[Federal Register: March 19, 2008 (Volume 73, Number 54)]
[Notices]
[Page 14794-14800]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19mr08-51]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0045; FRL-8354-2]
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 Panel 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
panel as a result of membership terms that will expire this year.
Public comment on the nominations is invited, as these comments will be
used to assist the Agency in selecting the new chartered Panel members.
DATES: Comments, identified by docket ID number EPA-OPP-2008-0045, must
be received on or before April 18, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0045, 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 Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation from 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 telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0045. 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 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 Federal 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.
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 Drive, 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 telephone number is (703) 305-
5805.
FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, Designated Federal
Official, FIFRA SAP, Office of Science Coordination and Policy (7201M),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 564-2045; fax number:
(202) 564-8382; e-mail addresses: bailey.joseph@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 DFO
listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
ii. 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.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. 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 the U.S. Environmental Protection Agency (EPA), 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
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Federal Advisory Committee Act. 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 the FQPA of 1996, established a Science Review Board
consisting of at least 60 scientists who are available to the
Scientific Advisory Panel on an ad hoc basis to assist in reviews
conducted by the Panel. 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 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 toxicology, pathology, endocrine disruption and
environmental exposure analysis. Nominees should be well published and
current in their fields of expertise. The statute further stipulates
that we publish the name, address, and professional affiliations in the
Federal Register.
III. Charter
A Charter for the FIFRA Scientific Advisory Panel dated October 25,
2006 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).
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 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 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 Deputy
Administrator shall require all nominees to the Panel 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 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 March 2007, requested that the National Institutes of Health (NIH)
and the National Science Foundation (NSF) nominate scientists to fill
two vacancies soon to occur on the Panel. The Agency requested
nominations of experts in the fields of toxicology, pathology,
endocrine disruption and environmental exposure analysis. NIH and NSF
responded by letter, providing the Agency with a total of 24 nominees.
Thirteen of the 24 nominees are interested and available to actively
participate in SAP meetings (see Unit IV. of this document). The
following 11 nominees are not available:
1. Barnthouse, Lawrence W., Ph.D., LWB Environmental Service, Inc.,
Hamilton, OH;
2. Daston, George, Ph.D., The Proctor and Gamble Company,
Cincinnati, OH;
3. Dement, John, Ph.D., CIH, Duke University Medical Centers,
Durham, NC;
4. Faustman, Elaine, Ph.D., DABT, University of Washington,
Seattle, WA;
5. MacGregor, James, Ph.D., Toxicology Consulting Services, Arnold,
MD;
6. Oberdorster, Eva, Ph.D., Southern Methodist University, Dallas,
TX;
7. Piegorsch, Water, Ph.D., University of South Carolina, Columbia,
SC;
8. Popp, James, DVM, Ph.D., Stratoxon, Lancaster, PA;
9. Wilson, Elizabeth, Ph.D., University of North Carolina, Chapel
Hill, NC;
10. Yager, James, Ph.D., Johns Hopkins University, Baltimore, MD;
11. Welsch, Frank, DVM, Ph.D., DABT, Orbitox, Santa Fe, NM.
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 expects
to select two of the nominees to fill vacancies occurring this year.
1. Nominee: Bruckner, James, Ph.D., Professor of Pharmacology and
Toxicology, Department of Pharmaceutical and Biomedical Sciences,
College of Pharmacy, University of Georgia, Athens, GA.
i. Expertise: Toxicology and Toxicokinetics;
ii. Education: B.S., Pharmacy, University of Texas at Austin,
College of Pharmacy; M.S., Toxicology, University of Texas at Austin;
Ph.D., Toxicology, University of Michigan;
iii. Professional Experience: James V. Bruckner has a B.S. in
pharmacy and a M.S. in Toxicology from the University of Texas, as well
as a Ph.D. in Toxicology from the University of Michigan. He has held
faculty positions at the University of Kansas, the University of Texas
Medical School at Houston, and the University of Georgia (UGA). Dr.
Bruckner served as a member of the University of Texas Health Sciences
Center internal review (human subjects) board for some 8 years. He is
currently Professor of Pharmacology and Toxicology at the UGA College
of Pharmacy. He was director of UGA's Interdisciplinary Graduate
Program in Toxicology for some 15 years. He is actively engaged in
graduate education and in research. Dr. Bruckner has served on the
editorial boards of Toxicology and Applied Pharmacology, Journal of
Toxicology and Environmental Health, Toxicology, Chemosphere and the
International Journal of Toxicology.
Dr. Bruckner's research focus is on the toxicology and
toxicokinetics of solvents, drug-solvent interactions at environmental
exposure levels, and toxicokinetic bases for susceptibility of children
to insecticides and other chemicals. The relevance of experimental
designs to ``real life'' chemical exposures is of particular interest.
One current project involves: characterization of presystemic
elimination as a protective mechanism against ingestion of trace levels
of trichloroethylene (TCE); and determination of the influence of
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metabolic interactions of alcohol and other drugs on cancer risks of
trace amounts of TCE. Another project involves development of a
physiological model to predict the toxicokinetics of pyrethroid
insecticides in children and adults. Dr. Bruckner has published more
than 200 journal articles, book chapters and abstracts. He has served
on a variety of expert panels and committees for the USEPA, NIH,
National Aeronautics and Space Administration, Air Force, Agency for
Toxic Substances and Disease Regitry/Center for Disease Control (CDC),
Food and Drug Administration (FDA) and the National Academy of Sciences
(NAS). The NAS appointments have included, among others, the Committees
on Safe Drinking Water, Pesticides in the Diets of Infants and
Children; Health and Safety Consequences of Child Labor; Use of Third
Party Toxicity Research with Human Participants; and Toxicology.
2. Nominee: Donnelly, Kirby, Ph.D., Professor and Head, Department
of Environmental and Occupational Health, Health Science Center, School
of Rural Public Health, Texas A and M University, College Station, TX.
i. Expertise: Toxicology and Exposure Assessment;
ii. Education: B.S., Microbiology, Texas A and M University; Ph.D.,
Toxicology, Texas A and M University;
iii. Professional Experience: Dr. K.C. Donnelly received a B.S. in
Microbiology from Texas A and M University in 1974. After graduation,
he worked as a technician for 10 years supervising a variety of field
research projects at the Texas A and M farm in Burleson County. In 1984
he entered a doctoral program and earned a Ph.D. in Toxicology in 1988.
Afterwards, he was employed as a Post-Doctoral Research Associate under
the direction of Dr. Kirk Brown in the Soil & Crop Sciences Department
at Texas A and M. He accepted a faculty position in 1991 and is
currently a Professor and Head of the Environmental & Occupational
Health Department in the School of Rural Public Health at the Texas A
and M University System Health Science Center. Teaching
responsibilities include an undergraduate course in Public Health
Practices and two graduate courses, the first covering Basic
Environmental Toxicology and a second lab course reviewing methods for
Chemical Hazard Assessment. Dr. Donnelly also organizes workshops on
Environmental Health for public health professionals, most recently in
June, 2007 in Baku, Azerbaijan. He also provides continuing education
courses for nurses and physicians in ``Children's Environmental
Health'' and ``Safe Drinking Water.'' Dr. Donnelly currently serves as
the Director of the Integrated Health Sciences Facility Core for the
National Institute for Environmental Health and Safety (NIEHS) Center
for Environmental & Rural Health; and, he is the Associate Director for
the NIEHS funded Superfund Basic Research Program at Texas A and M.
Responsibilities for the Environmental Health Center include analytical
support and sample collection for human population studies; and,
support for Community Outreach and Education activities. For the
Superfund Basic Research Program, Dr. Donnelly is the principal
investigator for Project 2, Genotoxicity of Complex Mixtures and
supervises cell culture, whole animal and human population studies to
obtain information regarding population exposures and toxicity of
complex chemical mixtures. He is currently involved in exposure studies
in Azerbaijan, Czech Republic, Shanxi, China and numerous locations in
the United States. Dr. Donnelly has conducted research on childhood
exposure to pesticides for more than 10 years. Most recently, this has
included a collaborative study with the Centers for Disease Control and
EPA to conduct a longitudinal study on pesticide exposure in children
from 90 households in four rural communities. He is currently in the
second year of a 3 year Health Resources and Service Administration
(HRSA) project to investigate the utility of health education as an
intervention to reduce childhood exposure to pesticides in Texas
colonias. This project employs promotoras (community health workers) to
deliver health education to individual families, and monitors
behavioral changes through a household inventory of pesticide use and
by monitoring urinary elimination of pesticides in children. Dr.
Donnelly has more than 30 years experience in basic and applied
research. More recent activities have incorporated health promotion
activities into research protocols as a means of preventing disease by
reducing exposures. Dr. Donnelly is also involved in collaboration with
the Texas Department of State Health Services, the Webb County Health
Department, and the Poison Control Center in San Antonio to develop a
``Physicians Handbook for Pesticide Exposures.''
3. Nominee: Harwell, Mark, Ph.D., Ecosystems Ecologist and Partner,
Harwell Gentile & Associates, LC, Hammock, FL.
i. Expertise: Ecological risk assessment and ecosystem management;
ii. Education: B.S., Biology, Emory University; M.S., Marine
Ecology, University of Miami, Institute of Marine Science; Ph.D.,
Systems Ecology, Emory University;
iii. Professional Experience: Dr. Harwell is an ecosystems
ecologist with expertise in ecological risk assessments and ecosystem
management. He (with colleague Dr. Jack Gentile) is currently a Partner
in Harwell Gentile & Associates, LC, following a 25-year career in
academia at Cornell University, the University of Miami Rosenstiel
School, and Florida A and M University. Drs. Harwell and Gentile were
leaders in the development of the USEPA ecological risk assessment
framework, and have led several large risk assessments, including
comparative ecological risk assessments of oil spills in Tampa Bay and
the Bay of Fundy; an ecological risk assessment of the effects of
climate change and the South Florida ecosystem restoration on the
Everglades and Biscayne Bay; an ecotoxicological risk assessment of the
Coeur d'Alene River watershed; and an assessment of the current
ecological significance of effects from the Exxon Valdez oil spill on
Prince William Sound. Dr. Harwell led a series of interdisciplinary
studies on human interactions with the South Florida environment,
including field, mesocosm, and modeling studies in Biscayne Bay and the
Florida Keys National Marine Sanctuary. He coordinated
interdisciplinary studies in five National Estuarine Research Reserves,
developing conceptual models of coupled human-environment systems, and
contributing to ecological assessments using remote sensing and
hyperspectral imagery. Dr. Harwell served for more than a decade as a
member of the USEPA Science Advisory Board (SAB), including two terms
as Chair of the Ecological Processes and Effects Committee. He led the
ecological risk component of the USEPA Unfinished Business Project, and
was a member of the USEPA SAB Reducing Risk project. He chaired the
U.S. Man and the Biosphere Human-Dominated Systems Directorate, and led
its project on ecological sustainability, ecosystem management, and an
ecosystem integrity report card framework. He led the Scientific
Committee on Problems of the Environment (SCOPE) 5-year international
study to assess the global environmental consequences of nuclear war
(ENUWAR), with emphasis on ecological responses to climate change. He
directed the PAN-EARTH Project, a series of national-level case studies
on the ecological and agricultural effects of climate variability on
Venezuela, India, Japan, China, and Sub-Saharan Africa; he was a member
of the U.S. Global
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Change Research Program's National Assessment working group on coastal
resources effects; and he serves as an expert reviewer for the
Intergovernmental Panel on Climate Change. He served on the National
Academy of Sciences panel on ecological risks in the United States and
Poland, and was a member of the NAS panel on risk communications. Dr.
Harwell also served as a member of the National Academy of Sciences
Board on Environmental Studies and Toxicology, and was elected a Fellow
of the American Association for the Advancement of Science.
4. Nominee: Haschek-Hock, Wanda, Ph.D., DVM, DACVP, DABT,
Veterinary Pathologist and Professor of Comparative Pathology,
Department of Pathobiology, College of Veterinary Medicine, University
of Illinois, Urbana, IL.
i. Expertise: Veterinary and Toxicologic Pathology;
ii. Education: BVSc (DVM equivalent), University of Sidney; Ph.D.,
Veterinary Pathology, Cornell University;
iii. Professional Experience: Dr. Wanda M. Haschek-Hock, a
veterinary pathologist and Professor of Comparative Pathology at the
University of Illinois College of Veterinary Medicine, has over 30
years of experience in veterinary and toxicologic pathology including
teaching, research and service. Dr. Haschek-Hock received her BVSc (DVM
equivalent) from the University of Sydney and her Ph.D. from Cornell
University. She is a diplomate of the American College of Veterinary
Pathologists (ACVP) and the American Board of Toxicology (ABT). Her
research has been in the pathophysiology of chemicals and natural
toxins found in the environment with the current focus on mycotoxins
and food safety. She 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) published by Academic Press. She developed
and directs the Graduate Training Program in Toxicologic Pathology and
the biannual international continuing education course in Industrial
Toxicology and Pathology. She served as head of the department for 6
years. In regard to professional service, 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 and currently for
Toxicologic Pathology; as Editorial Board member for Fundamental and
Applied Toxicology, Veterinary Pathology and Toxicologic Pathology. She
has also served as Councilor of the American College of Veterinary
Pathologists and as Executive Committee member and Secretary Treasurer
of the Society of Toxicologic Pathology. She has served on the USFDA
Veterinary Medicine Advisory Committee for the Center for Veterinary
Medicine and as an ad hoc member for the EPA's FIFRA Scientific
Advisory Panel. She was awarded the Society of Toxicologic Pathology's
Achievement Award in 2007.
5. Nominee: Kelly, Elizabeth J., Ph.D., Statistician, Statistical
Sciences Group, Los Alamos National Laboratory, Los Alamos, NM.
i. Expertise: Environmental Statistics and Risk Analysis;
ii. Education: B.S., M.A., Mathematics, University of Southern
California; Ph.D., Biostatistics, University of California at Los
Angeles;
iii. Professional Experience: Elizabeth J. Kelly has a Ph.D. in
Biostatistics from the University of California at Los Angeles and a
M.A. and a B.S. in Mathematics from the University of Southern
California. Dr. Kelly has worked in the areas of risk assessment,
statistics and operations research, using these disciplines to solve
problems in the fields of environmental risk, defense and medicine. Dr.
Kelly is a staff member in the Statistical Sciences Group at Los Alamos
National Laboratory. The mission of the Statistical Sciences Group is
to bring statistical reasoning and rigor to multi-disciplinary
scientific investigations through development, application, and
communication of cutting-edge statistical sciences research. Dr.
Kelly's research has focused on environmental risk assessments and
environmental statistics. She led the Risk Assessment Team for the
Environmental Restoration Program at Los Alamos, developing,
documenting, and communicating a cost-effective, defensible technical
approach for data collection, data evaluation, and human health and
ecological risk assessments in support of environmental decision-
making. Dr. Kelly has served on numerous NSF and EPA grant panels. She
served on the NSF Advisory Committee for Environmental Research and
Education (2000-2004) and was a contributor to the NSF report, Complex
Environmental Systems, Synthesis for Earth, Life, and Society in the
21st Century. Dr. Kelly also chaired the Committee of Visitors (COV)
for the NSF Biocomplexity Program, co-authoring the ``COV Report for
Biocomplexity in the Environment.'' In addition Dr. Kelly served on the
NSF Advisory Committee for Government Performance and Results Act,
which evaluates all of the NSF funded programs and reports to congress.
6. Nominee: Klaassen, Curtis, Ph.D., DABT, Distinguished Professor
and Chairman of the Department of Pharmacology, Toxicology and
Therapeutics; University of Kansas, Kansas City, KS.
i. Expertise: Toxicology;
ii. Education: B.A., Biology, Wartburg College; M.S., Pharmacology,
University of Iowa; Ph.D., Pharmacology, University of Iowa;
iii. Professional Experience: Dr. Klaassen is University
Distinguished Professor and Chairman of the Department of Pharmacology,
Toxicology and Therapeutics at the University of Kansas Medical Center
in Kansas City, Kansas. He received his B.S. from Wartburg College in
Waverly, Iowa in 1964, and a M.S. and Ph.D. in Pharmacology from the
University of Iowa in 1966 and 1968, respectively. He has been on the
faculty at the University of Kansas Medical Center since 1968. Dr.
Klaassen is certified in toxicology by the American Board of Toxicology
(1980) and the Academy of Toxicological Sciences (1991).
Dr. Klaassen's research interests have centered on how we adapt to
chemicals in the environment. Studies have included the hepatobiliary
disposition of xenobiotics, the toxicity of cadmium, the hepatotoxicity
of chemicals, and mechanisms of chemical-induced thyroid tumors. He has
published over 400 peer-reviewed articles, and more than 75 review
articles and chapters for books. He received the Achievement Award from
the Society of Toxicology in 1978 for his research accomplishments. He
was cited by Eugen Garfield in Current Contents (January 18, 1993) as
the scientist that had the fourth highest scientific impact in the
United States in the study of xenobiotics (drugs and other chemicals),
and in 2002 was named a ``Highly Cited Researcher'' in Pharmacology
(top 0.5%) by the Institute for Scientific Information.
Dr. Klaassen has been an associate editor of a number of journals
including the Journal of Pharmacology and Experimental Therapeutics for
24 years and Toxicology and Applied Pharmacology for 10 years. He was
the first Editor-in-Chief of Toxicological Sciences , the new journal
of the Society of Toxicology. He has served on numerous national and
international committees including those with the National Institutes
of Health, the Food and Drug Administration, the National
[[Page 14798]]
Library of Medicine, the Environmental Protection Agency, the National
Academy of Science, the National Toxicology Program, the National
Institute of Occupational Safety and the Health, International Life
Science Institute, United States Air Force, World Health Organization,
Agency for Toxic Substances and Disease Registry, American Dental
Association, and International Agency for Research on Cancer.
Dr. Klaassen has been elected by his peers to many national and
international offices in toxicology, including President of the Society
of Toxicology (USA) in 1990-1991, as well as President of the
International Union of Toxicology (1992-1995). He was also President of
the Seventh International Congress of Toxicology (1995) and the Fourth
International Metallothionein Meeting (1997).
Dr. Klaasen is a leader in toxicology education. He has trained
over 80 Ph.D. and Postdoctoral students. He is Founder (1980) and
Course Director of the Mid-America Toxicology Course, an annual
postgraduate course in toxicology. He is author of the toxicology
section of Goodman and Gilman's Pharmacological Basis of Therapeutics
and Editor of Casarett and Doull's Toxicology: The Basic Science of
Poisons. He has presented over 400 lectures on toxicology around the
world. He received the ``Education Award'' from the Society of
Toxicology in 1993.
7. Nominee: Klaine, Stephen J., Ph.D., Professor, Department of
Biological Sciences, Clemson University, Clemson, SC.
i. Expertise: Environmental Toxicology;
ii. Education: B.S., Biology, University of Cincinnati, M.S.,
Environmental Science, Rice University; Ph.D., Environmental Science,
Rice University;
iii. Professional Experience: Stephen J. Klaine is a Professor in
the Department of Biological Sciences and the Graduate Program of
Environmental Toxicology at Clemson University. His research interest
involves quantifying the impact of land use on aquatic ecosystems and
developing strategies by which economically viable land-use can coexist
with good environmental quality. He received his doctorate from the
Department of Environmental Science and Engineering, Rice University in
1982 and has spent the last 25 years conducting environmental research
and educating graduate students. He joined the Department of Biology,
University of Memphis, in 1982 where he developed an undergraduate
concentration in toxicology, an extramurally-funded research program in
environmental toxicology, and a graduate program. In 1991, he moved his
laboratory to Clemson University to help found the graduate program in
environmental toxicology. Current research in his laboratory focuses on
characterizing the bioavailability of metals and pesticides in aquatic
systems; the comparative phytotoxicity of pesticides; the response of
aquatic organisms to episodic contaminant exposures; the water quality
consequences of land use; the effects of pharmaceuticals on fish
behavior; the bioavailability of single-walled carbon nanotubes in
aquatic systems; and the bioavailability of PCBs in aquatic systems and
the movement of PCBs through the aquatic and terrestrial food chain.
Dr. Klaine has published over 100 scientific publications and has
served as principal investigator or co-principal investigator on over
$8 million in research funding. He has previously served on the board
of directors for the Society of Environmental Toxicology and Chemistry
(SETAC) and is currently an aquatic toxicology editor for the journal
Environmental Toxicology and Chemistry. He also sits on the board of
the SETAC foundation and is a member of SETAC World Council finance
committee. In the last decade, he has served on several USEPA
Scientific Advisory Panels and workshops involving pesticide and metal
fate, effects and risk. Most recently, he received the Outstanding
Researcher award from the Sigma Xi chapter at Clemson University.
8. Nominee: Krieger, Robert I., Ph.D., Cooperative Extension
Specialist (Toxicology), Department of Entomology, Personal Chemical
Exposure Program, University of California at Riverside, Riverside, CA.
i. Expertise: Toxicology and Exposure Assessment;
ii. Education: B.S., Chemistry, Pacific Lutheran University; Ph.D.,
Toxicology, Cornell University;
iii. Professional Experience: Dr. Krieger is a Cooperative
Extension Toxicologist in the Department of Entomology, University of
California at Riverside and a member of the Graduate Program in
Environmental Toxicology. He holds a B.S. cum laude in Chemistry from
Pacific Lutheran University (1967) and a Ph.D. from Cornell University
(1970) where he was a student in the Department of Entomology and NIEHS
Trainee in Environmental Toxicology. Graduate study fields included
toxicology, physiology and biochemistry. He has held tenured academic
appointments at the University of California at Davis (1971-1980) and
in the Washington-Oregon-Idaho Regional Veterinary Medical Education
Program (1981-1986) where he was Professor of Veterinary and
Comparative Toxicology. In 1986 he became staff toxicologist and later
Branch Chief, Worker Health and Safety, California Department of Food
and Agriculture (now California EPA). Dr. Krieger worked with two major
Washington D.C. consulting firms (1991-1994) in exposure and risk
assessment before returning to the University of California as an
Extension Toxicologist (1994-present) specializing in pesticide
exposure assessment and worker health and safety. He has taught
toxicology at both the undergraduate and graduate levels and received
several teaching awards including the Society of Toxicology's Education
Award in 1986. His research concerns the fate and effects of pesticides
in humans, risk assessment, and risk communication. Current studies
concern methods and techniques for determining the availability of
chemical residues on surfaces, exposure biomonitoring of urban and
agricultural populations that are exposed to pesticides and other
chemicals. At the Universty of California at Riverside, Dr. Krieger
heads the Personal Chemical Exposure Program that includes research and
extension activities in urban and agricultural settings. He also headed
the distinguished editorial team that produced the Handbook of
Pesticide Toxicology (2001).
9. Nominee: La Point, Thomas, Ph.D., Director of the Institute of
Applied Sciences and Professor and Senior Scientist in the Department
of Biological Sciences, University of North Texas, Denton, TX.
i. Expertise: Ecosystem Toxicology;
ii. Education: B.S., Zoology and Physiology, University of Wyoming;
M.S., Population Biology, University of Houston; Ph.D., Aquatic
Biology, Idaho State University;
iii. Professional Experience: Dr. La Point directs the Institute of
Applied Sciences at the University of North Texas and is a Professor in
the Department of Biological Sciences. He received his Ph.D. from the
Department of Biological Sciences at Idaho State University in Aquatic
Biology. His primary research and teaching interests include
contaminant effects on freshwater aquatic communities, specifically in
how metals and organic contaminants affect benthic population dynamics
and freshwater fisheries. He has published on ecosystem measures,
contaminant bioaccumulation, and sub-lethal effects on aquatic
populations. Dr.
[[Page 14799]]
La Point has served on several USEPA Scientific Advisory Panels
concerned with pesticides and ecological risk and has worked as a
consultant on Superfund issues at large sites. Dr. La Point also served
on a National Academy of Science NRC Committee on Superfund Site
Assessment and Remediation in the Coeur d'Alene River Basin. He is
serving as Chair of a Water Environment Research Foundation
subcommittee on whole-effluent testing as an indicator of aquatic
health. He has served on several NSF, USEPA and United States
Geological Survey panels to review proposals submitted for funding. He
is on the editorial board for Chemosphere and Environmental Toxicology
and Pharmacology and has served as Editor of the Society of
Environmental Toxicology and Chemistry (SETAC) Special Publication
Series. Dr. La Point's current research is funded by the USEPA, U.S.
Army Corps of Engineers, and the City of Denton, TX.
10. Nominee: Law, Jerry, DVM, Ph.D., ACVP, Associate Professor of
Pathology and Aquatic Ecotoxicology, Department of Population Health
and Pathobiology, College of Veterinary Medicine, North Carolina State
University, Raleigh, NC.
i. Expertise: Pathology;
ii. Education: D.V.M. , Veterinary Medicine, Louisiana State
University, Baton Rouge, LA; Ph.D., Veterinary Pathology, Louisiana
State University, Baton Rouge, LA;
iii. Professional Experience: Dr. Law received his D.V.M in
Veterinary Medicine from Louisiana State University in 1985 and his
Ph.D. in Veterinary Pathology from Louisiana State University in 1995.
He is a certified Diplomate of the American College of Veterinary
Pathologists and serves as an Education Committee Member of the
Americal College of Veterinary Pathologists, as an Advisory Board
Member of the Genetics and Environmental Mutagenesis Society and as a
Council Member of the North Carolina Society of Toxicology. Dr. Law's
research focuses on mechanisms of carcinogenesis and comparative
pathology of aquatic animals. The approach is twofold:
a. Mechanistic investigations using histopathology, molecular
biology, and analytical techniques such as gas chromatography/mass
spectrometry and high performance liquid chromatography with
electrochemical detection to further establish small fish species as
viable alternative animal models in toxicologic testing. Fish models
such as the medaka, Oryzias latipes, and the zebrafish, Danio rerio,
are used in these studies.
b. Laboratory, mesocosm, and field investigations designed to
establish reliable biological markers in aquatic organisms as sentinels
of environmental degradation. These biomarkers incorporate
histopathology, clinical pathology, and immunologic techniques to
determine the health of aquatic animals and ecosystems. Expected
benefits of Dr. Law's research include increased knowledge of basic
mechanisms of carcinogenesis, more rapid and economical testing of
potential carcinogens, sensitive monitoring of aquatic pollutants, and
better assessment of seafood safety.
11. Nominee: Pope, Carey, Ph.D., Professor, Head and Sitlington
Chair in Toxicology, Department of Physiological Sciences, College of
Veterinary Medicine, Oklahoma State University, Stillwater, OK.
i. Expertise: Toxicology;
ii. Education: B.S., Biology, Austin State University; M.S.,
Biology, Austin State University; Ph.D., Pharmacology/Toxicology,
University of Texas Graduate School of Biomedical Sciences;
iii. Professional Experience: Dr. Carey Pope is Professor, Head and
Sitlington Chair in Toxicology in the Department of Physiological
Sciences at the Oklahoma State University Center for Veterinary Health
Sciences, Stillwater, Oklahoma. He received a Ph.D. degree from the
University of Texas Graduate School of Biomedical Sciences in Houston,
Texas in 1985, and completed postdoctoral training in the Neurology
Department at Baylor College of Medicine (1985) and the U.S.
Environmental Protection Agency's National Health and Environmental
Effects Research Laboratory (1986-1989). He previously served on the
faculty of the College of Pharmacy, University of Louisiana at Monroe
(1989-1999). Dr. Pope's research primarily involves the evaluation of
intrinsic and extrinsic factors that modify neurotoxicity from exposure
to acetylcholinesterase inhibitors. He has previously served as a
consultant for the U.S. Army's external research programs, was a member
of the NAS/National Research Council Subcommittee on Toxicologic
Assessment of Low-Level Exposures to Chemical Warfare Agents and is
currently a member of the NIEHS Neurotoxicology and Alcohol study
section. Dr. Pope has been a member of the Food Quality Protection Act
Science Review Board since 1996.
12. Nominee: Spitsbergen, Jan, Ph.D., DVM, ACVP, Research Assistant
Professor, Center for Fish Disease Research, Oregon State University,
Corvallis, OR.
i. Expertise: Veterinary Pathology and Toxicology;
ii. Education: B.S., Fisheries and Wildlife, Michigan State
University; D.V.M., Michigan State University College of Veterinary
Medicine; Ph.D., Immunology and Pathology, Cornell University;
iii. Professional Experience: Dr. Spitsbergen is one of a few
board-certified veterinary pathologists in the world who has strong
expertise in fish diseases, fish pathology, and toxicologic pathology.
She taught finfish histology, histopathology and tumor biology for 7
years in the Aquavet Program, an educational program based in Woods
Hole, MA, to train veterinarians, veterinary students, and fish health
scientists about aquatic animal health, husbandry, and diseases. She
has conducted field epidemiology and experimental laboratory research
studies in fish toxicology and pathology for over 25 years. Her
research includes studies in early life stage toxicity of environmental
contaminants; effects of toxicants on sex determination, fertility and
fecundity; effects of halogenated aromatic hydrocarbons on disease
resistance and immune responses; naturally occurring thiamine
deficiency as the cause of early life stage mortality in salmonids in
natural waters; field and laboratory studies of the complex causes of
epizootics of neoplasia in skin and liver of fish. She has focused her
research on spontaneous and carcinogen-induced tumors in zebrafish for
the past 12 years. She has collaborated with scientists from the
University of Oregon, the University of Wisconsin at Madison,
Children's Hospital and the Dana Farber Cancer Research Institute at
Harvard University, the National University of Singapore, and
biotechnology companies in the United States and Hungary. Recently her
collaborations involve development of zebrafish models for the study of
Fanconi anemia, an inherited disease of humans that results in aplastic
anemia or leukemia by young adulthood. Survivors of the current
treatment of choice, a bone marrow transplant, are at high risk for
developing solid tumors such as squamous cell carcinoma of head and
neck. Fanconi anemia results from genomic instability and increased
susceptibility to oxidant damage when homozygous mutation occurs in one
of 12 genes in the Fanconi anemia signaling network. Dr. Spitsbergen
also studies myelodysplastic syndrome and leukemia which occur
spontaneously in certain mutant lines of zebrafish. One remarkable
finding in Dr. Spitsbergen's recent zebrafish tumor research is the
[[Page 14800]]
fact that diet and husbandry systems can profoundly influence tumor
incidences in tanks of zebrafish. These findings are important because
zebrafish husbandry practices are much less standardized currently than
the protocols for most other laboratory animals like mice.
13. Nominee: Timchalk, Charles, Ph.D., DABT, Staff Scientist,
Pacific Northwest National Laboratories, Center for Biological
Monitoring and Modeling, Richland, WA.
i. Expertise: Toxicology;
ii. Education: B.S., Biology, State University of New York at
Oneonta; Ph.D., Toxicology/Pharmacology, The Albany Medical College of
Union University;
iii. Professional Experience: Charles Timchalk received a B.S. in
Biology in 1978 from the State University of New York, and a Ph.D. in
1986 from the Department of Pharmacology and Toxicology, The Albany
Medical College. He is currently certified as a Diplomat of the
American Board of Toxicology. In 1986 he joined the Dow Chemical
Company as a post-doctoral fellow within the Biotransformation and
Molecular Toxicology Group of the Toxicology Research Laboratory. At
Dow he was a research and technical leader within the Pharmacokinetics
and Metabolism group prior to accepting his current position. In 1997
he joined the Center for Biological Monitoring and Modeling within
Battelle Pacific Northwest Laboratory as a Staff Scientist. In this
position he is continuing to pursue his interest in the application of
pharmacokinetics for evaluation of human health risk. His research is
currently focused around three themes:
a. The development of new technologies and approaches for non-
invasive biological monitoring;
b. Advancing pharmacokinetic and pharmacodynamic modeling to focus
on the assessment of risk to potentially sensitive populations, such as
children, and to evaluate the health risk implications of exposure to
low dose chemical mixtures; and
c. The utilization of advanced imaging and 3-dimensional modeling
approaches to develop new dosimetry and biological response models.
Dr. Timchalk is currently the principal investigator or co-
investigator on seven Department of Health and Human Services/National
Institutes of Health (DHHS/NIH) grants and has four recently completed
projects for DHHS and EPA. He has also provided technical leadership in
support of several Pacific Northwest National Laboratory (PNNL)
initiatives including: The Environmental Health and Environmental
Biomarkers Initiative. He has likewise provided support on technical
review and advisory committees including: NIH/NIEHS Superfund Basic
Research Grant Review; NIH/National Cancer Institute Special Emphasis
Review; Dichloromethane Peer Review Panel; Austrian Science Fund Grant
Review; International Life Sciences Institute, Health and Environmental
Science Institute, Agricultural Chemical Safety Assessment Steering
Committee; CDC/National Institute for Occupational Safety and Heatlh
Safety and Occupational Health Study Section and the EPA-STAR Grant
Review Panel. He has served as President of the Society of Toxicology,
Biological Modeling Specialty Section. Over the course of his career
Dr. Timchalk has been acknowledged both for his professional
accomplishments and for his ongoing interest in supporting the
development of young scientist. His research has been recognized by
awards from the Environmental Business Journal (Technical Merit award,
2001), and R & D 100 Nomination (2004). In addition, he received the
Department of Energy, Office of Science Outstanding Mentor Award
(2002); and the PNNL, Chester I. Cooper Mentor of the Year Award
(2003).
List of Subjects
Environmental protection, Pesticides and pests.
Dated: March 13, 2008.
Mary Belefski,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. E8-5556 Filed 3-18-08; 8:45 am]
BILLING CODE 6560-50-S