i vSfri \ UNITED states environmental protection agency
i -SXl/Z I WASHINGTON D.C. 20460
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OFFICE OF THE ADMINISTRATOR
EPA SCIENCE ADVISORY BOARD
February 1, 2008
MEMORANDUM
SUBJECT: Science Advisory Board (SAB) Acrylamide Toxicological Review Panel-
Documentation for Panel Formation Determinations
FROM: Sue Shallal, Ph.D., Designated Federal Officer
Science Advisory Board Staff Office (1400F)
TO:
Vanessa Vu, Ph.D., Director
Science Advisory Board Staff Office (1400F)
THRU: Daniel Fort, Ethics and FACA Officer
Science Advisory Board Staff Office (1400F)
This memorandum documents the steps taken in regard to forming the SAB Ad Hoc Panel to
conduct a peer review of EPA's Draft IRIS Toxicol ogical Review of Acrylamide. It provides
background information on this SAB review activity and addresses:
• The expertise needed to address the charge;
• Conflict of Interest Considerations and Appearance of Lack of Impartiality;
• How individuals were selected for the Panel.
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EPA's Office of Research and Development (ORD) requested that the Science Advisory
Board (SAB) peer review its external draft assessment entitled, "Toxicological Review of
Acrylamide" (August 2006). Acrylamide polymer is primarily used in waste water treatment, paper
and pulp processing, and mineral processing. Other uses include as a water soluble polymer in crude
oil production, as a cosmetic additive, for soil and sand stabilization, grouting agents for sewer line
sealing and manhole sealing, and in electrophoresis gels used in research. Acrylamide has been
detected in a wide range of baked and fried foods. The detection of acrylamide in food prompted
intense international interest and on-going research to better characterize its hazard effects, and to
modify cooking practices to minimize levels in processed foods. EPA's National Center for
Environmental Assessment, within the Office of Research and Development, has been updating the
human health hazard and dose-response assessment for Acrylamide. EPA previously developed an
oral reference dose (RfD) for non-cancer effects and a cancer oral slope factor for Acrylamide
which are described in EPA's Integrated Risk Information System (IRIS) assessment (1988). An
inhalation reference concentration (RfC) was added to IRIS in 1990. The current EPA draft
assessment incorporates more recent studies and methods to derive an oral RfD and inhalation RfC
for non-cancer effects, and an oral slope factor and inhalation unit risk for carcinogenic effects.
ORD requested that the SAB comment on the scientific soundness of EPA's "Toxicological Review
of Acrylamide".
1) Panel Formation: The peer review will be conducted by a SAB Ad Hoc Review Panel. This
Panel, known as the Acrylamide Review Panel, will be composed of SAB members and invited
outside experts. A federal register notice was published on March 29, 2007 requesting nominations
of individuals with the following expertise, expertise in one or more of the following areas,
especially with respect to the health effects of Acrylamide: neurotoxicology; epidemiology;
toxicology, including reproductive/developmental toxicology, genetic toxicology and mechanisms
of action for carcinogenicity; metabolism; pharmacokinetics and modeling; dose-response
assessment; and exposure and risk assessment (see Attachment 1). On the basis of the candidates'
credentials and willingness to serve on the panel, the SAB Staff Office initially identified twenty
one (21) nominees for the "short list" of candidates and later identified four (4) additional
candidates.
On July 24, 2007, the SAB Staff Office posted a notice on the SAB Web site inviting public
comments on the prospective candidates being considered for the Panel (Attachment 2). In
particular, the notice on the Web site stated that the Staff Office would welcome any information,
analysis or documentation that the SAB Staff Office should consider in evaluating the candidates on
the "Short List". The notice also asked that any advice, observations or comments which would be
helpful in selecting the final candidates be provided to the SAB Staff Office no later than August
13, 2007. On September 18, 2007, the SAB Staff Office posted an updated notice on the SAB Web
site inviting public comments on the additional prospective candidates being considered for the
Panel; comments were due no later than October 2, 2007. The SAB Staff Office received three
submissions with comments on "short list" candidates for the Acrylamide Review Panel
(Attachment 3).
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2) Conflict of Interest Considerations:
For financial Conflict of Interest (COI) issues, 18 U.S.C. 208 provision states that:
"An employee is prohibited from participating personally and substantially in an official
capacity in any particular matter in which he, to his knowledge, or any person whose
interests are imputed to him under this statue has a financial interest, if the particular matter
will have a direct and predictable effect on that interest [emphasis added]."
For a conflict of interest to be present, all elements in the above provision must be present. If an
element is missing, the issue does not involve a formal conflict of interest. However, the general
provisions in the "appearance of a lack of impartiality guidelines" may still apply and need to be
considered.
Personal and Substantial Participation:
Participating personally means participating directly. Participating substantially refers to
involvement that is of significance to the matter. [5C.F.R. 2640.103(a)(2)], For this review,
panel members will be participating personally in the matter through attendance at meetings,
teleconferences and other means. SAB Review Panel members will provide advice that
might influence the Agency's carcinogenicity assessment of Acrylamide.
Direct and Predictable Effect:
A direct effect on a participant's financial interest exists if. "... a close causal link exists
between any decision or action to be taken in the matter and any expected effect of the
matter on the financial interest... A particular matter does not have a direct effect...if the
chain of causation is attenuated or is contingent upon the occurrence of events that are
speculative or that are independent of, and unrelated to, the matter. A particular matter that
has an effect on a financial interest only as a consequence of its effects on the general
economy is not considered to have a direct effect." [5 C.F.R. 2640.103(a)(i)]. A predictable
effect exists if, "...there is an actual, as opposed to a speculative, possibility that the matter
will affect the financial interest." [5 C.F.R. 2640.103(a) (ii)].
Particular Matter:
A "particular matter" refers to matters that "...will involve deliberation, decision, or action
that is focused upon the interests of specific people, or a discrete and identifiable class of
people." It does not refer to "...consideration or adoption of broad policy options directed to
the interests of a large and diverse group of people." [5 C.F.R. 2640.103 (a)(1)].
While acrylamide has been detected in a wide range of baked and fried foods and may be
considered a particular matter of general applicability, IRIS toxicologic reviews typically
focus on health effects and do not include exposure estimates or make any conclusions
regarding the risk associated with such exposures. The work of this SAB Advisory Panel
qualifies as a particular matter because the resulting advice will be part of a deliberation, and
under certain circumstances the advice could involve the interests of a discrete and
identifiable class of people and does involve specific parties. That group of people is the set
of people that are employed or have significant financial interests in organizations that could
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be considered part of the life-cycle of the chemical (Acrylamide) to be considered by the
panel (including, but not limited to, manufacture, use, treatment and disposal).
Additionally, 5 CFR 2637.102(a)(7) defines a particular matter involving specific parties to
mean any judicial or other proceeding, application, request for ruling or other determination,
contract, claim, controversy, investigation, change, accusation, arrest or other particular
matter involving a specific party or parties in which the United States is a party or has a
direct and substantial interest.
The number of manufacturers or users of Acrylamide are limited in number and
represent a discrete and identifiable class of people or specific parties. Therefore, the
work to be done by the Panel meets the criteria for a particular matter involving
specific parties.
3) Appearance of a Lack of Impartiality Considerations:
The Code of Federal Regulations [5 C.F.R. 2635.502(a)] states that:
"Where an employee knows that a particular matter involving specific parties is likely to
have a direct and predictable effect on the financial interest of a member of his household,
or knows that a person with whom he has a covered relationship is or represents a party to
such matter, and where the person determines that the circumstances would cause a
reasonable person with knowledge of the relevant facts to question his impartiality in the
matter, the employee should not participate in the matter unless he has informed the agency
designee of the appearance problem and received authorization from the agency designee."
Further, 5 C.F.R. 2635.502(a)(2) states that:
"An employee who is concerned that circumstances other than those specifically described
in this section would raise a question regarding his impartiality should use the process
described in this section to determine whether he should or should not participate in a
particular matter."
As noted above, the subject of this SAB review can be considered as a particular matter
involving specific parties. Each potential advisory panel member was evaluated against the 5
C.F.R. 2635.502(a)(2) general requirements for considering an appearance of a lack of
impartiality. Information used in this evaluation has come from information provided by
potential advisory panel members (including, but not limited to, EPA 3110-48 confidential
financial disclosure forms) and public comment.
For prospective advisory panel members who hold grants, cooperative agreements or
contracts or are involved with organizations that can be considered specific parties, the
"reasonable person" criterion is met in the following manner:
i) Those who are or have previously been employed by the regulated community were
considered to meet this criterion.
ii) Those who have a pending grant, cooperative agreement, or contract whose funds could
be directly received from specific parties as part of a prospective advisory panel member's
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salary for efforts to research the health and ecological effects of Acrylamide were
considered to met the criterion.
To evaluate any potentially appearance of a lack of impartiality, the following five (5)
questions were posed to prospective advisory panel members:
a) Do you know of any reason that you might be unable to provide impartial advice on
the matter to come before the Panel or any reason that your impartiality in the matter
might be questioned?
b) Have you had any previous involvement with the issue(s) or document(s) under
consideration, including authorship, collaboration with the authors, or previous peer
review functions? If so, please identify those activities.
c) Have you served on previous advisory panels or committees that have addressed the
topic under consideration? If so, please identify those activities.
d) Have you made any public statements (written or oral) on the issue? If so, please
identify those statements.
e) Have you made any public statements that would indicate to an observer that you have
taken a position on the issue under consideration? If so, please identify those
statements.
4) Conflict of Interest and Appearance of a Lack of Impartiality Determination for Review Panel
Members
Prospective advisory panel members were required to submit a confidential financial disclosure
form (EPA Form 3110-48, "Confidential Financial Disclosure Form for Special Government
Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection
Agency). As a result of a review of these forms, the responses to the five questions above, along
with other information provided by each prospective advisory panel member and public
commenters, the Deputy Ethics Official of the Science Advisory Board, in consultation with the
SAB Ethics and FACA Policy Officer, has determined that there are no conflict of interest or
appearance of a lack of impartiality for the members of this panel.
5) How individuals were selected for the final Panel: The SAB Staff Office Director makes the
decision about who serves on this Review Panel during the "Panel Selection" phase. Members of
the Panel were selected from the "short list" candidates. Selection criteria included: scientific
credentials and expertise; willingness to serve on the Panel, and availability to meet during the
proposed time period; absence of conflict of interest and absence of a lack of appearance of
impartiality issues, and balance of relevant expertise and diversity of scientific viewpoints. Based
on the above specified criteria, the membership of the Acrylamide Review Panel includes the
following experts:
Dr. Deborah Cory-Slechta, University of Rochester (CHAIR)
Dr. Alfred Branen, University of Idaho
Dr. Daniel Doerge, Food and Drug Administration- National Center for Toxicological Research
Dr. James Felton, Lawrence Livermore National Laboratory
Dr. Timothy Fennell, Research Triangle Institute (RTI) International
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Dr. Pennelope Fenner-Crisp, Consultant
Dr. Jeffery Fisher, University of Georgia
Dr. Sean Hays, Summit Toxicology
Dr. Steven Heeringa, University of Michigan
Dr. Richard LoPachin, Montefiore Medical Center
Dr. Lorelei Mucci, Harvard University
Dr. Jerry M. Rice, Georgetown University
Dr. Dale Sickles, University of Georgia
Dr. Gina Solomon, National Resources Defense Council
Dr. Anne Swenney, Texas A&M University
Dr. Lauren Zeise, California EPA
Concurred, Date
[s[ February 1. 2008
Vanessa Vu, Ph.D., Director
EPA Science Advisory Board Staff Office (1400F)
ATTACHMENTS
Attachment 1
Attachment 2
Attachment 3
Federal Register Notice- Request for nomination of experts
Invitation for comments on the "Short List" candidates
List of public commenters on the "Short List" candidates
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ATTACHMENT 1
EPA Science Advisory Board Staff Office; Request for Nominations of Experts for the Acrylamide
Review Panel
[Federal Register: March 29, 2007 (Volume 72, Number 60)]
[Notices]
[Page 14804-14805]
ENVIRONMENTAL PROTECTION AGENCY
[FRL-8293-3]
EPA Science Advisory Board Staff Office; Request for
Nominations of Experts for the Acrylamide Review Panel
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
SUMMARY: Requesting the nomination of experts for the Science
Advisory Board (SAB) Acrylamide Review Panel.
DATES: Nominations should be submitted by April 19, 2007, per
instructions below.
FOR FURTHER INFORMATION CONTACT: Any member of the public
wishing further information regarding this Request for
Nominations may contact Dr. Suhair Shallal, Designated
Federal Officer (DFO), SAB Staff Office, by telephone/voice
mail at (202) 343-9977; by fax at (202) 233-0643; or via e-
mail at shallal.suhair@epa.gov. General information
concerning the EPA Science Advisory Board can be found on the
EPA SAB Web Site at: http://www.epa.gov/sab.
SUPPLEMENTARY INFORMATION:
Background: Acrylamide polymer is primarily used in waste
water treatment, paper and pulp processing, and mineral
processing. Other uses include as a water soluble polymer in
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crude oil production, as a cosmetic additive, for soil and
sand stabilization, grouting agents for sewer line sealing
and manhole sealing, and in electrophoresis gels used in
research. Acrylamide has been detected in a wide range of
baked and fried foods. The detection of acrylamide in food
prompted intense international interest and on-going research
to better characterize its hazard effects, and to modify
cooking practices to minimize levels in processed foods.
EPA's National Center for Environmental Assessment, within
the Office of Research and Development, has been updating the
human health hazard and dose-response assessment for
Acrylamide. EPA previously developed an oral reference dose
(RfD) for non-cancer effects and a cancer oral slope factor
for Acrylamide which are described in EPA's Integrated Risk
Information System (IRIS) assessment (1988) . An inhalation
reference concentration (RfC) was added to IRIS in 1990. The
current EPA draft assessment incorporates more recent studies
and methods to derive an oral RfD and inhalation RfC for non-
cancer effects, and an oral slope factor and inhalation unit
risk for carcinogenic effects. ORD has requested that the
Science Advisory Board (SAB) review its draft assessment
entitled sToxicological Review of Acrylamide''.
The EPA Science Advisory Board (SAB) was established by
42 U.S.C. 4365 to provide independent scientific and
technical advice, consultation and recommendations to the EPA
Administrator on the technical basis for Agency positions and
regulations. The SAB Acrylamide Review Panel, conducting the
review of the Agency's draft assessment of Acrylamide, will
consist of members of the chartered SAB, SAB Committee
members and additional external experts. This panel will
comply with the provisions of the Federal Advisory Committee
Act (FACA) and all appropriate SAB procedural policies. Upon
completion, the panel's report will be submitted to the
chartered SAB for final approval for transmittal to the EPA
Administrator. The SAB Acrylamide Review Panel is being asked
to comment on the scientific soundness of this draft
assessment.
Availability of the Review Materials: The EPA draft
document to be reviewed by the SAB Panel will be made
available by the Office of Research and Development. For
questions and information concerning the review materials,
please contact Dr. Rob Dewoskin, at (919) 541-1089, or
dewoskin.rob@epa.gov.
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Request for Nominations: The SAB Staff Office is
requesting nominations of nationally recognized experts with
expertise in one or more of the following areas, especially
with respect to the health effects of Acrylamide:
neurotoxicology; epidemiology; toxicology, including
reproductive/developmental toxicology, genetic toxicology and
mechanisms of action for carcinogenicity; metabolism;
pharmacokinetics and modeling; dose-response assessment; and
exposure and risk assessment.
Process and Deadline for Submitting Nominations: Any
interested person or organization may nominate qualified
individuals for possible service on the Acrylamide Review
Panel in the areas of expertise described above. Nominations
should be submitted in electronic format through the SAB Web
site at the following URL: http://www.epa.gov/sab; or
directly via the Form for Nominating Individuals to Panels of
the EPA Science Advisory Board link found at URL:
http://www.epa.gov/sab/panels/pane1topics.html. Please follow
the instructions for submitting nominations carefully. To be
considered, nominations should include all of the information
required on the associated forms. Anyone unable to submit
nominations using the electronic form and who has any
questions concerning the nomination process may contact Dr.
Suhair Shallal, DFO, as indicated above in this notice.
Nominations should be submitted in time to arrive no later
than April 19, 2007.
For nominees to be considered, please include: contact
information; a curriculum vitae; a biosketch of no more than
two paragraphs (containing information on the nominee's
current position, educational background, areas of expertise
and research activities, service on other advisory committees
and professional societies; the candidate's special expertise
related to the panel being formed; and sources of recent
grant and/or contract support) .
The EPA SAB Staff Office will acknowledge receipt of
nominations. The names and biosketchs of qualified nominees
identified by respondents to the Federal Register notice and
additional experts identified by the SAB Staff will be posted
on the SAB Web Site at: http://www.epa.gov/sab. Public
comments on this "Short List" of candidates will be accepted
for 21 calendar days. The public will be requested to provide
relevant information or other documentation on nominees that
the SAB Staff Office should consider in evaluating
candidates.
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For the EPA SAB Staff Office, a balanced subcommittee or
review panel includes candidates who possess the necessary
domains of knowledge, the relevant scientific perspectives
(which, among other factors, can be influenced by work
history and affiliation), and the collective breadth of
experience to adequately address the charge. In establishing
the final Acrylamide Review Panel (ARP), the SAB Staff Office
will consider public comments on the "Short List" of
candidates, information provided by the candidates
themselves, and background information independently gathered
by the SAB Staff Office. Selection criteria to be used for
Panel membership include: (a)Scientific and/or technical
expertise, knowledge, and experience(primary factors); (b)
availability and willingness to serve; (c)absence of
financial conflicts of interest; (d) absence of an appearance
of a lack of impartiality; and (e) skills working in
committees, subcommittees and advisory panels; and, for the
Panel as a whole, (f) diversity of, and balance among,
scientific expertise, viewpoints, etc.
The SAB Staff Office's evaluation of an absence of
financial conflicts of interest will include a review of the
"Confidential Financial Disclosure Form for Special
Government Employees Serving on Federal Advisory Committees
at the U.S. Environmental Protection Agency" (EPA Form 3110-
48). This confidential form allows Government officials to
determine whether there is a statutory conflict between that
person's public responsibilities (which includes membership
on an EPA Federal advisory committee) and private interests
and activities, or the appearance of a lack of impartiality,
as defined by Federal regulation. The form may be viewed and
downloaded from the following URL address:
http://www.epa.gov/sab/pdf/epaform3110-4 8.pdf.
The approved policy under which the EPA SAB Office
selects subcommittees and review panels is described in the
following document: Overview of the Panel Formation Process
at the Environmental Protection Agency Science Advisory Board
(EPA-SAB-EC-02-010), which is posted on the SAB Web Site at:
http://www.epa.gov/sab/pdf/ec02010.pdf.
Dated: March 21, 2007
Anthony F. Maciorowski,
Deputy Director, EPA Science Advisory Board Staff Office.
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ATTACHMENT 2
Invitation for Comment on the EPA Science Advisory Board
Additional Short List Candidates for the Acrylamide Review Panel
September 18, 2007
The EPA Science Advisory Board (SAB) Staff Office announced in a Federal Register
Notice (Volume 72, Number 60, Pages 14804-14805) that it was forming a panel to conduct a peer
review of EPA's Draft Toxicological Review of Acrylamide. To form the panel, the SAB Staff
Office sought public nominations of nationally recognized experts with expertise in one or more of
the following areas, especially with respect to the health effects of Acrylamide: neurotoxicology;
epidemiology; toxicology, including reproductive/developmental toxicology, genetic toxicology and
mechanisms of action for carcinogenicity; metabolism; pharmacokinetics and modeling; dose-
response assessment; and exposure and risk assessment. On July 24, 2007, the SAB Staff Office
posted a short list of 21 candidates for public comment.
The SAB Staff Office has identified 4 additional candidates who have the relevant expertise
for panel membership. Brief biographical sketches ("biosketches") on these expert candidates are
provided below. We hereby invite comments from members of the public for relevant information,
analysis or other documentation that the SAB Staff Office should consider in evaluating these
additional candidates.
The SAB Staff Office Director makes the final decision about who serves on the review
panel, based on all relevant information. This includes a review of the member's confidential
financial disclosure form (EPA Form 3110-48) and an evaluation of a lack of impartiality. For the
EPA SAB Staff Office, a balanced committee or panel is characterized by inclusion of candidates
who possess the necessary domains of knowledge, the relevant scientific perspectives (which
among other factors, can be influenced by work history and affiliation), and the collective breadth
of experience to adequately address the general charge. Specific criteria to be used in evaluating an
individual Panel member include: (a) scientific and/or technical expertise, knowledge, and
experience; (b) availability and willingness to serve; (c) absence of financial conflicts of interest;
(d) absence of an appearance of a lack of impartiality; and (e) skills working in committees,
subcommittees and advisory panels; and, for the Panel as a whole, (f) diversity of, and balance
among, scientific expertise, viewpoints, etc.
Please provide any comments you may have with respect to the "Updated Short List" candidates, no later than
October 2, 2007. Please make your comments to the attention of Dr. Suhair Shallal, Designated Federal Officer.
Emailing comments (shallal.suhair@epa.gov) is the preferred mode of receipt.
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List of Additional Candidates for the Acrylamide Review Panel
Jack Colford, MD PhD is an Associate Professor of Epidemiology at the University of California,
Berkeley, School of Public Health. He is a graduate of the Johns Hopkins School of Medicine (MD
1985) and the UC Berkeley School of Public Health (PhD, Epidemiology, 1996). He completed a
residency in Internal Medicine and a fellowship in Infectious Diseases at the University of California,
San Francisco. He was Chief Medical Resident at Stanford University Hospital. He is board-certified
in both Internal Medicine and Infectious Diseases and is also an Attending Physician at the San
Francisco VA Medical Center ID clinic. Dr. Colford is the sole instructor in semester-long courses in
advanced epidemiologic methods, intervention trial design, and meta-analysis and has received
several teaching awards. He has taught for many years as a visiting professor each summer at the
University of Michigan (meta-analysis) and the University of Zurich, Switzerland (epidemiologic
methods). Dr. Colford has been an author of more than 40 peer-reviewed scientific publications,
including numerous peer-reviewed articles on the health effects of waterborne diseases. He has
received more than $11.0 million in research funding. He is the Principal Investigator of four triple-
blinded, randomized controlled trials of drinking water and health effects funded by the National
Institutes of Health, the Centers for Disease Control, and the Environmental Protection Agency, and
the University of California. These have included large trials in the United States as well as a
drinking water study in 22 villages now underway in Bolivia. He was the Principal Investigator of the
Mission Bay Epidemiology study of the health effects of recreational water exposure, funded by the
California Regional Water Quality Control Board. He was asked by an NRC committee to review all
health evidence of associations between recreational water indicators and health outcomes. Dr.
Colford recently returned to UC Berkeley after a one year sabbatical at the World Health Organization
(Water, Sanitation, and Health Division) in Geneva, Switzerland where he collaborated with the World
Bank in a published monograph and peer-reviewed manuscript evaluating the effectiveness of
drinking water treatments throughout the world.
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Heeringa,Steven
Dr. Anne Sweeney is an Associate Professor of Epidemiology at the Texas A&M University System
School of Rural Public Health in Bryan, Texas. She received a B.S. degree in Nutrition and Dietetics in
1975 from Marywood College. She earned both her MPH and Ph.D. degrees in Epidemiology from the
University of Pittsburgh, Graduate School of Public Health in 1988 and 1991, respectively. Dr.
Sweeney served as a member of the Institute of Medicine's Gulf War and Health Study Committee, on
the expert panel assessing the health effects of pesticides. She is also a member of the Fertility and
Early Pregnancy Committee, assigned to the National Longitudinal Cohort Study Planning Committee,
sponsored by the National Institute of Child Health and Human Development, the National Institute
for Environmental Health Sciences, the Centers for Disease Control and Prevention, and the U.S. EPA.
Her research interests include environmental and occupational exposures to toxic agents and the
relation to adverse reproductive effects, particularly infertility, early pregnancy loss, and congenital
anomalies. Dr. Sweeney has had extensive experience conducting large population-based studies of
cohorts exposed to endocrine active compounds, including PCBs, PBBs, dioxin, and phthalates, and
their effects on pregnancy outcome. She is currently the Principal Investigator on a project under the
FRIENDS Children's Environmental Health Center, awarded to the University of Illinois at Urbana-
Champaign, by the National Institute for Environmental Health Sciences and the U.S. EPA, as well as
a project to assess PCBs and OCs and fecundity and fertility, awarded by the National Institute for
Child Health and Human Development.
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Invitation for Comment on the EPA Science Advisory Board
Short List Candidates for the Acrylamide Review Panel
July 23, 2007
The EPA Science Advisory Board (SAB) Staff Office announced in a Federal Register
Notice (Volume 72, Number 60, Pages 14804-14805) that it was forming a panel to conduct a peer
review of EPA's Draft Toxicological Review of Acrylamide. To form the panel, the SAB Staff
Office sought public nominations of nationally recognized experts with expertise in one or more of
the following areas, especially with respect to the health effects of Acrylamide: neurotoxicology;
epidemiology; toxicology, including reproductive/developmental toxicology, genetic toxicology and
mechanisms of action for carcinogenicity; metabolism; pharmacokinetics and modeling; dose-
response assessment; and exposure and risk assessment.
Background information on the project and details on the nomination process appeared in
the cited notice. The notice is available on the SAB Website at http J/www, epa. gov/ sab/.
Based on qualifications, interest and willingness to serve of the nominees, the SAB Staff
Office has identified 21 candidates who have the relevant expertise for panel membership. Brief
biographical sketches ("biosketches") on these expert candidates are provided below. We hereby
invite comments from members of the public for relevant information, analysis or other
documentation that the SAB Staff Office should consider in evaluating these candidates.
The SAB Staff Office Director makes the final decision about who serves on the review
panel, based on all relevant information. This includes a review of the member's confidential
financial disclosure form (EPA Form 3110-48) and an evaluation of a lack of impartiality. For the
EPA SAB Staff Office, a balanced committee or panel is characterized by inclusion of candidates
who possess the necessary domains of knowledge, the relevant scientific perspectives (which
among other factors, can be influenced by work history and affiliation), and the collective breadth
of experience to adequately address the general charge. Specific criteria to be used in evaluating an
individual Panel member include: (a) scientific and/or technical expertise, knowledge, and
experience; (b) availability and willingness to serve; (c) absence of financial conflicts of interest;
(d) absence of an appearance of a lack of impartiality; and (e) skills working in committees,
subcommittees and advisory panels; and, for the Panel as a whole, (f) diversity of, and balance
among, scientific expertise, viewpoints, etc.
Please provide any comments you may have with respect to the "Short List" candidates, no later than August
13, 2006. Please make your comments to the attention of Dr. Suhair Shallal, Designated Federal Officer. Emailing
comments (shallal.suhair@epa.gov) is the preferred mode of receipt.
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List of Prospective Candidates for the Acrylamide Review Panel
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has been the President of the US Environmental Mutagen Society and served on the Board of
Scientific Counselors to the NCI Division of Cancer Etiology. He is a past member of subcommittee E
of the NCI reviewing POls, UOls, and R03s related to cancer prevention, control, and causation. He
also in 1993 served as chair of an NCI committee to study the 10 year research accomplishments in
basic cancer mechanisms. Currently, his research is looking at susceptibility to heterocyclic amine
carcinogens in the diet. He has developed mass spectrometric methods to analyze human urinary
metabolites of these carcinogens based on a single meal of well-done chicken or meat. He is the PI
on a NCI funded POl grant (15th yr) to study in a comprehensive way the risks from consuming
these carcinogens in our diet. This work is broad based, as it uses genomics, bio-computations,
analytical chemistry, accelerator mass spectrometry, synthetic chemistry, mutation analysis,
biomarkers, and epidemiology to understand this possible etiology of human cancers.
Fennell,Timoth;
RTI International
Dr. Timothy Fennell is currently employed as a Senior Research Chemist at RTI International in
Research Triangle Park, NC. He has over 25 years of experience in drug and chemical metabolism and
pharmacokinetics. Tim joined the RTI staff in July 2002. Prior to that time (1986-2002), he was a
Scientist at the CUT Centers for Health Research. He has a B.Sc. (1976) and Ph.D. (1980) in
Biochemistry from the University of Surrey in England. He conducted postdoctoral research at the
McArdle Laboratory for Cancer Research at the University of Wisconsin - Madison. Dr. Fennell has
been involved in research on a variety of chemicals, with particular emphasis on understanding the
effects of metabolism and disposition on the generation of adverse effects. He has expertise in the
measurement of DNA and protein adducts. Much of his recent research has focused on the
metabolism and adduct formation of acrylamide and glycidamide. Dr. Fennell and colleagues were
instrumental in elucidating the metabolism of acrylamide in rodents and people. He has used adducts
derived from acrylamide and glycidamide to make comparisons of internal dose between species,
between route of exposure and administered dose. Dr. Fennell is a member of a number of
professional societies, including the Society of Toxicology, the American Chemical Society, and the
American Association for the Advancement of Science. He has served as Vice President, President
Elect, President and Past President of the North Carolina Chapter of the Society of Toxicology. He has
served on the editorial board of a number of journals including Toxicological Sciences, Toxicology
Letters, and was Associate Editor of Biomarkers (1996-2001). He has served as an adjunct faculty
member at Duke University, and the University of North Carolina at Chapel Hill.
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a transformation in the design of human industry to achieve sustainability. She has served on the
board of the American Board of Toxicology. She is a Charter member of the Society for Risk Analysis
(SRA), having received its first Risk Practitioner's Award in 1996, the Capital Area Chapter of SRA, and
a long-time member of the Society of Toxicology and its National Capital Area Chapter.
Fisher,Jeffrey
University of Georgia
Dr. Jeffrey Fisher is a Professor in the Department of Environmental Health Science, College of Public
Health at the University of Georgia (UGA). He joined the University of Georgia in 2000 and served as
Department Head of the Department of Environmental Health Sciences from 2000 to 2006. He now
serves a Director of the Interdisciplinary Toxicology Program at UGA. Dr. Fisher research interests are
in the development and application of biologically based mathematical models to ascertain health
risks from environmental and occupational chemical exposures. Dr. Fisher's modeling experience
includes working with chlorinated and non-chlorinated solvents, fuels, PCB, pyrethroids and
perchlorate. He has developed PBPK models for use in cancer risk assessment, estimating lactational
transfer of solvents, understanding in utero and neonatal dosimetry, quantifying metabolism of
solvent mixtures and developing biologically motivated models for the hypothalamic-pituitary-thyroid
axis in rodents and humans. Dr. Fisher has 20 years of experience in physiological modeling and has
trained several graduate students and postdoctoral fellows on the concepts and application of
physiological models. Dr. Fisher's laboratory and computational research are funded through grants
provided by the USEPA, CDC/ATSDR, AFOSR, DOE, and occasionally subcontracts with nonprofit
organizations or trade groups. He spent most of his career at the Toxicology Laboratory, Wright
Patterson AFB, where he was Principal Investigator and Senior Scientist in the Toxics Hazards Division
and Technical Advisor for the Operational Toxicology Branch. He was a Visiting Scientist at the
Chemical Industry Institute of Toxicology in 1996 and at the NIOSH Taft Laboratory in 1999. During
this time, he also served as Adjunct Professor in the Department of Pharmacology and Toxicology at
Wright State University. Dr. Fisher has published over 100 papers on pharmacokinetics and PBPK
modeling in laboratory animals and humans. He has served on several panels and advisory boards for
the DoD, ATSDR, USEPA and non-profit organizations. He also has been a U.S. delegate for the North
Atlantic Treaty Organization. Dr. Fisher served on the International Life Sciences Institute Steering
Committee, which evaluated chloroform and dichloroacetic acid using EPA-proposed Carcinogen Risk
Guidelines. He is Past President of the Biological Modeling Specialty Section of the Society of
Toxicology, reviewer for several toxicology journals, and was Co-Principal Investigator on a National
Institutes of Health (NIH)-supported workshop on Mathematical Modeling at the University of Georgia
in the fall of 2003. He is a member of the National Academy of Sciences subcommittee on Acute
Exposure Guideline Levels (AEGLs) since 2004 and is a Fellow of the Academy of Toxicological
Sciences. He is currently on the editorial boards for the International Journal of Toxicology and the
Journal of Toxicology and Environmental Health. Dr. Fisher has a B.S. degree in biology from the
University of Nebraska at Kearney, a M.S. degree in biology/ecology from Wright State University, and
a Ph.D. in Zoology/Toxicology from Miami University.
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develop a PBPK model for chromium), and has specialized in developing models for pregnancy and
the developing child. He has over nine years of experience performing pharmacokinetic modeling of
lead in humans and in using the O'Flaherty lead PBPK and IEUBK models to assess potential health
risks for a wide range of potential exposure scenarios. Mr. Hays has used the lead PBPK model to set
site-specific clean-up goals for numerous lead impacted properties, to model the potential for
elevated blood lead levels among children exposed to elevated levels of lead in school drinking water
supplies, and for modeling the likely changes in blood lead levels among astronauts who experience
rapid and substantial bone loss while on extended space travel. Mr. Hays has experience using U.S.
EPA's IEUBK model for risk assessment purposes and has performed detailed analyses to evaluate the
scientific differences between the various lead pharmacokinetic models and to evaluate in which risk
assessment scenarios each lead model is scientifically valid for predicting changes in blood lead
levels.Mr. Hays is a member of the Society of Toxicology, the International Society of Regulatory
Toxicology and Pharmacology, the American Conference of Governmental Industrial Hygienists, the
International Society of Exposure Analysis, and the Society of Risk Analysis. He is currently serving as
the Vice President-Elect of the Biological Modeling Section of the Society of Toxicology. Over the past
two years, Mr. Hays has received funding related to lead from Wyle Laboratories (a subcontractor to
NASA) to develop a lead PBPK to predict the potential impact that extended periods of exposure to
microgravity would have on the blood lead levels of astronauts. He has also received funding from a
large school district in the Pacific Northwest to help model the likely blood lead levels of children who
had been exposed to elevated levels of lead in their school drinking water. In Mr. Hays' other
consulting efforts, he has received funding from the U.S. EPA to develop PBPK models, from private
industry to develop PBPK models and exposure and risk assessments for a variety of chemicals and to
develop methods for interpreting biomonitoring data.
Kleinman,Michael T.
University of California, Irvine
Michael T. Kleinman is a Professor of Community and Environmental Medicine at the University of
California, Irvine. He is an inhalation toxicologist and has been studying the health effects of
exposures to environmental contaminants found in ambient air for more than 30 years. He holds a MS
in Chemistry (Biochemistry) from the Polytechnic Institute of Brooklyn and a Ph.D. in Environmental
Health Sciences from New York University. He is a Professor and Co-Director of the Air Pollution
Health Effects Laboratory in the Department of Community and Environmental Medicine at University
of California, Irvine. Prior to joining the faculty at U.C.I, in 1982, he directed the Aerosol Exposure
and Analytical Laboratory at Rancho Los Amigos Hospital in Downey, CA. He has published more than
95 articles in peer-reviewed journals dealing with environmental contaminants and their effects on
cardiopulmonary and immunological systems. He has directed more than 50 controlled exposure
studies of human volunteers and laboratory animals to ozone and other photochemical oxidants,
carbon monoxide, ambient particulate matter and laboratory-generated aerosols containing
chemically or biologically reactive metals such as lead, cadmium, iron and manganese. He recently
served on two National Academy committees to examine issues in protecting deployed US Forces
from the effects of chemical and biological weapons. Dr. Kleinman's current studies focus on
neurological and cardiopulmonary effects of inhaled particles, including nanomaterials and ultrafine,
fine and coarse ambient particles in humans and laboratory animals. His current studies have
demonstrated that inhalation of combustion-generated particles can promote airway allergies and
accelerate the development of cardiovascular disease and that these effects may be associated with
organic and elemental carbon components of the ultrafine fraction of the ambient aerosol. His studies
have also demonstrated that inhalation of ambient particles is associated with persistent inflammation
in the brain and that particles associated with manganese can alter dopamine and serotonin levels in
the brain and can cause changes in nerve structure during brain development. Dr. Kleinman has
previously served on the U.S. EPA Science Advisory Board' Clean Air Scientific Advisory Committee
(CASAC) Ozone panel and currently serves as the Chair of the California Air Quality Advisory
Committee.
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Albert Einstein College of Medicine
Dr. Richard M. LoPachin is a Professor of Anesthesiology and Director of Research at the Albert
Einstein College of Medicine. He holds a B.S. in Biochemistry and a M.S. in Pharmacology from the
University of Georgia and a Ph.D. in Pharmacology/Toxicology from the University of Wisconsin,
Madison. Dr. LoPachin has been on the faculty of the Albert Einstein College of Medicine since 1994.
He is a molecular neurotoxicologist and has published over 90 research papers, reviews and book
chapters on this subject. Dr. LoPachin is an Associate Editor for NeuroToxicology and he is a member
of numerous editorial boards for other scientific journals. He has served extensively on scientific
review panels for government (NIEHS, NIOSH, NINDS, NIMH, CDC) and private funding institutions.
He has also participated in several workshops on acrylamide in food (JIFSAN/NCFST workshop). Dr.
LoPachin's research over the past twenty-five years has focused on molecular mechanisms of
neurotoxicity. Specifically, he has demonstrated that acrylamide (ACR) neurotoxicity is mediated by
nerve terminal dysfunction in the central and peripheral nervous systems. Results from proteomic and
chemical studies conducted in his laboratories have suggested that this damage occurs when ACR
forms adducts with cysteine sulfhydryl groups on many presynaptic proteins that are involved in
neurotransmitter uptake, release and storage. The National Institute of Environmental Health
Sciences (NIEHS) has supported this research program for over 20 years. Dr. LoPachin's research
interest also include defining the mechanism of axon atrophy induced by exposure to 2,5-
hexanedione (HD), the active metabolite of n-hexane. His recent studies suggest that HD forms
adducts with lysine residues on the "tail" portion of heavy neurofilament subunits. This impairs their
incorporation into the axon cytoskeletal polymer and results in loss of caliber. This research has been
funded by NIEHS for 12 years.
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Rice,Jerry M.
Georgetown University Medical Center
Jerry M. Rice, Ph.D., received his doctorate in biochemistry from Harvard University in 1966. His
research interests include comparative tumor pathology; perinatal and transplacental chemical
carcinogenesis; tumor promotion; the molecular biology of transforming and tumor suppressing genes
in tumors; and the carcinogenic hazards presented by infections and infectious agents. He joined the
U. S. National Cancer Institute as a commissioned officer in the U.S. Public Health Service in 1966,
becoming chief of the Laboratory of Comparative Carcinogenesis in 1981, and Associate Director for
the Frederick Cancer Research and Development Center and Acting Director of the Division of Cancer
Etiology in 1994. In 1996 he retired from the U.S. Public Health Service and joined the International
Agency for Research on Cancer in Lyon, France, where he served as Chief of the Unit of Carcinogen
Identification and Evaluation and Director of the IARC Monographs Programme on Evaluation of
Carcinogenic Risks to Humans. He retired from the World Health Organization in 2002, but continues
to be actively involved with the WHO in various capacities. He is currently Distinguished Professor of
Oncology in the Lombardi Cancer Center at Georgetown University Medical Center, Washington,
where he lectures in graduate courses and does research on tobacco-related carcinogenic hazards. He
also consults on issues related to carcinogenic hazard identification and carcinogenic risk assessment.
He has published 180 research papers and more than 70 book chapters, reviews, and editorials, and
has co-edited seven books. His awards include the Meritorious Service Medal of the U.S. Public Health
Service and the Toxicology Forum's George Scott Award in Toxicology.
Sickles,Dale
Medical College of Georgia
Dr. Dale Sickles is a Professor and Vice-Chair of the Department of Cellular Biology and Anatomy at
the Medical College of Georgia in Augusta, GA. He received his BS in Biology and Chemistry and his
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organized by the U.S. Environmental Protection Agency's Science Advisory Board, and the National
Academy of Sciences. He is especially concerned with risk assessment issues arising from the effects
of environmental chemicals on brain development and brain aging. He is the editor or co-editor of
seven books and monographs and author or co-author of over 200 articles. His special interests and
publications lie primarily in areas that involve chemical influences on behavior; these include the
neurobehavioral toxicology of metals such as lead, mercury and manganese; endocrine disrupter such
as dioxin; solvents such as toluene and methanol; drugs such as cocaine; and air pollutants such as
ozone.
Zeise,Lauren
California Environmental Protection Agenc
Dr. Lauren Zeise is Chief of Reproductive and Cancer Hazard Assessment within the California
Environmental Protection Agency's Office of Environmental Health Hazard Assessment. In that
position since 1991, she has overseen a variety of the state's cancer, reproductive and ecological risk
assessment activities. Current work addresses cancer and reproductive risk methodologies and
characterizations, development of ecological risk guidance, establishment of baseline risks from
gasoline use in California and guidance for evaluating risks to the fetus, children and adolescents
from environmental exposures. Her group also conducts scientific evaluations mandated by
California's Proposition 65. Her research has focused on cancer risk assessment methodology and
applications. Dr. Zeise currently serves on the EPA Science Advisory Board (SAB), and has served
previously as a member of the SAB Environmental Health Committee, Research Strategies Advisory
Committee and Integrated Risk Project, and as consultant to the Clean Air Act Scientific Advisory
Committee, Environmental Engineering Committee, FIFRA Science Advisory Panel, EPA Board of
Scientific Counselors, and on various Ad-hoc advisory committees of the Agency. Other service
includes membership on various committees of the National Institute of Medicine (IOM), National
Research Council (NRC), Consumer Product Safety Commission, National Toxicology Program, Office
of Technology Assessment. She currently serves on the IOM Board of Health Promotion and Disease
Prevention and NRC Board on Environmental Sciences and Toxicology. She is a member, fellow and
councilor of the Society of Risk Analysis and is on the editorial board for the Society's journal. The
National Cancer Institute Smoking and Tobacco Smoke Monograph Health Effects of Environmental
Tobacco Smoke was conceived and developed under her editorial direction. She is co-author and co-
editor of the 1999 International Agency for Research on Cancer monograph Quantitative Estimation
and Prediction of Cancer Risk. She received in 1977 her M.S. and in 1984 her Ph.D. from Harvard
University, where she also conducted postdoctoral research on risk assessment methodology.
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ATTACHMENT 3
Adrienne Kiley North American Polyelectrolyte Producers Association (NAPPA)
Kirsten Stade Center for Science in the Public Interest (CSPI)
Michael Jacob son Center for Science in the Public Interest (CSPI)
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