Minnesota Department of Health
Environmental Health Tracking and Biomonitoring
Advisory Panel Meeting
March 11, 2008
1:00 p.m. – 4:00 p.m.
Snelling Office Park
Mississippi Room
1645 Energy Park Drive
St. Paul, Minnesota
Meeting agenda
Minnesota Department of Health
Environmental Health Tracking and Biomonitoring Advisory Panel Meeting
March 11, 2008
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
Conflicts of interest
Presenter
Item type/Anticipated outcome
Michonne Bertrand
Discussion and decision item.
*VOTE NEEDED* The advisory panel is asked
to vote to adopt the revised conflict of interest
policy (included in the operating procedures).
Suggested motion: I move to adopt the revised
conflict of interest policy as presented (or with the
following modifications…).
*VOTE NEEDED* The advisory panel is asked
to vote to adopt a method for addressing and
declaring conflicts of interest (i.e., the
affirmations referring to conflicts of interest form,
the conflict of interest disclosure form, or some
other method).
Suggested motion: I move to adopt the
Affirmations Referring to Conflicts of Interest
Form OR I move to adopt the Conflict of Interest
Disclosure Form (or: some other method for
declaring conflicts of interest).
1:20
Panel member comments
and questions
Sharing relevant journal
articles with panel
members
Michonne Bertrand
Information sharing.
Panel members are invited to ask questions or
provide input on this item.
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Time
Agenda item
Presenter
Item type/Anticipated outcome
1:25
Biomonitoring pilot
program guidelines
Jean Johnson
David Orren
Discussion item.
The panel is invited to provide suggestions for
revising and strengthening the draft biomonitoring
pilot program guidelines.
In particular, the panel is asked to provide input
on the following specific questions:
•
•
•
•
Are the values expressed through the draft
guidelines the appropriate values?
Are the guidelines consistent with each other,
and with the Legislation, or are there
conflicts?
Will the guidelines help staff to make
decisions for planning and conducting the
four pilot projects?
Are there additional areas where guidelines
are needed?
Staff are NOT seeking a vote to adopt the
program guidelines, but instead are seeking to
uncover the range of viewpoints held by panel
members.
2:25
Break
2:40
Chemical selection
Adrienne Kari
Discussion item.
The panel is invited to provide suggestions for the
criteria and process to use in indentifying
chemicals to be recommended for future study by
the biomonitoring program.
In particular, the panel is asked to provide input
on the following specific questions:
Questions related to chemical selection criteria:
• What other criteria should be added to the list
provided in order to ensure that chemicals
recommended for study will yield useful data
for advancing public health?
• Which of the criteria are the most important
for ensuring that chemicals recommended for
study will yield useful data for advancing
public health? Which are less important? How
should the criteria be weighted? Which
criteria should factor into the recommendation
the most?
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Time
Agenda item
Presenter
Item type/Anticipated outcome
Questions related to the chemical selection
process:
• What process might be used to prioritize the
chemicals proposed for inclusion?
o Should the process for recommending
chemicals for the pilot project differ
from the process for the base
program?
o Who should be responsible for
nominating chemicals for
consideration and for providing
supporting evidence related to each
chemical?
o What role, if any, might the public
play in helping to identify and
recommend chemicals?
o How formal or informal should the
recommendation process be? (E.g., a
formal scoring procedure, consensus
model, or some other method)
o Should the panel work jointly or
separately to arrive at its
recommendations? For example, if a
scoring process is used, will one score
be assigned by the full panel or will
each panel member assign a score
independently?
Other questions:
• What information can MDH provide to the
panel to assist in identifying additional
chemicals or criteria for consideration? What
role should EHTB staff play in supporting the
panel’s process for recommending chemicals
to be studied? What steps can staff take on?
Staff are NOT seeking a vote to adopt the
selection criteria, but instead are seeking to
uncover the range of viewpoints held by panel
members.
3:25
3:55
Project status updates
• PFCs (10 min)
• Mercury (10 min)
• Tracking (5 min)
• Arsenic (5 min)
Michonne Bertrand
Louise Liao
Jean Johnson
Adrienne Kari
Closure
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Information sharing.
Panel members are invited to ask questions or
provide input on any of these items.
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Meeting Materials for March 11, 2008
Environmental Health Tracking & Biomonitoring Advisory Panel
Table of Contents
Agenda........................................................................................................................................... i
Table of contents ........................................................................................................................v
Materials related to specific agenda items
Conflicts of interest
Section overview: Conflicts of interest......................................................................................1
Operating procedures (revised draft) .........................................................................................3
Options for addressing conflicts of interest
Affirmations referring to conflicts of interest form (revised draft) .....................................9
Conflict of interest disclosure form (draft) ........................................................................11
Panel member comments and questions
Section overview: Panel member comments and questions ....................................................13
Arsenic citations.......................................................................................................................15
PFC citations............................................................................................................................21
Biomonitoring pilot program guidelines
Section overview: Biomonitoring pilot program guidelines....................................................33
Draft biomonitoring pilot program guidelines.........................................................................35
Minn. Stat. 13.386....................................................................................................................43
Chemical selection
Section overview: Chemical selection .....................................................................................45
Possible criteria for selecting chemicals for biomonitoring ....................................................47
Background materials on selecting chemicals .........................................................................49
Email from Rep. Paul Gardner regarding fourth chemical ......................................................57
Project status updates
Section overview: Project status updates.................................................................................59
PFC biomonitoring
Status update on PFC biomonitoring .................................................................................61
PFC biomonitoring pilot project: Questions and answers .................................................67
Letter received from Women’s Environmental Institute ...................................................81
Input from and response to Clean Water Action ...............................................................85
v
Letter received from Representative Julie Bunn and EHTB’s response............................89
Letter received from Senator Katie Sieben ........................................................................99
Status update on mercury biomonitoring...............................................................................101
Status update on tracking .......................................................................................................105
Status update on arsenic biomonitoring.................................................................................109
General reference materials
Section overview: General reference materials ...........................................................................111
Meeting summary, December 17, 2007.......................................................................................113
Environmental health tracking and biomonitoring advisory panel (roster) .................................123
Biographical sketches of advisory panel members......................................................................125
Environmental health tracking and biomonitoring steering committee (roster)..........................129
Environmental health tracking and biomonitoring inter-agency workgroup (roster) .......................131
Glossary of terms used in environmental health tracking and biomonitoring .............................133
Acronyms used in environmental health tracking and biomonitoring.........................................139
Minnesota Environmental Health Tracking & Biomonitoring (Minn. Statutes 144.995-144.998).......141
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Section overview: Conflicts of interest
Operating procedures
Included in the meeting packet is a revision to the operating procedures, based on comments
made at the December panel meeting. The only changes made are to the section,
“Responsibilities and Expectations of Advisory Panel Members,” item number 6, which
describes conflicts of interest.
As requested, 6a now refers only to the organization’s interests and 6b refers to the interests of
the panel members and their families. A revision was made to the first paragraph of number 6 to
indicate that panel members are to declare actual and apparent conflicts of interest, but need
abstain from voting only on actual conflicts of interest.
Please note that the operating procedures specifically define conflicts of interest as situations in
which (1) a member, the member’s organization, or the member’s family member would
personally benefit from the outcome of a decision made by the panel; and/or (2) a member is not
able to be objective in decision making. In addition, the operating procedures state that
professional expertise in itself does not constitute a conflict of interest.
The conflict of interest policy (or any other part of the operating procedures) can be revised
again at a future date at the request of the panel members.
ACTION NEEDED: The advisory panel is asked to vote to adopt the revised conflict of
interest policy. (Note: the rest of the operating procedures were adopted at the December
meeting.)
Suggested motion: I move to adopt the revised conflict of interest policy as presented (or with
the following modifications…).
Declaring conflicts of interest
At the December meeting, panel members expressed differing points of view about the type of
procedure necessary for ensuring that conflicts of interest are declared. As a result, two options
for addressing conflicts of interest are included in the meeting materials.
The first option would require panel members to sign an affirmation indicating that they agree to
disclose any conflicts of interest as they arise. The form has been revised to reflect changes in
1
wording to the conflict of interest policy included in the operating procedures. This form could
be filled out once at the beginning of each panel member’s three-year term (or more frequently
as panel members deem necessary).
The second option would require panel members to list in writing any known conflicts of
interest. This form could be filled out once per year (or more frequently as panel members deem
necessary). If additional conflicts of interest arise during the year, panel members are asked to
verbally disclose these conflicts.
ACTION NEEDED: The advisory panel is asked to vote to adopt one of the methods for
addressing and declaring conflicts of interest (either as presented in the meeting packet or with
modifications) or to propose and adopt some other method.
Suggested motion: I move to adopt the Affirmations Referring to Conflicts of Interest Form OR
I move to adopt the Conflict of Interest Disclosure Form (or: some other method for declaring
conflicts of interest).
2
Operating Procedures
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.
3
Responsibilities and Expectations of Advisory Panel Members
In accepting appointments to the advisory panel, members are expected to:
1. Attend advisory panel meetings and other assigned meetings. Any member missing two consecutive
full advisory panel meetings may be notified in writing that missing a third consecutive meeting may
result in the member’s removal from the advisory panel.
2. Serve on committees, work groups, and other task forces as requested by the chair.
3. Prepare for active participation in discussions and decision-making by reviewing meeting materials
prior to the meeting dates.
4. Act as a liaison when appropriate between constituent groups and the advisory panel.
5. Inform the represented constituent groups of advisory panel activities, actions, and issues.
6. Declare any actual or apparent conflicts of interest and abstain from voting on advisory panel matters
that create an actual conflict of interest. A conflict of interest is a situation in which an advisory panel
member, her/his organization, or a family member would personally benefit based on the outcome of
a particular decision, endorsement, or action taken by the advisory panel. A conflict of interest exists
if one of the following conditions applies:
a. The member’s organization has a direct financial or organizational interest in the matter under
consideration. Note that employees of large organizations may have little or no personal
knowledge about certain financial interests of their employers. In those cases, members are
required to declare only conflicts for which they have direct knowledge. They are not required to
inquire about further details from their employers. In some situations, members may hold a
position in which they exercise some authority with respect to projects in which they are not
personally involved. In those cases, inquiry into additional information about the interest could be
helpful in preventing unintentional conflicts of interests or appearances of impropriety.
b. The member or a family member has a financial or personal interest in the matter under
consideration and is not so free from personal bias, prejudice, or preconceived notion as to make
it possible for her/him to objectively consider the evidence presented and base her/his decision
solely on the evidence.
c. The member has placed her/himself in a position where she/he finds it difficult, if not impossible,
to devote her/himself to a consideration of the matter with complete energy, loyalty, and
singleness of purpose to the general public interest.
It should be noted that many members of the advisory panel will have exceptional professional or
personal experience with environmental health tracking or biomonitoring. These qualities, by
themselves, do not constitute a conflict of interest. Informed decision-making will benefit from
personal experiences; however, personal interests should not distract from objective decision-making
for the public good.
4
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).
5
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. February 19, 2008
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Affirmations Referring to Conflicts of Interest
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 my organization has a direct
financial or organizational 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 and/or my family members
have a financial or personal interest in the matter under consideration such that personal bias,
prejudice, or preconceived notions preclude 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 February 19, 2008
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Conflict of Interest Disclosure Form
Advisory Panel for the
Minnesota Department of Health
Environmental Health Tracking and Biomonitoring Program
Definition: 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 and/or a situation in which an advisory panel member or family
member has a financial or personal interest in the matter under consideration such that personal bias,
prejudice, or preconceived notions would preclude the panel member from objectively considering the
evidence presented and making decisions for the public good.
Please describe below any relationships, transactions, positions held (paid or volunteer), or circumstances
that you believe could contribute to a conflict of interest between your role on the EHTB advisory panel
and your personal interests, financial or otherwise:
_____
I have no conflicts of interest to report
_____
I have the following conflicts of interest to report:
1.__________________________________________________________________
2.__________________________________________________________________
3.__________________________________________________________________
4.__________________________________________________________________
5.__________________________________________________________________
I hereby certify that the information set forth above is true and complete to the best of my knowledge. I
will verbally disclose any additional conflicts of interest that arise before I am asked to complete the
Conflict of Interest Form again.
Name: ________________________________________________________________
Signature: _____________________________________________________________
Date: ________________________
Form created February 19, 2008
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Section overview: Panel member comments and questions
Several panel members contacted EHTB program staff with suggestions for articles related to
our first two biomonitoring pilot projects that could be routed to all panel members. MDH staff
rely on panel members to deepen the expertise available to the EHTB program and appreciate the
attention that panel members pay to the literature. Unfortunately, copyright restrictions at MDH
prevent us from being able to distribute full-text articles outside of MDH unless we purchase
reprints.
It is MDH’s goal to ensure that relevant information is shared with the full panel membership, to
conserve resources (e.g., time, money), and to limit the number of emails being sent to panel
members between meetings. As such, MDH staff propose to alert panel members to new
citations in the following way:
1) MDH staff will assemble a list of citations, with abstracts, for each topic under consideration
by the advisory panel. This list will be updated before each panel meeting and included in the
meeting materials. 2) MDH staff will bring full copies of any new articles to panel meetings so
that panel members can review them if they wish.
Attached are updated bibliographies on both arsenic and PFCs. Articles added since the last
panel meeting are asterisked.
ACTION NEEDED: Panel members are invited to ask questions or provide input on the
proposed process for making the panel aware of articles relevant to the EHTB program.
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Arsenic Citations (Updated 2/2008)
Baker, BA et al. 2005. “Persistent neuropathy and hyperkeratosis from distant arsenic exposure.”
Journal of Agromedicine. 10(4): 43-54.
The purpose of this case series is to assess long-term sequelae of arsenic exposure in a
cohort acutely exposed to arsenic in drinking water from a well dug into a landfill
containing arsenical pesticides. Ten of the 13 individuals (or next of kin) in the initial study
agreed to participate in the follow-up study. Next of kin provided questionnaire data and
released medical information on the three individuals who had died. The remaining seven
cohort members were assessed by an interview, questionnaire, detailed physical examination
and sensory nerve testing. Available medical records were obtained and reviewed. Sensory
testing was performed using an automated electrodiagnostic sensory Nerve Conduction
Threshold (sNCT) evaluation. Sensory complaints and electrodiagnostic findings consistent
with polyneuropathy were found in a minority (3/7) of subjects 28 years after an acute toxic
arsenic exposure. Two of the seven patients examined (1 of 3 with neuropathic findings)
also had hyperkeratotic lesions consistent with arsenic toxicity and one of the patients had
hyperpigmentation on their lower extremities possibly consistent with arsenic toxicity.
**Bussieres, D et al. 2004. “Exposure of a Cree population living near mine tailings in norther
Quebec (Canada) to metals and metalloids.” Archives of Environmental Health. 59(12): 732-41.
The authors investigated the effect of residues from copper- and gold-mining on the Cree
population of Oujé-Bougoumou, located 560 km north of Quebec City, Canada. Subjects
(225) from Oujé-Bougoumou and a control population (100) completed a questionnaire on
lifestyle and dietary habits and provided blood and urine samples for analysis. Geometric
means of arsenic, lead, cadmium, and copper concentrations were not significantly different
for subjects or controls 15 yr and older or children (8-14 yr old). However, blood zinc was
higher and selenium was lower in Oujé-Bougoumou samples. Mean blood lead level was
higher in children from Oujé-Bougoumou, but lower in adults aged 40 yr and older. For
adults (15 yr and older) blood lead level increased with age and was higher in men, those
who hunted, and consumed wild meat (R2 = 0.43). Blood cadmium increased with age and
smoking (R2 = 0.61). No influence of mine residues was observed among residents of OujéBougoumou, but lifestyle exposure associations were noted for both communities.
Davey, J et al. 2007. “Arsenic as an endocrine disruptor: Arsenic disrupts retinoic acid receptor
and thyroid hormone receptor-mediated gene regulation and thyroid hormone-mediated
amphibian tail metamorphosis.” Environmental Health Perspectives Online. October 26, 2007.
(Available online at: http://www.ehponline.org/docs/2007/10131/abstract.html)
BACKGROUND: Chronic exposure to excess arsenic (As) in drinking water has been
strongly associated with increased risks of multiple cancers, diabetes, heart disease, and
reproductive and developmental problems in humans. We previously demonstrated that As
is a potent endocrine disruptor at low, environmentally relevant levels, alters steroid
signaling at the level of receptor-mediated gene regulation for all five steroid receptors.
OBJECTIVES: The goal of this study was to determine whether As can also disrupt gene
regulation via the retinoic acid (RA) receptor (RAR) and/or thyroid hormone (TH) receptor
15
(TR) and whether these effects are similar to previously observed effects on steroid
regulation.
METHODS AND RESULTS: Human embryonic NT2 or rat pituitary GH3 cells were
treated with 0.01-5 µM sodium arsenite for 24 hr, with or without RA or TH, respectively,
to examine effects of As on receptor-mediated gene transcription. At low, non-cytotoxic
doses As significantly altered RAR-dependent gene transcription of a transfected RAR
response elementluciferase construct and the native RA-inducible cytochrome P450
CYP26A gene in NT2 cells. Likewise, low dose As significantly altered expression of a
transfected TR response elementluciferase construct and the endogenous TR-regulated Type
I Deiodinase (DIO1) gene in a similar manner in GH3 cells. An amphibian ex vivo tail
metamorphosis assay was used to examine whether endocrine disruption by low dose As
could have specific patho-physiological consequences since tail metamorphosis is tightly
controlled by TH through TR. TH-dependent tail shrinkage was inhibited in a dosedependent manner by 0.1- 4.0 µ M As.
CONCLUSIONS: As had similar effects on RAR- and TR-mediated gene regulation as
those previously observed for the steroid receptors, suggesting a common mechanism or
action. As also profoundly affected a TR-dependent developmental process in a model
animal system at 6 very low concentrations. Since RAR and TH are critical for both normal
human development and adult function and their dysregulation is associated with many
disease processes, disruption of these hormone receptor-dependent processes by As is also
potentially relevant to human developmental problems and disease risk.
Hwang, Y et al. 1997. “Environmental arsenic exposure of children around a former copper
smelter site.” Environmental Research. 72: 72-81.
Arsenic residues in the communities surrounding former smelters remain a public health
concern, especially for infants and children. To evaluate environmental exposure among
these children, a population-based cross-sectional study was conducted in the vicinity of a
former copper smelter in Anaconda, Montana. A total of 414 children less than 72 months
old were recruited. First morning voided urine samples and environmental samples were
collected for arsenic measurements. The geometric mean of speciated urinary arsenic was
8.6 µg/liter (GSD = 1.7, N = 289). Average arsenic levels of different types of soil ranged
from 121 to 236 µg/g, and were significantly related to proximity and wind direction to the
smelter site. The same significant relationship was observed for interior dust arsenic.
Speciated urinary arsenic was found to be significantly related to soil arsenic in bare areas in
residential yards (P < 0.0005). In general, elevated excretion of arsenic was demonstrable
and warranted parents’ attention to reduce exposure of their children to environmental
arsenic.
Pellizzari, ED and Clayton, CA. (2006) “Assessing the Measurement Precision of Various
Arsenic Forms and Arsenic Exposure in the National Human Exposure Assessment Survey
(NHEXAS).” Environmental Health Perspectives. 114:220–227. (Added 2/2008)
Archived samples collected from 1995 to 1997 in the National Human Exposure
Assessment Survey (NHEXAS) in U.S. Environmental Protection Agency Region 5 (R5)
and the Children’s Study (CS) in Minnesota were analyzed for total arsenic, arsenate
[As(V)], arsenite, dimethyl arsenic acid (DMA), monomethyl arsenic acid (MMA),
arsenobetaine (AsB), and arsenocholine. Samples for the CS included drinking water, urine,
16
hair, and dust; both studies included food (duplicate plate, composited 4-day food samples
from participants). Except for AsB and As(V), the levels for As species measured in the
food and drinking water samples were very low or nonexistent. The analytical methods used
for measuring As species were sensitive to < 1 ppb. During the analysis of food and
drinking water samples, chromatographic peaks appeared that contained As, but they did not
correspond to those being quantified. Thus, in some samples, the sum of the individual As
species levels was less than the total As level measured because the unknown forms of As
were not quantified. On the other hand, total As was detectable in almost all samples (>
90%) except for hair (47%), indicating that the analytical method was sufficiently sensitive.
Population distributions of As concentrations measured in drinking water, food (duplicate
late), dust, urine, and hair were estimated. Exposures to total As in food for children in the
CS were about twice as high as in the general R5 population (medians of 17.5 ppb and 7.72
ppb, respectively). In addition, AsB was the most frequently detected form of As in food
eaten by the participants, while As(V) was only rarely detected. Thus, the predominant
dietary exposure was from an organic form of As. The major form of As in drinking water
was As(V). Spearman (rank) correlations and Pearson (log-concentration scale) correlations
between the biomarkers (urine, hair) and the other measures (food, drinking water, dust) and
urine versus hair were performed. In the NHEXAS CS, total As and AsB in the food eaten
were significantly correlated with their levels in urine. Also, levels of As(V) in drinking
water correlated with DMA and MMA in urine. Arsenic levels in dust did not show a
relationship with urine or hair levels, and no relationship was observed for food, drinking
water, and dust with hair. Urine samples were collected on days 3, 5, and 7 of participants’
monitoring periods. Total As levels in urine were significantly associated across the three
pairwise combinations—i.e., day 3 versus day 5, day 3 versus day 7, and day 5 versus day 7.
Because the half-life of As in the body is approximately 3 days, this suggests that some
exposure occurred continually from day to day. This trend was also observed for AsB,
suggesting that food is primarily responsible for the continual exposure. DMA and MMA in
urine were also significantly correlated but not in all combinations.
Schoof, R and J Yager. 2007. “Variation of total and speciated arsenic in commonly consumed
fish and seafood.” Human and Ecological Risk Assessment. 13(5): 946-965.
This article compiles available data and presents an approach for predicting human intakes
of inorganic arsenic (Asi), monomethylarsonic acid (MMA), and dimethylarsinic acid
(DMA) from marine, estuarine, and freshwater seafood when only total arsenic (Astot)
concentrations are reported. Twenty studies provided data on total arsenic (Astot) and Asi.
Mean Asi concentrations were approximately 10 to 20 ng/g wet weight (ww) in freshwater,
anadromous, and marine fish, whereas crustaceans and molluscs had mean Asi
concentrations of 40 to 50 ng/g ww. Thirteen studies provided data for MMA and DMA.
MMA was seldom detected, whereas DMA averaged 10 ng/g ww in freshwater fish, and 45
to 95 ng/g ww in anadromous fish, marine fish, crustaceans, and molluscs. There was little
correlation between Astot concentrations and Asi concentrations; however, when only Astot
data are available to assess health risks from arsenic in seafood, these data could support
conservative, upper end estimates of the percent of Astot likely to be Asi. For marine and
estuarine fish, and crustaceans and molluscs 2–3% of Astot was Asi at the 75th percentile of
the dataset. For freshwater fish Asi was 10% of Astot at the 75th percentile. Due to the
17
nonlinearity and low carcinogenic potency of DMA, the reported DMA concentrations
should not contribute substantially to potential health risks from arsenic in seafood.
Spevacova, V et al. 2002. “Population-based biomonitoring in the Czech Republic: Urinary
arsenic.” Journal of Environmental Monitoring. 4(5):796-798. (Added 2/2008)
The method of Guo et aL (AnaL Chim. Acta, 1997, 349, 313-318) for the determination of
the toxicologically relevant arsenic in urine was verified and then used for the determination
of arsenic in urine of the Czech population for monitoring purposes. Statistical evaluation at
the level alpha = 0.05 did not prove any significant differences between industrial and
agricultural regions, between males and females and smokers and nonsmokers. Likewise no
differences were found among children in all the regions monitored. In the adult population
small differences were found between some regions but these differences were not
dependent on industrial pollution. The values of toxicologically relevant arsenic are low for
all regions. The summarised value of the median for all groups together is 3.5 microg (g
creatinine)(-1).
Tsuji, J et al. 2005. “Evaluation of exposure to arsenic in residential soil.” Environmental Health
Perspectives. 113(12): 1735-1740.
In response to concerns regarding arsenic in soil from a pesticide manufacturing plant, we
conducted a biomonitoring study on children younger than 7 years of age, the age category
of children most exposed to soil. Urine samples from 77 children (47% participation rate)
were analyzed for total arsenic and arsenic species related to ingestion of inorganic arsenic.
Older individuals also provided urine (n = 362) and toenail (n = 67) samples. Speciated
urinary arsenic levels were similar between children (geometric mean, geometric SD, and
range: 4.0, 2.2, and 0.89–17.7 µg/L, respectively) and older participants (3.8, 1.9, 0.91–19.9
µg/L) and consistent with unexposed populations. Toenail samples were < 1 mg/kg.
Correlations between speciated urinary arsenic and arsenic in soil (r = 0.137, p = 0.39; n =
41) or house dust (r = 0.049, p = 0.73; n = 52) were not significant for children. Similarly,
questionnaire responses indicating soil exposure were not associated with increased urinary
arsenic levels. Relatively low soil arsenic exposure likely precluded quantification of arsenic
exposure above background.
Tsuju, J et al. 2007. “Use of background inorganic arsenic exposures to provide perspective on
risk assessment results.” Regulatory Toxicology & Pharmacology. 48: 59-68.
Background exposures provide perspective for interpreting calculated health risks associated
with naturally occurring substances such as arsenic. Background inorganic arsenic intake
from diet and water for children (ages 1–6 years) and all ages of the U.S. population was
modeled stochastically using consumption data from USDA, published data on inorganic
arsenic in foods, and EPA data on arsenic in drinking water. Mean and 90th percentile
intakes for the U.S. population were 5.6 and 10.5 µg/day, assuming nationwide compliance
with the 10 µg/L U.S. drinking water standard. Intakes for children were slightly lower (3.5
and 5.9 µg/day). Based on the current EPA cancer slope factor for arsenic, estimated
lifetime risks associated with background diet and water at the mean and 90th percentile are
1 per 10,000 and 2 per 10,000, respectively. By comparison, reasonable maximum risks for
arsenic in soil at 20 (higher typical background level) and 100 mg/kg are 4 per 100,000 and
2 per 10,000, using EPA default exposure assumptions. EPA reasonable maximum
18
estimates of arsenic exposure from residential use of treated wood are likewise within
background intakes. These examples provide context on how predicted risks compare to
typical exposures within the U.S. population, thereby providing perspective for risk
communication and regulatory decision-making on arsenic in the environment and in
consumer products.
Yost, L et al. 2004. “Estimation of dietary intake of inorganic arsenic in U.S. children.” Human
and Ecological Risk Assessment. 10(3): 473-483.
Arsenic is a natural component of the environment and is ubiquitous in soils, water, and the
diet. Because dietary intake can be a significant source of background exposure to inorganic
arsenic (the most toxicologically significant form), accurate intake estimates are needed to
provide a context for risk management of arsenic exposure. Intake of inorganic arsenic by
adults is fairly well characterized, but previous estimates of childhood intake were based on
inorganic arsenic analyses in a limited number of foods (13 food types). This article
estimates dietary intake for U.S. children (1 to 6 years of age) based on reported inorganic
arsenic concentrations in 38 foods and in water used in cooking those foods (inorganic
arsenic concentration of 0.8 µg/L), and U.S. Department of Agriculture food consumption
data. This information is combined using a probabilistic software model to extract food
consumption patterns and computer exposure distributions. The mean childhood dietary
intake estimate for inorganic arsenic was 3.2 µg/day with a range of 1.6 to 6.2 µg/day for the
10th and 95th percentiles, respectively. For both the mean and 95th percentile inorganic
arsenic intake rates, intake was predominantly contributed by grain and grain products,
fruits and fruit juices, rice and rice products, and milk.
Other resources:
ATSDR 2000. Toxicological Profile for Arsenic. US Department of Health and Human Services.
Available at: http://www.atsdr.cdc.gov/toxpro2.html
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.
National Library of Medicine, 2007. Haz-Map. Available at http://hazmap.nlm.nih.gov
** Articles added since the last advisory panel meeting.
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20
PFC Citations (Updated 2/2008)
3M Company. (2007) "Estimation of Half-Life of Serum Elimintation of Perflourobutyrate (PFBA) in
Four 3M Male Employees." 3M Company, St Paul MN 55114.
**Alexander BH et al. (2003) “Mortality of employees of a perfluorooctanesulphonyl fluoride
manufacturing facility.” Occup Environ Med. Oct;60(10):722-9.
AIM: To evaluate the mortality experience of a cohort of employees of a perfluorooctanesulphonyl
fluoride (POSF) based fluorochemical production facility. METHODS: A retrospective cohort
mortality study followed all workers with at least one year of cumulative employment at the
facility. The jobs held by cohort members were assigned to one of three exposure subgroups; high
exposed, low exposed, and non-exposed, based on biological monitoring data for perfluorooctane
sulphonate (PFOS). RESULTS: A total of 145 deaths were identified in the 2083 cohort members.
Sixty five deaths occurred among workers ever employed in high exposed jobs. The overall
mortality rates for the cohort and the exposure subcohorts were lower than expected in the general
population. Two deaths from liver cancer were observed in the workers with at least one year of
high or low exposure (standardised mortality ratio (SMR) 3.08, 95% CI 0.37 to 11.10). The risk of
death from bladder cancer was increased for the entire cohort (three observed, SMR 4.81, 95% CI
0.99 to 14.06). All three bladder cancers occurred among workers who held a high exposure job
(SMR 12.77, 95% CI 2.63 to 37.35). The bladder cancer cases primarily worked in non-production
jobs, including maintenance and incinerator and wastewater treatment plant operations.
CONCLUSION: Workers employed in high exposure jobs had an increased number of deaths from
bladder cancer; however it is not clear whether these three cases can be attributed to
fluorochemical exposure, an unknown bladder carcinogen encountered during the course of
maintenance work, and/or non-occupational exposures. With only three observed cases the
possibility of a chance finding cannot be ruled out.
**Andersen ME et al. (2008) "Perfluoroalkyl Acids and Related Chemistries - Toxicokinetics and
Modes of Action." Toxicological Sciences 102: 3-14.
The perfluoroalkyl acid salts (both carboxylates and sulfonates, hereafter designated as PFAAs)
and their derivatives are important chemicals that have numerous consumer and industrial
applications. However, recent discoveries that some of these compounds have global distribution,
environmental persistence, presence in humans and wildlife, as well as toxicity in laboratory
animal models, have generated considerable scientific, regulatory, and public interest on an
international scale. The Society of Toxicology Contemporary Concepts in Toxicology Symposium,
entitled "Perfluoroalkyl Acids and Related Chemistries: Toxicokinetics and Modes-of-Action
Workshop" was held February 14–16, 2007 at the Westin Arlington Gateway, Arlington, VA. In
addition to the Society of Toxicology, this symposium was sponsored by 3M Company, DuPont,
Plastics Europe, and the U.S. Environmental Protection Agency. The objectives of this 3-day
meeting were to (1) provide an overview of PFAA toxicity and description of recent findings with
the sulfonates, carboxylates, and telomer alcohols; (2) address the toxicokinetic profiles of various
PFAAs among animal models and humans, and the biological processes that are responsible for
these observations; (3) examine the possible modes of action that determine the PFAA toxicities
observed in animal models, and their relevance to human health risks; and (4) identify the critical
21
research needs and strategies to fill the existing informational gaps that hamper risk assessment of
these chemicals. This report summarizes the discourse that occurred during the symposium.
**Apelberg BJ et al. (2007) "Cord Serum Concentrations of Perfluorooctane Sulfonate (PFOS) and
Perfluorooctanoate (PFOA) in Relation to Weight and Size At Birth." Environmental Health
Perspectives. 114: 1670-6.
BACKGROUND: Recent studies have reported developmental toxicity among rodents dosed with
perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA).OBJECTIVES: We examined
the relationship between PFOS and PFOA cord serum concentrations (surrogates for in utero
exposures) and gestational age, birth weight, and birth size in humans. METHODS: We conducted
a hospital-based cross-sectional epidemiologic study of singleton deliveries in Baltimore, MD.
Cord serum samples (n = 293) were analyzed for PFOS and PFOA by on-line solid-phase
extraction, coupled with reversed phase high performance liquid chromatography-isotope dilution
tandem mass spectrometry. Maternal characteristics and anthropometric measures were obtained
from medical charts. RESULTS: After adjusting for potential confounders, both PFOS and PFOA
were negatively associated with birth weight [per ln-unit: beta = -69 g, 95% confidence interval
(CI), -149 to 10 for PFOS; beta = -104 g, 95% CI, -213 to 5 for PFOA], ponderal index (per lnunit: beta = -0.074 g/cm(3) x 100, 95% CI, -0.123 to -0.025 for PFOS; beta = -0.070 g/cm(3) x
100, 95% CI, -0.138 to -0.001 for PFOA), and head circumference (per ln-unit: beta = -0.32 cm,
95% CI, -0.56 to -0.07 for PFOS; beta = -0.41 cm, 95% CI, -0.76 to -0.07 for PFOA).No
associations were observed between either PFOS or PFOA concentrations and newborn length or
gestational age. All associations were independent of cord serum lipid concentrations.
CONCLUSIONS: Despite relatively low cord serum concentrations, we observed small negative
associations between both PFOS and PFOA concentrations and birth weight and size. Future
studies should attempt to replicate these findings in other populations.
Betts KS. (2007) "Perflouroalkyl Acids: What is the Evidence Telling Us." Environmental Health
Perspectives. 115: 251-256.
**Butenhoff JL et al. (2006) “The applicability of biomonitoring data for perfluorooctanesulfonate to
the environmental public health continuum.” Environ Health Perspect. Nov;114(11):1776-82.
Perfluorooctanesulfonate and its salts (PFOS) are derived from perfluorooctanesulfonyl fluoride,
the basic chemical building block for many sulfonyl-based fluorochemicals used as surfactants and
for their repellent properties. PFOS is highly persistent in the environment and has a long serum
elimination half-life in both animals and humans. PFOS has been detected globally in the
environment and in blood serum in various populations throughout the world, with the majority of
human sampling done in the United States and Japan. The mechanisms and pathways leading to
the presence of PFOS in human blood are not well characterized but likely involve both direct
exposures to PFOS or chemicals and materials that can degrade to PFOS, either in the environment
or from industrial and commercial uses. In 2000 the 3M Company, a major manufacturer,
announced a phaseout of PFOS-related materials. Animal studies indicate that PFOS is well
absorbed orally and distributes mainly in blood serum and the liver. Several repeat-dose toxicology
studies in animals consistently demonstrated that the liver is the primary target organ. In addition
there is a steep dose response for mortality in sexually mature rats and primates as well as in
neonatal rats and mice exposed in utero. Several biomonitoring research needs that have been
identified on PFOS include additional data from general populations pertaining to other matrices
22
besides blood; matched serum and urine samples from humans and research animals; and
comparison of whole blood, serum, and plasma concentrations from the same individuals.
**Calafat AM et al. (2006) “Perfluorochemicals in pooled serum samples from United States residents
in 2001 and 2002.” Environ Sci Technol. Apr 1;40(7):2128-34.
Manufacturers have used perfluorochemicals (PFCs) since the 1950s in many industrial and
consumer products, including protective coatings for fabrics and carpet, paper coatings, insecticide
formulations, and surfactants. Some PFCs are persistent ubiquitous contaminants in the
environment and in humans. Exposures to PFCs result in potential developmental and other
adverse effects in animals. The sources of human exposure to PFCs and the potential health risks
associated with exposure are still unclear, and differences in patterns of human exposure may vary.
We measured the serum concentrations of perfluorooctane sulfonic acid (PFOS), perfluorooctanoic
acid (PFOA; C8), perfluorohexane sulfonic acid (PFHxS), and 8 other PFCs in 54 pooled serum
samples collected from 1832 participants of the 2001-2002 National Health and Nutrition
Examination Survey. Participants were 12 years of age and older. The pools represented three
major racial groups/ethnicities (non-Hispanic blacks, non-Hispanic whites, and Mexican
Americans), four age categories (12-19 years, 20-39 years, 40-59 years, and 60 years and older),
and both genders. PFCs were extracted from 100 microL of serum using on-line solid-phase
extraction coupled to isotope dilution-high performance liquid chromatography-tandem mass
spectrometry. The limits of detection ranged from 0.05 ng/mL to 0.2 ng/mL. The concentrations of
most PFCs were similar among the four age groups. For PFOS, the estimated least-squares mean
(LSM) concentrations among non-Hispanic white males (40.19 ng/mL) and females (23.97 ng/mL)
were greater than among non-Hispanic black males (18.27 ng/mL) and females (17.93 ng/mL) or
Mexican American males (13.71 ng/mL) and females (10.40 ng/ mL). Similarly, for PFOA, the
LSM concentrations among non-Hispanic white males (6.98 ng/mL) and females (3.97 ng/ mL)
were greater than among non-Hispanic black males (3.62 ng/mL) and females (2.85 ng/mL) or
Mexican American males (2.89 ng/mL) and females (2.08 ng/mL). Non-Hispanic whites had also
greater LSM concentrations of PFHxS than non-Hispanic blacks and Mexican Americans. These
findings indicate different patterns of human exposure to PFCs among the population groups
examined and stress the importance of conducting research to identify the environmental sources
and pathways of human exposure to PFCs.
Calafat AM 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
2999-2000." Environmental Health Perspectives. 111: 1596-602.
BACKGROUND: Polyfluoroalkyl chemicals (PFCs) have been used since the 1950s in numerous
commercial applications. Exposure of the general U.S. population to PFCs is widespread. Since
2002, the manufacturing practices for PFCs in the United States have changed considerably.
OBJECTIVES: We aimed to assess exposure to perfluorooctane sulfonic acid (PFOS),
perfluorooctanoic acid (PFOA), perfluorohexane sulfonic acid (PFHxS), perfluorononanoic acid
(PFNA), and eight other PFCs in a representative 2003-2004 sample of the general U.S. population
>or= 12 years of age and to determine whether serum concentrations have changed since the 19992000 National Health and Nutrition Examination Survey (NHANES). METHODS: By using
automated solid-phase extraction coupled to isotope dilution-high-performance liquid
chromatography-tandem mass spectrometry, we analyzed 2,094 serum samples collected from
NHANES 2003-2004 participants. RESULTS: We detected PFOS, PFOA, PFHxS, and PFNA in >
23
98% of the samples. Concentrations differed by race/ethnicity and sex. Geometric mean
concentrations were significantly lower (approximately 32% for PFOS, 25% for PFOA, 10% for
PFHxS) and higher (100%, PFNA) than the concentrations reported in NHANES 1999-2000 (p <
0.001). CONCLUSIONS: In the general U.S. population in 2003-2004, PFOS, PFOA, PFHxS, and
PFNA serum concentrations were measurable in each demographic population group studied.
Geometric mean concentrations of PFOS, PFOA, and PFHxS in 2003-2004 were lower than in
1999-2000. The apparent reductions in concentrations of PFOS, PFOA, and PFHxS most likely are
related to discontinuation in 2002 of industrial production by electrochemical fluorination of PFOS
and related perfluorooctanesulfonyl fluoride compounds.
Calafat AM et al. (2007) "Serum concentrations of 11 polyfluoroalkyl compounds in the U.S.
population: Data from the National Health and Nutrition Examinaton Survey (NHANES) 1999 2000." Environmental Science and Technology. 41: 2237-2242.
We measured the concentrations of 11 polyfluoroalkyl compounds (PFCs), including
perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and perfluorohexane
sulfonic acid (PFHxS) in 1562 serum samples collected from a representative U.S. population 12
years of age and older in the 1999-2000 National Health and Nutrition Examination Survey.
Participants represented both sexes, three race/ethnicities (non-Hispanic blacks, non-Hispanic
whites, and Mexican-Americans), and four age categories (12-19 years, 20-39 years, 40-59 years,
and 60 years and older). PFCs were extracted from 100 microL of serum using on-line solid-phase
extraction coupled to isotope dilution-high performance liquid chromatography-tandem mass
spectrometry; limits of detection ranged from 0.05 to 0.2 ng/ mL. PFOS, PFOA, PFHxS, and
perfluorooctane sulfonamide were detected in all samples analyzed; 2-(N-ethyl-perfluorooctane
sulfonamido) acetic acid, 2-(N-methyl-perfluorooctane sulfonamido) acetic acid, and
perfluorononanoic acid were detected in more than 90% of samples, which suggests prevalent
exposures to several PFCs in the U.S. population. The concentrations of most PFCs were similar
regardless of the participants' ages but were higher in males than in females. Mexican Americans
had lower concentrations than non-Hispanic blacks and non-Hispanic whites, whose
concentrations were similar. Higher education was associated with higher concentrations of PFOS
and PFOA. These data will serve as a nationally representative baseline of the U.S. population's
exposure to PFCs to which other populations can be compared, and will play an important role in
public health by helping set research priorities, ranging from health effects studies to defining
sources and pathways of exposure.
**Emmett AE et al. (2006) “Community exposure to perfluorooctanoate: relationships between serum
concentrations and exposure sources.” J Occup Environ Med. Aug; 48(8):759-70.
OBJECTIVE: The objective of this study was to determine serum (perfluorooctanoate [PFOA]) in
residents near a fluoropolymer production facility: the contributions from air, water, and
occupational exposures, personal and dietary habits, and relationships to age and gender.
METHODS: The authors conducted questionnaire and serum PFOA measurements in a stratified
random sample and volunteers residing in locations with the same residential water supply but
with higher and lower potential air PFOA exposure. RESULTS: Serum (PFOA) greatly exceeded
general population medians. Occupational exposure from production processes using PFOA and
residential water had additive effects; no other occupations contributed. Serum (PFOA) depended
on the source of residential drinking water, and not potential air exposure. For public water users,
the best-fit model included age, tap water drinks per day, servings of home-grown fruit and
24
vegetables, and carbon filter use. CONCLUSIONS: Residential water source was the primary
determinant of serum (PFOA).
**Fei C et al. (2007) “Perfluorinated Chemicals and fetal growth: a study within the Danish National
Birth Cohort.” Environ Health Perspect. Nov;115(11):1677-82.
BACKGROUND: Perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) are manmade, persistent organic pollutants widely spread throughout the environment and human
populations. They have been found to interfere with fetal growth in some animal models, but
whether a similar effect is seen in humans is uncertain. OBJECTIVES: We investigated the
association between plasma levels of PFOS and PFOA in pregnant women and their infants' birth
weight and length of gestation. METHODS: We randomly selected 1,400 women and their infants
from the Danish National Birth Cohort among those who completed all four computer-assisted
telephone interviews, provided the first blood samples between gestational weeks 4 and 14, and
who gave birth to a single live-born child without congenital malformation. PFOS and PFOA were
measured by high performance liquid chromatography-tandem mass spectrometer. RESULTS:
PFOS and PFOA levels in maternal plasma were on average 35.3 and 5.6 ng/mL, respectively.
Only PFOA levels were inversely associated with birth weight (adjusted beta = -10.63 g; 95%
confidence interval, -20.79 to -0.47 g). Neither maternal PFOS nor PFOA levels were consistently
associated with the risk for preterm birth or low birth weight. We observed no adverse effects for
maternal PFOS or PFOA levels on small for gestational age. CONCLUSION: Our nationwide
cohort data suggest an inverse association between maternal plasma PFOA levels and birth weight.
Because of widespread exposure to these chemicals, our findings may be of potential public health
concern.
**Harada K et al. (2004) “The influence of time, sex and geographic factors on levels of
perfluorooctane sulfonate and perfluorooctanoate in human serum over the last 25 years.” J Occup
Health. Mar;46(2):141-7.
Perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) are important
perfluorochemicals (PFCs) in various applications. Recently, it has been shown that these
chemicals are widespread in the environment, wildlife and humans. But the kinds of factors that
affect their levels in serum are unclear, and it is also not clear whether exposure to them is
increasing or not. To investigate the impacts of time, geographical location and sex on the levels of
these chemicals, we measured PFOS and PFOA concentrations in human sera samples collected
both historically and recently in Miyagi, Akita and Kyoto Prefectures in Japan. The PFOS and
PFOA levels in sera [Geometric Mean (Geometric Standard Deviation)] (microg/L) in 2003 ranged
from 3.5 (2.9) in Miyagi to 28.1 (1.5) in Kyoto for PFOS and from 2.8 (1.5) to 12.4 (1.4) for
PFOA. Historical samples collected from females demonstrated that PFOS and PFOA
concentrations have increased by factors of 3 and 14, respectively, over the past 25 yr. There are
large sex differences in PFOS and PFOA concentrations in serum at all locations. Furthermore,
there are predominant regional differences for both PFOS and PFOA concentrations. In Kyoto the
concentrations of PFOA in dwellers who had lived in the Kinki area for more than 2 yr were
significantly higher than in people who had recently moved into the area, in both sexes. This
finding suggests that there are sources of PFOA in the Kinki area that have raised the PFOA serum
levels of its inhabitants. Further studies are needed to elucidate these sources in the Kinki area of
Japan.
25
**Inoue K et al. (2004) “Perfluorooctane sulfonate (PFOS) and related perfluorinated compounds in
human maternal and cord blood samples: assessment of PFOS exposure in a susceptible population
during pregnancy.” Environ Health Perspect. Aug;112(11):1204-7.
Fluorinated organic compounds (FOCs), such as perfluorooctane sulfonate (PFOS), perfluorooctanoate (PFOA), and perfluorooctane sulfonylamide (PFOSA), are widely used in the
manufacture of plastic, electronics, textile, and construction material in the apparel, leather, and
upholstery industries. FOCs have been detected in human blood samples. Studies have indicated
that FOCs may be detrimental to rodent development possibly by affecting thyroid hormone levels.
In the present study, we determined the concentrations of FOCs in maternal and cord blood
samples. Pregnant women 17-37 years of age were enrolled as subjects. FOCs in 15 pairs of
maternal and cord blood samples were analyzed by liquid chromatography-electrospray mass
spectrometry coupled with online extraction. The limits of quantification of PFOS, PFOA, and
PFOSA in human plasma or serum were 0.5, 0.5, and 1.0 ng/mL, respectively. The method enables
the precise determination of FOCs and can be applied to the detection of FOCs in human blood
samples for monitoring human exposure. PFOS concentrations in maternal samples ranged from
4.9 to 17.6 ng/mL, whereas those in fetal samples ranged from 1.6 to 5.3 ng/mL. In contrast,
PFOSA was not detected in fetal or maternal samples, whereas PFOA was detected only in
maternal samples (range, < 0.5 to 2.3 ng/mL, 4 of 15). Our results revealed a high correlation
between PFOS concentrations in maternal and cord blood (r2 = 0.876). However, we did not find
any significant correlations between PFOS concentration in maternal and cord blood samples and
age bracket, birth weight, or levels of thyroid-stimulating hormone or free thyroxine. Our study
revealed that human fetuses in Japan may be exposed to relatively high levels of FOCs. Further
investigation is required to determine the postnatal effects of fetal exposure to FOCs.
**Johansson N et al. (2008) "Neonatal exposure to perfluorooctane sulfonate (PFOS) and
perfluorooctanoic acid (PFOA) causes neurobehavioural defects in adult mice." Neurotoxiology 29:
160-169.
Perfluorinated compounds (PFCs) are found in applications such oil/water repellents for clothing
fabrics, carpets, food packaging, lubricants, surfactants and fire extinguishers. PFCs are persistent
in the environment. They have been found in humans and in wildlife. We reported earlier that
persistent organic pollutants (POPs), such as DDT, PCBs and BFRs, caused developmental
neurotoxic defects in mice, manifested as persistent aberrations in spontaneous behaviour,
habituation capability, learning and memory, and changes in the cholinergic system in adults,
when mice were exposed during a critical period of neonatal brain development. The present study
was conducted to see whether PFCs can cause similar developmental neurotoxic effects as earlier
observed for POPs as PCBs and PBDEs. NMRI male mice were exposed to a single-oral dose,
either 1.4 or 21 mumol/kg body weight of PFOS (0.75 or 11.3 mg), PFOA (0.58 or 8.70 mg), or
PFDA (0.72 or 10.8 mg), via a metal gastric-tube at the age of 10 days. The control animals
received in the same manner 10 ml/kg body weight of the 20% fat emulsion vehicle. Spontaneous
behaviour (locomotion, rearing, and total activity), and habituation were observed in 2- and 4month-old mice. The susceptibility of the cholinergic system was explored in a nicotine-induced
spontaneous behaviour test in 4-month-old mice. Deranged spontaneous behaviour was observed
in mice exposed to PFOS and PFOA, manifested as reduced and/or lack of habituation and
hyperactivity in adult mice. These effects were also seen to worse with age. Neonatal exposure to
PFOS and PFOA affected the cholinergic system, manifested as a hypoactive response to nicotine,
compared to a hyperactive response to nicotine in controls. These developmental neurotoxic
26
effects are similar to those we reported earlier for PCBs and PBDEs. This suggests that PFOS and
PFOA be included in the group of POPs known to be developmental neurotoxicants.
**Kannan K et al. (2006) “Association between perfluorinated compounds and pathological
conditions in southern sea otters.” Environ Sci Technol. Aug 15;40(16):4943-8.
Concentrations of four perfluorinated contaminants, including perfluorooctanesulfonate (PFOS)
and perfluorooctanoic acid (PFOA), were measured in liver tissue from 80 adult female sea otters
collected from the California coast during 1992-2002. Concentrations of PFOS and PFOA were in
the ranges of <1-884 and <5-147 ng/g, wet wt, respectively. Concentrations of PFOA in the livers
of these sea otters were among the highest values reported for marine mammals to date. Liver
tissue from 6 male sea otters also was analyzed and contained significantly higher concentrations
of PFOS than did tissues from female otters. To examine the association between exposures and
potential effects, concentrations of PFOS and PFOA were compared among the adult female otters
that died from infectious diseases, noninfectious causes, and from apparent emaciation.
Concentrations of both PFOA and PFOS were significantly higher in sea otters in the infectious
disease category than in the noninfectious category. Concentrations of PFOS and PFOA were not
significantly different between noninfectious and emaciated otters, suggesting that the poor
nutritive (body) status of emaciated otters did not affect the concentrations of perfluorochemicals
in livers. Concentrations of PFOA increased significantly from 1992 to 2002, whereas PFOS
concentrations increased from 1992 to 1998 and then decreased after 2000. Significant association
between infectious diseases and elevated concentrations of PFOS/PFOA in the livers of sea otters
is a cause for concern and suggests the need for further studies.
**Kannan K et al. (2004) “Perfluorooctanesulfonate and related fluorochemicals in human blood from
several countries.” Environ Sci Technol. Sep 1;38(17):4489-95.
Perfluorooctanesulfonyl fluoride based compounds have been used in a wide variety of consumer
products, such as carpets, upholstery, and textiles. These compounds degrade to
perfluorooctanesulfonate (PFOS), a persistent metabolite that accumulates in tissues of humans
and wildlife. Previous studies have reported the occurrence of PFOS, perfluorohexanesulfonate
(PFHxS), perfluorooctanoate (PFOA), and perfluorooctanesulfonamide (PFOSA) in human sera
collected from the United States. In this study, concentrations of PFOS, PFHxS, PFOA, and
PFOSA were measured in 473 human blood/serum/plasma samples collected from the United
States, Colombia, Brazil, Belgium, Italy, Poland, India, Malaysia, and Korea. Among the four
perfluorochemicals measured, PFOS was the predominant compound found in blood.
Concentrations of PFOS were the highest in the samples collected from the United States and
Poland (>30 ng/mL); moderate in Korea, Belgium, Malaysia, Brazil, Italy, and Colombia (3 to 29
ng/mL); and lowest in India (<3 ng/mL). PFOA was the next most abundant perfluorochemical in
blood samples, although the frequency of occurrence of this compound was relatively low. No ageor gender-related differences in the concentrations of PFOS and PFOA were found in serum
samples. The degree of association between the concentrations of four perfluorochemicals varied,
depending on the origin of the samples. These results suggested the existence of sources with
varying levels and compositions of perfluorochemicals, and differences in exposure patterns to
these chemicals, in various countries. In addition to the four target fluorochemicals measured,
qualitative analysis of selected blood samples showed the presence of other perfluorochemicals
such as perfluorodecanesulfonate (PFDS), perfluoroheptanoic acid (PFHpA), perfluorononanoic
acid (PFNA), perfluorodecanoic acid (PFDA), perfluorododecanoic acid (PFDoA), and
27
perfluoroundecanoic acid (PFUnDA) in serum samples, at concentrations approximately 5- to 10fold lower than the concentration of PFOS. Further studies should focus on identifying sources and
pathways of human exposure to perfluorochemicals.
**Karrman A et al. (2006) “Levels of 12 perfluorinated chemicals in pooled australian serum,
collected 2002-2003, in relation to age, gender, and region.” Environ Sci Technol. Jun 15;40(12):37428.
Pooled serum samples from 3802 Australian residents were analyzed for four
perfluoroalkylsulfonates, seven perfluoroalkylcarboxylates, and perfluorooctanesulfonamide
(PFOSA). Serum was collected from men and women of five different age groups and from rural
and urban regions in Australia. The highest mean concentration was obtained for perfluorooctane
sulfonate (PFOS, 20.8 ng/mL) followed by perfluorooctanoic acid (PFOA, 7.6 ng/mL),
perfluorohexane sulfonate (PFHxS, 6.2 ng/mL), perfluorononanoic acid (PFNA, 1.1 ng/mL), and
PFOSA (0.71 ng/mL). Additional four PFCs were detected in 5-18% of the samples at
concentrations near the detection limits (0.1-0.5 ng/mL). An increase in PFOS concentration with
increasing age in both regions and genders was observed. The male pool levels of some of the age
groups compared to females were higherfor PFOS, PFOA, and PFHxS. In contrast, PFNA
concentrations were higher in the female pools. No substantial difference was found in levels of
PFCs between the urban and rural regions. The levels are equal or higher than previously reported
serum levels in Europe and Asia but lower compared to the U.S.A. These results suggest that
emissions from production in the Northern Hemisphere are of less importance for human exposure.
**Midasch O et al. (2007) “Transplacental exposure of neonates to perfluorooctanesulfonate and
perfluorooctanoate: a pilot study.” Int Arch Occup Environ Health. Jul;80(7):643-8.
OBJECTIVES: Perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) can be released
of perfluorinated compounds by biotic and/or metabolic decomposition. Due to their ubiquitous
occurrence, persistence and bioaccumulative properties they can be found in blood of the general
population all over the world. In animal studies PFOS and PFOA provoked cancer and showed
developmental toxic potential besides other adverse health effects. On the basis of the comparison
of maternal and umbilical cord plasma sample pairs we wanted to examine whether infants are
exposed to PFOS and PFOA via their mothers' blood. METHODS: We determined PFOS and
PFOA in 11 plasma samples of mothers and the 11 corresponding cord plasma samples of
neonates. An analytical method based on plasma protein precipitation followed by HPLC with
MS/MS-detection was employed. As internal standards we used 1,2,3,4-(13)C(4)-PFOS and 1,2(13)C(2)-PFOA. RESULTS: We found PFOS and PFOA in every plasma sample analysed. In
maternal plasma samples PFOS concentrations were consistently higher compared to those of the
related cord plasma samples (median: 13.0 microg/l vs. 7.3 microg/l). In the case of PFOA we
observed only minor differences between PFOA concentrations within the analysed sample pairs
(median: 2.6 microg/l vs. 3.4 microg/l for maternal and cord plasma samples, respectively).
DISCUSSION: For both substances a crossing of the placental barrier could be shown. For PFOS
we observed a decrease from maternal to cord plasma concentrations by a factor of 0.41-0.80. To
the contrary, PFOA crosses the placental barrier obviously unhindered. These findings show that
neonates are exposed to PFOS and PFOA via their mothers' blood. Given the current situation that
only little is known about the consequences of PFOS and PFOA exposure in the early state of
development of humans and the fact that in animal studies both substances showed developmental
toxic effects further research regarding human health effects is indispensable.
28
**Olsen GW et al. (2000) “Plasma cholecystokinin and hepatic enzymes, cholesterol and lipoproteins
in ammonium perfluorooctanoate production workers.” Drug Chem Toxico. Nov;23(4):603-20.
Ammonium perfluorooctanoate is a potent synthetic surfactant used in industrial applications. It
rapidly dissociates in biologic media to perfluorooctanoate [CF3(CF2)6CO2-], which is the anion
of perfluorooctanoic acid [PFOA, CF3(CF2)6COOH]. PFOA is a peroxisome proliferator known
to increase the incidence of hepatic, pancreas and Leydig cell adenomas in rats. The pancreas
acinar cell adenomas may be the consequence of a mild but sustained increase of cholecystokinin
as a result of hepatic cholestasis. Although no significant clinical hepatic toxicity was observed,
PFOA was reported to have modulated hepatic responses to obesity and alcohol consumption
among production workers. To further assess these hypotheses, we examined medical surveillance
data of male workers involved in ammonium perfluorooctanoate production in 1993 (n=111), 1995
(n=80) and 1997 (n=74). Serum PFOA was measured by high-performance liquid chromatography
mass spectrometry methods. Plasma cholecystokinin was measured (only in 1997) by the use of
direct radioimmunoassay. Serum biochemical tests included hepatic enzymes, cholesterol and
lipoproteins. Serum PFOA levels, by year, were: 1993 (mean 5.0 ppm, SD 12.2, median 1.1 ppm,
range 0.0-80.0 ppm); 1995 (mean 6.8 ppm, SD 16.0, median 1.2 ppm, range 0.0-114.1 ppm); and
1997 (mean 6.4 ppm, SD 14.3, median 1.3 ppm, range 0.1-81.3 ppm). Cholecystokinin values
(mean 28.5 pg/ml, SD 17.1, median 22.7 pg/ml, range 8.8-86.7 pg/ml) approximated the assay's
reference range (up to 80 pg/ml) for a 12 hour fast and were negatively, not positively, associated
with employees' serum PFOA levels. Our findings continue to suggest there is no significant
clinical hepatic toxicity associated with PFOA levels as measured in this workforce. Unlike a
previously reported observation, PFOA did not appear to modulate hepatic responses to either
obesity or alcohol consumption. Limitations of these findings include: 1) the cross-sectional design
as only 17 subjects were common for the three surveillance years; 2) the voluntary participation
that ranged between 50 and 70 percent; and 3) the few subjects with serum levels > or = 10 ppm.
**Olsen GW et al. (2003) “Perfluorooctanesulfonate and other fluorochemicals in the serum of
American Red Cross adult blood donors.” Environ Health Perspect Dec;111(16):1892-901.
Perfluorooctanesulfonyl fluoride-based products have included surfactants, paper and packaging
treatments, and surface protectants (e.g., for carpet, upholstery, textile). Depending on the specific
functional derivatization or degree of polymerization, such products may degrade or metabolize, to
an undetermined degree, to perfluorooctanesulfonate (PFOS), a stable and persistent end product
that has the potential to bioaccumulate. In this investigation, a total of 645 adult donor serum
samples from six American Red Cross blood collection centers were analyzed for PFOS and six
other fluorochemicals using HPLC-electrospray tandem mass spectrometry. PFOS concentrations
ranged from the lower limit of quantitation of 4.1 ppb to 1656.0 ppb with a geometric mean of 34.9
ppb [95% confidence interval (CI), 33.3-36.5]. The geometric mean was higher among males (37.8
ppb; 95% CI, 35.5-40.3) than among females (31.3 ppb; 95% CI, 30.0-34.3). No substantial
difference was observed with age. The estimate of the 95% tolerance limit of PFOS was 88.5 ppb
(upper limit of 95% CI, 100.0 ppb). The measures of central tendency for the other
fluorochemicals (N-ethyl perfluorooctanesulfonamidoacetate, N-methyl
perfluorooctanesulfonamidoacetate, perfluorooctanesulfonamidoacetate,
perfluorooctanesulfonamide, perfluorooctanoate, and perfluorohexanesulfonate) were
approximately an order of magnitude lower than PFOS. Because serum PFOS concentrations
correlate with cumulative human exposure, this information can be useful for risk characterization.
29
**Olsen GW et al. (2004) "Quantitative Evaluation of Perfluorooctanesulfonate (PFOS) and Other
Flourochemicals in the Serum of Children." Journal of Children’s Health 2.1 Jan: 53-76.
Perfluorooctanesulfonyl fluoride (POSF)-based materials include surfactants, paper and packaging
treatments, and surface (e.g., carpet, upholstery, textile) protectants. A metabolite,
perfluorooctanesulfonate (PFOS, C8F17SO3-), has been identified in the serum and liver tissue of
nonoccupationally exposed adults and wildlife. Results from several repeat-dose toxicological
studies consistently demonstrate that the liver is the primary target organ with an apparent
threshold for the toxic effects of PFOS that can be expressed in terms of cumulative dose or body
burden. The purpose of this study was to characterize the distribution of PFOS and six other
fluorochemicals in 598 serum samples obtained from a multi-center study of children (ages 2-12)
diagnosed with group A streptococcal infections. Using high-pressure liquid chromatography
tandem mass spectrometry methods, serum PFOS concentrations ranged from 6.7 ppb (ng/mL) to
515 ppb (geometric mean 37.5 ppb, 95% CI 36.0-39.1) with an estimate of the 95th percentile (i.e.,
upper tolerance limit) of 89 ppb (upper 95% confidence limit 97 ppb). Serum perfluorooctanoate
(PFOA) concentrations were approximately an order of magnitude lower than PFOS. Unlike
comparable adult data reported elsewhere for PFOS and PFOA, children had substantially higher
estimates for the 95th percentile for perfluorohexanesulfonate (65 ppb) and N-methyl
perfluorooctanesulfonamidoacetate (12 ppb) (upper 95% confidence limits of 81 ppb and 15 ppb,
respectively). The reasons for these dissimilarities in a subgroup of children remain to be
determined. Different exposure and activity patterns between children and adults should be
considered.
**Olsen GW et al. (2005) “Historical comparison of perfluorooctanesulfonate, perfluorooctanoate, and
other fluorochemicals in human blood.” Environ Health Perspect May;113(5):539-45.
The purpose of this investigation was to determine whether there has been a change in the human
blood concentration of perfluorooctanesulfonate (PFOS), perfluorooctanoate (PFOA), and five
other fluorochemicals since 1974. Blood samples were collected in 1974 (serum) and 1989
(plasma) from volunteer participants of a large community health study. The study included a total
of 356 samples (178 from each time period). These samples were analyzed by high-pressure liquid
chromatography/tandem mass spectrometry methods. The median 1974 and 1989 fluorochemical
concentrations, respectively, were as follows: PFOS, 29.5 ng/mL vs. 34.7 ng/mL; PFOA, 2.3
ng/mL vs. 5.6 ng/mL; perfluorohexanesulfonate (PFHS), 1.6 ng/mL vs. 2.4 ng/mL; and N-ethyl
perfluorooctanesulfonamidoacetate (PFOSAA), less than the lower limit of quantitation (LLOQ;
1.6 ng/mL, vs. 3.4 ng/mL). For N-methyl perfluorooctanesulfonamidoacetate (M570),
perfluorooctanesulfonamide, and perfluorooctanesulfonamidoacetate, median serum
concentrations in both years were less than the LLOQ values (1.0, 1.0, and 2.5 ng/mL,
respectively). Statistical analysis of 58 paired samples indicated that serum concentrations of
PFOS, PFOSAA, PFOA, PFHS, and M570 were significantly (p < 0.001) higher in 1989 than in
1974. The data from 1989 were then compared with geometric mean fluorochemical
concentrations of serum samples collected in 2001 from 108 American Red Cross adult blood
donors from the same region. Except for M570, there were no statistically significant (p < 0.05)
geometric mean fluorochemical concentration differences between the 1989 and 2001 samples. In
conclusion, based on this study population, PFOS and other serum fluorochemical concentrations
have increased between 1974 and 1989. Comparison with other regional data collected in 2001 did
not suggest a continued increase in concentrations since 1989.
30
Olsen GW et al. (2007) "Half-life of serum elimination of perfluorooctansulfonate,
perfluorohexanesulfonate, and perfluorooctanotate in retired fluorochemical production workers."
Environmental Health Perspectives. Sep;115(9):1298-305.
BACKGROUND: The presence of perfluorooctanesulfonate (PFOS), perfluorohexanesulfonate
(PFHS), and perfluorooctanoate (PFOA) has been reported in humans and wildlife.
Pharmacokinetic differences have been observed in laboratory animals. OBJECTIVE: The purpose
of this observational study was to estimate the elimination half-life of PFOS, PFHS, and PFOA
from human serum. METHODS: Twenty-six (24 male, 2 female) retired fluorochemical
production workers, with no additional occupational exposure, had periodic blood samples
collected over 5 years, with serum stored in plastic vials at -80 degrees C. At the end of the study,
we used HPLC-mass spectrometry to analyze the samples, with quantification based on the ion
ratios for PFOS and PFHS and the internal standard (18)O(2)-PFOS. For PFOA, quantitation was
based on the internal standard (13)C(2)-PFOA. RESULTS: THE ARITHMETIC MEAN INITIAL
SERUM CONCENTRATIONS WERE AS FOLLOWS: PFOS, 799 ng/mL (range, 145-3,490);
PFHS, 290 ng/mL (range, 16-1,295); and PFOA, 691 ng/mL (range, 72-5,100). For each of the 26
subjects, the elimination appeared linear on a semi-log plot of concentration versus time; therefore,
we used a first-order model for estimation. The arithmetic and geometric mean half-lives of serum
elimination, respectively, were 5.4 years [95% confidence interval (CI), 3.9-6.9] and 4.8 years
(95% CI, 4.0-5.8) for PFOS; 8.5 years (95% CI, 6.4-10.6) and 7.3 years (95% CI, 5.8-9.2) for
PFHS; and 3.8 years (95% CI, 3.1-4.4) and 3.5 years (95% CI, 3.0-4.1) for PFOA.
CONCLUSIONS: Based on these data, humans appear to have a long half-life of serum
elimination of PFOS, PFHS, and PFOA. Differences in species-specific pharmacokinetics may be
due, in part, to a saturable renal resorption process.
**Pedersen et al. (2007) “Ethical issues related to biomonitoring studies on children.” Int J Hyg
Environ Health. May;210(3-4):479-82.
Human biomonitoring is a promising tool for assessing environmental exposure and its potential
relation with biomarkers, diseases and/or disorders in humans including children. Research with
children is essential; however, if the research questions can be resolved by recruitment of adults it
is not justified to include children. In general, considerations of using the less-invasive techniques
and cost-efficiency have to be taken into account. All stakeholders, especially the participants
should be well informed on the aim, procedures, benefits and risks, right to withdraw before the
kick-off and the recruitments. In the initial phase of planning a biomonitoring study consideration
of communication of results including risk and means of risk prevention should be made. Ethical
considerations regarding the study protocol should take into account (a) justification of biological
sampling related to the expected outcome(s), (b) causing no harm to the child, (c) appropriate and
comprehensive communication to the participating child as well as the parents and tutors, (d)
informed assent or consent including the right to withdraw (e) communication of results to
research participants and (f) access to own data respecting data protection including the right to
know or not to know. Data protection is important because stakeholders may also ask for insight at
various steps during human biomonitoring activities including children. Finally it is generally
recommended that aim, methods, and results from biomonitoring studies should be communicated
and study persons notified for further use of data and samples.
31
**Savitz, DA. (2007) “Biomarkers of perfluorinated chemicals and birth weight” Environmental
Health Perspectives November 115:11.
Tittlemier SA et al. (2007) “Dietary exposure of Canadians to perfluorinated carboxylates and
perflueorooctane sulfonate via consumption of meat, fish, fast foods, and food items prepared in their
packaging” Journal of Agricultural Food Chemicals 18:55(8):3203-10.
Human exposure to perfluorinated compounds is a worldwide phenomenon; however, routes of
human exposure to these compounds have not been well-characterized. Fifty-four solid food
composite samples collected as part of the Canadian Total Diet Study (TDS) were analyzed for
perfluorocarboxylates and perfluorooctanesulfonate (PFOS) using a methanol extraction liquid
chromatography tandem mass spectrometry method. Foods analyzed included fish and seafood,
meat, poultry, frozen entrées, fast food, and microwave popcorn collected from 1992 to 2004 and
prepared as for consumption. Nine composites contained detectable levels of perfluorinated
compounds-four meat-containing, three fish and shellfish, one fast food, and one microwave
popcorn. PFOS and perfluorooctanoate (PFOA) were detected the most frequently; concentrations
ranged from 0.5 to 4.5 ng/g. The average dietary intake of total perfluorocarboxylates and PFOS
for Canadians was estimated to be 250 ng/day, using results from the 2004 TDS composites. A
comparison with intakes of perfluorocarboxylates and PFOS via other routes (air, water, dust,
treated carpeting, and apparel) suggested that diet is an important source of these compounds.
There was a substantial margin of exposure between the toxicological points of reference and the
magnitude of dietary intake of perfluorinated compounds for Canadians >/= 12 years old.
**Wilhelm, M. et al (accepted for publication in 2008) “Contribution to the evaluation of reference
values for PFOA and PFOS in plasma of children and adults from Germany.” International Journal of
Hygiene and Environmental Health.
Perfluorinated compounds (PFC) are a large group of chemicals produced for several decades and
widely used for many industrial and consumer applications. Human Biomonitoring studies reveal a
background exposure of the general population to perfluorooctanoic acid (PFOA) and
pefluorooctane sulfonate (PFOS) in many parts of the world. Reference values for PFOS and
PFOA in the German population are currently not available. However, the data of three PFC
human biomonitoring studies are taken as basis for deriving a preliminary reference value. The
first two studies were performed in southern Germany with 105 (sampling period 2003-2004) and
356 adults (sampling period 2005). The third study was performed in North Rhine-Westphalia
(sampling period October and November 2006) in connection with the high PFOA contamination
of drinking water in the Sauerland region. Non PFOA exposed control groups comprised of 80
children and 153 females from Siegen and 103 men from Brilon. The whole study which could be
taken as a basis for PFOS reference considerations comprised of 170 children, 317 females and
204 men. Though the studies are not representative for the German population, they provide at
present the best available data basis for deriving reference values. The 95th percentile values of the
studies were used and the following preliminary reference values are recommended: PFOA,
10mug/l for all groups; for PFOS 10mug/l for children at school beginner age, 15mug/l for adult
females and 25mug/l for adult males.
** Articles added since the last advisory panel meeting.
32
Section overview: Biomonitoring pilot program guidelines
Draft biomonitoring program guidelines
Minn. Stat. 144.997, subd.4(a) directs that the Commissioner of Health, with the advice of the
panel, shall develop “program guidelines that address the science and practice of biomonitoring”
and that they be guided by similar guidelines developed by the CDC.
The draft biomonitoring program guidelines included in this section are a work in progress, and
will be reviewed, modified and built upon on an ongoing basis. This draft was developed based
on one meeting of a task force of the advisory panel, two conference calls with the CDC,
feedback from the EHTB steering committee and workgroup, and the EHTB legislation. It was
also informed by the recent publication of the National Research Council’s Committee on
Human Biomonitoring for Environmental Toxicants (NRC, 2006) and other publications that are
included in the attached bibliography.
The draft guidelines included here address the following:
• Pilot program purpose
• Privacy of information
• Informed consent
• Laboratory quality assurance
• Laboratory approval program
• Storage of specimens
• Communication of results
• Follow-up counseling
The draft also includes “placeholders” for several other areas for which guidelines have not yet
been developed:
• Pilot project design
• Use of stored specimens for future research
• Community acceptance and participation
• Selecting appropriate reference values
• Inclusion of children and other vulnerable populations
Guidelines for these topics will be developed for the next draft and will be addressed at a future
meeting, but panel members should feel free to offer suggestions in these areas.
These guidelines are a statement of the EHTB program’s overall values. The principles contained
herein will guide the decisions that are made on a day-to-day basis. For the immediate future, these
guidelines will help inform decisions made about the EHTB pilot projects. While we may not be
able to adhere to all of these principles during the pilot stage of the biomonitoring program, the
overall statement of values should still serve to make us think hard about any tradeoffs we make.
33
The goal of bringing the draft biomonitoring pilot program guidelines to the panel is not a formal
adoption of this document; instead staff are seeking the panel’s input and advice on the creation
of this document, and would like to uncover the range of viewpoints held by panel members.
This discussion will inform the further development of biomonitoring program guidelines.
Minnesota Government Data Practices Act/Data privacy
David Orren, MDH’s Chief Legal Counsel, will attend the March 11 EHTB advisory panel
meeting to discuss how the Minnesota Government Data Practices Act and other state laws could
affect how biomonitoring specimens and data are collected, stored, and/or disseminated. One
such law, included in this section of the meeting materials, is Minn. Stat. 13.386. This statute
governs the treatment of genetic information held by government agencies. This statute was
enacted in 2006 and is currently undergoing review to determine the effects of this law on public
health practice and other fields.
ACTION NEEDED: The panel is invited to provide suggestions for revising and strengthening the
draft biomonitoring pilot program guidelines to ensure that the guidelines reflect the appropriate
values and will adequately guide decision making. No formal vote is anticipated.
The panel is asked to discuss the following questions identified by staff:
•
•
•
•
Are the values expressed through the draft guidelines the appropriate values? Do you
agree or disagree with the values expressed?
Are the guidelines consistent with each other, and with the Legislation, or are there
conflicts?
Will the guidelines help us to make decisions for planning and conducting the four pilot
projects?
Are there additional areas where guidelines are needed?
34
Draft biomonitoring pilot program guidelines
Introduction
On a national and international level, biomonitoring is an area of rapid technicological advancement.
A decade ago, only a few dozen chemicals in a limited number of biological matrices (e.g., serum,
urine, hair, or toenails) were the subject of biomonitoring research. Today, a few hundred chemicals
or their metabolites have been measured, albeit often only in preliminary studies, in a much wider
range of biospecimens. These numbers are dwarfed by the 75,000 chemical substances that are
included on the EPA’s Toxic Substances Control Act (TSCA) Chemical Substance Inventory.
As public health laboratory scientists have forged ahead with developing and validating analytical
methods to measure internal doses of chemicals, there has been a corresponding acceleration in
the number of health research studies that include biomonitoring. Public health research
institutions now incorporate biomonitoring into major epidemiological studies such as the National
Children’s Study being conducted by the National Institute of Child Health and Development.
In public health agencies, biomonitoring has been used in a number of ways. For example,
biomonitoring can be a tool for exposure assessment, with potential applications to risk
assessment, and the development of environmental standards. When measures are repeated over
time, biomonitoring can serve in a surveillance capacity and can enable public health
practitioners to track the progress and efficacy of public health actions aimed at reducing
exposures (e.g., lead). And in the environmental community, biomonitoring has served to raise
public awareness of the prevalence of chemical exposures, particularly for emerging
contaminants such as PFCs. Many advocates view biomonitoring as a tool for shaping public
policy around chemical regulation.
Biomonitoring poses unique challenges when performed in a public health context. According to
a recent publication of the National Research Council’s Committee on Human Biomonitoring for
Environmental Toxicants “the challenge for public health agencies is to understand the health
implications of the biomonitoring data and to craft appropriate public health responses” (NRC,
2006). It is imperative that we direct our limited resources for biomonitoring pilot projects in
Minnesota towards activities which will best enable us to meet this challenge.
These guidelines are a statement of the EHTB program’s overall values. The principles contained
herein will guide the decisions that are made on a day-to-day basis. For the immediate future, these
guidelines will help inform decisions made about the EHTB pilot projects. While we may not be
able to adhere to all of these principles during the pilot stage of the biomonitoring program, the
overall statement of values should still serve to make us think hard about any tradeoffs we make.
These guidelines are a work in progress, and will be reviewed, modified and built upon on an
ongoing basis. There are numerous areas – marked in the text as “placeholders” – where draft
guidelines have yet to be developed.
35
Pilot program purpose
Biomonitoring pilot projects should provide information to individuals and communities about the
prevalence and range of exposure to chemicals in the selected community and compare those
values to a reference range.
The primary purpose of the EHTB biomonitoring pilot projects is to answer questions about the
prevalence and ranges of exposure to specific chemicals in the selected communities. Where
possible, projects should compare exposures in populations most vulnerable to the exposure to a
reference data set from the general population, and in so doing, may contribute to community
level health assessments.
Another fundamental value of the pilot projects hinges on their ability to build capacity in
Minnesota for implementing an ongoing biomonitoring program and/or to provide data that will
help to lay the groundwork for any potential follow-up projects down the road. For example,
valuable information can be learned through the pilot projects in terms of participant recruitment,
communication of results, community engagement, survey development, and methods for
specimen collection.
In addition, it is important to recognize that biomonitoring is an emerging laboratory science.
Analytical methods have not yet been developed to characterize many chemicals (and their
metabolites) in human specimens. Therefore, another important purpose of biomonitoring pilot
projects should be to gain knowledge about the robustness and comparability of laboratory
techniques, precision and accuracy of laboratory data, detection limits of analytical methods, and
the integrity of aged biospecimens.
Pilot projects are, by definition, limited in scope and resources. While pilot projects are designed
to provide valuable information useful for the development of future studies, they do not, on
their own, provide links between external exposures, internal dose, physiological effects, and
clinical health outcomes. Pilot projects also will likely not be sufficient for informing public
policy to protect the public from environmental toxicants, or contributing to toxicity assessments
or epidemiological studies of selected chemicals. These are appropriate objectives to be
considered in the development of the base program.
Pilot project design [Placeholder]
Once drafted, this section will address:
• Selection of communities
• Protocol development
• Choice of biospecimen
• Sample size
• Generalizability (or sampling frame)
36
Privacy of information
MDH data storage systems, in compliance with the Minnesota Government Data Practices Act,
provide adequate protection of data privacy; anonymization of samples and data collected by the
EHTB pilot program, which limits the potential uses of the data and the communication of
individual results, is not necessary to ensure data privacy.
Given that biomonitoring involves the collection of individual health data (e.g., information
about the levels of a chemical or its metabolites in the body), the utmost care must be taken to
protect the privacy of this information. The Minnesota Department of Health, as required by
Minnesota Statutes Chapter 13, classifies individual health data, such as biomonitoring data, as
“private” data. This means that participants’ individual data may be released only to the
participant and that protections are in place to prevent these data from being released even under
subpoena. While permanently removing all identifying information from a specimen and the
analytical data is one way to protect participants’ privacy, such anonymization severely limits the
ability of scientists to use the data for other research purposes in the future (e.g., to examine links
between exposure and health information). Anonymization of the result restricts the possibility
of contacting participants and communicating results, a fundamental value of the pilot projects
and a requirement under the EHTB statute.
An exception to this policy may be appropriate where the primary purpose for a particular
biomonitoring pilot project is to assess the technical feasibility or the development of a
laboratory method. Objectives of technical feasibility studies might include an assessment of
variation in laboratory measurements due to: (a) relative integrity of the biospecimens during
transport and storage; (b) chemicals in the biospecimens or collection containers that interfere
with the analytical technique; and (c) uncontrolled, ephemeral factors that influence the
chemistry of the biospecimen. For such projects, where the analytical methods are not strong
enough to ensure that the laboratory measurements have validity for reporting internal exposure
levels on individuals or for future studies, the use of anonymized specimens may be appropriate
Informed consent
Written informed consent will be obtained from each participant who provides a biospecimen as
part of EHTB biomonitoring pilot projects.
During the collection of biomonitoring data, careful attention must be paid to the informed
consent process to ensure that participants understand the research goals, the risks and benefits of
their participation, and how the data they provide will be stored and used. However, the specific
processes for obtaining adequate informed consent will vary depending on the situation. For
example, if new biospecimens are collected specifically for an EHTB project, participants will be
provided with information on the overall objectives of the research and specific information
about the chemicals being tested, and will be asked to provide written, informed consent. If a
biomonitoring project uses anonymized biospecimens collected by other researchers or
programs, obtaining project-specific informed consent is not possible or necessary (assuming
that a legal consent would have already been provided to use the specimens for research
purposes in general).
37
Laboratory quality assurance
Laboratories approved to provide biomonitoring data for the EHTB Program must fulfill many
criteria, including those listed herein. They must have a documented quality assurance plan and
must adhere to any required quality control procedures specified in an approved method. They
must ensure that the analytical data are scientifically valid and legally defensible. The data must
be of known and acceptable precision and accuracy.
Rigorous quality assurance/quality control procedures should be in place before a biomonitoring
project moves forward. This includes appropriate calibration of instruments, running standards
and blanks, reporting limits of detection, and other parameters. In addition, sample collection,
storage and transportation techniques must be specified in the project protocol to ensure the
integrity of the sample for analysis. Biospecimens must be stored at the proper temperature and
isolated from laboratory contaminants, standards, and highly contaminated specimens. Samples
must be assigned unique identification numbers and tracked from receipt by the laboratory
through analysis to long-term storage or disposal. Criteria must be specified for rejecting samples
that do not meet shipping, holding time, or preservation requirements.
The analytical method must describe the procedures for reducing, validating, reporting, and
verifying the data, as well as procedures for corrections or amended reports. At a minimum,
quality control parameters in the method should describe:
• Instrument performance check standards;
• Frequency and acceptability of calculations of the method detection limit;
• Frequency and acceptability of the demonstration of the minimum reporting limit;
• Calibration, internal, and surrogate standards;
• Laboratory reagent blank and laboratory matrix spike replicates;
• External quality control samples and proficiency testing samples (when available);
• Initial and continuing demonstrations of method capability;
• Identification of contaminants or confounders;
The method should describe responses to obtaining unacceptable results from internal quality
control checks and describe how corrective actions are taken and documented.
The laboratory facilities must be adequate to ensure the security and integrity of the samples and
the data. The analytical chemists must have the appropriate level of education and experience in
the specific discipline. Data produced by analytical chemists during their apprenticeship are
acceptable only when reviewed and validated by a fully qualified analytical chemist or the
laboratory supervisor.
38
Laboratory approval program
The EHTB program will utilize only those laboratories that have provided assurance that systems
are in place to generate reliable data.
At a minimum, an approved laboratory must have the appropriate equipment, trained analytical
chemists, demonstration of capability, validation of the method, and quality systems for
reporting laboratory data that are accurate and precise. The assessors should be experienced
professionals who have the appropriate levels of education and experience in the specific
discipline. The assessors should have experience in laboratory evaluation and quality assurance,
be technically conversant with the sample preparation methods and analytical techniques being
evaluated, and be competent to assess the quality of the laboratory reports and reporting system.
Storage of specimens
All biospecimens collected through the EHTB biomonitoring pilot projects will be stored for the
duration of the project (approximately one year), with the written, informed consent of the
participant. After the completion of the project, the specimen will be destroyed, unless a written
informed consent has been obtained to continue storage and use of the specimen for future
public health research and biomonitoring purposes.
Long term storage (or “biobanking”) of biospecimens may be important for future public health
research and biomonitoring, beyond the purposes of the pilot program. Therefore, the potential
for future or secondary use of the specimens must be carefully considered during the
development of biomonitoring protocols and the informed consent process. Where appropriate,
and in accordance with the law, participants may be asked to consent to continued storage and
use of the sample beyond the project time period. The samples or biological information MDH
collects for this pilot program will not be analyzed for the presence, absence, alteration, or
mutation of a gene, or for the presence or absence of a specific DNA or RNA marker. Therefore,
MDH does not intend to use biomonitoring pilot project samples for the creation of information
specifically defined as genetic information in Minn. Stat. 13.386.
Use of stored specimens for future research [Placeholder]
This section will describe the conditions under which stored biospecimens will be released for
research.
39
Communication of results
Individual participants have a right to know their individual results.
Biomonitoring data are often difficult to interpret. In some cases, information might be known
about the health effects of a high result without information about how to reduce exposure. In
other cases, there may not be information on what a high level means, but suitable information is
known about reducing exposure. In still other cases, neither information about the health
consequences nor exposure pathways may be known. Nevertheless, in all of these circumstances,
individual participants have the right to know their individual results if they choose and MDH
has an ethical obligation to make information available to participants. In particular, biomonitoring
results should be communicated for chemicals for which a reference value is known. Not making
individual results available to participants may compromise MDH’s credibility with the public.
However, in some cases (e.g., when anonymized specimens are used in technical feasibility
projects) communication of individual results is not possible. In these cases, there must be a
significant benefit to the state in conducting the biomonitoring project in order to justify the lack
of communication of individual results to participants. To ensure that communication efforts are
appropriate and effective, program staff will consult with relevant stakeholders (e.g., community
members, physicians, scientists, etc.) in designing communication materials and methods.
Community acceptance and participation [Placeholder]
This section will describe the involvement of community groups/representatives in developing
biomonitoring projects, materials, and messages to ensure that projects are sensitive to
community values and not contrary to community cultures and beliefs. This section will also
describe limitations to be placed on payments or gifts to participants in order to avoid coercion.
Follow-up counseling
Basic follow-up counseling services must be available for participants.
Because of the confusion that may be associated with receiving biomonitoring results,
participants must be provided with at least a basic level of follow-up counseling. At a minimum,
participants need to be provided a phone number to speak to a health educator at the health
department for assistance in interpreting their results. In cases where results are especially likely
to evoke fear or where there are known medical endpoints, an additional level of follow-up
counseling, such as having an opportunity to speak to a physician, is recommended. Providing an
appropriate level of follow-up counseling is important for instilling public confidence in MDH.
40
Selecting appropriate reference (comparison) values for data interpretation
[Placeholder]
This section will define different types of reference values and establish policies for determining
when a particular reference value is appropriate for interpretation of biomonitoring data
collected in the pilot projects.
Inclusion of children and other special populations [Placeholder]
This section will describe specific criteria for determining when it is appropriate or advisable to
include children (and other special populations) in a biomonitoring pilot project.
Bibliography
Bates MN et al. (2005). “Workgroup Report: Biomonitoring Study Design, Interpretation, and
Communication-Lessons Learned and Path Forward.” Environmental Health Perspectives. Vol.
113, No. 11. pp.1615-1621.
Brody, JG et al. (2007). “Is it Safe?: New Ethics for Reporting Personal Exposures to
Environmental Chemicals.” American Journal of Public Health. Vol, 97, No. 9, pp.1547-1554.
Needham LL, Calafat AM, Barr DB. (2007). “Uses and Issues of Biomonitoring.” Int. Journal of
Hygiene Environment Health. V. 210, pp.229-238.
NRC. (2006). National Research Academy. Human Biomonitoring for Environmental
Chemicals. National Academies Press.
Sexton K, Needham LL, Pirkle JL. (2004). “Human Biomonitoring of Environmental
Chemicals.” American Scientist. Vol. 92, pp 38-45.
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Minn. Statute 13.386
13.386 TREATMENT OF GENETIC INFORMATION HELD BY GOVERNMENT
ENTITIES AND OTHER PERSONS.
Subdivision 1. Definition. (a) "Genetic information" means information about an identifiable
individual derived from the presence, absence, alteration, or mutation of a gene, or the presence
or
absence of a specific DNA or RNA marker, which has been obtained from an analysis of:
(1) the individual's biological information or specimen; or
(2) the biological information or specimen of a person to whom the individual is related.
(b) "Genetic information" also means medical or biological information collected from an
individual about a particular genetic condition that is or might be used to provide medical care to
that individual or the individual's family members.
Subd. 2. Private data. Genetic information held by a government entity is private data on
individuals as defined by section 13.02, subdivision 12.
Subd. 3. Collection, storage, use, and dissemination of genetic information. Unless
otherwise expressly provided by law, genetic information about an individual:
(1) may be collected by a government entity, as defined in section 13.02, subdivision 7a, or
any other person only with the written informed consent of the individual;
(2) may be used only for purposes to which the individual has given written informed consent;
(3) may be stored only for a period of time to which the individual has given written
informed consent; and
(4) may be disseminated only:
(i) with the individual's written informed consent; or
(ii) if necessary in order to accomplish purposes described by clause (2). A consent to
disseminate genetic information under item (i) must be signed and dated. Unless otherwise
provided by law, such a consent is valid for one year or for a lesser period specified in the
consent.
History: 2006 c 253 s 4
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44
Section overview: Chemical selection
Before chemicals can be considered for inclusion in the biomonitoring pilot program (and for
ongoing biomonitoring), the criteria and process for identifying, prioritizing and recommending
chemicals must be developed.
Included in this section of the meeting materials are two documents:
1) A broad list of potential criteria that could be used when considering which chemicals should
be recommended for inclusion in the biomonitoring program.
2) An overview of the EHTB statute as it pertains to the chemical recommendation process and
a description of processes used by other biomonitoring programs.
Staff would like to hear what panel members think about which criteria should be used in a
recommendation process and which criteria should be weighted most heavily. Staff would also
like to know panel members’ initial thoughts about the process that should be used for
recommending chemicals. These discussions will inform the development of a process to be used
for making recommendations to the commissioner of health about priority chemicals.
Please note that the panel discussion on March 11 will not involve actually putting forth or
debating the merits of specific chemicals that could ultimately be included in a biomonitoring
program. Instead, the discussion will focus on making recommendations for the process to be
used in selecting those chemicals at a future date.
45
ACTION NEEDED: The advisory panel is asked to provide input on the selection criteria and
process to be used in identifying chemicals to be recommended for study by the
biomonitoring program. No formal vote is anticipated.
The panel is asked to provide specific input on the following questions identified by staff:
Questions related to chemical selection criteria:
• What other criteria should be added to the list provided in order to ensure that chemicals
recommended for study will yield useful data for advancing public health?
• Which of the criteria are the most important for ensuring that chemicals recommended for
study will yield useful data for advancing public health? Which are less important? How
should the criteria be weighted? Which criteria should factor into the recommendation the
most?
Questions related to the chemical selection process:
• What process might be used to prioritize the chemicals proposed for inclusion?
o Should the process for recommending chemicals for the pilot project differ from
the process for the base program?
o Who should be responsible for nominating chemicals for consideration and for
providing supporting evidence related to each chemical?
o What role, if any, might the public play in helping to identify and recommend
chemicals?
o How formal or informal should the recommendation process be? (E.g., a formal
scoring procedure, consensus model, or some other method)
o Should the panel work jointly or separately to arrive at its recommendations? For
example, if a scoring process is used, will one score be assigned by the full panel
or will each panel member assign a score independently?
Other questions:
• What information can MDH provide to the panel to assist in identifying additional
chemicals or criteria for consideration? What role should EHTB staff play in supporting
the panel’s process for recommending chemicals to be studied? What steps can staff take
on?
46
Possible criteria for selecting chemicals for biomonitoring
The following is a list of criteria that could potentially be used by the EHTB advisory panel to
make recommendations for chemicals to study as part of the biomonitoring program. This list
reflects criteria that are included in the EHTB statute, those used by other biomonitoring
programs, and those that are mentioned in the biomonitoring literature.
This list is intentionally broad, and the items on the list are intended to spark discussion and to
generate additional ideas about the kinds of factors that might influence the recommendation of
chemicals to study.
Public health impact
•
Degree of exposure in the population
o Proportion of the population likely to be exposed to the chemical at a level of known
or potential health significance
o Degree of exposure or potential exposure within a sub-population of interest, such as
an occupational group or vulnerable population
•
Seriousness of health effects associated with exposure
o Likelihood of a chemical being a human toxicant or carcinogen (based on peerreviewed health data, chemical structure, or the toxicology of chemically related
compounds)
o Seriousness of known or suspected human health effects resulting from the level of
exposure
Feasibility
•
Availability of analytical methods to detect the chemical or its metabolites with adequate
accuracy, precision, sensitivity (i.e., ability to detect the chemical at low enough levels),
specificity, and speed
•
Availability of adequate biospecimen samples (i.e., existence and ease of collecting a
biospecimen in which the chemical or its metabolites can be measured)
•
Degree to which the biomarker can be detected in the body (i.e., degree to which the
chemical stays in the body long enough to be measured)
•
Cost of laboratory analysis (staff time and dollars)
•
Degree to which laboratory capacity (e.g., equipment, expertise, etc.) exists (at the MDH
laboratory or other laboratories) to perform the analysis
47
Interpretability
•
Availability of an appropriate value against which individual and community biomonitoring
results can be compared (e.g., an average measure in the general population, or an established
clinical reference value, a “normal range”)
•
Degree of information known about what levels are considered safe/what levels are
associated with human health effects
•
Degree of information known about where the chemicals came from (sources of exposure)
and how someone can reduce their exposure
Actionability
•
High potential for policy or regulatory action to be taken based on biomonitoring results
(something can be done to stop the exposure)
•
Degree to which repeat measures of the chemical will assess the efficacy of public health
actions that are taking place to reduce exposure in the population as a whole or a subpopulation of interest (e.g., children, women of childbearing age, etc.)
Other factors
•
Degree to which the chemical selected will help build capacity within the state for future
biomonitoring efforts (e.g., development of new analytical methods)
•
Degree to which studying the chemical selected would add new information to the existing
knowledge base about chemical exposures
•
Degree to which studying a chemical is likely to create interest in and funding for future
biomonitoring efforts
•
Degree to which a community is concerned about a specific chemical (e.g., newly discovered
contaminants, etc.)
48
Background materials on selecting chemicals
Guidance provided by the EHTB statute
The EHTB statute provides some guidance for how chemicals should be selected for
biomonitoring:
Chemicals selected for biomonitoring (as part of the pilot or the ongoing base program) must
meet the statute’s definition for “designated chemicals.” Designated chemicals must be:
• 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
• Included in the list of chemical families or metabolites monitored by the CDC through
NHANES (listed in appendix A) and/or are specified by the commissioner after receiving
recommendations from the advisory panel.
Chemicals recommended to the commissioner for study must be agreed upon by at least nine of
the advisory panel members. The commissioner of health will ultimately make the decision about
which chemical or chemicals to be study.
Panel members may consider the criteria identified in the legislation (listed below) and may also
agree to use additional criteria for making recommendations of chemicals to study. The specific
criteria identified in the legislation are as follows:
1) the degree of potential exposure to the public or specific subgroups, including, but not
limited to, occupational;
2) 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;
3) 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;
4) exposure or potential exposure to the public or specific subgroups;
5) the known or suspected health effects resulting from the same level of exposure based on
peer-reviewed scientific studies;
6) the need to assess the efficacy of public health actions to reduce exposure to a chemical;
7) the availability of a biomonitoring analytical method with adequate accuracy, precision,
sensitivity, specificity, and speed;
8) the availability of adequate biospecimen samples;
9) other criteria that the panel may agree to.
49
Recommendations to be made by the EHTB panel
The legislation is otherwise silent on the specific process that should be used to select chemicals
for study.
The EHTB advisory panel must therefore:
1. Make recommendations for which criteria should be used in order to select chemicals for
study in the biomonitoring program.
2. Make recommendations for the specific process by which the decision should be made.
Note: The process for chemical selection may vary depending on the stated purposes of the
biomonitoring program. For example, the pilot projects are designed to measure one chemical in
each community identified as having been likely to be exposed to that chemical. The purpose of
the base biomonitoring project has yet to be determined; perhaps the pilot projects’ communitybased model will be continued or perhaps some other model will be suggested.
50
Sample processes for chemical selection
The following section describes the processes used by three other biomonitoring programs to
select chemicals for study. EHTB program staff are continuing to establish contacts with other
programs to gather information that could inform Minnesota’s decision.
NHANES
For NHANES, there is an opportunity for the public to nominate chemicals for consideration.
Nominators must provide a written statement describing which selection criteria the chemical
satisfies along with as much information as possible about the chemical.
Nominated chemicals are then considered for selection based on six weighted criteria. (Note: the
public is also offered the chance to provide comments on the selection criteria.) The six criteria
used (and their respective weights) are as follows:
• Independent scientific data which suggest that the potential for exposure of the U.S.
population to a particular chemical is changing or persisting (25 points)
• Seriousness of health effects known or suspected to result from exposure to the chemical (25
points)
• Proportion of the U.S. population likely to be exposed to levels of chemicals of known or
potential health significance (25 points)
• Need to assess the efficacy of public health actions to reduce exposure to a chemical in the
U.S. population or a large component of the U.S. population (10 points)
• Existence of an analytical method that can measure the chemical or its metabolite in blood or
urine with adequate accuracy, precision, sensitivity, and speed (10 points)
• Incremental analytical cost (in dollars and personnel) to perform the analyses. (Preference is
given to chemicals that can be added readily to existing analytical methods.) (5 points)
Nominated chemicals are scored by an expert panel. For each criterion, the panel scores the
chemical on a scale of 1 to 5, with a higher score indicating a higher priority. For each criterion
the score is then multiplied by the weighting factor, for a total maximum point value of 500.
Based on the score received, chemicals are assigned to one of five priority groups. CDC staff
publish the lists of priority groups and ultimately make the decision about which chemicals are
added.
The number of chemicals measured has expanded rapidly: The first report (2001) gave
information about 27 chemicals; the second (2003) included information on 116 chemicals; the
third (2005) included 148 chemicals. The fourth report, which should be published soon, will
include information on 275 chemicals.
For more information on the NHANES chemical selection process, go to
http://www.cdc.gov/exposurereport/default.htm.
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California
In California, chemicals are selected for study in three stages. In the first stage a panel of experts
assembles a complete list of “designated chemicals” from which chemicals for study will
eventually be chosen. As in Minnesota, the list of designated chemicals includes those monitored
through NHANES as well as additional chemicals recommended for inclusion by the expert
panel. In order to be added to the list of designated chemicals, chemicals not include in
NHANES must meet these criteria:
(1) Exposure or potential exposure to the public or specific subgroups.
(2) The known or suspected health effects resulting from some level of exposure based on
peer-reviewed scientific studies.
(3) The need to assess the efficacy of public health actions to reduce exposure to a chemical.
(4) The availability of a biomonitoring analytical method with adequate accuracy, precision,
sensitivity, specificity, and speed.
(5) The availability of adequate biospecimen samples.
(6) The incremental analytical cost to perform the biomonitoring analysis for the chemical.”
In the second step, the expert panel recommends “priority chemicals” for inclusion in the
biomonitoring program. The priority chemicals must meet an additional set of criteria.
(1) The degree of potential exposure to the public or specific subgroups, including, but not
limited to occupational.
(2) 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.
(3) 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.
(4) Other criteria that the panel may agree to.”
In the third step, biomonitoring program staff make the final decision about chemicals to be
included.
California’s biomonitoring program has scheduled three meetings to solicit input from the public
about what chemicals should be measured. These interactive workshops are five hours long and
will also serve to educate the public about the biomonitoring program in general. Program staff
will also be scheduling conference calls and developing an online survey to allow members of
the public to express their opinions about the chemicals to be selected.
For more information about the California chemical selection process, go to
http://www.oehha.ca.gov/multimedia/biomon/index.html.
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New York City
For NYC HANES, chemical selection was guided by research questions. For example, one set of
research questions was, “What is the prevalence of current smoking, according to self-report and
cotinine levels >15 ng/ml? What is the prevalence of substantial environmental exposure to smoking,
according to self-report and cotinine levels 1-15 ng/ml? What proportion of NYC adults do not report
smoking but have cotinine levels indicative of current smoking?” Another research question related
to how the levels of pesticides in an urban population compare to the rest of the country. It is likely
that some kind of prioritization process also occurred to help narrow the field. EHTB staff are
waiting to hear back from NYC HANES staff to find out more about the selection process used.
NYC HANES measured a limited number of chemicals, including cotinine, metals and
pesticides. The complete list of chemicals is as follows:
Pesticides:
Malathion dicarboxylic acid
para-Nitrophenol
3,5,6-Trichloro-2-pyridinol
2-Isopropyl-4-methyl-6hydroxypyrimidine
In urine
Trace metals:
Arsenic
Antimony
Barium
Beryllium
Cadmium
Cesium
Cobalt
Lead
Molybdenum
Platinum
Thallium
Tungsten
Uranium
In blood
Cotinine
Cadmium
Lead
Mercury
For more information about NYC HANES, go to
http://www.nyc.gov/html/doh/html/hanes/hanes.shtml.
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APPENDIX A
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)
An additional 127 chemicals were measured for the fourth report, which has not yet been
published.
Table continued on next page…
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Email from Rep. Paul Gardner regarding fourth chemical
"Paul Gardner" <[email protected]> 2/5/2008 3:04 PM >>>
Greetings. I have North Oaks in my district and they've been dealing with vinyl chloride for some time from the Hwy 96
landfill. The area is relatively small and the number of people involved not as huge as with PFCs in the east metro, so it
might meet the parameters for the fourth chemical. Thanks for your consideration.
Rep. Paul Gardner
Minnesota House of Representatives District 53A
(651) 296-2907
[email protected]
http://www.house.leg.state.mn.us/members/members.asp?district=53A
blog: www.paulgardner53a.blogspot.com
Home phone constituent line: (651) 797-4317
Response from MDH
Dear Rep. Gardner,
Thank you for your interest in the new Biomonitoring program and for your suggestion that we consider vinyl chloride in the
selection of a fourth chemical. I will pass your suggestion on to our Advisory Panel for consideration at the next panel
meeting in March. We plan to discuss the decision criteria for making the selection at a future meeting.
I am a resident of Shoreview and am familiar with the issues and concerns of our neighbors in North Oaks related to the
landfill.
Thanks again,
Jean
Jean Johnson, Ph.D.
Environmental Epidemiologist
Division of Health Promotion and Chronic Disease
Minnesota Department of Health
85 East Seventh Place, P.O. Box 64882
St. Paul, MN 55164-0882
Phone: 651-201-5902
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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/or
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 March agenda:
PFC biomonitoring
Included in this section is a written update on the steps taken to inform community members
about the PFC biomonitoring pilot project, the input received to date from community members,
and a description of how MDH staff have responded to the input received. Also included are
copies of a handout and public correspondence related to the PFC project.
Mercury biomonitoring
The potential mercury biomonitoring project that was briefly described in December (“Mercury
Levels in Blood from Newborns in the Lake Superior Basin”) will not be ready for consideration
by the advisory panel until the legislature makes a decision on a proposal put forth by MDH that
would explicitly permit MDH to use residual newborn specimens for research and public health
studies and would permit parents to decline to have the specimens used for research and public
health studies.
Included in this section is a written update on the steps taken by the MDH Public Health
Laboratory to prepare for analyzing newborn blood spots for mercury, including developing and
validating an analytical method to measure mercury in dried blood spots on filter paper. Mercury
biomonitoring will likely be on the agenda for the June advisory panel meeting.
Tracking
Included in this section is a written description of efforts underway to develop indicators for the
Minnesota Environmental Health Tracking System, including indicators for water quality, carbon
monoxide poisoning, air quality, hospitalizations for asthma and myocardial infarctions, and
birth defects. It is anticipated that tracking will be a major focus of the June advisory panel
meeting.
Arsenic biomonitoring
Included in this section is a written update on the status of the arsenic biomonitoring proposal,
including the timeline for review by MDH’s Institutional Review Board and a description of
changes made since the advisory panel last considered the arsenic proposal.
ACTION NEEDED: At this time, no formal action is needed by the advisory panel. Panel
members are invited to ask questions or provide input on any of these topics.
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Status update on PFC biomonitoring
Steps taken to inform community members and solicit community input
EHTB staff have met with representatives from the Washington County Department of Public
Health and Environment and with city administrators in each of the municipalities that will be
involved in the biomonitoring pilot project (i.e., Oakdale, Lake Elmo and Cottage Grove). City
and county staff took responsibility for notifying local elected officials in their respective areas.
A letter was sent to state legislators who represent the cities involved in the project as well as the
cities adjacent to the project area.
Three public meetings were held at the end of January to share preliminary plans with
community members, answer community members’ questions about the project, and solicit input
on the proposal. MDH issued a news release, and local newspapers in each of the communities
carried an article describing the upcoming meetings and the pilot project. Community members
were also notified about the meetings in other ways, which varied by municipality, including
direct mailings, articles in city newsletters, information posted on city and county websites,
announcements on local cable television stations, posters at city buildings, and announcements
on digital message boards.
EHTB staff have also testified at two legislative hearings since the last EHTB advisory panel
meeting.
Summary of input received to date
The three public meetings were well attended and community members expressed many
questions and concerns. Community members’ input can be summarized into the following
themes:
Sample size
There were numerous people who felt that the number of participants included in the
sample needed to be bigger, particularly for the Oakdale municipal water community.
Some expressed a feeling that it was unfair that a higher proportion of the people in the
private wells community would be tested (100 households out of 150) compared with the
proportion of people that would be tested in Oakdale (100 households out of 9000) and that
this would bias the results in some way. A couple of people asked whether MDH would
include their own privately obtained test results in the project in order to expand the
number of samples available for analysis.
Eligibility criteria
There were strong concerns voiced at each of the public meetings that MDH was proposing
not to include children in the sample, because children are considered by some to be one of
the most vulnerable populations. Given the limited availability of data on children’s
exposure, some community members felt it was MDH’s duty to contribute to the
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development of this data set, even if MDH is significantly limited in how those data could
be used. One or two parents indicated that they are better equipped to determine whether
having their child tested is appropriate and that the state should not make this decision for
them. At the Oakdale meeting two people made reference to the number of children at
Tartan High School who have had cancer recently. Staff of advocacy organizations were
present at each of the meetings, and some (but not all) of the most vocal comments about
including children in the project came from these individuals rather than from community
members per se.
There were also many concerns expressed that the eligibility criteria should give preference
to people who have been exposed to the contaminated water the longest, rather than trying
to obtain an exposure estimate for the community as a whole by including people with
different lengths of residency. Community members with this concern would like to see the
current length of residency requirement be changed to require participants to have lived in
the community for several more years.
Some community members felt preference should be given to people with health problems.
Purpose of the project
Many community members were surprised and disappointed that the pilot project was so
limited in scope – I.e., that what will be learned is limited to the levels of PFCs in people’s
bodies in the community and that currently no data exist that would help people determine
whether their level is risky. In particular, community members felt the project should be
expanded to include the ability to correlate PFC exposure with health effects. Attendees
also expressed the desire for the project to be able to correlate outcomes with length of
residency.
Pets
In each meeting one or two people expressed concerns about the number of pets they have
had who have died of cancer or had health problems.
Obtaining independent testing
At each meeting people wanted to know where they could go to be tested if they are not
selected to be part of the pilot project. People expressed concern about going through their
insurance company to be tested – or even being tested at their own expense – for fear that
their insurance company would deny future medical claims that might be related to PFC
exposure.
Time frame
Several people expressed frustration that the project was taking so long to get underway
and that it would take so long for the final results to be made available.
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Credibility/reliability
A number of people asked questions to determine whether MDH staff had adequate
expertise available (e.g., statistical and laboratory expertise) for carrying out this project
and whether MDH staff were appropriately free from bias. There were also a couple of
people who were concerned that MDH was not effectively using the resources allocated to
the biomonitoring program.
Water safety
Many attendees had questions about the safety of their water, steps being taken toward
permanent remediation of the disposal sites, well testing records, etc.
Data privacy
At each meeting, attendees had questions about whether MDH could legally share their test
results with their insurance companies and seemed reassured by the response that state law
explicitly forbids MDH from sharing private health data with anyone but the participant.
The following documents are included in the meeting materials to provide additional information
to panel members about the types of feedback EHTB staff have received on the PFC
biomonitoring pilot project:
•
Complete list of questions and answers from the three public meetings (Note: this
document will be posted on the MDH website, sent out via two MDH listservs, and
shared with legislators; MDH will likely also issue a news release to let community
members know about the resources available on the biomonitoring website and to provide
information on how MDH is responding to community concerns)
•
Letter received from Women’s Environmental Initiative requesting that children,
pregnant women, women of childbearing age, and mothers of young children be included
in the pilot project (no response has been provided by EHTB)
•
Action alert email from Clean Water Action requesting that children be included in the
pilot project; EHTB response
•
Letter from Representative Julie Bunn requesting clarification on why children are not
included in the pilot project, what reference data are available, why pregnant women are
not a focus of the project, how the project design will ensure people with long-term
exposure are included, and what types of information will be collected from participants;
EHTB response
•
Letter from Senator Katie Sieben requesting clarification on why children are not
included in the pilot project, and whether an appropriate reference value exists for
children; EHTB response
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EHTB program’s response to input received
MDH staff have considered community members’ input very carefully. Aside from concerns that
the scope of the biomonitoring pilot project was not broad enough (i.e., it will not explore
questions about the health effects of PFCs), most of the concerns raised by community members
related to the participant selection criteria, specifically the inclusion or exclusion of long-term
residents, pregnant women, and children in the biomonitoring project.
Long-term residents
MDH staff agree that it is important to include an adequate number of people with long-term
exposure to the PFCs. By using a random sampling procedure we expect our sample to include
both people with long-term exposure and people with shorter-term exposure. Participation in the
pilot project will be limited to people who have lived in the community since before January 1,
2005, which will ensure that all of the participants will have been exposed to the contaminated
water.
MDH staff continue to believe that it is not appropriate to limit participation only to people with
long-term exposure. By including participants with a range of exposure lengths, we will be able
to identify the variability in PFC levels in the community as a whole, which will help us to plan
future biomonitoring studies. In addition, by including participants with a range of exposure
lengths we may be able to conduct an analysis to make comparisons between subgroups based on
length of residence. While we may ultimately not be able to conduct this analysis given the pilot
project’s small sample size, if we were to include only participants with long-term exposure we
would not even have the possibility of attempting this type of analysis.
Based on community feedback, MDH staff considered a change to the eligibility criteria so that
long-time residents who would have been excluded from participation due to a recent relocation
within the city of Oakdale would still be eligible. This would require staff to collect a residential
history and to verify that each address was hooked up to the Oakdale municipal water supply.
Given staffing limitations, MDH staff determined that this change was not feasible to implement,
and the original eligibility requirements related to residence will remain in place.
Pregnant women and children
MDH staff agree that more information is needed about pregnant women’s and children’s
exposure to PFCs as well as the effects of that exposure. Furthermore, the EHTB statute states
that biomonitoring should be conducted on “pregnant women and minors on a voluntary basis,
when scientifically appropriate,” so we know that these populations are important to legislators
as well.
In addition to weighing scientific appropriateness, MDH staff must also take into account ethical
considerations and feasibility (e.g., financial resources, time, etc.) when making decisions about
which specific subgroups should be included in each of the biomonitoring pilot projects. In
response to concerns raised by community members, MDH staff re-opened the question of
whether it was scientifically appropriate – as well as ethically appropriate and feasible – to
include pregnant women and children in the biomonitoring pilot project. At this time, MDH staff
continue to believe it is most appropriate to limit participation to the general adult population.
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Pregnant women
After further consideration, MDH staff continue to believe that it is not feasible to recruit 100
pregnant women from each of the selected communities within the timeframe available for
completing the pilot project. Pregnant women will not be excluded from participating in the pilot
project, so we would expect pregnant women to occur in the sample at the same rate as they
occur in the general population. Furthermore, women of childbearing age will be included in the
sample, and results from these women will serve as an indicator of the levels of PFCs that a fetus
would be exposed to in utero. In addition, MDH staff continue to believe that the most
scientifically appropriate goal of the pilot project is to determine the variability in PFC levels in
the general population, which will inform recommendations for the development of future
studies of PFC exposures in the selected communities (including studies of specific subgroups).
Children
As stated above, MDH staff believe that the most appropriate goal of the pilot project is to
determine the variability in PFC levels in the general population, which will help to inform
recommendations for future studies, including studies to compare PFC levels in different age
groups. Limiting participation to adults at this time will allow us to better determine the
variability in PFC levels in the community as a whole.
MDH staff consider that it is most scientifically appropriate to include children in biomonitoring
projects when sufficient data exist to demonstrate that children are more likely to be exposed to
environmental chemicals than other age groups. While it is often the case that children are more
exposed to environmental chemicals than adults (given their small body size, the amount of air
they breathe, food they eat, water they drink, etc.), we do not know for PFCs whether this is true.
Some research suggests that children’s PFC levels are approximately the same as those of adults.
Further research is certainly needed in this area, but MDH staff do not believe that the
biomonitoring pilot project is able to explore this question because the sample size will likely
limit the ability to compare PFC levels across age groups.
Ethical considerations also come into play when considering the inclusion of children in a
biomonitoring project. The PFC pilot project involves a blood draw. MDH staff feel that
performing this type of invasive medical test on children, who are more likely to bruise, bleed,
and/or experience pain from the procedure, without providing a known health benefit is difficult
to justify from an ethical viewpoint. There is no follow-up or treatment that can remove PFCs
from the body, and the test does not provide information that will allow clinicians to predict
future health impacts or make medical recommendations. Other studies that have reported
children’s PFC levels have involved the analysis of blood samples that were collected for other
purposes, not only for the measurement of PFCs.
One factor that informed MDH’s initial proposal to focus on adults was the fact that there were
no NHANES data for PFC levels in children that could be used as a reference value. Based on
the input we received from community members, MDH staff conducted a more thorough search
for a potentially useful reference value. A review of the literature yielded a limited number of
studies that tested children for PFCs. One U.S. study (Olsen et al 2004) measured PFCs in stored
blood samples of children from 23 different states. Because the data were collected over 10 years
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ago and because the levels of PFCs in the general population have been declining, this value is
likely to be significantly elevated compared to children’s true levels today. To ensure a valid
comparison, we will want to choose reference data collected in a year that is as close as possible
to the sampling year of our project. Other researchers have reported PFC levels in children in
Australia and a preliminary reference value for children in Germany (Karrman et al 2006;
Wilhelm et al 2008). While international values provide an interesting contrast to values found in
the U.S., they do not provide a reliable reference value for the biomonitoring pilot project. MDH
staff found just one PFC study that included children in an exposed population (Emmett 2006).
However, this study did not publish a specific value for children. Also, because the study was of
an exposed population, rather than the general population, it would not be an appropriate
reference value for the biomonitoring project. At this time, MDH staff continue to believe that
there are no reference values for the general population to which children’s PFC levels could be
compared. However, in the process of researching this issue, MDH staff learned that the Centers
for Disease Control and Prevention plans to publish national reference values for children ages 311 based on pooled blood samples (blood combined from stored samples from multiple children)
in 2008 or 2009, which will facilitate the interpretation of Minnesota children’s results in any
future research projects.
MDH staff are firmly committed to conducting the biomonitoring pilot project in a way that will
enable recommendations to be made for including children in future studies. Based on
community concerns, MDH staff are considering the following changes to the PFC proposal:
•
We may include a question on the survey that will be sent to potential participants (650
households) to determine how many children reside at each residence. This will provide
MDH staff with a list of children who could be included in future studies.
•
We may expand our communications plans to provide information on reducing children’s
exposure to PFCs to all potential participants (and possibly to the community at large).
Information on possible ways to reduce exposure to PFCs was proposed to be provided to
all project participants. Expanding this plan to provide information on reducing children’s
exposures to PFCs as well would mean that parents would receive a benefit of
participation without having to subject children to the risks of participation.
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PFC biomonitoring pilot project:
Questions and answers
In late January 2008, the Minnesota Department of Health held three community meetings to
share plans for a biomonitoring pilot project to measure PFCs in people’s bodies. This document
provides a summary of the answers to community members’ questions about the project.
Purpose/scope of the biomonitoring project
The biomonitoring pilot project will help understand what levels of PFCs are getting into
people’s bodies. We currently know what the levels of PFCs are in the water, but we do not yet
know what the levels are in the people who have been drinking that water. The biomonitoring
pilot project will provide information to help inform decisions about additional research and
actions that should be taken. For the pilot project, detailed information about health and possible
sources of exposure will not be gathered.
What types of information will be collected from participants? Will MDH collect information on
the length of time a person has been at their residence?
Participants will be asked to complete a brief questionnaire, which will likely gather information
to determine their age, length of time living at their current residence, current drinking water
source, current use of alternative water supplies and/or water treatment devices, gender,
ethnicity, and potential occupational exposure to PFCs at 3M. Participants will also be asked to
provide their names and phone numbers so that they can be contacted by project staff, if needed.
Shouldn’t a health history be collected from each participant in order to understand the numbers
collected through the biomonitoring project? Could the participant survey be made more
complete to include information on health? Could participants attach their own medical records
to provide the researchers with more information?
It is true that if the purpose of the pilot project were to examine potential links between health
and PFC exposure researchers would need to gather health information from the participants.
However, the goal of the biomonitoring pilot project is to determine the range of exposures to
PFCs in the two communities sampled. Once this information is gathered, recommendations will
be made for additional types of research, which could include a health study. Such health studies
are more complex and time-consuming, while the scope of the PFC pilot project is more narrow
– and shorter in duration – in order to meet deadlines set in the law.
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Once the biomonitoring pilot project is done will it spur on other research? Will more studies be
conducted?
Once the pilot project is completed, MDH will make recommendations to the legislature for what
additional research might be needed. This could include more in-depth surveys of exposure, an
expansion of biomonitoring to other groups in the community (e.g., children), follow-up testing
to measure changes in exposure over time, or studies to learn more about the health effects of
being exposed to PFCs.
What is the point of doing this project? Don’t we already know that Minnesotans have the
highest levels of PFCs compared to the rest of the country?
The biomonitoring pilot project will help us learn how the PFC exposure levels of people in the
selected communities compare to people in the rest of the country. Unless this testing is done, we
may suspect that exposures are higher for people in Washington County, but we don’t know for
sure whether there’s a difference or how big that difference is.
Will a correlation between miscarriage and PFC exposure be studied?
No. Examining the relationship between birth outcomes and PFC exposure is beyond the scope
of the pilot project. Once the pilot project is completed, MDH will make recommendations for
conducting additional types of studies in the future.
How long will this project go on? Will it be one time only? Won’t you have to test again to learn
anything?
The pilot project involves a one-time measurement of participants’ PFC levels. The project will
help us learn what levels of PFCs people have in their bodies. At the end of the pilot project,
MDH will make recommendations about future areas of study that may be needed. One potential
recommendation could be to repeat the testing in the future to determine whether PFC levels are
falling.
Can MDH get access to 3M employees’ medical records in order to learn about health effects of
exposure to PFCs?
Data privacy laws prevent MDH from obtaining anyone’s private medical records without their
explicit permission. 3M scientists have published several reports of health studies among their
employees exposed to PFCs. These reports are available to MDH and the public.
Can MDH estimate people’s past exposure? Can MDH go back and calculate what people’s
PFC levels used to be?
Calculating past exposure and PFC levels can be done, but it is very complicated and is beyond
the scope of the pilot project. At the end of the pilot project, MDH will make recommendations
about future areas of study that may be needed.
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Participant eligibility
In order to be eligible to participate, participants must live in one of the two selected
communities. The first community is people who are currently living in residences served by the
Oakdale municipal water supply. The second community is households in Lake Elmo and
Cottage Grove who have or had private wells contaminated with PFOA and/or PFOS above trace
levels. In addition, participants must be aged 20 or over and they must have been living at their
current residence since before January 1, 2005.
What does “above trace level” of PFOA and PFOS in the water mean?
“Above trace level” means that PFOA or PFOS was detected in the water at more than 0.1 parts
per billion.
Will weight be given to those who have lived in the selected communities longer? Why isn’t some
length of residence a criterion for participation? Can MDH compare results along length of
residence? If there was a drastic difference between length of residence and concentration of
PFCs in the blood would there be a follow-up?
In order to be eligible, participants must have lived in their residence since before January 1,
2005. This ensures that everyone included in the project will have been exposed to the PFCs in
the water. Other than that, weight will not be given to those who have lived in the community the
longest. The goal of the biomonitoring project is to determine the range of exposures in the
community as a whole, including people who have lived there for both long and short amounts of
time. If the project focused heavily or exclusively on long-time residents, the results would no
longer represent the whole community. Learning the range of exposures in the community as a
whole is necessary for planning future biomonitoring studies. In addition, by including people
with different lengths of residency, MDH may be able to analyze the results to determine
whether there are differences in PFC levels based on how long someone has lived in the
community. At the end of the pilot project, MDH will make recommendations about areas for
future research.
Why are children not included in the biomonitoring project?
MDH agrees that children are an important population to be studied. Conducting the pilot project
will provide MDH with the information necessary to be able to make recommendations for
including children in future biomonitoring efforts. There are a number of reasons why children
are not included in the pilot project.
Research involving humans – and children in particular – is carefully scrutinized by
MDH’s Institutional Review Board to ensure that participants are treated in an ethical manner. A
blood draw is an invasive medical procedure, and one that is more likely to cause bruising,
bleeding and/or pain in children than in adults. It would be difficult to justify subjecting children
to these risks when there are no potential health benefits that children would receive in return.
In addition, there are currently no appropriate national values to which children’s results
could be compared. There has been one study conducted to measure U.S. children’s PFC levels
(using blood that was already collected for other purposes), but the blood samples were collected
69
too long ago to be a valid comparison and it is unclear whether the children included are
representative of the general population.
In order to make decisions about designing studies that would include children, MDH
must first determine the variability in PFC levels in the community as a whole, which the pilot
project will accomplish. MDH is committed to exploring ways that children could ethically be
included in future research projects. For example, one way to include children in future testing
would be to combine testing for PFCs with some other medical test (one that could provide
demonstrable benefit to the participants). However, this is beyond the scope of the pilot project.
Are there existing data for children from other sources (regional, national, international) to
which east metro child data could be compared if collected? Will any such data be available in
the near future?
There are few studies that have reported PFC levels for children. One U.S. study1 measured
PFCs in stored blood samples of children from 23 different states. Because the data were
collected over 10 years ago and because the levels of PFCs in the general population have been
declining, this value is likely to be significantly elevated compared to children’s true levels
today. To ensure a valid comparison, we will want to choose reference data collected in a year
that is as close as possible to the sampling year of our project.
Other articles have reported PFC levels in children in Australia2 and a preliminary
reference value for children in Germany3. While international values provide an interesting
contrast to values found in the U.S., they do not provide a reliable reference value for the
biomonitoring pilot project.
A fourth study4 measured PFC levels in children in Ohio and West Virginia, where the
water was contaminated with PFOA. However, the authors did not publish the specific values
that were measured in children.
The Centers for Disease Control and Prevention plans to publish national reference
values for children ages 3-11 based on pooled blood samples (blood combined from stored
samples from multiple children) in 2008 or 2009, which will facilitate the interpretation of
Minnesota children’s results in any future research projects.
1
Olsen GW et al (2004) “Quantitative Evaluation of Perfluorooctanesulfonate (PFOS) and Other
Fluorochemicals in the Serum of Children.” Journal of Children’s Health 2(1):53-76.
2
Karrman A, et al (2006) “Levels of 12 Perfluorinated Chemicals in Pooled Australian Serum, Collected in
2002-2003, in Relation to Age, Gender, and Region.” Environmental Science and Technology 40:37423748.
3
Wilhelm, M. et al (accepted for publication in 2008) “Contribution to the evaluation of reference values
for PFOA and PFOS in plasma of children and adults from Germany.” International Journal of Hygiene
and Environmental Health.
4
Emmett E, et al (2006) “Community exposure to perfluorooctanoate: Relationships between serum
concentrations and exposure sources.” Journal of Occupational and Environmental Medicine. 48:759-770.
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Could MDH learn anything by just including a couple of kids in the project, even if a reference
value doesn’t exist?
In order to obtain data that are statistically valid, a large number of children would need to be
included in the project. If we were to include just a few children, we could not be confident that
their data are reflective of children within the community in general.
Shouldn’t it be the parent’s decision whether or not to enroll their child in the study?
Research at MDH must be approved by an Institutional Review Board, so this is not simply an
issue that can be left to parents to decide. The Institutional Review Board exists to ensure that the
rights of research participants are protected and that participants are treated in an ethical way.
Why does the project not focus on pregnant women?
MDH recognizes that many community members are concerned about how PFCs might affect a
developing fetus, and that this is an important area for future research. For the pilot project, it is
not feasible to recruit 100 pregnant women from the selected communities within the timeframe
available for completing the project. While the project does not explicitly focus on testing
pregnant women, pregnant women will be eligible to participate. In addition, the sample will
include women of child-bearing years. Results from these women will serve as an indicator of
the levels of PFCs that a fetus would be exposed to in utero, and may be compared to similar
findings in the U.S. population.
Why does the project not focus on the Hmong or Latino populations, who may be more at risk for
PFC exposure?
Some research has shown that people from certain ethnic groups may have elevated levels of
PFCs in their bodies, perhaps due to the consumption of certain types of fish. Unfortunately, the
pilot project is not able to focus on all of the groups that could potentially be exposed to PFCs.
Once the pilot project is concluded, MDH will make recommendations for additional areas of
study, which may include biomonitoring in other groups than the ones included in the pilot.
For people with private wells, will only people who have had their wells tested be eligible to
participate?
Yes. In order to participate in the pilot project, people who have private wells must have a
documented well sampling result showing contamination with PFOA or PFOS in addition to
PFBA. MDH’s private well sampling was conducted to identify wells that were very likely to be
contaminated. Because of the methodical approach that was used for testing private wells, people
who were not contacted to have their wells tested are considered very unlikely to have PFOA or
PFOS contamination in their water.
In Oakdale, will preference be given to those who live closest to the contaminated wells?
No. The purpose of this project is to measure the range of exposure in the whole community.
This would include people living close to the wells and those farther away. The Oakdale
71
community water system delivers water to a broad area of the community; living near the wells
does not necessarily increase the likelihood that residents have more exposure to PFCs.
Why does the project not focus on people with known health problems?
The goal of the project is to determine the range of exposures in the community as a whole. Even
if the project were to focus only on people with health problems we would not be able to
determine whether those health conditions were caused by the PFCs or not.
Will people be excluded from the project based on their health status?
No.
Sample selection/sample size
Participants will be invited to be a part of the project through a specific recruitment process.
First, all of the eligible households in each community will be identified (through well sampling
records and city utility billing records). Then, some of the eligible households will be contacted
with a brief survey to determine how many eligible adults live at each address. MDH will
compile a list of eligible adults from the returned surveys and then 100 adults will be randomly
selected from the list and invited to participate.
Will all households in Oakdale, Lake Elmo & Cottage Grove be contacted with a survey?
No. In Lake Elmo and Cottage Grove, all households that are or were served by private wells
contaminated with PFOA or PFOS in addition to PFBA (this is estimated to be about 150
households) will be contacted and asked to complete a brief survey. In Oakdale, a sample of 500
households will be contacted.
Will the list of 500 households that will be contacted in Oakdale include people who were
previously on well water before being hooked up to municipal water?
The 500 people will be randomly drawn from the list of all households that are currently being
served by the Oakdale water supply, regardless of their previous water sources.
How was the number 100 chosen as the sample size?
The legislation that established the Environmental Health Tracking & Biomonitoring program
specifies that the pilot project should collect specimens from 100 participants from each of two
communities likely to have been exposed to PFCs. Having data on the PFC levels of 100 people
in each of the two communities will provide a statistically valid estimate of the range of
exposures in each community and is a good starting point for data collection.
72
If MDH is selecting 100 people out of 150 households served by contaminated private wells, and
100 people out of 9000 households served by the Oakdale municipal water supply, won’t there
be an over-selection in the Lake Elmo and Cottage Grove communities and an under-selection in
Oakdale?
While it is true that people served by contaminated private wells will have a higher likelihood of
being selected for the biomonitoring project than people served by the Oakdale water supply, this
does not mean that there will be over- or under-selection. The two communities will be treated as
two distinct groups. The results from the two groups will not be combined. Instead, there will be
information on one population with well water consumption and one with municipal water
consumption. A sample size of 100 people in each of the two communities will provide a
statistically valid estimate of the range of exposures in each community.
Is it statistically valid to sample just 100 people out of 9000 households?
The size of the sample needed in order to draw conclusions about community members’
exposure to PFCs depends on many factors, including the variability in the levels of PFCs
detected in the participants and what level of accuracy researchers are hoping to attain. As long
as random sampling methods are used, the size of the overall population actually has relatively
little impact on the sample size needed, except when the overall population is very small. A
sample size of 100 people in each of the two communities will provide a statistically valid
estimate of the range of exposures in each community and is a good starting point for data
collection.
Will participants truly be randomly selected? Will MDH stratify the sample based on age?
MDH will be using a simple random sampling procedure to select participants, which means that
100 participants will be randomly selected from the list of eligible adults that is compiled in each
of the two communities. This process should lead to a sample that is representative of the
community as a whole (e.g., based on gender, age, and other factors). However, some age groups
may be under-represented in the sample because some groups may be more likely to respond to
the invitation to participate than other groups. Stratified random sampling, which would ensure
representation in every defined age category, is beyond the scope of this pilot project.
What will MDH do about participants who die, move away, etc? Shouldn’t MDH recruit more
than 100 people to address the possibility that some of the participants won’t be able to complete
the project?
The biomonitoring pilot project is not a longitudinal study, which means we will not be
following the participants over time. The project involves a one-time collection of a blood
sample, so right now only 100 people will be recruited.
Will MDH be asking for volunteers to participate in the testing?
No. Participants will be invited to participate in the biomonitoring project based on specific
selection criteria. Once invited to participate in the project, the decision to participate is up to the
individual. In that sense, participation in the project is voluntary.
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Does MDH have a statistician involved on this project?
Yes. We have a statistician on our staff and also an external science advisory panel guiding our
project.
Measuring PFCs in the body
In order to measure PFCs, participants must provide a blood sample. Blood is used (as opposed
to urine or some other body fluid or tissue) because PFCs are known to circulate in the blood
while they are in the body. Participants will be referred to a clinic or hospital in the project area
in order to have the blood sample drawn.
What PFCs will the project measure?
Participants’ blood will be analyzed to determine the levels of PFOA, PFOS and PFBA in their
blood. These are the 3 most common PFCs that have been detected in the water in Washington
County.
How many blood samples will be taken from the individual?
Each participant will be asked to provide one blood sample, consisting of about 20 cc’s of blood.
Where will the blood samples be analyzed?
The Public Health Laboratory at MDH will conduct the laboratory analysis for the biomonitoring
pilot project. The Public Health Laboratory will work closely with the Centers for Disease
Control and Prevention to ensure that testing in Minnesota will be done in the same way as for
the national sample. The MDH Public Health Laboratory has extensive experience and
qualifications to analyze for PFCs.
Communicating project results
MDH will communicate the results from the biomonitoring projects in a number of ways.
Individual participants will receive their own results along with some information about how
their individual result compares to the national average. Summarized results of the project will
be shared with community members through articles in local newspapers, the Internet,
presentations at community meetings, and other methods as appropriate.
Will MDH let individual participants know their results? Will MDH just list participants’ results
or will MDH provide some analysis?
Each participant will be provided with their own result along with information explaining how
that result compares to the national average.
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If people in the community test higher for PFCs than the comparison value (NHANES), will there
be negative repercussions for our community?
MDH does not know of specific community-wide repercussions associated with the possibility of
detecting elevated levels of PFCs in people’s blood. Some residents have expressed concerns that
their housing values might decline based on publicity about the water contamination. Finding
that people in the community test higher for PFCs may increase the likelihood of future studies
taking place in the community.
Will the data from Cottage Grove and Lake Elmo be grouped or will MDH be able to separate
it?
The data collected from Cottage Grove and Lake Elmo participants will be grouped together.
The number of wells in Cottage Grove that are contaminated with PFOA or PFOS in addition to
PFBA is very small (about 30), and not all of these households will be selected to participate in
the project. With such a small number of households, it would be difficult to provide a
meaningful interpretation of the data.
When will the results be available?
Blood samples will be drawn and analyzed during the summer of 2008. Individuals will receive
their results within three months of having their blood drawn. Grouped data will be available by
early 2009.
Data privacy
All individual data collected for the biomonitoring pilot project is classified as private. This
means that MDH is not allowed to release data that would identify an individual participant. The
only information that will be shared with the public is summarized data.
Will these records be made public? Could my health provider find out? Will we MDH be sharing
the study information with insurance companies?
Individual results will only be released to the individual participants. MDH will not share
individual results with anyone else, including participants’ physicians or insurance companies.
Only summarized data will be released to the public.
After the project ends, who gets the data? Where does it go?
The data are stored in a secure location at the Minnesota Department of Health. MDH protects
private, non-public data; this means that individuals’ results are safeguarded.
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Project logistics
Why is this project so delayed in getting started? It’s been a long time since filters were put in
place [in Oakdale], so MDH will be less likely to find PFCs in people’s blood. Why does the
study take so long to conduct? Why does it take so long for results to become available?
The funding for this project stems from legislation that went into effect on July 1, 2007, so MDH
staff could not formally begin work on the project until then. Planning a scientifically valid
project takes considerable time, and the project proposal must be approved by a science advisory
panel and the MDH Institutional Review Board before the project can be implemented. Once the
project receives final approval (probably in April or May) participant recruitment and sample
collection will begin. Although most eligible participants have been using filtered or alternative
water sources, due to the long half life of PFOA and PFOS, these chemicals will still be
detectable in people’s bodies.
How much money was allocated to the biomonitoring program? Why is it costing MDH so much
money to test 200 people?
Approximately $300,000 is allocated to biomonitoring per year for two years, for a total of
$600,000. Of this total amount, approximately $370,000 is dedicated to the PFC biomonitoring
pilot project. This money pays for the costs of collecting blood samples at a clinic, costs of
laboratory analysis, and staff salaries, supplies and expenses necessary for implementing the
project (e.g., designing the project protocol, recruiting participants, analyzing data, reporting
results to participants, etc.).
Where did the money for the biomonitoring project come from? Shouldn’t 3M pay for it?
Funding for the project came from the state legislature. MDH does not have the authority to
compel 3M to pay for conducting the project, nor is 3M obligated to pay these costs.
Health effects of PFCs
How serious is exposure to PFCs? How elevated a PFC measurement does one need to have in
order to have ill health effects? Are there results from any other studies that give us a clue about
the health effects of PFCs?
So far there has not been a lot of research on the human health effects of exposure to PFCs,
including the health effects associated with specific levels of exposure to PFCs. There is
currently very little information available on the health effects of PFCs in the general population,
although a study of 70,000 people exposed to PFOA in drinking water in Ohio and West Virginia
is underway. Studies by 3M of workers exposed to PFCs during manufacturing show no apparent
impact on their health. Unfortunately, it can take many years to determine whether there are links
between exposure to a particular chemical and human health.
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If no one knows what level of PFCs in the body are related to health effects, then why is the
biomonitoring project being done?
While biomonitoring does not provide the same information as a health study would it does
provide information on current levels and variability of PFCs in people’s bodies. Having this
information will inform the design of future biomonitoring studies in the community. For
example, knowing this information will help researchers determine what sample size would be
needed to be able to make comparisons between different sub-groups in the population. In
addition, having information on the current levels of PFCs would also be useful as a comparison
if PFCs are measured again in the future to determine whether PFC levels are declining over
time. If we don’t see a decline over time this would suggest that there is another significant route
of exposure that needs to be considered. The biomonitoring project is a pilot study, meaning that
MDH will be testing how the state health department might conduct biomonitoring on a larger
scale and over a longer time frame in the future.
Are there other communities in the United States where research on PFCs is happening?
Yes. As a result of a large legal settlement with DuPont several studies are underway in Ohio and
West Virginia, where residents were exposed to PFOA in the drinking water. These studies
include testing for PFOA in people’s bodies and an examination of the health effects associated
with exposure to PFOA. The studies will be based on biomonitoring and health data gathered
from nearly 70,000 residents. In addition, some residents will be followed over a period of four
years to track new health conditions they develop. The studies will attempt to determine whether
there are links between PFOA exposure and cancer, birth outcomes, cardiovascular disease, and
liver, hormone and immune system disorders. Funding for the community health studies was
provided by DuPont as a result of a class-action lawsuit settlement. For more information about
this project, go to http://www.c8sciencepanel.org/ and/or http://www.hsc.wvu.edu/som/cmed/c8/.
Results will be posted at these websites as they become available. Some results will be available
in 2008, while other results will not be available until 2011.
My understanding is that even though the levels of PFCs in the treated water in Oakdale are
minimal, because PFCs have a long half-life, the concentrations of PFCs in people’s blood will
continue to rise if they drink the water. Is it true that the PFCs may never leave your body?
The rates at which PFCs accumulate and leave the body are not very well understood. Some
PFCs, such as PFOA and PFOS may take up to 20-30 years to leave the body. As exposure to
PFCs decreases, however, we would expect the levels of PFCs in the body to decrease as well.
We know that people all across the country have PFCs in their bodies, even those who are not
exposed through drinking water, so it is likely that most people will continue to have some
amount of PFCs in their bodies long after exposure through the water is reduced or eliminated.
Examining the rate at which PFC levels decline in people’s bodies is one potential area for future
research.
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Other questions
What is the national average for PFC levels? Who collects this information? How often do they
measure it?
Based on the most recent data reported (2003-2004), the national average for PFOA is 5 parts per
billion and the national average for PFOS is 25 parts per billion. The national survey does not
collect information on PFBA, so no national average exists for PFBA. This information is
collected by the Centers for Disease Control and Prevention (CDC), as part of the National
Health and Nutrition Examination Survey (NHANES). Biomonitoring results from this project
are reported every two years in the publication National Report on Human Exposure to
Environmental Chemicals. This report, along with additional results published since the report
was released, is available online at www.cdc.gov/exposurereport.
Has any thought been given to conducting PFC biomonitoring (or some other kind of research)
in pets? Can these chemicals affect animals? Many of my pets have died of cancer.
The legislation that funds the PFC biomonitoring project specifies that the samples must be
collected from humans. MDH understands that residents are concerned about their pets, and, in
fact, research on pets can be very instructive for learning about exposures to chemicals in the
environment. At this time, however, there is no funding for such a project. Residents who would
like to know more about why their pets have died could contact their veterinarian to arrange an
autopsy.
If someone wanted to participate and was not chosen as a volunteer where might they seek
testing independently of the study? Will insurance cover the costs of testing? Will MDH educate
physicians in the area so they are made aware that a PFC test exists?
At present there are very few laboratories in the country that can reliably measure PFCs in the
blood. MDH is currently investigating which labs are able to conduct this analysis for private
citizens and are also looking into the feasibility of making arrangements with a clinic in the
community to be a central location for residents who wish to be tested. Some insurance
companies may pay for this test, though some residents may prefer to have the test performed
without their insurance company’s knowledge. The likely cost for the laboratory analysis is
about $600, not including fees that a clinic might charge for drawing and shipping the blood.
MDH plans to reach out to physicians in the area so they are aware of the biomonitoring project
and have access to PFC-related educational materials.
What are the risks of participating in the project?
The risks of participating in the project are relatively few. Because participation requires a blood
draw, there is a risk of pain and bruising. In addition, some participants might become anxious
after learning about the levels of PFCs in their bodies.
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How can residents provide input back to the study planners?
Community members can provide input to the biomonitoring project staff by emailing or calling
Michonne Bertrand ([email protected] or 651-201-3661).
Will information about the biomonitoring project be available online?
Information about all of the biomonitoring pilot projects is available on the MDH website at
http://www.health.state.mn.us/divs/eh/tracking/biomonitoringpilot.htm. Additional information
will be added as it becomes available.
Rev. 2/27/08
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Letter received from Women’s Environmental Institute
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Input from and response to Clean Water Action
Text of the action alert on the Clean Water Action website
Take Action: Tell the Dept. of Health to Test for PFCs in MN Adults and Children
The Minnesota Department of Health is preparing a study to examine the level of PFCs in people's blood.
Right now, only adults are included. Children of families in PFC contaminated communities are being
denied inclusion in this important project.
We need to encourage the state to include children in this project because they are more
vulnerable to chemicals than adults.
Urge the Biomonitoring Project Director to include children.
Add your personal reasons why you care about including children in the biomonitoring
project here. Check out some suggestions below.
Personalized Text Suggestions:
•
As a parent, I should be given the opportunity to include my child in the biomonitoring project.
•
Our community's children have been exposed to toxic chemicals. Collecting information on PFCs
in children is an important first step in understanding the impacts of this chemical on our future
generations.
•
Since children are more vulnerable, there is no question we should be collecting this critical
information.
•
If funding is the only reason children are not included in this study, I urge our legislators to get
the funding needed to study this contamination problem properly.
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Text of emails received from Clean Water Action advocates
From:
To:
Date:
Subject:
(21 CWA advocates; including 4 from the project area)
Jean Johnson
(various)
Please include children in the biomonitoring project
Dear Dr. Johnson,
We urge the Minnesota Department of Health to include children in their Biomonitoring Project. Children
are at greater risk from exposure to chemicals because their developing bodies are less able to safely
metabolize toxic chemicals. Chemicals can also accumulate in their bodies at much greater levels than
adults because of their higher metabolic rates, since they drink more water pound for pound than adults.
There is also a growing body of science showing adverse impacts of low doses of chemicals over time
and at critical points in development. Understanding the level of PFCs in children is important public
health information. A study of PFCs in 599 children from 23 different states has already been conducted
and data from Minnesota could be compared to this study. Please include children - this data is too
critical to not collect.
Email response provided by EHTB staff
Thank you for your interest in the PFC biomonitoring pilot project and for taking the time to provide your
thoughts and suggestions about the project’s design. The Minnesota Department of Health (MDH) agrees
that it is important to include children in studies designed to determine people’s exposure to
environmental chemicals. As you know, there is a great deal that is still unknown in terms of how both
children and adults are exposed to PFCs and what the effects of that exposure are on health.
At this time the scientific Advisory Panel and staff at MDH continue to believe that participation in the PFC
pilot project should be limited to adults for several reasons. First, the adult population includes
individuals with many years of exposure to the contaminated drinking water, an important consideration
when measuring a chemical that stays in the body. It also includes women of child-bearing years, thus
providing a good indicator of potential exposure to newborns in the community.
Secondly, performing a medical test on children without providing a known health benefit raises ethical
concerns. Other studies that have reported children’s PFC levels (including the study of 599 children you
mention in your message) have used blood samples that were collected for other purposes, not only for
the measurement of PFCs. The risks involved with drawing blood from children, who are more likely to
bruise, bleed, and/or experience pain from the procedure, solely for the purpose of measuring PFCs as
part of a pilot project is difficult to justify when we are not able to provide a health benefit to the child.
There is no follow-up or treatment that can remove PFCs from the body, and the test does not provide
information that will allow clinicians to predict future health impacts or make medical recommendations.
Third, in order to interpret PFC biomonitoring results, it is helpful to have a reference or comparison
value from the general population. MDH staff consider the National Health and Nutrition Examination
Survey (NHANES) to be the best source of data for establishing a baseline or reference value for
interpreting PFC biomonitoring results. Unfortunately, the NHANES data do not currently include PFC
values for children under 12. The study that you mentioned of 599 children is not suitable for
establishing a current reference value. The blood samples were originally collected in 1994-1995 for a
clinical trial of children with streptococcal A infections by researchers at the University of Minnesota. The
stored blood samples were later obtained by Dr. Geary Olsen and colleagues for a PFC analysis. The
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results were published in the Journal of Children’s Health, Vol. 2, No. 1, in 2004. Given that levels of
PFCs in the general population have been falling in recent years, using a reference value based on
samples collected over a decade ago would result in an overestimation of what value is considered
“normal” for children.
Finally, by limiting participation to adults at this time, we will be better able to determine the variability in
PFC levels in the community as a whole, which is an essential first step for determining how many people
would need to be included in a larger, scientifically rigorous study of the population, including children.
Please be assured that MDH staff are already thinking about ways we can address the concerns of
parents in the community, and will look for appropriate methods for measuring PFCs in children in the
future. Studies that include children must provide useful information and be consistent with good public
health practice. Research being conducted elsewhere may provide us with appropriate reference values
for children in another year or two. We feel confident that based on the results of our pilot PFC
biomonitoring project, and the additional information that we will have obtained from other researchers,
we will be well-positioned to develop solid recommendations to the legislature for an ongoing base
biomonitoring program in Minnesota that will include children.
If you would like to receive updates on the PFC biomonitoring project, or other Environmental Health
Tracking & Biomonitoring activities, please go to
http://www.health.state.mn.us/divs/eh/tracking/index.html and click on the “subscribe” link on the righthand column.
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Letter received from Representative Julie Bunn
and EHTB’s response
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February 8, 2008
Dear Mr. Stine,
Please find below our responses to the questions posed by State Representative Julie Bunn in her
letter dated February 5, 2008. We wish to thank her and her colleagues for raising these
important questions on behalf of their constituents and we welcome the opportunity to talk
further with the members of the PFC Oversight Working Group about these issues.
Overall, we believe that the project design that has been proposed in the East Metro communities
will gather important data that will inform the individual participants and the communities about
PFC exposures in a way that is scientifically sound and consistent with good public health
practice. This project, together with the other pilot projects, will further serve to inform our
recommendations to the Legislature and other stakeholders in 2009 regarding an ongoing base
biomonitoring program in Minnesota.
1. Why are children not being included in the biomonitoring study proposal at this time?
There are several reasons why the scientific staff and the Advisory Panel recommended that the
pilot project be limited to include only adults over age 20. One reason is that the adult
population includes people with long-term exposure whom we consider to be most likely to have
the greatest cumulative exposure to the drinking water, and therefore are most likely to carry a
body burden of PFCs that may be greater than is found in the general population.
We know that the water contamination has existed in the community for many years. The
scientific panel and staff considered that within the selected communities, there are long-term
adult residents that are likely to have been exposed to the water over many years. In order to
capture this group with the most years of exposure we chose to focus the study on adults who
have lived in the community since before Jan. 1, 2005. The inclusion of children in the sample
would mean that fewer adults with long term exposure would be selected.
A second reason why this age group was selected was comparability to the national sample. The
scientific panel and staff recommended that the methods for sampling the population (which
includes the selection of age groups) be comparable to the NHANES methods so that a direct
comparison of PFC levels in the community with PFC levels found in the most recent national
sample (NHANES) is valid. NHANES remains the best source of data for establishing a
baseline or reference value useful for interpreting our PFC biomonitoring results.
The NHANES sample results collected from 1999-2000 and from 2003-2004 have found no
significant difference between the age groups (age 12 and up) in levels of PFOA and PFOS.
This observation in the general population may or may not be observed in our population
exposed to contaminated drinking water. In our pilot project, examining differences in
exposure between age groups may or may not be feasible. This is due to the fact that we are
uncertain of the variability we will find in the data and therefore cannot be certain that the
sample size of 100 will be sufficient to make such comparisons. Limiting the sample to the adult
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age range increases the likelihood that we can examine differences between young adults and
older adults, and to make additional (adult) age level comparisons to the national sample results.
A third reason for limiting the project to adults is that performing a medical test on children
without providing a known health benefit to the child raises ethical questions, and may be
disapproved by the MDH Institutional Review Board (IRB) and the partnering hospital IRB.
IRBs review all aspects of the protocol, particularly the informed consent, and oversee the
protection of human subjects used in research in accordance with federal laws.
During the informed consent process, the risks and benefits of participation will be described. If
children are included, then both parental consent and child assent is required. The consent/assent
will explain that the sampling of blood for PFCs involves a venipuncture and withdrawal of
approximately 20 cc of blood from the arm. This would take place in a clinic by a phlebotomist
or nurse. The risks of this procedure include possible bruising, bleeding, discomfort and pain. In
very young children, this risk is heightened due to the small size of the veins. Ultimately, the
IRB would decide whether this risk, given that there is no direct benefit to the child, is
acceptable. If the project is not approved by both IRBs, the MDH would need to revise the
protocol and resubmit it, thus delaying the project.
Finally, in making our recommendations, the panel and staff also considered the fact that a
population sample of adults age 20 and up would have an added benefit in that it would include
women of child-bearing years. PFC levels measured in these women will provide a useful
indicator of the levels of PFCs that a fetus would likely be exposed to in-utero, and may
(depending on the variability in the data and the number of women who participate) be compared
to women of the same age in the national sample.
The panel and staff recognize the concern that community members have for their children, and
will consider ways that we can include children in future biomonitoring activities and/or health
studies. This will be included in our recommendations to the Legislature for an ongoing base
biomonitoring program, and future research.
1. (cont’d) Is there existing baseline data for children from another source-regional, national,
international, or other known exposed hot spots-either available currently or anticipated to be
available in the future, to which east metro child data could be compared if it were collected?
Attached to this letter is a table listing the studies of PFCs in blood in samples of the general
population that may be considered “baseline data.” As stated previously, we consider the
NHANES data to be the best source of a reference value. Although it does not currently include
children under 12, we have learned that the CDC does intend to publish a reference value for
children ages 3-11 using pooled samples (combining blood from several children into one
sample) from blood that was collected and stored in a previous survey. A paper from Germany
recently reported preliminary reference values for PFCs in children and adults derived from 3
studies in the German population (Wilhelm et al., 2007)
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It is important to note the levels of PFCs in the general population have been declining.
NHANES reported a 32% decline from the 1999-2000 sampling period to the 2003-2004 period.
If this trend is continuing, then it is likely that reference levels will be lower in the next report
period. To ensure a valid comparison, we will want to choose reference data collected in a year
that is as close as possible to the same sampling year of our project (2008).
1. (cont’d)What can you tell us about how large a sample you would want in order to include
children in the biomonitoring study?
Without having a clear statement about what scientific question the study is designed to answer,
this question is difficult answer. Sample size calculations vary depending on the type of analysis
that is planned and are based on a number of factors. If the goal is to measure differences
between groups, then one of these factors that we need to know, or be able to reasonably
estimate, is the variability in the blood level data in the population under study and size of the
effect (difference) that we expect to measure. The pilot project sample of 100 people should
give a good measure of the variability, which we can then use to plan future studies, which may
include children, in these communities. Based on the limited information we currently have, the
sample size could range between 300 to 1,000 subjects (in each group under study).
2. What are the main sources of existing, or soon to be available baseline data that results from
this study could potentially be compared to?
The sources of existing baseline data are provided in the attached table. We consider the
NHANES data to be the best source of a reference value. It is likely that other reference values
will be published in the future as surveys similar to the NHANES are being conducted in other
countries, particularly in Europe.
3. Why is the testing of pregnant women not an objective of the study?
As stated previously, our approach has been to select the portion of the population that we
believe is the most likely to have been exposed over a long period of time to the drinking water.
Focusing the study solely on pregnant women excludes older women (and all men) with longer
exposure times. Another significant reason for not choosing this particular subgroup for study is
because the method needed to enroll 100 pregnant women from these communities would take
much longer and the project likely could not be completed before the 2009 legislative session.
While the project does not explicitly focus on testing pregnant women, our sample will include
women of child-bearing years, which serves as an indicator of the levels of PFCs that a fetus
would be exposed to in-utero, and may be compared to similar findings in the US population.
4. How does this selection process guarantee that the sample will include people who have been
exposed over long periods of time?
We agree that an adequate number of people with long-term exposure should be included to
ensure that the sample captures the population most likely to be exposed long-term to PFCs. As
stated previously, a random sample of adults who have lived in the community since before Jan.
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1, 2005 will capture this group with the most years of exposure. Due to the interventions that
were put in place during the years 2005-2006, persons with exposure to the municipal water only
in the past 3 years would be less likely to have long term exposure to the most contaminated
water. This limitation further shifts the study population toward residents with longer time in the
community.
Except for this Jan 1, 2005 criteria, we decided not to further limit participation to include only
adults with longer time of residence. We felt that it could be valuable to look at the range of
residence times in the community. Knowing the variability in this measure will help us to plan
future biomonitoring studies.
Your question also states that we should “be able to draw some conclusions about their average
blood serum levels as compared to those with shorter-term exposures”. We hope that we may
able to conduct an analysis that would allow us to make comparisons between subgroups based
on length of residence within our 100 person sample. However, as stated previously, our ability
to make any subgroup comparisons may be limited by the sample size and depends on the
variability in the data.
5. What types of exposure length, health, occupational and other personal data are you currently
considering collecting from the adult participants in the study and why? What tradeoffs are you
considering when making the decision about what information to collect?
Currently, we are considering a brief questionnaire that will be mailed to all eligible households
identified with a contaminated private well in Lake Elmo or Cottage Grove (approximately 150),
and approximately 500 households randomly selected from a list of Oakdale municipal water
customers. The questionnaire will gather information on all adults living in the household to
include:
a) name and telephone number (so that we may contact them later if they are
selected, and follow-up with a telephone call as needed),
b) birthdate and date when the adult first lived at that household (to determine
eligibility)
c) current drinking water source used in the home and the presence of any
alternative water supplies, or water treatment devices in the home.
d) Number of years the adult has lived in any home served by the contaminated
water source (to allow for an examination of the duration of exposure to the water
supply).
e) Gender and ethnicity (for comparison of grouped data to the national sample).
f) Prior occupation in a job with likely exposure from PFC manufacturing at 3M
(may be useful in interpreting extreme values in the serum levels if found).
We considered additional survey questions (directed at identifying additional sources of
exposure and/or health outcomes) to be beyond the scope of the pilot project as described in the
legislation, and also exceeds available resources.
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5. (cont’d.) How do these decisions affect the future potential for using this data to address
research question that may emerge in the future?
We agree that planning these projects should be done with an eye towards potential future
research. The informed consent document will include a statement which asks the participants to
agree that we may contact them at a future date if a follow-up study is planned. Follow-up may
include more in-depth surveys of exposure, expansion of biomonitoring to other groups within
the community or other family members, repeat testing to measures changes in exposure over
time, or health studies.
Thank you.
Jean Johnson
Director, Environmental Health Tracking and Biomonitoring Program
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Population Size
Population
1
NHANES data for 1999-2000
12-19
543
20-39
364
40-59
295
60+
360
Males
743
Females
819
All
1562
2
NHANES data from 2003-2004
12-19
640
20-39
490
40-59
387
60+
577
Males
1053
Females
1041
All
2094
Red Cross adult blood donors
(20-69 years of age) in 200020013
Males
332
Females
313
All
643
Group A streptococcal Infection
Group (2-12 years of Age) in
1994-19954
Males
300
Females
298
All
598
5
International Populations
Colombia (2003)
Males
31
Females
25
Brazil (2003)
Males
11
Females
17
Italy (2001)
Males
42
Females
8
96
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)
40.1(37.7-42.6)
35.2(33.3-37.2)
37.5(36.0-39.1)
5.2(4.9-5.4)
4.7(4.4-4.9)
4.9(4.7-5.1)
8.5(6.2-14)
8.0(4.6-13)
6.2(3.9-12.2)
6.1(3.7-9.2)
13.5(6.8-24)
10.7(4.3-35)
<20(<20-<20)
<20(<20-<20)
4.3(<1-10.3)
4.4(<1-8)
<3(<3-<3)
<3(<3-<3)
Poland (2003)
Males
Females
10
15
Belgium (1998 and 2000)
Males
16
Females
4
India (2000)
Males
34
Females
11
Malaysia (2004)
Males
16
Females
7
Korea (2003)
Males
25
Females
25
Japan (2002)
Males
25
Females
13
Australian General Population
2002-20036
<16 Males Pooled serum of
136 individuals
< 16 Females Pooled Serum of
146 individuals
All Males Pooled Serum
All Females Pooled Serum
40.9(21-116)
33.3(16-60)
20.5(11-40)
23.2(9.7-34)
16.8(4.5-27)
11.1(4.9-19)
5.0(1.1-13)
4.1(<1-7.6)
1.7(<1-3.1)
2.3(<1-3)
<3(<3-<3)
<3(<3-<3)
13.2(6.2-18.8)
11.7(7.6-17)
<10(<10-<10)
<10(<10-<10)
27.1(6.6-92)
15.1(3.0-61.3)
35.5(<15-71.4)
88.1(<15-71.4)
12.4(4.1-38)
20.1(6.3-40.3)
<6.8(<6.8-<6.8)
12.3(<6.8-12.3)
19.9
8.2
15.8
6.4
22.9
21.5
7.5
7.1
1
Calafat et al. (2007) “Serum concentrations of 11 polyfluroalkyl 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
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
Olsen GW et al (2003) “Perfluorooctanesulfonate and other fluorochemicals in the serum of American Red Cross
adult blood donors.” Environmental Health Perspectives 111: 1892-1901.
4
Olsen GW et al (2004) “Quantitative Evaluation of Perfluorooctanesulfonate (PFOS) and Other Fluorochemicals in
the Serum of Children.” Journal of Children’s Health 2(1):53-76.
5
Kannan K, et al (2004) Perfluorooctanesulfonate and Related Fluorochemicals in Human Blood from Several
Countries.” Environmental Science and Technology 38:4489-4495.
6
Karrman A, et al (2006) “Levels of 12 Perfluorinated Chemicals in Pooled Australian Serum, Collected in 20022003, in Relation to Age, Gender, and Region.” Environmental Science and Technology 40:3742-3748
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98
Letter received from Senator Katie Sieben
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100
Status update on mercury biomonitoring
At the December meeting of the Scientific Advisory Panel meeting, Pat McCann (research
scientist in the Environmental Health Division of the Minnesota Department of Health) provided
a brief overview of a grant awarded by the US EPA to MDH to measure “Mercury Levels in
Blood from Newborns in the Lake Superior Basin.” In December, it was anticipated that this
March meeting would include a discussion of whether this EPA-funded study could be
considered in partial fulfillment of the legislative instruction to include a mercury biomonitoring
pilot project within the EHTB Program.
Since the December meeting, MDH has chosen to consider two alternatives toward
implementing the EPA-funded study. One alternative is to seek written, informed consent from
parents to enroll residual, newborn specimens in this biomonitoring study. The other alternative
is to present a proposal to the state legislature that would explicitly permit MDH to use residual
newborn specimens for research and public health studies and permit parents to decline to have
the specimens used for research and public health studies. Consequently, this study is not ready
for presentation to the Scientific Advisory Panel until after resolution of the proposal by the
legislature. The legislative session ends in May.
This status report describes activities by the MDH Public Health Laboratory scientists to prepare
for implementation of the EPA study by developing and validating an analytical method to
measure mercury in dried blood spots on filter paper.
By way of background, since the 1970s, CDC scientists have measured total mercury in whole
blood as part of the National Health and Nutrition Examination Study (NHANES). In 2003, CDC
developed a new method, specific to a technologically advanced instrument, the inductively
coupled plasma-mass spectrometer (ICP-MS). This method uses whole blood and an alkaline
diluent. It has a detection limit for mercury of 0.15 µg/L.
Dr. Zheng Yang, research scientist in the MDH Public Health Laboratory, modified the current
CDC method to use an acidic diluent and organic additives, which would allow expansion of the
method to characterize mercury species, e.g. methylmercury and ethylmercury. He has reduced
the mercury “memory effect” at the nebulizer (the sample-introduction assembly for the ICPMS), in which residual mercury is carried forward from one sample into subsequent samples.
Because of this and other improvements, the detection limit for mercury is 0.12 µg/L. The
sensitivity may be improved further if we were to incorporate an auto-sampler, which requires
much smaller sample volumes. The importance of decreasing the detection limit is underscored
by data presented by CDC in the Third National Report on Human Exposure to Environmental
Chemicals (2005), in which almost half of the children ages 1-5 years had blood concentrations
of mercury that were below CDC’s detection limit of 0.15 µg/L.
Internal validation of this novel MDH method has been rigorous. Quality control steps in the
MDH mercury method for dried blood specimens on filter paper meet or exceed those in the
101
CDC method for mercury in whole blood. For example, the MDH method includes quality
control samples at low, medium, and high concentrations in every batch of twenty samples, and
every batch includes at least one duplicate sample. Calibration standards are traceable to the
National Institute for Standards and Technology (NIST). Data are reviewed to assure that they
meet stringent criteria for accuracy and precision.
A hallmark of external validation of analytical methods is a proficiency testing study, in which
single-blind samples with a rigorously defined true value are distributed by an approved provider
to participating laboratories. After each lab analyzes and reports its results, the provider awards
pass/fail grades, based on the lab’s ability to match the true value. To date, no proficiency testing
studies are available for mercury in dried blood spots on filter paper. The MDH Public Health
Laboratory is exploring other options for external validation. On a related note, this laboratory
participates in proficiency testing studies sponsored by CDC for measuring mercury in whole
blood. Since first enrolling in quarterly studies in 2004, this laboratory has passed every
proficiency test. This record affirms a high level of continuing performance, measured through
these inter-laboratory comparisons.
The EPA-funded study, “Mercury Levels in Blood from Newborns in the Lake Superior Basin”
depends on a close collaboration between the MDH Public Health Laboratory’s metals analytical
staff and staff in the newborn screening programs in Michigan, Minnesota, and Wisconsin.
Scientists in the newborn screening programs will punch eight 3-mm filter paper discs from each
residual specimen corresponding to infants who were born in the Lake Superior Basin. Several
types of quality control will be incorporated into the study. One control is to measure the
gain/loss of mercury in dried blood spots that have been kept under various storage conditions
for several weeks or months. Gain could arise from ambient mercury released from a
thermometer that may have broken in the laboratory in the past. Loss could arise from offgassing of mercury or deterioration of the filter paper. In fact, under controlled conditions within
the MDH Public Health Laboratory, the recovery of spiked mercury in commercial blood
samples spotted onto filter paper remained at 80-110% after three months.
Scientists in the newborn screening programs will punch eight 3-mm filter paper discs from a
blank area of each card so that the background level of mercury in the paper will be subtracted
from the amount observed in the blood specimens. Another control is that, before distributing the
punching devices to each of the three newborn screening programs, the metals laboratory staff
will assign unique ID numbers to each punching device and measure the extent of variability in
punch sizes. The storage bags for the punched specimens derive from a single lot; Dr. Yang has
found that the mercury level contributed by the bags is negligible.
During the punching process, the newborn screening staff will assure that: any spots that were
improperly layered onto the filter paper by the hospital staff are rejected; repeat samples from
any infant are eliminated; the punching devices are sterilized; at least five punches from a cloth
wiper are taken to eliminate cross-contamination before proceeding to the next card; specimens
are stored at -20 degrees Celsius before shipping; and chain-of-custody forms accompany each
shipment.
102
At the beginning of the study, each of the newborn screening programs will receive a set of cards
that the metals chemists have spotted with commercial blood containing defined amounts of
mercury. Every few weeks, the newborn screening programs will include at least one sample
collected from these control cards for mercury analysis, and these samples will be blinded to the
metals chemist. At the conclusion of the study, these (blinded) samples will be identified as
arising from the commercial blood source. A control chart of the recovered concentrations will
serve as a measure of accuracy and precision over the lifetime of the study.
Security of data privacy is an important feature of the study design. The MDH Public Health
Laboratory employees have created documents to assure that the newborn specimens from
Michigan, Minnesota, and Wisconsin are stripped of personal identifiers. For data submitted to
the MDH metals laboratory, the specimen information is limited to the state’s name, a unique ID
number, and the date that the residual specimen was punched. Each newborn screening program
will include the zip code cluster, gender, and month of birth in a separate document that it
submits to the project director in the MDH Environmental Health Division. Electronic data
transfers must adhere to the strict data privacy standards that are enforced by MDH and the State
of Minnesota.
In summary, the MDH Pubic Health Laboratory is assessing the technical feasibility of
measuring total mercury levels in dried blood spots on filter paper. Preliminary assessments of
aged specimens, filter paper lots, sample collection protocols, and variable storage conditions are
informing the determination of acceptable criteria for data precision and accuracy. As with any
novel analytical method for which an approved proficiency study is not yet available, the ability
to complement a rigorous internal validation process with an equally rigorous external validation
process is challenging. A goal is to disseminate this novel method to other laboratories so that,
through their adoption and enhancements, the reproducibility and robustness of the method will
improve.
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Status update on environmental health tracking
At the October 23, 2007, meeting, the EHTB advisory panel recommended that MDH proceed
with the priorities that MDH staff identified for the tracking program in the first year. This
included the development of a set of core environmental public health indicators consistent with
the CDC’s national tracking program (in addition to other Minnesota-specific indicators
identified as a priority through the strategic planning process). The progress on this work is
reported below.
Other priorities for the first year of the tracking program are to begin work on a strategic plan
and to develop a stakeholder communications and outreach plan. MDH staff expect to report
on/discuss these topics with the EHTB advisory panel in June.
Drinking water
MDH is currently participating in CDC’s National Environmental Public Health Tracking
Network (EPHT) efforts to track certain contaminants in drinking water. Although public water
supply compliance is monitored at the national level, few initiatives have examined the
feasibility of using state-specific, contaminant-level data to identify emerging issues, track
trends, or explore potential relationships between drinking water and human health. The first
contaminants selected for tracking by the EPHT program include trihalomethanes (THMs, a
class of disinfection byproducts), arsenic, lead, and nitrate. Initial tracking efforts will focus on
data collected from community water systems, used by approximately 80% of Minnesotans.
Although the goal of EPHT is to develop nationally consistent data and measures, this has been
challenging due to the wide variation across states in drinking water data collection and storage
practices. Despite this limitation, contaminant-specific datasets and measures have been selected
and are currently being produced by EPHT participants. Minnesota results for the four
contaminants listed above will likely be presented at the June EHTB advisory panel meeting.
Carbon monoxide poisoning
Carbon monoxide poisoning is one of the core indicators that is currently being developed by the
EPHT Carbon Monoxide Content Work Group and it is one of the more well-developed
indicators of the eight. The CO CWG has identified several data sources for evaluating COrelated events and measures within a particular state. Three are still under development
(hyperbaric chamber treatment data, CSTE and CDC database searches, and CDC database
searches) and one (BRFSS) cannot be currently utilized as a source of CO-related data in the
state of Minnesota. Unfortunately, the present BRFSS survey lacks the optional module on
indoor air quality containing the question related to the prevalence of CO detectors in
households. However, the remaining four data sources are fully developed and are in usable
condition (hospital discharge data, emergency department data, death certificate data, and Poison
Control Center data).
105
The hospital discharge, emergency department, and death certificate data sets based on the years
of 2002-2006 were easily obtainable from the Injury and Violence Prevention Unit within the
Minnesota Department of Health and data analysis is in its beginning stages. The progress so far
has been to classify cases within these data sets according to residency, intent, and firerelatedness. Furthermore, contact has been made with the Poison Control Center and a formal
data request for data over the same time period will ensue. The next steps are to determine counts
and rates at the state and county level for deaths, hospitalizations, and emergency department
visits based on age, gender, intent, fire-relatedness, and year. The state-level counts and rates of
CO exposure reports to the Poison Control Center will be classified according to intent, the
presence or absence of a health effect, and whether treatment followed. The rates listed above
will be calculated using U.S. census estimates, which are located at:
http://www.census.gov/popest/estimates.php. For further surveillance purposes, a capturerecapture analysis will also be conducted to determine the level of overlap between the Poison
Control Center data and the death certificate, hospital discharge, and emergency department data
sets. Additional analyses may be performed based on the availability of resources.
Hospitalizations
As members of the State Environmental Health Indicators Collaborative (SEHIC) of the Council
of State and Territorial Epidemiologists (CSTE), MDH has developed and piloted environmental
health indicators for asthma hospitalizations and chronic respiratory disease deaths. MDH will
repeat and expand upon these measures using more current data now available and the revised
indicator methods currently recommended the EPHT program. This will include the addition of
hospitalization data for cardiovascular events (myocardical infarctions).
Air quality
MDH is currently collecting particulate matter (PM 10 and PM 2.5) air monitoring data from the
Minnesota Pollution Control Agency for the years 2000-2005 in order to establish a baseline for
tracking trends in PM exposure in the Minneapolis-St. Paul metropolitan area and Olmsted
County. Changes in daily PM exposure will be linked with changes in daily acute health
outcomes (cardiovascular and respiratory hospitalizations and deaths) in order to measure the
public health impacts of PM reduction strategies in Minnesota. This work is being done with
research funding received from the EPA in 2007. The methods developed in this project will be
applied as part of the ongoing tracking activities of the state.
Birth defects
The Minnesota Department of Health Birth Defects Information System (BDIS) will be used to
fulfill the birth defects indicator surveillance goals. BDIS was designed using the National Birth
Defects Prevention Network surveillance guidelines, and is very consistent with the EPHT
program recommendations. BDIS includes information on each of the 12 different conditions
EPHT has recommended, collects information on diagnoses to live-born infants within the first
year of life, employs an active surveillance system, and contains 6-digit CDC/British Pediatric
Association codes and verbatim information. BDIS data are population-based for Hennepin and
Ramsey Counties, which is consistent with EPHT recommendations. Minnesota birth defects
data are available only from 2006 and on.
106
Future plans for birth defects indicators include classifying cases of the 12 priority EPHT birth
defects as syndromic, isolated, or multiple, and geocoding maternal residential address at
delivery. Prevalence data will be calculated using SAS.
The 12 priority conditions that currently make up the birth defects indicator include the
following:
• Anencephaly
• Spina bifida (without anencephaly)
• Hypoplastic left heart syndrome
• Tetralogy of Fallot (a type of heart defect)
• Transposition of the great arteries (vessels)
• Cleft lip with or without cleft palate
• Cleft palate without cleft lip
• Hypospadias (a defect of the male urethra)
• Gastroschisis (an opening in the abdominal wall through which internal organs push outside
the body)
• Upper limb deficiencies
• Lower limb deficiencies
• Trisomy 21 (among mothers 18-<35 years of age at delivery and among mothers 35-59 years
of age at delivery)
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108
Status update on arsenic biomonitoring
The arsenic project IRB application has been developed and submitted. The IRB meets the
second Wednesday of every month; the next meeting is March 12. For the arsenic protocol to be
reviewed at this meeting the application had to be submitted on February 27.
For the IRB submission the proposal previously reviewed by the EHTB advisory panel was
solidified, and the consent and assent materials, letters to participants, and instructions for
sample collection were all developed.
At the December 17 meeting, the EHTB advisory panel made a recommendation to collect and
analyze hair samples in addition to two urine samples. The main advantage discussed was that a
hair sample would reflect arsenic exposure in the preceding two months, whereas a urine sample
reflects exposure only in the previous 1-3 days. MDH staff considered that obtaining a measure
of longer-term exposure would be desirable to community members.
The disadvantages of collecting hair specimens discussed by the panel included the potential
difficulty in collecting sufficient hair samples close to the scalp; the reluctance of members of
some ethnic communities to provide hair samples; and the variability of arsenic deposition due to
hair-type (ethnicity), which may make interpretation of the results more difficult.
As the arsenic protocol was being developed, the workgroup considered this advice from the
panel and tried to identify ways to incorporate hair collection. However, due to staffing
constraints, biospecimens will be gathered using a “do it yourself” collection method rather than
having project staff present to collect samples. Biomonitoring staff felt that parents could
feasibly collect their children’s urine samples, but that it would be too difficult to obtain reliable
hair specimens with parents doing the collection. Therefore, the EHTB workgroup decided to
modify the protocol so that urine (two consecutive first-morning urine samples, which will be
combined before laboratory analysis) will be the sole specimen collected for measuring arsenic
levels in the community.
The rest of the recommendations made by the advisory panel regarding to the arsenic
biomonitoring project have been incorporated in the protocol, including the collection of two
consecutive urine samples; the collection of first-morning urine; instructing participants to
refrain from eating seafood for several days before the urine sample is collected; and speciation
of arsenic at ≥15 µg/L. (Note: Smiley’s Clinic has since changed their protocol so that arsenic is
speciated at ≥35 µg/L.)
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110
Section overview: General reference materials
A number of items are included in the meeting packet as background material:
•
EHTB meeting summary from December 17, 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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112
Summary of the
Minnesota Department of Health (MDH)
Environmental Health Tracking and Biomonitoring Advisory Panel Meeting
December 17, 2007
1:00 p.m.-4:00 p.m.
Advisory Panel Members - Present
Bruce Alexander
Debra McGovern
Beth Baker, Chair
Geary Olsen
Alan Bender
Susan Palchick
Cecilia Martinez
Gregory Pratt
Daniel Stoddard
David Wallinga
Samuel Yamin
Lisa Yost
Advisory Panel Member – Regrets
John Adgate
Welcome and introductions
Michonne Bertrand, the staff liaison between the Minnesota Department of Health (MDH) and
the Environmental Health Tracking and Biomonitoring (EHTB) Advisory Panel, announced that
the commissioner of Health has appointed Beth Baker to chair the panel. Beth convened the
meeting, and the panel members introduced themselves.
Operating procedures and conflicts of interest
Michonne Bertrand provided a brief summary of the proposed operating procedures, (including
procedures for recognizing conflicts of interest) that were contained in the meeting’s background
book. Several panel members commented on the proposal for handling conflicts of interest. Dan
Stoddard expressed the appropriateness of disclosing an apparent conflict of interest and the
appropriateness of abstaining from voting if he were to have an actual conflict of interest. Al
Bender pointed out that a panel member cannot be wholly responsible for another person’s
perception that the member would have an apparent conflict of interest. Bruce Alexander
observed that the panel was configured to have a broad base of scientific expertise, and that the
expectation should be that the members are objective in advising the program collectively. Deb
McGovern offered hypothetical examples in which either a member or a member’s organization
would have a direct financial interest in the matter under consideration. Panel members agreed
that such conflicts should result in the member abstaining from a vote. Several comments
suggested a consensus regarding the gravity of financial gain, the need to disclose and, if voting,
the need to keep an open mind for the public good.
Dan made a motion to amend the proposed text, presented on page 4 of the meeting’s
background book, which describes the conditions for which a conflict of interest exists. The
amendment is as follows:
113
In paragraph 6a, amend the first sentence: The member’s, her/his organization, or a family
member has a direct financial or personal or organizational interest in the matter under
consideration.
In paragraph 6b, amend the sentence: The member or a family member has an indirect
financial or personal interest in the matter under consideration and is not so free of 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.
Add text to direct each panel member to declare any actual or apparent conflicts of interest
and abstain from voting on any conflicts of interest due to financial gain.
The motion was seconded, and it passed by a unanimous show of hands. Beth Baker instructed
Michonne to present the amended text at the next panel meeting.
The panel considered whether the decision to abstain from voting due to a conflict of interest
should be made by the individual panel member, the panel as a whole, or the meeting’s
convener. Members agreed that disclosure and self-assessment should dictate a panel member’s
choice to vote or abstain.
Greg Pratt made a motion to accept the remainder of the text in the proposed operating
procedures, as presented in the meeting’s background book. The motion was seconded and
passed by a unanimous show of hands.
David Wallinga suggested that the proposed “Affirmations referring to conflicts of interest”
could be more explicit regarding whether the intent is to suggest a standard of conduct or to
identify specific topics. Discussion ensued that, if the affirmation is for a standard of conduct,
then the affirmation could be signed once at the beginning of a member’s three-year term. If the
affirmation is for specific topics, then the affirmation might be signed more frequently. Beth
instructed Michonne to present alternative text at the next panel meeting.
Panel member comments and questions
Michonne Bertrand noted that several panel members had contacted the program staff with
comments or questions after the previous meeting. A proposed mechanism for sharing
substantive items with the panel members and at the EHTB Program’s website was presented in
the meeting’s background book. She invited feedback on the proposal.
The members who had been contacted by the media since the October 2007 meeting expressed
their appreciation for the guidance document in the meeting’s background book for responding
to media inquiries. Susan Palchick asked whether the meeting summaries, which will be posted
on the EHTB Program’s website, are considered to be official meeting minutes. Michonne
replied that the draft summaries will be distributed to members shortly after the meetings to
solicit corrections. Once the corrections are incorporated, the summaries will be posted on the
website. As they are not official minutes, the panel will be not asked for formal approval.
114
Samuel Yamin expressed his satisfaction with the process whereby his formal letter, which he
submitted after the previous meeting, was included in this meeting’s background book, thereby
providing an opportunity for any ensuing discussion. Members commented that open
communications are desirable and that members should have opportunities to express themselves
more cogently and deliberately in writing. Nonetheless, debates should be carried out at the panel
meetings rather than at the EHTB Program’s website. Beth Baker requested that panel members
send communications to Michonne (rather than to all panel members), and she instructed
Michonne to use discretion in deciding which communications are substantive enough to
distribute to the panel. At times, Michonne could synthesize many individual comments on an
arising topic into a summary for the meeting’s background book. Because the background books
will be posted on the web, this could provide an appropriate level of public dissemination of
correspondence.
Arsenic biomonitoring
Rita Messing presented the revised arsenic biomonitoring proposal and asked the panel for
advice on specific questions regarding the study design; these were included in the meeting
background book. Beth Baker reminded the panel that the MN Statutes, time constraints, and
financial constraints put limits on the pilot project. Therefore, careful deliberations were
welcomed to maximize the utility of the pilot project.
Lisa Yost disclosed that she had worked on another arsenic biomonitoring project previously.
Dan Stoddard disclosed that he had been involved in the clean-up of the site in south
Minneapolis. David Wallinga disclosed that he had previously studied arsenic levels in chicken
feed.
In response to the question of what specimen(s) would be collected, the panel considered that the
half-life of arsenic in urine is 1-3 days, while the inch of hair that is closest to the scalp
represents exposure in the preceding two months. By choosing two urine specimens collected on
successive mornings, rather than a single urine void sample, the investigators would be more
likely to capture a child’s exposure to soil arsenic, especially if patterns of play in the yard are
dependent on weather. Furthermore, parents would have double the chance of collecting a child’s
first urine void. Combining the two urine samples prior to lab analysis would ensure that the lab
cost would remain low. The number of scientific publications regarding arsenic speciation in
children’s urine is increasing, making data interpretation more feasible.
Susan Palchick noted that the advantage of using hair to measure exposure over several weeks,
rather than a few days, could be offset by the difficulty in collecting sufficient hair samples close
to the scalp. Cecilia Martinez advised that members of some ethnic communities may be more
reluctant to provide hair than urine. Lisa noted that a disadvantage of hair samples is that the
inherent variability of arsenic deposition due to hair-type (ethnicity) may confound an
interpretation of the results. It may be that the levels of arsenic in hair do not correlate with
exposure levels, which will be a challenging message to present to the families and communities.
Furthermore, no convention exists for an “elevated” or “abnormal” arsenic level in hair.
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Toenail clippings were suggested as a biospecimen, as the exposure would probably be longer
than just a few days. Disadvantages are that the time between arsenic uptake in the nail bed and
their migration to the free, distal edge is variable and that the investigators would be challenged
to collect an adequate sample size from young children.
Bruce Alexander suggested that the panel consider if the purpose of the biomonitoring pilot
project is to delve into research (e.g. an investigation of uncertainty in hair arsenic levels) or into
a public health study (e.g. whether exposure to soil is a contributing factor to urinary arsenic
levels). Rita responded that the urinary arsenic measurements are relatively standardized, while
arsenic levels in hair are known to differ according to hair type and possibly by washing
protocols to remove external depositions (e.g. from hair-care products). Correlations between
exposure and a biospecimen would be easiest to interpret for a urine specimen.
Health education, community involvement, and managing expectations were discussed.
Bruce advised that, if the purpose of the study is for research rather than interpreting data about
particular individuals, then the documents for parental, informed consent should explain this.
Cecilia noted that the community should be informed of the limitations of any type of
biospecimen. Rita concurred with Al Bender’s observation that health education is an important
component of each of the biomonitoring pilot projects.
In response to David’s question about ongoing coordination by the Agency of Toxic Substances
and Disease Registry (ATSDR, an agency of the US Department of Health and Human Services),
Rita replied that ATSDR has provided a health assessment which is now available for public
comment and posted on the MDH website. In addition, the US Environmental Protection Agency
(EPA) has coordinated with the Minnesota Department of Agriculture to sample approximately
4,000 residential yards for arsenic. For yards that have levels of arsenic above 95 parts per
million (ppm), EPA is removing the top layer of soil and replacing it with clean soil. It is
expected that up to 30 residences will still have arsenic levels exceeding 95 ppm at the start of
the arsenic biomonitoring pilot project in summer 2008.
Beth asked the panel to make formal recommendations regarding the questions posed in the
meeting background book on selecting the arsenic biospecimens. Votes were by a show of
hands; several panel members chose to abstain from particular votes because they did not feel
they had adequate expertise at this time.
The majority of panel members voted “yes” to collecting and combining two urine
specimens.
The majority voted “yes” to collecting the first void volume of each day, rather than “spot”
urine samples, as feasible.
The majority voted “yes” to collecting a hair sample, in addition to the urine specimens.
Beth instructed the panel to consider the remaining questions. Rita asked whether the study
participants should be instructed to refrain from consuming fish and seafood prior to donating a
urine specimen. The answer would reflect whether the study’s aim is to measure total exposure
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or to focus on soil exposure. Several panel members commented that the relative toxicity of
various arsenic species differs widely and that inorganic arsenic is generally considered to be
more toxic than the arsenobetaine and arsenocholine species associated with fish consumption. It
was noted that the lack of rigorous control populations (e.g. no soil exposure or exposure to soil
only in the child’s yard) would limit the investigators’ ability to convey a public health message
to the community. Bruce recommended inclusion of a survey question as to whether the child
had been at home for the few days prior to specimen collection (rather than out of town or
somewhere else where arsenic exposures may differ).
The majority of panel members voted “yes” to providing instructions to the parents that the
children should avoid eating fish (including tuna) and seafood for the few days prior to
collecting the urine specimens.
The majority voted “yes” to arsenic speciation if the total arsenic level is above 15 µg/L and,
at the investigators’ discretion, above 10 µg/L. The cost of the secondary laboratory analysis
could be a determining factor in establishing the trigger level.
Rita asked the panel for input on determining appropriate reference levels for arsenic in urine
and hair that would trigger a communication to the physician about an elevated level that needs
attention. Beth suggested that a trigger of 1.0 ppm for hair arsenic might be too high. Lisa
recommended that, in addition to the health education training for the physicians in the
community, the investigators should provide consultative services of a toxicologist to the
physicians. Al advised that the partnership of the physician (who observes the patient) and the
toxicologist (with expertise in interpreting arsenic data) is much stronger than either acting alone.
Perfluorochemicals (PFCs) biomonitoring
Rita Messing presented the revised perfluorochemicals biomonitoring proposal and asked the
panel for advice on specific questions regarding the study design. Michonne Bertrand referred
the panel to the meeting background book for documentation. Dan Stoddard disclosed that he
had previously worked at a disposal site, Bruce Alexander disclosed that he is investigating PFCs
as part of his University of Minnesota faculty research, and Geary Olsen disclosed that he is a
staff scientist at 3M Company and is studying health effects of PFCs.
Jean Johnson summarized her presentation and ensuing discussion with the East Metro
Legislative Work Group, which met on December 14, 2007. She described the proposed PFC
biomonitoring pilot project for two communities, one served by the Oakdale municipal water
supply and one served by private drinking water wells. The participants would be adults 20 years
and older so as to readily compare to CDC’s NHANES publications. The legislators asked no
questions about the selection of communities, and they were interested in upcoming MDH
meetings in their districts. A legislator had asked if the funding level was sufficient to support all
four biomonitoring pilot projects. A few legislators were concerned about publications
describing PFC levels in cord blood and expressed an interest in including pregnant women in
the biomonitoring pilot project.
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Geary outlined two of the studies that the legislators had discussed. Apelberg of Johns Hopkins
University was one of the lead authors of two articles published by Environmental Health
Perspectives in November 2007 Apelberg et al. measured PFOA and PFOS levels in the cord
blood of approximately 300 newborn infants. Negative associations were reported between birth
weight and PFOA and PFOS concentrations. In the other paper published in the same issue,
funded by 3M, investigators from UCLA and IEI (Fei et al.) reported a weaker association
between birth weight and PFOA, and no association with PFOS. Fei et al. examined 1400 first
trimester maternal samples from the Danish National Birth Cohort. Neither Apelberg et al. nor
Fei et al. showed an association with the categorization of low birth weight babies. David Savitz
has an accompanying commentary about these two papers in Environmental Health Perspectives.
Lisa Yost asked if the toxicological endpoints caused by dangerously high levels of PFCs point
to reproductive or developmental abnormalities. Pam Shubat replied that the major concern is
liver toxicity. According to a publication by Geary Olsen, et al., PFOA and PFOS have half-lives
of at least a few years. MDH is proposing protective levels that would protect the liver over a
lifetime. At these protective levels, the fetus should be well protected, as fetal toxicological
endpoints would be expected only at PFC concentrations that are higher by orders of magnitude.
Geary added that, in rodent studies, decreased pup weight at birth and increased mortality were
found with levels of PFCs that are much higher than the serum levels found in the general
population.
Rita described the selection of communities for the PFC biomonitoring pilot project. For
residents served by the Oakdale municipal water supply, exposures to PFOA and PFOS were
markedly reduced from October 2006 forward because the city installed a treatment system for
its two most contaminated wells. Residents continue to be exposed to PFBA in the water and to
PFCs in non-water sources.
The second community will be comprised of residents of Lake Elmo and Cottage Grove with
private drinking water wells who have had detectable levels of PFOA and/or PFOS in their well
water prior to January 1, 2008. Many of these residences have been supplied with alternative
drinking water sources or with a treatment system. For both communities, eligibility for the
biomonitoring pilot project will be limited to those residents who have resided in their current
residence since before January 1, 2005.
Beth Baker asked the panel to make its recommendation regarding the question as to whether
participant eligibility should be limited to adults 20 years and older (to facilitate comparisons to
CDC’s NHANES data). It was suggested that the communities might be very interested in
enrolling children, yet the scientific rationale would favor an adult population. Deb McGovern
advised that a study of PFC levels in children could be incorporated into the panel’s
recommendations for further studies once the initial pilot projects are concluded.
The majority of panel members voted “yes” to requiring that participants must be 20 years of
age or older (to facilitate comparisons to CDC’s NHANES data on PFC concentrations).
The panel agreed that eligibility should be limited to participants who have been living in
their current residence (and not just living in the community) prior to January 1, 2005.
118
Rita asked the panel to consider if eligibility requirements for residents using private wells
should be limited to participants who had PFOA or PFOS at levels greater than 0.1 part per
billion (ppb), as opposed to trace detection, greater than 0.2 ppb, or other threshold. In response
to questions, Rita reported that measurements were invariant by season and that the health risk
limits are 0.5 ppb for PFOA and 0.3 ppb for PFOS in drinking water.
Geary asked if community members might be resistant to this eligibility criterion if residences
with only trace levels of PFOA and PFOS might be eliminated from the study despite having
high amounts of PFBA. Rita replied that the number of residences with PFBA levels greater than
2.0 ppb is remarkably few. The study could be redesigned to specifically include participants
from these residences.
The majority of panel members voted “yes” to requiring that participants from residences
served by private well water must have had PFOA or PFOS levels of greater than 0.1 ppb in
the well water.
Rita asked for advice regarding the participant survey (which is distinct from eligibility criteria).
Participants could be asked to identify the drinking water source that they use currently. David
Wallinga noted that many participants would probably not recall accurately the drinking water
source that they used prior to January 2005. Al Bender advised that, if the investigators will not
be interpreting exposure sources, then caution should be exercised in gathering exposure sources.
With respect to PFC sources other than the drinking water supply, Geary noted that the American
Red Cross studies now indicate that serum levels of PFOS have declined from approximately 35
ppb in 2000 to approximately 15 ppb in 2006. He suspects that Calafat, et al. will likely report a
similar 50% decline in PFOS nationally when the CDC scientists compare the concentrations for
serum collected from 1999-2000 NHANES participants to the 2006 NHANES participants.
Therefore, interpreting the results of this biomonitoring pilot project should attend not only to the
particular circumstances of the east metro water supply but also to national exposure trends.
Panel members agreed that this participant survey should focus only on current sources of
drinking water.
Rita asked if participants should also be queried if they ever worked at the 3M Cottage Grove
facility. Geary recommended that the question contain three components to track relevant
occupational exposure: (1) in any 3M facility; (2) in a fluorochemical research center on the
Maplewood campus, and (3) in a perfluorochemical production area at the Cottage Grove
facility.
Bruce expressed concern about a proposed enrichment aspect of the study design for the
community of residents served by private drinking water wells. The list of all households in this
community which have PFOA or PFOS concentrations above the threshold may not be
substantially above the 100 needed for the study. In the event that fewer than 100 households
respond to the solicitation to enroll, the proposed study design would select a second adult
randomly from the responding households to reach the target size of 100 participants. He
cautioned that bias might be better controlled by simply collecting a second sample from one of
the original participants.
119
Mercury biomonitoring
Pat McCann, an MDH research scientist, briefly described an EPA grant that was recently
awarded but not yet initiated. The $40,000 grant will support laboratory analyses to measure
“Mercury levels in newborns in the Lake Superior basin.” Michonne Bertrand explained that, at
the upcoming March 2008 meeting, the panel members will be asked to consider how the EHTB
Program should meet requirements for a mercury biomonitoring pilot project. One option could
be to provide financial support for this planned EPA-funded study in lieu of conducting a
separate mercury biomonitoring study.
In response to questions by Deb McGovern, Greg Pratt, and Samuel Yamin, Pat identified
possible areas of support, viz. developing a detailed study design, implementing an informed
consent process, synthesizing and interpreting data, overall project management, enhanced fish
consumption advisories or other health education communications, and supporting mercury
analysis of a community outside of the Lake Superior basin. Under consideration as a potentially
exposed population is the Hmong community in Ramsey County.
Pat answered questions that the EPA-funded project will not survey participants for exposure
pathways. This planned project is an anonymized study using residual dried-blood specimens
from newborns, with the intent of interpreting population-based exposures, not individual
exposures. Geary Olsen advised the MDH Public Health Laboratory to augment its internal
validations with external validations of its laboratory measurements for scientific rigor.
Beth Baker commented that this focus on the Lake Superior basin provides a balance to the Twin
Cities metropolitan-based pilot projects for arsenic and PFCs. Lisa Yost observed that financial
leveraging may augment the limited funds. Beth noted that documents in the October 2007
meeting’s background book indicated that, once funds were allocated for arsenic and PFCs
biomonitoring pilot projects, only $67,000 would remain for biomonitoring of mercury and a
fourth, designated chemical.
Biomonitoring for designated chemicals
Pam Shubat introduced the topic of “biomonitoring for designated chemicals” by describing
options for developing a pilot biomonitoring project for a fourth, to-be-designated chemical, as
described in the MN Statutes. While this topic could be discussed in-depth at a future panel
meeting, the members were asked to reflect on three options:
1. do not select a fourth chemical for study;
2. select a fourth chemical in the 2007-2008 biennium for study;
3. conduct strategic planning, research, and outreach on the selection and identification of
specific chemicals to study under a prospective base biomonitoring program (beyond the
2007-2008 biennium).
Dan Stoddard expressed his preference for the third option. Putting resources into the
development of a strategic plan would allow the EHTB Program to transition from its reactive
120
mode to a proactive mode with opportunities for scientific and legislative debates on appropriate
chemicals for study.
Samuel Yamin made a motion that the panel should bring forward a recommendation for a
designated chemical at the next one or two meetings. This short time-frame would aid in
approaching the legislature with a tangible plan for additional funds. Several panel members
discussed the advantages of taking the time to develop a framework, criteria, plans, and a
prioritized list of chemicals before designating a specific chemical. Samuel amended his motion
so that the designation would occur within a reasonable timeframe.
With most panel members abstaining, the remainder voted “yes” that the panel is to bring
forward a recommendation for a designated chemical within a reasonable timeframe.
Biomonitoring program guidelines
Jean Johnson noted that the MN Statutes require the EHTB Program, in consultation with the
advisory panel, to develop biomonitoring program guidelines. She invited panel members to
volunteer for a task-force that would meet before the upcoming March 2008 panel meeting to
initiate the discussions. Topics could include: sample size; secondary use of stored specimens; data
comparisons to established reference values; communication of results and risks; and ethical and
societal implications. In response to questions, Jean said that the task-force might meet once or
twice before March, and the time commitment could be as little as a one-hour teleconference. Pam
Shubat encouraged panel members to view this as an opportunity to provide formative consultation
rather than the alternative mode of reacting to ideas developed by staff members. Beth Baker
encouraged panel members to identify themselves to Michonne Bertrand if they would be willing
to serve on a task-force to develop biomonitoring program guidelines.
Environmental Health Tracking updates
Michonne Bertrand announced that, due to the fact that the meeting had already exceeded its
planned adjournment time, she would communicate updates in the Environmental Health
Tracking aspect of the EHTB Program via an e-mail message rather than via an oral report at the
meeting. Comments and advice from the panel members are welcomed at any time.
Closure
Beth Baker thanked the panel for a productive meeting. Michonne Bertrand noted that the next
scheduled meeting will be on Tuesday, March 11, 2008 from 1:00 to 4:00. The venue will again
be the Mississippi Room at Snelling Office Park in Saint Paul. Suggestions for meeting logistics
or any other feedback can be submitted directly to Michonne.
Updated January 25, 2008
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122
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
Cecilia Martinez, PhD
Center for Energy and Environmental Policy
University of Delaware
Newark, Delaware 19716
302-831-8405
Local office:
Inver Grove Heights, Minnesota
651-470-5945
[email protected]
[email protected]
Nongovernmental organization representative
Bruce H. Alexander, PhD
University of Minnesota School of Public Health
Environmental Health Sciences Division
MMC 807 Mayo
420 Delaware Street SE
Minneapolis, Minnesota 55455
612-625-7934
[email protected]
Minnesota House of Representatives appointee
Debra McGovern
Minnesota Steel Industries, LLC
Environmental & Regulatory Affairs
2550 University Avenue, Suite 244S
St Paul, Minnesota 55114
651-209-7707
[email protected]
Statewide business organization representative
Beth Baker, MD, MPH
Specialists in Occupational and Environmental
Medicine
Fort Road Medical Building
360 Sherman Street, Suite 470
St. Paul, MN 55102
952-270-5335
[email protected]
At-large representative
Geary Olsen, DVM, PhD
3M Medical Department
Corporate Occupational Medicine
MS 220-6W-08
St. Paul, Minnesota 55144-1000
651-737-8569
[email protected]
Statewide business organization representative
Alan Bender, DVM, PhD
Minnesota Department of Health
Health Promotion and Chronic Disease Division
85 East 7th Place
PO Box 64882
Saint Paul, MN 55164-0882
651-201-5882
[email protected]
MDH appointee
Susan Palchick, PhD, MPH
Hennepin County Human Services and Public
Health Department
Public Health Protection
1011 South 1st Street, Suite 215
Hopkins, Minnesota 55343
612-543-5205
[email protected]
At-large representative
123
Gregory Pratt, PhD
Minnesota Pollution Control Agency
Environmental Analysis and Outcomes Division
520 Lafayette Road
St. Paul, MN 55155-4194
651-296-7664
[email protected]
MPCA appointee
Samuel Yamin, MPH
Minnesota Center for Environmental
Advocacy
26 E. Exchange St., Ste. 206
St. Paul, MN 55101
(651) 223-5969
[email protected]
Minnesota Senate appointee
Daniel Stoddard, MS, PG
Minnesota Department of Agriculture
Pesticide and Fertilizer Management Division
625 Robert Street North
St. Paul, Minnesota 55155-2538
651-201-6291
[email protected]
MDA appointee
Lisa Yost, MPH, DABT
Exponent, Inc.
15375 SE 30th Pl, Ste 250
Bellevue, Washington 98007
Local office
St. Paul, Minnesota
651-225-1592
[email protected]
At-large representative
David Wallinga, MD, MPA
Institute for Agriculture & Trade Policy
Food and Health Program
2105 First Avenue South
Minneapolis, Minnesota 55404
612-870-3418
[email protected]
Nongovernmental organization representative
Rev. February 20, 2008
Please submit corrections to [email protected]
124
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.
125
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.
126
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
127
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]
128
Environmental Health Tracking and Biomonitoring
Steering Committee
Mary Manning, RD, MBA
Division Director
Health Promotion and Chronic Disease
Division
Minnesota Department of Health
PO Box 64882
St. Paul, Minnesota 55164-0882
651-201-3601
[email protected]
Norman Crouch, PhD (chair)
Assistant Commissioner
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0975
651-201-5063
[email protected]
Joanne Bartkus, PhD
Division Director
Public Health Laboratory Division
Minnesota Department of Health
PO Box 64899
St Paul, Minnesota 55164-0899
651-201-5256
[email protected]
John Linc Stine
Division Director
Environmental Health Division
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0975
651-201-4675
[email protected]
Rev. February 19, 2008
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Environmental Health Tracking and Biomonitoring
Inter-Agency Workgroup
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]
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]
Pam Shubat, PhD
Health Risk Assessment
Environmental Health Division
Minnesota Department of Health
PO Box 64975
St Paul, Minnesota 55164-0899
651-201-4925
[email protected]
Jean Johnson, PhD
Chronic Disease & Environmental
Epidemiology
Health Promotion and Chronic Disease
Division
Minnesota Department of Health
PO Box 64882
St. Paul, Minnesota 55164-0882
651-201-5902
[email protected]
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]
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]
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]
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]
Rev. October 8, 2007
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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.
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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.
134
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.
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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.
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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.
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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]
138
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
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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]
140
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.
(j) "Environmental health tracking" means
collection, integration, analysis, and dissemination of
data on human exposures to chemicals in the
environment and on diseases potentially caused or
aggravated by those chemicals.
144.995 DEFINITIONS; ENVIRONMENTAL
HEALTH TRACKING AND
BIOMONITORING.
(a) For purposes of sections 144.995 to 144.998,
the terms in this section have the meanings given.
(b) "Advisory panel" means the Environmental
Health Tracking and Biomonitoring Advisory Panel
established under section 144.998.
(c) "Biomonitoring" means the process by which
chemicals and their metabolites are identified and
measured within a biospecimen.
(d) "Biospecimen" means a sample of human fluid,
serum, or tissue that is reasonably available as a
medium to measure the presence and concentration of
chemicals or their metabolites in a human body.
(e) "Commissioner" means the commissioner of the
Department of Health.
(f) "Community" means geographically or
nongeographically based populations that may
participate in the biomonitoring program. A
"nongeographical community" includes, but is not
limited to, populations that may share a common
chemical exposure through similar occupations,
populations experiencing a common health outcome
that may be linked to chemical exposures,
populations that may experience similar chemical
exposures because of comparable consumption,
lifestyle, product use, and subpopulations that share
ethnicity, age, or gender.
(g) "Department" means the Department of Health.
(h) "Designated chemicals" means those chemicals
that are known to, or strongly suspected of, adversely
impacting human health or development, based upon
scientific, peer-reviewed animal, human, or in vitro
studies, and baseline human exposure data, and
consists of chemical families or metabolites that are
included in the federal Centers for Disease Control
and Prevention studies that are known collectively as
the National Reports on Human Exposure to
Environmental Chemicals Program and any
substances specified by the commissioner after
receiving recommendations under section 144.998,
subdivision 3, clause (6).
(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.
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
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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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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.
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
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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(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.
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
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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