E8-5556. Nominations to the FIFRA Scientific Advisory Panel; Request for Comments

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice provides the names, addresses, professional affiliations, and selected biographical data of persons nominated to serve on the Scientific Advisory Panel (SAP) established under section 25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The 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 [phone].

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 [phone].

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: [phone]; fax number: [phone]; e-mail addresses: [e-mail].

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 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 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 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 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. 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 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.