Minnesota Department of Health
Environmental Health Tracking and Biomonitoring
Advisory Panel Meeting
December 17, 2007
1:00 p.m. – 4:00 p.m.
Snelling Office Park
Mississippi Room
1645 Energy Park Drive
St. Paul, Minnesota
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Meeting agenda
Minnesota Department of Health
Environmental Health Tracking and Biomonitoring Advisory Panel Meeting
December 17, 2007
1:00 p.m. – 4:00 p.m.
Mississippi Room at Snelling Office Park
1645 Energy Park Drive, St. Paul, MN
Time
Agenda item
1:00
Welcome and introductions
1:05
Operating procedures and
conflicts of interest
Presenter
Item type/Anticipated outcome
Michonne Bertrand
Discussion item.
*VOTE NEEDED* The advisory panel is
asked to vote to adopt a set of operating
procedures, either as presented in the
meeting packet or with modifications.
Suggested motion: I move to adopt the
Environmental Health Tracking &
Biomonitoring Advisory Panel operating
procedures as presented (or: with the
following modifications…).
*VOTE NEEDED* The advisory panel is
asked to vote to adopt the affirmation
statement regarding conflicts of interest
(either as presented in the meeting packet or
with modifications) or to adopt an alternate
method for addressing and/or declaring
conflicts of interest.
Suggested motion: I move to adopt the
affirmations referring to conflicts of interest
form (or: some other method for declaring
conflicts of interest).
1:30
Panel member comments and
questions
• Minnesota Data Practices
Act
• Media inquiries
• Panel member comment on
biomonitoring pilot projects
Michonne Bertrand
Information sharing.
Panel members are invited to ask questions
or provide input on any of these items.
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Time
Agenda item
Presenter
Item type/Anticipated outcome
1:45
Arsenic biomonitoring
Rita Messing
Discussion item.
The panel is asked to provide comments in
order to strengthen the arsenic
biomonitoring proposal and to ensure that
the most meaningful results are obtained. In
addition, the panel is asked to provide input
on these specific questions:
•
•
•
•
•
•
What specimen (or specimens) should
be collected: urine or hair or both?
What are the relative merits of
collecting first morning void vs. spot
urine?
How important is it that participants be
instructed to refrain from fish/seafood
before specimens are collected?
Is speciation at15 µg/L appropriate?
Regarding the Smiley’s Clinic
algorithm: What changes do panel
members recommend making to the
algorithm? Is retesting with a 24-hour
urine at inorganic arsenic > 10 µg/L an
appropriate step?
What are appropriate established
reference levels for arsenic in urine or
hair?
*VOTE MAY BE NEEDED* If panel
members agree that collecting both urine
and hair specimens would strengthen the
arsenic biomonitoring project, EHTB staff
request that a vote be taken to formally
document this recommendation.
Suggested motion: I move that, given that
adding an additional specimen does not
significantly increase the cost of the
biomonitoring project, the arsenic
biomonitoring pilot project collect both
urine and hair samples to strengthen the
project.
2:30
Break
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Time
Agenda item
Presenter
Item type/Anticipated outcome
2:45
PFC biomonitoring
Rita Messing
Discussion item.
The panel is asked to provide comments in
order to strengthen the PFC biomonitoring
proposal and to ensure that the most
meaningful results are obtained. In addition,
the panel is asked to provide input on these
specific issues:
Issues related to participant eligibility:
• Proposed requirement that participants
must be over 20 years of age (to
facilitate comparisons with NHANES
data).
• Proposed requirement that participants
must have been living at current
residence (not just living in the
community) prior to Jan. 1, 2005.
• Proposed requirement that participants
must have PFOA or PFOS detection >
0.1 ppb in private wells (as opposed to
any detection).
Issues related to participant survey:
• Questions to be included on the
participant survey (beyond current water
source in the home, ever worked at 3M
Cottage Grove, and demographic
information).
3:30
Project status updates
• Mercury biomonitoring
• Biomonitoring for
“designated chemicals”
• Biomonitoring program
guidelines
• Tracking
Pat McCann
Pam Shubat
Jean Johnson
3:55
Closure
Michonne Bertrand
4:00
Adjourn
Information sharing only.
Panel members are invited to ask questions
or provide input on any of these items. Panel
members are also asked to consider
volunteering to serve on a subcommittee to
develop biomonitoring program guidelines.
Next meeting date: Tuesday, March 11, 1-4 pm, Mississippi Room of Snelling Office Park
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Meeting Materials for December 17, 2007
Environmental Health Tracking & Biomonitoring Advisory Panel
Table of Contents
Agenda........................................................................................................................................... i
Table of contents ........................................................................................................................v
Materials related to specific agenda items
Operating procedures and conflicts of interest
Section overview: Operating procedures and conflicts of interest ............................................1
Operating procedures (revised draft) .........................................................................................3
Affirmations referring to conflicts of interest (revised draft) ....................................................9
Panel member comments and questions
Section overview: Panel member comments and questions ....................................................11
Minnesota Data Practices Act summary ..................................................................................13
Responding to media inquiries.................................................................................................15
Letter from panel member (Samuel Yamin)............................................................................17
Arsenic biomonitoring
Section overview: Arsenic biomonitoring ...............................................................................21
Biomonitoring pilot project for arsenic: Draft proposal (revised) ...........................................23
South Minneapolis neighborhood soil sample results (map)...................................................29
Arsenic testing algorithm (draft; from Smiley’s Clinic)…......................................................31
Update on community engagement .........................................................................................37
PFC biomonitoring
Section overview: PFC biomonitoring.....................................................................................39
Biomonitoring pilot project for perfluorochemicals: Draft proposal (revised) .......................41
Rationale for selection of communities ...................................................................................47
PFBA in southeast metro, September 2007 (map)...................................................................49
Comparison values for PFCs in blood .....................................................................................51
Update on community engagement .........................................................................................53
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Project status updates
Section overview: Project status updates.................................................................................55
Mercury biomonitoring in newborns in Lake Superior Basin .................................................57
Mercury biomonitoring project timeline..................................................................................58
Lake Superior basin (map).......................................................................................................59
Biomonitoring pilot program for “designated chemicals”.......................................................61
Executive Summary: Human Biomonitoring for Environmental Chemicals ..........................71
General reference materials
Section overview: General reference materials .............................................................................85
Meeting summary, October 23, 2007 ............................................................................................87
Environmental health tracking and biomonitoring advisory panel (roster) ...................................97
Biographical sketches of advisory panel members........................................................................99
Environmental health tracking and biomonitoring steering committee (roster)..........................103
Environmental health tracking and biomonitoring inter-agency workgroup (roster) .......................104
Glossary of terms used in environmental health tracking and biomonitoring .............................105
Acronyms used in environmental health tracking and biomonitoring.........................................111
Minnesota Environmental Health Tracking & Biomonitoring (Minn. Statutes 144.995-144.998).......113
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Section overview: Operating procedures and conflicts of interest
Operating procedures
The meeting packet contains a draft version of advisory panel operating procedures, which has
been revised slightly since the last meeting. The main changes are as follows:
•
Offices other than advisory panel chair were removed as these other offices are not described
in statute. The term of the chair was changed to three years to parallel the terms of panel
members
•
Clarifying language was added related to sending alternates to meetings. In particular, it is
now suggested that registered lobbyists cannot serve as alternates. Panel members are
encouraged to contact EHTB program staff when they miss a meeting, as it may be
challenging for alternates to fully participate in meetings given that many panel discussions
will span several meetings.
•
Clarifying language was added to describe when formal votes are likely to be requested by
program staff (e.g., when required by statute, when program staff need to operate outside of
statutory requirements). As requested by panel members, EHTB program staff will make
note of agenda items requiring a formal vote when this is known ahead of time. Additional
votes may be taken during the course of a meeting at the request of panel members or
program staff. In many cases, program staff will be seeking general advice and input from
panel members rather than a specific vote or approval. In these cases, staff will clearly
identify discussion questions so that panel deliberations will reveal panel members’ full
range of opinions and advice.
•
Clarifying language was added to describe the EHTB program’s decision-making process.
This section was revised to acknowledge that not all panel discussions will result in a formal
recommendation by the full panel. In addition, the revision addresses the fact that EHTB
program staff, in making recommendations to the commissioner (or the commissioner’s
representative), will need to weigh the panel’s recommendations along with advice received
from other stakeholders, such as community members.
ACTION NEEDED: The advisory panel is asked to discuss the draft operating procedures and
to vote to adopt a set of operating procedures, either as presented in the meeting packet or
with modifications.
Suggested motion: I move to adopt the Environmental Health Tracking & Biomonitoring
Advisory Panel operating procedures as presented (or: with the following modifications…).
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Conflicts of interest
Panel members are also asked to consider whether they would like to adopt a mechanism for
formally agreeing to disclose conflicts of interest. One option, included in the meeting packet, is
to have each member sign an affirmation that they agree to disclose any conflicts of interest that
arise. This affirmation statement would be collected from all panel members and kept on file for
the duration of their appointments. The affirmations form has been modified slightly since the
last meeting to indicate that conflicts of interest are to be disclosed to advisory panel members in
addition to MDH staff.
ACTION NEEDED: The advisory panel is asked to vote to adopt the affirmation statement
(either as presented in the meeting packet or with modifications) or to adopt an alternate
method for addressing and/or declaring conflicts of interest.
Suggested motion: I move to adopt the affirmations referring to conflicts of interest form (or:
some other method for declaring conflicts of interest).
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Operating Procedures (revised draft)
Advisory Panel to the
Environmental Health Tracking and Biomonitoring Program of the
Minnesota Department of Health
Panel Name, Membership, Function, and Objectives
This advisory panel is known as the Environmental Health Tracking and Biomonitoring (EHTB)
Advisory Panel. This panel and its membership, functions, and objectives are described in Minnesota
Statute section 144.998.
Charge
The advisory panel is intended to function in an advisory capacity to the MDH program managers in
environmental health tracking and biomonitoring and, ultimately, to the Commissioner of Health. This
panel is to extend and supplement the range of expertise of MDH’s scientific staff, and to advise in setting
priorities for, designing, and evaluating the environmental health tracking and biomonitoring projects. It
is not intended that the advisory panel become involved in the day-to-day operational and administrative
aspects of program resources, program management, or personnel matters.
Reimbursement
Members of the panel shall serve without compensation but shall be reimbursed for travel and other
necessary expenses incurred through performance of their duties.
Terms of Appointment
1. Members appointed by the Commissioner are appointed for a three-year term and may be
reappointed. Legislative appointees serve at the pleasure of the appointing authority.
2. Each member will receive notification of the expiration of his or her term at least sixty days prior to
the termination date. Notification will also be sent to the chair of the advisory panel.
3. Members should communicate their intent to resign in writing to the appropriate appointing authority
and to the chair of the advisory panel. If the Commissioner of Health is not the appointing authority,
then the member should also notify the Commissioner of Health. The appropriate appointing
authority will appoint a new member to serve the remainder of the term if needed to maintain
membership from each of the representative groups listed in Minnesota Statute 144.998.
4. A member may be removed by the appointing authority at any time, at the discretion of the
appointing authority.
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Responsibilities and Expectations of Advisory Panel Members
In accepting appointments to the advisory panel, members are expected to:
1. Attend advisory panel meetings and other assigned meetings. Any member missing two consecutive
full advisory panel meetings may be notified in writing that missing a third consecutive meeting may
result in the member’s removal from the advisory panel.
2. Serve on committees, work groups, and other task forces as requested by the chair.
3. Prepare for active participation in discussions and decision-making by reviewing meeting materials
prior to the meeting dates.
4. Act as a liaison when appropriate between constituent groups and the advisory panel.
5. Inform the represented constituent groups of advisory panel activities, actions, and issues.
6. Declare any conflicts of interest and abstain from voting on advisory panel matters that create an
apparent or 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,
apparent or real, exists if one of the following conditions applies:
a. The member, her/his organization, or a family member has a direct financial or personal 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 has an indirect financial or personal interest in the matter under consideration and is
not so free from personal bias, prejudice, or preconceived notion as to make it possible for
her/him to objectively consider the evidence presented and base her/his decision solely on the
evidence.
c. The member has placed her/himself in a position where she/he finds it difficult, if not impossible,
to devote her/himself to a consideration of the matter with complete energy, loyalty, and
singleness of purpose to the general public interest.
It should be noted that many members of the advisory panel will have exceptional professional or
personal experience with environmental health tracking or biomonitoring. These qualities, by
themselves, do not constitute a conflict of interest. Informed decision-making will benefit from
personal experiences; however, personal interests should not distract from objective decision-making
for the public good.
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Advisory Panel Chair
The Commissioner of Health shall appoint a chair from the advisory panel’s membership. The term of
office is three years.
The duties of the chair are to:
1. Preside at all full advisory panel meetings.
2. At the request of the Commissioner, be the spokesperson and representative for the advisory panel.
3. Establish work groups as needed to carry out the advisory panel’s recommended actions, consulting
with staff to assure staff support will be available as needed.
Meetings
1. The advisory panel shall meet as often as it deems necessary but, at a minimum, on a quarterly basis.
Meetings will be held in Minneapolis or Saint Paul during the regular business day. The number and
scheduling of meetings will depend on the timing and urgency of particular issues being addressed.
Any work groups will meet outside of regularly scheduled meetings of the full advisory panel.
2. The advisory panel and work groups can meet more frequently, as requested by the chair or other
advisory panel members.
3. Meetings of the advisory panel and work groups may be cancelled and rescheduled by the
Commissioner in consultation with the chair. Advisory panel members and work group members will
be notified of cancellations in as timely a manner as possible.
4. All meetings are open to the public for observation.
Attendance
1. Attendance at each meeting is critical to the productivity of the advisory panel. While it is ideal to
have all members of the advisory panel present at meetings, this is not always feasible. Members for
whom travel time and distance are prohibitive may connect to meetings by telephone. Members who
make arrangements for telephone connections are strongly encouraged to attend at least two meetings
each year in person.
2. If a member cannot attend a meeting, she/he is to contact the advisory panel’s MDH staff liaison prior
to the meeting. Panel members are encouraged to speak to the staff liaison before and/or after any
meetings they are unable to attend to stay informed about panel deliberations and to share any
comments. Absent members may also send a colleague to the meeting, either as an observer or as a
formal alternate. Alternates do not have decision-making or voting privileges. Also, because
discussions will often span several meetings, it may be difficult for alternates to understand the
context of or participate in panel proceedings. Alternates must meet the same eligibility criteria as
panel members (e.g., they may not be registered lobbyists).
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Quorum and Voting
It is anticipated that many issues considered by the panel will not result in a formal vote, but rather in a
general exploration of the range of panel members’ opinions and advice. In some cases, program staff
may ask the panel to conduct a formal vote. Items that would prompt a formal vote include those
explicitly required by statute (e.g., the selection of the specific chemicals to study requires the agreement
of nine panel members) and those that require program staff to operate outside of statutory requirements.
During the course of panel meetings, panel members and program staff may request additional votes
regarding issues under discussion.
1. Whenever possible, decisions requiring a vote by the advisory panel will be indicated in the meeting
agenda, which will be distributed to panel members prior to the meeting.
2. A majority (51%) of the membership must be present at a given meeting. Decisions can be made
when a majority of voting members present reach agreement on a given matter.
3. The panel will operate using a relaxed version of Robert’s Rules of Order. As such, items for which a
vote is sought will require a motion, a second, discussion of the motion, and then a vote. Voting will
normally be recorded as the number of ayes, number of nays, and number of abstentions. When
specifically requested by a member of the advisory panel, the chair will take a roll call, and individual
votes will be recorded.
4. Votes by members attending the meeting by telephone are acceptable.
5. As described in Minnesota Statute section 144.998, one representative each shall be appointed by the
commissioners of the Pollution Control Agency, the Department of Agriculture, and the Department
of Health. All other state employees are ex-officio participants. With this status, the ex-officio
participants are allowed to participate but do not have decision-making or voting privileges. These exofficio participants are not appointed to the formal advisory panel membership.
6. Voting privileges for absent members are as follows:
a. Members participating by telephone are allowed to vote.
b. When an item requiring a vote is known in advance, members may submit absentee ballots by email, fax, or U.S. mail. Ballots must be received by the EHTB program staff at least one day prior
to the meeting.
c. When an item requiring a vote is known in advance, absent members may submit proxy votes to
the chair or another panel member beforehand. The proxy statement will declare her/his approval
or rejection of the issue that will be under discussion.
d. Alternately, the proxy statement will declare that a specific member, who must be present, serves
as the absent member’s delegate and has full authority to vote on a particular issue.
e. Absent members are not allowed to submit proxy votes or appoint a delegate for issues or votes
arising during meetings.
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Communications
Advisory panel members are expected to refrain from writing letters or engaging in other kinds of
communication in the name of the advisory panel unless such communication has been specifically
approved by the advisory panel or the Commissioner of Health.
Decision-Making Process
The following summarizes the key steps involved in the EHTB program’s decision-making process:
1. MDH staff members prepare background and supporting materials for advisory panel review.
a. MDH staff members may enlist work groups, task forces, or other external experts to study
complex issues.
b. Usually the information is provided to the advisory panel in written form, supplemented by staff
presentation, comments, and responses to questions during meeting discussions.
c. During this stage, MDH staff members begin to identify options and assess their relative merits.
2. The advisory panel provides advice to EHTB program staff and, in some cases, develops formal
recommendations.
a. Advisory panel members discuss and debate matters as ideas are formulated.
b. Discussions by the advisory panel members provide an important opportunity to test MDH staff
members’ reactions to ideas and, as appropriate, recommend alternative approaches.
c. In some cases, the advisory panel formalizes its advice and recommendations. Recommendations
may be recorded as a consensus opinion or by a formal vote. Upon request, voice reports of the
majority and minority opinions may be prepared.
3. MDH staff members prepare specific recommendations.
a. Advisory panel advice and recommendations are considered carefully in light of alternative
options. In many cases, EHTB program staff will need to weigh advisory panel recommendations
along with feedback received from other stakeholders (such as community members). The
relative merits of each option are examined thoroughly.
b. Specific staff recommendations are developed; justification is documented.
4. The Commissioner of Health reviews recommendations and makes final decisions.
a. MDH staff members present the advisory panel recommendations via written or verbal report to
the Commissioner or the Commissioner’s representative (e.g., EHTB Steering Committee).
Reports will include a summary of the issue, background, process, recommendations, and
outcome of discussion and voting on recommendations (including other motions, as appropriate).
b. MDH staff members present the staff recommendations, as well. These may support or enhance
the advisory panel’s recommendations; alternatively, they may present contrary perspectives.
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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.
Rev. November 30, 2007
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Affirmations Referring to Conflicts of Interest (revised draft)
Advisory Panel for the
Minnesota Department of Health
Environmental Health Tracking and Biomonitoring Program
The affirmations listed below refer to conflicts of interest regarding issues under consideration by the
Advisory Panel for the Environmental Health Tracking and Biomonitoring Program of the Minnesota
Department of Health (MDH). It should be noted that many members of the advisory panel will have
exceptional professional or personal experience with environmental health tracking and 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.
1. I affirm that I will inform MDH staff and advisory panel members if a situation arises in which I, my
organization, or a family member would personally benefit based on the outcome of a particular
decision, endorsement, or action taken by the advisory panel.
2. I affirm that I will inform MDH staff and advisory panel members if I, my organization, or a family
member has a direct financial or personal interest in the matter under consideration.
It is understood that employees of large organizations may have little or no personal knowledge
about certain financial interests of their employers. In those cases, members are asked to affirm
that they would inform MDH staff and advisory panel members only of 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.
3. I affirm that I will inform MDH staff and advisory panel members if I have an indirect financial or
personal interest, prejudice, or preconceived notion in the matter under consideration that precludes
me from objectively considering the evidence presented and making my decision for the public good.
I agree to these affirmations, and I agree to disclose to MDH staff and advisory panel members when
circumstances such as those stated above may prejudice my decisions on any issue that I am asked to
review within my role as a member of the advisory panel for the Environmental Health Tracking and
Biomonitoring Program of the Minnesota Department of Health.
Signature
Date
form updated November 30, 2007
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Section overview: Panel member comments and questions
Several panel members contacted EHTB program staff with comments or questions after the last
meeting. It is the intent of EHTB staff that such comments and questions be shared with the full
panel so that all panel members have an opportunity to discuss these items. EHTB program staff
will reserve time at each meeting to address substantive items and will include these items in the
packet of meeting materials. This will also serve the purpose of making these comments and
questions readily available to the public.
Three such items are on the agenda for December:
1) A request was made to have program staff clarify requirements related to public access to
panel members’ communications. A copy of the original response provided by EHTB
program staff, along with an addendum proposing how EHTB staff will handle betweenmeeting comments is included.
2) An inquiry was made about the appropriateness of panel members giving interviews to
members of the media. A proposal for how panel members might respond to media
requests is provided in the meeting packet.
3) A written comment was submitted by a panel member in response to the panel’s
discussion of the biomonitoring pilot projects. A copy of this letter is included in the
meeting packet.
ACTION NEEDED: Panel members are invited to ask questions or provide input on any of
these items.
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Minnesota Data Practices Act summary
Environmental Health Tracking and Biomonitoring Advisory Panel
December 2007
The following information on the Data Practices Act is provided to EHTB panel members in
response to a question raised by a panel member about public access requirements and
committee correspondence. Note that this document contains an addendum related to
procedures for addressing comments and questions that are received in between meetings
that was not included in the response that was distributed to panel members by email in
November.
The Data Practices Act requires public agencies such as MDH to facilitate access to all government
data which should be rightfully disclosed while safeguarding the privacy rights of data subjects.
Unless specifically designated otherwise by statute, all “data” collected, created, received,
maintained, or disseminated by MDH are considered public. “Data” refers to anything that is written
down or otherwise recorded in any storage medium, such as electronic files, video recordings,
audiotapes, etc.
In general, most information related to the EHTB program and the advisory panel is considered
public information. This means that not only are advisory panel meetings open to the public but also
that all written documents related to the panel and the EHTB program are available to the public
upon request. Specific examples of data that are available to the public include the following:
• written general correspondence (letters and e-mails), including those to and from advisory panel
members
• names and other information on advisory panel members (including contact information)
• any publications or promotional materials produced by the program including background
reading materials for panel meetings
• research protocols, including those in draft form
• research results and data analyses and summaries (provided they do not contain identifying
information)
• budget information
• evaluation information
• documents related to strategic planning for the program
Data that would not be considered public include things like individual consent forms and individual
health/survey data.
Aside from making public data available on request, we do not have any so-called affirmative
requirements related to public access to our data. In other words, we are not obligated to proactively
make any of the information available to the public, such as by posting things on a website or having
a formal public comment period, for example. However, we may certainly choose to promote some
data in the interest of keeping the public informed about our activities.
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For example, we plan to post the minutes of any advisory panel meetings on our website. Should any
panel members provide formal, written advice/comments in between meetings, we will probably
make that available online as well.
Panel members should be aware that all written correspondence, including electronic format, such as
e-mail, that is sent to or from MDH could be requested by a member of the public (e.g., in the event
that someone makes a very broad data request related to the EHTB program). With that in mind, if
there is anything you do not wish to be accessible to the public, you should avoid putting it in
writing.
Addendum: In an effort to foster open communications among panel members and facilitate public
access to panel proceedings while also minimizing the amount of staff time needed to process
comments received between panel meetings, EHTB staff propose to handle communications from
panel members in the following way. Substantive comments and questions received from panel
members between meetings will be placed on the agenda for the next panel meeting and will be
included in the background materials for that meeting along with any respond EHTB staff may have
provided. By including these items on a meeting agenda, the full advisory panel will have an
opportunity to discuss any issues raised since the previous meeting. In addition, including these items
as part of a formal meeting will ensure that any significant communications that are received between
panel meetings are entered into the public record, as they will be included in the packet of meeting
materials and will be summarized in the meeting notes.
Because the advisory panel meets only four times per year, some comments and questions may need
a response from the full panel before the next meeting is convened. In those cases, a synthesis of all
panel members’ comments on a particular issue will be included in the next packet of meeting
materials.
Panel members are welcome to submit comments and questions at any time.
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Responding to media inquiries
Environmental Health Tracking and Biomonitoring Advisory Panel
December 2007
The following information is provided to address a question raised by an EHTB panel
member who wondered whether it was appropriate to respond to a media inquiry. Because
other members of the advisory panel may also be contacted by members of the media in the
future, EHTB staff would like to offer some guidance.
EHTB panel members are selected to serve on the advisory panel because they are experts in
their fields. When members of the media develop stories about biomonitoring and environmental
health tracking, it is natural that they will contact panel members and ask them to share their
expertise and opinions on those topics.
Panel members are welcome to speak to members of the media about their areas of expertise if
they so choose. In doing so, panel members are asked to remember that they represent only
themselves – and not the EHTB panel or EHTB program – when they speak. The only panel
member authorized to speak on behalf of the panel is the chair of the advisory panel.
EHTB staff kindly request that panel members notify MDH when they receive media inquiries,
so that staff are aware of any stories that may appear. In return, EHTB staff will inform panel
members whenever MDH issues a news release related to the EHTB program. EHTB staff are
available to provide consultation to any panel members who desire assistance in preparing to
respond to media inquiries.
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Section overview: Arsenic biomonitoring
A revised version of the arsenic biomonitoring proposal is included in the meeting packet. The
revision includes added detail related to participant recruitment, specimen collection, laboratory
analysis, and communication of results.
Additional supporting materials for arsenic biomonitoring include a map of south Minneapolis
arsenic soil sample results; an algorithm developed by Smiley’s Clinic to guide medical
treatment for individuals seeking arsenic testing (note: Smiley’s clinic is currently revising this
algorithm; this document is provided as an example of the type of algorithm that might be
developed by EHTB staff to guide participant follow-up); and a summary of EHTB staff’s
community engagement efforts to date. Panel members are also asked to review the resources
that were routed by Lisa Yost and David Wallinga, as these items may help inform panel
recommendations about specific components of the arsenic proposal.
The panel is asked to keep in mind the constraints on the EHTB program, including statutory
requirements, time, and financial resources. In light of those constraints, the panel is asked to
provide comments in order to strengthen the biomonitoring proposal and ensure that the most
meaningful results are obtained.
In addition, the panel is asked to provide input on these specific issues:
•
What specimen (or specimens) should be collected: urine or hair or both?
•
What are the relative merits of collecting first morning void vs. spot urine?
•
How important is it that participants be instructed to refrain from fish/seafood before
specimens are collected?
•
Is speciation at15 µg/L appropriate?
•
Regarding the Smiley’s Clinic algorithm: What changes do panel members recommend
making to the algorithm? Is retesting with a 24-hour urine at inorganic arsenic > 10 µg/L an
appropriate step?
•
What are appropriate established reference levels for arsenic in urine or hair?
EHTB staff recommend that both urine and hair samples be collected. Not only would this detect
arsenic exposure in a longer timeframe, but we anticipate (based on feedback received from
community stakeholders already) that this is what community members will be asking for. Costs
for gathering both specimens were factored into the initial cost estimates that were routed for
October’s advisory panel meeting; adding a second specimen did not significantly increase
program costs. However, the EHTB statute specifies that we are to collect one biospecimen from
each participant. If the advisory panel agrees that collecting two specimens would strengthen the
21
arsenic biomonitoring project, EHTB staff request that a vote be taken to formally document this
recommendation.
It is anticipated that this will be the last time the panel is asked to consider the arsenic proposal
before the proposal is taken to MDH’s Institutional Review Board for approval.
ACTION NEEDED: The panel is asked to provide comments on any aspect of the arsenic
biomonitoring proposal. The panel is asked to provide input on the following specific questions
identified by EHTB program staff:
•
•
•
•
•
•
What specimen (or specimens) should be collected: urine or hair or both?
What are the relative merits of collecting first morning void vs. spot urine?
How important is it that participants be instructed to refrain from fish/seafood before
specimens are collected?
Is speciation at15 µg/L appropriate?
Regarding the Smiley’s Clinic algorithm: What changes do panel members recommend
making to the algorithm? Is retesting with a 24-hour urine at inorganic arsenic > 10 µg/L an
appropriate step?
What are appropriate established reference levels for arsenic in urine or hair?
If panel members agree that collecting both urine and hair specimens would strengthen the
arsenic biomonitoring project, EHTB staff request that a vote be taken to formally document
this recommendation.
Suggested motion: I move that, given that adding an additional specimen does not significantly
increase the cost of the biomonitoring project, the arsenic biomonitoring pilot project collect both urine
and hair samples to strengthen the project.
22
BIOMONITORING PILOT PROJECT FOR ARSENIC
Draft Proposal
Revised November 30, 2007
Purpose and Objective
The purpose of the pilot project is to measure exposure to arsenic in one community with people
identified as likely to be exposed. People likely to be exposed to arsenic are young children
exposed to soil contaminated with arsenic.
Arsenic is a general cellular toxin that is thought to exert many of its toxic effects by reversible
binding of a single molecule to closely located sulfhydryl groups on proteins. Arsenic is known
to exert effects on over 200 enzymes and other proteins (cf. Baker et al., 2005). Chronic
exposures to arsenic are associated with increased risk of progressive diseases that develop over
many years, including cancers, cardiovascular diseases and peripheral neuropathy. These
relationships have been established in studies of workers and populations exposed to relatively
high levels of arsenic in drinking water over many years (ATSDR, 2000).
Arsenic is rapidly cleared from the blood (half-life = 3-4 hrs); the half-life in urine is 1-3 days.
Small amounts of arsenic are sequestered in hair, nails and skin. The two cm of hair nearest the
scalp reflect arsenic exposure in the preceding 2 months. However, external contamination from
dust makes measurement of incorporation of arsenic in hair and nails problematic (ATSDR,
2000). There are no generally established protocols for measuring arsenic in hair or nails (e.g.,
for washing before assay), and no established data indicating expected levels in the general
population (although the MARS study and others indicate that levels in hair are generally below
0.1-0.2 µg/g) (MDH, 2001).
A Biological Exposure Index of 35 µg/L of inorganic arsenic and its metabolites in urine at the
end of a 40-hour work-week has been established by the ACGIH. Exposure to arsenic is limited
for workers with more than this amount of urinary arsenic (NLM, 2007). In the general
population urinary arsenic levels are almost always under 15µg/L, and below detection limits of
many assays (ATSDR, 2000; MDH 2001).
At numerous public meetings over the last 3 years, residents of South Minneapolis in the vicinity
of the former CMC Heartland Lite-Yard site, which manufactured arsenicals, have expressed
concern that their young children are being exposed to harmful amounts of arsenic in
contaminated soil present in their residential yards. Accordingly, the objectives of this pilot
project are to: 1) measure arsenic in urine of children who live in houses with yards containing
elevated amounts of arsenic; 2) determine if detections of urinary arsenic are correlated to the
level measured in their residential yard.
23
Background
The CMC Lite Yard site is a 5 acre triangle located at 28th Street and Hiawatha Avenue.
Arsenical pesticides were produced, and the site was heavily contaminated. Production of
arsenicals ceased in 1963. The site was excavated in 2004-2005, and capped with clean soil. The
site is covered with a new building housing Smiley’s Clinic. Starting in 2001, MDH and MDA
conducted surficial soil sampling to determine if windblown arsenic from the site had
contaminated residential yards. In 2003, MDA sampled additional yards. Since 2004, EPA has
expanded the sampling area, and to date yards of 3,575 properties, including 13 child care
centers and 4 schools within a ¾ mile radius, have been sampled. Most properties (2,900) have
less than 20 ppm arsenic. There are 478 properties with arsenic greater than 20 ppm up to 95
ppm. One hundred ninety-seven properties were found with arsenic above 95 ppm, the EPA
action level (see map).
EPA is in the process of removing soil from yards where the arsenic concentration exceeds 95
ppm to protect people (mostly young children) from acute effects of ingesting a single large soil
bolus, and expects to be done by the autumn of 2008. The site has recently been added to the
NPL (Superfund). The listing makes remediation funds available to address properties with
lower arsenic levels that might pose health risks from chronic ingestion of small amounts of soil.
A final remediation level remains to be determined, but will likely be between 20 and 40 ppm.
EPA analyses indicate that background concentrations in the area range up to 16 ppm. For more
information see http://www.health.state.mn.us/divs/eh/hazardous/sites/sitesbyname.html#cmc
Young children are most at risk from chronic soil exposures. Children play in soil, and they also
play indoors on carpets and floors that might have dirt tracked in from outdoors. Children have
high levels of hand to mouth and toy to mouth behaviors that can result in soil or dust ingestion.
Total urinary arsenic includes arsenic of inorganic origin and organic arsenic. Inorganic arsenic
(such as from pesticides) is excreted in the urine as trivalent arsenic and pentavalent arsenic. It
may also be methylated in the kidneys. Mononomethyl arsonic acid (MMA) and dimethylarsinic
acid (DMA) are of inorganic origin and are also excreted in the urine. Organic arsenic, including
arsenobetaine and arsenocholine from dietary sources (e.g., fish) is not as toxic as inorganic
arsenic. If high levels of arsenic are found in urine, it is necessary to speciate the arsenic in order
to determine how much of the arsenic is of inorganic origin, identify the type of exposure and to
assess the toxicity (ATSDR, 2000).
Aside from soil, arsenic is also found in drinking water (although not in Minneapolis), in foods,
homeopathic medicines, dietary supplements (e.g., those containing chitins), shell-fish and
cigarette smoke. Wood treated with chromated copper arsenate (CCA; green treated lumber)
contains a large quantity of arsenic and represents an important source of childhood exposure.
Thus, when arsenic is found in urine it is necessary to determine the source in order to effectively
reduce exposure (ATSDR, 2000).
24
Pilot Project Design
Population
Children living in South Minneapolis in houses at which the US Environmental Protection
Agency (EPA) has conducted soil sampling in the yard and found arsenic concentrations
>20ppm.
Eligibility
Participants must be children ≥ 3 years of age and ≤ 10 years of age living in houses where the
yards contain arsenic > 20 ppm.
Pilot Project Methods
Population Sample Selection
A list of all households with yards containing >20 ppm of arsenic and not yet remediated by EPA
will be obtained from the EPA. Each household will be sent a letter explaining the pilot project
and a household survey. The survey will ask for information about the name and age of eligible
children ages 3-10 living in the household. Returned survey information from households with
eligible children will be entered into a secure database.
A sample of 100 households will be selected for the pilot project to include all households with
yards containing >95 ppm arsenic plus a random sample of the remaining households containing
arsenic > 20 ppm and ≤ 95 ppm until the total number of households reaches 100. For each
selected household, one eligible child will be randomly selected and invited to participate.
Time-frame
In order to maximize the likelihood of contact with soil, all urine samples will be collected
between May 15 and October 15, 2008.
Participant Recruitment and Informed Consent
An adult care-giver for each selected participant will be mailed a letter explaining the purpose of
the pilot project and inviting the child to participate in biomonitoring. Care-givers who agree to
the participation of their child will be asked to return the signed informed consent form to MDH
by mail. If the form is not returned within two weeks, MDH staff will follow-up with a phone
call to explain the project, review the consent, and answer questions.
Specimen Sample Collection
Participants will be mailed a sample collection container with instructions for collecting the
sample. Caregivers will be instructed to collect a first morning void sample from the child, to
label and secure the container, and store the container in a cool place. Caregivers will be given
the option to have the sample picked up at their home by MDH project staff, or they may drop it
off at a designated clinic in the community (Smiley’s Clinic). A brief questionnaire will also be
given to care-givers about the child’s recent exposure to dietary supplements, homeopathic
medicines, secondhand tobacco smoke, and contact with CCA treated wood. Caregivers will be
instructed to turn in the questionnaire with the sample container. Labels matching the
questionnaire with the sample container will be provided. If hair samples are also collected, a 1
inch length of hair (approximately 100-250 mg) will be cut from the nape of the neck and placed
25
in a sample bag by MDH staff either in the home, or at a designated sample collection site.
Samples will be transported to the MDH Environmental Chemistry Lab for analysis of urinary
and hair arsenic.
Laboratory Analysis Methods
The MDH Public Health Laboratory will analyze all urine samples received for both arsenic and
creatinine and will report creatinine-corrected arsenic results for the project. The laboratory will
not reject urine samples if the appropriate collection procedures are followed. The laboratory will
use CDC method CTL-TMS-2.01 (or the current version) at the time of the project.
The method report level (MRL) for total arsenic in urine will be 0.5 µg/L. A threshold above
which arsenic speciation in urine should be conducted for the samples will be 15 µg/L total
arsenic. The laboratory is able to characterize inorganic and organic components including AsIII,
AsV, MMA, DMA, arsenobetaine and arsenocholine for arsenic, but the detection levels and
report levels for these speciated components have yet to be determined.
If collected, hair samples will be gently rinsed in distilled water to remove external
contamination before drying. The method report level (MRL) for arsenic in hair will be 0.1 µg/g
if a minimum of 200 mg hair sample is collected. If the sample is less than 200 mg, the MRL
should be reassessed accordingly.
Data Management and Analysis
Analytical results will be sent to the MDH Biomonitoring Project Coordinator for entry into the
database. A descriptive analysis of the sample results will be conducted, and differences in
results by soil arsenic level will be examined. Individual results will be compared to reference
values established in the published literature.
Communication of Biomonitoring Results to Participants
Biomonitoring results for each individual participant will be provided to the participant’s caregiver within 2 months of sample collection along with a letter and health recommendations as
appropriate. General information about soil contamination, health risks, actions to prevent
exposure, and additional resources will also be provided.
If a urine sample result exceeds 15 µg/L total arsenic, the participant will be provided with the
speciated arsenic lab result. If the inorganic arsenic component exceeds 10 µg/L, follow-up with
a health care provider for a repeat 24 hour urine sample collection will be recommended to
confirm the finding, along with a questionnaire to identify the source of the arsenic exposure,
and education about ways to reduce exposure. A physician consultant will be available to
provide follow-up counseling and answer questions for caregivers and their medical providers.
If a hair sample result exceeds >1.0 ppm arsenic, caregivers will be advised to consult their
health care provider for follow-up and to identify and limit possible sources of arsenic exposure.
26
Communication of Biomonitoring Results to the Community
Summary information about the range and distribution of the arsenic levels found in the sample
of 100 children will be presented to the community in written form (brief report, newsletter or
factsheet) and community members will be provided with an opportunity for public comment
and questions. Community members will be encouraged to participate in the identification of
methods for communicating results and identifying community level interventions.
Data Privacy
All information about individual participants collected by MDH in this pilot project will be
private and will be protected in accordance with the Minnesota Government Data Practices Act
and federal laws. No individuals will be identified in any reports or publications. Only summary
information which does not identify individuals will be public.
Limitations
This pilot project will not measure or be able to determine the source(s) of exposure to arsenic in
the participants. Detailed information about water consumption, food consumption, use of
consumer products and other potential sources of exposure will not be collected. The measured
concentrations in urine will be an indication of exposure in the 24-48 hours prior to sample
collection and will not be able to determine any prior exposure. Hair may provide a general
measure of exposure in the recent past (1-2 months).
Risks and Benefits
There are no health risks to participants in the pilot project. Parents of participants will receive
analytical results of the measured concentrations of arsenic in their child’s urine and hair at the
time of the sample collection, and a comparison to existing normative values. The tests will be
done at no expense to the participant.
For children whose results exceed the normal clinical reference range values and are indicative
of arsenic exposure, the parents will be advised to consult a health care provider for a follow-up
test and medical consultation. Participants and their health care providers will be provided with
health information, action steps to avoid additional exposure, and other resources.
References
ATSDR 2000. Toxicological Profile for Arsenic. US Department of Health and Human Services.
Available at: http://www.atsdr.cdc.gov/toxpro2.html
Baker, BA, AR Topliff, RB Messing, D Durkin, JS Johnson 2005. J Agromedicine 10(4): 43-54.
MDH 2001. Messing, RB, JS Johnson, R Soule, D Durkin, M Salisbury, L Souther, B Cuffel,
BA Baker, JE Connett, M Berndt, D Van Horne, The Minnesota Arsenic Study (MARS). ATSDR,
US Department of Health and Human Services, December 2001.
NLM, 2007. Haz-Map. Available at http://hazmap.nlm.nih.gov
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Update on community engagement
Arsenic biomonitoring pilot project
Legislative mandate
According to Minn. Statute144.997, Subd 4(a)(6), the commissioner shall develop “a method for
informing affected communities and local governments representing those communities
concerning biomonitoring activities and for receiving comments from citizens concerning those
activities.”
Steps taken to inform community members and solicit community input
In an effort to inform neighborhood stakeholders about our activities and receive guidance on
effectively reaching out to community members, EHTB program staff have met or talked with
city council members’ aides, a county commissioner’s aide, staff from the Minneapolis
Department of Health and Family Support, staff from the city’s Environmental Management
division, staff from Smiley’s Clinic, and the city’s Public Health Advisory Committee.
In anticipation of a public meeting scheduled for Thursday, December 6 (a verbal update will be
provided on the results of this public meeting at the advisory panel’s December 17 meeting), a
news release was issued. The story was picked up by the Star Tribune, MPR, WCCO TV, KARE
TV, KMSP TV, KSTP TV, and several community newspapers. MPR and the Star Tribune have
both indicated that they may run a more in-depth story on the biomonitoring project after the
community meeting occurs. EHTB staff also contacted community newspapers to include the
community meeting in their community events calendars.
EHTB staff have posted flyers announcing the community meeting at libraries, parks, and other
sites in the community (e.g., YWCA, Boys & Girls Club, CUHHC Clinic, Smiley’s Clinic). The
same flyer was sent home with students attending schools in the project area. EHTB staff have
also contacted the community police liaison and the neighborhood organizations in the project
area to solicit their assistance in spreading the word about the project and the community
meeting; several of these organizations sent an announcement to their e-mail lists about the
project. Information about the project has been added to the MDH website and will be updated as
needed.
State legislators who represent the neighborhoods who will be included in the pilot project have
been sent a letter describing the project and inviting them to the community meeting. As a
courtesy, copies of this letter were also sent to the chairs of the health and environment
committees in the House and Senate.
We have developed a very general handout describing the pilot project and will be producing
additional materials as we solidify the details of the proposal. The City of Minneapolis has
offered their assistance in translating materials into Spanish.
37
Next steps to solicit community input
We know that we will reach only a portion of the target population through the outreach that we
have already conducted. As we move ahead, we plan to offer other opportunities for community
input on the project. We are considering developing a parent/neighborhood advisory committee
to provide input on specific components of the project and we will continue to explore
mechanisms for reaching residents who do not speak English. At the same time, we are
cognizant of the constraints on our time and resources and will need to find ways to balance
those with our sincere desire to have community involvement in and awareness of the pilot
project.
Summary of input received to date
Input we’ve received from the contacts we’ve made so far has been extremely valuable. In
addition to suggestions for publicizing our community meeting and names of people we should
contact, stakeholders have provided input on specific components of the initial project proposal
and for involving community members in an ongoing manner:
Suggestions to strengthen project proposal:
• Consider collecting samples late in the summer, when the weather is dryer and there may
be more exposure to bare soil
• Carefully consider ways of recruiting participants, as it may be difficult to get to 100
participants through standard methods. For example, consider collaborating with a
community agency when recruiting participants rather than having letters arrive from
MDH directly; going door-to-door to recruit rather than relying on letters; or finding a
way to offer participant incentives by collaborating with another organization
• Consider sampling both hair and urine, as community members are likely to want a
measurement of longer-term exposure
• Consider developing follow-up protocols that will mirror what Smiley’s Clinic is already
doing
• Consider including a more robust participant survey as part of the project, including
assessing how much time the child spends in the yard and how long the child has lived at
the property (given the high resident turnover in the neighborhood)
• Consider Monday morning sample collection to maximize contact with soil
Suggestions to foster community involvement
• Consider forming a parent/neighborhood advisory committee to provide input on
recruitment strategies and effective ways to educate the community, disseminate results
and develop community interventions
• Consider conducting outreach to neighborhood clinics, so area physicians are aware of
the project and can adequately address patient concerns upon follow up
38
Section overview: PFC biomonitoring
A revised version of the PFC biomonitoring proposal is included in the meeting packet. The
revisions, which are minor, include additional background information about the selected
communities and slight changes to the description of community 2 and eligibility requirements.
Additional supporting materials for PFC biomonitoring include a more detailed rationale for
selecting the two communities that have been chosen; a map of PFBA levels in the southeast
metro area; a chart of PFC levels from NHANES and the Red Cross study which may be used as
comparison values for biomonitoring results; and a summary of EHTB staff’s community
engagement efforts to date.
The panel is asked to keep in mind the constraints on the EHTB program, including statutory
requirements, time, and financial resources. In light of those constraints, the panel is asked to
provide comments in order to strengthen the biomonitoring proposal and ensure that the most
meaningful results are obtained.
In addition, the panel is asked to provide input on these specific issues:
Issues related to participant eligibility:
• Proposed requirement that participants must be over 20 years of age (to facilitate
comparisons with NHANES data).
• Proposed requirement that participants must have been living at current residence (not just
living in the community) prior to Jan. 1, 2005.
• Proposed requirement that participants must have PFOA or PFOS detection > 0.1 ppb in
private wells (as opposed to any detection).
Issues related to participant survey:
• Questions to be included on the participant survey (beyond current water source in the home,
ever worked at 3M Cottage Grove, and demographic information).
Because the community engagement process for the PFC biomonitoring pilot project is just
beginning, there is a small chance that the advisory panel will be asked to consider the PFC
proposal again at a later meeting. However, we will strive to complete as much of the discussion
of the PFC proposal as possible in December, returning to the advisory panel only if community
engagement efforts yield a substantial change to the proposal. It is likely that the December
meeting will be the last time the advisory panel discusses the PFC proposal at length before it is
submitted to MDH’s Institutional Review Board for approval.
39
ACTION NEEDED: The panel is asked to provide comments on any aspect of the PFC
biomonitoring proposal. The panel is asked to provide specific input on the following issues
identified by EHTB program staff:
Issues related to participant eligibility:
• Proposed requirement that participants must be over 20 years of age (to facilitate
comparisons with NHANES data).
• Proposed requirement that participants must have been living at current residence (not just
living in the community) prior to Jan. 1, 2005.
• Proposed requirement that participants must have PFOA or PFOS detection > 0.1 ppb in
private wells (as opposed to any detection).
Issues related to participant survey:
• Questions to be included on the participant survey (beyond current water source in the
home, ever worked at 3M Cottage Grove, and demographic information).
40
BIOMONITORING PILOT PROJECT FOR
PERFLUOROCHEMICALS
Draft Proposal
Revised November 30, 2007
Purpose and Objective
The purpose of the pilot project is to measure exposure to perfluorochemicals, including
perfluorobutanoic acid (PFBA), in two communities with people identified as likely to be
exposed. People likely to be exposed to PFBA and other perfluorochemicals including
perfluorooctanoic acid (PFOA) and perfluoroctane sulfonate (PFOS) are people exposed through
drinking water contamination.
PFOA and PFOS or related chemicals have been used in consumer products and various
industrial processes, and are known contaminants in the food supply (Tittlemeir et al., 2007).
They have been found in blood serum of people and animals throughout the world (Olsen et al.,
2006). Limited data collected by law firms, provide indications that some people exposed to
PFOA and PFOS in drinking water in the cities of Oakdale and Lake Elmo in Washington
County have elevated PFCs in their blood when compared to 3M/Red Cross and CDC studies
(Billot, 2007). PFOA and PFOS have long half-lives (3.8 and 5.4 years, respectively) (Olsen et
al., 2007). PFBA is seen occasionally in some of the people tested in Washington County, mostly
in Oakdale (3/38 people); occurrence in the general population is unmeasured. A recent study of
three 3M workers found half-lives for PFBA to be less than 5 days (3M, 2007). Thus, unlike
PFOA and PFOS, PFBA does not bioaccumulate, and is less likely to be detected in blood.
Accordingly, the objective of this pilot project is to measure perfluorochemicals, including
PFOA, PFOS and PFBA in blood sera of people in two communities exposed to these chemicals
in drinking water and compare these results with national survey data, including data from Red
Cross studies and the CDC National Health and Nutrition Examination Survey (NHANES). In
2007, the CDC published the results of an analysis of PFC concentrations in 1,562 serum
samples collected in 1999-2000 NHANES participants. According to the authors, “These data
will serve as a nationally representative baseline of the US population/s exposure to PFCs to
which other populations can be compared” (Calafat et al., 2007).
Background
PFOA and PFOS were discovered in four municipal wells in the City of Oakdale, MN early in
2005. Analyses were conducted by the MDH Public Health Laboratory. Following this
discovery, PFOA and PFOS were detected in samples from private wells in the City of Lake
Elmo. Early in 2006, the MDH Public Health Laboratory developed the capacity to analyze an
extended list of PFCs, and widespread PFBA contamination of drinking water was found in
Oakdale and Lake Elmo.
41
Four of eight Oakdale municipal wells are contaminated with PFOA and PFOS above MDH
Health Based Values for drinking water (0.5 and 0.3 ppb, respectively). Combined PFOA and
PFOS hazard indices calculated for individual wells range from 1.5 to 4.8), although actual
hazard indices for drinking water in the distribution system are unknown because the water
comes from several wells, and levels in the distribution system vary also by region within the
City of Oakdale. Three of the four wells contain PFBA between 1 and 2.1 ppb, and the fourth
well has measured PFBA concentrations from 0.6-1.1 ppb. Two other wells in Oakdale also
contain low concentrations of PFBA (0.1-0.5 ppb). When the contamination of the Oakdale
water supply was discovered, the City began preferentially using its less contaminated wells to
reduce public exposure to PFCs. In October 2006 a large granular activated carbon (GAC)
system was installed on the two most contaminated wells, and these wells were then used
preferentially. However, PFBA began appearing in the post-treatment water within 2 months,
although other PFCs are still retained by the GAC system. Current post-treatment levels of
PFBA are at about 2 ppb. Thus, exposure to PFCs is still occurring in Oakdale, both because
some untreated water from contaminated wells with no treatment systems continues to be used,
and because PFBA is not entirely eliminated by GAC treatment.
During 2005 and 2006, households using private wells in Lake Elmo with contamination above
MDH drinking water criteria were supplied with alternative drinking water sources. Maximum
levels of PFOA, PFOS and PFBA detected were 2.4, 3.5 and 12 ppb, respectively. The Lake
Elmo public water supply was extended to serve some of the residences previously depending
upon private wells. Other residences were supplied with whole-house granular activated carbon
(GAC) systems. These systems are effectively eliminating PFOA, PFOS and PFBA from the
drinking water.
In late 2006 and early 2007 widespread PFBA contamination was discovered to the south, in the
cities of Cottage Grove, St. Paul Park, Newport, Woodbury, Hastings and South St. Paul. Levels
above 1 ppb of PFBA were observed in water supply wells in Cottage Grove and St. Paul Park.
Many private wells in this area also contain PFBA. However, PFOS has only been detected at
more than trace levels (>0.1 ppb) in one drinking water well in this area, and PFOA above trace
levels (>0.1 ppb) has been detected only in a few (approximately 30) private wells in a small area
of Cottage Grove.
Pilot Project Design
Population
Two Communities in Washington County with likely exposure to PFCs in drinking water, where
elevated levels of PFOA and PFOS may be detected along with other chemicals, including
PFBA.
Community 1: Residents of the city of Oakdale or Lake Elmo living in homes served by
the Oakdale municipal water supply. Through July, 2006, 120 households in the city of Lake
Elmo were served with drinking water through the Oakdale municipal water supply. There are
approximately 27,000 people in Oakdale and approximately 9,000 city water connections.
Community 2: Residents of Lake Elmo and Cottage Grove who have ever been served by
private drinking water wells, and who have had PFOA and/or PFOS detected above trace levels
42
(>0.1 ppb) in at least one sample of their well water tested by the MDH Public Health Laboratory
prior to January 1, 2008. (Note: all of the private wells containing PFOA and/or PFOS also are
contaminated with PFBA). There are approximately 150 private wells in Lake Elmo and Cottage
Grove that have been found to be contaminated with PFOA or PFOS above trace levels.
Eligibility
Participants must be adult community residents, 20 years of age or older, and have been living at
their current residence before January 1, 2005, prior to the first discovery of perfluorochemical
contamination of wells in Oakdale and Lake Elmo early in 2005.
Pilot Project Methods
Population Sample Selection
Community 1: A complete list of all City of Oakdale and City of Lake Elmo residents
served by the Oakdale municipal water supply will be obtained from the city water
customer/billing records to include name and address of the water customer. Approximately 300
households will be randomly selected from this list and each household will be sent a letter
containing a household survey form. The letter will explain the pilot project. The survey will ask
for information about the name and age of current adult household members, and the year the
household member began living in the current residence. Information from returned surveys will
be entered into a secure database from which 100 eligible adults from 100 different households,
who resided in their current residence before January 1, 2005 will be randomly selected.
Community 2: A list of all households in Lake Elmo and Cottage Grove who have ever
been served by private wells contaminated with PFBA, PFOA and/or PFOS will be obtained
from MDH well sampling records. All of these households (approximately 150) will be sent a
letter containing a household survey form (see above). Using data from the returned surveys, 1
adult will be randomly selected from up to 100 households, who resided in the current residence
before January 1, 2005(see above). In the event that fewer than 100 households respond, a
second adult will be randomly selected from responding households, until 100 adults are enrolled
as described above.
Participant Recruitment and Informed Consent
Each adult selected to participate will be mailed a letter explaining the purpose of the pilot
project and inviting them to participate in the biomonitoring. Participants who agree to
participate and return the signed informed consent form to MDH will be referred to a clinic to
obtain a blood sample. Participants will be asked to contact the clinic for appointment times. A
brief self-administered questionnaire will collect information about the current drinking water
source at the home, whether the individual ever worked for the 3M Cottage Grove facility, and
demographics.
Blood Sample Collection, Storage and Transport
A health clinic under contract with MDH and located in close proximity to the selected
communities will collect blood samples by venipuncture from participants. Blood samples will
be frozen and stored at the clinic, then transported by MDH staff to the MDH Public Health
Laboratory, where they will be stored at -70°C until analysis.
43
Laboratory Analysis Methods
Samples will be analyzed according to methods developed by the CDC for measuring serum
concentrations of eleven PFCs. The CDC reference method will be expanded to include PFBA.
Methodology includes solid-phase extraction, followed by a high performance liquid
chromatography–tandem mass spectrometry (LC-MS/MS) analytical system. Similar to the CDC
reference method, the method report limit (MRL), a.k.a. limit of quantitation (LOQ) will range
from 0.05 ng/ml (ppb) to 0.2 ng/ml.
Data Management and Analysis
Analytical results will be sent to the MDH Biomonitoring Pilot Project Coordinator for entry into
a secure database. A descriptive analysis of the sample results will be conducted to include the
mean, median, and distribution. These findings will be compared to published national survey
(NHANES) serum sample results. A summary of these findings will be reported.
Communication of Biomonitoring Results to Participants
Biomonitoring results for each individual participant will be provided to the participant within 3
months of sample collection along with a letter explaining the relationship of their results to
national studies. General information about drinking water quality, health risks, actions to
prevent exposure to PFCs, and additional resources will also be provided.
Data Privacy
All information about individual participants collected by MDH in this pilot project will be
private and will be protected in accordance with the Minnesota Government Data Practices Act
and federal laws. No individuals will be identified in any reports or publications. Only summary
information which does not identify individuals will be public.
Limitations
This pilot project will not measure or be able to determine the source(s) of exposure to PFCs in
the participants. Detailed information about water consumption, food consumption, use of
consumer products containing PFCs and other potential sources of exposure will not be
collected. Except for prior history working at the 3M Cottage Grove facility, occupational and
environmental exposure histories will not be collected.
Risks and Benefits
The risks to participant include the possibility of bruising, bleeding, discomfort, and pain from
the blood draw. Risk is greater for individuals with bleeding disorders, such as aplastic anemia,
and for persons on blood thinning medications (Coumadin), and other therapies. Participants
should consult with their health care provider if they have any of these conditions prior to
visiting the clinic.
Participants will receive analytical results of the measured concentrations of PFCs in their blood
and a comparison to national reference values no later than 3 months after sample collection. The
44
tests will be done at no expense to the participant. Some participants may have increased anxiety
about chemicals detected in the body for which only very limited information is known about
health effects, particularly for those whose results may exceed the “normal” reference range
values. Participants and their health care providers will be provided with health information,
action steps to avoid additional exposure, and other resources to address these concerns.
References
3M 2007b. Estimation of the Half-life of Serum Elimination of Perfluorobutyrate (PFBA) in
Four 3M Male Employees. Medical Department, 3M Company, St. Paul, MN 55144. July 18,
2007.
Betts, K.S. 2007. Perfluoroalkyl Acids: What is the Evidence Telling Us? Environmental Health
Perspectives 115: 251-256, May 2007.
Bilott, R. 2007. Perfluorochemical exposure data for Washington County, Minnesota.
Correspondence from Robert A. Bilott, Taft, Stettinius & Hollister LLP to EPA, MDH, and
MPCA staff. February 2, 2007.
Calafat, A.M., Kuklenyik, Z., Reidy, J.A., Caudill, S., Tully, J.S., and Needham, L.L. 2007a.
Serum concentrations of 11 polyfluoroalkyl compounds in the U.S. population: data from the
National Health and Nutrition Examination Survey (NHANES) 1999-2000. Environmental
Science and Technology 41: 2237-2242.
Calafat, A.M., Wong, L-Y., Kuklenyik, Z., Reidy, J.A., and Needham, L.L. 2007b.
Polyfluoroalkyl chemicals in the U.S. population: data from the National Health and Nutrition
Examination Survey (NHANES) 2003-2004 and comparisons to NHANES 1999-2000.
Environmental Health Perspectives, published online on August 29, 2007.
doi:10.1289/ehp.10598.
Olsen, G.W., Burris, J.M., Ehresman, D.J., Froehlich, J.W., Seacat, A.M., Butenhoff, J.L., and
Zobel, L.R. 2007a. Half-life of serum elimination of perfluorooctanesulfonate,
perfluorohexanesulfonate, and perfluorooctanoate in retired fluorochemical production workers.
Environmental Health Perspectives online, published June 12, 2007.
Tittlemier, SA, Pepper, K et al., 2007. Dietary exposure of Canadians to perfluorinated
carboxylates and perfluorooctane sulfonate via consumption of meat, fish, fast foods, and food
items prepared in their packaging. J Agric Food Chem 55: 3203-3210.
45
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46
Rationale for Selection of Communities:
PFC Biomonitoring Proposal
November 28, 2007
The purpose of the program is to measure exposure to perfluorochemicals, including
perfluorobutanoic acid (PFBA), in two communities with people identified as likely to be
exposed. In Minnesota, the highest exposures are likely to occur among people who worked at
PFC manufacturing facilities, such as the 3M plant located in Cottage Grove. However, these
workers were not selected for biomonitoring in this program because 3M has already conducted
extensive biomonitoring of workers at this facility, and it would not address the concerns of
Minnesota residents with non-occupational exposure.
People in Minnesota likely to be exposed to perfluorochemicals from non-occupational sources
are people exposed through drinking water contamination in Washington County. Limited data
collected by law firms, indicate that some people exposed to PFOA and PFOS in drinking water
in the cities of Oakdale and Lake Elmo in Washington County have elevated PFCs (PFOA and
PFOS) in their blood when compared to levels found in American Red Cross blood samples, and
CDC biomonitoring studies of the US population (Billot, 2007). PFOA and PFOS have long
half-lives in the body (3.8 and 5.4 years, respectively) (Olsen et al., 2007).
Samples collected by the law firms also found PFBA in 3 out of 38 people tested in Washington
County, mostly in Oakdale, but levels in the general population have not been measured and
reported so no comparison can be made. One reason why this chemical has generally not been
measured is because it has a very short half-life in the body. A recent study of three 3M workers
found half-lives for PFBA to be less than 5 days (3M, 2007). Thus, unlike PFOA and PFOS,
PFBA does not bioaccumulate in the body, and is much less likely to be detected in blood.
The 2 communities in Washington County recommended by the EHTB workgroup are:
Community 1: Residents of the city of Oakdale or Lake Elmo living in homes served by
the Oakdale municipal water supply. There are approximately 27,000 people in Oakdale and
approximately 9,000 city water connections. Through July, 2006, 120 households in the city of
Lake Elmo were also served with drinking water through the Oakdale municipal water supply.
Four of eight Oakdale municipal wells are contaminated with PFOA and PFOS above MDH
Health Based Values for drinking water (0.5 and 0.3 ppb, respectively). Three of the four wells
contain PFBA between 1 and 2.1 ppb, and the fourth well has measured PFBA concentrations
from 0.6-1.1 ppb. In October 2006 a large granular activated carbon (GAC) system was installed
on the two most contaminated wells, and these wells were then used preferentially. However,
PFBA began appearing in the post-treatment water within 2 months, although other PFCs are
still retained by the GAC system. Current post-treatment levels of PFBA are at about 2 ppb.
Thus, exposure to PFCs is still occurring in the Oakdale water supply, both because some
untreated water from contaminated wells with no treatment systems continues to be used, and
because PFBA is not entirely eliminated by GAC treatment.
47
Community 2: Residents of Lake Elmo and Cottage Grove who have ever been served by
private drinking water wells, and who have had PFOA and/or PFOS detected above trace
levels (>0.1 ppb) in at least one sample of their well water tested by the MDH Public
Health Laboratory prior to January 1, 2008.
There are approximately 150 private wells in Lake Elmo and Cottage Grove that have been
found to be contaminated with PFOA or PFOS above trace levels. All of the private wells
containing PFOA and/or PFOS also are contaminated with PFBA. Maximum levels of PFOA,
PFOS and PFBA detected were 2.4, 3.5 and 12 ppb, respectively. During 2005 and 2006,
households using private wells in Lake Elmo with contamination above MDH drinking water
criteria were supplied with alternative drinking water sources. The Lake Elmo public water
supply was extended to serve some of the residences previously depending upon private wells.
Other residences were supplied with whole-house granular activated carbon (GAC) systems.
These systems are effectively eliminating PFOA, PFOS and PFBA from the drinking water so
that persons drinking treated private well water are not currently exposed.
Other communities considered:
In late 2006 and early 2007 widespread PFBA contamination was discovered in the cities of
Cottage Grove, St. Paul Park, Newport, Woodbury, Hastings and South St. Paul. Levels above 1
ppb of PFBA were observed in water supply wells in Cottage Grove and St. Paul Park. Many
private wells in this area also contain PFBA. However, PFOS has only been detected at more
than trace levels (>0.1 ppb) in one drinking water well in this area, and PFOA above trace levels
(>0.1 ppb) has been detected only in a few (approximately 30) private wells in a small area of
Cottage Grove. Due to the very short half-life of PFBA and in order to increase the likelihood of
detecting elevated PFCs in the blood samples, it was determined that communities in
Washington County with exposure to PFBA contamination only, and no detections of PFOA or
PFOS above trace levels in the drinking water supply, were not selected.
Eligibility criteria for participants:
Due to the fact that various remedies for the water contamination have been implemented in
these communities since 2005, eligibility for participation in the biomonitoring project is limited
to adult participants, 20 years of age or older, who have been living at their current residence
since before January 1, 2005, prior to the first discovery of perfluorochemical contamination of
wells in Oakdale and Lake Elmo early in 2005. This increases the likelihood that the participants
will have had sufficient past exposure.
48
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50
Comparison values for PFCs in blood
Population
NHANES data for 1999-20001
12-19
20-39
40-59
60+
Males
Females
All
NHANES data for 2003-20042
12-19
20-39
40-59
60+
Males
Females
All
Red Cross adult blood donors
(20-69 years of age) in 20002001 3
Males
Females
All
PFOS
Geometric mean in ppb
(95% confidence interval)
PFOA
Geometric mean in ppb
(95% confidence interval)
29.1 (26.2-32.4)
27.5 (24.9-30.2)
33.0 (28.0-38.8)
33.3 (28.5-38.8)
33.4 (29.6-37.6)
28.0 (24.6-31.8)
30.4 (27.1-33.9)
5.5 (5.0-6.0)
5.2 (4.7-5.7)
5.4 (4.7-6.2)
4.8 (4.3-5.5)
5.7 (5.2-6.3)
4.8 (4.3-5.5)
5.2 (4.7-5.7)
19.3 (17.5-21.4)
18.7 (17.3-21.4)
22.0 (19.7-24.5)
23.2 (20.8-25.9)
23.3 (21.1-25.6)
18.4 (17.0-20.0)
20.7 (19.2-22.3)
3.9 (3.5-4.4)
3.9 (3.6-4.2)
4.2 (3.8-4.8)
3.7 (3,3-4.1)
4.5 (4.1-4.9)
3.5 (3.2-3.8)
3.9 (3.6-4.3)
37.8 (35.5-40.3)
32.1 (30.0-34.3)
34.9 (33.3-36.5)
4.9 (4.6-5.3)
4.2 (3.9-4.5)
4.6 (4.3-4.8)
1
Calafat et al. (2007) “Serum concentrations of 11 polyfluoroalkyl compounds in the U.S. population: Data from the
National Health and Nutrition Examination Survey (NHANES) 1999-2000.” Environmental Science &Technology.
41: 2237-2242.
2
Calafat 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.” Environmental
Health Perspectives. Published online on August 29, 2007. doi:10.1289/ehp.10598.
3
GW Olsen et al. (2003) “Perfluorooctanesulfonate and other fluorochemicals in the serum of American Red Cross
adult blood donors.” Environmental Health Perspectives. 111: 1892-1901.
51
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52
Update on community engagement
PFC biomonitoring pilot project
Legislative mandate
According to Minn. Statute144.997, Subd 4(a)(6), the commissioner shall develop “a method for
informing affected communities and local governments representing those communities
concerning biomonitoring activities and for receiving comments from citizens concerning those
activities.”
Steps taken to inform community members and solicit community input
Outreach in the east metro area is just beginning. To date, EHTB staff have met with
representatives from the Washington County Department of Public Health and Environment.
Next steps to solicit community input
Significant outreach will take place in December and January. EHTB staff plan to meet with city
administrators, public works officials, and local elected officials. A letter will be sent to state
legislators who represent the cities involved in the project. Other methods being considered for
outreach include direct mailings, community meetings, and a news release. It is likely that we
will seek ways to reach out to the medical community to help them prepare for advising patients
who are concerned about PFCs. As we continue meeting with stakeholders, we will undoubtedly
learn about additional ways that we can effectively reach out to community members.
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Section overview: Project status updates
Given the limited time available for advisory panel meetings, some items will be presented to the
panel as information items only. These are 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 to
alert panel members to items that will need to be discussed in greater depth at a future meeting.
There are four such items on the December agenda:
Mercury biomonitoring
Pat McCann (research scientist in the Environmental Health Division of the Minnesota
Department of Health) will provide a brief overview of a grant awarded by the EPA to MDH to
measure “Mercury Levels in Blood from Newborns in the Lake Superior Basin.” MDH, in
collaboration with state health departments in Wisconsin and Michigan, is planning to
prospectively measure levels of mercury in residual blood spots from infants born to families
living within these states’ respective land areas that drain water into Lake Superior. The data
collected will assist public health departments in targeting health protective outreach and advice
on fish consumption, which is the major source of methylmercury exposure. The time-line will
likely be influenced by deliberations during the spring session of the state legislature regarding
regulations affecting the storage and use of newborn specimens. This study will address many,
but not all, of the guidelines in the EHTB legislation. A brief description of this project is
included in the meeting packet along with a map of the Lake Superior basin and a project
timeline.
At this time, no formal action is needed by the advisory panel, though panel members are invited
to ask questions and provide comments. At the March advisory panel meeting, panel members
will be asked to consider how the EHTB program should proceed in terms of meeting legislative
requirements to conduct a pilot biomonitoring project for mercury. One option could be to
provide support to the existing mercury exposure study in lieu of conducting a separate pilot
biomonitoring project for mercury. Support could mean providing funding for in-kind
contributions by MDH to the project, performing statistical analyses, or coordinating some
aspect of project communications efforts. In March, the advisory panel will be asked to consider
this study and other options for conducting biomonitoring of mercury as required by statute.
ACTION NEEDED: Panel members are invited to ask questions or provide input.
Biomonitoring for “designated chemicals”
Information is included in the meeting packet to describe a number of options identified by
program staff for proceeding with developing a pilot biomonitoring project for a fourth, to-bedesignated chemical as required by statute. These options include 1) not selecting a new
chemical for study; 2) selecting a new chemical in the 2007-2008 biennium for study; and 3)
conducting strategic planning, research and outreach on the selection and identification of
specific chemicals to study under the base biomonitoring program in the future.
55
No decisions or specific advice are being sought at the panel’s December meeting, though panel
members are invited to ask questions and provide comments. At the March panel meeting, panel
members will be asked to consider the options outlined by program staff and to provide advice
on how to proceed with the fourth biomonitoring project.
ACTION NEEDED: Panel members are invited to ask questions or provide input.
Biomonitoring program guidelines
The EHTB statute requires the EHTB program, in consultation with the advisory panel, to
develop program guidelines or protocols that address the science and practice of biomonitoring,
including procedures for changing the protocols to incorporate new technologies; guidelines for
ensuring privacy of information, informed consent, follow-up counseling and communicating
results; and methods for developing culturally appropriate educational and outreach materials.
A copy of the executive summary for “Human Biomonitoring for Environmental Chemicals” is
included in the meeting packet. This book, developed by the National Research Council, is one
source from which program guidelines might be drawn and is provided as a starting point for
panel members’ consideration. The full text of the book can be viewed online for free at
www.nap.edu/catalog/11700.html. A PDF or hard copy of the book can be purchased at the same
site. The EHTB program may be able to order copies of this book for panel members.
At the December meeting, EHTB staff will solicit panel members to serve on a subcommittee to
begin working on drafting program guidelines for biomonitoring. The subcommittee would meet
before the March panel meeting so that draft program guidelines could be considered by the full
panel in March. No further formal action is needed at this time, though panel members are
invited to ask questions and provide comments.
ACTION NEEDED: Panel members are invited to ask questions or provide input. Panel
members are also asked to consider volunteering to serve on a subcommittee to develop
biomonitoring program guidelines.
Tracking
No written materials about tracking are included in the meeting packet. A brief verbal update
will be provided at the panel meeting. No formal action is needed by the advisory panel, though
panel members are invited to ask questions and provide comments about tracking activities.
ACTION NEEDED: Panel members are invited to ask questions or provide input.
56
Mercury Biomonitoring in Newborns in Lake Superior Basin
57
58
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60
BIOMONITORING PILOT PROGRAM FOR
“DESIGNATED CHEMICALS”
Legislative directive
Minnesota Statutes Section 144.997, subdivision 1, directs the commissioner of health to
implement a Biomonitoring Pilot Program that includes collection of biospecimens for arsenic,
mercury, perfluorinated chemicals and a commissioner-identified designated chemical.
Biospecimens for a “designated chemical” collected as part of the Biomonitoring Pilot Program
must be collected from 30 voluntary participants from each of three communities (i.e., 90 total
biospecimens). “Communities” is further defined in 144.995 (f).
Options for consideration
The EHTB Workgroup has considered several options for implementation of a pilot program for
a designated chemical:
•
Do not select a new chemical for study. Conserve resources for additional data collection
to enhance the PFC and arsenic projects (such as exposure assessment questionnaires or
increased numbers of participants).
•
Select a new chemical in the 2007-2008 biennium for study.
o Conduct an independent pilot project in three communities as described in the
legislation.
o Add a chemical to one of the currently proposed biomonitoring projects (PFCs or
Arsenic) and analyze 90 specimens in one or more communities.
o Identify another health study or program activity currently collecting or storing
biospecimens for other purposes and propose to add a biomonitoring component
as an ancillary study (see Appendix D).
•
Conduct strategic planning, research, and outreach on the selection and identification of
specific chemicals to study under the base biomonitoring program in the future (beyond
the 2007-2008 biennium).
o Convene focus groups comprised of various stakeholders (e.g., citizens,
physicians, public health scientists) to aide the selection of designated chemicals.
o Use advisory panel meetings or workshops to review guidelines and identify
chemicals (see the following guidance and Appendices) and funding sources.
o Convene a conference of experts to discuss options, policies and guidelines for
biomonitoring (Appendix D).
o In collaboration with other investigators, add biomonitoring components ancillary
to health studies planned for other purposes (Appendix D).
61
Considerations
Cost
Biomonitoring pilots (and ongoing biomonitoring studies) of the scope prescribed in authorizing
statutes are costly to plan, implement, and analyze. Base costs for study design and planning,
data management and for community participation, and education are typically $100,000 to
$200,000 for a 2-year pilot. Biospecimen laboratory analyses costs must be considered in
addition to the base costs (see Appendix A).
The remaining funding dedicated to the biomonitoring pilot projects, after accounting for the
arsenic and PFC pilot projects, does not cover the base costs for an independent pilot project for
the commissioner-identified designated chemical.
Feasibility
To conduct an independent project in the 2007-2008 biennium, time is a factor. It may not be
feasible to select a chemical, plan and carry out an independent project in accordance with the
statute in the 18 months remaining in this biennium. It generally takes 4-6 months at a minimum
to develop protocols and obtain necessary approvals before a project begins, and can be
considerably longer with multiple partners involved. It is likely that additional staff would be
needed to coordinate the project in this short time frame.
The option of collaborations and possible ancillary studies (either in this biennium or in the
future) with other investigators may be feasible if suitable studies with the appropriate
biospecimens are planned for collection and/or storage, and project protocols permit ancillary
studies. In general, the use of a biospecimen collected for a given scientific or public health
purpose may not be used for additional purposes without the permission of the participant under
federal and state rules governing human subject protection and government data practices.
Biomonitoring program statute and guidelines
There are specific guidelines in the statute regarding the selection of a designated chemical that
need review and consideration. These are described in the next section, Chemical Selection
Guidance.
Minn.Statute 144.997, subd. 4(a) further stipulates that the Commissioner of Health, with the
advice of the panel, develop “protocols or program guidelines that address the science and
practice of biomonitoring to be utilized” and that they be guided by protocols and guidelines
developed the CDC. Discussion and adoption of these specific guidelines may be necessary
before moving forward with a decision to select a chemical. In addition to scientific guidelines,
guidelines for data privacy, informed consent, follow-up support and communicating findings to
participants, communities, and the general public, required by the statute, should be a
consideration in the decision to move forward with a given project.
62
Chemical selection guidance
“Designated chemicals,” as defined in Section 144.995 (h), “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).” (emphasis added)
Section 144.998 establishes the creation of an Environmental Health Tracking and
Biomonitoring Advisory Panel and outlines its duties. In Subdivision 3, clause (6), criteria are
established for the selection of “specific chemicals to study under the biomonitoring program,”
and requires that when making recommendations to the commissioner and the legislature there
be “agreement with at least nine of the advisory panel members.” The advisory panel is made up
of thirteen members.
Biospecimens collected for designated chemicals in future base program biomonitoring activities
can be collected from any number of voluntary participants in any number of communities likely
to have been exposed to the designated chemical.
The authorizing statute creates the following guidelines to designate chemicals for the
biomonitoring pilot program and any future base biomonitoring program:
1. Designated chemicals will be specified by MDH, and
2. Will be selected from among
a. The chemical families or metabolites included in the National Reports on Human
Exposure to Environmental Chemicals (see Appendices A & B); and/or
b. Substances recommended to the commissioner by agreement of nine (of thirteen)
members of the advisory panel, according to specified criteria (see Appendix C).
63
APPENDIX A
Selecting a Designated Chemical from NHANES Chemical Families
The advantages to selecting a designated chemical from among those currently monitored in the
National Report on Human Exposure to Environmental Chemicals4 (a report of biomonitoring
data collected through the National Health and Nutrition Examination Survey – NHANES)
include the availability of:
•
•
•
Baseline human exposure data against which comparisons of the pilot program can be
made;
Chemical-specific scientific studies associated with biomonitoring, exposure data and
health outcomes; and
Well-established laboratory methods to characterize biospecimens.
These advantages can be linked to the criteria outlined in 144.998 subd. 3(6).
The summary table below shows the chemical groups (families) that are included in analyses of
blood or urine samples collected as part of NHANES (the complete list of chemical families, and
the actual chemicals or metabolites monitored in biospecimens are included in Appendix B). The
table also provides a brief summary of potential exposure sources for each chemical family, the
biospecimen, and a relative cost per biospecimen as follows:
$$$$ = $600 to $1000
$$$
= $300 to $600
$$
= $100 to $300
$
= $30 to $100
For most chemical families listed, costs may quickly escalate with the number of parameters for
which information is sought (e.g., there are 24 individual PAHs for which lab standards would
need to be obtained).
Chemical Family
Metals
Tobacco Smoke
Polycyclic Aromatic
Hydrocarbons (PAHs)
Exposure Source(s)
Various (depending on metal); natural;
diet; workplace (see NHANES for
details).
Cigarette smoke.
Air, water, soil, or food; air from motor
vehicle exhaust, residential and
industrial furnaces, tobacco smoke,
volcanoes, agricultural burning,
residential wood burning, and
wildfires.
a. Biospecimen
b. Lab cost/
Biospsecimen
a. Blood; Urine; Both
b. $
a. Cotinine (metabolite
of nicotine) in blood
b. $$ - $$$
a. Metabolites in urine
b. $$$
4
Centers for Disease Control and Prevention. Third National Report on Human Exposure to Environmental
Chemicals. Atlanta (GA): CDC, 2005.
64
Chemical Family
Polychlorinated Dibenzo-pdioxins, Polychlorinated
Dibenzofurans, and Coplanar
and Mono-ortho-substituted
Polychlorinated Biphenyls
Non-dioxin-like
Polychlorinated Biphenyls
(PCBs)
Phthalates
Phytoestrogens
Organochlorine Pesticides
Organophosphate Pesticides:
Dialkyl Phosphate Metabolites
Exposure Source(s)
Ingestion of foods contaminated with
polychlorinated dibenzo-p-dioxins and
dibenzofurans as a result of the
accumulation of these substances in the
food chain; Breast feeding is a source
for infants.
PCBs enter the food chain by a variety
of routes, including migration into food
from packaging materials,
contamination of animal feeds, and
accumulation in the fatty tissues of
animals.
Exposure through direct contact
phthalate-containing products; vinyl
flooring; adhesives; detergents;
lubricating oils; solvents; automotive
plastics; plastic clothing, such as
raincoats; and personal-care products,
such as soap, shampoo, deodorants,
fragrances, hair spray, nail polish; and
some medical pharmaceuticals.
Phthalates are widely used in flexible
polyvinyl chloride plastics, such as
plastic bags, garden hoses, inflatable
recreational toys, blood-storage bags,
intravenous medical tubing, and
children’s toys.
Naturally occurring in certain plants
that may interact with estrogen
receptors to produce estrogenic effects;
major groups of dietary phytoestrogens
are isoflavones and lignans (primarily
from soybeans and soy-based
products).
Though most are no longer used in the
U.S., they are persistent and soluble in
fat; diet is the main source of exposure,
primarily through the ingestion of fatty
foods (such as milk, dairy products,
and fish).
Insecticides accounting for about ½ of
those used in the U.S.; higher level of
exposures may occur among farm
workers, pesticide applicators, and
manufacturers of these pesticides via
ingestion, inhalation, or dermal contact.
a. Biospecimen
b. Lab cost/
Biospecimen
a. Blood
b. $$$$
a. Blood
b. $$$
a. Metabolites in urine
b. $$$
a. Urine
b. $$$
a. Pesticide or
metabolite(s) in
blood or urine
b. $$
a. Metabolites in urine
b. $$$
65
Chemical Family
Organophosphate Pesticides:
Specific Metabolites
Differ from the dialkyl
phosphates because each
specific metabolite derives
from one or only a few parent
pesticides
Herbicides
Pyrethroids Pesticides
Other Pesticides
DEET; Ortho-phenylphenol;
2,5-dichlorophenol
Carbamate Insecticides
Exposure Source(s)
Agriculture; public health control of
mosquitoes.
a. Biospecimen
b. Lab cost/
Biospecimen
a. Metabolites in
urine
b. $$$
From use in residential, forestry, or
agricultural applications, or from diet or
drinking water.
a. Metabolites in
urine
b. $$$
From food or from residential use; from
skin lotion and shampoo to treat lice and
scabies (limited systemic absorption
through the skin); pesticide applicators
occupational exposure.
Personal insect repellent applied to skin
(DEET); groundwater, or ingestion of
fruits and vegetables treated to control
fungal/bacaterial growth during storage
(Ortho-phenylphenol); moth balls and
some room deodorizers (2,5dichlorophenol) .
Ingestion of food products or from
residential use; exposure during aerial
spraying, or during the manufacture,
formulation, or application of these
chemicals; agricultural workers reentering areas that have recently been
treated with these chemicals.
a. Metabolites in
urine
b. $$$
a. Metabolites in
urine
b. $$$
a. Metabolites in
urine
b. $$$
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APPENDIX B
Expanded List of NHANES Chemical Families
Chemical families or metabolites included in the National Report on Human Exposure to
Environmental Chemicals (Table 1 from the Centers for Disease Control and Prevention. Third
National Report on Human Exposure to Environmental Chemicals. Atlanta (GA): CDC, 2005)
Table continued on next page…
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APPENDIX C
Criteria to Be Considered in Recommending and Selecting a Designated Chemical
Criteria described in Section 144.998 subd. 3(6):
a. The degree of potential exposure to the public or specific subgroups, including, but
not limited to, occupational;
b. The likelihood of a chemical being a carcinogen or toxicant;
c. The limits of laboratory detection for the chemical;
d. Exposure or potential exposure to the public or specific subgroups;
e. The known or suspected health effects resulting from the same level of exposure
based on scientific studies;
f. The need to assess the efficacy of public health actions to reduce exposure;
g. The availability of a biomonitoring analytical method;
h. The availability of adequate biospecimen samples; or
i. Other criteria.
Additional Considerations:
Collecting and analyzing biospecimens for chemicals and interpreting the results can be
complicated by several factors. For example, although chlorpyrifos may be a chemical of interest
for biomonitoring, it is metabolized to both diethylphosphate and diethythiophosphate (both of
which are included in the NHANES study). Each of the six urinary dialkyl phosphate metabolites
can be produced from the metabolism of more than one organophosphate pesticide. Therefore,
without other information, the presence of dialkyl phosphate metabolites cannot be linked to
exposure to a specific organophosphate pesticide, but could be linked to overall organophosphate
exposure.
The National Report on Human Exposure to Environmental Chemicals and the National Center
for Environmental Health’s Environmental Health Laboratory at the U.S. Centers for Disease
Control and Prevention should be consulted for details related to the sample collection and
measurement of each chemical or metabolite, so that the implications of selecting a designated
chemical for the biomonitoring are completely understood.
A thorough literature review on the chemical’s presence in humans should be conducted before
making a final selection in order to understand any potential complexities in data interpretation
and communication of results.
The cost of sampling and sample analysis must be considered in the selection of designated
chemicals, and in consultation with the MDH or other public health laboratories.
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APPENDIX D
Building consensus for chemical exposures to be included in
an ongoing base biomonitoring program
The 2007 legislation directed MDH to develop plans and strategies to continue to conduct
biomonitoring and in those plans to integrate tracking and biomonitoring activities. MDH
believes that building consensus on these issues and developing plans for future biomonitoring
(including selecting a chemical or chemicals for an additional pilot project) may require us to
strengthen resources in 2007-2008 (s) for strategic planning and scientific review. The specific
activities may include:
1. Confer with biomonitoring and tracking experts through a scientific conference open to
all interested persons. MDH is interested in conferring with experts in the field of
biomonitoring and tracking to understand a) how the two activities can be best integrated so that
public health goals for reducing environmental risks are enhanced, and b) what substances might
be selected for future biomonitoring. Subject matter experts in other states that have tracking
and/or biomonitoring programs or experts in the federal government may be asked to share their
successes and failures, and to reflect on potential priorities for Minnesota programs. There are
great advantages in bringing experts to Minnesota to discuss this work, in particular because a
wide Minnesota audience could participate and benefit from the lessons shared with the
programs. A second advantage is that the experts could be asked to consider the environmental
hazards to which Minnesotans may be disproportionately exposed, the programmatic point at
which Minnesota is poised, and the specific concerns of the programs.
2. Identify the potential projects to which biomonitoring could be added as an
enhancement and determine the feasibility of adding a biomonitoring component to a study
already planned or in progress. For example, the National Children’s Study (NCS), which now
has two locations in Minnesota, will collect biological specimens and NCS study directors are
already aware that researchers are interested in ancillary studies on mother-infant pairs. Other
studies may be planned at academic and government institutions. Over the next year the
biomonitoring and tracking programs could inventory the studies that are taking place in
Minnesota, interview the study directors, and discuss the feasibility of adding or expanding
biomonitoring in those studies in order to achieve biomonitoring goals for the state. This activity
would also result in productive discussions on the merits of including specific chemical analysis
and exposure measures in these studies and provide further consultation and critique of the
selection of substances for future and long-term biomonitoring.
3. Research individual chemicals proposed for pilot studies. When chemicals are considered
for selection, staff will need to research the methods for conducting biomonitoring. The advisory
panel may advise staff on this research.
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Section overview: General reference materials
A number of items are included in the meeting packet as background material:
•
EHTB meeting summary from October 23, 2007
•
Environmental health tracking and biomonitoring advisory panel (roster)
•
Biographical sketches of advisory panel members
•
Environmental health tracking and biomonitoring steering committee (roster)
•
Environmental health tracking and biomonitoring inter-agency workgroup (roster)
•
Glossary of terms used in environmental health tracking and biomonitoring
•
Acronyms used in environmental health tracking and biomonitoring
•
Minnesota Environmental Health Tracking & Biomonitoring (Minn. Statutes 144.995-144.998)
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Meeting Summary
Minnesota Department of Health (MDH)
Environmental Health Tracking and Biomonitoring Advisory Panel Meeting
October 23, 2007
12:30 p.m.-4:00 p.m.
Advisory Panel Members - Present
John Adgate
Cecilia Martinez
Bruce Alexander
Debra McGovern
Beth Baker
Geary Olsen
Alan Bender
Susan Palchick
Gregory Pratt
Daniel Stoddard
Samuel Yamin
Lisa Yost
Advisory Panel Member – Regrets
David Wallinga
Guest (presented a report to the panel and is not a state agency representative)
Mark Werner (Wisconsin Department of Health and Family Services)
Welcome and introductions
On behalf of the Minnesota Department of Health (MDH), Jean Johnson and John Stine
welcomed panel members to the meeting of the Environmental Health Tracking and
Biomonitoring Advisory Panel. It is anticipated that the Commissioner of Health will appoint a
chair from among the panel membership before the December meeting. The panel members
introduced themselves.
Overview of the 2007 legislation establishing the Environmental Health Tracking and
Biomonitoring (EHTB) Program
John Stine provided an overview of Minnesota Statutes, section 144.995–144.998, which
established the Environmental Health Tracking and Biomonitoring Program. He pointed out that
funding is from the state’s environment and energy appropriation, while accountability resides
with the Commissioner of Health.
In response to John Adgate’s question about the statute’s specifications for the biomonitoring
pilot projects, Samuel Yamin replied that the Minnesota Center for Environmental Advocacy had
originally proposed language that was somewhat similar in an effort to achieve a compromise
that would provide MDH with enough resources to launch an environmental health tracking and
biomonitoring program without proposing an unacceptably costly program. The Minnesota
Center for Environmental Advocacy’s first objective was to establish the program, to be
followed by plans to parlay the pilot projects into a bigger, sustainable program. Even as written,
these scaled-down biomonitoring pilot projects were estimated to require $2 million and four
years; nonetheless, the appropriation was significantly less and for only two years.
Alan Bender asked how the legislature might react if the outcome of the biomonitoring pilot
projects would be that MDH learned how to conduct biomonitoring but did not provide answers
about possible associations with health outcomes or sources of exposure. John S. and Samuel
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responded that both MDH and the Minnesota Center for Environmental Advocacy had conveyed
their expectations that pilot projects have limited scope, may provide information about how to
engage communities, may lead to more focused questions, and may serve as building blocks to a
bigger program.
Debra McGovern asked if the legislators from greater Minnesota contributed to the bill’s
language. John S. replied that the chief authors represent the east metro area, and their priorities
did not include agricultural pesticides. Based on the protracted discussions about agricultural
pesticides in other bills and other sessions, the absence of a prescribed pesticide study may have
contributed to this bill’s passage into law.
Geary Olsen commented that the statutory specification of 100 participants from communities
for three of the biomonitoring pilot projects could have some scientific merit. Based on
American Red Cross blood donor analyses, research undertaken between Dr. Tim Church, a
professor of environmental health sciences at the University of Minnesota and 3M, considered
distribution free tolerance limits with sample sizes of 100 to provide an estimate of the upper 95th
percentile of a targeted study population with 95 percent confidence.
Charge and operations of the advisory panel
Michonne Bertrand referred the panel to a document of proposed operating procedures, which
was included in the background book. She asked for input specifically on the voting procedures,
as the panel would be expected to vote on a few recommendations during this meeting.
Discussion of other segments of the proposed operating procedures could be postponed for a
future meeting.
Debra McGovern made a motion to adopt a modified version of Robert’s Rules of Order such
that voting procedures would entail a motion, a second to the motion, discussion, and then a vote,
which could be a voice vote of “aye” and “no”. Her motion was seconded. After a brief
discussion for clarification, the motion was passed unanimously by voice vote.
Following a short discussion of voting privileges for absentee members, it was suggested that
this topic and other aspects of the draft operating procedures could be pursued at the next
meeting. Dan Stoddard suggested that, in addition to input during the meetings, the panel could
provide written comments between meetings. Along with the meeting minutes, these
submissions would be part of the public record. Michonne suggested that future discussion topics
could include procedures for conflicts of interest and policies for when formal votes are taken
rather than the chair simply declaring an informal consensus at the close of a discussion period.
Debra McGovern asked that the panel also consider if alternates could be allowed to vote and if
alternates can be registered lobbyists.
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Resources available to the EHTB program
Resources, or the limitations thereof, that are available to the program include staff, finances, and
time. MDH is delighted to announce that Michonne Bertrand is the first full-time staff person
recruited into this new program. She brings expertise in community health education and is the
staff liaison supporting this panel. Recruitment for other positions is underway.
Louise Liao referred the panel members to a document in the background book that describes the
financial resources available for the Environmental Health Tracking and Biomonitoring
Program. It was noted that the actual appropriation was less than the projected budget which
MDH had submitted for the bill. For example, as a consequence of the lower appropriation, the
program would not provide follow-up counseling and support for participants in biomonitoring
projects. A challenge for the panel will be to address other gaps between the budget and the text
of the statutes.
Joe Zachmann reported that plans for a biomonitoring pilot project of a designated chemical will
be presented at a future meeting. In brief, the plans are to enlist the panel to make
recommendations for specific chemicals, based on the criteria outlined in Minnesota Statutes,
section 144.998. The panel will be asked to consider the timeline for implementation of a
biomonitoring study that focuses on specific chemicals to be designated. Implementation could
begin either during or after this 2-year budget period.
Jean Johnson briefly highlighted a document describing protocol development for biomonitoring
pilot projects, contained in the background book. She noted that the process is iterative and that
the projected timeline may be overly optimistic. For example, the Institutional Review Board
(IRB) often requires modifications or supplementary documents, which might delay the process
by one or two months. Jean described the role of the IRB and referenced the definition included
in the background book.
Environmental health tracking programs
Mark Werner, an employee of the Division of Public Health, Wisconsin Department of Health
and Family Services, presented “Wisconsin’s Progress in Environmental Health Tracking”. He
described several challenges in creating a national environmental public health tracking network.
Examples include:
• Confidentiality of health data in light of diverse policies among states and nations for
contributing partially de-identified data into a national network;
• Conforming state-supplied data to national data-exchange standards (e.g. aggregating data for
race and ethnicity in light of differences among states in definitions and data collection
practices);
• Harmonized messages at the CDC website for communicating risk analysis and risk
management to a wide spectrum of audiences for this national network.
Mark’s PowerPoint presentation highlighted several projects funded by CDC’s national
environmental health tracking program. One project is “Public Health Air Surveillance
Evaluation” (PHASE), a collaborative effort among the health departments in Maine, New York,
and Wisconsin. Different approaches to characterizing air quality are being evaluated for how
well they allow researchers to estimate individual exposures to ozone or particulate matter less
than 2.5 microns. Each of the air quality characterizations has been spatially and temporally
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linked with hospitalization data for asthma and myocardial infarction (a form of cardiovascular
disease) to understand the strengths and limitations of these models.
Mark’s presentation was augmented with 3 handouts:
• “Implementing the National Environmental Public Health Tracking Network: An Overview –
Healthy Informed Communities” Centers for Disease Control and Prevention (trifold
brochure)
•
“Mini-Monograph: Public Health Tracking” a series of seven articles reprinted from
Environmental Health Perspectives, 112 (14) pp. 1409-1445; originally published in October
2004
•
“Keeping Track, Promoting Health, …Connecting the Dots” Centers for Disease Control and
Prevention (43 pages; description of the National Environmental Public Health Tracking
Program); 2007
In response to questions from the panel, Mark noted that CDC’s current objective for drinking
water systems is to track nitrates, arsenic, lead, and disinfection byproducts. At present, CDC’s
air quality studies are focusing only on outdoor air and not indoor air. One of the challenges of
data visualization is to display complex data lucidly; this may take the form of a summary map
that links to derivatives, stepwise details, and explanatory notes. He agreed that Minnesota and
other states that are not currently funded by CDC’s environmental public health tracking network
should be given access to the data exchange standards so that they could align their state-specific
data with the national database.
In response to John Adgate’s question about identifying an exemplary case to demonstrate an
association of exposure with disease, Mark replied that the association of air quality with
hospitalizations due to asthma or myocardial infarction is perhaps the most compelling example
of environmental health tracking to date. The 43-page handout, “Keeping Track, Promoting
Health, …Connecting the Dots” (described above) includes other examples.
Samuel Yamin asked if the Wisconsin program has experience in securing alternate funding for
projects that may be relevant to the Upper Midwest but not identified as top priorities in the
CDC’s national program. Mark replied that Wisconsin is pursuing a limited biomonitoring study
of polybrominated diphenylethers (PBDEs, a class of flame retardants). However, the PBDEs
study is not yet at the surveillance or tracking phase.
Al Bender asked about studies that might associate exposures with birth defects, as these health
outcomes would have an intrinsic advantage over other disease outcomes that have lag times of
decades. In response to Mark’s comment that low birth weights are under consideration, Geary
Olsen cautioned that the use of low birth weights as health endpoints would be confounded by
several other major factors besides environmental exposures. Geary also advised that plans to
pursue environmental health tracking projects benefit from decision trees to examine if particular
areas of study should be discontinued, especially in light of limited resources.
Proposal: Minnesota Environmental Health Tracking Program
Jean Johnson briefly summarized documents in the background book that describe
environmental health tracking projects in which MDH staff members have participated.
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Background materials included a description of the State Environmental Health Indicators
Collaborative (SEHIC). She highlighted a new project, funded through an EPA STAR grant, for
“Measuring the impact of particulate matter reductions by environmental health outcome
indicators.” The principal investigators of the EPA STAR grant are Jean Johnson, Gregory Pratt,
and Barbara Yawn.
Frank Kohlasch briefly described a few of the environmental health tracking activities conducted
by the Minnesota Pollution Control Agency (MPCA). The MPCA Environmental Data Access
system allows users to view and download environmental data that are collected by MPCA and
its partner organizations. Users currently have access to data on air quality and surface water
quality; MPCA plans to post ground water data later this fall. Current air quality studies involve
the speciation and sources of fine particulate matter. Other studies focus on fish contaminants,
such as perfluorochemicals (PFCs) and endocrine disruptors. The MPCA website, “What’s in my
neighborhood?” allows users to view an interactive, GIS-based map to locate sites that MPCA
has investigated or cleaned up. Frank invited the panel members to provide feedback,
particularly to help MPCA evaluate and upgrade its data access tools.
Jean asked the panel members to consider if it could endorse all or parts of the document,
“Proposal for establishing the Minnesota environmental health tracking system”, included in the
background book. Questions centered on the priorities for year 1, with the intention of addressing
the priorities for year 2 at future meetings.
Greg Pratt noted that the proposed budget for year 1 of the environmental health tracking
component is $325,000, as displayed in the financial resources document in the background
book. He asked about the alignment of the budget with the year 1 priorities. Jean replied that the
first two priorities (viz. develop a communications and outreach plan, and initiate the
development of a strategic plan) would be budgeted primarily through the funds set aside for
program management, to be carried out by Michonne Bertrand. In fact, most of the $325,000
budget would support new staff members dedicated to the third priority, viz. select, evaluate and
report a set of core environmental public health indicators. Greg endorsed this strategy and asked
if MDH has ideas for narrowing down the environmental hazards, represented broadly as air
quality and drinking water quality. Jean replied that MDH might align with CDC and SEHIC in
studying particulate matter and ozone in air, and studying arsenic, lead, nitrates, and
trihalomethanes (THMs, a class of disinfection byproducts) in water.
Frank and Jean asked the panel members to consider the balance between Minnesota-specific
issues and the priorities articulated by CDC for a national environmental health tracking
network. Samuel Yamin recommended that in designing the environmental health tracking
program, MDH should not limit itself at the outset to considering only the CDC core indicators.
While he recognized the long-term benefits of building a Minnesota environmental health
tracking program that is largely compatible with CDC’s national network, he pointed out that
Minnesota has no obligation to exclusively investigate the indicators that CDC grantees will be
studying. He recommended that MDH and panel members be open to considering environmental
hazards, exposures or health outcomes that are important to Minnesota even though they are not
significant in other regions of the United States. In response to Debra McGovern’s question, Jean
replied that, indeed, MDH staff will seek input from the panel regularly as the strategic plan
takes shape.
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Cecilia Martinez recommended that MDH staff make progress reports on the environmental
health tracking proposal to the panel. Michonne Bertrand agreed, and she cautioned that the
December meeting might be too soon for a substantive report.
Lisa Yost asked for clarification regarding the proposal for priorities in year 1. Because the
selected environmental hazards lack concordance with the selected health outcomes, it may be
more appropriate to use these lists only as starting points, to be re-examined throughout the year.
She expressed her willingness to support the proposal for year 1, with the understanding that
some items may be abandoned.
John Adgate recommended that MDH staff seek input from the panel members in narrowing its
target list of environmental hazards. Bruce Alexander recommended that the initial assessments
should carefully consider data inputs before turning to data outputs. Several panel members
pointed out that the proposal is very broad and that an important aim of the strategic planning
process should be to narrow the scope significantly before translating the concepts to
implementation.
Greg Pratt made a motion to endorse the priorities for tracking in year 1, as described in the
document, “Proposal for establishing the Minnesota environmental health tracking system,” with
the modification proposed by Samuel Yamin that the indicators considered and selected in
Minnesota not be automatically limited to the set that CDC is using. The motion was seconded,
discussion followed (as described above), and the motion was passed by a unanimous voice vote.
Proposal: Arsenic biomonitoring pilot project
Rita Messing presented a preliminary proposal for an arsenic biomonitoring pilot project in south
Minneapolis. She referred to the documents in the background book, including a draft proposal, a
map of soil sample results, a summary of the Minnesota Arsenic Study, and fact sheets on the
arsenic site in south Minneapolis. She explained that the most compelling reasons for
recommending south Minneapolis residents as the community are: (1) a high level of community
concern; and (2) analysis of environmental data has been completed. In fact, arsenic levels have
already been measured at approximately 3,500 residential sites near the former CMC Heartland
site in south Minneapolis.
Rita explained that the Minnesota Arsenic Study (conducted in 1998-1999 for rural sites in
western Minnesota) yielded elevated or detectable amounts of arsenic in hair and urine
specimens for only a small fraction of the study participants. Elevated arsenic levels in hair and
urine corresponded to high arsenic levels in the drinking water wells but did not correspond to
the participants’ self-reports on amounts of well-water that they drank. She commented that the
results of soil studies in other parts of the U.S. would infer that only a very few yards in south
Minneapolis have arsenic levels in soils sufficiently high to yield an elevated biomonitoring
result. In fact, EPA is removing soil from the yards with the highest concentrations of arsenic
now and plans to continue remediation through next spring for all yards with arsenic levels of
>30-40 ppb. Other exposure routes, such as fish and shellfish in the diet or playing on chromated
copper arsenate (CCA) treated lumber, might overwhelm associations with soil exposures.
Although arsenic is not included in the NHANES studies, several other reference studies are
available for comparisons.
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Beth Baker advised MDH staff to collect both hair and urine specimens, particularly because the
experience gained through the Minnesota Arsenic Study was that very few study participants had
detectable amounts of arsenic in urine. She also cautioned to take note of hair type, as previous
findings showed that coarse, black hair accumulated more arsenic than fine, red or blond hair.
In response to a question from Greg Pratt, Rita stated that the scientific literature has no reports
of elevated soil arsenic leading to elevated urine arsenic. However, reports have correlated
elevated soil lead and elevated arsenic and lead in the air from smelting operations with elevated
levels in biospecimens.
Lisa Yost offered to send a paper to Rita that looked for correlations between soil arsenic and
elevated levels in biospecimens. She pointed to the controversy on interpreting whether arsenic
levels in hair are due to internal doses or external deposition. She suggested that dietary fish and
shellfish might be the principal exposure routes, so dietary questions should be included in a
questionnaire. It was recognized that young children may not be knowledgeable enough to
describe the types of fish that they ate. Rita said that the MDH laboratory will speciate the
arsenic, thereby distinguishing between dietary sources and inorganic arsenic.
Bruce Alexander recommended that the study design include an “unexposed” control group in
which the residential soil levels would be <20 ppb. A comparison of the arsenic range in the
“unexposed” group with the arsenic range in the “exposed” group would aid in interpreting the
biomonitoring results. John Adgate suggested that an “unexposed” group, either from south
Minneapolis or from a rural part of the state, would provide a more convincing presentation to
the lay public, particularly if one or more children have abnormally high arsenic levels.
Cecilia Martinez asked if either the study design or the educational outreach materials would
address ways to reduce long-term exposures. Rita responded that the most effective approaches
are the EPA program to remove contaminated soil and educational materials to reduce accidental
intake of contaminated soils.
Greg Pratt recommended that further discussions of the sampling plan be revisited at future
meetings of the panel. Other advisors recommended a survey of CCA-treated lumber in
residential yards, intentional oversampling of yards with the highest soil arsenic concentrations,
and a further discussion of the biospecimen types (e.g. urine, hair or toenails).
Greg Pratt made a motion to endorse the selection of south Minneapolis as the community for the
biomonitoring pilot project for arsenic, as described in the document, “Biomonitoring pilot
project for arsenic – draft proposal”. The motion was seconded, discussion followed (as
described above), and the motion was passed by a unanimous voice vote.
Proposal: Perfluorochemicals biomonitoring pilot project
Rita Messing introduced a draft proposal for a biomonitoring pilot project for perfluorochemicals
(PFCs), which was furnished in the background book. In brief, the proposal is to examine two
communities in Washington County with likely exposure to PFCs in drinking water. One
community would include residents served by a municipal water system, and the other
community would be comprised of residents served by private drinking water wells. Serum
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specimens would be collected from adults, and results would be compared to CDC reports of
PFC concentrations in serum samples from its NHANES studies. Based on scientific studies by
3M, the serum half-lives have been estimated to be 2-4 days for PFBA and 3-6 years for PFOA
and PFOS.
Analogous to the selected community for the arsenic study, the most compelling reasons for
recommending these two communities are: (1) a high level of community concern; and (2)
analysis of environmental data has been completed. Specifically, PFBA, PFOA and PFOS
concentrations have been determined in each of these drinking water wells. Particularly for the
municipal water system, the history of water treatment and alternate water supplies is
documented. It is anticipated that most study participants would have discontinued their
exposure to untreated water for at least a year before donating serum specimens.
Al Bender cautioned that the study design might become biased, particularly if a litigious
atmosphere contributes to under-representation of citizens who are presumably the highest
exposed. In response to a question from Lisa Yost, Rita clarified the highest drinking water
levels in the past few years compared with the highest drinking water currently.
Geary Olsen informed the panel that his position as a staff scientist at 3M, through which he has
been actively engaged in PFC studies, compels him to declare a conflict of interest before
contributing to the discussion. He asked if the proposed study would examine possible exposure
routes, particularly because the detection of PFCs in the NHANES study was likely due to
exposures other than just primarily drinking water. Rita responded that the proposed study design
would only collect information about the current drinking water source at home and whether the
individual ever worked in the 3M Cottage Grove facility; these questions could be refined and
improved. Geary cautioned the MDH laboratory to work closely with CDC or other highly
competent laboratories for technology transfer and method validation, as the PFC analyses in
serum can be challenging. Indeed, the MDH laboratory scientists already work with CDC
scientists and plan to increase the collaborative efforts during the coming year.
Geary and Rita discussed the provision of risk analysis in the communications to participants,
communities, and the general public as one of the final steps for the PFCs biomonitoring pilot
project. While health implications will be part of the data interpretation, it is difficult to associate
exposures with defined health outcomes. Undoubtedly, the MDH staff will be seeking input from
the panel in interpreting and communicating findings to the public.
Cecilia Martinez asked if other exposure routes, such as fish consumption, are understood
enough to inform the study design. Rita replied that, at this time, not enough is known about
PFCs in various fish species, consumer products, and occupational settings; nonetheless, these
other exposure routes are intriguing and could be substantial. Greg Pratt recommended that
further discussions of the sampling plan be revisited at future meetings of the panel. It was
suggested that this pilot study could become a building block for a longitudinal study, with the
possibility that a second set of serum specimens could be collected from the participants a few
years hence.
Greg Pratt made a motion to endorse the selection of the two communities in Washington
County for the biomonitoring pilot project for perfluorochemicals, as described in the
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background book. The motion was seconded, discussion followed (as described above), and the
motion was passed by a unanimous voice vote. (Note: This vote was taken after the scheduled
time of adjournment and a few members of the panel were no longer present.)
Closure
Jean Johnson thanked the panel for a constructive and productive meeting. Michonne Bertrand
noted that the next scheduled meeting will be on Monday, December 17, 2007, from 1:00 to
4:00. The venue will again be the Mississippi Room at Snelling Office Park in Saint Paul. MDH
staff members are committed to adjourning upcoming meetings on time. Debra McGovern
suggested that MDH staff more clearly indicate on the agenda any specific questions that panel
members will be asked to discuss or vote on; several other panel members concurred. Panel
members may submit comments at any time. Suggestions for meeting logistics or any other
feedback can be submitted directly to Michonne.
updated November 30, 2007
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Environmental Health Tracking and Biomonitoring
Advisory Panel
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
Health Partners
Occupational & Environmental Medicine
250 North Wabasha Avenue
St. Paul, Minnesota 55107
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
2550 University Avenue, Suite 244S
St Paul, Minnesota 55114
651-209-7707
[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
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Gregory Pratt, PhD
Minnesota Pollution Control Agency
Environmental Analysis and Outcomes Division
520 Lafayette Road
St. Paul, MN 55155-4194
651-296-7664
[email protected]
MPCA appointee
Samuel Yamin, MPH
Minnesota Center for Environmental
Advocacy
26 E. Exchange St., Ste. 206
St. Paul, MN 55101
(651) 223-5969
[email protected]
Minnesota Senate appointee
Daniel Stoddard, MS, PG
Minnesota Department of Agriculture
Pesticide and Fertilizer Management Division
625 Robert Street North
St. Paul, Minnesota 55155-2538
651-201-6291
[email protected]
MDA appointee
Lisa Yost, MPH, DABT
Exponent, Inc.
15375 SE 30th Pl, Ste 250
Bellevue, Washington 98007
David Wallinga, MD, MPA
Institute for Agriculture & Trade Policy
Food and Health Program
2105 First Avenue South
Minneapolis, Minnesota 55404
612-870-3418
[email protected]
Nongovernmental organization representative
Local office
St. Paul, Minnesota
651-225-1592
[email protected]
At-large representative
Rev. November 30, 2007
Please submit corrections to
[email protected]
98
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.
99
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).
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 WisconsinMadison.
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.
100
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 multidisciplinary technical organizations and projects, and he is a licensed Professional Geologist. He
currently administers the MDA’s non-point source programs for pesticides and inorganic
fertilizer. These include: monitoring surface water and groundwater for pesticides; monitoring
pesticide use; registering pesticide products; developing and promoting voluntary best
management practices; developing regulatory options; and, responding to local contamination
problems. He previously worked in or managed a variety of other environmental and regulatory
programs at the MDA and the Minnesota Pollution Control Agency, and as an environmental
consultant.
David Wallinga is Director of the Food and Health Program at the Institute for Agriculture and
Trade Policy. Dr. Wallinga applies a systems perspective to the intersection of public health,
agriculture, food and the environment. His expertise includes the impacts of food contamination
and the means of food production on human health, including impacts on obesity and ecological
health impacts from the inappropriate use of antibiotics and arsenic in livestock and poultry. Dr.
Wallinga also has for several years researched and advocated around the impacts on fetuses,
children and adults of early-life exposures to neurotoxins—including many found in fish and
other foods—on brain and nervous system function in children and adults, developing brains and
other organs in fetuses and children. Dr. Wallinga authored “Playing Chicken: Avoiding Arsenic
in Your Meat,” “Poultry on Antibiotics: Hazards to Human Health,” as well as “Putting Children
First: Making Pesticide Levels in Food Safer for Infants & Children.” He is a co-author of “In
Harm’s Way: Toxic Threats to Child Development” and co-developer of the Pediatric
Environmental Health Toolkit. He received a medical degree from the University of Minnesota
Medical School, a Masters degree from Princeton University, and a Bachelors from Dartmouth
College.
Samuel Yamin is the Public Health Scientist for the Minnesota Center for Environmental
Advocacy. Before joining MCEA, Samuel worked as a toxicologist for the New Hampshire
Bureau of Environmental and Occupational Health, and prior to that as an environmental
epidemiologist for the Delaware Division of Public Health. While working for those agencies,
his responsibilities included exposure assessment, risk analysis and hazard communication for
pollutants in water, air, soils and indoor environments. Samuel has also worked extensively on
the subject of environmental carcinogens and the potential impacts on public health. Samuel’s
experience in hazardous materials management and environmental regulatory programs also
includes two years of work with the Environmental Health and Safety Department at Ionics, Inc.,
a Massachusetts-based manufacturer of drinking water purification technology. Samuel holds a
Master of Public Health in Environmental Health Sciences from Tufts University School of
Medicine and a Bachelor of Science in Environmental Health and Safety from Oregon State
University
101
Lisa Yost is a Managing Scientist at Exponent Inc., a national consulting firm, in their Health
Sciences Group and she is based in Saint Paul, Minnesota. Ms. Yost completed her training at the
University of Michigan School of Public Health and is a board-certified toxicologist with
expertise in evaluating human health risks associated with substances in soil, water, and the food
chain. She has conducted or supervised risk assessments under CERCLA, RCRA, or state-led
regulatory contexts involving a wide range of chemicals and exposure situations. Her particular
areas of specialization include exposure and risk assessment, risk communication, and the
toxicology of chemicals such as PCDDs and PCDFs, PCBs, pentachlorophenol (PCP),
trichloroethylene (TCE), mercury, and arsenic. Ms. Yost is a recognized expert in risk assessment
and has collaborated in original research on exposure issues including background
dietary intake of inorganic arsenic. She is currently assisting in a number of projects including a
complex multi-pathway risk assessment for PDDD/Fs that will integrate extensive biomonitoring
data collected by the University of Michigan. Ms. Yost is also an Adjunct Instructor at the
University of Minnesota School of Public Health.
Rev. November 30, 2007
Please submit additions and corrections to [email protected]
102
Environmental Health Tracking and Biomonitoring
Steering Committee
Norman Crouch, PhD
Assistant Commissioner
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0975
651-201-5063
[email protected]
Chris Everson, MBA
Assistant Division Director
Public Health Laboratory Division
Minnesota Department of Health
PO Box 64899
St Paul, Minnesota 55164-0899
651-201-5062
[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. November 30, 2007
103
Environmental Health Tracking and Biomonitoring
Inter-Agency Workgroup
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]
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]
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]
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]
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]
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]
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]
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. October 8, 2007
104
Glossary of Terms used in Environmental Public 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.
105
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.
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 http://www.cste.org/OH/SEHIC.asp and
http://www.cdc.gov/nceh/indicators/introduction.htm for more information.
106
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
http://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 http://www.cdc.gov/nceh/tracking/
for more information.
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.
107
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 wellbeing 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.
108
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 http://www.cdc.gov/exposurereport/report.htm for more information.
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
http://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.
109
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]
110
Acronyms used in Environmental Public 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
NGO
Non-governmental organization
111
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]
112
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;
(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
113
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
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.
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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,
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,
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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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