonstration of capability, validation of the method, and quality systems for
reporting laboratory data that are accurate and precise. The assessors should be experienced
professionals who have the appropriate levels of education and experience in the specific
discipline. The assessors should have experience in laboratory evaluation and quality assurance,
be technically conversant with the sample preparation methods and analytical techniques being
evaluated, and be competent to assess the quality of the laboratory reports and reporting system.
41
Storage of specimens
8B
Biospecimens collected through the EHTB biomonitoring pilot projects will be stored, at a
minimum, for the duration of the project (approximately one year), with the written, informed
consent of the participant. If continued storage of the specimens beyond the duration of the
project for future research purposes is planned, then the consent document will offer participants
the option to allow or refuse the storage and use of their specimen for future research. Specimens for
which such a written “blanket” consent for long-term storage and use has not been obtained from the
participant will be destroyed at the completion of the project.
Long-term storage (or “biobanking”) of biospecimens is important for future public health
research and biomonitoring, beyond the purposes of the pilot program. A blanket consent for the
banking and future use of specimens removes the practical difficulties and expense researchers
face in conducting repeated sample collection and analysis and obtaining new consent.
Therefore, the potential for future or secondary use of the specimens will be carefully considered
during the development of biomonitoring protocols and the informed consent process. Where
appropriate, and in accordance with the law, participants will be asked to consent to continued
storage and use of the sample beyond the project time period.
The samples or biological information MDH collects for this pilot program will not be analyzed
for the presence, absence, alteration, or mutation of a gene, or for the presence or absence of a
specific DNA or RNA marker. Therefore, MDH does not intend to use biomonitoring pilot
project samples for the creation of information specifically defined as genetic information in
Minn. Stat. 13.386
All consent documents will explain that long-term storage of specimens (beyond the project
period) is voluntary (optional). Participants will be notified that they have the right to request
that their specimen be destroyed at any time by submitting a written request to MDH.
*new section* Use of stored specimens for future research
9B
Researchers (both internal to MDH and external) who request to use stored specimens for
research beyond the pilot projects will be required to submit an Application for Sharing Biological
Samples to an MDH oversight committee for review and approval.
Applicants will provide information about what specimens they require, a description of the
intended use of the specimens, and what type of additional subject information or demographics
they require. Information which identifies individual participants will not be released.
Sharing of specimens or data cannot violate laws, rules or guidelines of the biomonitoring
program. All individual test results must be classified as private and not released or shared with
any person not employed by the investigator on the project. Any remaining specimen must be
destroyed or returned to MDH.
Researchers will be notified of the prevailing law under which the samples were collected.
Additional procedures for addressing these types of requests are needed including, the need for
42
contractual agreements or data use agreements and the specific review process by which
decisions to approve or reject such requests will be made.
Communication of results
10B
All individual participants have a right to know their individual results.
Biomonitoring data are often difficult to interpret. In some cases, information might be known
about the health effects of a high result without information about how to reduce exposure. In
other cases, there may not be information on what a high level means, but suitable information is
known about reducing exposure. In still other cases, neither information about the health
consequences nor exposure pathways may be known.
Nevertheless, in all of these circumstances, individual participants have the right to know their
individual results if they choose and MDH has an ethical obligation to make results available to all
participants. In particular, biomonitoring results should be communicated for chemicals for which
a reference value is known. Not making individual results available to participants may
compromise MDH’s credibility with the public.
However, in some cases (e.g., when anonymized specimens are used in technical feasibility
projects) communication of individual results is not possible. In these cases, there must be a
significant benefit to the state in conducting the biomonitoring project in order to justify the lack
of communication of individual results to participants.
In addition to communicating individual results, MDH is committed to providing information to
help participants interpret their results. Whenever possible, communication materials will be
designed to help participants understand (1) how their results compare to others in the study
and/or to the general population; and (2) how their results compare to values associated with
human health effects. In addition, when such information is known, advice will be provided for
reducing exposure to the chemical measured. To ensure that communication efforts are
appropriate and effective, program staff will consult with relevant stakeholders (e.g., community
members, physicians, scientists, etc.) in designing communication materials and methods.
*new section* Community acceptance and participation
1B
Biomonitoring staff will take steps to learn about the communities in which the pilot projects take
place and will solicit input from community members on specific aspects of the projects’ design
and materials. Project materials and procedures will be developed in ways that encourage
voluntary participation.
To ensure participation in the biomonitoring pilot projects, they ultimately must be designed in
ways that are acceptable to community members. This requires a mutual exchange of
information between project staff and the project communities: project staff need to share
information about the project with community members while also taking in information about
the project communities that could improve the project design.
43
As part of the pilot biomonitoring projects, opportunities will be provided for community
members and other stakeholders (e.g., local officials, community-based organizations, clinics,
etc.) to give input on the project and for project staff to learn about important community values.
Information will be shared and solicited through local news media, meetings with community
representatives, and/or public meetings. Contact information will be provided so community
members have ready access to program staff. Additional communication channels may be
explored based on feedback from community representatives.
Given the limited timeframe for the pilot projects, efforts to further engage community members
will be somewhat limited in scope. Community members may be asked for input on specific
aspects of the projects, including the development of methods and messages for communicating
results to participants and the community and making recommendations for further action. Input
provided by community representatives will be reviewed by staff and incorporated into project
design when feasible and when doing so does not compromise the scientific validity of the
project.
To encourage participation, all participant materials will be written at a suitable reading level. To
the extent possible, efforts will be made to identify community resources for assistance in
reaching residents who do not speak English and so participant materials can be translated into
other languages.
When participation in the pilot projects requires participants to spend a significant amount of
time or subjects participants to significant inconvenience, they may be compensated for their
time and inconvenience. Compensation levels will be reviewed by MDH’s IRB for
appropriateness.
Follow-up counseling
12B
Basic follow-up health education and counseling services must be available for participants.
Because of the confusion that may be associated with receiving biomonitoring results,
participants will be provided with the opportunity for follow-up health education and counseling.
At a minimum, participants will be provided a phone number to speak to a health educator at the
health department for assistance in interpreting their results. In cases where results are especially
likely to evoke fear or where there are specific medical concerns, an additional level of follow-up
counseling, such as having an opportunity to speak to a physician, will be offered. Providing an
appropriate level of follow-up counseling is important for meeting the needs of participants,
providing a health benefit and instilling public confidence in MDH.
*new section* Selecting appropriate reference (comparison) values for data
interpretation
13B
Appropriate (clinical) guideline-based or population distribution-based reference values should be
reviewed and used for the interpretation of individual and community pilot project results.
The National Biomonitoring Program of NHANES has identified three strategies for
communicating and interpreting the results of biomonitoring: guideline-based, distribution-
44
based, and risk-based (see below for definitions). The pilot biomonitoring projects will use the
first two of these strategies in determining appropriate reference or comparison values. The
selection of chemicals and specimens for biomonitoring should consider the adequacy of
available reference data for interpretation of results, and preference should be given to chemicals
for which guidance-based or distribution-based reference values are available.
Clinical guideline-based
Using this approach, participants’ results are compared to established health-based guidance
levels. MDH will review the available medical and occupational health literature and will
consult with medical experts and EHTB advisory panel members to determine whether an
established clinical guideline based on human health data exists and should be applied to the
interpretation of biomonitoring results.
U
Distribution-based
With this approach, individual and group results are compared to the ranges and distributions
for each chemical measured within the general (national) population. NHANES data are
particularly well suited for use in providing a distribution-based comparison or reference
range. Due to the potential for changes in population exposure levels over time, comparisons
using this approach should be made with the most recent general population distribution data
available.
U
If general population distribution data are not available for a given contaminant, individual
results may be compared to the study group as a whole (an internal comparison approach).
This requires that the entire group be analyzed before the result can be interpreted, however,
and without an external comparison there is no way to determine how the grouped results
compare to the general population. Other population studies may also provide comparison
values but should be evaluated carefully.
This approach allows for result levels to be characterized as “high,” “average” or “low,” even
though no statement of risk can be made. Where health concern over “high” values is raised
based upon this distributional analysis, recommendations for follow-up testing to repeat the
measure or consultation on possible sources of exposure may be appropriate.
Risk assessment-based
In this approach, results are compared to risk assessment-based values derived from
toxicological and epidemiological study findings. No observed adverse effect levels
(NOAELS), permissible occupational exposure levels (PELs), biological exposure indices
(BEIs), EPA reference doses (Rfds), and cancer potency factors are examples of risk
assessment-based values that may be compared with population exposure levels.
U
Due to the considerable policy and scientific debate regarding the risk assessment methods,
applicability and completeness of the available data, uncertainty about the actual internal
dose, and assumptions used to derived risk-based values, comparisons between individual or
community exposure levels measured in biomonitoring studies and these risk-based values is
not recommended. For example, occupational exposure guidelines assess risk for healthy,
working adults for specific exposure periods and are inappropriate for a community
45
population which includes children, the elderly, and the infirm. Similarly, a reference doses
(Rfd) based on animal toxicity studies is generally inappropriate for interpreting human
biomonitoring results. Only a reference value that is based on relevant health endpoints, at
internal doses measured in relevant (human) populations should be considered for use in
interpreting biomonitoring results.
*new section* Inclusion of children in biomonitoring pilot projects
14B
Children may be included in biomonitoring pilot projects as long as the ethical requirements for
protection of research subjects set forth by federal federal rules and policy developed by the
Department of Health and Human Services (45 CFR part 46) and accepted by the IRB of MDH and
other partnering institutions have been met. This means that to include children in the pilot
projects there will be no more than minimal risk unless there is a direct benefit to the child.
According to federal law 45 CFR part 46, if the research requires greater than minimal risk there
must then be a direct benefit to the child, or the results must provide generalizable information
about the child’s disease, or must provide the opportunity to understand, prevent, or alleviate a
serious problem affecting the health or welfare of children. If these stipulations are not met then
it is considered unethical to proceed with research in children.
The suggested definition of minimal risk provided in the literature is as follows: minimal risk is
the amount of risk a child usually encounters in daily life, such as at a routine medical or dental
appointment (Fisher et al, 2007; Iltis, 2007). Based on this interpretation the collection of
different biological samples would fall into the following categories:
Minimal Risk in Biomonitoring (i.e., the collection of these samples are events that occur
in a child’s everyday life)
1. Urine collection
2. Hair collection
3. Toenail collection
4. Capillary or heel stick blood draw
More than Minimal Risk in Biomonitoring
1. Venipuncture
2. Tissue biopsy
To include children in the biomonitoring pilot projects that involve a greater than minimal risk
there must be some form of direct benefit to the child. Direct benefit to the child may require that
chemical biomonitoring be included as a component of another study that is testing for a health
endpoint of concern and for which the test provides a benefit. An environmental endpoint of
concern would be a test for lead levels among children at risk for lead poisoning, where the
collection of these data would provide knowledge to better understand, prevent, or alleviate a
serious problem affecting the health or welfare of children. The testing of the lead level in the
child is a direct benefit to the child and would allow a researcher to use the rest of the available
biological sample for other biomonitoring processes. The biomonitoring protocol could also be
tied to an assessment of nutrition, such as hemoglobin, blood glucose, obesity, etc., the results of
which would be a direct benefit to the child as well as children as a group. If the requirements set
46
forth in 45 CFR part 46 are met by the biomonitoring pilot projects or the base program then
children may be included in the study population.
Special considerations need to be taken in regard to the amount of blood collected from a child.
The University of Minnesota guidelines, taking into consideration the age, weight, health,
collection procedure and the amount of blood to be collected, determined that the amount drawn
should not exceed the lesser of 50 ml per child or 3 ml per kg in an 8-week period and collection
may not occur more frequently than 2 times per week. These are in keeping with accepted
guidelines used by the NHANES national biomonitoring program and other institutions.
A secondary issue for a child’s participation in biomonitoring is that of informed consent.
Federal regulations state that a parent or guardian must consent to the research with the child’s
assent when the child is capable of providing such. Consistent with acceptable practices of many
IRBs, we will use an age of 7 as an appropriate age to begin assent. If a child is a ward of the
state, biomonitoring may only be completed if it pertains to her/his status as a ward or will be
conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of
children involved are not wards of the state. An advocate for the child must be present to provide
consent for the child. If a biomonitoring project were to maintain active involvement of the child
to her/his 18th birthday then re-consent would be required to continue with the research project.
If the biomonitoring project is no longer actively involving the participants but the biological
samples had been stored for research, MDH will make a good faith effort to obtain consent from
the child at the age of 18 to continue to store and use those samples for future research purposes.
However if that individual could not be located or contacted the study would continue to store
and use those specimens as they were consented to by the parent. We will operate under the legal
standing of the consent at the time it was obtained
47
Bibliography
15B
Bates MN et al. (2005). “Workgroup Report: Biomonitoring Study Design, Interpretation, and
Communication-Lessons Learned and Path Forward.” Environmental Health Perspectives. Vol.
113, No. 11. pp.1615-1621.
Brody, JG et al. (2007). “Is it Safe?: New Ethics for Reporting Personal Exposures to
Environmental Chemicals.” American Journal of Public Health. Vol, 97, No. 9, pp.1547-1554.
Fisher, C. Kornetsky, S. Prentice, E. Determining Risk in Pediatric Research with No Prospect of
Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations. The
American Journal of Bioethics 2007; 7(3):5-10.
Iltis, A. Pediatric Research Posing a Minor Increase Over Minimal Risk and No Prospect of
Direct Benefit: Challenging 45 CFR 46.406. Accountability in Research 2007 Jan-Mar; 14(1) 1934.
Needham LL, Calafat AM, Barr DB. (2007). “Uses and Issues of Biomonitoring.” Int. Journal of
Hygiene Environment Health. V. 210, pp.229-238.
NHANES (2008) – Jean, you cite this in the text, but I’m not sure what document you are
referring to here. We need to add it.
NRC. (2006). National Research Academy. Human Biomonitoring for Environmental
Chemicals. National Academies Press.
Sexton K, Needham LL, Pirkle JL. (2004). “Human Biomonitoring of Environmental
Chemicals.” American Scientist. Vol. 92, pp 38-45.
48
Figure 1: Stages of a Biomonitoring Study
Source: NRC. (2006). National Research Academy. Human Biomonitoring for Environmental
Chemicals. National Academies Press.
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Section overview: Environmental health tracking strategic plan
Minnesota Statue 144.996 requires the EHTB program to develop a strategic plan that includes
“a mission statement, the identification of core priorities for research and epidemiological
surveillance, and the identification of internal and external stakeholders, and a workplan
describing future program development and addressing issues having to do with compatibility
with the Centers for Disease Control and Prevention’s Environmental Public Health Tracking
Program.”
Tracking staff have begun to develop this plan, with input from the EHTB workgroup, and are
now ready to seek input from external stakeholders (including the EHTB advisory panel) on the
draft.
The draft strategic plan, included in this section of the meeting materials, includes a description
of the context for environmental health tracking (i.e., the reason that environmental health
tracking exists and what gaps it aims to fill) as well as a mission statement, a set of goals,
objectives and strategies, and a list of program stakeholders. The strategic plan strives to identify
what needs to be done in order to create a strong, effective program and to achieve our mission.
Other components of the strategic plan, such as the identification of core priorities for research
and surveillance, will be developed at a later date. Key objectives included in the draft strategic
plan include the engagement of stakeholders in order to develop these priorities.
Additional steps that will be taken before the strategic plan is finalized include soliciting input on
the draft from stakeholders, the refinement of strategies (which are rough at this point), and the
development of a timeline and specific implementation plans.
ACTION NEEDED: The panel is invited to provide suggestions for strengthening the draft
strategic plan for the environmental health tracking program. In particular, the panel is invited
to provide input on the following specific questions:
Mission statement:
• Does the draft mission clearly describe the purpose of the program?
• Does the mission differentiate the program from other programs operating in similar areas?
Goals and objectives:
• Do the draft goals and objectives reflect what the program must do to achieve its mission?
• Are there goals and objectives missing from the draft?
Stakeholders:
• Are there groups of stakeholders for the tracking program missing from the list?
• Thinking about the stakeholder groups that you represent, do you have any suggestions in
terms of how stakeholders should be involved in providing input on the draft strategic plan?
No formal vote is anticipated.
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52
Draft environmental health tracking strategic plan (2008-2012)
DRAFT CONTEXT: THE NEED FOR AN ENVIRONMENTAL HEALTH TRACKING
SYSTEM
We have witnessed a dramatic change in our nation’s health burden over the last half century
from infectious diseases, such as pneumonia and tuberculosis, to non-infectious diseases, such as
cancer and asthma. During this same period, we have also made rapid advances in the
development and production of tens of thousands of chemical compounds, many of which have
made their way into our water, soil and air. The health implications of long-term exposure to
low levels of these substances are not well understood. This uncertainty continues to raise
concern about whether environmental contamination contributes to the chronic disease burden in
the general population. Nonetheless, public health surveillance in the United States remains
heavily focused on infectious disease. Currently, no comprehensive system exists at the state or
national level to track many of the exposures and health effects that may be related to
environmental hazards.
Public health surveillance, or tracking, systems are critical for preventing and controlling disease
in populations. Surveillance data allow public health authorities to assess disease impacts and
trends, recognize clusters and outbreaks, identify populations and geographic areas most
affected, and evaluate the effectiveness of policy and environmental public health interventions.
The Institute of Medicine and the Pew Environmental Health Commission have attributed our
inadequate attention to environmental health surveillance to an ineffective environmental public
health infrastructure administered by a patchwork of fragmented government programs 1 . In
most cases, Minnesota’s existing environmental hazard, exposure, and disease tracking systems
are not linked together. This serves as an obstacle to studying and monitoring relationships
among these elements and to adequately responding to environmental threats.
The Minnesota Environmental Health Tracking System (MEHTS) represents a systematic,
expanded approach to gathering and integrating environmental and health data that will improve
our capacity to understand, respond to and prevent chronic disease in Minnesota. MEHTS
directly aligns with MDH’s primary goal to protect, maintain and improve the health of all
Minnesotans. Its potential benefits also extend beyond MDH, as the system will be designed for
maximum accessibility:
1
Institute of Medicine. The Future of Public Health. Washington, DC: National Academy Press; 1988.
Pew Environmental Health Commission. America’s Environmental Health Gap: Why the Country Needs a
Nationwide Health Tracking Network. Johns Hopkins School of Hygiene and Public Health; 2000. Available at:
http://healthyamericans.org/reports/files/healthgap.pdf.
53
• The public will be able to access data to help them learn about the environment and health
in their communities.
• Environmental health professionals will be able to easily access integrated environmental
health data.
• Partner organizations will be able to use these data to prioritize resources, complete needs
assessments, develop community health improvement plans, and improve interventions.
• Policy makers will be able to use the information and data to guide their public health
decisions.
DRAFT MISSION
The Minnesota Environmental Health Tracking Systems (MEHTS) provides ongoing monitoring
and analysis of information on hazards in the environment and the adverse health effects
potentially related to those hazards. MEHTS will integrate this information on the environment
and health and make it accessible to the general public, professionals and researchers in order to
build knowledge about health and the environment and to drive actions to improve and protect
the health of Minnesota communities.
54
DRAFT GOALS, OBJECTIVES AND STRATEGIES
Goal 1: Develop a strong environmental health tracking system for Minnesota based on the
collection and analysis of high-quality data
Objective A: Develop and strengthen environmental health tracking indicators in collaboration
with the National Environmental Public Health Tracking Network (EPHTN) and other groups
Strategies:
• Collect, analyze and summarize existing Minnesota data in accordance with the
EPHTN’s nationally consistent data and measures
• Submit Minnesota data to the national network
• Work to refine national indicators for use in Minnesota
• Actively participate in the national EPHT network and SEHIC to ensure
indicators developed are of high quality and are compatible with the national
system and other states
Objective B: Develop a process to identify and develop Minnesota-specific priorities for new
environmental health tracking indicators
Strategies:
• Develop criteria by which new indicators will be evaluated
• Engage stakeholders in identifying priorities
• Identify methods and data sources for developing new indicators
• Pilot indicators and identify areas for improvement
Objective C: Seek out opportunities to contribute to the development of new surveillance
systems in Minnesota to measure health effects, exposures and hazards.
Strategies:
• Assess data gaps and set priorities for the collection of new data
• Provide resources to programs seeking to develop or explore new surveillance
systems
Objective D: Evaluate the quality of the tracking system
Strategies:
• Evaluate tracking system attributes (e.g., data quality, stability,
representativeness, flexibility) using CDC’s evaluation guidelines
• Identify data limitations and develop specific plans to address them
• Ensure that automated data analysis systems are in place and that procedures are
documented and sustainable
55
Goal 2: Ensure environmental health tracking data are accessible and used
Objective A: Develop a state portal to ensure data are readily available
Strategies:
• Define portal requirements and tools in consultation with the EPHTN’s Portal,
Analysis, Visualization and Reporting Team to ensure compatibility with CDC’s
portal
• Develop and pilot test the portal
Objective B: Evaluate Minnesota’s tracking program to assess whether data are useful and are
being used to guide public health decisions.
Strategies:
• Survey data users to evaluate tracking system performance (e.g., acceptability,
simplicity, timeliness) using CDC evaluation guidelines
• Implement changes based on results of the program evaluation
Goal 3: Build awareness, knowledge and skills among potential data users related to
environmental health tracking in order to inform actions to improve public health (e.g.,
policies, programs)
Objective A: Develop and implement communications strategies for key audiences
Strategies:
• Define key messages for various audiences, including the goals, scope and
limitations of the tracking program
• Develop and distribute written program materials
• Develop, promote and maintain a web presence
• Develop a data dissemination plan, including plans for developing ongoing
surveillance reports
• Respond to users’ questions and data requests
• Publish articles in peer-reviewed journals
Objective B: Provide opportunities for data users to build capacity related to environmental
health tracking data and related concepts
Strategies:
• Assess data users’ differing training needs
• Offer training courses, conferences, and/or materials targeted to specific
audiences (e.g., on risk communication, using the network, data limitations,
interpreting data, etc.)
• Actively pursue opportunities to speak at conferences to describe MEHTS and
MEHTS data
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Goal 4: Build relationships to enhance environmental health tracking in Minnesota
Objective A: Engage stakeholders/data stewards and data users to guide program development
and implementation
Strategies:
• Conduct an assessment of stakeholder needs and interests
• Develop and implement plans for ongoing stakeholder communication (e.g., input
on network development, input on indicator development, input on message
development, etc.)
Objective B: Collaborate with researchers to develop priorities for research on environmental
health hazards and disease
Strategies:
• Identify researchers at the U of M and/or other institutions who might have a
stake in the tracking program
• Identify the role of the University of Minnesota and the relationship between the
University of Minnesota and the tracking program
• Develop and implement an outreach plan
Goal 5: Build and maintain a strong infrastructure within partnering state agencies to
support the environmental health tracking program
Objective A: Build tracking staff knowledge and program resources
Strategies:
• Develop a plan to capitalize on external expertise in the field of environmental
health tracking
• Assess skills needed to implement the tracking program, identify gaps, and
develop staff capacity in needed areas
Objective B: Develop and maintain a program structure in which roles, responsibilities and
decision-making processes are clear
Strategies:
• Define roles and expectations of the workgroup, steering committee, advisory
panel and program staff
• Define how program resources are allocated across divisions and agencies
Objective C: Build program support among department leadership
Strategies:
• Develop and implement effective internal communications strategies with MDH
leadership and across divisions and agencies
57
DRAFT PROGRAM STAKEHOLDERS
•
General public (and specific communities within the state)
•
Tribes
•
Health and environmental advocacy groups
o (e.g., AHA, ALA, MCEA, IATP, Clean Water Action, Preventing Harm Minnesota,
Land Stewardship Project, Sierra Club, Sustainable Resources Center, Clean Air
Minnesota, National Birth Defects Prevention Network, March of Dimes, Folic Acid
Council, Spina Bifida Association, Minnesota Safety Council, Autism Society of
Minnesota)
•
Legislators/elected officials/decision-makers/policy makers
•
Professional organizations/associations
o (e.g., Minnesota Environmental Health Association, American Waterworks
Association, Minnesota Public Health Association, Advisory Council on Water
Supply Systems and Waste Water Treatment Facilities, Minnesota Water Quality
Association, American Industrial Hygiene Association, Association of Public Health
Laboratories)
•
Local public health and environmental programs/staff
o (e.g., Local Public Health Association, Local public health departments/CHS
agencies, Municipal drinking water treatment facilities)
•
State public health and environmental programs/staff
o (e.g., MDH [Drinking Water Program, Public Health Lab, Asthma, MCSS, Heart
Disease & Stroke Prevention, Injury and Violence Prevention Unit, Minnesota
Children with Special Health Needs, Refugee Health Program, Indoor Air Program,
Office of Emergency Preparedness, BRFSS, Office of Public Health Practice,
Maternal and Child Health, Environmental Surveillance & Assessment Section, Birth
defects program, Lead program, etc.]; PCA; MDA; DNR; DOT; MN Geological
Survey; Minnesota Department of Public Safety; Minnesota Board of Water and Soil
Resources)
•
Health care providers and associations
o (e.g., Physicians, EMTs, Hospitals, HMOs, Clinics, Minnesota Council of Health
Plans, Minnesota Hospital Association, Indian Health Service
•
Researchers
o (e.g., academicians, health care researchers, state agency researchers, students and Ag
Extension [the link between the U of M and growers])
58
•
Federal public health and environmental programs/staff
o (e.g., CDC/National EPHTN, EPA, US Geological Survey)
•
Other states and countries involved in tracking
o (e.g., neighboring states, other states in the EPHTN; Canada, WHO, European Union)
•
Industry groups and trade associations
o (e.g., chemical manufacturers/users, utilities, pesticide producers)
•
Farmers/growers (would be affected by policy decisions)
•
Media
•
EHTB advisory panel, workgroup and steering committee
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60
Section overview: General reference materials
Two new documents are included in this meeting packet as items that may be of interest to panel
members:
•
New PFC citations (added since June 3, 2008)
•
EHTB advisory panel meeting summary (from June 3, 2008)
In addition, the following items are included in each meeting packet as reference materials:
•
EHTB advisory panel roster (revised)
•
Biographical sketches of advisory panel members
•
EHTB steering committee roster
•
EHTB inter-agency workgroup roster (revised)
•
Glossary of terms used in environmental health tracking and biomonitoring
•
Acronyms used in environmental health tracking and biomonitoring
•
EHTB statute (Minn. Statutes 144.995-144.998)
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New PFC Citations (added since June 3, 2008)
The following articles and reports have recently been added to the EHTB program’s PFC citation list,
which is updated on an ongoing basis. This list is not intended to be comprehensive and reflects only a
small portion of the available research on PFCs. Note that not all citations on this list have been
published in peer-reviewed journals. A study’s inclusion on this list does not imply endorsement by the
EHTB program.
Buttenhoff J et al. (2004) “Characterization of risk for general population exposure to
perfluorooctanoate.” Regulatory Toxicology and Pharmacology 39: 363-380.
Perfluorooctanoate (PFOA), an environmentally and metabolically stable perfluorinated carboxylic
acid, has been detected in the serum of children, adults and the elderly from the United States with
the upper bound of the 95th percentile estimate in the range of 0.011-0.014 microg/mL (ppm). In this
risk characterization, margins of exposure (MOE), which can provide a realistic perspective on
potential for human risk, were determined by comparison of general population serum PFOA
concentrations with serum concentrations from toxicological studies that are associated with the
lower 95% confidence limit of a modeled 10 percent response or incidence level (LBMIC(10)) using
USEPA BMDS software. The LBMIC(10) was estimated using surrogate data from other studies or
pharmacokinetic relationships if serum PFOA data were not available. Modeled dose-responses
(with resulting LBMIC(10) values) included post-natal effects in rats (29 microg/mL), liver-weight
increase (23 microg/mL), and body-weight change (60 microg/mL) in rats and monkeys, and
incidence of Leydig cell adenoma (125 microg/mL) in rats. MOE values based on the upper bound
95th percentile population serum PFOA concentration were large, ranging from 1600 (liver-weight
increase) to 8900 (Leydig cell adenoma). These MOE values represent substantial protection of
children, adults, and the elderly.
Gilliland F and J Mandel. (1995) “Serum perfluorooctanoic acid and hepatic enzymes, lipoproteins, and
cholesterol: A study of occupationally exposed men.” American Journal of Industrial Medicine. 29(5):
560-8.
Perfluorooctanoic acid (PFOA) produces marked hepatic effects, including hepatomegaly, focal
hepatocyte necrosis, hypolipidemia, and alteration of hepatic lipid metabolism in a number of animal
species. In rodents, PFOA is a peroxisome proliferator, an inducer of members of the cytochrome
P450 superfamily and other enzymes involved in xenobiotic metabolism, an uncoupler of oxidative
phosphorylation, and may not be a cancer promoter. Although PFOA is the major organofluorine
compound found in humans, little information is available concerning human responses to PFOA
exposure. This study of 115 occupationally exposed workers examined the cross-sectional
associations between PFOA and hepatic enzymes, lipoproteins, and cholesterol. The findings
indicate that there is no significant clinical hepatic toxicity at the PFOA levels observed in this
study. PFOA may modulate the previously described hepatic responses to obesity and xenobiotics.
Karrman A et al. (2006) “Perfluorinated chemicals in relation to other persistent organic pollutants in
human blood.” Chemosphere. 64(9): 1582-91.
In order to evaluate blood levels of some perfluorinated chemicals (PFCs) and compare them to
current levels of classical persistent organic pollutants (POPs) whole blood samples from Sweden
were analyzed with respect to 12 PFCs, 37 polychlorinated biphenyls (PCBs), p,p'-dichlorodiphenyldichloroethylene (DDE), hexachlorobenzene (HCB), six chlordanes and three polybrominated
diphenyl ethers (PBDEs). The median concentration, on whole blood basis, of the sum of PFCs was
63
20-50 times higher compared to the sum of PCBs and p,p'-DDE, 300-450 times higher than HCB,
sum of chlordanes and sum of PBDEs. Estimations of the total body amount of PFCs and lipophilic
POPs point at similar body burdens. While levels of for example PCBs and PBDEs are normalized
to the lipid content of blood, there is no such general procedure for PFCs in blood. The distributions
of a number of perfluorinated compounds between whole blood and plasma were therefore studied.
Plasma concentrations were higher than whole blood concentrations for four perfluoroalkylated
acids with plasma/whole blood ratios between 1.1 and 1.4, whereas the ratio for
perflurooctanesulfonamide (PFOSA) was considerably lower (0.2). This suggests that the
comparison of levels of PFCs determined in plasma with levels determined in whole blood should be
made with caution. We also conclude that Swedish residents are exposed to a large number of PFCs
to the same extent as in USA, Japan, Colombia and the few other countries from which data is
available today.
Kubwabo C et al. (2005) “Occurrence of perfluorosulfonates and other perfluorochemicals in dust from
selected homes in the city of Ottawa, Canada.” Journal of Environmental Monitoring. 7(11): 1074-8.
A series of perfluorinated compounds (PFCs) including perfluorooctane sulfonate (PFOS) and
perfluorooctanoic acid (PFOA) have been recently measured in a variety of environmental samples
and biological matrices. In order to better understand the human exposure routes of these chemicals,
levels of PFOS, PFOA, perfluorobutane sulfonate (PFBS), perfluorohexane sulfonate (PFHS) and
perfluorooctane sulfonamide (PFOSA) in house dust samples were investigated. The data revealed a
correlation between the concentrations of PFCs and the percentage of carpeting in the house; older
houses tended to have less carpeting, hence lower levels of these perfluorinated compounds in their
dust.
Kudo N and Y Kawashima. (2003) “Toxicity and toxicokinetics of perfluorooctanoic acid in humans
and animals.” Journal of Toxicological Science. 28(2): 49-57.
Perfluorooctanoic acid (PFOA) is an octanoic acid derivative to which all aliphatic hydrocarbons are
substituted by fluorine. PFOA and its salts are commercially used in various industrial processes. The
chemical is persistent in the environment and does not undergo biotransformation. It was reported
that PFOA is found not only in the serum of occupationally exposed workers but also general
populations. Recent studies have suggested that the biological half-life of PFOA in humans is 4.37
years based on study of occupationally exposed workers. It is increasingly suspect that PFOA
accumulates and affects human health, although the toxicokinetics of PFOA in humans remain
unclear. In experimental animals, PFOA seems low in toxicity. PFOA is well-absorbed following oral
and inhalation exposure, and to a lesser extent following dermal exposure. Once absorbed in the
body, it distributes predominantly to the liver and plasma, and to a lesser extent the kidney and lungs.
PFOA is excreted in both urine and feces. Biological half-life of PFOA is quite different between
species and sexes and the difference is due mainly to the difference in renal clearance. In rats, renal
clearance of PFOA is regulated by sex hormones, especially testosterone. PFOA is excreted into urine
by active tubular secretion, and certain organic anion transporters are though to be responsible for the
secretion. Fecal excretion is also important in the elimination of PFOA. There is evidence that PFOA
undergoes enterohepatic circulation resulting in reduced amounts of fecal excretion. Elucidation of
the mechanisms of transport in biological systems leads to elimination and detoxification of this
chemical in the human body.
64
Moriwaki H et al. (2003) “Concentrations of perfluorooctane sulfonate (PFOS) and perfluorooctanoic
acid (PFOA) in vacuum cleaner dust collected in Japanese homes.” Journal of Environmental
Monitoring. 5(5): 753-7.
Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) are shown to be globally
distributed, environmentally persistent and bioaccumulative. Although there is evidence that these
compounds exist in the serum of non-occupationally exposed humans, the pathways leading to the
presence of PFOS and PFOA are not well characterized. The concentrations of PFOS and PFOA in
the vacuum cleaner dust collected in Japanese homes were measured. The compounds were detected
in all the dust samples and the ranges were 11-2500 ng g(-1) for PFOS and 69-3700 ng g(-1) for
PFOA. It was ascertained that PFOS and PFOA were present in the dust in homes, and that the
absorption of the dust could be one of the exposure pathways of the PFOS and PFOA to humans.
With regard to risk management, it is important to consider the usage of PFOS and PFOA in the
indoor environment in order to avoid further pollution.
Olsen G et al. (1998) “An epidemiologic investigation of reproductive hormones in men with
occupational exposure to perfluorooctanoic acid.” Journal of Occupational and Environmental
Medicine. 40(7): 614-22.
Perfluorooctanoic acid (PFOA), a potent synthetic surfactant used in industrial applications, is a
peroxisome proliferator that has resulted in dose-related increases in hepatic, pancreatic acinar, and
Leydig cell adenomas in laboratory animals. In addition, PFOA increased serum estradiol levels
through the induction of hepatic aromatase activity. In 1993 and 1995, we conducted two crosssectional studies of 111 and 80 production workers, respectively, and specifically measured their
serum PFOA in relation to several reproductive hormones to determine whether such an effect
occurs in humans. PFOA was not significantly associated with estradiol or testosterone in either
year's study. A 10% increase in mean estradiol levels was observed among employees who had the
highest levels of serum PFOA, although this association was confounded by body mass index.
Neither was PFOA consistently associated with the other measured hormones. Our results provide
reasonable assurance that, in this production setting, there were no significant hormonal changes
associated with PFOA at the serum levels measured. Limitations of this investigation include its
cross-sectional design, the few subjects exposed at the highest levels, and the lower levels of serum
PFOA measured, compared with those levels reported to cause effects in laboratory animal studies.
Olsen G et al. (2007) “Preliminary evidence of a decline in perfluorooctanesulfonate (PFOS) and
perfluorooctanoate (PFOA) concentrations in American Red Cross blood donors.” Chemosphere. 68(1):
105-11.
The purpose of this pilot study was to determine whether perfluorooctanesulfonate
(PFOS,C(8)F(17)SO(3)(-)) and perfluorooctanoate (PFOA,C(7)F(15)CO(2)(-)) concentrations in
American Red Cross blood donors from Minneapolis-St. Paul, Minnesota have declined after the
2000-2002 phase-out of perfluorooctanesulfonyl-fluoride (POSF, C(8)F(17)SO(2)F)-based materials
by the primary global manufacturer, 3M Company. Forty donor plasma samples, categorized by age
and sex, were collected in 2005, and PFOS and PFOA concentrations were compared to 100 (nonpaired) donor serum samples collected in 2000 from the same general population that were analyzed
at the time using ion-pair extraction methods with tetrahydroperfluorooctanesulfonate as an internal
standard. Eleven of the 100 samples originally collected were reanalyzed with present study methods
that involved (13)C- labeled PFOA spiked into the donor samples, original samples, control human
plasma, and the calibration curve prior to extraction, and was used as a surrogate to monitor
extraction efficiency. Quantification was performed by high performance liquid chromatography
tandem mass spectrometry methods. Among the 100 serum samples analyzed for PFOS, the
geometric mean was 33.1 ng ml(-1) (95% CI 29.8-36.7) in 2000 compared to 15.1 ng ml(-1) (95%
65
CI 13.3-17.1) in 2005 (p<0.0001) for the 40 donor plasma samples. The geometric mean
concentration for PFOA was 4.5 ng ml(-1) (95% CI 4.1-5.0) in 2000 compared to 2.2 ng ml(-1)
(95% CI 1.9-2.6) in 2005 (p<0.0001). The decrease was consistent across donors' age and sex. To
confirm these preliminary findings, additional sub-sets of year 2000 samples will be analyzed, and a
much larger biomonitoring study of other locations is planned.
Olsen G et al. (2008) “Decline in perfluorooctanesulfonate and other polyfluoroalkyl chemicals in
American Red Cross adult blood donors, 2000-2006.” Environmental Science and Technology. 42(13):
4989-95.
In 2000, 3M Company, the primary global manufacturer, announced a phase-out of
perfluorooctanesulfonyl fluoride (POSF, C8F17SO2F)-based materials after
perfluorooctanesulfonate (PFOS, C8F17SO3-) was reported in human populations and wildlife. The
purpose of this study was to determine whether PFOS and other polyfluoroalkyl concentrations in
plasma samples, collected in 2006 from six American Red Cross adult blood donor centers, have
declined compared to nonpaired serum samples from the same locations in 2000-2001. For each
location, 100 samples were obtained evenly distributed by age (20-69 years) and sex. Analytes
measured, using tandem mass spectrometry, were PFOS, perfluorooctanoate (PFOA),
perfluorohexanesulfonate (PFHxS), perfluorobutanesulfonate (PFBS), N-methyl
perfluorooctanesulfonamidoacetate (Me-PFOSA-AcOH), and N-ethyl
perfluorooctanesulfonamidoacetate (Et-PFOSA-AcOH). The geometric mean plasma concentrations
were for PFOS 14.5 ng/mL (95% CI 13.9-15.2), PFOA 3.4 ng/ mL (95% CI 3.3-3.6), and PFHxS 1.5
ng/mL (95% CI 1.4-1.6). The majority of PFBS, Me-PFOSA-AcOH, and Et-PFOSA-AcOH
concentrations were less than the lower limit of quantitation. Age- and sex-adjusted geometric means
were lower in 2006 (approximately 60% for PFOS, 25% for PFOA, and 30% for PFHxS) than those
in 2000-2001. The declines for PFOS and PFHxS are consistent with their serum elimination halflives and the time since the phase-out of POSF-based materials. The shorter serum elimination halflife for PFOA and its smaller percentage decline than PFOS suggests PFOA concentrations
measured in the general population are unlikely to be solely attributed to POSF-based materials.
Direct and indirect exposure sources of PFOA could include historic and ongoing electrochemical
cell fluorination (ECF) of PFOA, telomer production of PFOA, fluorotelomer-based precursors, and
other fluoropoly-mer production.
Olsen G et al. (2008) “Supporting information. Decline in perfluorooctanesulfonate and other
polyfluoroalkyl chemicals in American Red Cross adult blood donors, 2000-2006.”
Skutlarek D et al. (2006) “Perfluorinated surfactants in surface and drinking waters.” Environmental
Science and Pollution Research International. 13(5): 299-307.
GOAL, SCOPE AND BACKGROUND: In this paper recent results are provided of an investigation
on the discovery of 12 perfluorinated surfactants (PS) in different surface and drinking waters
(Skutlarek et al. 2006 a, Skutlarek et al. 2006 b). In the last years, many studies have reported
ubiquitous distribution of this group of perfluorinated chemicals, especially perfluorooctane sulfonate
(PFOS) and perfluorooctanoic acid (PFOA) in the environment, particularly in wildlife animal and
human samples (Giesy and Kannan 2001, Houde et al. 2006, Prevedouros et al. 2006). Perfluorinated
surfactants (e.g. PFOS and PFOA) have shown different potentials for reproductory interference and
carcinogenity in animal experiments as well as partly long half-lives in humans (Guruge et al. 2006,
FSA UK 2006a, FSA UK 2006b, 3M 2005, OECD 2002, Yao and Zhong 2005). They possess
compound-dependent extreme recalcitrance against microbiological and chemical degradation and, in
addition, they show variable potentials for bioaccumulation in animals and humans (Houde et al.
2006). METHODS: Surface and drinking water samples were collected from different sampling sites:
66
Surface waters: samples taken from the rivers Rhine, Ruhr, Moehne and some of their tributaries.
Further samples were taken from the Rhine-Herne-Canal and the Wesel-Datteln-Canal. Drinking
waters: samples taken in public buildings of the Rhine-Ruhr area. After sample clean-up and
concentration by solid-phase extraction, the perfluorinated surfactants were determined using HPLCMS/MS. RESULTS: All measured concentrations (sum of seven mainly detected components) in the
Rhine river and its main tributaries (mouths) were determined below 100 ng/L. The Ruhr river
(tributary of the Rhine) showed the highest concentration (94 ng/L), but with a completely different
pattern of components (PFOA as major component), as compared with the other tributaries and the
Rhine river. Further investigations along the Ruhr river showed remarkably high concentrations of PS
in the upper reaches of the Ruhr river and the Moehne river (tributary of the Ruhr) (Ruhr: up to 446
ng/L, Moehne: up to 4385 ng/L). The maximum concentration of all drinking water samples taken in
the Rhine-Ruhr area was determined at 598 ng/L with the major component PFOA (519 ng/L).
DISCUSSION: The surface water contaminations most likely stem from contaminated inorganic and
organic waste materials (so-called 'Abfallgemisch'). This waste material was legally applied to several
agricultural areas on the upper reaches of the Moehne. Perfluorinated surfactants could be detected in
some suchlike soil samples. They contaminated the river and the reservoir belonging to it, likely by
superficial run-off over several months or probably years. Downstream, dilution effects are held
responsible for decreasing concentrations of PS in surface waters of the Moehne and the Ruhr river.
In analogy to the surface water samples, PS (major component PFOA) can be determined in many
drinking water samples of the Rhine-Ruhr area where the water supplies are mainly based on bank
filtration and artificial recharge. CONCLUSIONS: The concentrations found in drinking waters
decreased with the concentrations of the corresponding raw water samples along the flow direction of
the Ruhr river (from east to west) and were not significantly different from surface water
concentrations. This indicates that perfluorinated surfactants are at present not successfully removed
by water treatment steps. RECOMMENDATIONS AND PERSPECTIVES: Because of their different
problematic properties (persistence, mobility, toxicity, bioaccumulation), the concentrations of
specific perfluorinated surfactants and their precursors in drinking waters and food have to be
minimised. Therefore, it is of utmost importance to take the initiative to establish suitable legal
regulations (limitations/ban) concerning the production and use of these surfactants and their
precursors. Furthermore, it is indispensable to protect water resources from these compounds. A
discussion on appropriate limit values in drinking water and foodstuffs is urgently needed.
Concerning the assumed soil contamination, the corresponding regulation (Bioabfall-Verordnung
1998--Regulation on Organic Waste 1998) should be extended to allow the control of relevant
organic pollutants.
Strynar M and A Lindstrom (2008) “Perfluorinated compounds in house dust from Ohio and North
Carolina, USA.” Environmental Science and Technology. 42(10): 3751-6.
The perfluoroalkyl acids (PFAAs), including perfluorooctanoic acid (PFOA) and perfluorooctane
sulfonate (PFOS), have come under increasing scrutiny due to their persistence, global distribution,
and toxicity. Given that their human exposure routes remain poorly characterized, the potential role
of house dust needs to be more completely evaluated. In this study, new methods for the analysis of
10 PFAAs and three fluorinated telomer alcohols (FTOHs) were developed for dust samples
collected from homes (n = 102) and day care centers (n = 10) in Ohio and North Carolina in 20002001. FTOHs were measured by GC/ MS and PFAAs were analyzed by LC-MS/MS. PFOS and
PFOA were the most prominent compounds detected, occurring in over 95% of the samples at
median concentrations of 201 and 142 ng/g of dust, respectively. Maximal concentrations of PFOS
were 12 100 ng/g (95th percentile, 2240 ng/g), PFOA 1960 ng/g (95th percentile, 1200 ng/g), and
perfluorohexanesulfonate (PFHS) 35 700 ng/g (95th percentile, 2300 ng/g). The 8:2 FTOH, which is
volatile and can degrade to PFOA, had a maximum concentration of 1660 ng/g dust (95th percentile,
67
669 ng/g). These results indicate that perfluorinated compounds are present in house dust at levels
that may represent an important pathway for human exposure.
Yeung L et al. (2006) “Perfluorooctanesulfonate and related fluorochemicals in human blood samples
from China.” Environmental Science and Technology. 40(3): 715-20.
Perfluorooctanesulfonylfluoride (POSF)-based compounds have been manufactured and used in a
variety of industrial applications. These compounds degrade to perfluorooctanesulfonate (PFOS)
which is regarded as a persistent end-stage metabolite and is found to accumulate in tissues of
humans and wildlife. PFOS, perfluorohexanesulfonate (PFHxS), perfluorooctanoate (PFOA), and
perfluorooctanesulfonamide (PFOSA) have been found in human sera from the United States. In this
study, concentrations of PFHxS, perfluorobutanesulfonate (PFBS), PFOS, perfluorohexanoic acid
(PFHxA), PFOA, perfluorononanoic acid (PFNA), perfluorodecanoic acid (PFDA),
perfluoroundecanoic acid (PFUnDA), perfluorododecanoic acid (PFDoDA), and PFOSA were
measured in 85 samples of whole human blood collected from nine cities (eight provinces) in China,
including Shenyang (Liaoning), Beijing (Hebei), Zhengzhou (Henan), Jintan (Jiangsu), Wuhan
(Hubei), Zhoushan (Zhejiang), Guiyang (Guizhou), Xiamen (Fujian), and Fuzhou (Fujian). Among
the 10 perfluorinated compounds (PFCs) measured, PFOS was the predominant compound. The
mean concentration of PFOS was greatest in samples collected from Shenyang (79.2 ng/mL) and
least in samples from Jintan (3.72 ng/mL). PFHxS was the next most abundant perfluorochemical in
the samples. No age-related differences in the concentrations of PFOA, PFOS, PFOSA, and PFHxS
were observed. Gender-related differences were found,with males higher for PFOS and PFHxS, and
females higher in PFUnDA. Concentrations of PFHxS were positively correlated with those of
PFOS, while concentrations of PFNA, PFDA, and PFUnDA were positively correlated with those of
PFOA. There were differences in the concentration profiles (percentage composition) of various
PFCs in the samples among the nine cities.
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EHTB advisory panel meeting summary
Summary of the
Minnesota Department of Health (MDH)
Environmental Health Tracking and Biomonitoring Advisory Panel Meeting
June 3, 2008
1:00 p.m.-4:00 p.m.
Advisory Panel Members - Present
Beth Baker (chair)
Debra McGovern
Alan Bender
Susan Palchick
Cecilia Martinez
Gregory Pratt
Daniel Stoddard
Samuel Yamin
Advisory Panel Members – Regrets
John Adgate
Geary Olsen
Bruce Alexander
David Wallinga
Lisa Yost
Welcome and introductions
Beth Baker, chairperson, welcomed panel members to the meeting. She invited members and
other participants to introduce themselves. She noted that today’s meeting would be devoted to
progress reports, particularly from program staff dedicated to the environmental health tracking
efforts. Beth reminded panel members of the policy for declaring conflicts of interest and asked
for comments or concerns; none were offered.
Environmental Health Tracking: Overview and Background
Jean Johnson, staff director of the Environmental Health Tracking and Biomonitoring (EHTB)
Program, referred panel members to the overview of environmental health tracking presented in
the background book. In a brief slide presentation, she summarized salient features from the
environmental health tracking presentation at the October 2007 panel meeting. She cited the
2000 report of the Pew Environmental Health Commission calling for systematic surveillance of
environmental hazards, exposures, and disease. She highlighted the establishment of CDC’s
National Environmental Public Health Tracking Network, which currently awards grants to 16
states (not Minnesota) to begin the collection, integration, and dissemination of nationally
consistent health and environmental data and measures (a.k.a. indicators). CDC’s efforts are
aligned with directions outlined by the State Environmental Health Indicators Collaborative
(SEHIC), sponsored by the Council of State and Territorial Epidemiologists (CSTE).
MN Statutes 144.995 – 144.998, the enabling legislation for our Environmental Health Tracking
and Biomonitoring Program, call for Minnesota state agencies to develop an environmental
health tracking system for Minnesota. At the October 2007 panel meeting, Jean had presented
priorities for year 1: to develop, assess, and re-examine indicators consistent with those of CDC
and CSTE/SEHIC. These efforts would lay a groundwork for priorities in year 2: to develop a
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strategic plan for Minnesota, make recommendations for further study, report to the legislature,
and develop a research plan with the University of Minnesota.
As described in the background book, environmental public health indicators are descriptive,
summary measures derived from data gathered by pre-existing programs. These indicators are
tools for surveillance which, when integrated together, enhance the accessibility and utility of
information for decision making. At the national level, these indicators are intended to provide
standardized methods for comparing public health and environmental data across multiple states
and for building a comprehensive, national, public health surveillance system.
Environmental Health Tracking: Indicator Updates
Jean introduced the next speakers, to be providing updates on Minnesota’s efforts to pilot the
indicators identified by CDC and CSTE/SEHIC. Program staff members are providing progress
reports on the nine indicators listed below:
air quality
water quality
childhood lead
respiratory disease
myocardial infarctions
cancer
carbon monoxide poisonings
birth defects
birth outcomes
Air quality, an environmental health indicator
Kari Palmer and Cassie McMahon, staff members in the Environmental Analysis and Outcomes
Division of the Minnesota Pollution Control Agency (MPCA), presented their pilot project on air
quality indicators. They examined the three indicators articulated nationally; these are:
short term exposure to ozone
short term exposure to PM2.5
long-term exposure to PM2.5
A correction to the presentation in the background book, page 7, is that the indicator for shortterm exposure to PM2.5, detailed in terms of days, should refer to 24-hour data collections rather
than 8-hour collection periods.
Summaries of Minnesota data and a Minnesota-based assessment were provided in the
background book. Kari described the limitations and challenges of using the nationally defined
data sources to draw associations between air quality and exposure. She noted that the Minnesota
Pollution Control Agency collects more detailed information that would probably be more
informative for associating air quality with health outcomes. Recommendations for next steps are
to: (1) continue to align with the national indicators project because of consistency in inter-state
comparisons and ease of implementation; and (2) adjust for limitations in the national indicators
by incorporating additional, Minnesota-specific indicators to balance a likely underestimation of
exposure if using only the national measures.
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Recognizing that the national measures only capture risks in counties that have air monitors,
Alan Bender asked if subpopulations in counties lacking air monitors but spatially close to
adjacent counties’ monitors are included in the modeling. Beth Baker asked if other indicators,
beyond the three articulated nationally, have been examined. Kari responded to both questions
by stating that this pilot study has been restricted to the national parameters.
Water quality, an environmental health indicator
Deanna Scher, research scientist with the MDH Environmental Health Division’s Health Risk
Assessment Unit, referred the panel to the background book, which describes the national
program’s indicators related to drinking water and her pilot project with Minnesota data. The
indicators focus on community water systems, the violations of water quality standards by
exceedances of regulated contaminants, and the routine contaminant levels. The initial focus of
the national indicators is on arsenic, lead, nitrate, and specific disinfection byproducts. While the
national drinking water content workgroup has established parameters for nationally consistent
data and measures, it is still developing guidelines that affect data quality and interpretation.
Deanna noted that the data sets have limitations; for example, only 80% of Minnesota’s
population is served by community water systems. Another limitation is that the (preliminary)
national guidelines accept data only from community water systems that are currently active,
although data are captured for the past 10 years.
Deanna recommended that Minnesota continue to participate in discussions of the national
workgroup, wait for the outcome of the national criteria on data quality issues (anticipated within
a few months), and then decide if Minnesota would continue to follow the national network’s
guidelines.
Susan Palchick asked for an elaboration about the inactive systems. Deanna explained that
Minnesota has almost 1,000 active community water systems currently. According to the
national workgroup, Minnesota’s data on 56 currently inactive systems, which were active at
some point between 1999 and present, would be excluded. Susan also asked about limitations in
interpreting data. Deanna replied that missing data due to infrequent sampling is common and
that contaminant concentrations between sampling time-points might be imputed by straight-line
connections between the time-points. Further, the population-based measures are of unknown
accuracy because the population served by each water system is oftentimes assumed to be 2.6
people x the number of connections, which is only an average. In response to Susan’s question if
the data set was different than data collected for compliance monitoring purposes. Deanna
replied that the data reported by the state to CDC are more detailed than the summary,
exceedance data that the state reports to the US EPA.
Greg Pratt expressed reservations about the national workgroup’s preliminary guidelines for data
reduction and interpretation of contaminant levels. Deanna concurred that ascribing a value to
concentrations below the minimum detection limit and ascribing values between sampling time
points may confound the interpretation.
Samuel Yamin asked Deanna to bring forward a recommendation to the national drinking water
content workgroup to include data from private drinking water wells. Because private wells are
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not monitored or regulated to the extent of community water systems, populations served by
private wells could be potentially exposed to higher contaminant levels (particularly nitrates) and
subject to relatively more adverse health effects. Samuel agreed with Deanna’s assessment that
maximum contaminant levels, set by federal regulations, reflect a composite of factors, not just
human health risk. Therefore, the Minnesota program could incorporate its health-based
guidelines into its assessment, compare our Minnesota data before and after incorporating the
health-based values, and advocate that the national workgroup also consider using health-based
values.
Respiratory disease, an environmental health indicator
Wendy Brunner, epidemiologist with the MDH asthma program, reported on two sets of
measures: (1) chronic lower respiratory disease and asthma mortality, and (2) asthma
hospitalizations. The source data for the chronic lower respiratory disease and asthma mortality
indicator will be the death records kept by the Minnesota Center for Health Statistics in MDH.
Although this pilot has not been launched yet, it would probably involve presenting county-level
data with data suppression rules to protect individual privacy. The literature shows that the rates
of these indicators are associated with ambient air quality. On a related note, MDH staff
members have an EPA grant to develop methods to link respiratory disease and air quality data
to measure the impacts of pollution reduction strategies.
Wendy addressed the second set of indicators, i.e. asthma hospitalizations, described in the
background book. The data source for the asthma hospitalizations is the Minnesota Hospital
Association. Available data elements include age, sex, zip code, date of admission, and date of
discharge. One limitation of the hospitalization data is that, because the data do not include
identifiers, repeat hospitalizations (i.e. subsequent hospitalizations by the same individual)
cannot be identified. The 2006 asthma hospitalization data were presented per day and
aggregated per month. September and October had the highest rates, consistent with a presumed
association with students returning to school and an associated increase in respiratory infections,
which is a known trigger of asthma attacks for many people with asthma.
Susan Palchick asked if data for emergency department visits were captured. As a participant in
the CSTE/SEHIC workgroup, Wendy is refining an indicator for asthma emergency department
visits using hospital outpatient data. While these data are available in Minnesota, they are not
available in all states.
In response to Samuel Yamin’s question about the unit of observation, Wendy explained that
hospitalizations are reported by zip code of the patient’s residence (or zip code of billing
address) and deaths by county of residence. Beth Baker expressed concern for interpreting data
on asthma hospitalizations. Such data would depend on whether asthma was listed as the primary
diagnosis on the medical record. Moreover, individuals with high access to primary care would
be more likely to avoid hospitalizations because they would be more actively involved in an
asthma management program that avoids triggers and uses appropriate medications. Wendy
concurred that the indicators for asthma hospitalization measure the burden on individuals whose
asthma is not managed well. Nonetheless, several studies have found associations between
asthma hospitalizations and poor air quality. Samuel recommended that MDH explore whether
the Minnesota Hospital Association could provide access to asthma medication prescriptions as
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an indicator of respiratory disease incidents. In fact, the Minnesota Hospital Association does not
collect data on medication use from hospitals. It was recognized that these types of managed
asthma incidents may be a significant component of all asthma incidents and reflect the burden
of poor air quality.
Carbon monoxide poisoning, an environmental health indicator
Mia Jewell, a student in the master’s program at the University of Minnesota’s School of Public
Health, has been working with MDH staff in the Chronic Disease and Environmental
Epidemiology Section to pilot the indicator for carbon monoxide poisoning, using Minnesota
data. Mia described the national indicators for carbon monoxide poisoning, which are listed in
the background book. Of the data sources that have been developed by CDC’s National
Environmental Public Health Tracking Program, four are available in Minnesota: hospital
discharge data, emergency department data, death certificate data, and Poison Control Center
data (extracted from the Toxicall database). Mia highlighted the reduced data from Minnesota
sources. She focused on the unintentional, non-fire related carbon monoxide poisonings as the
ones of most public health concern.
Recommendations for next steps are to refine the national guidelines to enhance data quality and
interpretation. Attention should be given to confidence intervals, spatial and seasonal analytical
methods, and determining the completeness and accuracy of case ascertainment. In response to
Susan Palchick’s question, Mia noted that the national guidelines allow for multiple counting of
an individual experiencing a single event. For example, a call to the Poison Control Center and a
subsequent hospitalization would result in two data captures. Therefore, guidance should be
developed for assessing the level of overlap between data sources.
Beth Baker remarked that the Poison Control Center data are difficult to interpret. Calls underrepresent burdens to the adult population, as the Poison Control phone number has been
marketed primarily for response to children’s exposures. Calls over-represent carbon monoxide
poisonings to children, as the Poison Control Center’s database may register a poisoning event
based on circumstantial reports but lacking direct carbon monoxide measurements. Beth also
advised caution in interpreting data on hyperbaric treatment, which is not a standard of care and
is used unevenly throughout the state.
Susan Palchick inquired about the high-risk activities associated with unintentional, nonoccupational, non-fire related poisonings. Mia replied that high-risk factors appear to be the
operation of generators or gas heaters in enclosed spaces. Another contributor is the accidental
inhalation of exhaust from boat engines and other small motors that burn fossil fuels. However,
the more common sources of exposure are the incomplete combustion of fuels that are burned by
improperly installed, maintained, or inappropriately used household appliances as well as the
operation of motorized vehicles in a non-ventilated garage.
Birth defects, an environmental health indicator
Jeannette Sample, MDH epidemiologist in the Chronic Disease and Environmental
Epidemiology Section, discussed progress on piloting Minnesota data using national guidelines
for the birth defects indicator. Referring to materials presented in the background book, Jeannette
noted that 1 in 33 babies is born in the U.S. with a structural defect. It is assumed that the causes
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are complex interactions between genetic predispositions and environmental factors, including
possible maternal exposure to environmental hazards.
The Minnesota data source is the Minnesota Birth Defects Information System, which collects
information from birthing hospitals in Hennepin and Ramey counties, accounting for half of all
Minnesota births. The 2006 data set included 174 cases diagnosed with at least one of the defects
selected for the national guidelines. Limitations on the data include the exclusion of babies
without a matched birth certificate to ascribe maternal county of residence, the existence of an
opt-out clause in Minnesota that allows parents to exclude their child’s identifying information
from the information system, and the lack of population-based records before 2006. Jeannette
recommended that the next steps for indicator development should address babies diagnosed
with more than one birth defect. Because the unit of analysis is the child, not the defect, further
classification of cases diagnosed with more than one defect would allow for the comparison of
cases within more homogenous categories. CDC’s National Environmental Public Health
Tracking Program has suggested cases diagnosed with more than one defect be classified as
isolated, syndromic, or multiple congenital anomaly.
Alan Bender inquired about the cases in which the parents opted out of the Minnesota Birth
Defects Information System. It was noted that personal identifiers (e.g. name and birth date)
were removed, but other data elements for each case are retained in the system. For the 2006 data
set, 18 cases have opted out. Although the numbers are small, no obvious bias in the types or
severity of birth defects exists between the opt-out cases and the full data set.
Birth outcomes, an environmental health indicator
Jeannette Sample referred panel members to the background book for a list of the national
indicators for birth outcomes. Pre-term and very pre-term births, low and very low birth-weight
births, infant mortality, depressed women’s fertility rate, and unbalanced sex ratio at birth are
measures of unhealthy fetal development. While the birth outcomes indicator has not been
piloted in Minnesota yet, the data sources could be the birth certificates and death certificates
kept by the MDH Vital Statistics Program. Alternatively, CDC’s National Environmental Public
Health Tracking Program may pilot this indicator nationally using data from the National Center
for Health Statistics. As with some of the other indicators identified by CDC’s National
Environmental Public Health Tracking Program, MDH staff may suppress some of Minnesota’s
data attributes in a national database due to small data sizes.
Debra McGovern asked about associations of environmental exposures with adverse birth
outcomes. Jeannette responded that associations in the scientific literature of air pollution
exposure and pesticide exposure during distinctive periods in fetal development suggest that
environmental hazards may contribute to the appreciable rise in recent years in pre-term births
and low birth-weight births.
Childhood lead, an environmental health indicator
Referring to information provided in the background book, Jeannette Sample described the
national indicators for childhood lead. Well-known sources of lead exposure in young children
include lead paint in older houses, particularly those built before 1950. Most states have
longstanding, early childhood lead surveillance programs. Elevated blood lead levels in young
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children have been associated with learning impairment and behavioral problems. No measurable
blood lead level is considered to be safe. MDH staff members have not piloted these indicators
using Minnesota data sources yet. The MDH Childhood Lead Poisoning Prevention Program
staff may recommend refinements to the data sets to address cases in which the zip codes on the
birth certificates differ from the zip codes listed at the time of the blood lead test.
Cancer, an environmental health indicator
The national indicators for cancer are the counts and incident rates of selected cancers. This
indicator has not been piloted in Minnesota yet. One limitation of the Minnesota data source is
that Minnesota’s Cancer Surveillance System reports only on a state level and not on a county
level. Another limitation is that the data sets lack personal exposure information such as tobacco
use, diet, sun exposure, and occupation.
Beth Baker asked about the rationale for the national program’s selection of particular cancers,
which exclude prominent cancers such as colon cancer and prostate cancer. Jeannette responded
that the national program chose particular types of cancer associated with possible environmental
etiology. Alan Bender pointed out that acute lymphoblastic leukemia (ALL), a childhood cancer
with an average latency of four years, is amenable to exposure linkage. By contrast, colon cancer
and prostate cancer have latency periods of several decades. Alan noted that, moreover, many
US citizens do not stay in one county for even ten years; therefore, any environmental exposure
tracked by county of residence may be difficult to link to cancers with long latencies.
Myocardial infarction, an environmental health indicator
Although MDH staff members have not yet piloted this indicator, the national guidelines for
myocardial infarctions, as measured by hospitalizations, seem to match well with accessible
Minnesota data. The Minnesota Hospital Association provides epidemiologists in the MDH
Heart Disease and Stroke Prevention Program with data elements such as age, sex, zip code of
residence, date of admission, and date of discharge. Incidents in which individuals suffer heart
attacks but are not hospitalized would not be in the data set.
Environmental health tracking: Next steps and planning
Jean Johnson, speaking on behalf of the Minnesota Environmental Health Tracking and
Biomonitoring (EHTB) Program, reported that staff members in MDH and the Minnesota
Pollution Control Agency plan to complete the pilot studies for all nine indicators identified by
CDC and CSTE/SEHIC. (These are described above.) Staff will continue to make
recommendations for further refinement of the national indicators, data quality, and data
interpretation.
EHTB staff members are seeking advice from the advisory panel with regards to submitting
Minnesota data to CDC’s National Environmental Public Health Tracking Program. Advantages
to submitting data to the national network include consistent comparisons between states;
national aggregate sets may be more meaningful for measures that are rare at the state level;
Minnesota’s program could benefit from alignment with a national effort. The chief disadvantage
of keeping consistent with the national program is the diversion of resources away from
Minnesota-specific objectives. As resources allow, the EHTB Program would like to pursue both
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paths: (1) participation in the national program, and (2) developing environmental health
tracking measures that reflect Minnesota’s priorities.
In response to questions, Jean replied that CDC’s National Environmental Public Health
Tracking Network is eager to receive Minnesota’s data submissions. One goal of the network has
been to develop measures that would be sufficiently accessible to all states, particularly the 34
states that have not received CDC EPHT grants. Minnesota may demonstrate that, even without a
CDC EPHT grant and using limited resources, state programs can contribute to the national
network. Jean also described a bill that has been gradually gaining momentum in the US
Congress to fund all state health agencies for environmental health tracking. If federal funds
were to become available in the future, Minnesota would be very competitive.
Jean reported that the CDC’s national guidelines emerged from deliberations of the
CSTE/SEHIC. At present, SEHIC is exploring a new content area: climate change. Future
indicators might include morbidity and mortality arising from extreme weather events and
vector-borne infectious diseases (e.g. Lyme and West Nile). Air quality measures may be
expanded to include hazardous air pollutants and traffic exposure.
Over the next several months, EHTB program staff members plan to develop communications
strategies and make data sets accessible to stakeholders. The program also plans to continue to
build relationships with data stewards who collect and manage data on environmental health and
public health. A new opportunity is to collaborate with MDH staff in the Community and Family
Health Division to develop a surveillance system for autism spectrum disorders in Minnesota.
Another intriguing possibility is to dovetail with the US National Institute for Occupational
Safety and Health (NIOSH) in its pursuit of occupational health exposures, particularly (a)
malignant mesotheliomas and (b) pesticide associated illness.
Alan Bender advised that the occupational arena would provide the EHTB Program with its
biggest impact for using environmental health indicators to sustain the fledgling program and to
improve public health. Al pointed out that the 2008 legislative session included significant
discussion regarding mesothelioma and funded two research areas for a total of $5 million.
Significantly, the discussions revealed a widespread interest in asbestos exposures in areas of
Minnesota beyond the Iron Range. The energy invested in highlighting mesothelioma as a public
health issue could serve the EHTB Program by providing a ready opportunity to demonstrate
success.
In response to questions from fellow panel members, Al noted that Minnesota has about 70
diagnoses of mesothelioma a year, and most are outside of northeast Minnesota. Although the
vast majority of cases are males, a recent increase in female cases may be a reflection of
women’s presence in the workplace. The disadvantage of an extremely long latency period is
offset by the extremely tight relationship between exposure to a particular hazard and a particular
disease. A small cluster of mesothelioma cases has been associated with the Conwed facility in
Cloquet, and another cluster appears in the Red Wing vicinity. If the EHTB Program were to
uncover an historical or ongoing exposure, it would demonstrate the value of environmental
health tracking. Beth Baker considered if the Minnesota legislature would be likely to fund such
an effort, which clearly has value from epidemiological and human health perspectives.
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Greg Pratt addressed Jean’s earlier question about whether the EHTB Program should continue
to invest its resources into the national indicators projects and submit data to the National
Environmental Public Health Tracking Program. He recommended that program staff submit
data to the national network and also explore Minnesota-specific ideas. Greg likened the
environmental health tracking program to a coarse sieve, which catches the really big linkages
between environmental hazards, exposures, and diseases. Over time, the environmental health
tracking system will evolve and improve, such that we will have the capability to catch less
obvious links. Greg recommended that the EHTB Program staff should continue to build
relationships with the existing programs that collect data for their own purposes. EHTB Program
staff can sensitize the program partners as to this secondary use of their data and for the needed
quality of the secondary data elements.
Michonne Bertrand, the staff liaison between the EHTB program and the advisory panel, invited
the panel members to provide input on SEHIC’s emerging indicators for climate change and air
quality. She also asked for suggestions for new, Minnesota-led areas to explore. Beth Baker
cautioned that Minnesota might diverge only if the content area is distinctive to Minnesota.
Dan Stoddard complimented the program staff in putting its resources first into piloting the
national indicators and in putting a small effort into distinctive Minnesota ventures. He noted
that the next big step is not defined yet, so the program should keep to its present paths until a
vision statement is adopted.
Cecilia Martinez expressed her hesitation to recommend a specific indicator, as each affected
community has unique issues. She advised the program staff to explore issues of concern to
Indian Health Service. She recognized that climate change is of concern and that international
efforts are substantial, but a distinctive role for Minnesota in developing indicators for climate
change is questionable. Cecilia echoed Dan’s recommendation for the EHTB Program to develop
a vision statement. The determinants of poverty, class, and race in tackling environmental health
issues should be framed in the program’s strategic directions.
Susan Palchick asked for clarification about submitting Minnesota’s data to the National
Environmental Public Health Tracking Program. Because the pilot data were analyzed to be
congruent with the national guidelines, Susan commented that there seemed to be no compelling
reason to withhold Minnesota’s data. Jean replied that the EHTB program staff agrees. The only
hesitation is that the national workgroup for the water quality indicators is still refining its
parameters. Once the methodology is finalized, the Minnesota program plans to submit the water
quality data accordingly. Deanna Scher noted that some states have websites to communicate if
or why its state program is presenting and interpreting its water quality data differently than
CDC might in its presentation of national, aggregate data.
Al Bender advised that, if Minnesota participates in the national network, the EHTB Program
staff would undoubtedly have more influence in refining the national measures than if it were to
withhold the Minnesota data.
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Cecelia Martinez asked for clarification as to any disadvantages of submitting data to the
national program. Michonne Bertrand and Jean Johnson responded that, if the national network
were to change its formulations for data reduction, then Minnesota would need to reduce its data
anew. Moreover, if Minnesota would want to diverge from the national guidelines in data
collection or interpretation, we might confuse our users by distributing two different data sets,
one for national consumption, and one aligned with Minnesota-specific parameters.
Al Bender returned to Greg Pratt’s earlier comment about sensitizing program partners to the
secondary use of data. He reinforced the value of capturing data elements that are critical to
secondary use by the environmental health tracking initiative. For example, a few of the
indicators rely on hospitalization data. Other than one or two exceptions across the U.S., state
health agencies do not receive personal identifiers with hospitalization data. Yet public health
would be well served by tracking cases at the individual level instead of by county or zip code.
Repeat hospital visits by a single individual are but one situation in which interpretation of data
can be challenging. Al pointed out that public health practices and data privacy protections are
not in conflict; in fact, public health practitioners are generally champions of data privacy
protection. Furthermore, the legislature seems to be willing to invest in evaluating
environmental/public health data to improve health outcomes. Thus, it might behoove the EHTB
Program to make a recommendation that the Minnesota Hospital Association submit data to
MDH that retains personal identifiers. Al noted that MDH would be legally obligated to protect
data privacy, and MDH would be capable of significant improvements in data quality and
evaluation.
Greg Pratt remarked that a similar initiative is underway with a subgroup of the Minnesota
component of the National Children’s Study. The subgroup recognizes the value of associating
environmental/public health data with individuals. In fact, Blue Cross/Blue Shield links
environmental data and personal health data within its own system. However, linkages cannot
occur between health care networks presently.
Beth Baker encouraged the EHTB Program staff to investigate if any other state health agencies
already obtain personal identifiers and to learn how this approach might be pursued in
Minnesota. Greg Pratt put forward a motion that MDH should look at outreach activities to
hospital associations and other entities to make them aware of the benefits to be gained to public
health programs if individual data elements are associated with the hospitalization data. The
motion was not seconded. Dan Stoddard suggested that MDH explore the options that have been
pursued by other state health agencies to obtain access to personal identifiers linked to
hospitalization records.
Chemical selection criteria
Michonne Bertrand referred the panel members to the background book, which contains an
updated version of the selection criteria for chemicals to be examined in biomonitoring studies.
Following the advisory panel’s earlier recommendation to give more weight to criteria for
seriousness of health effects and degree of exposure at levels of significance, she noted that the
weighted criteria give preference to well-studied chemicals rather than emerging toxins.
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Michonne also referred to the process and timeline for selecting chemicals. She noted that the
process is intended to make recommendations for priority chemicals for a biomonitoring base
program. The process is not specifically geared toward identifying a chemical for the fourth
biomonitoring pilot project. Because of the time constraints in this two-year funding period, the
selection of the fourth biomonitoring pilot project may be based on convenience.
The chemical selection process would begin by soliciting public input, with the expectation that
these nominations are suggestions (rather than ranked priorities) and indications of issues
important to Minnesota’s citizens. Advisory panel members and program staff will be
encouraged to put forward their own nominations during the public nomination period.
Subsequent steps in the process would include scoring by workgroup members and invited
experts. The scoring outcomes would be presented to the advisory panel for further deliberation,
perhaps at the September panel meeting.
Cecilia Martinez concurred that chemicals with known health effects should carry more weight
in the scoring system. Political motivation is an important factor, as well. She asked how
perfluorochemicals and arsenic ranked, using this scoring system. Jean Johnson and Michonne
replied that the EHTB workgroup members determined that perfluorochemicals ranked in the
middle of the scoring range, particularly due to its high marks for public concern but low marks
for known, serious health effects. Arsenic scored quite high and lead scored very high, mainly
because it has been characterized extensively regarding exposed populations and health effects.
In response to Debra McGovern’s inquiry, Jean replied that the EHTB workgroup did not
include mercury in its scoring exercise.
Beth Baker asked about the role of the advisory panel at the September meeting in making
recommendations about the nominated chemicals. Dan Stoddard recommended that all
NHANES chemicals be included in the list of nominated chemicals and that they be scored, at
least according to broad chemical categories. Dan emphasized that the scoring system is
dependent on the program’s vision, yet to be finalized. The scoring process will be highly
dependent on the types of biomonitoring projects that get sustainable funding, which is an
important goal for the biomonitoring program.
After some discussion by the committee on biomonitoirng options, Dan suggested that the EHTB
program staff and advisory panel could collaborate on two or three proposals to present to the
legislature. Each of these would address a different vision for biomonitoring in Minnesota: a
baseline study that monitors the public every few years, an emphasis on emerging issues, and/or
a focus on known problems. An important role for the advisory panel would be to ensure that the
proposals are scientifically defensible. Al Bender agreed that the advisory panel could serve as a
critical buffer to bring a scientific perspective to the many pressures felt by legislators.
Beth asked the panel members to consider the tasks that should be accomplished by September.
Dan responded that the biomonitoring program vision should be articulated first, as that would
shed light on whether the scoring process should favor well studied, known contaminants or
emerging, relatively uncharacterized contaminants. He suggested that the visioning process
should proceed with a long term focus on what biomonitoring and environmental health tracking
could accomplish decades from now assuming funding were unlimited. Projects should then be
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small, achievable and technically defensible steps building towards the long term vision. Cecilia
cautioned the EHTB program to avoid having to choose between only known contaminants and
only emerging contaminants.
Beth pointed out that the EHTB program staff would be challenged to score all NHANES
chemicals in the chemical selection process. Dan suggested that due to technological limitations
it might be very difficult or impossible to conduct biomonitoring for some of the chemicals and
therefore some could be scored relatively quickly as pass vs. concern vs. fail. He recommended
that chemicals would fail if they lack an analytical method. Michonne commented that the
laboratory cost is another criterion amenable to pass vs. concern vs. fail. She suggested that the
public nomination process would be the first step, and that a later step would screen chemicals
by adequacy of an analytical method. Jean suggested that the screening process should not
eliminate chemicals that lack an analytical method currently because the EHTB program may
choose to invest in developing laboratory capability. Dan agreed, and he noted that the scoring
criteria may differ between known chemicals and emerging chemicals. He recommended that a
score of “concern” could be used when there are significant short term obstacles to
biomonitoring, however funds and effort could be dedicated to developing analytical methods for
emerging toxins.
Project status updates
Jean Johnson reported that the arsenic biomonitoring pilot project is beginning to recruit
community participants. The objective is to recruit 100 children, 3 to 10 years of age, living in
homes with high soil levels of arsenic near the site of a former pesticide facility. Introductory
postcards were sent in May to the 894 eligible households. Introductory letters are being sent
now, with a brief questionnaire about the ages of children in the household. Field staff will be
recruiting non-English speakers through door-to-door and phone solicitations. Current plans are
that sample collection will begin in late June or early July.
Jean announced that the perfluorochemicals biomonitoring pilot project is pending approval from
the MDH Institutional Review Board (IRB). Two HealthEast clinics have been contracted for
participants to donate blood specimens. Program staff members plan to send letters of
recruitment to eligible participants in July. Sample collection may occur in August and
September. MDH Public Health Laboratory scientists will analyze serum specimens for 7
perfluorochemicals, including PFBA, PFOA, and PFOS.
A mercury biomonitoring pilot project is being explored. The EHTB Steering Committee is
considering if an EPA-funded mercury project could partially fulfill the expectations of the
EHTB program. At this juncture, no input is requested from the advisory panel.
Candidates for a fourth biomonitoring project are being explored. Jean reported that she is
meeting with researchers at the University of Minnesota who might provide convenient access
for secondary use of their specimens. Specimen availability, time, cost, and laboratory capacity
are limiting the choices.
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Biomonitoring: Next Steps
Beth Baker recommended that topics at the September meeting of the advisory panel could
include a presentation of the list of chemicals nominated by the public during the summer
months and a presentation of options for the fourth biomonitoring pilot project.
Jean Johnson reported that EHTB program staff members are continuing to develop the
biomonitoring pilot program guidelines, including a vision for the biomonitoring program. She
listed three options for the vision: (a) public health surveillance (monitoring overall trends in the
state’s population); (b) a research perspective that encompasses exposure sources and health
outcomes; and (c) studies that address community concerns around contamination sites.
Al Bender noted that the Minnesota Statutes require the EHTB program to report progress to the
legislature. Jean responded that the statutes require reports on both the biomonitoring program
and the environmental health tracking program by January 2009. Michonne Bertrand noted that
the program fulfilled its obligation to provide a biomonitoring report to the legislature in January
2008, and the report outlined plans to submit a biomonitoring update in January 2009.
Jean suggested that another topic for the September meeting could be a report on visions and
objectives of biomonitoring programs that are being pursued in other states. In fact, members of
the State Environmental Health Indicators Collaborative (SEHIC) have suggested a collaborative
effort to articulate a vision for state biomonitoring programs.
Cecilia Martinez asked about the status of the chemical selection process used by California’s
biomonitoring program. Michonne reported that the survey was released in April; the survey asks
for input on the types of chemicals that should be studied and the criteria for selecting chemical
categories. A copy of California’s survey of the public is provided in the background book. The
biomonitoring programs in both Minnesota and California are choosing a chemical selection
process that involves nominations from the public, recommendations from the scientific advisory
panel, and evaluation by the program staff. The agenda for the June meeting of California’s
scientific guidance panel includes a discussion of the survey results. The website for the
California biomonitoring program has many useful documents.
Closure
Beth Baker thanked the panel members for their continued dedication. The next meeting is
scheduled for September 9, 2008, for 1:00 to 4:00. The meeting will be held at Snelling Office
Park in Saint Paul. Michonne Bertrand asked the panel members to contact her at any time with
comments and suggestions to sustain constructive interactions between the panel and the EHTB
program staff.
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EHTB advisory panel roster
John L. Adgate, PhD
University of Minnesota School of Public Health
Environmental Health Sciences Division
MMC 807 Mayo
420 Delaware Street SE
Minneapolis, Minnesota 55455
612-624-2601
[email protected]
University of Minnesota representative
Cecilia Martinez, PhD
Center for Energy and Environmental Policy
University of Delaware
Newark, Delaware 19716
302-831-8405
Local office:
Inver Grove Heights, Minnesota
651-470-5945
[email protected]
[email protected]
Nongovernmental organization representative
Bruce H. 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]
Minnesota House of Representatives appointee
Debra McGovern
Minnesota Steel Industries, LLC
Environmental & Regulatory Affairs
555 West 27th Street
Hibbing, MN 55746
218-263-3331
[email protected]
Statewide business organization representative
Beth Baker, MD, MPH
Specialists in Occupational and Environmental
Medicine
Fort Road Medical Building
360 Sherman Street, Suite 470
St. Paul, MN 55102
952-270-5335
[email protected]
At-large representative
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
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
Susan Palchick, PhD, MPH
Hennepin County Human Services and Public
Health Department
Public Health Protection
1011 South 1st Street, Suite 215
Hopkins, Minnesota 55343
612-543-5205
[email protected]
At-large representative
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Gregory Pratt, PhD
Minnesota Pollution Control Agency
Environmental Analysis and Outcomes Division
520 Lafayette Road
St. Paul, MN 55155-4194
651-296-7664
[email protected]
MPCA appointee
Samuel Yamin, MPH
Minnesota Center for Environmental
Advocacy
26 E. Exchange St., Ste. 206
St. Paul, MN 55101
(651) 223-5969
[email protected]
Minnesota Senate appointee
Daniel Stoddard, 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
Lisa Yost, MPH, DABT
Exponent, Inc.
15375 SE 30th Pl, Ste 250
Bellevue, Washington 98007
Local office
St. Paul, Minnesota
651-225-1592
[email protected]
At-large representative
David Wallinga, MD, MPA
Institute for Agriculture & Trade Policy
Food and Health Program
2105 First Avenue South
Minneapolis, Minnesota 55404
612-870-3418
[email protected]
Nongovernmental organization representative
Rev. August 20, 2008
Please submit corrections to [email protected]
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Biographical sketches of advisory panel members
John L. Adgate is an Associate Professor in the Division of Environmental Health Sciences at
the University of Minnesota School of Public Health. His research focuses on improving exposure
assessment in epidemiologic studies by documenting the magnitude and variability of human exposure to
air pollutants, pesticides, metals, and allergens using various measurement and modeling techniques,
including biomonitoring. He has written numerous articles and book chapters on exposure assessment,
risk analysis, and children’s environmental health. He has also served on multiple U.S. EPA Science
Advisory Panels exploring technical and policy issues related to residential exposure to pesticides, metals,
and implementation of the Food Quality Protection Act of 1996, and was a member of the Institute of
Medicine’s Committee on Research Ethics in Housing Related Health Hazard Research in Children.
Bruce H. Alexander is an Associate Professor in the Division of Environmental Health Sciences
at the University of Minnesota School of Public Health. Dr. Alexander is an environmental and
occupational epidemiologist with expertise in cancer, reproductive health, respiratory disease,
injury, exposure assessment, and use of biological markers in public health applications.
Beth Baker is Medical Director of Employee Health at Regions Hospital and a staff physician at the
HealthPartners. She is President of Medical and Toxicology Consulting Services, Ltd. Dr. Baker is an
Assistant Professor in the Medical School and Adjunct Assistant Professor in the School of Public Health at
the University of Minnesota. She is board certified in internal medicine, occupational medicine and medical
toxicology. Dr. Baker is a member of the Board of Trustees for the Minnesota Medical Association and is
on the Board of Directors of the American College of Occupational and Environmental Medicine.
Alan Bender is the Section Chief of Chronic Disease and Environmental Epidemiology at the
Minnesota Department of Health. He holds a Doctor of Veterinary Medicine degree from the
University of Minnesota and a PhD in Epidemiology from Ohio State University. His work has focused
on developing statewide surveillance systems, including cancer and occupational health, and exploring
the links between occupational and environmental exposures and chronic disease and mortality.
Cecilia Martinez has a B.S. degree from Stanford University and a Ph.D from the University of Delaware.
She is an Adjunct Faculty at the Center for Energy and Environmental Policy where she leads projects on
environmental mapping and community health. Her research interests include environmental policy,
indigenous rights and the environment, and sustainable development. Dr. Martinez has numerous publications
including Environmental Justice: Discourses in International Political Economy with John Byrne and Leigh
Glover. Her interests include policy research on sustainable energy and environmental policy.
Debra McGovern has more than 28 years of environmental experience. She has 15 years of
experience in Minnesota governmental regulation and 13 years of experience in heavy process
industry, and is well versed in Minnesota’s regulatory requirements. Ms. McGovern has created and
implemented numerous environmental programs and is active in many organizations. Ms. McGovern is
the former Environmental Policy Committee Chairperson for the Minnesota Chamber of Commerce,
and currently serves on the Board of Directors for the Minnesota Environmental Initiative (MEI).
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Geary Olsen is a staff scientist in the Medical Department of the 3M Company. He obtained a
Doctor of Veterinary Medicine (DVM) degree from the University of Illinois and a Master of
Public Health (MPH) in veterinary public health and PhD in epidemiology from the University
of Minnesota. For 22 years he has been engaged in a variety of occupational and environmental
epidemiology research studies while employed at Dow Chemical and, since 1995, at 3M. His
primary research activities at 3M have involved the epidemiology, biomonitoring (occupational
and general population), and pharmacokinetics of perfluorochemicals. Recently, he completed a
3-year appointment on the Board of Scientific Counselors for the U.S. Centers for Disease
Control and Prevention (CDC) ATSDR/NCEH.
Susan Palchick is the Administrative Manager for Epidemiology, Environmental Health,
Assessment and Public Health Emergency Preparedness at Hennepin County Human Services
and Public Health Department. She has been with Hennepin County for 11 years and also serves
as the Environmental Health Director for Hennepin County. Prior to coming to Hennepin
County, Susan was the program manager for the Metropolitan Mosquito Control District
(MMCD) for 10 years. Susan is on the National Association of County and City Health Officials
(NACCHO) environmental health essential services committee. She is the principal investigator for an
Advanced Practice Center (APC) grant from NACCHO which focuses on environmental health
emergency preparedness. Susan received her Ph.D. in Medical Entomology from the University of
California-Davis; Master of Public Health in Epidemiology from the University of California-Berkeley;
M.S. in Entomology from University of Wisconsin-Madison; and B.S. (with honors) in Agricultural
Journalism-Natural Science from the University of Wisconsin-Madison.
Greg Pratt is a research scientist at the Minnesota Pollution Control Agency. He holds a Ph.D.
from the University of Minnesota in Plant Physiology where he worked on the effects of air
pollution on vegetation. Since 1984 he has worked for the MPCA on a wide variety of issues
including acid deposition, stratospheric ozone depletion, climate change, atmospheric fate and
dispersion of air pollution, monitoring and occurrence of air pollution, statewide modeling of air
pollution risks, and personal exposure to air pollution. He is presently cooperating with the
Minnesota Department of Health on a research project on the Development of Environmental
Health Outcome Indicators: Air Quality Improvements and Community Health Impacts.
Daniel Stoddard is the Assistant Director for Environmental Programs for the Pesticide and
Fertilizer Management Division at the Minnesota Department of Agriculture (MDA). He holds a master’s
degree in Management of Technology which focuses on the management of multi-disciplinary technical
organizations and projects, and he is a licensed Professional Geologist. He currently administers the
MDA’s non-point source programs for pesticides and inorganic fertilizer. These include: monitoring
surface water and groundwater for pesticides; monitoring pesticide use; registering pesticide products;
developing and promoting voluntary best management practices; developing regulatory options; and,
responding to local contamination problems. He previously worked in or managed a variety of other
environmental and regulatory programs at the MDA and the Minnesota Pollution Control Agency, and as
an environmental consultant.
David Wallinga is Director of the Food and Health Program at the Institute for Agriculture and Trade
Policy. Dr. Wallinga applies a systems perspective to the intersection of public health, agriculture, food
and the environment. His expertise includes the impacts of food contamination and the means of food
production on human health, including impacts on obesity and ecological health impacts from the
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inappropriate use of antibiotics and arsenic in livestock and poultry. Dr. Wallinga also has for several
years researched and advocated around the impacts on fetuses, children and adults of early-life exposures
to neurotoxins—including many found in fish and other foods—on brain and nervous system function in
children and adults, developing brains and other organs in fetuses and children. Dr. Wallinga authored
“Playing Chicken: Avoiding Arsenic in Your Meat,” “Poultry on Antibiotics: Hazards to Human Health,”
as well as “Putting Children First: Making Pesticide Levels in Food Safer for Infants & Children.” He is a
co-author of “In Harm’s Way: Toxic Threats to Child Development” and co-developer of the Pediatric
Environmental Health Toolkit. He received a medical degree from the University of Minnesota Medical
School, a Masters degree from Princeton University, and a Bachelors from Dartmouth College.
Samuel Yamin is the Public Health Scientist for the Minnesota Center for Environmental
Advocacy. Before joining MCEA, Samuel worked as a toxicologist for the New Hampshire
Bureau of Environmental and Occupational Health, and prior to that as an environmental
epidemiologist for the Delaware Division of Public Health. While working for those agencies, his
responsibilities included exposure assessment, risk analysis and hazard communication for pollutants in
water, air, soils and indoor environments. Samuel has also worked extensively on the subject of
environmental carcinogens and the potential impacts on public health. Samuel’s experience in
hazardous materials management and environmental regulatory programs also includes two years of
work with the Environmental Health and Safety Department at Ionics, Inc., a Massachusetts-based
manufacturer of drinking water purification technology. Samuel holds a Master of Public Health in
Environmental Health Sciences from Tufts University School of Medicine and a Bachelor of Science
in Environmental Health and Safety from Oregon State University.
Lisa Yost is a Managing Scientist at Exponent Inc., a national consulting firm, in their Health
Sciences Group and she is based in Saint Paul, Minnesota. Ms. Yost completed her training at the
University of Michigan School of Public Health and is a board-certified toxicologist with
expertise in evaluating human health risks associated with substances in soil, water, and the food
chain. She has conducted or supervised risk assessments under CERCLA, RCRA, or state-led
regulatory contexts involving a wide range of chemicals and exposure situations. Her particular
areas of specialization include exposure and risk assessment, risk communication, and the
toxicology of chemicals such as PCDDs and PCDFs, PCBs, pentachlorophenol (PCP),
trichloroethylene (TCE), mercury, and arsenic. Ms. Yost is a recognized expert in risk assessment
and has collaborated in original research on exposure issues including background
dietary intake of inorganic arsenic. She is currently assisting in a number of projects including a
complex multi-pathway risk assessment for PDDD/Fs that will integrate extensive biomonitoring
data collected by the University of Michigan. Ms. Yost is also an Adjunct Instructor at the
University of Minnesota, School of Public Health.
Rev. November 30, 2007
Please submit additions and corrections to [email protected]
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EHTB advisory panel operating procedures
Panel Name, Membership, Function, and Objectives
This advisory panel is known as the Environmental Health Tracking and Biomonitoring (EHTB)
Advisory Panel. This panel and its membership, functions, and objectives are described in Minnesota
Statute section 144.998.
Charge
The advisory panel is intended to function in an advisory capacity to the MDH program managers in
environmental health tracking and biomonitoring and, ultimately, to the Commissioner of Health. This
panel is to extend and supplement the range of expertise of MDH’s scientific staff, and to advise in setting
priorities for, designing, and evaluating the environmental health tracking and biomonitoring projects. It
is not intended that the advisory panel become involved in the day-to-day operational and administrative
aspects of program resources, program management, or personnel matters.
Reimbursement
Members of the panel shall serve without compensation but shall be reimbursed for travel and other
necessary expenses incurred through performance of their duties.
Terms of Appointment
1. 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.
2. Each member will receive notification of the expiration of his or her term at least sixty days prior to
the termination date. Notification will also be sent to the chair of the advisory panel.
3. Members should communicate their intent to resign in writing to the appropriate appointing authority
and to the chair of the advisory panel. If the Commissioner of Health is not the appointing authority,
then the member should also notify the Commissioner of Health. The appropriate appointing
authority will appoint a new member to serve the remainder of the term if needed to maintain
membership from each of the representative groups listed in Minnesota Statute 144.998.
4. A member may be removed by the appointing authority at any time, at the discretion of the
appointing authority.
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Responsibilities and Expectations of Advisory Panel Members
In accepting appointments to the advisory panel, members are expected to:
1. Attend advisory panel meetings and other assigned meetings. Any member missing two consecutive
full advisory panel meetings may be notified in writing that missing a third consecutive meeting may
result in the member’s removal from the advisory panel.
2. Serve on committees, work groups, and other task forces as requested by the chair.
3. Prepare for active participation in discussions and decision-making by reviewing meeting materials
prior to the meeting dates.
4. Act as a liaison when appropriate between constituent groups and the advisory panel.
5. Inform the represented constituent groups of advisory panel activities, actions, and issues.
6. Declare any actual or apparent conflicts of interest and abstain from voting on advisory panel matters
that create an actual conflict of interest. A conflict of interest is a situation in which an advisory panel
member, her/his organization, or a family member would personally benefit based on the outcome of
a particular decision, endorsement, or action taken by the advisory panel. A conflict of interest exists
if one of the following conditions applies:
a. The member’s organization has a direct financial or organizational interest in the matter under
consideration. Note that employees of large organizations may have little or no personal
knowledge about certain financial interests of their employers. In those cases, members are
required to declare only conflicts for which they have direct knowledge. They are not required to
inquire about further details from their employers. In some situations, members may hold a
position in which they exercise some authority with respect to projects in which they are not
personally involved. In those cases, inquiry into additional information about the interest could be
helpful in preventing unintentional conflicts of interests or appearances of impropriety.
b. The member or a family member has a financial or personal interest in the matter under
consideration and is not so free from personal bias, prejudice, or preconceived notion as to make
it possible for her/him to objectively consider the evidence presented and base her/his decision
solely on the evidence.
c. The member has placed her/himself in a position where she/he finds it difficult, if not impossible,
to devote her/himself to a consideration of the matter with complete energy, loyalty, and
singleness of purpose to the general public interest.
It should be noted that many members of the advisory panel will have exceptional professional or
personal experience with environmental health tracking or biomonitoring. These qualities, by
themselves, do not constitute a conflict of interest. Informed decision-making will benefit from
personal experiences; however, personal interests should not distract from objective decision-making
for the public good.
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Advisory Panel Chair
The Commissioner of Health shall appoint a chair from the advisory panel’s membership. The term of
office is three years.
The duties of the chair are to:
1. Preside at all full advisory panel meetings.
2. At the request of the Commissioner, be the spokesperson and representative for the advisory panel.
3. Establish work groups as needed to carry out the advisory panel’s recommended actions, consulting
with staff to assure staff support will be available as needed.
Meetings
1. The advisory panel shall meet as often as it deems necessary but, at a minimum, on a quarterly basis.
Meetings will be held in Minneapolis or Saint Paul during the regular business day. The number and
scheduling of meetings will depend on the timing and urgency of particular issues being addressed.
Any work groups will meet outside of regularly scheduled meetings of the full advisory panel.
2. The advisory panel and work groups can meet more frequently, as requested by the chair or other
advisory panel members.
3. Meetings of the advisory panel and work groups may be cancelled and rescheduled by the
Commissioner in consultation with the chair. Advisory panel members and work group members will
be notified of cancellations in as timely a manner as possible.
4. All meetings are open to the public for observation.
Attendance
1. Attendance at each meeting is critical to the productivity of the advisory panel. While it is ideal to
have all members of the advisory panel present at meetings, this is not always feasible. Members for
whom travel time and distance are prohibitive may connect to meetings by telephone. Members who
make arrangements for telephone connections are strongly encouraged to attend at least two meetings
each year in person.
2. If a member cannot attend a meeting, she/he is to contact the advisory panel’s MDH staff liaison prior
to the meeting. Panel members are encouraged to speak to the staff liaison before and/or after any
meetings they are unable to attend to stay informed about panel deliberations and to share any
comments. Absent members may also send a colleague to the meeting, either as an observer or as a
formal alternate. Alternates do not have decision-making or voting privileges. Also, because
discussions will often span several meetings, it may be difficult for alternates to understand the
context of or participate in panel proceedings. Alternates must meet the same eligibility criteria as
panel members (e.g., they may not be registered lobbyists).
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Quorum and Voting
It is anticipated that many issues considered by the panel will not result in a formal vote, but rather in a
general exploration of the range of panel members’ opinions and advice. In some cases, program staff
may ask the panel to conduct a formal vote. Items that would prompt a formal vote include those
explicitly required by statute (e.g., the selection of the specific chemicals to study requires the agreement
of nine panel members) and those that require program staff to operate outside of statutory requirements.
During the course of panel meetings, panel members and program staff may request additional votes
regarding issues under discussion.
1. Whenever possible, decisions requiring a vote by the advisory panel will be indicated in the meeting
agenda, which will be distributed to panel members prior to the meeting.
2. A majority (51%) of the membership must be present at a given meeting. Decisions can be made
when a majority of voting members present reach agreement on a given matter.
3. The panel will operate using a relaxed version of Robert’s Rules of Order. As such, items for which a
vote is sought will require a motion, a second, discussion of the motion, and then a vote. Voting will
normally be recorded as the number of ayes, number of nays, and number of abstentions. When
specifically requested by a member of the advisory panel, the chair will take a roll call, and individual
votes will be recorded.
4. Votes by members attending the meeting by telephone are acceptable.
5. As described in Minnesota Statute section 144.998, one representative each shall be appointed by the
commissioners of the Pollution Control Agency, the Department of Agriculture, and the Department
of Health. All other state employees are ex-officio participants. With this status, the ex-officio
participants are allowed to participate but do not have decision-making or voting privileges. These exofficio participants are not appointed to the formal advisory panel membership.
6. Voting privileges for absent members are as follows:
a. Members participating by telephone are allowed to vote.
b. When an item requiring a vote is known in advance, members may submit absentee ballots by email, fax, or U.S. mail. Ballots must be received by the EHTB program staff at least one day prior
to the meeting.
c. When an item requiring a vote is known in advance, absent members may submit proxy votes to
the chair or another panel member beforehand. The proxy statement will declare her/his approval
or rejection of the issue that will be under discussion.
d. Alternately, the proxy statement will declare that a specific member, who must be present, serves
as the absent member’s delegate and has full authority to vote on a particular issue.
e. Absent members are not allowed to submit proxy votes or appoint a delegate for issues or votes
arising during meetings.
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Communications
Advisory panel members are expected to refrain from writing letters or engaging in other kinds of
communication in the name of the advisory panel unless such communication has been specifically
approved by the advisory panel or the Commissioner of Health.
Decision-Making Process
The following summarizes the key steps involved in the EHTB program’s decision-making process:
1. MDH staff members prepare background and supporting materials for advisory panel review.
a. MDH staff members may enlist work groups, task forces, or other external experts to study
complex issues.
b. Usually the information is provided to the advisory panel in written form, supplemented by staff
presentation, comments, and responses to questions during meeting discussions.
c. During this stage, MDH staff members begin to identify options and assess their relative merits.
2. The advisory panel provides advice to EHTB program staff and, in some cases, develops formal
recommendations.
a. Advisory panel members discuss and debate matters as ideas are formulated.
b. Discussions by the advisory panel members provide an important opportunity to test MDH staff
members’ reactions to ideas and, as appropriate, recommend alternative approaches.
c. In some cases, the advisory panel formalizes its advice and recommendations. Recommendations
may be recorded as a consensus opinion or by a formal vote. Upon request, voice reports of the
majority and minority opinions may be prepared.
3. MDH staff members prepare specific recommendations.
a. Advisory panel advice and recommendations are considered carefully in light of alternative
options. In many cases, EHTB program staff will need to weigh advisory panel recommendations
along with feedback received from other stakeholders (such as community members). The
relative merits of each option are examined thoroughly.
b. Specific staff recommendations are developed; justification is documented.
4. The Commissioner of Health reviews recommendations and makes final decisions.
a. MDH staff members present the advisory panel recommendations via written or verbal report to
the Commissioner or the Commissioner’s representative (e.g., EHTB Steering Committee).
Reports will include a summary of the issue, background, process, recommendations, and
outcome of discussion and voting on recommendations (including other motions, as appropriate).
b. MDH staff members present the staff recommendations, as well. These may support or enhance
the advisory panel’s recommendations; alternatively, they may present contrary perspectives.
93
c. If substantial differences exist between advisory panel and MDH staff recommendations, the
advisory panel chair is invited to meet with the Commissioner of Health or the Commissioner’s
representative to provide further information concerning the rationale for the advisory panel
recommendations.
d. The Commissioner of Health or the Commissioner’s representative makes the final decision
based on consideration of information and recommendations received.
Adopted March 11, 2008
94
EHTB steering committee roster
Mary Manning, RD, MBA
Division Director
Health Promotion and Chronic Disease
Division
Minnesota Department of Health
PO Box 64882
St. Paul, Minnesota 55164-0882
651-201-3601
[email protected]
Norman Crouch, PhD (chair)
Assistant Commissioner
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0975
651-201-5063
[email protected]
Joanne Bartkus, PhD
Division Director
Public Health Laboratory Division
Minnesota Department of Health
PO Box 64899
St Paul, Minnesota 55164-0899
651-201-5256
[email protected]
John Linc Stine
Division Director
Environmental Health Division
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0975
651-201-4675
[email protected]
Rev. February 19, 2008
95
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96
EHTB inter-agency workgroup roster
Louise Liao, PhD
Environmental Laboratory
Public Health Laboratory Division
Minnesota Department of Health
PO Box 64899
St Paul, Minnesota 55164-0899
651-201-5303
[email protected]
Michonne Bertrand, MPH
Chronic Disease & Environmental
Epidemiology
Health Promotion and Chronic Disease
Division
Minnesota Department of Health
PO Box 64882
St. Paul, Minnesota 55164-0882
651-201-3661
[email protected]
Rita Messing, PhD
Site Assessment & Consultation
Environmental Health Division
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0899
651-201-4916
[email protected]
Carin Huset, PhD
Environmental Laboratory
Public Health Laboratory Division
Minnesota Department of Health
PO Box 64899
St Paul, Minnesota 55164-0899
651-201-5329
[email protected]
Pam Shubat, PhD
Health Risk Assessment
Environmental Health Division
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0899
651-201-4925
[email protected]
Jean Johnson, PhD
Chronic Disease & Environmental
Epidemiology
Health Promotion and Chronic Disease
Division
Minnesota Department of Health
PO Box 64882
St. Paul, Minnesota 55164-0882
651-201-5902
[email protected]
John Soler, MS
Chronic Disease & Environmental
Epidemiology
Health Promotion and Chronic Disease
Division
Minnesota Department of Health
PO Box 64882
St. Paul, Minnesota 55164-0882
651-201-5481
[email protected]
Frank Kohlasch, JD
Environmental Data Management Unit
Environmental Analysis & Outcomes
Division
Minnesota Pollution Control Agency
520 Lafayette Road N
St. Paul, Minnesota 55155-4194
651-205-4581
[email protected]
97
Allan Williams, MPH, PhD
Chronic Disease & Environmental
Epidemiology
Health Promotion and Chronic Disease
Division
Minnesota Department of Health
PO Box 64882
St. Paul, Minnesota 55164-0882
651-201-5905
[email protected]
Erik Zabel, PhD
Environmental Impact Analysis
Environmental Health Division
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0899
651-201-4931
[email protected]
Joe Zachmann, PhD
Pesticide & Fertilizer Management Division
Minnesota Department of Agriculture
625 Robert Street North
St. Paul, Minnesota 55155-2538
651-201-6588
[email protected]
Rev. August 20, 2008
98
Glossary of terms used in environmental health tracking and
biomonitoring
Biomarker: According to the National Research Council (NRC), a biomarker is an indicator of a
change or an event in a human biological system. The NRC defines three types of biomarkers in
environmental health, those that indicate exposure, effect, and susceptibility.
Biomarker of exposure: An exogenous substance, its metabolites, or the product of an
interaction between the substance and some target molecule or cell that can be measured
in an organism.
Biomarker of effect: A measurable change (biological, physiological, etc.) within the
body that may indicate an actual or potential health impairment or disease.
Biomarker of susceptibility: An indicator that an organism is especially sensitive to
exposure to a specific external substance.
Biomonitoring: As defined by Minnesota Statute 144.995, biomonitoring is the process by which
chemicals and their metabolites are identified and measured within a biospecimen. Biomonitoring data
are collected by analyzing blood, urine, milk or other tissue samples in the laboratory. These samples
can provide physical evidence of current or past exposure to a particular chemical.
Biospecimen: As defined by Minnesota Statute 144.995, 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.
Community: As defined by Minnesota Statute 144.995, 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.
Designated chemicals: As defined by Minnesota Statute 144.995, designated chemicals are those
chemicals that are known to, or strongly suspected of, adversely impacting human health or
development, based upon scientific, peer-reviewed animal, human, or in vitro studies, and baseline
human exposure data. They consist of chemical families or metabolites that are included in the federal
Centers for Disease Control and Prevention studies that are known collectively as the National Reports
on Human Exposure to Environmental Chemicals Program and any substances specified by the
commissioner after receiving recommendations from the advisory panel in accordance with the criteria
specified in statute for the selection of specific chemicals to study.
Environmental data: Concentrations of chemicals or other substances in the land, water, or air. Also,
information about events or facilities that release chemicals or other substances into the land, water, or air.
99
Environmental epidemiology: According to the National Research Council, environmental
epidemiology is the study of the effect on human health of physical, biologic, and chemical factors in
the external environment. By examining specific populations or communities exposed to different
ambient environments, environmental epidemiology seeks to clarify the relation between physical,
biologic, and chemical factors and human health.
Environmental hazard: As defined by Minnesota Statute 144.995, an environmental hazard is a
chemical or other substance for which scientific, peer-reviewed studies of humans, animals, or cells
have demonstrated that the chemical is known or reasonably anticipated to adversely impact human
health. People can be exposed to physical, chemical, or biological agents from various environmental
sources through air, water, soil, and food. For EPHT, environmental hazards include biological toxins,
but do not include infectious agents (e.g. E. coli in drinking water is not included).
Environmental health indicators: Environmental health indicators or environmental public health
indicators are descriptive summary measures that identify and communicate information about a
population’s health status with respect to environmental factors. Within the environmental public health
indicators framework, indicators are categorized as hazard indicators, exposure indicators, health effect
indicators, and intervention indicators. See www.cste.org/OH/SEHIC.asp and
www.cdc.gov/nceh/indicators/introduction.htm for more information.
Environmental justice: The fair treatment and meaningful involvement of all people regardless of
race, national origin, color or income when developing, implementing and enforcing environmental
laws, regulations and policies. Fair treatment means that no group of people, including a racial, ethnic,
or socioeconomic group, should bear more than its share of negative environmental impacts.
Environmental health tracking: As defined in Minnesota Statute 144.995, environmental health
tracking is the collection, integration, integration, analysis, and dissemination of data on human
exposures to chemicals in the environment and on diseases potentially caused or aggravated by those
chemicals. Environmental health tracking is synonymous with environmental public health tracking.
Environmental public health surveillance: Environmental public health surveillance is public
health surveillance of health effects integrated with surveillance of environmental exposures and hazards.
Environmental Public Health Tracking Network: The National Environmental Public Health
Tracking Network is a Web-based, secure network of standardized health and environmental data. The
Tracking Network draws data and information from state and local tracking networks as well as
national-level and other data systems. It will provide the means to identify, access, and organize hazard,
exposure, and health data from these various sources and to examine and analyze those data on the
basis of their spatial and temporal characteristics. The network is being developed by the Centers for
Disease Control and Prevention (CDC) in collaboration with a wide range of stakeholders. See
www.cdc.gov/nceh/tracking/network.htm for more information.
Environmental Public Health Tracking Program: The Congressionally-mandated national
initiative that will establish a network that will enable the ongoing collection, integration, analysis, and
interpretation of data about the following factors: (1) environmental hazards, (2) exposure to
environmental hazards, and (3) health effects potentially related to exposure to environmental hazards.
Visit www.cdc.gov/nceh/tracking/ for more information.
100
Epidemiology: The study of the distribution and determinants of health-related states or events in
specified populations, and the application of this study to the control of health problems.
Exposure: Contact with a contaminant (by breathing, ingestion, or touching) in such a way that the
contaminant may get in or on the body and harmful effects may occur.
Exposure indicator: According to the Council of State and Territorial Epidemiologists (CSTE), an
exposure indicator is a biological marker in tissue or fluid that identifies the presence of a substance or
combination of substances that may potentially harm the individual.
Geographic Information Systems (GIS): Software technology that enables the integration of
multiple sources of data and displaying data in time and space.
Hazard: A factor that may adversely affect health.
Hazard indicator: A condition or activity that identifies the potential for exposure to a contaminant or
hazardous condition.
Health effects: Chronic or acute health conditions that affect the well-being of an individual or
community.
Health effect indicator: The disease or health problem itself, such as asthma attacks or birth defects,
that affect the well-being of an individual or community. Health effects are measured in terms of illness
and death and may be chronic or acute health conditions.
Incidence: The number of new events (e.g., new cases of a disease in a defined population) within a
specified period of time.
Institutional Review Board: An Institutional Review Board (IRB) is a specially constituted review
body established or designated by an entity to protect the welfare of human subjects recruited to
participate in biomedical or behavioral research. IRBs check to see that research projects are well
designed, legal, ethical, do not involve unnecessary risks, and include safeguards for participants.
Intervention: Taking actions in public health so as to reduce adverse health effects, regulatory, and
prevention strategies.
Intervention indicator: Programs or official policies that minimize or prevent an environmental
hazard, exposure or health effect.
National Health and Nutrition Examination Survey (NHANES): A continuous survey,
conducted by CDC, of the health and nutritional status of adults and children in the United States. The
survey is unique in that it combines interviews and physical examinations. Since 1970, children in the
survey were biomonitored for lead poisoning, and since 1999, an increasing number of environmental
contaminants has been included in the survey. Visit www.cdc.gov/exposurereport/report.htm for more
information.
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National Human Exposure Assessment Survey (NHEXAS): An EPA survey designed to
evaluate comprehensive human exposure to multiple chemicals on a community and regional scale.
The study was carried out in EPA Region V, of which Minnesota is a part. Individual households from
four Minnesota Counties were included in the survey. Visit www.epa.gov/heasd/edrb/nhexas.htm for
more information.
Persistent chemicals: Chemical substances that persist in the environment, bioaccumulate through
the food web, and pose a risk of causing adverse effects to human health and the environment.
Population-based approach: A population-based approach uses a defined population or
community as the organizing principle for targeting the broad distribution of diseases and health
determinants. A population-based approach attempts to measure or shape a community’s overall health
status profile, seeking to affect the determinants of disease within an entire community rather than
simply those of single individuals.
Prevalence: The number of events (e.g., instances of a given health effect or other condition) in
a given population at a designated time.
Public health surveillance: The ongoing, systematic collection, analysis, and interpretation of
outcome-specific data used to plan, implement, and evaluate public health practice.
Standard: Something that serves as a basis for comparison. A technical specification or written
report drawn up by experts based on the consolidated results of scientific study, technology, and
experience; aimed at optimum benefits; and approved by a recognized and representative body.
Revised October 10, 2007
Please submit additions and changes to [email protected]
102
Acronyms used in environmental health tracking and
biomonitoring
ACGIH
American Conference of Governmental Industrial Hygienists
ATSDR
Agency for Toxic Substances and Disease Registry, DHHS
CDC
Centers for Disease Control and Prevention, DHHS
CERCLA
Comprehensive Environmental Response; Compensation and Liability Act
(Superfund)
CSTE
Council of State and Territorial Epidemiologists
DHHS
US Department of Health and Human Services, including the US Public Health
Service, which includes the CDC, ATSDR, NIH and other agencies
EPA
US Environmental Protection Agency
EHTB
Environmental Health Tracking and Biomonitoring (the name of Minnesota
Statutes 144.995-144.998 and the program established therein)
EPHI
Environmental Public Health Indicators
ICD
International Classification of Diseases
IRB
Institutional Review Board
MARS
Minnesota Arsenic Study, conducted by MDH in 1998-1999
MDA
Minnesota Department of Agriculture
MDH
Minnesota Department of Health
MEHTS
Minnesota Environmental Health Tracking System
MNPHIN
Minnesota Public Health Information Network, MDH
MPCA
Minnesota Pollution Control Agency
NCEH
National Center for Environmental Health, CDC
NCHS
National Center for Health Statistics
103
NGO
Non-governmental organization
NHANES
National Health and Nutrition Examination Survey, National Center for Health
Statistics (NCHS) in the CDC
NHEXAS
National Human Exposure Assessment Survey, EPA
NIOSH
National Institute for Occupational Safety and Health, CDC
NIEHS
National Institute of Environmental Health Sciences, NIH
NIH
National Institutes of Health, DHHS
NLM
National Library of Medicine, NIH
NPL
National Priorities List (Superfund)
NTP
National Toxicology Program, NIEHS, NIH
PFBA
Perfluorobutanoic acid
PFC
Perfluorochemicals, including PFBA, PFOA and PFOS
PFOA
Perfluorooctanoic acid
PFOS
Perfluorooctane sulfonate
PHL
Public Health Laboratory, MDH
PHIN
Public Health Information Network, CDC
POP
Persistent organic pollutant
SEHIC
State Environmental Health Indicators Collaborative
Revised October 10, 2007
Please submit additions and changes to [email protected]
104
EHTB statute: Minn. Statutes 144.995-144.998
Minnesota: Environmental Health Tracking and Biomonitoring
$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.
(i) "Environmental hazard" means a chemical or
other substance for which scientific, peer-reviewed
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.
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, peer-reviewed 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 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).
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 state
agencies and organizations, and develop additional
procedures as needed to protect individual privacy;
105
(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;
(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.
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 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
106
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 communitybased 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 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.
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 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,
107
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
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 peerreviewed 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.
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
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=20
07&sn=0&num=57
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