[Federal Register Volume 74, Number 154 (Wednesday, August 12, 2009)]
[Notices]
[Pages 40584-40588]
From the Federal Register Online via the Government Publishing 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.
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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: http://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
http://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 http://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 http://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: [email protected].
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
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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.
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
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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-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
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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 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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