Browse by Year
/ 2003
/ November
/ Monday, November 10, 2003
[Federal Register: November 10, 2003 (Volume 68, Number 217)]
[Notices]
[Page 63779-63786]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no03-36]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0337; FRL-7333-9]
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 Panel was created on November 28, 1975, and made a
statutory Panel by amendment to FIFRA, dated October 25, 1988. Public
comment on the nominations is invited, as these comments will be used
to assist the Agency in selecting three new chartered Panel members.
[[Page 63780]]
DATES: Comments, identified by docket ID number OPP-2003-0337, must be
received on or before December 10, 2003.
ADDRESSES: Comments may be submitted electronically (preferred),
through hand delivery/courier, or by mail. Follow the detailed
instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Steven Knott, Assistant Executive
Secretary, FIFRA SAP Staff (7201M), Office of Science Coordination and
Policy, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8450; fax number: (202) 564-8382; e-mail address: knott.steven@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. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0337. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically (preferred), through hand
delivery/courier, or by mail. To ensure proper receipt by EPA, identify
the appropriate docket ID number in the subject line on the first page
of your comment. Please ensure that your comments are submitted within
the specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. Do not use EPA Dockets or e-mail to submit CBI or
information protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2003-0337. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or
[[Page 63781]]
other contact information unless you provide it in the body of your
comment. ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2003-0337. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you hand deliver or send by courier to the address identified in
Unit I.C.2. or mail to the mailing address identified in Unit I.C.3.
These electronic submissions will be accepted in WordPerfect or ASCII
file format. Avoid the use of special characters and any form of
encryption.
2. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2003-0337. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
3. By mail. Due to potential delays in EPA's receipt and processing
of mail, respondents are strongly encouraged to submit comments either
electronically or by hand delivery or courier. We cannot guarantee that
comments sent via mail will be received prior to the close of the
comment period. If mailed, please send your comments to: Public
Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID
Number OPP-2003-0337. For questions about delivery options, please
contact the person listed under FOR FURTHER INFORMATION CONTACT.
II. Background
Amendments to FIFRA, enacted November 28, 1975, include a
requirement under section 25(d) that notices of intent to cancel or
reclassify pesticide registrations pursuant to section 6(b)(2), as well
as proposed and final forms of rulemaking pursuant to section 25(a), be
submitted to a Scientific Advisory Panel prior to being made public or
issued to a registrant. In accordance with section 25(d), the
Scientific Advisory Panel is to have an opportunity to comment on the
health and environmental impact of such actions. The Panel shall also
make comments, evaluations, and recommendations for operating
guidelines to improve the effectiveness and quality of analyses made by
Agency scientists.
In accordance with the statute, the SAP is a permanent panel
composed of seven members, selected and appointed by the Deputy
Administrator of EPA from nominees submitted by both the National
Science Foundation (NSF) and the National Institutes of Health (NIH).
The Agency is, at this time, selecting three new members to serve on
the panel as a result of membership terms that will expire this year.
The Agency requested nominations of experts to be selected from the
fields of ecological risk assessment (especially probabilistic
ecological risk assessment), human health risk assessment methodology
and uncertainty analysis, and veterinary pathology. Nominees should be
well published and current in their fields of expertise. The statute
further stipulates that we publish the name, address, professional
affiliation, and a brief biographical sketch of each nominee in the
Federal Register and solicit public comments regarding the candidates
nominated.
III. Charter
A Charter for the FIFRA Scientific Advisory Panel, dated October
25, 2002, was issued in accordance with the requirements of the Federal
Advisory Committee Act, Public Law 92-463, 86 Stat. 770 (5 U.S.C. App.
I). The qualifications of members as provided by the Charter follow.
A. Qualifications of Members
Members are scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments as to the impact on health and the
environment of regulatory actions under sections 6(b) and 25(a) of
FIFRA. No persons shall be ineligible to serve on the Panel 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 Deputy Administrator appoints individuals
to serve on the Panel for staggered terms of 4 years. Panel members are
subject to the provisions of 40 CFR part 3, subpart F, Standards of
Conduct for Special Government Employees, which include rules regarding
conflicts of interest. Each nominee selected by the Deputy
Administrator, before being formally appointed, is required 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) of FIFRA, the Deputy Administrator
shall require all nominees to the Panel to furnish information
concerning their professional qualifications, educational background,
employment history, and scientific publications. The Agency is required
to publish in the Federal Register the name, address, and professional
affiliations of each nominee and to seek public comment on the
nominees.
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 Scientific Advisory Panel. These
regulations appear in 40 CFR part 3, subpart F. 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
May 2003, requested NIH and NSF to nominate scientists to fill three
vacancies occurring on the Panel. The Agency requested nomination of
experts in the fields of ecological risk assessment (especially
probabilistic ecological risk assessment), human health risk assessment
methodology and uncertainty analysis, and veterinary pathology. NIH and
NSF responded by letter, providing the Agency with a total of 29
nominees. Fifteen of the 29 nominees are interested and available to
actively participate in SAP meetings.
IV. Nominees
The following are the names, addresses, professional affiliations,
and selected biographical data of nominees being considered for
membership on the FIFRA Scientific Advisory Panel. The Agency seeks to
fill three vacancies occurring this year.
A. Nominations for the Field of Ecological Risk Assessment
1. Nominee. Burger, Joanna, Ph.D., Distinguished Professor of
Biology,
[[Page 63782]]
Division of Life Sciences, Rutgers University; Professor in the School
of Public Health in New Jersey, Piscataway, NJ.
i. Expertise. Ecotoxicology methods, design, data collection and
analysis, ecological risk methods and assessment.
ii. Education. Ph.D., Ecology and Behavioral Ecology, University of
Minnesota.
iii. Professional experience. Dr. Burger has had over 30 years of
experience in ecological studies of a wide range of animals in their
natural environments, and nearly 25 years working in the fields of
ecological risk and ecotoxicology. She has served as Director of the
Graduate Program in Ecology at Rutgers University for 15 years, and has
served as Director of the Chemical Analysis Laboratory for the National
Institute of Environmental Health Sciences (NIEHS) Center of Excellence
at Rutgers University/University of Medicine and Dentistry of New
Jersey (UMDNJ), Robert Wood Johnson Medical School. During this period,
she has been actively involved in research on the effects of toxic
chemicals on behavior and neurodevelopment, on biomonitoring of toxic
chemicals and ecological endpoints, on the risks from chemical
contaminants in fish and wildlife, and on developing methods for
ecological risk assessment at different levels of ecological
complexity. She has published over 350 refereed papers in these areas,
and has written or edited over 15 books. Dr. Burger has served as a
member of the National Research Council (NRC) Board of Environmental
Science and Toxicology, Board on Biology, Commission of Life Sciences
and other NRC committees. She also has served on several SCOPE
committees, most recently as the Co-Chair of an international meeting
on endocrine disruptors. Dr. Burger has served on EPA, U.S. Fish and
Wildlife Service, and National Oceanic and Atmospheric Administration
(NOAA) advisory councils as well as the New Jersey Endangered and
NonGame Species Council. She teaches ecological risk and serves as an
environmental advisor to numerous local, State, and Federal agencies.
2. Nominee. James, Margaret O., Ph.D., Professor and Chair,
Department of Medicinal Chemistry, College of Pharmacy, University of
Florida, Gainesville, FL.
i. Expertise. Xenobiotic metabolism, environmental pollutants.
ii. Education. B.Sc. (Honors), Chemistry, University College
London, UK; Ph.D., Organic Chemistry, St. Mary's Hospital Medical
School, University of London.
iii. Professional experience. Dr. James completed a 3-year post-
doctoral fellowship in the pharmacology branch of the National
Institute of Environmental Health Sciences (NIEHS). She was appointed
as a research associate, and then a senior staff fellow at the NIEHS
satellite laboratory at the Whitney Laboratory in St. Augustine, FL.
She has been on the faculty of the Departments of Medicinal Chemistry
and Pharmacology and Therapeutics at the University of Florida since
1980. Dr. James also serves as the director of the University of
Florida Superfund Basic Research Program project grant. Dr. James is a
founding member of the interdisciplinary toxicology graduate program at
the University of Florida. She has authored or co-authored over 100
peer reviewed original research papers and several book chapters. Dr.
James served on the Environmental Health Sciences review panel from
1991 to 1995, and on the Toxics Advisory Committee, National Marine
Fisheries Service, NOAA from 1992 to 1994. She has served as Secretary
of the International Society for the Study of Xenobiotics (2000 to
2003) and is a former member of the editorial board of Chemico-
Biological Interactions. Dr. James currently serves on the editorial
boards of Drug Metabolism and Disposition and Aquatic Toxicology. She
is the guest editor of a special volume of Marine Environmental
Research to be published in 2004. Dr. James' research interests are in
biotransformation pathways involved in the formation or detoxification
of chemically reactive metabolites of xenobiotics.
3. Nominee. Portier, Kenneth M., Ph.D., Associate Professor of
Statistics and Agricultural Experiment Station Statistician, Institute
of Food and Agricultural Sciences, University of Florida, Gainesville,
FL.
i. Expertise. Applied statistics, biostatistics, statistical
computing, and the teaching of statistics.
ii. Education. B.S., Mathematics, Nicholls State University; M.S.,
Statistics, University of North Carolina, Chapel Hill; Ph.D. in
Biostatistics, University of North Carolina, Chapel Hill.
iii. Professional experience. Dr. Portier has taught statistical
methods on the graduate level, and has served as a statistical
consultant to researchers in agriculture, natural resources, and the
environment at the University of Florida since 1979. His participation
in the U.S. Department of Agriculture (USDA) Higher Education Programs
(HEP) funded teaching grants has included development of web-based
materials for teaching natural resources sampling, and developing a
senior graduate course in forested watersheds. Dr. Portier is
collaborating with other University of Florida researchers on grants
from the NSF, USDA, NOAA, and the Department of Interior (DOI). Dr.
Portier has been a regular member of EPA and National Toxicology
Program science advisory panels reviewing ecological risks from
agriculture-related chemicals and practices. He has co-authored papers
in many of the premier journals in agriculture, natural resources, and
environmental sciences.
4. Nominee. Regan, Helen M., Ph.D., Assistant Professor, Department
of Biology, Ecology Program, San Diego State University, San Diego, CA.
i. Expertise. Ecological risk assessment, quantitative conservation
ecology, population models and mathematical treatments of uncertainty
in ecological risk assessment.
ii. Education. B.S. (with first-class honors), Applied Mathematics,
Latrobe University, Victoria, Australia; Ph.D., Applied Mathematics,
University of New England, New South Wales, Australia.
iii. Professional experience. Dr. Regan's research activities
include: Treatment of uncertainty in contaminant exposure models for
wildlife; population-level ecological risk assessment of endangered and
threatened species using stochastic population models; systematic
decisionmaking for management and conservation planning; and assessment
of uncertainty in endangered species classification protocols. She has
held postdoctoral research fellow appointments with the University of
Melbourne and the National Center for Ecological Analysis and
Synthesis, University of California, Santa Barbara. Dr. Regan has
served as a consultant for the Cooperative Research Center for
Catchment Hydrology (Australia) and for Forestry Tasmania (Australia).
She has served as an invited panelist for the Industrial Risk
Management Forum, Environmental Futures Forum (Victorian Environmental
Protection Authority, Australia) and as a member of the review team for
Improvements in Applications of Models in Ecological Risk Assessment
(sponsored by the American Chemistry Council). She is a contributing
author to Ecological Modeling in Risk Assessment: Chemical Effects on
Populations, Ecosystems, and Landscapes (Pastorok, Bartell, Ferson and
Ginzburg, eds.), Lewis publishers, Boca Raton, FL, 2001. She was a
[[Page 63783]]
scientific reviewer for the US Fish and Wildlife Service Revised
Proposal for Critical Habitat for Forty-Seven Plant Species on the
Island of Hawaii and served on the scientific review panel for Forest
Service Species Viability Assessment Processes at the National Center
for Ecological Analysis and Synthesis, University of California, Santa
Barbara. In September 2003, she was an invited participant for the
Pellston Workshop on Population-Level Ecological Risk Assessment (focus
on chemical contaminants), sponsored by the Society for Environmental
Toxicology and Chemistry, held in Roskilde, Denmark.
5. Nominee. Scott, Geoffrey I., Ph.D., Acting Director, Charleston
Center for Coastal Environmental Health and Biomolecular Research
(CCEHBR), National Ocean Services, National Oceanic and Atmospheric
Administration, U.S. Department of Commerce, Charleston, SC.
i. Expertise. Aquatic and marine toxicology, ecological assessments
of the impacts of agricultural runoff, oil spills, pesticides,
bacterial contamination, and water chlorination.
ii. Education. B.S., Biology, Wofford College; M.S. and Ph.D.,
Marine Science, University of South Carolina.
iii. Professional experience. Dr. Scott's research experience
includes working as an Aquatic Toxicologist for the EPA, where he
helped develop a suite of rapid assessment indices for assessing
ecological damages from oil spills. He has served as a tenured
Associate Professor in the School of Public Health at the University of
South Carolina (USC) where he received the 1989 Outstanding Young
Researcher Award in Public Health. While at USC, most of Dr. Scott's
research focused on the impacts of agricultural pesticide non-point
source runoff on estuarine ecosystems. Dr. Scott served as Chief of the
Marine Ecotoxicology Branch at NOAA CCEHBR from 1993 to 2001. He has
collaborated with peers in his discipline to write both the conceptual
framework for the Urbanization in the Southeast Estuarine Systems
(USES) study, and the conceptual framework for the Land Use Coastal
Environmental Study (LUCES). Dr. Scott was appointed by the NOAA
Administrator to represent NOAA in a Federal agency task force on
endocrine disruptors, culminating in the Raleigh Workshop, where he co-
chaired the sessions on neuro-endocrine effects. Dr. Scott has served
on numerous government and industry advisory panels, including the EPA
advisory board on endocrine disrupting chemicals; EPA's Food Quality
Protection Act Science Review Board; the EPA Environmental Technology
Verification Program, Water Stakeholder Committee; the South Carolina
Coastal Pesticide Advisory Committee; the United Nations Gulf of Guinea
Large Marine Ecosystem Team; and the Research Delegation Exchange with
the Black Sea Research Institute. Dr. Scott has served as a board
member, Vice President, and President of the Carolina Chapter of the
Society of Environmental Toxicology and Chemistry. Dr. Scott is also an
Associate Professor in the Medical University of South Carolina, the
University of Charleston, and an Adjunct Associate Professor in the
Institute of Human and Environmental Health, Texas Tech University.
B. Nominations for the Field of Human Health Risk Assessment
Methodology and Uncertainty Analysis
1. Nominee. Anderson, Elizabeth L., Ph.D., President and Chief
Executive Officer, Sciences International, Inc., Alexandria, VA.
i. Expertise. Risk assessment and carcinogenicity.
ii. Education. B.S., Chemistry, College of William and Mary; M.S.,
Organic Chemistry, University of Virginia; Ph.D., Organic Chemistry,
American University.
iii. Professional experience. Dr. Anderson regularly participates
in and directs an interdisciplinary group of scientists and engineers
specializing in risk assessment. She has over 20 years of experience
working in the field of risk assessment and is currently the Editor-in-
Chief of Risk Analysis: An International Journal. Previously, while
employed by the EPA, Dr. Anderson founded the Agency's central risk
assessment program, and directed it for 10 years. In this capacity, she
served as the Executive Director of the EPA committee that initially
adopted risk assessment as the basis for implementing the Agency's
regulatory mandates. She also founded EPA's Carcinogen Assessment Group
and the Office of Health and Environmental Assessment. Dr. Anderson
received the EPA Gold Medal for exceptional service. She has
participated in numerous risk-related panels and committees including
those for inter-agency risk assessment initiatives, the National
Academy of Sciences, and the National Cancer Institute. Dr. Anderson
has worked extensively on international risk assessment issues to
address human health and ecological consequences of exposure to
environmental toxicants for organizations that include the World Health
Organization and the Pan American Health Organization. She was
President, Chief Executive Officer, and Chairman of the Board of
Clement International Corporation and on the Board of Directors of ICF-
Kaiser International. Dr. Anderson is a co-founder and past-President
of the Society for Risk Analysis. She has participated in numerous
national and international commissions and organizations concerned with
risk based issues, and has lectured and published widely in the field
of risk assessment.
2. Nominee. Crawford-Brown, Douglas, Ph.D., Professor, Departments
of Environmental Sciences and Engineering and in Public Policy
Analysis; also on the Resource Faculty of the Department of Philosophy;
Chairman, Environmental Sciences and Studies Undergraduate Program; and
Director, Carolina Environmental Program, University of North Carolina,
Chapel Hill, NC.
i. Expertise. Environmental modeling, exposure assessment, risk
assessment, and the application of scientific models in the assessment
and selection of environmental policies.
ii. Education. B.S., M.S., and Ph.D., Physics and Nuclear Science,
Georgia Institute of Technology.
iii. Professional experience. Dr. Crawford-Brown's teaching and
research are in the areas of environmental modeling, exposure
assessment, risk assessment, and the application of scientific models
in the assessment and selection of environmental policies. His current
research focuses on risk assessment in support of policy in water and
air; on development of biomathematical models of human health risk
following exposure to radionuclides, chemicals, and microbes; on dose
reconstruction methodologies; and on the development of decision
support systems to analyze risks from environmental contaminants. He
has worked extensively in the field of exposure and dose assessment in
support of epidemiological studies, with a primary focus on exposure to
radionuclides and radiation. Dr. Crawford-Brown has written over 120
journal articles in his discipline, and has authored a series of books
on environmental risk assessment: Theoretical and Mathematical
Foundations of Human Health Risk Analysis (1997), Risk-Based
Environmental Decisions: Methods and Culture (1999), and Mathematical
Methods of Environmental Risk Modeling (2001). Dr. Crawford-Brown has
served on a number of federal advisory committees for EPA, and
currently serves as a Technical Advisor for the American Waterworks
Association in the areas of risk and
[[Page 63784]]
decisions. He has chaired, or has served as a member of a wide variety
of national and international committees in areas related to risk and
the environment, including those established by EPA, the World Trade
Organization, the Department of Energy, NIH, the International Life
Sciences Institute, and the Chemical Industry Institute of Toxicology.
3. Nominee. Frey, H. Christopher, Ph.D., Associate Professor,
Department of Civil, Construction, and Environmental Engineering, North
Carolina State University, Raleigh, NC.
i. Expertise. Quantification of variability and uncertainty,
measurement, modeling and evaluation of energy and environmental
control systems, and exposure and risk assessment.
ii. Education. B.S., Mechanical Engineering, University of
Virginia; Master of Engineering, Mechanical Engineering, Carnegie-
Mellon University; Ph.D., Engineering and Public Policy, Carnegie-
Mellon University.
iii. Professional experience. Dr. Frey's research interests are
primarily in: Development and demonstration of methods for
quantification of variability and uncertainty; modeling and evaluation
of energy and environmental control systems; measurement and modeling
of real-world tailpipe emissions; and exposure and risk assessment. He
has been a principal or co-principal investigator for 25 externally
sponsored university research projects in these areas. Dr Frey has
published 26 peer-reviewed journal papers, co-authored the book,
Probabilistic Techniques in Exposure Assessment: A Handbook for Dealing
with Variability and Uncertainty in Models and Inputs, authored three
other book chapters and authored or co-authored numerous conference
proceedings papers and technical reports. He has served as a reviewer
for 14 journals, and as an external reviewer for 8 draft EPA reports, 2
USDA risk assessments, and a draft Food and Agriculture Organization
(FAO)/World Health Organization (WHO) exposure assessment guideline. He
has served in numerous advisory capacities for EPA including on the
EPA's Scientific Advisory Panel and on the Science Advisory Board. Dr.
Frey has participated in the development of guidance documents and
handbooks, including chairing a workshop in 1998 that recommended
methods for developing input distributions in probabilistic analysis,
and a 2001 workshop that recommended approaches for sensitivity
analysis applied to food safety risk models. Dr. Frey participated in
international expert panels for the Intergovernmental Panel on Climate
Change, pertaining to guidelines for uncertainty analysis, and for FAO/
WHO regarding guidelines for probabilistic exposure assessment. Dr.
Frey is active in the Society for Risk Analysis (SRA) and the Air and
Waste Management Association (AWMA) and also is a member of the
American Society of Civil Engineers. Formerly, he was president of the
Research Triangle Chapter of SRA, a member of the SRA Council, and
Chair of the AWMA's EE-1 Exposure and Health Effects Technical
Committee. He is a recipient of a 1992 AAAS/EPA Fellowship, the 1992
AAAS Barnard Scholarship, a National Science Foundation CAREER award,
and the SRA's 1999 Chauncy Starr Award for exceptional contributions to
the field of risk analysis.
4. Nominee. Gray, George M., Ph.D., Executive Director, Harvard
Center for Risk Analysis, Harvard School of Public Health, Boston, MA.
i. Expertise. Risk assessment, interpretation of rodent bioassays,
risk management, risk communication.
ii. Education. B.S., Biology, University of Michigan; M.S. and
Ph.D., Toxicology, University of Rochester.
iii. Professional experience. Dr. Gray's primary research interests
are risk characterization and risk communication with a focus on food
safety and agriculture and chemicals in the environment. He has
published on both the scientific bases of human health risk assessment
and its application to risk policy with a focus on risk/risk tradeoffs
in risk management. Dr. Gray teaches toxicology and risk assessment to
graduate students and to participants in the Continuing Professional
Education Program at the Harvard School of Public Health. He serves on
the Risk Assessment Task Force of the Society of Toxicology, and on
government panels, including a Food and Drug Administration (FDA),
Center for Food Safety and Applied Nutrition (CFSAN) Food Advisory
Committee, and the NIEHS National Advisory Environmental Health Science
Council.
5. Nominee. Zeise, Lauren, Ph.D., Chief, Reproductive and Cancer
Hazard Assessment Section, Office of Environmental Health Hazard
Assessment, California Environmental Protection Agency, Oakland, CA.
i. Expertise. Cancer and reproductive risk assessment methodologies
and applications.
ii. Education. M.S. and Ph.D., Harvard University.
iii. Professional experience. Dr. Zeise has served as Chief of the
Reproductive and Cancer Hazard Assessment Section since 1991,
overseeing a variety of the State's cancer, reproductive, and
ecological risk assessment activities. Dr. Zeise currently serves on
the EPA Science Advisory Board Research Strategies Advisory Committee,
on the National Institute of Medicine Board of Health Promotion and
Disease Prevention, and on the NRC Board on Environmental Sciences and
Toxicology. She is a member, fellow, and councilor of the Society of
Risk Analysis and is on the editorial board of that society's journal.
The National Cancer Institute Smoking and Tobacco Smoke monograph,
Health Effects of Environmental Tobacco Smoke, was conceived and
developed under her editorial direction. She is co-author and co-editor
of the 1999 International Agency for Research on Cancer monograph
Quantitative Estimation and Prediction of Cancer Risk. Dr. Zeise has
served on the EPA Science Advisory Board Environmental Health Committee
and Integrated Risk Project, and as a consultant to the Clean Air Act
Scientific Advisory Committee, Environmental Engineering Committee,
FIFRA Scientific Advisory Panel, EPA Board of Scientific Counselors,
and on other ad hoc committees of EPA. She also has served on
committees of the National Institute of Medicine, National Research
Council, Consumer Product Safety Commission, National Toxicology
Program, and the Office of Technology Assessment.
C. Nominations for the Field of Veterinary Pathology
1. Nominee. Chambers, Janice E., Ph.D., Director, Center for
Environmental Health Sciences, and William L. Giles Distinguished
Professor, College of Veterinary Medicine, Mississippi State
University, MS.
i. Expertise. Pesticide toxicology, neurochemical and behavioral
effects of pesticides, potential effects of pesticides on infants and
children, mechanism of action and biotransformation of neurotoxicants
and other xenobiotics, predictive modeling of the effects of mixtures.
ii. Education. B.S., Biology, University of San Francisco and
Ph.D., Animal Physiology, Mississippi State University.
iii. Professional experience. Dr. Chambers directs several research
projects that deal with the effects of pesticides in mammalian systems
to determine the potential human health effects of pesticide exposures.
[[Page 63785]]
Specifically, there are projects related to the neurochemical and
behavioral effects of pesticides in developing organisms as well as the
metabolism of pesticides in developing organisms to yield predictions
about potential effects of pesticides in infants and children. Other
Projects are involved in developing mathematical predictions of the
effects of mixtures of pesticides on the nervous system so that
predictive models can be generated to potentially describe the effects
of future uncharacterized mixtures. Dr. Chambers has been the Principal
Investigator for numerous federally funded competitive grants in the
field of toxicology. Because of her expertise, she has been asked to
serve on a number of advisory boards and prestigious committees. Dr.
Chambers is board certified as a toxicologist by the American Board of
Toxicology and the Academy of Toxicological Sciences. As Director of
the Center for Environmental Health Sciences, she has developed an
interdisciplinary research center specializing in pesticide toxicology
and funded primarily by NIH. The center comprises the areas of
neurotoxicology, biochemical toxicology, analytical chemistry,
biostatistics, epidemiology, computational chemistry, computational
simulation, biochemistry, and endocrinology.
2. Nominee. Dragan, Yvonne P., Ph.D., Program Director,
Hepatotoxicology Center for Excellence, National Center for
Toxicological Research, FDA, Jefferson, AR.
i. Expertise. Pharmacology, toxicology, carcinogenesis, mode of
action, and human health risk assessment.
ii. Education. B.A., Biology, Smith College; Ph.D., Pharmacology
and Toxicology, Medical College of Virginia.
iii. Professional experience. Dr. Dragan received her Ph.D. in
Pharmacology and Toxicology from the Medical College of Virginia in
1988. She performed postdoctoral work in the Department of Oncology at
the University of Wisconsin in Madison at the McArdle Laboratory for
Cancer Research from 1988 until 1998. She was a member of the School of
Public Health faculty at the Ohio State University from 1998 until
2001. Dr. Dragan is currently the Director of the Program in
Hepatotoxicity at the National Center for Toxicological Research in
Jefferson, AR. She has held her current position at NCTR since 2002 and
is an adjunct Associate Professor in Pharmacology and Toxicology at the
University of Arkansas for Medical Sciences.
3. Nominee. Haschek-Hock, Wanda M., Ph.D., Director, Graduate
Training Program in Toxicologic Pathology and Professor, Comparative
Pathology, Department of Veterinary Pathobiology, College of Veterinary
Medicine, University of Illinois at Urbana-Champaign, Urbana, IL.
i. Expertise. Pathology, veterinary diagnostic and toxicologic;
mycotoxicology.
ii. Education. B.V.Sc., University of Sydney; Ph.D., Veterinary
Pathology, Cornell University.
iii. Professional experience. Dr. Haschek-Hock has 30 years of
experience in diagnostic and toxicologic pathology including teaching,
research, and service. Her research has been in pathophysiology of
chemicals and natural toxins found in the environment. Her current
research focus is mycotoxins and food safety. Dr. Haschek-Hock has over
100 scientific peer-reviewed publications in the fields of pathology
and toxicology, and is senior editor of the Handbook of Toxicologic
Pathology (1991, 2002), and Fundamentals of Toxicologic Pathology
(1998). She developed and directs the Graduate Training Program in
Toxicologic Pathology and the biannual international Continuing
Education Course in Industrial Toxicology and Pathology. She was Head
of the Department of Veterinary Pathology at the University of Illinois
for 6 years. She has served as President of the Society of Toxicology's
Comparative and Veterinary Specialty Section; on the Board of Directors
of the American Board of Toxicology; as Associate Editor for
Toxicological Sciences; as an Editorial Board member for Fundamental
and Applied Toxicology, Veterinary Pathology, and Toxicologic
Pathology. Dr. Haschek-Hock also has served as Councilor of the
American College of Veterinary Pathologists and as Councilor and,
currently, Secretary Treasurer of the Society of Toxicologic Pathology.
She recently served on the FDA Veterinary Medicine Advisory Committee
for the Center for Veterinary Medicine.
4. Nominee. Songer, J. Glenn, Ph.D., Professor, Department of
Veterinary Science and Microbiology, University of Arizona, Tucson, AZ.
i. Expertise. Infectious disease epidemiology and diagnosis,
pathogenesis of gram-positive bacterial infections, clostridial toxins,
clostridial enteric disease.
ii. Education. B.S., Biology, Mid-America Nazarene College; M.A.,
Preventive Medicine, University of Texas Medical Branch; Ph.D.,
Veterinary Microbiology, Iowa State University.
iii. Professional experience. Dr. Songer's research has focused on
two primary areas. The major emphasis at present is elucidation of the
role of membrane active bacterial toxins in pathogenesis of animal
disease. In addition, he has developed and applied in vitro methods,
including rapid molecular approaches, to diagnosis of animal disease.
Dr. Songer is a member of the American Society for Microbiology, the
American Association of Veterinary Laboratory Diagnosticians, the
Conference of Research Workers in Animal Disease, the U.S. Animal
Health Association and is a Fellow of the American Academy of
Microbiology. He has authored and co-authored numerous papers in his
field during the past 20 years. He has served on numerous national and
international panels on matters of interest in his field including
committees and panels for USDA and NIH.
5. Nominee. Woods, Leslie Willis, D.V.M., Associate Professor,
Clinical Diagnostic Pathology, California Animal Health and Food Safety
Laboratory System, School of Veterinary Medicine, University of
California, Davis, CA.
i. Expertise. Toxicology and infectious diseases in mammalian
wildlife and avian species.
ii. Education. B.A., Chemistry, University of San Diego; D.V.M.,
University of California, Davis; Ph.D. in Comparative Pathology,
University of California.
iii. Professional experience. Dr. Woods became a professor of
clinical diagnostic pathology in 1997 and has a joint appointment at
the California Animal Health and Food Safety Laboratory System and the
Pathology, Microbiology, and Immunology Department in the School of
Veterinary Medicine, University of California. Her research interests
are in infectious diseases and toxicoses of wildlife and exotic and
companion avian species, and infectious diseases of mammalian wildlife
species. Dr. Woods discovered and described a new adenoviral
hemorrhagic disease of deer that has been responsible for high
mortality in the mule deer species in the western United States. Dr.
Woods' other area of interest is toxicology. Her graduate research
program included in vitro and in vivo studies using respiratory toxins.
Dr. Woods has been a Diplomate of the American College of Veterinary
Pathologists since 1993.
List of Subjects
Environmental protection, pesticides and pests.
[[Page 63786]]
Dated: November 3, 2003.
Joseph J. Merenda,
Director, Office of Science Coordination and Policy.
[FR Doc. 03-28217 Filed 11-7-03; 8:45 am]
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