Minnesota Department of Health
Environmental Health Tracking and Biomonitoring
Advisory Panel Meeting
December 9, 2008
1:00 p.m. – 4:00 p.m.
Snelling Office Park
Red River Room
1645 Energy Park Drive
St. Paul, Minnesota
Meeting agenda
Minnesota Department of Health
Environmental Health Tracking and Biomonitoring Advisory Panel Meeting
December 9, 2008
1:00 p.m. – 4:00 p.m.
Red River 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
Susan Palchick
1:05
Biomonitoring vision and Barb Deming
purpose
(facilitator)
Discussion item.
The advisory panel is asked to provide critical
input on the development of a final vision
statement for the biomonitoring program and
on the various purposes that a state
biomonitoring program could serve in the
future.
2:50
Break
3:05
Advisory panel roles
Mary Manning
Discussion item.
Panel members are invited to ask questions to
clarify their role and to provide suggestions to
MDH for improving the operation of the
panel in the future.
3:25
EHTB legislative report
Michonne
Bertrand
Discussion item.
Panel members are invited to ask questions
and to provide suggestions for strengthening
the legislative report.
i
Time
Agenda item
3:40
Project updates:
Various staff
• Environmental
health tracking data
portal
• Chemical selection
process
• Minneapolis
Children’s Arsenic
Study
• East Metro PFC
Biomonitoring Study
• Lake Superior
Mercury
Biomonitoring Study
• Riverside Prenatal
Biomonitoring Study
4:00
Presenter(s)
Item type/Anticipated outcome
Information sharing.
Panel members are invited to ask questions or
provide input on any of these items.
Adjourn
Next EHTB advisory panel meeting:
Tuesday, March 10, 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 December 9, 2008
Environmental Health Tracking & Biomonitoring Advisory Panel
Table of Contents
Agenda........................................................................................................................................... i
Table of contents ...................................................................................................................... iii
Materials related to specific agenda items
Biomonitoring vision and purpose
Section overview: Biomonitoring vision and purpose...............................................................1
Summary of biomonitoring interviews and focus groups..........................................................3
Biomonitoring vision and purpose retreat: Meeting summary ................................................41
Draft vision statement: Minnesota biomonitoring program.....................................................51
Advisory panel roles
Section overview: Advisory panel roles ..................................................................................53
Summary of advisory panel evaluation results ........................................................................55
Advisory panel roles and decision-making processes .............................................................57
EHTB legislative report
Section overview: EHTB legislative report .............................................................................61
Outline for 2009 EHTB legislative report ...............................................................................63
Project updates
Section overview: Project updates ...........................................................................................67
Status update on the environmental health tracking data portal ...............................................69
Status update on chemical selection process ...........................................................................71
Chemical nomination results..............................................................................................73
Appendix A: Letter from Minnesota Center for Environmental Advocacy ......................83
Appendix B: Letter and attachments from the Minnesota Department of Agriculture .....87
Appendix C: NHANES chemicals list.............................................................................109
Status update on the Minneapolis Children’s Arsenic Study.................................................111
Status update on the East Metro PFC Biomonitoring Study..................................................112
Status update on the Lake Superior Mercury Biomonitoring Study......................................113
Status update on the Riverside Prenatal Biomonitoring Study..............................................114
General reference materials
Section overview: General reference materials ...........................................................................117
NEW: New PFC citations (added since September 9, 2008) .......................................................119
NEW: Local, national and global tracking and biomonitoring news ...........................................123
NEW: EHTB advisory panel meeting summary (from September 9, 2008)................................125
REVISED: EHTB advisory panel roster ......................................................................................139
iii
REVISED: Biographical sketches of advisory panel members....................................................141
EHTB advisory panel operating procedures ................................................................................145
EHTB steering committee roster .................................................................................................151
REVISED: EHTB inter-agency workgroup roster..........................................................................153
Glossary of terms used in environmental health tracking and biomonitoring .............................155
Acronyms used in environmental health tracking and biomonitoring.........................................159
EHTB statute (Minn. Statutes 144.995-144.998)..................................................................................... 161
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Section overview: Biomonitoring vision and purpose
The EHTB statute requires the program to make recommendations to the legislature about the
development of an ongoing biomonitoring program in Minnesota. To guide a strategic planning
process for arriving at these recommendations, MDH has enlisted the assistance of a consultant
from Management, Analysis and Development at the State Department of Administration.
The planning process will involve the EHTB workgroup, steering committee and advisory panel.
The aims of the process are to articulate a vision and purpose of a state biomonitoring program.
The purpose statement is intended to describe why a state biomonitoring program exists, whereas
the vision will seek to describe more broadly what will be different in Minnesota as a result of
biomonitoring.
In addition, the planning process will lead to the development of recommendations for practical
strategies that would help the program reach its vision. This may include an exploration of
specific biomonitoring models that could be applied within a state program, such as a broadbased or targeted surveillance-type model to track trends in population exposure and a
community-based model operating in response to specific communities’ concerns.
The first step of the planning process was a series of interviews conducted with the staff of other
biomonitoring programs in the United States and with members of the EHTB workgroup,
steering committee, and advisory panel. A summary of biomonitoring interviews and focus
groups is included in this section. This document is provided so that advisory panel members
have an understanding of the many viewpoints about biomonitoring that are held by panel
members and state agency staff.
The next steps of the planning process was a full-day visioning retreat held on November 12,
2008. Members of the EHTB workgroup, steering committee and advisory panel were invited to
attend. A meeting summary of the discussion that occurred during the retreat is included here.
This document is provided so that advisory panel members who were unable to attend the retreat
can nevertheless benefit from the further insights gained and progress made during the retreat.
A draft vision statement for a biomonitoring program is also included in this section. The draft,
which was developed based on discussions at the November 12 retreat and a subsequent subgroup meeting, is provided as a starting point for discussion by the advisory panel of their vision
for a state biomonitoring program.
At the December 9 meeting, the advisory panel will also be asked to consider various purposes
that a state biomonitoring program could serve.
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ACTION NEEDED: Advisory panel members individually are key program stakeholders
and, as a group, the advisory panel is a vital source of guidance to both MDH and the
legislature. The advisory panel is asked to provide critical input on the development of a final
vision statement and on the various purposes that a state biomonitoring program could serve
in the future. Barb Deming from Management, Analysis and Development will lead a
discussion during the December panel meeting.
In preparation for this meeting, panel members are asked to carefully consider the following
questions:
o What is surprising or noteworthy to you about the interview summary and/or meeting
summary? What additional comments or insights do you have about a state
biomonitoring program after reading through the summaries?
o In your own desired vision for the future, what will be different in 5, 10, or 50 years as
a result of a state biomonitoring program in Minnesota? Is your vision reflected in the
draft vision statement?
No formal vote is anticipated for this agenda item.
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Minnesota Environmental Health
Tracking and
Biomonitoring Program
Summary of biomonitoring
interviews and focus groups
November 2008
Minnesota Management & Budget, 203 Administration Building, 50 Sherburne Avenue, St. Paul, MN 55155
Telephone: 651-201-2290 • Fax: 651-297-1117 • TTY: 800-627-3529 • www.admin.state.mn.us/mad
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Project team
Barb Deming
Renee Raduenz
Division director
Bill Clausen
Contact information
Voice: 651-201-2290
E-mail: [email protected]
Fax: 651-297-1117
Website: www.admin.state.mn.us/mad
Address:
203 Administration Building
50 Sherburne Avenue
St. Paul, Minnesota 55155
Other formats
To obtain these materials in an alternative format, — for example, large print or cassette tape —
call voice 651-201-2290 or Minnesota relay, 7-1-1 or 800-627-3529 (voice, TTY, ASCII).
Copies of this report
For more information or copies of this report, contact the Agency Name.
Management Analysis & Development
Management Analysis & Development is Minnesota government’s in-house fee-for-service
management consulting group. We are in our 24th year of helping public managers increase their
organization’s effectiveness and efficiency. We provide quality management consultation
services to local, regional, state, and federal government agencies, and public institutions.
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Contents
Introduction ................................................................................................ 1
Themes from Interviews and Focus Groups ........................................... 3
History of biomonitoring in Minnesota .................................................................. 3
Strengths of the pilot program ............................................................................... 3
Governance Structure: Environmental Health Tracking
and Biomonitoring Program ................................................................................... 5
Definition of biomonitoring ..................................................................................... 6
Purpose and vision.................................................................................................. 6
Purpose ............................................................................................................ 6
Vision ................................................................................................................ 7
Models .............................................................................................................. 8
Guidelines .............................................................................................................. 10
Concerns that the program be scientifically defensible..................................... 11
Known vs. emerging risks .................................................................................... 11
Funding concerns.................................................................................................. 12
Potential drawbacks .............................................................................................. 12
Whom to target....................................................................................................... 13
Partnership and involvement opportunities ........................................................ 13
Communication...................................................................................................... 15
Appendices
Appendix A: Descriptions of biomonitoring models .......................................... 17
Appendix B: Information on other biomonitoring programs ............................. 19
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Introduction
Background
The 2007 Minnesota Legislature created an environmental health tracking and biomonitoring
program, and charged the Minnesota departments of Health (MDH), Agriculture (MDA), and the
Pollution Control Agency (MPCA) with its implementation. Minnesota Statute 144.995 Subd. 2
directs the Minnesota Department of Health commissioner to:
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 (established under section 144.998) 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.
The statute also established a biomonitoring pilot program, which is in progress.
The legislation did not state a purpose for the biomonitoring program. The work group and
steering committee for this program, made up of representatives of the Minnesota Departments
of Health and Agriculture, and the Pollution Control Agency, would like to establish a statement
of purpose and vision for biomonitoring in Minnesota, to guide them in developing
recommendations for the program that will continue after completion of the pilot projects.
Purpose
The Minnesota Department of Health asked the division of Management Analysis &
Development (MAD) to assist the state staff and external stakeholders involved with the
biomonitoring program with a process to create a statement of purpose and vision. During
October and November 2008 MAD consultants contacted all state agency staff and Science
Advisory Panel members individually or in focus groups to discuss the future direction of a state
biomonitoring program.
The consultants also contacted representatives of eight biomonitoring programs at the national,
state and city level.
The results of those interviews and focus groups are summarized in this report, which will
provide the foundation for a purpose and vision retreat involving staff and science advisory panel
members on Nov. 12, 2008.
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Methodology
To gather information about the Minnesota biomonitoring pilot program, MAD interviewed 12
members of the Science Advisory Panel (one member declined), and 20 staff of MDH, MDA and
MPCA in four focus groups. Three of the focus groups were were organized into MDH division
groups, including the Public Health Laboratory, Health Promotion and Chronic Disease, and
Environmental Health. A fourth group comprised staff from the MDA and MPCA.
Interviews with representatives of other biomonitoring programs included:
CDC NHANES
California Department of Public Health
New York City Department of Health and Mental Hygiene
New Mexico Department of Health
Washington State Department of Health
University of Illinois (conducting feasibility study for state biomonitoring program)
Massachuetts Department of Public Health
Rhode Island Department of Health
One representative of each program was contacted, except in the case of CDC NHANES, for
which three representatives were contacted.
Consultants also reviewed background documents, including articles about biomonitoring, work
group and Science Advisory Panel meeting notes, and numerous biomonitoring Web sites.
Acknowledgment
Participants in interviews and focus groups contributed generously of their time and insights
about the need and possibilities for an ongoing state biomonitoring program. Their commitment
to excellence in their work was evident as they engaged in in-depth discussions that were
practical as well as visionary. The consultants benefitted by their patience in explaining technical
aspects of biomonitoring and the broader context in which biomonitoring takes place.
Any errors in the report are the responsibility of the consultants.
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Themes from Interviews and Focus Groups
History of biomonitoring in Minnesota
Biomonitoring is not new in Minnesota. Testing lead levels in blood dates back to the 1970s.
More recently the Minnesota Department of Health (MDH) has pursued development of a state
biomonitoring program to address other chemicals that may pose a hazard to public health. MDH
received a $500,000 biomonitoring planning grant from the Centers for Disease Control and
Prevention (CDC) from 2001 through 2003. From 2003 to the present, MDH has received
>$500,000 annually to build laboratory capacity to measure chemical threats in human
specimens. Since 2006, the MDH Public Health Laboratory is one of ten state labs selected by
CDC in its network of ‘Level-1 Labs’ that have special involvement in developing methods and
transferring technology for analyzing toxic chemicals or their metabolites in blood and urine. In
2006, discovery of perflourocarbons (PFCs) in drinking water in the east Metro area heightened
interest in enhancing Minnesota’s capacity to use biomonitoring in assessing the impact of
environmental contaminants on the public’s health.
In 2007, the third year in which legislation was introduced, the Minnesota Legislature created a
state Environmental Health Tracking and Biomonitoring (EHTB) pilot program. The legislation
required MDH to conduct four biomonitoring pilot projects, three directed by the Legislature,
and one to be determined by the involved state agencies and a representative science advisory
panel. The chosen projects focused on PFCs, arsenic, mercury, and environmental phenols.
MDH established an interagency agreement with the Minnesota Pollution Control Agency, the
Department of Agriculture and the University of Minnesota to implement the tracking and
biomonitoring programs.
The legislature did not appropriate the full amount requested by MDH for the pilot program
mandated in its enabling legislation, and the program’s implementers have worked hard to carry
out the pilot projects within the available budget and under tight deadlines for completion.
The legislation requires MDH to report to the Legislature about the results of the four pilot
projects and to provide recommendations for an ongoing biomonitoring program in Minnesota.
Strengths of the pilot program
Despite the tight budget and timelines, interviewees for this report had many positive
observations about the program to date:
The people involved in implementing the projects, and the Science Advisory Panel involved with
planning and consulting on the project designs, were considered to be the right ones. They
represent a wide range of scientific and public health expertise, as well as the interests of
environmental advocacy groups, industry, and other stakeholders. The participants themselves
spoke with high regard for each other’s expertise, especially as they acknowledged the difficulty
of managing the complex scientific, ethical, and political issues inherent in planning and
executing the pilot projects.
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Interviewees said that the structure (Fig. 1), as a system for organizing the various state agency
players and representatives on the science advisory panel, comprised the right people and had the
potential to function as an effective system. At the same time, the participants acknowledged that
more attention is needed to issues of governance, communication, roles and responsibilities, and
relationships in order for the structure to operate as effectively as it could.
The science advisory panel was particularly noted as a strength, in the way it had helped MDH
and its partners to refine the design for the pilot projects, and had looked for ways to ensure the
program’s scientific value. This was particularly important to most interviewees, who expressed
over and over the importance of providing biomonitoring data that was scientifically valid and
useful in advancing the state’s understanding of environmental toxins and their health effects.
Participants also expressed appreciation for the program’s efforts to manage risks inherent in
biomonitoring, such as raising alarm in communities being studied, and breaching data privacy.
The current program was described as well designed to prevent “doing harm” by including three
levels of protection:
ƒ
ƒ
ƒ
Science Advisory Panel: A 13-member Science Advisory Panel consults with MDH on
the development and implementation of biomonitoring projects; this helps to ensure that
biomonitoring projects are based on sound science and practice.
Community outreach: The biomonitoring legislation requires MDH to inform and take
comments from project communities and local governments about biomonitoring
activities; this helps to ensure that biomonitoring projects are conducted in a way that is
acceptable to the communities involved.
MDH Internal Review Board: The protocols and materials for pilot biomonitoring
projects are reviewed by the MDH IRB; this helps to ensure that participants’ rights are
protected and that they are treated in an ethical manner.
Many people also noted the success of the program in finding ways to make efficient use of
limited funds by collaborating with planned or existing studies to execute the third and fourth
projects. And although the pilot projects are not complete, interviewees said they expect the
projects will provide useful insights into the feasibility and design of future biomonitoring
efforts. They also expect that the projects will demonstrate the state's abilities in the field of
biomonitoring.
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Fig. 1: Governance Structure
Environmental Health Tracking and Biomonitoring Program
Commissioner of Health
Sanne Magnan
MPCA Management
Michael Sandusky
MDA Management
Greg Buzicky
Steering Committee
MDH/EO – Norm Crouch
(chair)
MDH/PHL – Joanne Bartkus
MDH/EH – John Stine
MDH/HPCD – Mary
Manning
Work Group
MDH/HPCD – Jean Johnson (chair),
John Soler, Al Williams
MDH/PHL – Louise Liao, Carin Huset
MDH/EH – Pam Shubat, Rita
Messing, Erik Zabel
MDH/IS&TM – Jerry Alholm
MPCA – Frank Kohlasch
MDA – Joe Zachmann
Key to Acronyms
EH: Environmental Health
Division
EO: Executive Office
HPCD: Health Promotion
and Chronic Disease
Division
IS&TM: Information
Systems & Technology
Management
MDA: Minnesota
Department of Agriculture
MDH: Minnesota
Department of Health
MPCA: Minnesota Pollution
Control Agency
PHL: Public Health
Laboratory Division
Advisory Panel
Beth Baker (chair) John Adgate,
Bruce Alexander, Alan Bender,
Cecilia Martinez, Debra
McGovern, Geary Olsen, Susan
Palchick, Gregory Pratt, Daniel
Stoddard, David Wallinga,
Samuel Yamin, Lisa Yost
Program Management
MDH/HPCD
Environmental Public Health
Tracking
Biomonitoring
Biomonitoring – Lab (PHL)
EPHT – Environmental Hazards
and Exposures (EH)
EPHT – Chronic Disease
(HPCD)
Biomonitoring – Support
(HPCD)
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Definition of biomonitoring
The CDC defines biomonitoring as the direct measurement of people’s exposure to toxic
substances in the environment by measuring the substances or their metabolites in human
specimens, such as blood or urine.
Interviewees agreed with this generic definition, but some added to it in order to distinguish
biomonitoring from other methods of assessing exposure, or to describe the role biomonitoring
can play:
ƒ Biomonitoring offers the ability to look at exposure to chemicals in a person,
providing information that can be used in epidemiological environmental investigations.
ƒ Biomonitoring is a tool for figuring out whether a person is exposed to a certain
chemical.
ƒ Biomonitoring could be a measure of exposure. Or biomonitoring for certain substances
could be defined more narrowly as exposure with a health effect.
ƒ A biomonitoring program fills in gaps in current knowledge about Minnesota’s
environment and health: What chemicals exist in the environment, and what is in
people’s bodies?
These expanded definitions led into a discussion of purpose and vision for biomonitoring, in
which participants sought to put biomonitoring into a broader context.
Purpose and vision
If the definition of biomonitoring describes “what it is,” then purpose describes “why it exists.”
Beyond purpose, the vision seeks to describe “what will be different because it exists.”
Purpose
Interviewees agreed that the purpose of biomonitoring should be to protect public health through
establishing a link between toxic substances in the environment and their health effects. As one
interviewee said, biomonitoring is a tool to “pull those end points closer together.”
The CDC’s description of the purpose of biomonitoring puts it inside the context of an
environmental public health tracking system (Fig. 2), alongside other methods of tracking
exposures, however, biomonitoring is the only exposure tracking method that actually measures
the presence of hazardous agents in the human body.
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Figure 2. CDC model of Environmental Public Health Tracking 1
Hazards
→
Exposures
ƒ
ƒ
→
Health effects
Biomonitoring
Other exposure
measures
This context was in the background, but not always evident, in people’s discussion of the
purpose of a state biomonitoring program. For example, some people cautioned that
biomonitoring not be done “for biomonitoring’s sake,” or that it only be used when it is
necessary to determine a public health response. One example given was that when arsenic is
found at harmful levels in drinking water, the common sense and cost-effective public health
response would be to simply stop people from drinking the contaminated water. Biomonitoring
could be superfluous. Or if a compound is quickly degraded atmospherically, biomonitoring may
not have value.
Many interviewees stressed that biomonitoring is one tool in the toolbox. “All biomonitoring
does is measure the levels of chemicals in people.”
Some people called for a greater connection between the Environmental Health Tracking and the
biomonitoring tracks of the work resulting from the EHTB legislation. They said that it is
important to frame the purpose of a state biomonitoring program in this context. “The purpose is
most useful when it’s integrated with environmental health tracking, looking at health outcomes
and what’s correlated with them.”
It was noted that developing an integrated approach and demonstrating that the program is
informing other scientific and regulatory efforts conducted by state agencies would help to sell
the program’s value to key stakeholders. Biomonitoring can be useful to show that actions taken
to decrease exposure are actually decreasing people’s risks. Biomonitoring can prove that
regulation is working, so it is an important tool for evaluating regulation and clean-up efforts.
Vision
Participants in interviews and focus groups did not generally discuss vision in the sense of “What
would be different as a result of a state biomonitoring program?” Such a description of a desired
future state, as influenced by an effective biomonitoring effort, would help to guide decisions
1
CDC definitions:
Hazard: An environmental hazard is an agent or factor in the environment that may adversely affect human health.
People can be exposed to physical, chemical, or biologic agents from various environmental sources through air,
water, soil, and food.
Health Effects: Health effects are chronic or acute health conditions that affect the wellbeing of an individual or
community. Effects are measured in terms of illness and death and understood in terms of environmental,
psychological, physiological, or genetic factors and conditions that predispose an individual to the development of a
disease or health condition.
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about the scope and structure of a future program.
Models
Discussion tended to center around four models, which were provided to interviewees:
ƒ Population-based surveillance, or a state-level Health and Nutrition Examination Survey
(HANES)
ƒ Community-based response investigation
ƒ Investigator-initiated research
ƒ Laboratory-based research
Descriptions of these models are found in Appendix A.
Often the discussion focused on the merits of a state-level HANES approach vs. more targeted
approaches, such as community-based response and investigator- and laboratory-initiated
research. Generally the HANES approach was considered more expensive than the other
approaches, although specific cost estimates were not examined.
Discussion of the models included these main themes:
Statewide HANES study: Some people called this model “the gold standard,” which would
(from a list provided by MDH program staff):
ƒ Identify chemicals found in human tissues
ƒ Investigate the distribution of exposure among the general population and sub-groups of
the population (racial/ethnic, age, gender, and geographic distributions)
ƒ Monitor changes in human population exposure to chemicals over time
ƒ Identify highly exposed communities for targeting public health interventions.
ƒ Evaluate the effectiveness of interventions and policies designed to reduce exposure
(such as product bans/replacements, drinking water treatment, behavioral education,
contaminant abatement)
ƒ Establish priorities for future research and community investigations
ƒ Support research by establishing a repository of biospecimens for ancillary research
projects and laboratory methods development research (capacity building) for emerging
contaminants.
ƒ Support research by establishing a cohort(s) of individuals who consent to be contacted
for ancillary, follow-up studies to explore potential linkages to health outcomes and
sources of exposure.
ƒ Build and sustain laboratory and environmental epidemiology capacity at the state level
to enhance response capacity to environmental incidents.
Most people discussed this option as a general concept without defining the frequency or scope
of the surveillance. However, one participant suggested doing a baseline study at the outset of
the biomonitoring program, and following that every five years to compare to the baseline and to
national HANES (NHANES) data.
Several interviewees did not support the statewide surveillance approach, and raised the
following objections:
ƒ The value provided may not justify the increased cost.
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ƒ
ƒ
ƒ
Why not just rely on CDC NHANES data for baseline research? The CDC has a large,
statistically representative sample size.
Minnesota should focus more on responding to known risks, and not be “researchdriven.”
Sustainability: “If we collect a whole bunch of data, hoping something comes out, will
we have the resources or the patience for that?”
Targeted population-based surveillance: Several interviewees suggested that Minnesota
develop a population-based surveillance system focused on certain at-risk groups, such as
children or workers in certain occupations. For example, a Minnesota Children’s HANES could
look at lead, mercury, obesity measures, and nutrition.
This approach was thought to offer many of the benefits of a statewide surveillance program, but
in a more cost-effective way. One observer suggested that focusing on underserved populations
might increase the cost-benefit ratio, for example, by offsetting future health care costs.
With both statewide and targeted surveillance, it was expected that the surveillance data could
lead to community-response and investigator-initiated research.
Community-based response: Many interviewees considered this approach more practical and
less expensive. Some described it as consistent with the traditional public health focus on
communities. This approach would:
ƒ Identify chemicals found in human tissues
ƒ Identify the distribution of exposure in the community and subgroups
ƒ Identify highly exposed individuals or groups within the community for further
intervention
ƒ Respond to community concerns about chemicals in the environment
ƒ Provide data to support risk assessment and/or regulatory decision making
ƒ Provide data to help prioritize future research
ƒ Build laboratory and environmental epidemiology capacity at the state level to enhance
response capacity to environmental incidents.
Community-based projects would reference NHANES data, and if Minnesota wanted to test for a
new chemical based on a MN-specific concern, the state could request the CDC to add this to its
NHANES research. Investigator-initiated research could be handed off to the university, such as
for research on health outcomes.
It was noted that legislators are concerned about cost and constituents, which tends to draw them
toward community-based response investigations vs. population-based surveillance.
Investigator-initiated research: Some interviewees thought the state would have a role in this
type of research. Others saw the state’s role as identifying questions in need of follow-up and
handing off to the university to conduct the research. This approach would:
ƒ Increase or advance generalizable knowledge about chemical exposure and/or laboratory
methods.
ƒ Build state laboratory capacity to analyze human specimens.
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One suggested approach to investigator-initiated research was to annually identify chemicals of
concern, and to divide them into two groups: known and emerging health concerns. The process
for prioritizing and seeking funding for each group would be separate, as the goals for each type
of research would be different.
One interviewee attempted to quantify the balance needed between approaches, suggesting 75
percent community-based and 25 percent investigator-initiated research.
Laboratory-based research: This approach was probably the least well understood and the least
discussed of the four models. When it was discussed, participants sometimes didn’t know what
lab-based research would be. The approach would:
ƒ Build state laboratory capacity to analyze human specimens.
ƒ Advance generalizable knowledge about laboratory methods…
ƒ Conduct internal and external validation studies
Laboratory capacity was not considered a limiting factor for a state biomonitoring program, but
some interviewees said it could be, depending on the scope of the program. A few people asked
how the state would sustain the laboratory capacity needed for biomonitoring if each study
required different capabilities, and if demand fluctuated over time.
A couple of interviewees cautioned against having a laboratory-driven program. One suggested
using cost-benefit analysis to determine whether to develop lab capacity at state labs or to
contract out to other labs. Some people recommended networking with other laboratories, such
as to share methods developed here and in other labs.
Guidelines
Beyond the discussion of models, interviewees offered a number of possible guidelines for
establishing a successful state biomonitoring program:
ƒ A Minnesota state biomonitoring program should focus on exposures likely to be
prevalent in Minnesota.
ƒ Let good science guide the choices, so that choices are not solely determined by
advocacy groups’ agendas, legislators’ local projects, or community perceptions of risk.
Interviewees also noted that there is tension between the community response model,
which is susceptible to external influence, and this guideline
ƒ Design studies that can get maximum value for the cost involved.
ƒ Factor in feasibility. For example: Is the target population transient? Can the chemical of
interest be measured effectively?
ƒ Focus on investigations where we are able to interpret the meaning of the results.
ƒ Focus on things to which we know people have been exposed and which are known to
have a health impact, but where more knowledge may be gained by further study.
ƒ Make sure that chemicals are chosen based on some health outcome associated with
them, those known to be the really bad guys. It’s got to be really clear to the public why
we’re doing this.
ƒ Use biomonitoring like a surgical tool where it is known that a chemical can be linked to
health effects; and a community is exposed.
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Link biomonitoring to environmental health tracking, pollutant regulation, and other
related efforts.
Study subjects must be given information about the study results. An example was given
of a group of frequently studied people in Baltimore who organized so that all
biomonitoring studies had to go through them, because they felt that previous studies had
not sufficiently focused on their health.
Apply “Scoring Criteria for Nominated Chemicals,” used in selecting a chemical for the
fourth pilot project.
Because individual guidelines were suggested by different people, some of them are
contradictory. In addition, some of the guidelines are more relevant to certain biomonitoring
models than to others.
Concerns that the program be scientifically defensible
The choice of the two community-based pilot projects drew many comments in interviews. Some
said that the communities selected made sense as pilot studies, but said the Legislature should
have left the study design up to the pilot program staff and science advisory panel. Others
questioned the selection of the two communities whose legislators had developed the
biomonitoring legislation.
No matter what their opinion was about the pilot projects, interviewees agreed that a future
biomonitoring program should be independent of undue political influence and should establish
procedures to ensure that biomonitoring projects are “science based.” Not only would this
approach provide the most useful results, but it would be essential to developing a reputation as a
reliable source of health exposure data, they said. One poorly designed project could raise
questions about the scientific integrity of the program and jeopardize support for a long time to
come.
One way to manage the balance between scientific and political considerations would be for the
biomonitoring program to prioritize projects, and then ask elected representatives along with
other stakeholders, “Do you agree with this?” Interviewees noted that the need to balance
scientific and political considerations reinforces the importance of adequately engaging and
managing stakeholders.
Known vs. emerging risks
Several interviewees advocated for limiting the scope of the program to known contaminants, in
order to avoid the risk of not being able to answer the question, “So what?” if levels of a
chemical with unknown health effects are found in people.
This dilemma seemed ripe for further discussion, as it wasn't always clear what people meant
when they mentioned “unknown” or “emerging” concerns. Sometimes it seemed people were
referring to population-based surveillance as they cautioned against “research-driven”
biomonitoring and instead argued for community-based or investigator-initiated research into
known concerns. In most cases the caution was not associated with discussion of a particular
model. Some people argued for focusing on “known” contaminants because they saw it as
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having greater potential benefit for the cost.
Funding concerns
The biomonitoring pilot program was funded at a lower level than was initially proposed, and
concerns linger that funds for an ongoing program would be limited or unstable. For some
people, this made it difficult to envision a program that would go beyond the kind of communityresponse and investigator-initiated projects that were done in the pilot phase. One
recommendation was to approach developing the program incrementally – continuing to build
support by showing success in limited-scope projects. Over time, the program’s leadership could
design a program with greater scope, such as the population-based surveillance approach, which
may have gained broader support as legislators and other stakeholders became convinced of its
necessity.
Another consideration raised was how cost would be affected by the length of the study. One
interviewee put it, “How much is collecting the data going to cost us for five years? Will we still
have the will to keep doing it for 5, 15, 20 years? A lot of the things we’re looking at are chronic,
not acute.” Plans need to be made to sustain the program; the program will not be successful if it
is funded inadequately or funding is uncertain from year to year.
Several people discussed opportunities to better leverage the resources already available for
biomonitoring research, including:
ƒ Samples already collected for another purpose;
ƒ Data in state agencies on populations at risk for exposure. Information is organized by zip
code and county, and includes particular spills, such as mercury and arsenic, and
distributions of chemicals around the state; and
Other state laboratories, which can provide testing of some chemicals, and can develop new
tests.
Potential Drawbacks
The benefits of biomonitoring are discussed under “Purpose” and “Vision” above, and potential
drawbacks are mentioned in association with many of the topics above. However, the topic of
drawbacks associated with biomonitoring was raised often enough to warrant summarizing the
themes in one section.
Some interviewees described potential unintended consequences of a biomonitoring program:
ƒ Raising public alarm about exposures before health impact is understood;
ƒ Negative impact on industry without establishing a cause and effect relationship;
ƒ Prompting changes that are riskier than the status quo, such as unproven replacement
chemicals;
ƒ Negative impact on property values; and
ƒ Interfering with responsible party negotiations.
Others described possible threats to the long-term viability of a biomonitoring program:
ƒ Insufficient scientific rigor, such as too-small sampling size;
ƒ Under-communicating or ignoring impact on participants;
ƒ Greater interest in scientific or laboratory advancement than in public health outcomes.
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Many interviewees also pointed out that biomonitoring studies can also ease fears by showing no
risk to the exposed population.
Whom to target
Many interviewees listed groups that they would like to see benefit from biomonitoring. They
also pointed out the need for a transparent decision-making framework related to health benefits
and sampling protocols, so that the state is able to explain why it is looking at some communities
and not others.
Those who listed groups that should be targeted mentioned:
ƒ Children – because they take in more air and water for body weight, and because of the
ability to prevent exposures (whereas adults have already had more exposures). It was
noted that children and health disparities are priorities of MDH. However, participants
said that tying the program too closely to disparities could unintentionally direct the
program to follow only one model for biomonitoring. Perhaps different models could be
used to address disparities. Consideration would need to be given to how resources for
biomonitoring should be allocated across. No single model was seen as unable to address
disparities if proper attention were paid to design (e.g., oversampling could be done
within a surveillance model or surveillance could be supplemented with communityspecific projects).
ƒ Newborns/pregnant women;
ƒ Unique groups at higher risk to be affected by exposure, such as immigrants, Indians,
low-income;
ƒ Disadvantaged people – because they tend to be more at risk because of the general
stresses they’re under;
ƒ People with special needs, such as serious medical conditions;
ƒ People exposed to contaminants in their occupations – because most people’s exposure
comes from the workplace, and often an opportunity exists to do something about it.
Some people suggested that no group be treated as primary or secondary. “We need to look at
where exposures happen.”
One overall suggestion was to focus on projects that would benefit the greatest number of people
and would allow for extrapolation to the larger population.
Partnership and involvement opportunities
Interviewees saw many opportunities to build on the partnerships mandated in the legislation:
State agencies involved with environmental health: The perspectives of the three units in
MDH, the Department of Agriculture and the Pollution Control Agency are essential to the
success of the current program. However, this approach also creates a challenge to create a team
approach in which the different perspectives are understood and reconciled. For example, the
mix of epidemiologists, toxicologists, risk assessors, and chemists brings a wide range of
expertise, but also means that people don’t always understand each other’s language and
approaches.
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Interviewees also noted that the current program timeline did not allow enough time for up-front
planning and development of a team approach, and called for making planning and teamwork a
priority for an ongoing program.
Some interviewees called for greater coordination within MDH, beyond the three sections
already involved, such as the Office of Minority and Multicultural Health, Refugee Health, and
other MDH programs that might be interested in biomonitoring data for other reasons, such as
the diabetes and heart disease programs.
Some pointed out opportunities to broaden connections among MDH, MDA and MPCA, as well.
It was noted that if the decision is made to focus on a particular pollutant or class of pollutants, it
is useful to see who has been working on those pollutants to date. “Who are they, what are they
doing, and are there opportunities to work with them?”
Science advisory panel: As noted above, interviewees endorsed the composition and quality of
the science advisory panel. Some interviewees suggested elevating the profile of the SAP, so that
it is regarded as a weighty and reliable voice for scientific integrity of biomonitoring studies.
Some also noted that the role of the SAP may be too administrative, and that their scope is too
broad to be manageable. Further work to clarify the role of this group was recommended.
Academic and other research institutions: Most interviewees considered the University of
Minnesota a key research partner. If the state is conducting population-based surveillance, or
community-response investigations within its public health mission, academic and other research
institutions were seen as the research arm to conduct follow-up investigations based on the state
program’s findings.
CDC: The CDC was typically mentioned as the source of reference biomonitoring data, to which
Minnesota data may be compared. For some interviewees, the partnership with the CDC meant
that it was not necessary for Minnesota to conduct population-based surveillance. Others pointed
to a need for Minnesota surveillance, referenced to CDC data, to identify highly exposed
communities in the state in order to know where to target further biomonitoring research, and to
design and then evaluate public health interventions.
The public: Many people called for allowing a greater voice for the public, both as participants,
and to provide input on community concerns. The mechanism for involvement wasn’t clear, but
possibilities included creating community advisory panels, publishing documents for feedback,
and more actively going out to provide education and seek input. One person suggested creating
additional advisory panels that would represent community health clinics and other community
health organizations, representatives of potentially at-risk communities, and physicians and
practitioners who serve those communities. The interviewee said that these perspectives were not
represented strongly enough in the pilot program.
Some interviewees noted the challenges of working with the public, including lack of interest on
the one hand and fear, anger, and disappointment with the state’s approach on the other.
Nevertheless, they said it is worth the effort to find meaningful ways to involve the public, and
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the state should make the most of its communications specialists for help.
Advocacy groups: The role of advocacy groups was discussed as providing the perspective of
their respective interests, and assisting with public communication and education.
Manufacturers: As potentially responsible parties, they were seen as having strong feelings
about ensuring that the biomonitoring information is accurate and useful.
Health care providers: Interviewees raised the need to work with health care providers to make
sure they understand and can help interpret results for biomonitoring participants.
Communication
Discussion of partnerships often led into the need for plenty of education to explain and build
support for biomonitoring efforts. Suggestions included:
ƒ Provide lots of education for legislators so that they understand the capabilities and
limitations of biomonitoring.
ƒ When communicating biomonitoring results to participants and the general public, make
sure to include adequate interpretation of data.
ƒ Take advantage of the skilled health educators and risk communicators among state
agency staff.
Several people raised an internal communication challenge: With the different scientific
disciplines drawn together in this program, sometimes language means different things to
different groups. They noted that it would be helpful to clarify their understanding of one
another’s terminology as part of establishing a common understanding of the purpose and vision
for biomonitoring.
An initial list of terms that may mean different things to different people would include:
ƒ Community-based
ƒ Exposure
ƒ Known health impacts
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Appendix A: Descriptions of
biomonitoring models
These descriptions were developed for discussion purposes with the Minnesota Biomonitoring
work group, steering committee and Science Advisory Panel:
Population-based surveillance: Ongoing, systematic collection and analysis of human
biological specimens in a representative sample of the population for chemicals of interest to
public health (or to support public health action and programs).
Community-based response investigation: Collection of human biological specimens in a
sample of an exposed community for the purpose of responding to a chemical exposure incident,
site or discovery.
Investigator-initiated research: Investigator-initiated study designed to answer a specific
research question and/or test a hypothesis that includes the collection of human specimens and
analysis for a given chemical for the purpose of advancing generalizable knowledge.
Lab-based research: Studies that collect human biospecimens and are designed to develop or
test laboratory analytical methods for purposes of advancing generalizable knowledge about
analytical methods.
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Appendix B: Information on other
biomonitoring programs
Representatives of eight biomonitoring programs, which are either under way or in the planning
stages, were interviewed for this report. The programs included:
ƒ CDC NHANES
ƒ New York City
ƒ California
ƒ Washington State
ƒ Massachusetts
ƒ New Mexico
ƒ Rhode Island
ƒ Illinois
Three representatives of the CDC program were interviewed; One representative of each other
program was contacted. The interviews varied widely based on the nature and stage of
development of the program. Therefore, the summary below includes highlights from each
interview that may not be comparable across all of the programs. The interviewees did express
willingness to provide follow-up information, if needed.
Purpose and vision
Summary
Of the six states included in this survey, most of their programs 1) did not create a vision, 2)
considered their biomonitoring activities as “projects” vs. “programs,” and, 3) developed a
vision for a wider-surveillance program, but have had to scale back (to communityresponse projects) due to lack of funding/resources. In the U.S., the only states with
legislation that guides biomonitoring are California, Illinois and Minnesota.
A brief summary of statements about purpose includes:
ƒ Identify populations that are more exposed to a given problem/chemical/toxin for
intervention purposes.
ƒ Look at exposures (biomonitoring) and adverse health outcomes (environmental
public health tracking).
ƒ Find out if exposure to environmental chemicals in a particular city (NYC) or
geographic area is different than the national findings.
ƒ Assess exposure, follow trends, and see if legislative acts or industrial bans are
actually affecting human levels of these chemicals.
ƒ Provide reference-based data for the US population to determine if people are more at
risk if they live in specific geographic areas. Create comparison data to evaluate
trends and exposures. (CDC-NHANES)
California:
ƒ The statutory directive was to develop an ongoing survey of a representative sample
of individuals in California to 1) establish baseline levels; 2) track them over time; 3)
assess the efficacy of regulatory programs that were intended to address chemicals of
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interest; 4) use as an early warning system to potential new or emerging chemicals.
They had planned to address several dozen chemicals; however, that approach was
not funded adequately. Their management has told them, “Keep planning for a
statewide survey.”
California’s base project was given $1.6 million, which has caused the planners to
focus on more community-based projects (communities or populations that share a
common exposure, such as pregnant women, workplace exposures, etc., not
necessarily geographic communities).
Massachusetts
On paper, Massachusetts envisioned a surveillance program, which is broader than the
program has turned out to be. The program would have involved taking specimens
gathered for other purposes and looking at environmental chemicals. They have
equipment, but lack staff to coordinate the studies, and analyze the data.
Rhode Island
No vision was articulated. There is no dedicated funding or personnel. There is interest.
Rhode Island would like to conduct HANES-like studies, but funding is not available.
The goal (in absence of HANES studies) is to identify populations that are more exposed
to a given problem and study those.
Illinois
State legislation directed the University of Illinois School of Public Health to conduct a
biomonitoring feasibility study. They are in the early stages of their study, and have met
with other cities and states to identify what others are doing in the field of biomonitoring.
Advice:
ƒ The overall purpose of a surveillance biomonitoring program is to identify exposures
for intervention. “If you’re doing it just for the sake of doing it, that’s not helpful.”
Examples include measuring mercury in women of childbearing age, then launching a
public health campaign to educate about those hazards, or measuring lead for purpose
of intervention.
ƒ Weigh the value the different approaches based on how they would be linked to
public health action. The most useful is when you suspect you have a problem and
you focus in on that.
ƒ If a state had unlimited funding, a combination of NHANES-approach with a targeted
approach would be good.
ƒ The goal would eventually be to link the two kinds of environmental surveillance:
exposure-based and health-based.
New Mexico
ƒ As the administrative lead for the Rocky Mountain Consortium, the New Mexico
Department of Health received a CDC biomonitoring implementation grant five years
ago. The award followed a CDC planning grant, in which New Mexico worked with
five other states (Arizona, Colorado, Utah, Montana, and Wyoming) with similar
interests (mining, arsenic, etc.). The states identified biomonitoring studies that were
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of common interest to the Rocky Mountain states and also surveyed interested
stakeholders (NGOs, interested groups, public agencies, etc.) about their interests in
environmental issues that might be amenable to biomonitoring studies.
Environmental epidemiologists and toxicologists were also included in the planning
group.
The purpose was to biomonitoring that would give them information for
environmental health tracking, which would dovetail with the public health tracking
studies. The intent was not to look only at human exposure, but to also look at
adverse health outcomes. The two should be linked: If you want to look at exposure
(biomonitoring) it’s because you want to look at adverse outcomes (environmental
public health tracking).
Even though the money came to the labs, they didn’t want that to drive the study.
They advised against allowing the technology you have overshadow the health
concerns you should be looking at.
During the 2001-2003 planning grant period, New Mexico and other states in the
Rocky Mountain Consortium pursued a project selection process that included:
1. Contact external parties and ask, “What is the community concerned with?”
2. Look at priority issues of the community as well as epidemiologists
3. Ask the labs, “Analytically, what makes sense? If these are our concerns and our
priorities, what do you have the technology to do? For which of these issues do
you have tools that can give us info that will be meaningful?”
This approach worked out well. They came up with issues common to all six states that
allowed them to compete successfully for a CDC biomonitoring implementation grant.
New York City
NYC HANES was set up to better understand risk factors and antecedents for chronic
disease. Biomonitoring is a small part within the larger NYC HANES program, which
looks at smoking, depression, and other health related outcomes. The vision was to find
out if exposure to environmental chemicals in New York City was different than the
national findings, and if so to implement polices to respond appropriately. They narrowed
their interest to the chemicals they knew more about, and where they knew how to
interpret the findings. These ended up being chemicals with more literature about
relationships between exposure and health outcomes.
Washington
Washington has some biomonitoring projects underway, but no ongoing program. They
received grant funding for a health exam but did not have funds for a complementary
biomonitoring program.
The state convened an advisory committee and conducted key informant interviews to
develop a biomonitoring plan in 2002. They also joined a consortium of western states to
develop a proposal to send to the National Center for Environmental Health, which was
not funded.
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CDC NHANES
ƒ NHANES is administered by the National Center for Health Statistics (Washington
D.C). It has been around for 50 years, so part of their vision is articulated in history.
Their charter is to get national medical prevalence statistics/measurements for
analysis and public policy purposes.
ƒ While it varies from year to year, NHANES monitors up to around 260 environmental
chemicals in any given year. They report in two-year increments. They have a
nationally representative sample. NHANES randomly selects 15 counties a year and
takes actual medical measures (blood, weight, height, etc.) versus self-reported
measures. They focus more on individuals than environments; however they do track
some environmental exposure because they are a national sample versus a local
sample. They are looking at persistent and non-persistent chemicals trying to assess
exposures like pesticides, personal care products, metals, and VOCs.
ƒ The primary goal is to provide reference data for the US population to determine if
people are more at risk if they live in specific geographic areas. They create
comparison data to evaluate trends and exposures. Currently, they are using data to
monitor regulations. The question they are seeking to answer is, “Did regulatory
effects really reduce exposures?”
Advice for other states:
ƒ States should pick and choose chemicals based on their capacity, so Minnesota would
probably want to look at chemicals being used in the state (for example, pesticides).
ƒ Make sure to have a good way to estimate sample size.
ƒ Be “actionable and measurably so.” NHANES accountability is diffuse. “In
Minnesota you’ll be using state taxes; you’ll need to see some state benefits. At the
very least, an output that describes the health issues the state faces.” For example,
Canada’s biomonitoring program is doing a survey using the research question, “How
healthy is the Canadian workforce?” Make sure to have a tight question that lends
itself to a politically actionable answer. Furthermore, make clear how the study is
connected to the state’s budget.
Process used to determine the vision, purpose, priorities
Summary
The other programs contacted reported the following methods to determine the focus of
their biomonitoring programs and/or projects:
ƒ Formal/mandated approach: scientific advisory panel
ƒ Internal process (health department/EH division, schools of public health
ƒ Feasibility analysis
ƒ Community input /filter process (list all concerns, filter through epis, then lab)
All of the programs used some form of criteria/guidelines to determine chemicals to be
studied. They differed in the extent to which they sought out input from the larger
stakeholder community, including the public.
California
The departments of Health, Toxic Substances Control, and Environmental Health Office
of Hazard Assessment) work very closely with a nine-member scientific advisory panel.
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Panel members are very supportive of the process and realize the budgetary and
bureaucratic constraints they have to deal with.
Legislation mandated that they select chemicals from the CDC list (although panel
members could recommend chemicals not on the list for consideration). The departments
have had to work iteratively and in public (on record with court reporters and transcripts)
with the panel to select chemicals. The process is quite formal. They have a set of clear
guidelines and principles in place for making decisions.
Massachusetts
Massachusetts worked closely with the state health department lab and Environmental
Health program to set priorities. They also worked with Harvard's School of Public
Health to see what they were looking at, with an interest in possibly piggy-backing on
clinical specimens they collected. They discuss biomonitoring with public health
directors in six other New England states on a quarterly basis. If they had received
implementation funding thy would have sought input from other stakeholders.
“The sooner you involve the community, the smoother the process goes.” They received
input from a variety of area physicians and they had a strong medical perspective.
Rhode Island
Many different ideas were considered. One criterion used was feasibility. If they didn’t
have the equipment to test the chemical, they didn’t select it.
Illinois
Illinois recommended the approach of doing a careful kind of exposure assessment in
order to identify what to focus on. For example, Illinois has a lot of information on
environmental exposure from the federal EPA, state EPAs, and from local health
departments. We know what the levels of ambient air pollutants are and where the
hazardous waste sites are. “You can either throw the net in the ocean or say you want to
fish for tuna.”
New Mexico
See three-step decision process above.
New York City
New York City went through an internal process within the health department and
solicited input from staff. They conducted a variety of key interviews with external
stakeholders (academic, scientific, policy world), but they did not set up a scientific
advisory panel.
They then asked health department staff to propose chemicals for the NYC HANES
study. Staff had to describe how monitoring the particular chemical would matter, why it
mattered from a health perspective, and whether there was clear guidance on how to
interpret the findings. They evaluated the proposals internally, using criteria such as
whether the chemical could be measured and how, the cost, burden analysis, and the
amount of time it would take. The department also evaluated how onerous it would be for
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the participant.
They rapidly figured out that they could do just a handful of things. They felt it had to be
fairly simple. They decided not to do hair samples or mouth swabs, because no one else
was doing that. They chose analytes that they could reasonably analyze (blood and urine).
CDC-NHANES
The CDC publishes the criteria they are using in the federal register. Anyone can nominate
a chemical to be monitored.. Then they ask if there is a method available, and decide
whether they can incorporate that chemical into their analytical method.
Advice:
ƒ Most states have a process to involve stakeholders in prioritizing what they should be
measuring.
ƒ Begin with the end in mind” and ask the question, “What are the issues that
Minnesota permanently faces?”
Examples of biomonitoring projects
California
ƒ No projects have been done yet. They needed to hire people, and buy lab equipment
built to specification. The buildings needed to be renovated, which was a year-long
process. The lab equipment will be up and running in the next 2 months. They put
out a request for information for frozen samples, identified the chemicals that the lab
could test, and then asked the panel if they wanted us to use them for further
biomonitoring.
ƒ The nature of the projects will depend on what samples they get from the inquiry. It
could include children of women who work in agriculture in CA, a birth cohort, cord
blood samples that have been archived They hopeto start making those decisions in
early November.
Massachusetts
ƒ The state has conducted targeted biomonitoring studies since the mid-1980s,
including six to eight PCB studies. At the moment, the state is piggy-backing on an
outside study to test wells. The state will collect urine specimens to test for arsenic
and uranium.
ƒ The state has typically used an internal decision process to initiate projects, usually as
a result of a community concern. Epidemiologists and toxicologists initiated the
process. Following this, the state held a large public meeting and moved forward
from there.
Advice:
ƒ The lab and toxicologists should be working together right from the beginning. Make
sure what the labs can reasonably do, and then work together closely to determine the
appropriate test and how to test it.
ƒ It really helps to get the community involved right away. They can help guide the
process and get buy-in to recruit participants.
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Rhode Island
ƒ Rhode Island's project is to measure cotinine and mercury in cord blood samples from
a local hospital and compare them to national averages.
ƒ Rhode Island convened a scientific advisory board and asked them what concerns
they had about chemical exposure and what they deemed important. They also had a
public meeting for the public to express their views. Cord blood emerged as the
priority project, along with other projects that didn’t receive funding. The process has
worked well.
New Mexico
With New Mexico as the administrative lead, the Rocky Mountain Consortium piloted a
large study with heavy metals, and actually uncovered some uranium exposure problems
that had not previously been known. They also did a feasibility pilot on using newborn
blood spots to check methods. It turned out that certain metals were good for this
method, and some were not. Additionally, New Mexico and Utah received
environmental public health tracking grants given by CDC to epidemiologists in the state
to link environmental problems with adverse health results. Since the Rocky Mountain
area has one of the highest levels of arsenic in their drinking water, they did a study of
bladder cancer linked with high arsenic in drinking wells. Overall, the six states in the
Rocky Mountain Consortium have monitored arsenic, uranium, mercury, phthalates, and
blood spot methods. They have a longer list of chemicals that they would monitor if any
funding comes along.
Illinois
Illinois is currently in the planning stages and has not carried out any projects.
New York City
New York City has monitored mercury exposure in blood (methyl mercury) through fish
consumption. They’ve published a manuscript on this and have done a lot of public
education about the topic. They’ve also looked at elemental mercury salts (found in
urine; inorganic mercury). In follow-up research, they determined that the chemical was
linked to a skin-lightening facial cream. They are still working on a pesticides project.
Preliminary results show that urban pesticides in New York City are higher than the rest
of the nation (possibly related to pest control products used in households). Lastly,
they’ve done some work with cotinine under a broader tobacco control program. They
hope to do another NYC HANES in 2010.
Washington
The department received a two-year grant, along with Kansas and Arkansas, to conduct a
health examination study mainly focused on cardiovascular disease. Hair was sampled for
mercury in women of reproductive age and the elderly. (A small number of studies had
linked mercury to cardiovascular disease in elderly.) A study in the Environmental
Health unit was conducted at the same time for a different purpose that measured
mercury in hair samples in women and connected it to fish consumption.
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Advantages and disadvantages of the approach described
Summary
Advantages/strengths: Ablility to reduce exposures to chemicals of harm/negative
health outcomes, laboratory development, working with scientific advisory panel,
partnerships/collaborating, introducing biomonitoring to state, informing the public,
improve public health of citizens.
Disadvantages/weaknesses: Small sample sizes, population not representative of larger
population, lack of environmental epidemiologistss, not knowing what the results mean
clinically (what does an elevated level mean? Is there risk for adverse health outcomes?),
interpretability of results (lack of baseline data, research, etc.)
California
Advantages: Two really strong laboratories that will be focused on strength and analysis,
and multi-departmental work is good.
Weaknesses: Three departments are working on this. Everyone brings different
abilities/strengths/weaknesses/culture/management hierarchy. At the upper management
level, there is division on where this program should be going. The fiscal situation is
terrible.
Strengths: A really good panel that is knowledgeable about different exposures in
California. They would like to see things done that will benefit the state, like looking at
flame retardants in furniture. California is phasing out perchloroethylene (chemical used
in dry cleaners) so many dry cleaners are substituting another chemical, which may be
harmful, too. Everything they are doing is being monitored by the chemical industry.
The perspective of an outside panel is helpful.
Partnership opportunities: Working with community organizations (NGOs) and
academicians to design specific studies of specific communities; getting money from
other sources (foundations). California does not expect to have the money to do a
statewide survey (they’ve cost it out at 10 million a year) in the next five years, so they
think they are going to focus on community-based projects. They could use
representative samples already collected on newborn blood spots and piggy-back on
existing programs too, archiving maternal blood samples.
Massachusetts
Strengths: Working collaboratively.
Weaknesses: It would be helpful to integrate academia a little more in the process. If it
was a surveillance effort, more people would need to be involved to ask questions such
as, “Are we looking at right analytes? Should we continue to measure, or should we
replace a chemical in the ongoing/surveillance effort?”
Rhode Island
Advantages: The project introduces biomonitoring to the state. Also, regardless of how
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small a population is, the results will reveal how exposed they are to a specific chemical,
and you can then try to reduce that exposure.
Disadvantages:
ƒ Control over population being studied wasn’t as great as expected. If they had
selected a different hospital that served a larger population, it might have been
different. The results are not truly comparable to national geometric means.
ƒ The project lacks professional medical follow-up. We did give information to
doctors about the results and what to do in given situations. Many doctors are not
used to dealing with this type of issue – they are either intimidated or unwilling to
become involved in the care of the patient in this specific aspect.
ƒ Other programs/states have reported lack of environmental epidemiologists (as
opposed to infectious disease epidemiologists).
ƒ Frequently we find something and don’t know what it means.
ƒ It’s hard to replicate what CDC is doing. Some kind of prioritization should be
done early on. Rhode Island relied too heavily on opinion poll versus systematic
approach (review of concentrations of environmental chemicals).
Washington
Disadvantages:
The length of the participant survey that accompanied the specimen collection offered
little opportunity to ask questions about the participants’ exposure history, habits, etc.
Fewer people were surveyed then they originally hoped to. The specimen collection
process was not under tight control due to two projects going on at the same time with
different purposes;
Advantages:
To create a biomonitoring program that is sustainable, you have to identify a “core” that
is conducted on an ongoing basis in order to track trends over time, and “supplemental”
activities to amplify what you’re doing with the core. This kind of structure produces the
best of both worlds.
CDC-NHANES
Disadvantages: One of the problems with NHANES is that it looks at ages six and up
and twelve and up. It would be really good to look at younger and older populations.
Another limitation is that they can’t get regional levels. You don’t know what state/city
the data is collected from. It’s important for other cities/states to look at exposure more
specific to their population base.
Key ethical, political, scientific, financial considerations
Summary
ƒ Know what you are going to do with the results (avoid causing unnecessary fear in
chemicals, communicating results, interpreting results, remaining objective)
ƒ Public health/science experts in the driver’s seat vs. politicians
ƒ Don’t waste money
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Massachusetts
Massachusetts has authority to do these studies under public health laws. They get
informed consent from participants and they get IRB approval.
Rhode Island
State programs need to know what they are going to do when they find elevated results.
Anticipate what might happen after the results come in, such as tracking down
populations/participants that may have moved, what role the participant’s physician will
play, etc.
Illinois
ƒ If you take a sample on an individual, how do you communicate the results if you
don’t know the risks of that toxin?
ƒ Are you over- or under-sampling any particular groups?
ƒ You can’t ignore the people. Example: A public health department was concerned
about the use of mercury in certain religious rituals, specifically the exposure to
children by sprinkling mercury around cribs. A complaint from a community group
said they were discriminating against them because of their religion. They had
prolonged discussions with the IRB and decided to not go ahead with that program.
ƒ Decisions should be independent of political pressures. The health department should
be insulated by having an expert committee with representatives from various
stakeholder groups.
New York City
ƒ This is largely locally determined. They had to address some ethical concerns
regarding coerciveness. They didn’t want to overcompensate people. Additionally,
they had concerns with sharing un-interpretable results to the participants (for
example, they didn’t give participants their individual pesticide level after they tested
them). However, they made sure that people got a brochure on how to better control
the use of pesticides, etc. Think in advance of how you would respond/react to
participants - what you will share with them, etc.
ƒ The political viewpoint should be the last lens to look through things, but not the first.
First look at whether there is a scientific rationale. Then, look at which studies would
have the best support for action.
Washington
One issue is developing lab capacity for an episodic exposure assessment (periodically
testing for early detection of chemical terrorist attack, for example). People who think a
chemical terrorist attack will never happen will not be influenced by that.
CDC-NHANES
ƒ You really have to think about what you’re going to do with the results. How do you
get the data back to the people? For most chemicals there are no health guidelines.
ƒ Decide whether or not you’re going to make data public for others to use.
ƒ Advocacy groups/industry will have different perspectives. Try to remain objective
without pleasing one group over another.
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Projects need to be worthwhile. You don’t want money wasted on unnecessary
research. Maybe don’t sample every year, things like that. Figure out the best way to
manage your resources. Maintain objectivity in evaluating the data.
You can not comprise on ethics. One piece of bad publicity and people will think you
are the bad guys. In CDC-NHANES projects they do not diagnose or prescribe.
Rather, they publish a “report of findings.” They refer participants to free clinics (or
their physician) for follow-up or if results are out of range. The best resources are the
county health departments. They are knowledgeable and make things work.
Overall benefits and challenges of biomonitoring programs
Summary
Benefits
ƒ Raise public awareness of health risks/exposure to chemicals
ƒ Get rich data
ƒ Improve public health outcomes
ƒ Influence public policy
Challenges
ƒ Costly
ƒ Using only one tool (biom) in the tool box
ƒ Causing unnecessary fear about certain chemicals being tested/monitored
ƒ Misinterpreting data, under or over-estimating exposure
ƒ Public concern about what results mean (when health dept. doesn’t know either)
Massachusetts
Benefits:
ƒ Biomonitoring can help to inform individuals or communities if they are exposed to
toxins. We may find that there is mercury in their environment, but that they don’t
appear to be absorbing it. This reassures people.
ƒ Biomonitoring can work effectively for development and implementation of public
policy.
Challenge: There isn’t always a baseline number for comparison to tell people what their
results mean.
Rhode Island
Benefits: The main benefit is raising public awareness of what one could be exposed to
in the environment and how to avoid exposure. The main advantage is to offer a new tool
for assessing exposure to chemicals based on environmental concentrations. It’s a more
direct way of testing exposure.
Challenges: The downside is, when something is detected, people become very
concerned. There aren’t definitive links between levels of concentration, and how or
what levels of concentrations might link to disease. It is easier to think of in terms of
populations.
New Mexico
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Benefits:
ƒ The best use of biomonitoring depends on what the selection process tells us.
ƒ The state legislature in New Mexico expects employees of the state health department
to engage in public health practice that directly benefits public health. In other states
the lab and health departments are allowed to have more of a pure research focus, but
in New Mexico they are not. Are employees of the Minnesota Department of Health
encouraged to do pure research?
ƒ If the labs in Minnesota end up doing more pure research, pick projects that will
directly affect public health policies and regulations - projects that will give an
applied outcome. “Then they’ll get bang for their buck in a fairly short time.”
New York City
Challenges: Biomonitoring is a “piece of a puzzle.” By itself it is interesting and even
fascinating - but for a cross-section study, if there isn’t the rest of the puzzle that fits with it then it isn’t as useful. It would be best to “complete a puzzle” and use results influence
action and policy.
At the state level there is more of an expectation from the public to act on results. It requires
a broader understanding of what is contributing to exposure, etc.
Washington
Benefit: Even though the state doesn’t have a full program, it was a useful experience to
develop the purposes for biomonitoring. After settling on the purposes, the state looked at the
applications and ended up with a ranked list of biomonitoring applications and highest
priorities.
CDC-NHANES
Benefits
ƒ Assess and see if certain chemicals people are being exposed to are more than or less
than the US population in general.
ƒ NHANES finds the closest exposure measurement. With a stronger measurement,
there is more strength in association with exposure and health outcome for an
individual.
ƒ You find very important things about public health by getting a very rich data set.
Lots of little things also result (health-related findings and information, etc.).
Challenges
ƒ Unnecessarily alarming people about exposure;
ƒ Under-estimating exposure, misinterpreting the data, etc.;
ƒ You spend a lot of money.
Advice
Keep costs low and opportunity costs very wide. Keep people informed and use free
materials and existing expertise when you can. Don’t get caught up on any one thing.
Lessons learned
Summary
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Plan ahead: What are you going to do with results? What are you going to
communicate to public and participants? Are you going to share results with
participant? If so, when? How are you going to improve participation rate to get
specimens? What is mechanism for taking chemicals off list?
Think small: Don’t overreach, go slow, don’t be overly ambitious, and don’t go ahead
without funding.
Think ahead: What will you do with specimens after collected? How will you educate
public and communicate results? What about funding – can you access other
resources (NGOs, foundations, etc.)? Be actionable – have an agenda/plan for
affecting public policy.
Public health benefit: communities/state want “best bang for the buck,” link to
improving public health outcomes.
Scientific approach: sampling, representativeness in data.
California
ƒ California legislation requires that any participant in a biomonitoring study wanting
their results can get them. However, the department doesn’t necessarily know what
the results mean clinically. This is a potential strength: Participants may receive their
results and get motivated to get involved in the political process as a result. The
activists who wanted the legislation would not have supported the bill without this
requirement.
ƒ Get the public extensively involved throughout the whole process. California held
three public meetings and statewide teleconferences at which the public could
nominate chemicals. They had to have all of their criteria ahead. The process was
labor-intensive.
ƒ States that are working on, or have biomonitoring programs, should have some
regular dialogue.
Massachusetts
ƒ It’s important that toxicologists and epidemiologists work together; they need each
other.
ƒ The community can be very, very helpful, though it is very costly and it is sometimes
difficult to recruit participants because of the time commitment involved. The
department said they were lucky to receive a 50-60 percent participation rate, even
with a targeted population. The department holds a public meeting and provides
aggregate data, and participants get their individual results.
Rhode Island
ƒ Don’t embark on a program without funding. Whenever the state dedicates funds
internally for biomonitoring there has to be a buy-in process involving other
interested parties/stakeholders to build support for the cause.
ƒ Quite a bit of education is required to help people understand the value of a
biomonitoring program, especially if there is no direct treatment and it is not clear
what it means. A lot of epidemiologists do not find value in biomonitoring, so there’s
also a need to educate other professionals and physicians, etc.
ƒ Multi-state consortia might be more feasible than single-state programs.
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New Mexico
ƒ A lot of people think biomonitoring is looking at the lab int the lead. The work ends
up being done at the lab, but you really need to have the epidemiologists and the
environmental health officials in the foreground setting the direction. Then the lab
needs to let them know, can we do that, or can we not do that?
ƒ The CDC grant awarded to the Rocky Mountain Consortium was about one fourth of
what they wanted for funding. They had to curtail their plans, and weren’t able to do
many of the things they wanted to do over the five years. Now that the grant has
ended, they are in limbo. They have lab capability and people interested. New Mexico
and Utah are trying to move forward using environmental health tracking resources and
they have accessed other funding through a portion of emergency terrorism grants.
New York City
ƒ New York City reported that their program has been successful, in part because it was
small and didn’t overreach. It was bundled with NYC HANES, which replicates the
national CDC-NHANES model, so costs were spread out and lower, and the sample
size was possible.
ƒ It is important to get good population estimates. Other successes included attaching
their program to a policy and action agenda, and preparing a unit to handle the
follow-up, communication, and development of educational materials. They are a
self-funded program.
ƒ Representativeness in the data was critical to what they learned about mercury.
Washington
ƒ Use a simple approach; focus on something that is common (based on
frequencies/magnitude).
ƒ Create a program that is actionable; public health action that can be taken. They’ve
identified a problem, they can get data, they can use it for program planning and
policy making - something can be done.
ƒ Just because something can be done doesn't mean people have the political will to do
it.
ƒ In the planning stages you have to understand the reasons why programs would or
would not want to participate (example: tobacco unit declined to participate in
biomonitoring of cotinine because there was miscommunication about the purpose of
the study in the planning stages).
ƒ You have to get the best and the brightest people on your team at the beginning.
Generalists or people who think broadly about programs in the agency have to be the
core of the planning process.
ƒ Cast a wide net and let everybody come to the table with their ideas.
ƒ If you really want a biomonitoring program that is sustainable, you have to say you
want to identify a “core” that is conducted on an ongoing basis. When you've got that
kind of structure you get the best of both worlds; you have stability to track trends
over time, and “supplemental” activities to amplify what you’re doing with the core.
ƒ Get all the stakeholders at the table; work it out
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CDC-NHANES
ƒ One of the issues NHANES faced was advocacy groups and industry wanting to
remove chemicals from their list. A lot of attention goes into developing criteria up
front to get chemicals on the list, but there must be a mechanism to take chemicals off
the list as well.
ƒ Get into it slowly – don’t be too ambitious, get into too many chemicals and overtax
your laboratory. Really focus on what is most important. Conduct pilot studies first to
assess what’s out there.
ƒ Have a plan of communication: how will you report results to the public and media?
Be careful about reporting and causing an unnecessary fear of exposure.
ƒ Look at biomarkers. Are they appropriate? Some are not good biomarkers.
ƒ Come up with a plan to reserve specimens for future analysis (work this into the
consent form).
ƒ Determine a way to evaluate proposals for how to use specimens.
ƒ A state program should try to get the younger population.
ƒ For drawing blood, consider whether to have centers for people to come into or
moving vans.
ƒ Minnesota was advised to have some follow-up conversations with the CDC. They
would begin by asking, “What are the objectives? What are the concerns?” and then
tie it to money.
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Biomonitoring vision and purpose retreat: Meeting summary
November 12, 2008
In attendance: Beth Baker, Joanne Bartkus, Alan Bender, Michonne Bertrand, Norm Crouch,
Carin Huset, Jean Johnson, Frank Kohlasch, Mary Jeanne Levitt, Louise Liao, Mary Manning,
Rita Messing, Geary Olsen, Susan Palchick, Deanna Scher, Adrienne Kari, Pam Shubat, John
Soler, John Linc Stine, Al Williams, Joe Zachmann; Facilitator: Barbara Deming
Review of biomonitoring interviews report
Participants read the draft report: Summary of biomonitoring interviews and focus groups,
prepared by Barb Deming for this retreat. After reading the report, participants walked through
the report, raising questions and offering comments about each section of the report. The
discussion points below represent individual views expressed, and are not necessarily points on
which all participants agreed:
Governance Structure
ƒ
In response to a question about the current governance structure, steering committee
members offered the following comments:
o We’ve struggled within the current governance structure
o The short timeline has caused stress. It’s not just the short timeline, but
working across disciplines and cultures that is a struggle.
o Workgroup relationships and perspectives have posed a challenge. The
steering committee spends lots of time clarifying, and not resolving conflicts.
o We haven’t kept MPCA and MDA as involved as we would like to.
o Biomonitoring is so new, and we’re working out how to interact.
ƒ
The comment on P. 6 about the program having “Three levels of protection” reflects good
public policy: Protecting the public is critical. Legislators and others sometimes perceive
us as “close to doing harm.”
o However, it should be noted that some surveillance and community studies in
the future may not need to go through IRB (they are not all research) so this
step is not automatic.
o Another level of protection is that MDH is required by statute to protect
private data.
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The Science Advisory Panel’s (SAP) role in “design of pilot projects” has been to
“tweak” or “help implement” more than to “design.” The SAP felt some frustration at
how directive the legislation was. Another SAP role question has to do with the role the
SAP thought they would have, and what it has turned out to be.
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Success of the pilot projects may turn out to be a decision to not proceed with a state
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biomonitoring program. We should not assume that the recommendation that stems from
the pilot projects will be to continue a state biomonitoring program.
Definition
ƒ
A question was raised about how a biomonitoring program accounts for genetic factors
and behaviors, which may affect the relationship between exposure and health effects.
o Genetic factors go in a different place on Jean’s toolbox map than behaviors
do. (See Jean’s “Making the Link” Toolbox Map, which was enhanced during
the meeting, below.)
“Making the Link” Toolbox
Biomonitoring
External
Exposure
Internal
Dose
Exposure Science
Pharmacokinetics
Effective
Dose
Preclinical
Effect
Toxicology
Epidemiology
Environmental Chemistry
Altered
structure/
function
Clinical
Disease
Clinical Medicine
------------------------------------------Public Health Application and Action-----------------------------------------------
Exposure Assessment
Risk Assessment
Risk Communication
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EH Tracking
Risk Management
Disease Prevention
Disease Management
Health Education
There were differences of opinion about how broadly or narrowly biomonitoring should
be defined:
o We need a broader definition than the CDC’s. We shouldn’t exclude things
that are not biomarkers of exposure. We may want to include biomarkers of
effect or response.
o We should include anything that’s a fairly direct measure of external exposure.
o It’s fundamental to know what we mean, and to distinguish our program from
CDC‘s. This points us to what our purpose is.
o “Measurement” is the definition. “Everything else” is the purpose.
o Possible definition: “Biomonitoring is an internal measure of exposure.” This
leaves the door open to measurements that go beyond the CDC’s definition.
Purpose
ƒ Biomonitoring as a tool/means for mitigating risk is important in public policy. We want
to show that when you reduce or manage exposure, people’s risks are reduced.
ƒ We could put more emphasis on biomonitoring as a tool to make that association from the
regulatory community’s point of view. The regulated community also wants this
verification – that efforts to reduce exposure are effective.
ƒ Biomonitoring can help show how regulatory actions have a beneficial result.
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At the same time, we don‘t want to raise false expectations that biomonitoring can always
provide answers. Biomonitoring results cannot always be applied, but can still be
valuable.
We need to emphasize successes – what biomonitoring has accomplished (e.g., lead).
Perhaps biomonitoring should focus on chemicals with known exposures that are of
known concern. This would make it easier to align biomonitoring results with future
actions.
Regulatory and industry perspectives about biomonitoring are equally valid. We have the
public health perspective.
In response to a quote in the summary report, a comment was made that it is not accurate
to say that all biomonitoring does is “Detect or no detect.” Biomonitoring measures the
levels of chemicals in people’s bodies – i.e., The dose makes the poison.
Models
ƒ The biomonitoring-on-demand model was missing from the report summary. While
agency staff don’t see this model as a viable option, perhaps on-demand biomonitoring is
what legislators wanted.
ƒ Regarding the NHANES model:
o What is considered a statistically valid sample size for Minnesota? Why is
there an assumption by some that a surveillance model is not feasible?
(Answer: We haven’t calculated sample size or costs yet so we don’t know if
it’s feasible or not.)
o If we want to determine a baseline average exposure, we can use a smaller
sample size. To better understand full distribution of exposures, we would
need a larger sample. The sample depends on what the purpose is, and what
questions we want to answer.
Possible guidelines for biomonitoring
ƒ There is a chicken and egg phenomenon: Should we focus on the “really bad guys”
(chemicals with known adverse health outcomes) or on identifying emerging risks.
o If you look at emerging risks you can look at trends, identify actual risks and
prompt additional research.
o Or we may find that the “bad actor” is not a widespread exposure issue and
can dismiss it as a concern.
ƒ In terms of feasibility, it was noted that chemicals that disappear quickly from the body
may not be good candidates for biomonitoring, at least under certain models/study
designs. We need to look carefully at exposures. Other types of monitoring also come
into play.
ƒ There is a tension between scientific validity and political reality. Community perception
of risk will exist no matter what.
ƒ Stakeholder engagement – and management – is important in balancing political and
scientific considerations.
ƒ The third bullet from the bottom (“Link biomonitoring to environmental health tracking,
pollutant regulation, and related efforts”) links biomonitoring through all functions of
government. Biomonitoring can demonstrate the utility of government actions and the
value of money spent. This point should be elevated.
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Some of these suggested guidelines are mutually exclusive or represent a menu of
options. What will be done with these guidelines? Response: These suggestions are input
for the discussion of vision and purpose.
Is the program “biomonitoring” or “environmental health biomonitoring”? Response: The
legislation left this open. We can tell them what we think it should be.
o Some felt the program should be biomonitoring for environmental exposures.
ƒ This would require us to define “environmental.”
o Workgroup discussions of NHANES as a model have focused on chemicals,
not the nutrition and chronic disease portions of the NHANES model.
ƒ Others felt we should not exclude those portions of the NHANES
model. This may be something we want to look at down the road
(expanding into other areas or health outcomes).
ƒ Excluding these outcomes would exclude input and cooperation with
other programs.
o We need to see where we would have most benefit and where we’re not
overlapping with other programs.
Funding concerns
ƒ Other biomonitoring programs warned us not to start something without sustainable
funding.
ƒ We need to know what the chances are of long-term funding support. This is a strategic
issue to examine so that policy makers understand.
ƒ In some ways, it would be wise to kill the program now – or make plans to sustain it.
Legislators should know that it is unwise to let the program limp along on uncertain
funding.
Risks
ƒ In response to the comment in the report that there is a risk that biomonitoring could
interfere with responsible party negotiations: This may be less of a risk than some people
think because by the time biomonitoring comes in, MDH is already involved.
ƒ We need to clearly define “risk” here and elsewhere, because risk means different things
in different contexts. The potential “risks” of a biomonitoring program might better be
described as the threats to the long-term viability of a biomonitoring program.
Whom to target
ƒ MDH has a statutory mandate is to eliminate health disparities. We should think about
biomonitoring’s role in helping to meet this mandate. What are the public policy
implications?
ƒ We should look through the lens of eliminating health disparities.
ƒ If we’re targeting populations with disparities, does this mean we are choosing not to do
surveillance?
o No, because we could put this in a framework of oversampling certain
populations to get better data.
o Also, we need to understand what’s going on across the whole population in
order to know what’s going on with any one sub-population.
ƒ A disparities framework would make us ask questions like: Should we put resources into
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measuring PFCs in an affluent population or into measuring lead in low-income
populations?
Eliminating disparities does not dictate one approach to biomonitoring (e.g., community
studies, surveillance), but could be addressed through multiple models, either used
separately or in conjunction with each other
This gets to the reality of constrained resources. Abstract realities become not feasible.
Partnership possibilities
ƒ We should include other programs within MDH as possible partners: Heart disease,
diabetes, other chronic diseases; Minority and Multicultural Health; Refugee Health;
Maternal and Child Health.
ƒ Regarding the public as a partner in biomonitoring: We need to address the challenge of
making sure the squeakiest wheel doesn’t get all the grease. We need to find ways to get
balanced input from the public.
Communication
ƒ In communicating about biomonitoring, the program needs to ensure that it is transparent.
o While we can use different methods of communicating the same thing to different
audiences, we need to be consistent in the messages we are providing. For
example, an individual person is given his/her individual biomonitoring result and
a population has a distribution of measurements. We should be consistent in our
messages to both groups.
Conclusions from the report discussion
ƒ We don’t all agree. There are lots of things to discuss.
ƒ It’s hard to ignore the funding problem.
ƒ It’s hard to have a vision for biomonitoring without understanding what we can do
technically. Some of the concepts may not be feasible. For example: Cost of recruitment.
ƒ We have the right people and the right intellectual resources to set a vision.
ƒ We need to define our scope: Are we talking about biomarkers of exposure, effect and
susceptibility? Environmental chemicals only or other types of exposures?
ƒ Biomonitoring is not in a silo. We need the situation context to determine the right
approach.
ƒ Nobody has identified an overarching problem in Minnesota that we could solve through
biomonitoring.
ƒ We’ve been focused on capacity and infrastructure, and we can feel good about that.
We’re poised to do more.
ƒ We need to determine how a given model would change what we do in public health. We
should look at what we’ve done to date.
ƒ One model could be the Behavioral Risk Factor Surveillance System. We could look at
statewide or populations. Ask them to add our questions.
ƒ Should tracking data drive biomonitoring projects?
ƒ Another model (from infectious disease): Focus on outbreaks – identify general
categories for surveillance, then focus in on trends.
ƒ Whatever we do, biomonitoring should be measurable, meaningful, and manageable.
ƒ We can use CDC findings to point to the need for further studies in Minnesota.
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Biomonitoring should be tied to our public health actions and programs (e.g., regulatory,
educational, etc.).
The state is poised – we have learned from the pilots.
Measurement is easy – everything else is hard. (Counterpoint: Measurement is not
necessarily easy.)
If we already have CDC reference ranges (the firehouse) now we have fire truck to use to
put out fires. This can be a model.
There is no right or wrong approach. It depends on the question we are trying to answer.
46
Vision
The following lists were developed by the participants in an 11-12-08 vision and purpose discussion, in
response to the question, “What will be different in 5 – 10 – 50 years as a result of a state
biomonitoring program in Minnesota?” The list headings represent the group’s agreement about the
category of vision, while the bulleted ideas below the headings represent individual participants’
brainstormed ideas. The group developed preliminary “vision statements” for two of the lists, in order
to translate the brainstormed list into prose for communication outside of the 11-12 meeting.
Safer living through biomonitoring
ƒ Environmental safety
ƒ Eliminate environmental hazards
ƒ Safer communities
ƒ A safer environment
Risk and disease are better understood
Initial statement translating brainstormed list to prose: We better understand the relationship between
environmental pollution, behavior, and exposure; and exposure and disease. We can put those risks in
perspective with other disease risks. We can use results to put exposures into perspective. All this is
being done in order to improve public health.
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ƒ
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ƒ
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Better ability to identify adverse health outcomes related to chemical exposures
Greater understanding by all of the exposure-disease continuum
Emphasis on personal responsibility
Biomonitoring offers rapid, real time analysis of link between environmental hazards and
chronic disease, or no link to disease
“Acceptable risk” is defined
Understanding environmental risks
Exposures related to disease
More knowledge about the effects of chemicals on health
We will know what is NORMAL
Environmental risk factors for disease are better understood
Disease understood
Potentially exposed communities will have additional knowledge to make wise choices to
promote health
Environmental data becomes health knowledge
Adequate funding
ƒ We’ll have sustained $$ to do biomonitoring and health effects studies; to connect exposure and
effects/risk.
ƒ A constitutional amendment to use sales tax $ for biomonitoring
ƒ The “Franken-Stine” biomonitoring initiative will be fully funded.
Biomonitoring capacity
ƒ Quickly sample, measure and analyze internal exposures when potentially harmful exposures
are suspected
ƒ Be poised to take advantage of evolving research on individual or multiple effective doses and
47
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ƒ
ƒ
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clinical disease
MDH has better defined which groups are “at risk” for increased exposure/health outcomes
using biomonitoring
We can compare exposures to “X” in Minnesota and “X” nationally
We will have a definition of biomonitoring
Minnesota is considered a leader in the field
Do something
Initial statement translating brainstormed list to prose: We (everyone) use the data and information
from biomonitoring to support effective ways to reduce exposure of all Minnesotans to environmental
hazards. We put the data and information, in a useable form, into the hands of people who could use
them. The program makes connections with others who have some responsibility for exposure and
disease management. Data and information are also used by industry and advocacy organizations to
inform their practices.
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Effective ways to reduce exposure to environmental risks
Occupational health is improved through targeting exposures via biomonitoring in Minnesota
More effective programs to protect the public’s health
Better prioritization of resources for environmental health programs
We can understand and prioritize environmental contaminant risks in Minnesota
Inform/guide risk management
Increased knowledge of risk exposures leads to reduced anxiety and/or regulatory measures
Local and state health officials have a new tool for responding to environmental health
problems
Proactive vs. reactive (e.g. Identification of next “lead” before it becomes a health issue)
Disparities in risk are discovered and reduced
Evaluation of effectiveness
ƒ A new ability to evaluate policies and programs
ƒ Better evaluate effectiveness of intervention or policy changes
Effective communication
ƒ Better understanding of how to communicate results and risk perception
ƒ Knowledgeable public regarding the health issues associated with risks from the environment
and their behaviors
ƒ Better communication on reducing risk
Policy approaches
ƒ Competitive market advantage by Minnesota businesses via green chemistry and products
ƒ “Reactionary” or “precautionary” action taken on a host of chemicals regardless of known or
suspected cause-effect relationships. (Not a vision for the desired future, but one which could
result.)
ƒ As a result of previous biomonitoring studies, and new regulations, some chemicals will be
banned/eliminated from the market. Then we can biomonitor their replacements. (Not
necessarily a vision for the desired future, but one which could result.)
48
Follow up and next steps
1.
2.
3.
4.
5.
Barb will document today’s meeting.
The EHTB program should document the discussion on the utility of biomonitoring and the lessons
from other states:
ƒ This could include the pluses and minuses across various points raised in this report.
ƒ Other states could benefit from such a report being developed.
ƒ Maybe work with another state.
ƒ CSTE, ASTHO, NACCHO may also be interested.
Revise the interview summary report incorporating edits raised during today’s meeting.
Send documents to SAP ahead of time.
ƒ Ask for critical assessment of the draft vision.
ƒ Ask them to review the interview summary report and summary of comments from today. (Ask
them to catch up with conversation from today.)
ƒ Ask them to respond to specific questions that can be posed in advance.
ƒ Refine list of the purposes of biomonitoring and bring to SAP for discussion.
Refine vision: After people receive the Nov. 12 meeting summary, small group will do homework
to develop statements of vision: Pam, Louise, John Stine, Jean, Michonne.
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Draft vision statement: Minnesota biomonitoring program
November 2008
Note: The following draft vision statement reflects the efforts of workgroup, steering committee,
and advisory panel members at its November 12 retreat. During the retreat, participants
brainstormed for ideas of what would be different in the future as a result of a Minnesota state
biomonitoring program. Individual ideas were grouped into categories and then labeled. [Read
the “Biomonitoring vision and purpose retreat: Meeting summary” to see the original list of
individual ideas and categories.]
A subgroup of retreat participants met on November 24 met to further refine the initial
brainstormed list of vision elements. During this meeting, some of the initial categories were
combined and the brainstormed elements were translated into sentence format.
Safer living
Minnesotans will lead healthier lives and live in safer environments.
Risk and disease are better understood
Scientists will better understand and communicate the relationships between environmental
hazards, exposures and disease. The public will have increased knowledge about risk and disease
in order to make wise choices to promote their own health and the health of their communities.
Adequate capacity and resources
Minnesota’s biomonitoring program will have the capacity and resources to measure
environmental chemicals in people’s bodies accurately and efficiently. The program will shape
biomonitoring research in Minnesota and will also be responsive to arising public health
concerns.
Biomonitoring data are effectively used
Biomonitoring results will be used by state agencies, advocacy groups, industry, decision
makers, and other stakeholders to create and evaluate programs to minimize risk, promote health,
and reduce disparities.
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Section overview: Advisory panel roles
Advisory panel evaluation
This section includes a summary of advisory panel evaluation results from the evaluation
survey of EHTB panel members that was completed in September and October. Eleven of the 13
panel members completed the evaluation form. In addition, program staff followed up with some
panel members for further clarification about their views.
Information from the evaluation was very useful in helping program staff assess what is going
well and what needs to be improved. For some of the areas evaluated, there was a high level of
satisfaction. In these cases, the program will strive to maintain the same practices in the future
(e.g., the level of detail included in meeting background materials, the timeframe for distributing
the meeting background materials and meeting summaries).
Other areas of the evaluation indicated some opportunities for improvement. For example, staff
will look for ways to improve the ways the meetings are focused, the level of detail in the
meeting summaries, how panel members are engaged in making recommendations, the clarity of
decision-making processes and the clarity of panel members’ roles and responsibilities.
Clarification of advisory panel roles and decision-making processes
The first step that the program will take to improve the experience of advisory panel members is
to try to clarify the roles and responsibilities of panel members and the decision-making
processes of the program.
Included in this section of the meeting materials is some information on EHTB advisory panel
roles and decision-making processes. This includes a description of the roles of the panel as
defined in statute along with a summary of the ways MDH applies the statute. Also included is a
brief summary of the process that MDH uses to make program decisions.
This information is provided in part to try to clarify panel members’ roles, but is primarily
provided as a starting point for a discussion between advisory panel members and MDH staff. At
the December meeting, advisory panel members are invited to ask questions to further clarify the
role of the panel and to provide suggestions for improving the operation of the panel.
ACTION NEEDED: The advisory panel is invited to ask questions to clarify their – and
MDH’s – role and to provide suggestions for improving the operation of the panel in the
future.
No formal vote is anticipated on this agenda item.
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Summary of advisory panel evaluation results
Finalized October 20, 2008
Please indicate the extent to which you agree or disagree with each of the following statements.
Strongly Disagree Agree
Strongly
disagree
Agree
Meeting background materials and summaries
1. Meeting background materials arrive in enough time
to allow me to adequately prepare for panel meetings.
2. Meeting background materials provide sufficient
context and detail to support informed discussion
and decision-making.
3. Meeting summaries are distributed in a timely manner.
4. Meeting summaries include an appropriate level of detail.
Comments on meeting materials:
•
•
•
•
1
5
6
6
5
5
6
6
4
I have been well satisfied with the background materials.
Just a thought…you could save some money by sending mail instead of FedEx.
The briefing materials and summaries are well prepared and of appropriate length and detail.
Meeting summaries have perhaps a little too much detail.
Meeting summaries are too detailed and focus too much on process and not enough on decisions.
•
Panel meetings
5. Meeting time is used effectively.
6. Panel members have enough time during meetings
to discuss issues and ask questions before needing
to make decisions.
7. Meetings are appropriately focused on matters of
importance.
8. The advisory panel meets with sufficient frequency
and duration to adequately conduct its business.
9. Meetings are structured in a way that allows me to
participate as much as I want to.
Comments on panel meetings:
•
•
•
•
•
•
•
1
1
8
9
2
1
2
7
2
9
2
9
2
I think that the meetings are well designed and carried out and I appreciate the effort that goes into making
that run smoothly.
Sometimes it’s not possible to flush out all of the issues in the panel discussions. The alternative would be
to have more and/or longer meetings, but that is a difficult burden on people’s time,
Much time is often wasted on trivial matters and arcane details, rather than on big-picture decisions or on the longterm trajectory of the EHTB program. Responsibility for this lies not just with MDH but also with panelists.
Sometimes the meetings get a little hung up on procedural stuff and it leaves little time at the end for
thorough discussion of the technical things that we are being asked to do.
Some of the meetings seem to focus only on things that MDH has already decided to do. Sometimes the
panel seems to have little input into MDH decisions about biomonitoring
There were a couple of meetings where I felt the discussion was rushed because we were running out of
time. I would recommend placing the key discussion items early on the agenda if possible. Overall the
MDH staff support is excellent, my compliments to the staff!
Sometimes the panel gets side-tracked, but there is little that can be done about this given the strong
beliefs and personalities.
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Strongly
disagree
Disagree
Agree
Strongly
Agree
1
7
3
1
8
2
4
1
5
8
2
2
2
7
2
General panel membership
10. As a member of the EHTB panel, I feel my input is
valued.
11. Panel members are effectively engaged in making
recommendations to guide program decisions.
12. Decision-making processes are clearly defined.
13. I am clear about my roles and responsibilities as a
member of the EHTB panel.
14. I have found my participation on the EHTB panel to
be rewarding.
Comments on general panel membership:
•
•
•
•
Sometimes decision making is not clear.
The general atmosphere is that MDH seeks panel input on trivial matters and arcane details, rather than on
key decisions. On big-picture decisions, the agencies (MDH, MPCA, MDA) who have representatives on
both the panel and the interagency work group create a great deal of resistance to any alternate proposals
or questioning of the predetermined course of action presented at each meeting. Furthermore, MDH would
do well to hire a meeting moderator who is not an MDH staffer, in order to maintain impartiality in that role.
On the positive side, when issues have come to a vote, it appears that MDH follows the guidance of the
panel. This is a very good way to ensure that panelists feel we have a stake in matters discussed at these
meetings. Roles, decision-making processes, etc., have been lacking in clarity from the outset.
Responsibility for this lies not just with MDH but also with panelists and the chairperson.
Sometimes it is not totally clear where the line is between panel roles and MDH roles.
I think an advisory panel is a good idea but sometimes I feel we are just going through the motions and
being asked to approve things that MDH has already decided to do.
Thank you very much for your input!
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Advisory panel roles and decision-making processes
Drafted November 2008
Advisory panel roles: Statutory language
The role of the advisory panel, as defined in statute, is broad and includes responsibilities for
providing advice on both big picture program planning decisions and very detailed elements of
program implementation. Per statute, the advisory panel is to do all of the following:
BIOMONITORING
• Consult with MDH in developing:
o 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;
o Guidelines for ensuring the privacy of information; informed consent; follow-up
counseling and support; and communicating findings to participants, communities,
and the general public;
o Educational and outreach materials that are culturally appropriate for dissemination to
program participants and communities;
o A training program that is culturally sensitive specifically for health care providers,
health educators, and other program administrators;
o A designation process for state and private laboratories that are qualified to analyze
biospecimens and report the findings; and
o A method for informing affected communities and local governments representing
those communities concerning biomonitoring activities and for receiving comments
from citizens concerning those activities.
(144.997 Biomonitoring Pilot Program. Subdivision 4a, 1-6)
•
Provide advice to MDH, after the program guidelines in subdivision 4 are developed, on
implementing a biomonitoring pilot program. (144.997 Biomonitoring Pilot Program.
Subdivision 1)
•
Work with MDH to interpret analytical results from biomonitoring, communicate findings to
the public, and plan ensuing stages of biomonitoring work (144.996 Environmental Health
Tracking; Biomonitoring. Subdivision 2.4)
•
Following the conclusion of the pilot program, work with MDH 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; work with MDH to assess the pilot program, including but not limited to the
validity and accuracy of the analytical measurements and adequacy of the guidelines and
protocols (144.997 Biomonitoring Pilot Program. Subdivision 2b, 1-2)
57
•
Make recommendations to MDH and the legislature on:
o priorities for biomonitoring that are based on sound science and practice, and that will
advance the state of public health in Minnesota;
o specific communities and geographic areas on which to focus biomonitoring efforts;
o specific chemicals to study under the biomonitoring program, with the agreement of
at least nine of the advisory panel members;
o other aspects of the design, implementation, and evaluation of the biomonitoring
program, including, but not limited to:
ƒ identifying possible community partners and sources of additional public or
private funding;
ƒ developing outreach and educational methods and materials; and
ƒ disseminating biomonitoring findings to the public.
(144.998 Environmental Health Tracking and Biomonitoring Advisory Panel. Subdivision 3.)
ENVIRONMENTAL HEALTH TRACKING
• Make recommendations to MDH and the legislature on:
o priorities for health tracking;
o specific chronic diseases to study under the environmental health tracking system;
o specific environmental hazard exposures to study under the environmental health
tracking system, with the agreement of at least nine of the advisory panel members;
o specific communities and geographic areas on which to focus environmental health
tracking efforts;
o other aspects of the design, implementation, and evaluation of the environmental
health tracking system, including, but not limited to:
ƒ identifying possible community partners and sources of additional public or
private funding;
ƒ developing outreach and educational methods and materials; and
ƒ disseminating environmental health tracking findings to the public.
(144.998 Environmental Health Tracking and Biomonitoring Advisory Panel. Subdivision 3.)
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Advisory panel roles: Application of statutory language
The broad scope of the panel’s statutorily defined role combined with time constraints faced by
MDH (e.g., the limited number of meetings/hours available to meet with the advisory panel, the
number of projects needing to be launched) have presented – and will probably continue to
present – challenges in terms of involving the panel in all areas defined in the legislation.
Staff need to be selective about determining which items to present to the advisory panel for
discussion and input. This choice may be affected by a number of issues, including the
following:
o which program decisions can be held until the panel meets again (versus those that need
to made quickly in order to keep projects moving)
o which decisions are most important and/or would benefit most from broad input by panel
members
o which decisions are potentially the most contentious
o which decisions statutorily require a vote
Some elements of program design, especially in terms of the biomonitoring pilot projects, are
articulated in the legislation. This at times limits the opportunities for panel members to provide
input on some program design issues.
This set of circumstances has been challenging for program staff to navigate and has also been
understandably frustrating for many panel members. As the EHTB program enters the next phase
of implementation, there will be new opportunities to shape the way the advisory panel interacts
with the program. It is the intention of the program to take full advantage of the range of
expertise represented on the panel and to seek ways to involve the panel in meaningful ways in
setting the course for the environmental health tracking and biomonitoring programs. In the
future, an increased emphasis will likely be placed on longer-term planning and priority setting
for both the tracking and biomonitoring parts of the program.
Program staff welcome feedback at any point on how to improve the advisory panel’s role and
relationship to the EHTB program. A portion of the December agenda will be dedicated to
soliciting panel members’ input on this topic.
59
Decision-making processes
The EHTB program’s governance structure involves multiple groups, including program staff, an
interagency workgroup, a steering committee (which functions as the commissioner of health’s
designated representative), and a science advisory panel. Each of these groups has a role in the
decision-making process for the EHTB program.
Broadly speaking, the role of the workgroup is to provide the EHTB program with internal
expertise for designing and implementing the program’s workplan and activities. The role of the
advisory panel is to provide the EHTB program with external expertise and to make
recommendations regarding development and implementation of the program. The steering
committee provides the EHTB program administrative guidance, serves as a liaison to legislative
leaders, informs the commissioner of health, and makes program-related decisions in the absence
of consensus on recommendations among workgroup, staff or advisory panel members.
The key steps in the decision-making process (which are described in more detail in the EHTB
advisory panel operating procedures) include the following:
1. MDH staff and workgroup members prepare background and supporting materials for
advisory panel review. Preliminary consideration of issues and the preparation of materials
may involve the EHTB staff, members of the workgroup, other internal or external experts, or
members of the advisory panel. Materials pertaining to specific topics are usually provided
to the panel in written form for discussion during a panel meeting.
2. The advisory panel provides advice to the EHTB program and, in some cases, develops
formal recommendations. Advisory panel members are asked to discuss and debate the issues
under consideration. This may result in a formal vote on a specific recommendation being
made to MDH, though more often panel members’ advice is in the form of a range of
opinions for program staff to consider in further developing program plans.
3. MDH staff members refine program plans. The range of advice provided by the advisory
panel – along with advice received from other sources, such as community members and
other stakeholders – is carefully considered by staff and adjustments are made to program
plans and materials accordingly. When a formal recommendation is made by the advisory
panel, program staff will consider it particularly carefully. If for any reason the EHTB
workgroup or staff do not feel they can implement the recommendations made by the panel,
they refer the issue to the EHTB steering committee, which officially represents the
commissioner of health, for a decision.
4. The commissioner of health, represented by the EHTB steering committee, reviews
recommendations and makes final decisions. Program staff hold monthly meetings with the
EHTB steering committee to keep them apprised of program plans. Steering committee
members also attend advisory panel meetings directly. Advice and recommendations from the
advisory panel are presented to the steering committee at these meetings. If the EHTB
workgroup does not feel they can implement specific advisory panel recommendations, the
workgroup provides the steering committee with a summary of all known viewpoints on the
issue. The steering committee then makes a final decision. If a specific recommendation of
the advisory panel is not adopted, the advisory panel will be notified at their next meeting.
60
Section overview: EHTB legislative report
The Environmental Health Tracking and Biomonitoring statute requires the EHTB program to
submit a report to the legislature on January 15, 2009. This report is to describe the status of
biomonitoring and environmental health tracking activities. The report is currently under
development and will be reviewed by the EHTB workgroup and steering committee as well as
the MDH communications office and executive office before being finalized.
Included in this section is an outline of the legislative report. This is provided to give advisory
panel members a sense of what will be included in the required legislative report.
The legislative report will not include specific results for any of the biomonitoring pilot projects,
data from the tracking program, or recommendations for the development of an ongoing
biomonitoring program. This information will be released through separate reports during 2009.
As defined in statute, the advisory panel has a role in advising both the department of health and
the legislature. MDH wishes to ensure that the advisory panel’s voice is adequately heard in
relation to the legislative report. To this end, panel members are asked to provide input on what
information and recommendations should be incorporated into the January legislative report. A
portion of the December advisory panel meeting will be dedicated to this topic.
In addition, panel members are welcome to submit their own responses to the legislative report
and/or their own program recommendations directly to the legislative committee members
receiving the legislative report if they choose. Program staff will gladly provide contact
information for the legislators who receive the legislative report.
ACTION NEEDED: Panel members are invited to ask questions and to provide suggestions
for strengthening the legislative report.
No formal vote is anticipated on this agenda item.
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Outline for 2009 EHTB legislative report
1) Executive summary
2) Biomonitoring
i) Biomonitoring pilot program: Introduction
(a) Definition of biomonitoring
(b) Description of statute creating biomonitoring pilot program
(c) Comparison of design features (similarities and differences) of the four pilot
projects
ii) Minneapolis Children’s Arsenic Study
(a) Study community
(b) Study population
(c) Biospecimen
(d) Recruitment and enrollment
(e) Specimen collection and analysis
(f) Communication of individual results
(g) Community outreach
(h) Data analysis and dissemination of results
iii) East Metro PFC Biomonitoring Study
(a) Study communities
(b) Study population
(c) Biospecimen
(d) Recruitment and enrollment
(e) Specimen collection and analysis
(f) Communication of individual results
(g) Community outreach
(h) Data analysis and dissemination of results
iv) Lake Superior Mercury Biomonitoring Study
(a) Study community
(b) Study population
(c) Biospecimen
(d) Recruitment and enrollment
(e) Specimen collection and analysis
(f) Communication of individual results
(g) Community outreach
(h) Data analysis and dissemination of results
v) Riverside Prenatal Biomonitoring Study
(a) Study community and population
(b) Biospecimen
(c) Recruitment and enrollment
(d) Specimen collection and analysis
63
(e) Communication of individual results
(f) Community outreach
(g) Data analysis and dissemination of results
vi) Biomonitoring pilot program: Conclusions
(a) Description of how capacity has been built at MDH
1. Laboratory infrastructure/equipment/staffing
2. Laboratory analysis
3. Designing studies and obtaining necessary approvals to ensure high
quality work
4. Recruitment and enrollment of study participants
5. Community engagement and establishing community contacts
6. Communication of biomonitoring results
(b) MDH is poised to capitalize on the capacity that has been built if funding is
made available
vii) Biomonitoring program guidelines
(a) Description of how guidelines were developed
(b) Summary of main content areas and overarching guideline statements
(c) Description of how guidelines will be revised to inform future biomonitoring
efforts
viii)
Recommendations for ongoing biomonitoring in Minnesota
(a) Description of process being used to develop recommendations for
biomonitoring
(b) Summary of the vision statement for a state biomonitoring program
(c) Description of possible purposes and models for biomonitoring
(d) Description of process being used to develop recommendations for chemicals
to include in a biomonitoring program
(e) Description of plans for releasing a report on recommendations
3) Environmental Health Tracking
i) Minnesota Environmental Health Tracking System (MEHTS): Introduction
(a) Background on tracking
(b) Goals of MEHTS
(c) Types of data that are part of tracking programs in general (hazard, exposure,
health outcomes)
(d) Relationship between MEHTS and the national tracking program
ii) MEHTS progress report
(a) Data collection and analysis
1. Description of specific data and measures being analyzed, including
rationale for selection
2. Description of steps involved in data analysis
3. General limitations of the data
4. Benefits and challenges of focusing on nationally consistent data as a
starting point
64
(b) New indicator development
(c) Developing indicators of public health impact: air quality and health data
linkage study
(d) Data dissemination
1. Plans for releasing surveillance report in 2009
2. Plans for developing an online data portal
(e) Stakeholder engagement efforts
(f) Strategic planning efforts
1. MEHTS mission statement
2. Strategic goal areas
(g) Recommendations for a comprehensive tracking program
iii) MEHTS: Future directions
(a) Evaluation of the initial data and measures
(b) Further development of Minnesota-specific priorities
(c) Assessing gaps in the available data
(d) Dissemination of MEHTS data
(e) Education of potential data users
4) EHTB advisory panel
i) Composition of the panel
ii) Scope of the panel’s duties
iii) Description of meetings held and types of decisions made in 2007-08
iv) Challenges faced and future directions
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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 status updates on the following items:
•
Environmental health tracking data portal
•
Chemical selection process
•
Minneapolis Children’s Arsenic Study
•
East Metro PFC Biomonitoring Study
•
Lake Superior Mercury Biomonitoring Study
•
Riverside Prenatal Biomonitoring Study
ACTION NEEDED: At this time, no formal action is needed by the advisory panel. Panel
members are invited to ask questions or provide input on any of these topics during the
designated time on the meeting agenda.
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Status update on the environmental health tracking data portal
As has been previously described, the CDC-funded state Environmental Public Health Tracking
programs have been developing state web sites that will facilitate access to tracking data. CDC
itself is developing a National Environmental Public Health Tracking Network, a data portal that
will include state and national data. Unfortunately, the CDC national portal has just been delayed
a second time, and is now expected to be rolled out in February 2009.
The EHTB program, with the concurrence of the advisory panel, has been following CDC
guidelines and definitions in developing indicators to maintain comparability with other states
and allow for the possibility of providing Minnesota indicator data to the national portal.
Dissemination of tracking data is a primary objective of the EHTB program. EHTB staff
recognize that developing a data portal would not only be consistent with the work being done in
other tracking states but would be an effective way of making data widely available to the public.
To this end, staff are beginning work to develop such a portal specific to Minnesota.
EHTB staff have viewed webinar demonstrations of portals under development in other states
and conducted a site visit to the Wisconsin Department of Health Services (a CDC-funded
tracking state) to identify various approaches to a data portal and to learn more about the
resources required for portal development. Following these activities, EHTB staff determined
that it would not be feasible to develop a tracking web portal “from scratch.” However, it may be
feasible to adapt (with appropriate authorizations) an existing data portal for use in Minnesota.
An obvious candidate to consider is the system developed by the Utah Department of Health, the
Indicator-Based Information System for Public Health (IBIS-PH, or just IBIS). The IBIS site can
be accessed at: http://ibis.health.utah.gov/home. Not only is this a well-established and powerful
data portal, this system is being adapted for use in several other CDC-funded tracking programs
(Missouri, New Jersey, New Mexico, and Arizona).
EHTB staff have been working with the MDH Information Systems & Technology Development
(IS&TM) division staff to identify internal and external resources needed to evaluate the Utah
IBIS system and begin designing a Minnesota web portal based on this system. IS&TM is
providing project management, systems architecture development, and other IT consultation to
EHTB as needed.
To date, evaluation of the IBIS system has shown that the development environment and
software used for IBIS is compatible with systems used at MDH, thus minimizing the costs and
development resources. Furthermore, a software license agreement between MDH and Utah has
been accepted and should be signed in the very near future. This will allow MDH to download
programs from the IBIS site and begin detailed evaluation of the resources and time required to
adapt these programs to EHTB program needs.
69
Concurrent with the evaluation and development of a data portal architecture, EHTB staff are
moving forward with prioritizing indicators to be included initially on the data portal. Staff have
selected the indicators for drinking water quality as the initial content area to be put into the data
portal. EHTB staff are currently working with the MDH drinking water program staff to
determine the specific drinking water quality data that might be included in the portal, how that
data could best be represented (maps, tables, charts), needs of data users, etc.
Depending on the resources required to adapt IBIS and develop the portal for drinking water
quality indicator data, a late spring 2009 timeframe is planned. It is hoped that at least one health
outcome indicator will also be included in the initial deployment of a Minnesota IBIS system in
2009.
70
Status update on chemical selection process
At the advice of the EHTB advisory panel, and in accordance with the EHTB statute (which
directs MDH to make recommendations for an ongoing biomonitoring program), MDH is
engaged in a process to prioritize chemicals for possible inclusion in a future state biomonitoring
program. [For more information about this topic, please see the meeting materials and summaries
for the June 3 and March 11 advisory panel meetings.]
The first stage of this process was to solicit nominations for chemicals from the public and from
state agency staff. The input MDH received is summarized in the following documents, which
are included in this section of the meeting materials:
•
•
•
•
Chemical nomination results (Note: This includes a summary of the public survey and
interviews with state agency staff)
Appendix A: Letter from Minnesota Center for Environmental Advocacy
Appendix B: Letter and attachments from the Minnesota Department of Agriculture
Appendix C: NHANES chemicals list
The next stage in the chemical selection process will be to score the nominated chemicals, along
with the list of chemicals included in NHANES, using the selection criteria previously reviewed
by the advisory panel. The criteria include the degree of exposure to the chemical in the
population; the seriousness of health effects associated with the chemical; the adequacy of a
method to detect the chemical; the interpretability of the result; actionability based on the result;
feasibility; and the potential for information building. The scoring process will likely involve
both internal and external experts.
It is anticipated that the scoring process will be completed by the March advisory panel meeting,
when the panel will be asked to make recommendations for chemicals for possible inclusion in
an ongoing biomonitoring program. These recommendations may be based in part on the scores
received by the nominated chemicals and in part on other factors that panel members wish to
consider. The recommendations made by the advisory panel will be reviewed by program staff in
consultation with the commissioner of health; the final recommendations of the commissioner
will likely be included in a report to the legislature in Spring 2009.
71
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72
Chemical nomination results
November 2008
Background
The Environmental Health Tracking and Biomonitoring (EHTB) program is required to submit
recommendations to the legislature for developing an ongoing biomonitoring program in
Minnesota. One component of these recommendations will be to describe priorities for chemicals
that should be measured in a future biomonitoring program. To inform these recommendations,
the EHTB program sought input on priority chemicals from both the public and targeted state
agencies.
Part 1: Online survey
An online survey was developed to provide an opportunity for members of the public to make
recommendations for the types of chemicals that are important to them. The online survey was
posted for four weeks, from September 3 through October 1, 2008. An announcement about the
survey was sent out via the EHTB program’s email list of over 225 people. A link to the survey
was also posted on the EHTB program’s website. EHTB workgroup and advisory panel members
were asked to distribute the survey link to their contact lists. Potential respondents also had the
option of providing input on priority chemicals via email or U.S. mail.
Part 2: Input from state agencies
Staff from seven state and regional agencies that potentially deal with environmental chemicals
were contacted to provide input on priority chemicals. In many cases, more than one division or
program within an agency was contacted. Potential respondents were offered the option of
providing input via email, phone, or in person. The contacted agencies included the following:
•
•
•
•
•
•
•
Minnesota Department of Agriculture
o Pesticide and Fertilizer Management Division
Minnesota Department of Health
o Environmental Health Division
o Health Promotion and Chronic Disease Division
o Public Health Laboratory Division
Minnesota Department of Labor and Industry (MN OSHA)
o Industrial Hygiene
o Research and Education Unit
Minnesota Department of Transportation
o Office of Environmental Services
Minnesota Poison Control System
Minnesota Pollution Control Agency
o Environmental Analysis and Outcomes Division
Metropolitan Council
o Environmental Services Division
73
Part 1: Online Survey
Respondent demographics
Response to the online survey was limited, with only 15 respondents. The low response was
most likely due to the fact that limited outreach was undertaken to promote the survey and
because the biomonitoring program in general is not well known throughout the state.
All of the respondents were Minnesota residents.
The majority of respondents (60%; n=9) were from state (n=7) or local/regional (n=2)
government agencies.
State government
Individual
Local or regional government
Nonprofit/Community-based organization
Business
Tribal
Other (please specify)
47% (7)
20% (3)
13% (2)
7% (1)
7% (1)
7% (1)
0% (0)
Given the limited response and the fact that so many of the respondents were from government
agencies, the survey does not reflect true public opinion about priority chemicals. In addition,
some of the respondents who completed the online survey may also have been included in the
input gathering process from state agencies, so some results may be duplicative.
74
Results
Respondents were asked to rank their five highest priorities from a list of different types of
chemicals. Respondents’ priorities spanned the whole list of chemical types. Each type of
chemical included in the list received at least three votes. All but three of the chemical types
listed were selected by at least one respondent as their top priority. Metals were indicated as the
top priority by the most respondents (n=4). Metals and chemicals used in farming received the
most votes overall (9 each); pesticides, herbicides and other chemicals used in homes and
schools and chemicals found in or on food ranked next highest.
Q1. We are exposed to chemicals in many
different ways. The table below lists different
kinds of chemicals. Please tell us which five
categories of chemicals you think are the most
important for Minnesota's biomonitoring
program to measure. Check 1 for your highest
priority, 2 for your next highest priority, etc. You
can check each number only once.
a. Metals, such as mercury, lead and arsenic
b. Pesticides, herbicides or other chemicals used
in farming, including those used to control
weeds, insects and fungi
c. Pesticides, herbicides or other chemicals used
in or around homes and schools, including
those used to control weeds, fleas, ticks, and
other insects
d. Chemicals found in or on food
e. Chemicals found in plastics, such as those
used in packaging, toys, water bottles, and
other consumer products
f. Chemicals found in personal care products,
such as cosmetics and shampoo
g. Chemicals that may contaminate the drinking
water
h. Chemicals that result from burning trash,
plastic, and tires
i. Chemicals that result from burning oil,
gasoline, diesel or coal, such as from cars,
buses, trucks and power plants
j. Flame or fire retardants, such as those found
in furniture and electronics
k. Chemicals found in cleaning supplies
l. Chemicals found in workplaces
m. Chemicals from industrial plants or hazardous
waste sites
n. Other (Please specify)
• Not specified
• PM 2.5
• Indoor air pollution & ETS
1
4
1
2
2
2
3
2
1
4
1
4
5
0
1
Total
respondents
ranking this
chemical
group in their
top five
9
9
0
1
4
0
3
8
1
1
3
0
1
3
3
2
0
0
8
6
3
0
0
1
1
5
1
3
1
0
0
5
1
1
0
1
1
4
0
0
1
0
3
4
1
0
0
0
2
3
1
1
0
0
0
1
1
0
0
0
1
1
1
1
1
3
3
3
3
1
1
1
75
Fewer than half of the respondents answered the open-ended survey questions. Six respondents provided suggestions for specific
chemicals or types of chemicals. At least one of the respondents indicated chemicals that would be measured in environmental
samples, not through human biomonitoring. Five respondents provided a rationale for why the chemicals they selected were important to
measure. Several of the respondents’ answers related to their top five selections for types of chemicals (Q1) rather than to a specific
chemical that they had singled out in question 2.
Q2. What specific chemicals do
you think are most important for
Minnesota’s biomonitoring
program to measure?
Respondent 1
(from local/
regional govt.)
diesel fumes, welding fumes
Respondent 2
(from
individual
citizen)
Respondent 3
(from
individual
citizen)
Respondent 4
(from state
govt.)
Respondent 5
(from tribal
agency)
VOCs
Respondent 6
(from local/
regional govt.)
I think all the above are important.
I am personally most interested to
know about man made chemicals
that are of particular harm to
unborn and young children.
Q3. Nominated chemicals will be scored
according to the criteria listed below.*
Keeping these criteria in mind, why do you
think it is important to measure the
chemicals that you listed above?
b. Seriousness of health effects resulting from
exposure *
water quality - phosphorous in
lakes
health effects
BP-3, Parabens, Musk fragrances,
Siloxanes, PCBs, Dioxin
A, B, D, E, F, G *
Heavy metals
(1) Water is life (2) You are what you eat (3) ...
and Breathe (4) Pesticides and herbicides often
end up in the water (see 1) (5) Fossil fuel
combustion products end up in the Air.
Q4. Please provide any additional
comments you may have regarding
Minnesota’s biomonitoring
program.
I have called risk management and
they say they will monitor the
situation but they never seem to
follow through.
I appreciate the efforts of the PCA
Good Luck! Hope you get funding.
76
Respondent 7
(from state
govt.)
Lead, mercury and arsenic are known human
health hazards and current exposures in the
general population occur at levels that are likely
to affect population health. Lead and mercury
in particular affect children. MDH should be
monitoring the effectiveness of programs that
are currently in place to minimize exposure to
these chemicals. This is my first priority.
Second priority should go to chemicals in the
indoor environment, particularly ETS exposure.
This chemical is a likely contributor to disease
in the general population from an
environmental exposure, especially to children.
Other chemicals used indoors and household
products, such as pesticides, should also be
examined. Individuals can control these
exposures if they are more aware of the risks.
Emphasis should be place on chemicals that
affect children and other vulnerable people.
Program should look for and identify subgroups with greater exposure so that prevention
resources are directed appropriately.
*Scoring criteria
A. Degree of exposure in the state population or a sub-population of interest
B. Seriousness of health effects resulting from exposure
C. Interpretability of the result (e.g., availability of appropriate numbers for comparing the results; degree of information known
about what different levels in the body mean)
D. Actionability (e.g., ability for public health action to be taken to stop the exposure; there is a need to assess the effectiveness of
prior public health actions to reduce exposure)
E. Potential for information building (e.g., degree to which studying the chemical would add to the existing knowledge base about
chemical exposures; degree of public concern)
F. Ability to measure the chemical (e.g., adequacy of analytical methods to detect the chemical; availability of adequate biospecimen
samples; degree to which the chemical stays in the body long enough to be measured)
G. Feasibility (e.g., cost; capacity)
77
Four additional responses containing suggestions for chemicals to measure were received via email and
U.S. mail. (Potential respondents were offered the option of completing the survey online or submitting
suggestions by email or U.S. mail.) The following chemicals were suggested:
o Atrazine
o Sprayed or “drift” exposure to agricultural pesticides (in general)
o Vinyl chloride
o Metabolites of organophosphate insecticides: diethyl-phosphate, diethyl-thiophosphate
(metabolites of chlorethoxyfos, chlorpyrifos, diazinon, disulfoton, phorate and terbufos) [See
letter from the Minnesota Center for Environmental Advocacy in Appendix A.]
Part 2: State agency input
Respondent demographics
Most contacted agencies participated by providing input. Most input came via in-person meetings/group
discussions attended by EHTB staff. In four cases, input came via email or phone.
In almost all cases the contacted person from each agency consulted with several others in their agency
in assembling a response. Over 40 people were included in the process.
Results
Respondents were asked to suggest priority chemicals for biomonitoring based on their specific
perspective and knowledge. They were also asked to describe how having biomonitoring data for the
chemicals suggested would be useful to their programs. Specific questions posed to potential
respondents included the following:
1. Based on your program’s expertise, what chemicals (or chemical families/types of chemicals)
should be biomonitored in Minnesota? These might be chemicals that:
• Are a particular concern for your program or your program’s stakeholders
• Your program sees as an emerging concern or an ongoing concern
• Are of concern because Minnesotans have higher exposure than people in other states
• Are of concern because exposure is widespread, either statewide or within specific
subpopulations
• Have the potential to cause significant health effects
• Your program would like to see biomonitored because doing so would help you assess your
program’s effectiveness or plan future program directions
2. Why is it important to your program that these chemicals be biomonitored?
3. How would your program use the information gained by biomonitoring for these chemicals?
78
Suggestions for priority chemicals were made without specific discussion of the feasibility of measuring
the chemicals in the body. As such, some nominated chemicals may be inappropriate for human
biomonitoring, but may be feasible to measure through ongoing disease surveillance, environmental
health tracking, medical research, and other mechanisms.
Specific chemicals or families of chemicals mentioned by state agency staff are listed below. If
chemicals were suggested by more than one program, this is indicated in parentheses.
•
•
•
•
•
•
•
•
Metals
o arsenic (x3)
o copper
o lead (x4)
o mercury (x2)
o cadmium (x2)
o manganese
Environmental phenols
Phthalates (x2)
Parabens
Polybrominated diphenyl ethers (PBDEs)
Perfluoronated chemicals (PFCs) (x2)
Volatile organic compounds (VOCs)
(generally)
o Formaldehyde (specifically)
o Methyline chloride
(specifically)
Pesticides and herbicides (generally) (x3)
o Atrazine (specifically)
o Pyrethroids (specifically)
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Polycyclic aromatic hydrocarbons (PAHs)
PCBs
Nitrosamines
Cotinine (x2)
Carbon Monoxide (x2)
Hydrogen Sulfide (x2)
Radon (x2)
Mold
Sulfates
Disinfection byproducts
Asbestos (x2)
Isocyonates (x2)
Dioxins (x3)
Glyphosate
Ethyl alcohol
Silica
Hexavalent chromium
Siloxanes
Nitrates
PM 2.5
The Minnesota Department of Agriculture did not submit specific suggestions for chemicals for
biomonitoring, but provided a great deal of data on the sale of pesticide ingredients sold in Minnesota.
These data will be helpful as the biomonitoring program weighs future priorities. [See Appendix B.]
In addition to specific chemicals or chemical families, broad types of chemicals and exposures were also
mentioned by some respondents. Some specific subpopulations were also suggested as a priority for
biomonitoring. These included the following:
• Endocrine disruptors and estrogenic chemicals (x2)
• Pharmaceuticals
• Emerging contaminants and/or chemicals of strong public concern (x3)
• Chemicals with known neuro-developmental effects
• Chemicals used in the highest volumes in Minnesota
• Occupational exposures (e.g., roofing, mining, construction, beauty shops, casinos) (x4)
• Exposed geographic communities (x2)
• Children
• Newborns (e.g., using newborn blood spots) (x2)
79
State agency staff members were not asked to make their nominations for specific chemicals within the
context of a specific model for biomonitoring (e.g., population-based surveillance, site-specific
biomonitoring, etc.). Some of the chemicals nominated were suggested within the context of specific
subpopulations – such as people working in certain occupations (e.g., construction, mining,
manufacturing, agriculture, hair salons, casinos) or people living in a particular area (e.g., geographic
areas with known contamination issues, people living near feedlots or water treatment facilities) – and
others were suggested within the context of a population-wide biomonitoring program. Once the purpose
of an ongoing biomonitoring program is determined, state agency staff may be able to provide more
meaningful input for selecting priority chemicals.
Those consulted expressed varied opinions about the factors that should be considered in determining
the focus of a statewide biomonitoring program. One question that came up in several interviews related
to the degree to which a biomonitoring program should focus on exposures about which something is
known and for which something can be done to stop further exposure from occurring. Some suggested
that chemicals chosen should be linked to specific interventions that could be implemented and that
there must be a demonstrable public health benefit to any testing done.
Other considerations cited by those consulted included the following:
• The degree to which a biomonitoring program could contribute to other organizations’ research
(e.g., by establishing a bio-bank of specimens) even if the state itself could not feasibly conduct
health research.
• Whether it would be possible to add biomarkers of health status to the analysis of biospecimens
(e.g., glucose levels, lipids, kidney function, liver function).
• The need to coordinate with programs and to communicate what chemicals are ultimately
selected for biomonitoring.
• The potential for collaboration with public utilities and county officials if a site-based approach
were selected.
• The need to gather detailed participant information (e.g., exposure information, worksites, health
outcomes) in order to make the biomonitoring data most useful.
• The potential for supplementing NHANES data by focusing on specific ethnic groups (e.g.,
Somali, Hmong) or to look at exposures that may be higher in Minnesota than the rest of the
nation.
Many of those consulted had a difficult time articulating how the results of biomonitoring would directly
impact their work. Some of the suggested chemicals were deemed by respondents to be of great
academic or research interest but of limited practical use. However, some of the suggested chemicals did
have direct implications for programs’ work. For example, information on lead and mercury could be
used to evaluate efforts at MDH to reduce these exposures. Data on dioxins could potentially be used to
encourage voluntary reductions in emissions. Information on siloxane levels in humans could help
guide program decisions about future environmental sampling. Again, once the purpose of
biomonitoring is determined, stage agency staff may be able to provide more meaningful insight into the
applications of biomonitoring data to their work.
80
Next steps
All of the chemicals that were nominated through the online survey or by state agency staff – in addition
to the full list of chemicals that were measured in the 2003-2004 NHANES [see Appendix C] – will be
scored using the criteria listed above. The scores assigned to each nominated chemical will be provided
to the Environmental Health Tracking & Biomonitoring science advisory panel. The advisory panel will
then make recommendations to the Commissioner of Health about the chemicals that are the highest
priority for future biomonitoring.
This process will help inform planning for the biomonitoring program in Minnesota. Whether or not
biomonitoring is conducted in the future is dependent on issues of feasibility, including whether the
biomonitoring program receives additional funding.
81
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82
Appendix A: Letter from Minnesota Center for Environmental Advocacy
83
84
85
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86
Appendix B: Letter and attachments from Minnesota Department of Agriculture
87
88
89
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108
Appendix C: NHANES chemical list
109
110
Status update on the Minneapolis Children’s Arsenic Study
Recruitment and specimen collection
Recruitment, enrollment and specimen collection are completed. A total of 65 children were
enrolled in the study. This includes 40 children from households with soil arsenic levels above
20 ppm and 25 children from households with soil arsenic levels below the threshold. Program
staff are currently completing descriptive statistics of the recruitment and enrollment process.
Laboratory analysis
The MDH Public Health Laboratory incorporates numerous assessments of its quality system. In
spring 2008, the laboratory was inspected and was found to perform its procedures for urinary
arsenic in accordance with the federal Clinical Laboratory Improvement Amendments of 1988
(CLIA). Three times annually, the laboratory enrolls in proficiency testing studies hosted by
CDC for urinary arsenic and has reported satisfactory results consistently.
The Public Health Laboratory received an APHL/ CDC training award for biomonitoring
methods. Dr. Betsy Edhlund completed a training session at the Colorado state public health lab
and vendor-hosted sessions to become proficient on the method for speciating arsenic in urine.
The method for separating the arsenic species uses high-performance liquid chromatography
(HPLC), and the method for quantifying arsenic uses inductively coupled plasma mass
spectrometry (ICP-MS).
Dr. Edhlund analyzed the 65 urine samples for the Minneapolis Children’s Arsenic Study for
both arsenic and creatinine levels. Her arsenic results are reported as both µg/L urine and µg/g
creatinine. In accordance with the study protocol, all specimens with arsenic levels >15 µg/g
creatinine were speciated. Of the 65 samples collected, 23 met this criterion. Three of the total
arsenic levels were >50 µg/g creatinine, which is the study’s cut-off for a normal arsenic level.
This includes two specimens that had total arsenic levels between 150 and 200 µg/g creatinine.
Speciation results of these two samples indicate a very high percentage of organic arsenic
(arsenobetaine or arsenocholine), suggesting a dietary source. However, nothing on the surveys
of these two participants indicated a likely source of exposure. Final verification of speciation
results is expected in late November or early December.
Data interpretation and results dissemination
Individual total arsenic results have been sent to all participants. The three participants with
higher than normal results received a letter encouraging further follow-up with a physician. The
two participants with the highest results were also contacted by phone and arrangements were
made for them to see a physician for repeat testing. A second letter will be sent to participants
whose specimen is being speciated. Summary data analysis will begin shortly. Engagement of
the community around results dissemination will begin soon as well.
111
Status update on the East Metro PFC Biomonitoring Study
Recruitment and sample collection
As of November 17, 86 people have completed the consent process in the Lake Elmo/Cottage Grove
community; 61 people have completed the process in the Oakdale community. So far, 91 blood draws
have been completed, including 56 in the Lake Elmo/Cottage Grove community and 35 in the Oakdale
community.
The recruitment process has been challenging. Consent forms were initially sent to 100 randomly
selected individuals in each community. The names of these individuals were drawn from the
lists of names MDH received from its recruitment mailing. As refusals are received by MDH, a
replacement name is randomly generated from the original list of names in each community.
In the Lake Elmo/Cottage Grove community study staff have mailed consent forms to 124
individuals, which has resulted in 86 completed consents, 37 refusals, and no response from 1
person. In the Oakdale Community study staff have mailed out 124 consent forms, which has
resulted in 61 completed consents, 24 refusals, and 39 who have not yet responded.
Laboratory analysis
The lab has completed its internal method validation which included determining the precision
and accuracy of the method and the method detection limit. The lab is currently participating in
an external validation program which begins in November.
Specimen analysis is expected to begin in early December. As previously communicated to the
advisory panel (June 2008) the lab will be measuring 7 PFCs:
o PFBA Perfluorobutanoic acid
o PFBS
Perfluorobutane sulfonate
o PFPeA Perfluoropentanoic acid
o PFHxS Perfluorohexane sulfonate
o PFOS
Perfluorooctane sulfonate
o PFHxA Perfluorohexanoic acid
o PFOA Perfluorooctanoic acid
Physician education
Program staff have made presentations at two clinics in the study area. The purpose of the
presentations is to inform medical providers about the biomonitoring study; to provide them with
an overview of the current research on the health effects of PFCs; and to offer suggestions for
appropriate follow-up care for individuals who are concerned about their exposure to PFCs.
Additional presentations will be scheduled as needed.
Participant communication
The results letter and fact sheet have been approved by the MDH IRB. These communications materials
have been challenging to develop because there are so many unknowns concerning PFCs and health.
112
Status update on the Lake Superior Mercury Biomonitoring
Study
Approvals
Since the advisory panel meeting in September, the Lake Superior Mercury Biomonitoring Study
has received approval of the project Quality Assurance Project Plan from U.S. EPA and the
MDH IRB approved the informed consent materials and process.
Community outreach
Healthcare providers in northeastern Minnesota have been notified of the study through a letter
which provided background on the study and information on where to get further information.
The letter was co-signed by the Carlton-Cook-Lake-St. Louis County Community Health Board
Medical Consultant.
Study staff updated northeastern Minnesota county public health directors on the project status.
Meetings with local public health nursing supervisors are scheduled for week of December 1st to
work out logistics for their assistance in obtaining informed consent.
Recruitment
The first letters requesting informed consent were sent on November 24th.
113
Status update on the Riverside Prenatal Biomonitoring Study
Protocol development
Project protocols are being further refined by staff. Together with Dr. Logan Spector at the
University of Minnesota, staff are developing participant recruitment methods and materials
including an informational flyer, an introductory letter, and the informed consent document. The
informed consent document provides an opportunity for pregnant women enrolled in the
Riverside Birth Study to choose to participate in the biomonitoring project by collecting a urine
specimen at home and returning it via a courier service to the MDH laboratory for analysis. The
consent also offers the option for participants to choose whether to receive their individual
results and whether to allow MDH to store leftover specimen for future research purposes. When
materials are complete they will be submitted to the University of Minnesota Institutional
Review Board (IRB) and the MDH IRB for approval. Efforts to contact area community groups
are planned to engage them in discussion of results communication and interpretation.
Laboratory method development
The lab is working on methods development, using the protocol developed by CDC. Native
environmental phenol standards and appropriate labeled standards, where available, have been
received. Analyses will be processed on the lab’s triple quad mass spectrometer. Chemicals currently
proposed for analysis by the MDH lab include the following environmental phenols: bisphenol A
(BPA), triclosan, benzophenone (BP-3), methyl paraben, ethyl paraben, propyl paraben, and butyl
paraben. The development of the methodology will not be finalized until PFC analyses are completed.
MDH will submit subsamples to a designated commercial lab for cotinine analysis; cotinine
measurements will be compared to a national reference range for non-smokers as an indicator of
exposure to environmental tobacco smoke.
The table below summarizes the limits of detection (LOD) in urine for each of these
environmental phenols as determined by CDC as well as the range found, geometric mean, 95th
percentile values and the % of detects above LOD for the population studied.
Analyte
Bisphenol A1
Triclosan2
Benzophenone-33
Methyl Paraben4
Ethyl Paraben4
Propyl Paraben4
Butyl Paraben4
LOD as
determined
by CDC
(ng/mL)
0.4
2.3
0.34
0.13
0.10
0.18
0.10
Range
(ng/mL)
Geometric
mean
(ng/mL)
0.4-149a
2.3-3790a
0.4-21700a
0.13-1670b
NRc
0.18-820b
NRc
2.6a
13a
22.9a
43.9b
1.0b
9.1b
0.5b
95th
percentile
value
(ng/mL)
15.9a
459a
1040
680b
47.5b
279b
14.5b
% detects in
reference
population
92.6a
74.6a
96.8a
99b
58b
96b
69b
114
1
Calafat A M et al. (2008) “Exposure of the U.S. Population to Bisphenol A and 4-tertiary-Octylphenol: 2003–2004.”
Environmental Health Perspectives. 116(1):39-44.
2
Calafat A M et al. (2008) “Urinary Concentrations of Triclosan in the U.S. Population: 2003–2004.” Environmental Health
Perspectives. 116(3): 303-307.
3
Calafat A M et al. (2008) “Concentrations of the Sunscreen Agent Benzophenone-3 in Residents of the United States: National
Health and Nutrition Examination Survey 2003-2004.” Environmental Health Perspectives. 116(7): 893-897.
4
Ye X et al. (2006) “Parabens as Urinary Biomarkers of Exposure in Humans.” Environmental Health Perspectives.
114(12):1843-1846.
a
NHANES 2003-2004, n = 2517
b
Other n = 100
c
NR, not reported
115
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116
Section overview: General reference materials
Three new documents are included in this meeting packet as items that may be of interest to
panel members:
•
New PFC citations (added since September 9, 2008)
•
Local, national and global biomonitoring and tracking news briefs
•
EHTB advisory panel meeting summary (from September 9, 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 (revised)
•
EHTB steering committee roster
•
EHTB interagency 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)
117
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118
New PFC Citations (added since September 9, 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.
Calafat A et al. (2007) “Polyfluoroalkyl Chemicals in the U.S. Population: Data from the National
Health and Nutrition Examination Survey (NHANES) 2003–2004 and Comparisons to NHANES 1999–
2000. Supplemental Material”
Chang S et al. (2008) Toxicological Sciences. “Comparative Pharmacokinetics of Perfluorobutyrate in
Rats, Mice, Monkeys, and Humans and Relevance to Human Exposure via Drinking Water.” 104(1):
40–53.
Perfluorobutyrate (PFBA) has been detected in precipitation, surface waters, water treatment
effluent, and in public and private wells in Minnesota at up to low mg/l concentrations. We evaluated
the pharmacokinetics of PFBA in rats, mice, monkeys, and humans to provide a rational basis for
dose selection in toxicological studies and to aid in human-health-risk assessment. Studies included
(1) rats—iv and oral; (2) mice—oral; (3) monkeys—iv; and (4) humans—occupationally exposed
volunteers. PFBA was determined in serum (all species), liver (rats and mice), urine (rats, mice, and
monkeys), and feces (rats and mice). In addition, we characterized serum PFBA concentrations in
177 individuals with potential exposure to PFBA through drinking water. Mean terminal serum
PFBA elimination half-lives for males (M) and females (F), respectively, in h were (1) for rats given
30 mg/kg, 9.22 and 1.76 (oral), and 6.38 and 1.03 (iv); (2) for mice given oral doses of 10, 30, or
100 mg/kg ammonium PFBA, 13.34 and 2.87 at 10 mg/kg, 16.25 and 3.08 at 30 mg/kg; and 5.22 and
2.79 at 100 mg/kg; (3) for monkeys given 10 mg/kg iv, 40.32 and 41.04; and (4) for humans, 72.16
and 87.00 (74.63 combined). Volume of distribution estimates indicated primarily extracellular
distribution. Among individuals with plausible exposure via drinking water, 96% of serum PFBA
concentrations were < 2 ng/ml (maximum 6 ng/ml). These findings demonstrate that PFBA is
eliminated efficiently from serum with a low potential for accumulation from repeated exposure.
D’Eon J and Mabury S. (2007) “Production of Perfluorinated Carboxylic Acids (PFCAs) from the
Biotransformation of Polyfluoroalkyl Phosphate Surfactants (PAPA): Exploring Routes of Human
Contamination.” Environmental Science and Technology. 41(13): 4799-805.
Perfluorinated acids are detected in human blood worldwide, with increased levels observed in
industrialized areas. The origin of this contamination is not well understood. A possible route of
exposure, which has received little attention experimentally, is indirect exposure to perfluorinated
acids through ingestion of chemicals applied to food contact paper packaging. The current
investigation quantified the load of perfluorinated acids to Sprague-Dawley rats upon exposure to
polyfluoroalkyl phosphate surfactants (PAPS), nonpolymeric fluorinated surfactants approved for
application to food contact paper products. The animals were administered a single dose at 200
mg/kg by oral gavage of 8:2 fluorotelomer alcohol (8:2 FTOH) mono-phosphate (8:2 monoPAPS),
or the corresponding di-phosphate (8:2 diPAPS), with blood taken over 15 days post-dosing to
monitor uptake, biotransformation, and elimination. Upon completion of the time-course study the
animals were redosed using an identical dosing procedure, with sacrifice and necropsy 24 h after the
second dosing. Increased levels of perfluorooctanoic acid (PFOA), along with both 8:2 PAPS
119
congeners, were observed in the blood of the dosed animals. In the 8:2 monoPAPS-dosed animals,
8:2 monoPAPS and PFOA blood concentrations peaked at 7900 ± 1200 ng/g and 34 ± 4 ng/g
respectively. In the 8:2 diPAPS-dosed animals, 8:2 diPAPS peaked in concentration at 32 + 6 ng/g,
and 8:2 monoPAPS and PFOA peaked at 900 ± 200 ng/g and 3.8 ± 0.3 ng/g, respectively. Several
established polyfluorinated metabolites previously identified in 8:2 FTOH metabolism studies were
also observed in the dosed animals. Consistent with other fluorinated contaminants, the tissue
distributions showed increased levels of both PFOA and the 8:2 PAPS congeners in the liver relative
to the other tissues measured. Previous investigations have found that PAPS can migrate into food
from paper packaging. Here we link ingestion of PAPS with in vivo production of perfluorinated
acids.
Fei C et al. (2008) “Prenatal Exposure to Perfluorooctanoate (PFOA) and Perfluorooctanesulfonate
(PFOS) and Maternally Reported Developmental Milestones in Infancy.” Environmental Health
Perspectives.16(10): 1391-95.
BACKGROUND: Perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) are fluorinated
organic compounds present in the general population at low concentrations. Animal studies have
shown that they may affect neuromuscular development at high concentrations. OBJECTIVES: We
investigated the association between plasma levels of PFOS and PFOA in pregnant women and
motor and mental developmental milestones of their children. METHODS: We randomly selected
1,400 pairs of pregnant women and their children from the Danish National Birth Cohort. PFOS and
PFOA were measured in maternal blood samples taken in early pregnancy. Apgar score was
abstracted from the National Hospital Discharge Register in Denmark. Developmental milestones
were reported by mothers using highly structured questionnaires when the children were around 6
months and 18 months of age. RESULTS: Mothers who had higher levels of PFOA and PFOS gave
birth to children who had similar Apgar scores and reached virtually all of the development
milestones at the same time as children born to mothers with lower exposure levels. Children who
were born to mothers with higher PFOS levels were slightly more likely to start sitting without
support at a later age. CONCLUSION: We found no convincing associations between
developmental milestones in early childhood and levels of PFOA or PFOS as measured in maternal
plasma early in pregnancy.
Spliethoff H et al. (2008) “Use of Newborn Screening Program Blood Spots for Exposure
Assessment: Declining Levels of Perfluorinated Compounds in New York State Infants.” Environmental
Science and Technology. 42(14): 5361-67.
Temporal biomonitoring studies can assess changes in population exposures to contaminants, but
collection of biological specimens with adequate representation and sufficient temporal resolution
can be resource-intensive. Newborn Screening Programs (NSPs) collect blood as dried spots on filter
paper from nearly all infants born in the United States (U.S.). In this study, we investigated the use
of NSP blood spots for temporal biomonitoring by analyzing perfluorooctane sulfonate (PFOS),
perfluorooctane sulfonamide (PFOSA), Perfluorohexane sulfonate (PFHxS), perfluorooctanoic acid
(PFOA), and perfluorononanoic acid (PFNA) in 110 New York State (NYS) NSP blood spot
composite specimens collected between 1997 and 2007, representing a total of 2640 infants. All
analytes were detected in g90% of the specimens. Concentrations of PFOS, PFOSA, PFHxS, and
PFOA exhibited significant exponential declines after the year 2000, coinciding with the phase-out
in PFOS production in the U.S. Calculated disappearance half-lives for PFOS, PFHxS, and PFOA
(4.4, 8.2, and 4.1 years, respectively) were similar to biological half-lives reported for retired
fluorochemical workers. Our results suggest sharp decreases in perinatal exposure of NYS infants to
PFOS, PFOSA, PFHxS, and PFOA and demonstrate, for the first time, the utility of NSP blood spots
for assessment of temporal trends in exposure.
120
Washino N et al. (2008) “Correlations Between Prenatal Exposure to Perfluorinated Chemicals and
Reduced Fetal Growth.” Environmental Health Perspectives. doi:10.1289/ehp.11681 available via
http://dx.doi.org/ [Online 4 November 2008]
Background: Perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA) are man-made,
ubiquitous, and persistent contaminants in the environment, wildlife, and humans. Though recent
studies have reported interference with fetal growth in humans, the results are inconsistent.
Objectives: To investigate the correlation between relatively low levels of PFOS and PFOA in
maternal serum and birth weight and birth size. Methods: We conducted a hospital-based
prospective cohort study between July 2002 and October 2005 in Sapporo, Japan. A total of 428
women and their infants were involved in the study. Characteristics of the mother and infant were
obtained from self-administered questionnaire surveys and from medical records. Maternal serum
samples were analyzed for PFOS and PFOA by liquid chromatography-tandem mass spectrometry
(LC/MS/MS). Results: After adjusting for confounding factors, PFOS levels negatively correlated
with birth weight (per log10-unit: β = –148.8g, 95% confidence interval (CI): –297.0 to –0.5). In
addition, analyses stratified by gender revealed that PFOS levels negatively correlated with birth
weight only in female infants (per log10-unit: β = –269.4g, 95% CI: –465.7 to –73.0). However, no
correlation was observed between PFOA levels and birth weight. Conclusion: Our results indicate
that in utero exposure to relatively low levels of PFOS negatively correlated with birth weight.
121
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122
Local, national and global tracking and biomonitoring news
Star Tribune article on Minnesota’s biomonitoring program
In October 2008 the Star Tribune ran an article on Minnesota’s biomonitoring program. The
article describes the biomonitoring pilot projects (with a particular emphasis on the arsenic
project) and discusses some of the limitations of biomonitoring as a science. Panel members
Beth Baker and Samuel Yamin were both interviewed for the story, as was program director,
Jean Johnson. To read the complete article, go to www.startribune.com/local/30873604.html.
Canadian Health Measures Survey
Statistics Canada recently published a preliminary release of the Canadian Health Measures
Survey (CHMS). The survey, which is being conducted from 2007 to 2009, is similar to
NHANES. The survey collects direct physical measurements such as blood pressure, height,
weight, and physical fitness. Blood and urine samples are also being collected to test for
infectious diseases, nutrition, and environmental contaminants. Five thousand randomly selected
Canadians between the ages of 6 and 79 are being tested in fifteen collection sites.
Data from the CHMS will have a variety of uses. One of the most important contributions of the
CHMS will be to establish current levels for a broad range of environmental chemicals. This will
provide baseline data to track trends and to allow for comparisons with sub-populations in
Canada and with other countries. The results will also help to focus future research efforts on the
links between exposure and health, and provide information to guide action by governments.
The preliminary CHMS release includes biomonitoring data from about 2,500 respondents in the
first eight collection sites and results for levels of lead, mercury, and cadmium measured in the
blood of survey participants. This release is the subject of a report published by Statistics Canada
in the November 2008 issue of their journal “Health Reports” and can be accessed at
www.statcan.ca/healthreports. Complete results of the biomonitoring component of the survey,
including all the substances being measured, will be available in Summer 2010.
White paper on the National Report on Biochemical Indicators of Diet and Nutrition in the
U.S. Population – 1999-2002.
The National Association of Chronic Disease Directors recently released a report titled, “Diet
and Nutrition Surveillance for Chronic Disease” in response to CDC’s release of the first
“National Report on Biochemical Indicators of Diet and Nutrition in the U.S. Population, 19992002.” The national report and the white paper discuss data on biomarkers of nutrition status that
were collected as part of NHANES. The white paper can be found at www.chronicdisease.org;
the national report can be found at www.cdc.gov/nutritionreport.
123
Additional C8 Health Project preliminary results released
In October 2008, the C8 Health Study Science Panel held a press conference to release the first
study results. Dr. Kyle Steenland presented factors associated with high C8 levels in the
community, including current or former residence in water districts near to the DuPont
Washington Works plant, and having ever worked at the plant. He also discussed the increased
cholesterol levels among those with higher C8 levels in their blood, and the difficulty of knowing
whether the increase in cholesterol came before or after the increase in C8. He also discussed
another result which showed no increase in diabetes with increasing C8 levels. The three reports
describing the initial results can be found at www.c8sciencepanel.org/study_results.
124
EHTB advisory panel meeting summary
Summary of the
Minnesota Department of Health (MDH)
Environmental Health Tracking and Biomonitoring Advisory Panel Meeting
September 9, 2008
1:00 p.m.-4:00 p.m.
Advisory Panel Members - Present
Beth Baker (chair)
Geary Olson
John Adgate
Gregory Pratt
Bruce Alexander
Daniel Stoddard
Alan Bender
Advisory Panel Members – Regrets
Cecilia Martinez
Debra McGovern
David Wallinga
Samuel Yamin
Lisa Yost
Susan Palchick
Guest
Logan Spector
Welcome and introductions
Beth Baker, chairperson, welcomed all present to the meeting. Panel members and other participants
introduced themselves. Beth asked members to submit their signed conflict of interest forms, if they had
not done so already. She explained that Bruce Alexander would be presiding as chair for the latter part of
the meeting, as she needed to leave early. Beth reported that Susan Palchick will chair the next meeting
(scheduled for December 9, 2008) in Beth’s absence. Beth also noted the one-year anniversary of the
panel.
Receiving hospital data
Norman Crouch, chair of the EHTB Steering Committee and MDH Assistant Commissioner, reminded
the panel of the discussion related to hospital data from the previous meeting (and highlighted on page 78
of the meeting packet). It had been suggested that MDH look into how other states use personal data from
hospitalization records and how, at times, it would be important to link those data to environmental health
outcomes. Norm stated that MDH will be putting together a workgroup to explore the issue. He noted that
MDH must always be vigilant in guarding the privacy of individuals, and that this is a politically sensitive
issue.
Chemical selection process for future biomonitoring
Michonne Bertrand, EHTB program coordinator, reported that a public survey has been opened to
nominate chemicals for a future biomonitoring program. She noted that the timeline for the chemical
selection process that was included in the background book for the June 2008 panel meeting has since
been revised. The program staff has taken care to consider its aims, thereby delaying the start date for
125
soliciting nominations and public comment. The program will also solicit input state agency staff. The
intent is to present the results of the nomination process for the December 2008 advisory panel meeting
and to present the results of the scoring process for the March 2009 advisory panel meeting. It is
anticipated that the panel will develop a set of recommendations to the MDH commissioner for priority
chemicals for future biomonitoring. These recommendations would be made available to the state
legislature, in the event that any legislation is introduced to extend the biomonitoring program beyond its
current, two-year funding period.
A vision for biomonitoring in Minnesota
Michonne Bertrand reported that the EHTB program staff is enlisting a consultant to help articulate the
vision and goals for future biomonitoring in Minnesota. The hope is to include the vision in the report due
to the legislature on January 15, 2009. Alan Bender noted that a universal perception of biomonitoring
goals is lacking, so Minnesota is challenged to develop its own vision. Michonne acknowledged the
challenge, and she noted that different approaches to biomonitoring include community-initiated projects,
broad-based surveillance, and capturing an arising opportunity. She hopes to schedule a visioning retreat
in November, and the panel members are invited to participate. The outcome, which might encompass a
variety of models or goals, will be presented at the December 2008 panel meeting.
Arsenic and PFC biomonitoring pilot projects
Panel members were asked if they had questions or comments about the written updates provided in the
meeting materials (i.e., arsenic and PFC biomonitoring pilot projects). Lisa Yost noted the difficulties
biomonitoring staff have faced in recruiting participants for the arsenic study and recommended that any
remaining spots be filled with older children (e.g. teenagers) who reside in homes with high amounts of
arsenic in their soil.. Lisa acknowledged that such participants are less likely to ingest soil than young
children. Nonetheless, by focusing on households with high soil arsenic levels, the study might be more
likely to find individuals whose internal arsenic levels could lead to adverse health outcomes.
In response to questions, Adrienne Kari, EHTB biomonitoring coordinator, stated that approximately 90
children (including siblings) are now on the list representing parents who have agreed to enroll their
children in the arsenic study. Slightly more than half correspond to >20 ppm soil arsenic levels. She
pointed out that, because schools are in session and the weather is cooler in the fall, exposure to arsenic
from the soil in the yard is expected to be lower and there was an urgency to recruit children as soon as
possible.
Samuel Yamin asked if Smiley’s Clinic could contribute to the recruitment effort. Adrienne replied that
Smiley’s Clinic has also faced obstacles in recruiting participants for its own arsenic biomonitoring study,
even though prospective participants are already in the clinic and could readily hand a filled urine cup to a
clinic staff member.
Alan Bender commented that an important finding of this pilot relates to the methodological aspects of a
community-based recruitment scheme. The experiences learned in recruiting children in a diverse
neighborhood with multiple languages and low home ownership rates can inform future biomonitoring
study designs.
Beth Baker pointed out that, by contrast, the recruitment of adults from the eastern suburbs for the
perfluorochemicals (PFCs) biomonitoring study is relatively easy. Jean Johnson, EHTB Program
Director, noted that the EHTB program is ready to concentrate its recruitment efforts on the PFCs pilot.
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Mercury biomonitoring pilot project
John Stine, EHTB Steering Committee member and the MDH Environmental Health Division Director,
provided a brief status report for the mercury biomonitoring pilot project. He commented that, although
the panel has received reports on the study design for this Lake Superior basin mercury pilot at previous
meetings, the project has not started yet. The delay was chiefly due to a controversy regarding the use of
residual specimens stored by the MDH newborn screening program. Now the pilot is ready to move
forward. The EHTB steering committee has determined that the EHTB program will provide support to
the Lake Superior basin mercury pilot in lieu of conducting an independent mercury pilot primarily
because (1) it is prudent for MDH to accept the EPA grant for the Lake Superior basin study, and
Michigan and Wisconsin should not be held back by Minnesota, and (2) key legislators who co-authored
the EHTB enabling legislation provided favorable feedback for pursuing the proposed Lake Superior
basin study for the EHTB program.
Pat McCann, principal investigator for the EPA-funded study and the MDH fish consumption advisory
program director, gave an overview of the proposed biomonitoring study, “Mercury levels in blood from
newborns in the Lake Superior Basin.” She distributed a 2-page handout, “Lake Superior Mercury
Biomonitoring Study” that contained her PowerPoint presentation. Elaborating on informational materials
in the background book for the panel meting, she described the foundation for the study. Established in
1991, the Binational Program to Restore and Protect the Lake Superior Basin is a partnership between
federal, state and tribal governments. Lake Superior was selected as a demonstration site for zero
discharge of several persistent toxic substances. The reduction schedule for mercury calls for a reduction
from 1990 levels of 80% by 2010 and zero discharge by 2020.
In 2007, the EPA Great Lakes National Program Office awarded a grant to MDH for this Lake Superior
mercury biomonitoring study, and it plans to add a $25,000 supplement to the original $40,000 award.
The purpose is to assess Lake Superior population exposure to mercury by measuring mercury in residual
blood spots from newborns. Participants will be drawn from eligible ZIP codes in Michigan, Minnesota,
and Wisconsin. A noteworthy distinction of the Minnesota population is that MDH will seek and obtain
informed, written consent from Minnesota mothers before including their babies’ residual specimens in
the study.
With the anticipated EPA supplemental funding, the project will measure mercury levels in approximately
2,100 infants. Reflecting the proportion of recent births in the Lake Superior basin, this roughly
corresponds to 810 Michigan newborns, 1,160 Minnesota newborns, and 140 Wisconsin newborns.
The newborn screening programs from all three states will anonymize (i.e. remove personal identifiers
from) the residual specimens before submitting them to the biomonitoring study. Retained information
will be: state of mother’s residence, urban or non-urban based on mother’s ZIP code, gender, and month
of birth. Data analysis will describe population exposures, not individual exposures.
The EHTB program is providing $50,000 to this study to offset some of the in-kind costs that MDH staff
would be donating. These include costs incurred for the informed consent process for Minnesota
participants, the method development for mercury analysis in dried-blood spots on filter paper, drafting of
a detailed quality assurance project plan (QAPP), data analysis, overall project management, and
communications.
Because of the informed consent process and the desire to be sensitive to parents’ anguish if their babies
had a tragic outcome, the study program staff will exclude Minnesota newborns who meet the following
criteria: (1) risk factors have been checked on the newborn blood-spot card for sick baby, deceased
sibling, congenital anomalies, and maternal pregnancy complications; (2) results from newborn screening
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are abnormal; (3) the baby has been admitted to a neonatal intensive care unit (NICU) or had a birth
weight under 2,000 grams; and (4) the baby is known to be deceased.
In response to a question about potential bias in the sample compared to other states due to Minnesota’s
exclusion criteria, Pat replied that some exclusion criteria are applicable to all three states. For example, if
visual inspection of the newborn specimen card indicates that the hospital staff did not draw the blood
properly, the specimen will be rejected. Also excluded will be repeat specimens (i.e. specimens other than
the first specimen collected from a particular baby), and specimens collected from any baby whose blood
had been transfused.
Alan Bender asked if the extent of bias could be measured and reduced. He recognized that informed
consent was imposed on the original study design and recommended that the impact of an informed
consent process should be highlighted in the legislative report. For example, the exclusion of sick infants
from the Minnesota pool may bias the results, particularly since abnormally high mercury exposures
cause deleterious fetal health outcomes. Pat noted that exclusion criteria account for approximately 17%
of the Minnesota newborn specimens.
Greg Pratt recommended that the publication of study results could list the percentage of newborns in
each of the three states that would have met the Minnesota exclusion criteria. Thus the reader could
extrapolate the results for the missing Minnesota babies. It was recognized that such extrapolations should
not inadvertently normalize any differences in exposure between the three states.
In response to a question, Pat explained that the definitions of urban and non-urban followed the US
census definitions and were based on the number of people per square mile in each ZIP code. The
distinction might correlate with dietary intake of mercury. Geary Olsen recommended that the study’s
terminology of urban and non-urban to describe the Lake Superior basin might be misleading to the lay
public. He suggested that terms such as high- and low-population density might be received better.
The population exposure levels will be compared to the EPA methyl mercury RfD and CDC’s NHANES
mercury results (for women of childbearing age and for children ages 1-5). In the published NHANES
studies, 6 % of the women had mercury exposures above the reference dose. Among children aged 1-5
years, the estimated percentage who had mercury levels above the reference dose was too low for the
sample size to calculate a reliable population estimate. Newborns were not included in the NHANES
studies. David Wallinga asked if the Lake Superior basin measurements would distinguish between total
mercury and methyl mercury. Pat responded that the MDH laboratory will only measure total mercury. In
previous studies by CDC, almost all of the blood mercury in their specimens was found to be present as
methyl mercury.
Pat reported that the study is pending final approval by EPA, which is reviewing the QAPP document,
and by the MDH Institutional Review Board (IRB), which is reviewing the informed consent materials.
She anticipates a start date in October 2008.
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Fourth biomonitoring pilot project
Jean Johnson introduced the topic of the fourth biomonitoring pilot project. As described in the
Minnesota Statutes, the EHTB program is to conduct a pilot project that enrolls voluntary participants
from each of three communities likely to have been exposed to a designated chemical. The biospecimen
selected must be the biospecimen that most accurately represents body concentration of the chemical of
interest. Each biospecimen must be analyzed for one type or class of related chemicals.
Recruitment strategy for the fourth pilot
Jean explained that, in light of the time constraints and limited resources for pursuing this fourth
biomonitoring pilot, the EHTB program staff searched for an existing research investigation that could
accommodate an ancillary biomonitoring study. Fortunately, she found that the “Riverside Birth Study” is
starting in fall 2008, and that the principal investigator is willing to let the EHTB program add on the
collection of a urine sample onto his study. She invited the investigator to present the Riverside Birth
Study to the panel.
Logan Spector, Assistant Professor of Pediatrics in the Division of Epidemiology/Clinical Research at the
University of Minnesota, introduced himself to the panel. His research focuses on the causes of childhood
cancers. He distributed handouts that describe the study design for the Riverside Birth Study. The study
plans to enroll 500 pregnant women in Minneapolis clinics who plan to give birth at the University of
Minnesota Medical Center, Riverside campus. The study (without the EHTB biomonitoring component)
will measure specific metabolites in pregnant women and in newborn infants that may be involved in
causing childhood cancer. He plans to collect both dried-blood specimens and buccal cells from the
women. Dried-blood specimens, cord blood, and meconium will be collected from the infants. One aim of
the study is to evaluate storage conditions for bio-banked specimens for long-term recovery of biomarkers
of interest.
As designed currently, participants in the Riverside Birth Study constitute a convenience cohort from two
local clinics that feed into the Riverside hospital. To increase the diversity, Logan would like to include
participants from Smiley’s Clinic, but he lacks the financial resources for Somali and Spanish translation
and interpretation services. Jean Johnson has offered the use of EHTB resources to cover these expenses.
Logan explained that he had not planned to collect urine specimens from pregnant women in the
Riverside Birth study, but he is willing to allow the EHTB program to add this component. To ensure that
patient privacy is protected, the logistics would be greatly simplified if MDH does not receive any
personal identifiers. Rather, any communications to the participants about the biomonitoring pilot would
come from the Riverside Birth Study team at the University of Minnesota. Post cards, letters, and at-home
urine collection kits would have the MDH logo, but would be mailed by his team. Unique study ID
numbers would connect EHTB data with individual participants. Individual results for the fourth chemical
would be printed on MDH letterhead and would be mailed by the University of Minnesota study team.
Communications about the EHTB biomonitoring results would be segregated from any communications
of results arising from the Riverside Birth Study.
To meet the legislative stipulation for 30 participants form each of three communities, Jean described the
EHTB intent to enroll women in three ethnic/racial communities: 30 Hispanic, 30 non-Hispanic black,
and 30 non-Hispanic white. In reply to questions about the recruitment strategy and access to personal
interpretation services, Logan reported that the recruiter began on the previous day and has recruited the
first voluntary participant for the Riverside Birth Study. If the proposed EHTB biomonitoring pilot were
to be adopted, then the recruiter would introduce this component at the time of recruitment into the
Riverside Birth Study.
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The written, informed consent materials offer each participant to choose among three types of permission
for sample disposition and future studies: (1) samples destroyed and data de-identified after initial assays;
(2) samples retained for future laboratory assays but data de-identified and (3) samples retained and
identifying data retained so that participants may be contacted to hear about future participatory research.
In response to questions, Logan explained that only those participants who agreed to the third level of
consent for any future study would be contacted (via postcard) for the EHTB biomonitoring pilot. He
predicted that approximately 85% of the participants who enroll in the Riverside Birth Study would agree
to this third level of consent.
In response to questions, Logan described the metabolic markers that he will be following in blood and
meconium. These include markers for folate metabolism and high birth weight. The questionnaire will ask
about the woman’s diet and exposure to tobacco products and pesticides.
Logan agreed to consider altering study protocols to include collecting urine at the clinic if recruitment
and specimen collection through the mail is not successful.
Bruce Alexander expressed his appreciation that adding a biomonitoring component onto an existing
study is for convenience given constraints on resources, and that this clinic-based, convenience sample
method is commonly used for establishing birth cohorts for study. He asked if this recruitment strategy
would shed light on a future biomonitoring program. Jean replied that, to the extent this study would
demonstrate and assess clinic recruitment as an alternative method to the two EHTB pilot projects that use
community-based recruitment.
Biospecimen for the fourth pilot
Geary Olsen asked why the EHTB program is choosing to add a urine specimen, rather than a blood
specimen. Logan explained that the women’s blood specimens for the Riverside Birth Study are only
capillary draws (finger pricks) and stored as tiny amounts of dried blood. Jean explained that the EHTB
program staff chose urine because collection is relatively non-invasive, less expensive, and easier to
manage because it can be collected by the participant at home and shipped through the mail.
Lisa Yost, John Adgate, and Geary Olsen asked the EHTB program to consider measuring blood lead
levels, particularly because of the relatively high level of exposure to household lead paint expected for
women in the recruitment area. If this option were to be pursued, then Logan would be willing to consider
a request to change the study protocol in the future if the procedure would not change the participant
accrual rate for his study. It was recognized that lead measurements in capillary draws are of poor quality
due to dust on the skin surface, and that venipunctures are preferred for accurate lead measurements.
Chemical selection for the fourth pilot
Beth Baker asked the panel members to turn to pages 21-31 in the background book. EHTB workgroup
members have nominated four classes of chemicals as possible candidates for the fourth biomonitoring
pilot project. These are:
1. environmental phenols (to include bisphenol A and 6 other, specific phenols)
2. phthalates (to include metabolites of 5 specific phthalates)
3 pyrethroids (to include 5 specific metabolites)
4. cotinine
Jean Johnson explained that the EHTB workgroup considered several classes of chemicals as candidates
for the fourth biomonitoring pilot study. The candidates were based on the assumption that the fourth
study would ancillary to the Riverside Birth Study and would collect urine from pregnant women in the
Minneapolis area. Some potential candidates were eliminated because either urine was not the appropriate
biospecimen for measurement or because an adequate laboratory method does not exist to detect them at
physiological levels. EHTB workgroup members scored the remaining candidates according to the
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chemical selection criteria on page 31; panel members had reviewed these criteria at a previous meeting.
She invited the panel members to recommend additional chemicals. As stipulated in the Minnesota
statutes, at least nine of the thirteen advisory panel members are to agree on the specific chemicals to
study under the biomonitoring program.
Regarding the four classes of chemicals that have been nominated by the EHTB workgroup, Bruce
Alexander asked if the MDH laboratory has capability to perform the analyses or if it has preferences
based on capacity. Louise Liao, representing the MDH Public Health Laboratory, replied that the
laboratory does indeed have the equipment and scientists to measure these chemicals. In terms of
laboratory feasibility, the staff has no preference. Although the MDH laboratory has no experience with
these chemicals in biospecimens, the CDC laboratory is willing to share its expertise and has trained
MDH staff on other biomonitoring methods via on-site visits and other communications. CDC has
developed methods for each of these four chemical classes and reported its results in NHANES studies.
Louise noted that the CDC methods capture particular subsets of these chemical classes. If the panel were
to recommend specific chemicals beyond those captured in the CDC methods, then the MDH lab may or
may not be able to measure those other chemicals.
Appreciating that reference values are already published for cotinine, Bruce asked if clinical reference
values were available for the other chemical classes. It was recognized that the NHANES data provide a
national baseline for general population exposure ranges and thus, provide distribution-based reference
values.
Lisa Yost expressed her concern that exposures to the chemicals under discussion, other than lead and
cotinine, may not be at levels close to causing adverse health effects. Jean commented that the National
Toxicological Program (supported by NIEHS) has issued a report that current human exposure levels to
bisphenol A have the potential to cause harm to fetal development and reproductive health. David
Wallinga suggested that, because the cohort is pregnant women, then it would be sensible to study a
potential endocrine disruptor. Beth Baker suggested that infant development might be more affected by
bisphenol A and phthalates than by pyrethroids.
John Adgate advised that all four chemical classes are worthy of study. He pointed out that the costs
associated with recruitment and collection are substantial, and that the cost of lab analysis is relatively
minor. Jean replied that the study has limited resources and the study is to be completed by June 2009.
Louise agreed that the MDH lab would need at least a few months to validate and perform the
measurements for each chemical class. Moreover, while the lab cost for analyzing one chemical vs. a few
closely related chemicals in a single family is nearly the same (e.g. bisphenol A and specific
environmental phenols), the lab cost would double for analyzing both the environmental phenols and
another chemical family (phthalates or the pyrethroids).
John asked if the sample volume of the urine specimen would be adequate for the MDH lab to measure all
four chemical classes. Louise replied that, assuming that a urine spot sample would contain at least 30
mls, then the volume would indeed be sufficient for all four analyses. John pointed out that urinary
cotinine analyses are cheap and routine. He recommended that the EHTB program measure the cotinine
levels, regardless of its priority ranking.
Bruce commented that the enabling legislation states that “Each biospecimen from the voluntary
participants must be analyzed for one type or class of related chemicals”. He recommended that, rather
than analyzing for more than one chemical class during the fourth biomonitoring pilot, the EHTB
program should store any residual urine specimens and then seek the legislature’s support for future
analysis of the other chemical classes. Dan Stoddard asked if the legislation’s intent was to limit the
analysis to only one class. Panel members and staff did not know the answer. Jean commented that the
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legislature gave the EHTB program only a restricted timeline and restricted funding for the four pilot
projects. The EHTB staff members have recognized that the scope of each pilot is necessarily limited.
John and David asked if CDC could provide some of these lab analyses. Michonne Bertrand agreed that
CDC offers such a service and for no cost, but that the queue of samples submitted by researchers is
sufficiently long that CDC might not complete the analyses for at least a few years. John suggested that
the program staff could work with the CDC foundation to draw up a contract for payment in exchange for
more timely analyses.
Beth Baker remarked that the study design for the fourth pilot is driven by convenience and restricted
resources. In addition, this project includes only 30 participants from each of three ethnic/racial groups.
Thus, it lacks a compelling reason to invest in multiple lab analyses. John commented that almost all birth
studies are non-representative of the general population; only the NHANES study design is rigorous
enough to represent the general population. He suggested that the results of the EHTB pilot could be
compared to the NHANES results, and he appreciated that the interpretation of the pilot results would be
challenging.
Logan Spector offered to include the urine collection, if feasible, as part of his core study for a subset of
the Riverside Birth Study so as to remove one layer of bias from the convenience sampling. He estimated
that 3/5 of the pregnant Somali population in Minneapolis give birth at the Riverside Hospital. Three
clinics, including Smiley’s Clinic, funnel into this hospital. Currently, the Riverside Birth Study is
drawing from two of the clinics. He would be willing to add Smiley’s Clinic if the EHTB program saw a
rationale for targeting the Somali community and could translate the materials.
Greg Pratt recommended that the sample collection should be leveraged to allow for opportunities for
measuring chemicals that are beyond the scope of the fourth pilot project. Future studies may be
conducted at CDC, MDH, or elsewhere.
Geary Olsen remarked that the laboratory would analyze whichever chemicals are feasible and are
assigned to it. He wondered how the EHTB program selected the Riverside Birth Study and if other
opportunities were available in a timely fashion. Jean replied that she has looked into the Minnesota Heart
Survey, in which blood specimens had been collected over many years. The lengthy review process
before permitting an ancillary study would be prohibitive. Thus, she focused her search on an
investigator-initiated study that would be actively enrolling participants in fall 2008. She was pleased to
find an active study with a University of Minnesota researcher who is very willing to accommodate the
EHTB objectives. Furthermore, this study involves pregnant women, which would be responsive to
criticism received from some community members and legislators when the study designs for the arsenic
and perfluorochemicals (PFCs) studies did not target pregnant women.
Geary Olsen thanked Jean for her response and advised the EHTB staff to highlight these constraints in its
report to the legislature. Jean agreed that the obstacles to accessing previously bio-banked specimens or to
capturing a sufficient cohort of pregnant women are noteworthy.
Beth Baker asked for a motion to identify the chemical (or chemical family) to be studied in this fourth
biomonitoring pilot. David Wallinga made a motion to select environmental phenols, including bisphenol A.
Lisa Yost expressed her concern that the likely levels in the pregnant women to chemicals such as
environmental phenols, phthalates and pyrethroids would be so far below the levels of adverse health
outcomes that an unintended consequence of this study might be to alarm the women unnecessarily.
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The motion on the floor was restated as “to select environmental phenols as the primary chemical class to
measure in urine and to recommend other chemicals if opportunities arise”. John offered a friendly
amendment to include a recommendation for bio-banking any residual urine and to at least consider
submitting specimens to a commercial lab for cotinine analyses. Alan Bender supported the nomination of
cotinine because of its tight association with defined health outcomes. Alan also expressed his support for
novel studies that would increase the scientific knowledge as to any linkage between emerging chemicals
and health outcomes.
Dan and John recommended that the motion reflect the desire to measure multiple analytes if
opportunities present themselves.
Beth asked about the questionnaire that will be given to pregnant women as part of the Riverside Birth
Study. She asked if questions about exposure to nicotine or other environmental toxins would be
included. Logan replied that the questionnaire already includes questions about environmental tobacco
smoke, smoking, and some pesticides. In response to comments, he remarked that questions about
exposure to plastics are not included, as it is difficult to identify point sources meaningfully. Logan
volunteered to provide the questionnaire responses for MDH participants, stripped of personal identifiers,
when they become available.
With assistance from other participants, John restated the motion as follows: “I move that environmental
phenols be the compounds measured in the urine and that specimens be banked for potential future
analysis; and considering the low cost, we recommend doing cotinine if possible and, in light of
legislative restraints, if permissible.” The motion was seconded, and it passed unanimously by voice vote.
With ten voting members, the motion met the legislative requirement for agreement by at least nine panel
members for the specific chemicals to be studied under the biomonitoring program.
In closing this agenda topic, Beth and Jean extended their appreciation, on behalf of the panel and EHTB
staff, to Logan for his willingness to associate his Riverside Birth Study with the fourth biomonitoring
pilot and for his contributions to the discussions at this meeting.
Anniversary celebration
Beth Baker announced that this meeting marks the one-year anniversary since the inaugural meeting of
the advisory panel. Jean Johnson invited participants to enjoy slices of the anniversary cake during the
refreshment break. Jean commended the team on its accomplishments to date. These include:
A. Biomonitoring
• Two biomonitoring pilots are already underway. Steps that have been completed already include
the study design, IRB approval, and lab method validation. (arsenic and perfluorochemicals)
•
Two biomonitoring pilots are pending final approvals and will be entering the enrollment phase
soon. (mercury and environmental phenols)
•
The first annual legislative report was submitted in January 2008.
•
The chemical selection process for future biomonitoring has been vetted, and the survey inviting
public nominations and comments has been released.
•
Guidelines for the biomonitoring pilot program have been drafted and reviewed.
•
The process for identifying the purpose, vision, and goals of an ongoing biomonitoring program
is underway.
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B. Environmental Health Tracking
• Using Minnesota data, program staff have collected data and piloted indicators in nine content
areas that were identified as part of the National Environmental Public Health Tracking Program.
(air quality, water quality, childhood lead, respiratory disease, myocardial infarctions, cancer,
carbon monoxide poisonings, birth defects, and birth outcomes)
•
New content areas for environmental health tracking in Minnesota have been identified.
•
A strategic plan for environmental health tracking in Minnesota is underway, to include planning
for communications, education, and an assessment for portal development and data dissemination
for public access.
C. Building Capacity
• Relationships have been augmented between state agencies (viz. Minnesota Department of
Agriculture, Minnesota Department of Health, and Minnesota Pollution Control Agency) and
with the University of Minnesota.
•
MDH has hired 4 additional, full-time professional staff and supported a few part-time student
workers who are dedicated to the EHTB program.
•
The MDH Public Health Laboratory has purchased equipment and built scientific expertise in
conducting analyses for toxic chemicals in human biospecimens.
When the advisory panel took its scheduled break, Beth Baker, Geary Olsen, and Samuel Yamin excused
themselves from the remainder of the meeting. Bruce Alexander became the acting chair.
Biomonitoring pilot program guidelines
Jean Johnson reported that the panel had discussed a draft version of the biomonitoring pilot program
guidelines at its March 2008 meeting. Since then, the EHTB program staff has incorporated the suggested
revisions and added text to the unfilled sections of the draft. Bruce Alexander, as acting chair, directed the
panel to pages 33-49 of the background book and invited comments regarding the new sections. The new
sections on “Pilot project design” and “Community acceptance and participation” did not elicit comments.
Use of stored specimens for future research
In reviewing the section on “Use of stored specimens for future research”, Bruce Alexander suggested
that the text could describe the specific procedures for permitting use of residual specimens by other
teams engaged in research or public health studies. In responding to questions, Louise Liao noted that the
MDH Public Health Laboratory uses a review process and material transfer agreements before releasing
specimens. Joanne Bartkus, a member of the EHTB steering committee and the MDH Public Health
Laboratory Director, explained that the current process is not as uniform or formal as desired. She
thanked Bruce for his advice to standardize the evaluation and to clarify the decision-making committee
and the decision criteria for valid, secondary use of stored specimens. Alan Bender recommended that the
EHTB program seek enabling legislation that would support rule-making to formalize the process for
reviewing and validating the secondary use of stored specimens. Minnesota Rules would be more durable
than the existing MDH policies.
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Selecting appropriate reference (comparison) values for data interpretation
Several participants commented on the new section, “Selecting appropriate reference (comparison) values
for data interpretation”. Jean Johnson introduced the topic by explaining that the ideas are patterned on
NHANES program policy and on the 2006 monograph of the National Research Council’s Committee on
Human Biomonitoring for Environmental Toxicants. This new policy guideline describes three
approaches for selecting reference values. The first is a clinical reference value, and this will be used for
the arsenic biomonitoring study. It has the strongest foundation for interpreting results in terms of healthbased, clinical guidelines. The second approach uses a distribution-based reference value, and it will be
applied to the perfluorochemicals (PFCs) biomonitoring study. For example, the individual and
community results are compared to the distribution of exposures (range, percentiles and means) measured
in another reference population, such as those established in the NHANES national population
distribution.
In the absence of reference values based on clinical guidelines or distribution ranges in a larger
population, biomonitoring results may be compared to risk-assessment-based values derived from
toxicological and epidemiological study findings where appropriate. Jean explained that the riskassessment approach is the most controversial and uses comparison values that are not necessarily
relevant to the population under study.
Lisa Yost remarked that, if EHTB were to delve into reference values for future biomonitoring projects,
then the concept of “biomonitoring equivalents” would provide another option for interpreting results.
She referred participants to a recent publication by Sean Hays and Lesa Aylward in the Journal of
Regulatory Toxicology and Pharmacology. This pharmacokinetic approach examines the links between
dosimetry, biomonitoring, toxicity, and risk assessment. Lisa relayed that these investigators had asked
her and Jean Johnson if they could speak to this group. It was suggested by Lisa and Jean that a lunch
presentation at a future advisory panel meeting should be considered. Pam Shubat, an EHTB workgroup
member and supervisor of the MDH health risk assessment unit, replied that the MDH staff follows their
published research, and she offered to contact the investigators and explore options for additional
communications.
Greg Pratt commented that, if he were to receive his individual biomonitoring results, he would prefer to
receive information using all acceptable approaches for interpreting the results. This would be preferable
to choosing only a single approach. Jean concurred, and she told the panel that the EHTB staff is
developing physician education materials for the PFCs pilot so that physicians can assist individuals with
a more detailed interpretation of results. Although MDH will provide the participants with a relatively
limited foundation for interpreting their results, MDH is trying to provide a more textured interpretation
for the physicians. Greg and Jean agreed that environmental health programs find it difficult to convey
complex chemical risk communication messages to interpret individual results.
David Wallinga noted that the absence of particular messages is also interesting. The mixture of
chemicals and the mixture of exposures could lead to a complex risk profile. Panel members reflected on
striking an appropriate balance between communicating too much and too little information. Lisa noted
that websites using a Q&A format provide their readers with an easy way to selectively glean the more
sophisticated information.
Inclusion of children in biomonitoring pilot projects
The panel was invited to comment on the new section, “Inclusion of children in biomonitoring pilot
projects”. In response to questions, Michonne Bertrand and Jean Johnson described the initial dismay by a
few legislators that children will be excluded from the study on PFCs in serum. While those legislators
appreciated that children are often excluded from studies requiring venipuncture specimens, some of the
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parents were still keen to enroll their children. One parent-based sentiment was that the parents, and not
the state agency, should decide if their children should participate in the study.
Bruce Alexander noted an apparent conflict between the two sentences in the preamble to this section.
While the first sentence seems to be permissive, the second sentence seems to be overly restrictive in
offering guidance to include children. John Adgate and Bruce suggested that venipuncture might be
classified as “minimal risk” rather than in the restrictive class of “more than minimal risk”. Adrienne
Kari, EHTB biomonitoring coordinator, said that she made this distinction based on the Common Rule
described in the federal policy for the protection of human research subjects. Following guidance in the
Common Rule that activities which a child would encounter in everyday life would be considered
minimal risk, she classified venipuncture collections as “more than minimal risk.” While some children
with special health-care needs would indeed have frequent venipuncture draws, such an event would be
uncommon for healthy children.
John and Bruce advised that the interpretation of the risk associated with venipuncture specimens
undoubtedly varies among institutional review boards (IRBs) in Minnesota and across the nation. They
cautioned the EHTB program to not be unduly restrictive, as this could limit the ability to include
children in future biomonitoring studies when appropriate. The guidelines should acknowledge the
differing perspectives and should be sensitive to definitions that are based on public health rather than
individual health care. Lisa Yost concurred, and she suggested that the text could be modified to defer the
risk assessment to the attending IRBs rather than declaring the relative risk of venipunctures in this
document. Alan Bender agreed that the IRBs should be the authoritative bodies. Because societal norms
are in flux regarding the roles of parents, physicians, or others in acting on behalf of children, a guideline
based on the IRB decisions could remain current even when a particular position becomes obsolete.
Strategic plan for environmental health tracking
Michonne Bertrand reminded the panel that the Minnesota statutes direct the EHTB program to develop a
strategic plan for environmental health tracking, and that the plan must contain particular elements. She
invited the panel to provide suggestions for strengthening the draft strategic plan developed by EHTB
staff. Specifically, she asked for input on the (a) mission statement, (b) goals and objectives, and (c)
stakeholders. She referred participants to pages 51-59 in the background book.
With respect to the statement of need and the mission, Alan Bender asked if other state programs are
pursuing similar strategies in terms of planning. Jean replied that programs which are part of CDC’s
National Environmental Public Health Tracking Network are working under a cooperative agreement
grant and are tightly focused on the collection and dissemination of their states’ data for the indicators
project. They are preparing for the imminent launch of state portals to support CDC’s effort to
disseminate nationally consistent data. The EHTB staff is just beginning to develop the Minnesota portal.
David Wallinga recommended that the statement of need could benefit from specific examples that would
help the reader relate to the abstract concepts. One example would be to showcase how environmental
health tracking has contributed to reduced environmental lead exposures. He suggested that the statement
of need could explicitly spell out how this program could guide public investment in broad-based health
outcomes that save money for the state.
In turning to the section on goals and objectives, Michonne listed the five goals identified in the
background book on pp. 55-57 and asked for input. Bruce Alexander suggested that an overreaching goal,
either for this section or for the mission statement, would be to establish priorities for data to be tracked.
Priorities would not be based only on convenience and national comparison sets, but also on indicators
that would have high impact for Minnesota. Michonne said that this idea is captured as an objective in the
136
first goal and could be elevated to a higher stature. Bruce suggested that an overreaching goal would be to
focus on the diseases and exposures that have the potential for the highest impact on Minnesota health.
Autism surveillance is an example of a project that offers potential benefits for tracking. Alan Bender
recommended that the strategic plan specifically identify occupational health as a vital component of
environmental health tracking. He noted that the reduction of particular occupational exposures could
have the highest potential for impacting the health of Minnesotans.
Comments were invited on the “stakeholders” section. Greg Pratt recommended that the item for “local
public health and environmental programs/staff” should be expanded to all units of local government.
Alan and Lisa suggested the addition of organized labor and nurses’ unions. David suggested that the
stakeholder group of “tribes” should be expanded to encompass other at-risk communities, environmental
justice advocates, faith-based communities, and entities that are considering the health impacts of climate
change.
Greg and Michonne agreed that the concept of environmental health tracking is relatively inaccessible to
many of the stakeholder groups. Inherently, its lack of immediacy presents a challenge in engaging
stakeholders on this topic. While acknowledging the barriers, Michonne mentioned that she had a positive
experience recently in presenting the tracking concept to school nurses. Jean mentioned that she provided
an overview of environmental health tracking to the tri-county board of Wadena, Todd and Morrison
counties, and they may be interested in applying the ideas to pesticide drift issues.
Closure
Final comments were solicited. Alan Bender noted that the sentence on page 75 of the background book
should clarify that the Minnesota Cancer Surveillance System has data available on the county level. Lisa
Yost noted that the word “panel” is misspelled on page 36 of the background book.
Michonne Bertrand announced that the next meeting will be held on Tuesday, December 9, 2008 at 1-4
p.m. at Snelling Office Park. The 2009 meeting dates are listed on page iii at the front of the background
book. An important agenda topic for the December meeting will be to develop recommendations to be
included in the report that is due to the legislature in January 2009. In closing, she thanked the
participants for their constructive contributions to the EHTB program.
Summary finalized October 8, 2008
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138
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
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
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
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
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
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
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
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
139
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
Note: As of November 26, 2008, there is a vacancy on the EHTB advisory panel for a
nongovernmental organization representative. This vacancy will be posted with the Secretary of
State’s Office.
Rev. November 26, 2008
Please submit corrections to [email protected]
140
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).
141
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.
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
142
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 24, 2008
Please submit additions and corrections to [email protected]
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144
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.
145
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.
146
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.
149
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
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EHTB steering committee roster
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]
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]
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
151
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152
EHTB inter-agency workgroup roster
Jerry Alholm
Information Systems & Technology Management
Minnesota Department of Health
PO Box 64975
St. Paul, Minnesota 55164-0975
651-201-4973
[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]
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]
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]
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]
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]
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]
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]
153
John Soler, MPH
Chronic Disease & Environmental
Epidemiology
Health Promotion and Chronic Disease
Division
Minnesota Department of Health
PO Box 64882
St. Paul, Minnesota 55164-0882
651-201-5481
[email protected]
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. November 14, 2008
154
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.
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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.
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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]
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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
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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]
160
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.
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).
(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.
144.996 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;
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(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
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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,
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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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