Nominations to the FIFRA Scientific Advisory Panel; Request for Comments, 40584-40588 [E9-19313]
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• Mail: Send comments by mail to:
Board of Scientific Counselors (BOSC),
2009 Clean Air Subcommittee Meetings
Docket, Mailcode: 28221T, 1200
Pennsylvania Ave., NW., Washington,
DC, 20460, Attention Docket ID No.
EPA–HQ–ORD–2009–0225.
• Hand Delivery or Courier. Deliver
comments to: EPA Docket Center (EPA/
DC), Room B102, EPA West Building,
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Washington, DC, Attention Docket ID
No. EPA–HQ–ORD–2009–0225. Note:
this is not a mailing address. Such
deliveries are only accepted during the
docket’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–ORD–2009–
0225. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
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Information (CBI) or other information
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consider to be CBI or otherwise
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or contact information unless you
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If you send an e-mail comment directly
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address will be automatically captured
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submit an electronic comment, EPA
recommends that you include your
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Docket: All documents in the docket
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listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
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material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either
electronically in https://
www.regulations.gov or in hard copy at
the Board of Scientific Counselors
(BOSC), 2009 Clean Air Subcommittee
Meetings Docket, EPA/DC, EPA West,
Room B102, 1301 Constitution Ave.,
NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the ORD Docket is (202)
566–1752.
FOR FURTHER INFORMATION CONTACT: The
Designated Federal Officer via mail at:
Heather Drumm, Mail Code 8104–R,
Office of Science Policy, Office of
Research and Development,
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460; via phone/voice
mail at: (202) 564–8239; via fax at: (202)
565–2911; or via e-mail at:
drumm.heather@epa.gov.
SUPPLEMENTARY INFORMATION:
General Information
Any member of the public interested
in receiving a draft BOSC agenda or
making a presentation at this meeting
may contact Heather Drumm, the
Designated Federal Officer, via any of
the contact methods listed in the ‘‘FOR
FURTHER INFORMATION CONTACT’’ section
above. In general, each individual
making an oral presentation will be
limited to a total of three minutes.
Proposed agenda items for the
teleconference include, but are not
limited to: reviewing the
subcommittee’s draft report and
finalizing the report for BOSC Executive
Committee review. The meetings are
open to the public.
Information on Services for
Individuals with Disabilities: For
information on access or services for
individuals with disabilities, please
contact Heather Drumm at (202) 564–
8239 or drumm.heather@epa.gov. To
request accommodation of a disability,
please contact Heather Drumm,
preferably at least ten days prior to the
meeting, to give EPA as much time as
possible to process your request.
Dated: August 4, 2009.
Fred Hauchman,
Director, Office of Science Policy.
[FR Doc. E9–19337 Filed 8–11–09; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2008–0177; FRL–8429–2]
Nominations to the FIFRA Scientific
Advisory Panel; Request for
Comments
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: This notice provides the
names, addresses, professional
affiliations, and selected biographical
data of persons nominated to serve on
the Scientific Advisory Panel (SAP)
established under section 25(d) of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). The FIFRA
SAP was created on November 28, 1975,
and made a statutory panel by
amendment to FIFRA, dated October 25,
1988. The Agency is, at this time,
selecting two new members to serve on
the FIFRA SAP as a result of a
membership term that will expire this
year and the sudden and unexpected
loss of a FIFRA SAP member. Public
comment on the nominations is invited,
as these comments will be used to assist
the Agency in selecting the new
chartered FIFRA SAP members.
DATES: Comments must be received on
or before September 11, 2009.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2008–0177, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2008–
0177. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
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the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Myrta R. Christian, Designated Federal
Official (DFO), FIFRA SAP, Office of
Science Coordination and Policy
(7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–8498; fax number:
(202) 564–8382; e-mail address:
christian.myrta@epa.gov.
SUPPLEMENTARY INFORMATION:
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I. General Information
A. Does This Action Apply to Me?
This action is directed to the public
in general. This action may, however, be
of interest to persons who are or may be
required to conduct testing of chemical
substances under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
FIFRA, and the Food Quality Protection
Act of 1996 (FQPA). Since other entities
may also be interested, the Agency has
not attempted to describe all the specific
entities that may be affected by this
action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
When submitting comments,
remember to:
1. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
2. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
3. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
4. Describe any assumptions and
provide any technical information and/
or data that you used.
5. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
6. Provide specific examples to
illustrate your concerns and suggest
alternatives.
7. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
8. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
The FIFRA SAP serves as the primary
scientific peer review mechanism of
EPA’s Office of Prevention, Pesticides
and Toxic Substances and is structured
to provide scientific advice,
information, and recommendations to
the EPA Administrator on pesticides
and pesticide-related issues as to the
impact of regulatory actions on health
and the environment. The FIFRA SAP is
a Federal advisory committee,
established in 1975 under FIFRA, that
operates in accordance with
requirements of the Federal Advisory
Committee Act (FACA). The FIFRA SAP
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is composed of a permanent panel
consisting of seven members who are
appointed by the EPA Administrator
from nominees provided by the National
Institutes of Health (NIH) and the
National Science Foundation (NSF).
FIFRA, as amended by FQPA,
established a Science Review Board
consisting of at least 60 scientists who
are available to the FIFRA SAP on an ad
hoc basis to assist in reviews conducted
by the FIFRA SAP. As a peer review
mechanism, the FIFRA SAP provides
comments, evaluations, and
recommendations to improve the
effectiveness and quality of analyses
made by Agency scientists. Members of
the FIFRA SAP are scientists who have
sufficient professional qualifications,
including training and experience, to
provide expert advice and
recommendation to the Agency. The
Agency is, at this time, selecting two
new members to serve on the permanent
FIFRA SAP as a result of a membership
term that will expire this year and the
sudden and unexpected loss of a FIFRA
SAP member. The Agency requested
nominations of experts to be selected
from the field of environmental risk
assessment including: planning,
scoping, and problem formulation;
analysis; and interpretation and risk
characterization (including the
interpretation and communication of
uncertainty). Nominees should be well
published and current in their fields of
expertise. The statute further stipulates
that we publish the names, addresses,
and professional affiliations in the
Federal Register.
III. Charter
A charter for the FIFRA SAP, dated
October 24, 2008, was issued in
accordance with the requirements of
FACA, Public Law 92–463, 86 Stat. 770
(5 U.S.C. App.).
A. Qualifications of Members
FIFRA SAP members are scientists
who have sufficient professional
qualifications, including training and
experience, to be capable of providing
expert comments as to the impact of
pesticides on health and the
environment. No persons are ineligible
to serve on the FIFRA SAP by reason of
their membership on any other advisory
committee to a Federal department or
agency or their employment by a
Federal department or agency (except
the EPA). The EPA Administrator
appoints individuals to serve on the
FIFRA SAP for staggered terms of 4
years unless the appointment serves to
fill an unexpired term for a vacancy that
has occurred due to a member
resignation or reason other than
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expiration of a term. The FIFRA SAP
members, as Special Government
Employees, are subject to the provisions
of 5 CFR Part 2635–Standards of Ethical
Conduct for Employees of the Executive
Branch. Each nominee selected by the
EPA Administrator before being
formally appointed, is requested to
submit a confidential statement of
employment and financial interests,
which shall fully disclose, among other
financial interests, the nominee’s
sources of research support, if any.
In accordance with section 25(d)(1) of
FIFRA, the EPA Administrator shall
require all nominees to the FIFRA SAP
to furnish information concerning their
professional qualifications, educational
background, employment history, and
scientific publications.
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B. Applicability of Existing Regulations
With respect to the requirements of
section 25(d) of FIFRA that the
Administrator promulgate regulations
regarding conflicts of interest, the
charter provides that EPA’s existing
regulations applicable to Special
Government Employees, which include
advisory committee members, will
apply to the members of the FIFRA SAP.
These regulations appear in 5 CFR part
2635. In addition, the charter provides
for open meetings with opportunities for
public participation.
C. Process of Obtaining Nominees
In accordance with the provisions of
section 25(d) of FIFRA, EPA, in April
2009, requested that NIH and NSF
nominate scientists for consideration to
serve on the FIFRA SAP. The Agency
requested nominations of experts in the
field of environmental risk assessment
including: planning, scoping, and
problem formulation; analysis; and
interpretation and risk characterization
(including the interpretation and
communication of uncertainty). NIH
and NSF responded by letter, providing
the Agency with a total of 14 nominees.
Seven of the 14 nominees are interested
and available to actively participate in
FIFRA SAP meetings (see Unit IV.). The
following 7 nominees are not available:
1. Blomquist, Gary, Ph.D., University
of Nevada, Reno, NV.
2. Greer, Linda, Ph.D., National
Resources Defense Council, San
Francisco, CA.
3. Haws, Laurie C., Ph.D., DABT,
ToxStrategies Inc., Austin, TX.
4. Kim, Amy, Ph.D., DABT,
Genentech, Inc., San Francisco, CA.
5. Lanno, Roman P., Ph.D., Ohio State
University, Columbus, OH.
6. Thomas, Russell S., MS, Ph.D., The
Hamner Institutes for Health Sciences,
Research Triangle Park, NC.
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7. Tickner, Joel A., ScD, MSc, BA,
University of Massachusetts– Lowell,
Lowell, MA.
IV. Nominees
The following are the names,
addresses, professional affiliations, and
selected biographical data of nominees
being considered for membership on the
FIFRA SAP. The Agency expects to
select two of the nominees to fill the
vacancies described in this notice.
1. Nominee. Braverman, Michael,
Ph.D., Manager, Biopesticide Program—
Rutgers University, Princeton, NJ.
i. Expertise. Efficacy and
environmental fate of pesticides.
ii. Education. B.S., Agriculture/
Biology, Murray State University, KY;
M.S., Agronomy (Weed Science),
University of Arkansas; Ph.D.,
Horticulture (Vegetable Crops),
University of Florida.
iii. Professional experience. Dr.
Michael Braverman is currently a Senior
Scientist and Manager of the
Biopesticide and Organic Support
Program for the IR-4 Project at Rutgers
University. He oversees a cooperative
research project with the United States
Department of Agriculture (USDA),
State Agriculture Experimental Station,
and industry scientists to develop data
to support the registration of
biopesticides on specialty crops. Dr.
Braverman earned his Ph.D. in
Horticulture from the University of
Florida with an emphasis on herbicide
fate and transport in muck soils. Dr.
Braverman has 20 years experience in
pesticide research and regulations
involving efficacy, laboratory analysis of
pesticide residues, herbicide
physiology, and environmental fate. Dr.
Braverman currently supervises a
national efficacy grant program
involving the review of research
proposals designed to develop efficacy
data involving biopesticides. Dr.
Braverman has provided education,
guidance, and technical expertise in the
design, interpretation of research and
scientific literature review aligned with
EPA Product Chemistry, Residue,
Human Health and Non-Target
Ecotoxicology Guidelines on behalf of
USDA, university scientists from other
institutions and small businesses. The
emphasis of his program has been in
synchronization with EPA’s
Biopesticides and Pollution Prevention
Division. He co-manages and co-reviews
research programs with EPA’s Office of
Pollution Prevention and Toxics to
promote the adoption of reduced risk
products. He has also been an advisor to
USDA’s Agricultural Research Service
(ARS) in regulation, risk assessment,
and monitoring and distribution
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agreements of Plant Incorporated
Protectants (PIPs) developed by USDA
researchers. He has served as a panel
member on several USDA’s Cooperative
State Research, Education, and
Extension Service research grant review
programs as well as editorial reviewer of
research in the flagship journals of the
Weed Science Society of America and
the American Phytopathological
Society. He has been a leader of
intensive regulatory workshops for
Agriculture and Ag Food Canada as well
as a participant with EPA in workshops
involving biopesticide regulations. He
has trained M.S. and Ph.D. level
graduate students, one of which
currently works in EPA’s Environmental
Fate and Effects Division performing
risk assessments on endangered species.
On an international level, under the
auspices of USDA’s Foreign Agricultural
Service, he has conducted regulatory
workshops to develop regulatory
expertise on how to conduct risk
assessments in Benin, Colombia, Egypt,
Ethiopia, Kenya, Mali, Nigeria, Senegal,
South Africa, Tanzania, and Uganda for
natural products, microorganism and
biotechnology products. He is currently
managing a global residue zoning
project in over 20 countries in Africa,
Asia, Australia, Europe, the Middle
East, and North and South America in
cooperation with EPA’s Office of
Pesticide Programs, Analytical
Chemistry Laboratory, Fort Meade, MD.
2. Nominee. Fisher, Jeffrey W., Ph.D.,
Professor and Director, Interdisciplinary
Toxicology Program, University of
Georgia, Athens, GA.
i. Expertise. Development and
application of biologically based
mathematical models to ascertain health
risks from environmental and
occupational chemical exposures.
ii. Education. B.S., Biology,
University of Nebraska at Kearney; M.S.,
Biology/Ecology, Wright State
University, Dayton, OH; Ph.D., Zoology/
Toxicology, Miami University of Ohio.
iii. Professional experience. Dr. Jeffrey
W. Fisher is a Professor in the
Department of Environmental Health
Science, College of Public Health at the
University of Georgia (UGA) and
Director of the Interdisciplinary
Toxicology Program. Dr. Fisher’s
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, polychlorinated
biphenyls, pyrethroids, and perchlorate.
Dr. Fisher has published over 100
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papers on computational modeling for
dose response analyses in laboratory
animals and humans. He has developed
physiologically based pharmacokinetic
models for use in cancer risk
assessment, estimating lactational
transfer of solvents, understanding in
utero and neonatal dosimetry and
quantifying metabolism of solvent
mixtures. Over the last 10 years Dr.
Fisher has developed systems biology
models for the hypothalamic-pituitarythyroid axis (biologically based dose
response (BBDR) models in rodents and
humans). He has trained several
graduate students and postdoctoral
fellows on the concepts and application
of physiological and system biology
models. Dr. Fisher’s laboratory and
computational research are funded
through grants provided by EPA,
Centers for Disease Control and
Prevention, Agency for Toxic
Substances and Disease Registry
(ATSDR); Air Force Office of Scientific
Research; United States Air Force;
Department of Energy; and occasionally
subcontracts with nonprofit
organizations or trade groups. He has
served on several national panels and
advisory boards for the Departement of
Defense, ATSDR, EPA, and non-profit
organizations. He also has been a U.S.
delegate for the North Atlantic Treaty
Organization. He is currently on the
Science Advisory Board for EPA and is
associate editor for Toxicological
Sciences.
3. Nominee. Hattis, Dale, Ph.D.,
Research Professor, Center for
Technology, Environment, and
Development, George Perkins Marsh
Institute, Clark University, Worcester,
MA.
i. Expertise. Modeling and uncertainty
analysis in risk assessment.
ii. Education. B.S., Biochemistry,
University of California, Berkeley, CA;
Ph.D., Genetics, Stanford University,
Stanford, CA.
iii. Professional experience. Dr. Dale
Hattis is a Research Professor with the
George Perkins Marsh Institute at Clark
University. For the past 3 decades he
has been engaged in the development
and application of methodology to
assess the health, ecological, and
economic impacts of regulatory actions.
His work has focused on approaches to
incorporate inter-individual variability
data and quantitative mechanistic
information into risk assessments for
both cancer and non-cancer endpoints.
Recent past research has explored agerelated differences in sensitivity to
carcinogenesis and other effects, a
taxonomy of different non-mutagenic
modes of action for carcinogenesis with
likely differential implications for age-
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related sensitivity, and physiologically
based pharmacokinetic (PBPK)
modeling of acrylamide dose in rats and
humans, and mechanism-based dose
response modeling of carcinogenic
effects from ionizing radiation. Current
efforts are using PBPK modeling to
better assess dose response relationships
for human birth weight changes and
developmental delays associated with
exposure to the insecticide chlorpyrifos
during pregnancy. He is a leader in
efforts to replace the current system of
uncertainty factors for non-cancer
effects with distributions based on
empirical observations. He is a member
of the Clean Air Science Advisory
Committee reviewing EPA efforts to
reassess the National Ambient Air
Quality Criteria for nitrogen oxides and
sulfur oxides, and for several years he
has served as a member of the Food
Quality Protection Act Science Review
Board. Until recently he has also been
a member of the Environmental Health
Committee of the EPA Science Advisory
Board. For 2007 he was the Chair of the
Dose Response Specialty Group of the
Society for Risk Analysis. He has also
served as a member of the National
Research Council Committee on
Estimating the Health-Risk-Reduction
Benefits of Proposed Air Pollution
Regulations. He has been a counselor
and is a Fellow of the Society for Risk
Analysis, and serves on the editorial
board of its journal, Risk Analysis.
4. Nominee. Hayes, Tyrone B., Ph.D.,
Professor, University of California,
Berkeley, CA.
i. Expertise. Role of steroid hormones
in amphibian development and effects
of pesticides on amphibian
development, growth, reproduction, and
immune function.
ii. Education. B.A., Biology, Harvard
University, Cambridge, MA; Ph.D.,
Integrative Biology, University of
California, Berkeley, CA.
iii. Professional experience. Dr.
Tyrone B. Hayes’ research focuses on
the role of steroid hormones in
amphibian development in laboratory
and field studies in Africa and the
United States. The two main areas of
interest are metamorphosis and sex
differentiation, but Dr. Hayes is also
interested in growth (larval and adult)
and hormonal regulation of
reproductive behavior. His work
addresses problems on several levels
including ecological, organismal, and
molecular questions. Studies of
metamorphosis examine the effects of
temperature on developmental rates,
interactions between the thyroid
hormones and steroids, and hormonal
regulation of skin gland development.
Dr. Hayes is also examining the effects
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of tadpole density on developmental
rates and measuring metamorphic rates
and hormone levels of tadpoles in the
field and in the laboratory. His work on
sex differentiation involves the African
clawed frog (Xenopus laevis), and
several other species for comparison.
Studies in African Reedfrogs
(Hyperolius spp), for example, examine
the role of steroid hormones in both
primary sex differentiation and in
secondary sex differentiation. Ongoing
studies also examine the role of steroids
in sex differentiation in reptile species
that display genetic sex determination.
In all of his research, his main goal is
to synthesize ecological/evolutionary,
organismal/physiological, and
biochemical/molecular studies to learn
how an animal translates changes in its
external environment to internal
changes, how these internal changes are
coordinated, what molecular
mechanisms are involved, and in turn,
how changes at the molecular level
affect an animal’s ability to adapt to the
changes in its external environment.
Most recently, Dr. Hayes’ studies have
been used as models to develop
laboratory and field techniques to
examine the effects of endocrine
disrupting contaminants on amphibian
development. His current research in
this area focuses on the effects of
pesticides mixtures on larval
development and the potential role of
pesticides in amphibian declines of
laboratory and field studies. This work
has also expanded to use human cell
lines and to examine the potential role
of endocrine-disrupting contaminants in
ethnic/racial disparities in cancer
outcomes.
5. Nominee. LeBlanc, Gerald A.,
Ph.D., Professor and Head of the
Department of Environmental and
Molecular Toxicology, North Carolina
State University, Raleigh, NC.
i. Expertise. Environmental endocrine
toxicology.
ii. Education. B.S., Biology,
University of Massachusetts, North
Dartmouth, MA; M.A., Biology,
Bridgewater State College, Bridgewater,
MA; Ph.D., Biology, University of South
Florida, Tampa, FL.
iii. Professional experience. Dr.
Gerald A. LeBlanc maintains an active
research program in environmental
endocrine toxicology. This research
involves elucidating processes that
contribute to the endocrine regulation of
reproduction and development and
their disruption by environmental
agents. Dr. LeBlanc’s research also has
been instrumental in developing
modeling approaches for evaluating the
toxicity of complex chemical mixtures.
Dr. LeBlanc has published over 130
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research articles and 12 text book
chapters. He has served on numerous
Federal and international science
advisory committees, panels, and
boards, including serving as chairman of
the EPA Endocrine Disruptors Methods
Validation Advisory Committee.
6. Nominee. Shah, Dilip M., Ph.D.,
Research Scientist and Principal
Investigator, Donald Danforth Plant
Science Center, St Louis, MO.
i. Expertise. Molecular biology and
agricultural biotechnology.
ii. Education. B.S., Botany and
Chemistry, South Gujarat University,
India; M.S., Genetics, North Carolina
State University, Raleigh, NC; Ph.D.,
Genetics, North Carolina State
University, Raleigh, NC.
iii. Professional experience. Dr. Dilip
M. Shah is a Research Scientist and
Principal Investigator at the Donald
Danforth Plant Science Center in
Missouri where his lab is involved in
studying the interactions of fungal
pathogens with their host plants and
developing strategies for the
development of disease resistant
mycotoxin-free transgenic crops. His lab
is investigating the modes of action and
biological roles of a group of proteins
that act as antifungal agents on a broadspectrum of fungal pathogens and
expressing these proteins in transgenic
crops for control of economically
important fungal pathogens. Dr. Shah
has over 25 years of experience in plant
molecular biology and agricultural
biotechnology. He has made substantial
contributions to the development of
herbicide- and virus-resistant crops and
led a team of scientists working on
fungus-resistant crops during his
previous tenure at Monsanto Company.
He played a major role in the
establishment of Monsanto Company’s
Research and Development Center in
India. He has served on the study
section of NIH and has served on the
review panel at NSF. He is a co-inventor
on a number of patents and his patents
on glyphosate-tolerant crops were listed
as the ‘‘Ten Patents That Changed the
World’’ in 2003 year-end publication of
Intellectual Property Worldwide.
7. Nominee. Zacharewski, Timothy R.,
Ph.D., Professor, Department of
Biochemistry and the National Food
Safety and Toxicology Center, Michigan
State University, East Lansing, MI.
i. Expertise. Mechanistic toxicology.
ii. Education. B.S., Chemistry with
microbiology emphasis, University of
Guelph, Guelph, Ontario, Canada; Ph.D.,
Toxicology, Texas A & M University,
College Station, TX.
iii. Professional experience. Dr.
Timothy R. Zacharewski is a Professor
in the Department of Biochemistry and
VerDate Nov<24>2008
16:38 Aug 11, 2009
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Molecular Biology and member of the
Center for Integrative Toxicology and
the National Food Safety and
Toxicology Center at Michigan State
University. He graduated with a Ph.D. in
Toxicology in 1990 from Texas A&M
University in the laboratory of Dr.
Stephen Safe. He received a Medical
Research Council of Canada Post
Doctoral Fellowship to study with
Professor Pierre Chambon in Strasbourg,
France from 1990–1992. In 1992, Dr.
Zacharewski accepted an Assistant
Professor position in the Department of
Pharmacology and Toxicology at the
University of Western Ontario. In 1997,
he relocated to Michigan State
University where he has been pursuing
research interests in the areas of
mechanistic toxicology. More
specifically, his research interests
include the elucidation of receptormediated mechanisms of toxicity using
comparative omic and computational
approaches in order to inform sciencebased quantitative risk assessment,
identify biomarkers of toxicity, and
develop high through-put assays to
screen drugs and chemicals for toxicity.
He has published more than 100 peerreviewed research papers, presented at
numerous national and international
meetings, and participated in various
workshops addressing issues related to
toxicogenomics, food safety, mixture
toxicology, environmental risk
assessment, stem cells in toxicology,
endocrine disruptors, and mechanisms
of toxicology. Dr. Zacharewski has
served as a member on two committees
for the National Academies of Science
(i.e., Emerging Issues in Environmental
Health Sciences, Identifying and
Assessing Unintended Effects of
Genetically Engineered Foods on
Human Health), and as a consultant to
the National Centers for
Toxicogenomics, the Science Advisory
Board for EPA, the International Life
Sciences Institute/Health and
Environmental Sciences Institute
Technical Committee on the
Application of Genomics to MechanismBased Risk Assessment, and the Science
Advisory Panel for Chemical Industry
Institute of Toxicology Centers for
Health Research.
List of Subjects
Environmental protection.
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0540; FRL–8427–5]
Bromonitrostyrene; Product
Cancellation Order
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: This notice announces EPA’s
order for the cancellation of products
containing the pesticide
bromonitrostyrene, pursuant to section
6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), as amended. This cancellation
order follows an August 27, 2008
Federal Register Notice of Receipt of
Requests from the bromonitrostyrene
registrants to voluntarily cancel all their
bromonitrostyrene product registrations.
These are the last bromonitrostyrene
products registered for sale or
distribution in the United States. In the
August 27, 2008 Notice, EPA indicated
that it would issue an order accepting
the requests for voluntary cancellation
and implementing the cancellations,
unless the Agency received substantive
comments within the 30–day comment
period that would merit its further
review of these requests, or unless the
registrants withdrew their requests
within this period. The Agency did not
receive any comments on the notice.
Further, the registrants did not
withdraw their requests. Accordingly,
EPA hereby issues in this notice a
cancellation order accepting the
requested cancellations and cancelling
the affected registrations. Any
distribution, sale, or use of the
bromonitrostyrene products subject to
this cancellation order is permitted only
in accordance with the terms of this
order, including any existing stocks
provisions.
DATES: The cancellations are effective
August 12, 2009.
FOR FURTHER INFORMATION CONTACT:
ShaRon Carlisle, Antimicrobials
Division (7510P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 308–6427; fax number:
(703) 308–8481; e-mail address:
carlisle.sharon@epa.gov.
SUPPLEMENTARY INFORMATION:
Dated: August 7, 2009.
Frank Sanders,
Director, Office of Science Coordination and
Policy.
[FR Doc. E9–19313 Filed 8–11–09; 8:45 am]
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I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general, and may be of interest to a
wide range of stakeholders including
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[Federal Register Volume 74, Number 154 (Wednesday, August 12, 2009)]
[Notices]
[Pages 40584-40588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19313]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0177; FRL-8429-2]
Nominations to the FIFRA Scientific Advisory Panel; Request for
Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice provides the names, addresses, professional
affiliations, and selected biographical data of persons nominated to
serve on the Scientific Advisory Panel (SAP) established under section
25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). The FIFRA SAP was created on November 28, 1975, and made a
statutory panel by amendment to FIFRA, dated October 25, 1988. The
Agency is, at this time, selecting two new members to serve on the
FIFRA SAP as a result of a membership term that will expire this year
and the sudden and unexpected loss of a FIFRA SAP member. Public
comment on the nominations is invited, as these comments will be used
to assist the Agency in selecting the new chartered FIFRA SAP members.
DATES: Comments must be received on or before September 11, 2009.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0177, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0177. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless
[[Page 40585]]
the comment includes information claimed to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Do not submit information that you consider to be CBI or
otherwise protected through regulations.gov or e-mail. The
regulations.gov website is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Myrta R. Christian, Designated Federal
Official (DFO), FIFRA SAP, Office of Science Coordination and Policy
(7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8498; fax
number: (202) 564-8382; e-mail address: christian.myrta@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
When submitting comments, remember to:
1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
2. Follow directions. The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
4. Describe any assumptions and provide any technical information
and/or data that you used.
5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
6. Provide specific examples to illustrate your concerns and
suggest alternatives.
7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
8. Make sure to submit your comments by the comment period deadline
identified.
II. Background
The FIFRA SAP serves as the primary scientific peer review
mechanism of EPA's Office of Prevention, Pesticides and Toxic
Substances and is structured to provide scientific advice, information,
and recommendations to the EPA Administrator on pesticides and
pesticide-related issues as to the impact of regulatory actions on
health and the environment. The FIFRA SAP is a Federal advisory
committee, established in 1975 under FIFRA, that operates in accordance
with requirements of the Federal Advisory Committee Act (FACA). The
FIFRA SAP is composed of a permanent panel consisting of seven members
who are appointed by the EPA Administrator from nominees provided by
the National Institutes of Health (NIH) and the National Science
Foundation (NSF). FIFRA, as amended by FQPA, established a Science
Review Board consisting of at least 60 scientists who are available to
the FIFRA SAP on an ad hoc basis to assist in reviews conducted by the
FIFRA SAP. As a peer review mechanism, the FIFRA SAP provides comments,
evaluations, and recommendations to improve the effectiveness and
quality of analyses made by Agency scientists. Members of the FIFRA SAP
are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency. The Agency is, at this time, selecting
two new members to serve on the permanent FIFRA SAP as a result of a
membership term that will expire this year and the sudden and
unexpected loss of a FIFRA SAP member. The Agency requested nominations
of experts to be selected from the field of environmental risk
assessment including: planning, scoping, and problem formulation;
analysis; and interpretation and risk characterization (including the
interpretation and communication of uncertainty). Nominees should be
well published and current in their fields of expertise. The statute
further stipulates that we publish the names, addresses, and
professional affiliations in the Federal Register.
III. Charter
A charter for the FIFRA SAP, dated October 24, 2008, was issued in
accordance with the requirements of FACA, Public Law 92-463, 86 Stat.
770 (5 U.S.C. App.).
A. Qualifications of Members
FIFRA SAP members are scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments as to the impact of pesticides on health and
the environment. No persons are ineligible to serve on the FIFRA SAP by
reason of their membership on any other advisory committee to a Federal
department or agency or their employment by a Federal department or
agency (except the EPA). The EPA Administrator appoints individuals to
serve on the FIFRA SAP for staggered terms of 4 years unless the
appointment serves to fill an unexpired term for a vacancy that has
occurred due to a member resignation or reason other than
[[Page 40586]]
expiration of a term. The FIFRA SAP members, as Special Government
Employees, are subject to the provisions of 5 CFR Part 2635-Standards
of Ethical Conduct for Employees of the Executive Branch. Each nominee
selected by the EPA Administrator before being formally appointed, is
requested to submit a confidential statement of employment and
financial interests, which shall fully disclose, among other financial
interests, the nominee's sources of research support, if any.
In accordance with section 25(d)(1) of FIFRA, the EPA
Administrator shall require all nominees to the FIFRA SAP to furnish
information concerning their professional qualifications, educational
background, employment history, and scientific publications.
B. Applicability of Existing Regulations
With respect to the requirements of section 25(d) of FIFRA that
the Administrator promulgate regulations regarding conflicts of
interest, the charter provides that EPA's existing regulations
applicable to Special Government Employees, which include advisory
committee members, will apply to the members of the FIFRA SAP. These
regulations appear in 5 CFR part 2635. In addition, the charter
provides for open meetings with opportunities for public participation.
C. Process of Obtaining Nominees
In accordance with the provisions of section 25(d) of FIFRA, EPA,
in April 2009, requested that NIH and NSF nominate scientists for
consideration to serve on the FIFRA SAP. The Agency requested
nominations of experts in the field of environmental risk assessment
including: planning, scoping, and problem formulation; analysis; and
interpretation and risk characterization (including the interpretation
and communication of uncertainty). NIH and NSF responded by letter,
providing the Agency with a total of 14 nominees. Seven of the 14
nominees are interested and available to actively participate in FIFRA
SAP meetings (see Unit IV.). The following 7 nominees are not
available:
1. Blomquist, Gary, Ph.D., University of Nevada, Reno, NV.
2. Greer, Linda, Ph.D., National Resources Defense Council, San
Francisco, CA.
3. Haws, Laurie C., Ph.D., DABT, ToxStrategies Inc., Austin, TX.
4. Kim, Amy, Ph.D., DABT, Genentech, Inc., San Francisco, CA.
5. Lanno, Roman P., Ph.D., Ohio State University, Columbus, OH.
6. Thomas, Russell S., MS, Ph.D., The Hamner Institutes for Health
Sciences, Research Triangle Park, NC.
7. Tickner, Joel A., ScD, MSc, BA, University of Massachusetts-
Lowell, Lowell, MA.
IV. Nominees
The following are the names, addresses, professional affiliations,
and selected biographical data of nominees being considered for
membership on the FIFRA SAP. The Agency expects to select two of the
nominees to fill the vacancies described in this notice.
1. Nominee. Braverman, Michael, Ph.D., Manager, Biopesticide
Program--Rutgers University, Princeton, NJ.
i. Expertise. Efficacy and environmental fate of pesticides.
ii. Education. B.S., Agriculture/Biology, Murray State University,
KY; M.S., Agronomy (Weed Science), University of Arkansas; Ph.D.,
Horticulture (Vegetable Crops), University of Florida.
iii. Professional experience. Dr. Michael Braverman is currently a
Senior Scientist and Manager of the Biopesticide and Organic Support
Program for the IR-4 Project at Rutgers University. He oversees a
cooperative research project with the United States Department of
Agriculture (USDA), State Agriculture Experimental Station, and
industry scientists to develop data to support the registration of
biopesticides on specialty crops. Dr. Braverman earned his Ph.D. in
Horticulture from the University of Florida with an emphasis on
herbicide fate and transport in muck soils. Dr. Braverman has 20 years
experience in pesticide research and regulations involving efficacy,
laboratory analysis of pesticide residues, herbicide physiology, and
environmental fate. Dr. Braverman currently supervises a national
efficacy grant program involving the review of research proposals
designed to develop efficacy data involving biopesticides. Dr.
Braverman has provided education, guidance, and technical expertise in
the design, interpretation of research and scientific literature review
aligned with EPA Product Chemistry, Residue, Human Health and Non-
Target Ecotoxicology Guidelines on behalf of USDA, university
scientists from other institutions and small businesses. The emphasis
of his program has been in synchronization with EPA's Biopesticides and
Pollution Prevention Division. He co-manages and co-reviews research
programs with EPA's Office of Pollution Prevention and Toxics to
promote the adoption of reduced risk products. He has also been an
advisor to USDA's Agricultural Research Service (ARS) in regulation,
risk assessment, and monitoring and distribution agreements of Plant
Incorporated Protectants (PIPs) developed by USDA researchers. He has
served as a panel member on several USDA's Cooperative State Research,
Education, and Extension Service research grant review programs as well
as editorial reviewer of research in the flagship journals of the Weed
Science Society of America and the American Phytopathological Society.
He has been a leader of intensive regulatory workshops for Agriculture
and Ag Food Canada as well as a participant with EPA in workshops
involving biopesticide regulations. He has trained M.S. and Ph.D. level
graduate students, one of which currently works in EPA's Environmental
Fate and Effects Division performing risk assessments on endangered
species. On an international level, under the auspices of USDA's
Foreign Agricultural Service, he has conducted regulatory workshops to
develop regulatory expertise on how to conduct risk assessments in
Benin, Colombia, Egypt, Ethiopia, Kenya, Mali, Nigeria, Senegal, South
Africa, Tanzania, and Uganda for natural products, microorganism and
biotechnology products. He is currently managing a global residue
zoning project in over 20 countries in Africa, Asia, Australia, Europe,
the Middle East, and North and South America in cooperation with EPA's
Office of Pesticide Programs, Analytical Chemistry Laboratory, Fort
Meade, MD.
2. Nominee. Fisher, Jeffrey W., Ph.D., Professor and Director,
Interdisciplinary Toxicology Program, University of Georgia, Athens,
GA.
i. Expertise. Development and application of biologically based
mathematical models to ascertain health risks from environmental and
occupational chemical exposures.
ii. Education. B.S., Biology, University of Nebraska at Kearney;
M.S., Biology/Ecology, Wright State University, Dayton, OH; Ph.D.,
Zoology/Toxicology, Miami University of Ohio.
iii. Professional experience. Dr. Jeffrey W. Fisher is a Professor
in the Department of Environmental Health Science, College of Public
Health at the University of Georgia (UGA) and Director of the
Interdisciplinary Toxicology Program. Dr. Fisher's 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,
polychlorinated biphenyls, pyrethroids, and perchlorate. Dr. Fisher has
published over 100
[[Page 40587]]
papers on computational modeling for dose response analyses in
laboratory animals and humans. He has developed physiologically based
pharmacokinetic models for use in cancer risk assessment, estimating
lactational transfer of solvents, understanding in utero and neonatal
dosimetry and quantifying metabolism of solvent mixtures. Over the last
10 years Dr. Fisher has developed systems biology models for the
hypothalamic-pituitary-thyroid axis (biologically based dose response
(BBDR) models in rodents and humans). He has trained several graduate
students and postdoctoral fellows on the concepts and application of
physiological and system biology models. Dr. Fisher's laboratory and
computational research are funded through grants provided by EPA,
Centers for Disease Control and Prevention, Agency for Toxic Substances
and Disease Registry (ATSDR); Air Force Office of Scientific Research;
United States Air Force; Department of Energy; and occasionally
subcontracts with nonprofit organizations or trade groups. He has
served on several national panels and advisory boards for the
Departement of Defense, ATSDR, EPA, and non-profit organizations. He
also has been a U.S. delegate for the North Atlantic Treaty
Organization. He is currently on the Science Advisory Board for EPA and
is associate editor for Toxicological Sciences.
3. Nominee. Hattis, Dale, Ph.D., Research Professor, Center for
Technology, Environment, and Development, George Perkins Marsh
Institute, Clark University, Worcester, MA.
i. Expertise. Modeling and uncertainty analysis in risk assessment.
ii. Education. B.S., Biochemistry, University of California,
Berkeley, CA; Ph.D., Genetics, Stanford University, Stanford, CA.
iii. Professional experience. Dr. Dale Hattis is a Research
Professor with the George Perkins Marsh Institute at Clark University.
For the past 3 decades he has been engaged in the development and
application of methodology to assess the health, ecological, and
economic impacts of regulatory actions. His work has focused on
approaches to incorporate inter-individual variability data and
quantitative mechanistic information into risk assessments for both
cancer and non-cancer endpoints. Recent past research has explored age-
related differences in sensitivity to carcinogenesis and other effects,
a taxonomy of different non-mutagenic modes of action for
carcinogenesis with likely differential implications for age-related
sensitivity, and physiologically based pharmacokinetic (PBPK) modeling
of acrylamide dose in rats and humans, and mechanism-based dose
response modeling of carcinogenic effects from ionizing radiation.
Current efforts are using PBPK modeling to better assess dose response
relationships for human birth weight changes and developmental delays
associated with exposure to the insecticide chlorpyrifos during
pregnancy. He is a leader in efforts to replace the current system of
uncertainty factors for non-cancer effects with distributions based on
empirical observations. He is a member of the Clean Air Science
Advisory Committee reviewing EPA efforts to reassess the National
Ambient Air Quality Criteria for nitrogen oxides and sulfur oxides, and
for several years he has served as a member of the Food Quality
Protection Act Science Review Board. Until recently he has also been a
member of the Environmental Health Committee of the EPA Science
Advisory Board. For 2007 he was the Chair of the Dose Response
Specialty Group of the Society for Risk Analysis. He has also served as
a member of the National Research Council Committee on Estimating the
Health-Risk-Reduction Benefits of Proposed Air Pollution Regulations.
He has been a counselor and is a Fellow of the Society for Risk
Analysis, and serves on the editorial board of its journal, Risk
Analysis.
4. Nominee. Hayes, Tyrone B., Ph.D., Professor, University of
California, Berkeley, CA.
i. Expertise. Role of steroid hormones in amphibian development
and effects of pesticides on amphibian development, growth,
reproduction, and immune function.
ii. Education. B.A., Biology, Harvard University, Cambridge, MA;
Ph.D., Integrative Biology, University of California, Berkeley, CA.
iii. Professional experience. Dr. Tyrone B. Hayes' research
focuses on the role of steroid hormones in amphibian development in
laboratory and field studies in Africa and the United States. The two
main areas of interest are metamorphosis and sex differentiation, but
Dr. Hayes is also interested in growth (larval and adult) and hormonal
regulation of reproductive behavior. His work addresses problems on
several levels including ecological, organismal, and molecular
questions. Studies of metamorphosis examine the effects of temperature
on developmental rates, interactions between the thyroid hormones and
steroids, and hormonal regulation of skin gland development. Dr. Hayes
is also examining the effects of tadpole density on developmental rates
and measuring metamorphic rates and hormone levels of tadpoles in the
field and in the laboratory. His work on sex differentiation involves
the African clawed frog (Xenopus laevis), and several other species for
comparison. Studies in African Reedfrogs (Hyperolius spp), for example,
examine the role of steroid hormones in both primary sex
differentiation and in secondary sex differentiation. Ongoing studies
also examine the role of steroids in sex differentiation in reptile
species that display genetic sex determination. In all of his research,
his main goal is to synthesize ecological/evolutionary, organismal/
physiological, and biochemical/molecular studies to learn how an animal
translates changes in its external environment to internal changes, how
these internal changes are coordinated, what molecular mechanisms are
involved, and in turn, how changes at the molecular level affect an
animal's ability to adapt to the changes in its external environment.
Most recently, Dr. Hayes' studies have been used as models to
develop laboratory and field techniques to examine the effects of
endocrine disrupting contaminants on amphibian development. His current
research in this area focuses on the effects of pesticides mixtures on
larval development and the potential role of pesticides in amphibian
declines of laboratory and field studies. This work has also expanded
to use human cell lines and to examine the potential role of endocrine-
disrupting contaminants in ethnic/racial disparities in cancer
outcomes.
5. Nominee. LeBlanc, Gerald A., Ph.D., Professor and Head of the
Department of Environmental and Molecular Toxicology, North Carolina
State University, Raleigh, NC.
i. Expertise. Environmental endocrine toxicology.
ii. Education. B.S., Biology, University of Massachusetts, North
Dartmouth, MA; M.A., Biology, Bridgewater State College, Bridgewater,
MA; Ph.D., Biology, University of South Florida, Tampa, FL.
iii. Professional experience. Dr. Gerald A. LeBlanc maintains an
active research program in environmental endocrine toxicology. This
research involves elucidating processes that contribute to the
endocrine regulation of reproduction and development and their
disruption by environmental agents. Dr. LeBlanc's research also has
been instrumental in developing modeling approaches for evaluating the
toxicity of complex chemical mixtures. Dr. LeBlanc has published over
130
[[Page 40588]]
research articles and 12 text book chapters. He has served on numerous
Federal and international science advisory committees, panels, and
boards, including serving as chairman of the EPA Endocrine Disruptors
Methods Validation Advisory Committee.
6. Nominee. Shah, Dilip M., Ph.D., Research Scientist and
Principal Investigator, Donald Danforth Plant Science Center, St Louis,
MO.
i. Expertise. Molecular biology and agricultural biotechnology.
ii. Education. B.S., Botany and Chemistry, South Gujarat
University, India; M.S., Genetics, North Carolina State University,
Raleigh, NC; Ph.D., Genetics, North Carolina State University, Raleigh,
NC.
iii. Professional experience. Dr. Dilip M. Shah is a Research
Scientist and Principal Investigator at the Donald Danforth Plant
Science Center in Missouri where his lab is involved in studying the
interactions of fungal pathogens with their host plants and developing
strategies for the development of disease resistant mycotoxin-free
transgenic crops. His lab is investigating the modes of action and
biological roles of a group of proteins that act as antifungal agents
on a broad-spectrum of fungal pathogens and expressing these proteins
in transgenic crops for control of economically important fungal
pathogens. Dr. Shah has over 25 years of experience in plant molecular
biology and agricultural biotechnology. He has made substantial
contributions to the development of herbicide- and virus-resistant
crops and led a team of scientists working on fungus-resistant crops
during his previous tenure at Monsanto Company. He played a major role
in the establishment of Monsanto Company's Research and Development
Center in India. He has served on the study section of NIH and has
served on the review panel at NSF. He is a co-inventor on a number of
patents and his patents on glyphosate-tolerant crops were listed as the
``Ten Patents That Changed the World'' in 2003 year-end publication of
Intellectual Property Worldwide.
7. Nominee. Zacharewski, Timothy R., Ph.D., Professor, Department
of Biochemistry and the National Food Safety and Toxicology Center,
Michigan State University, East Lansing, MI.
i. Expertise. Mechanistic toxicology.
ii. Education. B.S., Chemistry with microbiology emphasis,
University of Guelph, Guelph, Ontario, Canada; Ph.D., Toxicology, Texas
A & M University, College Station, TX.
iii. Professional experience. Dr. Timothy R. Zacharewski is a
Professor in the Department of Biochemistry and Molecular Biology and
member of the Center for Integrative Toxicology and the National Food
Safety and Toxicology Center at Michigan State University. He graduated
with a Ph.D. in Toxicology in 1990 from Texas A&M University in the
laboratory of Dr. Stephen Safe. He received a Medical Research Council
of Canada Post Doctoral Fellowship to study with Professor Pierre
Chambon in Strasbourg, France from 1990-1992. In 1992, Dr. Zacharewski
accepted an Assistant Professor position in the Department of
Pharmacology and Toxicology at the University of Western Ontario. In
1997, he relocated to Michigan State University where he has been
pursuing research interests in the areas of mechanistic toxicology.
More specifically, his research interests include the elucidation of
receptor-mediated mechanisms of toxicity using comparative omic and
computational approaches in order to inform science-based quantitative
risk assessment, identify biomarkers of toxicity, and develop high
through-put assays to screen drugs and chemicals for toxicity. He has
published more than 100 peer-reviewed research papers, presented at
numerous national and international meetings, and participated in
various workshops addressing issues related to toxicogenomics, food
safety, mixture toxicology, environmental risk assessment, stem cells
in toxicology, endocrine disruptors, and mechanisms of toxicology. Dr.
Zacharewski has served as a member on two committees for the National
Academies of Science (i.e., Emerging Issues in Environmental Health
Sciences, Identifying and Assessing Unintended Effects of Genetically
Engineered Foods on Human Health), and as a consultant to the National
Centers for Toxicogenomics, the Science Advisory Board for EPA, the
International Life Sciences Institute/Health and Environmental Sciences
Institute Technical Committee on the Application of Genomics to
Mechanism-Based Risk Assessment, and the Science Advisory Panel for
Chemical Industry Institute of Toxicology Centers for Health Research.
List of Subjects
Environmental protection.
Dated: August 7, 2009.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. E9-19313 Filed 8-11-09; 8:45 am]
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