E9-19313. Nominations to the FIFRA Scientific Advisory Panel; Request for Comments

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice provides the names, addresses, professional affiliations, and selected biographical data of persons nominated to serve on the Scientific Advisory Panel (SAP) established under section 25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FIFRA SAP was created on November 28, 1975, and made a statutory panel by amendment to FIFRA, dated October 25, 1988. The Agency is, at this time, selecting two new members to serve on the FIFRA SAP as a result of a membership term that will expire this year and the sudden and unexpected loss of a FIFRA SAP member. Public comment on the nominations is invited, as these comments will be used to assist the Agency in selecting the new chartered FIFRA SAP members.

DATES:

Comments must be received on or before September 11, 2009.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2008-0177, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2008-0177. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Myrta R. Christian, Designated Federal Official (DFO), FIFRA SAP, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [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 person listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

When submitting comments, remember to:

1. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

2. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

4. Describe any assumptions and provide any technical information and/or data that you used.

5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

6. Provide specific examples to illustrate your concerns and suggest alternatives.

7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

8. Make sure to submit your comments by the comment period deadline identified.

II. Background

The FIFRA SAP serves as the primary scientific peer review mechanism of EPA’s Office of Prevention, Pesticides and Toxic Substances and is structured to provide scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. The FIFRA SAP is a Federal advisory committee, established in 1975 under FIFRA, that operates in accordance with requirements of the Federal Advisory Committee Act (FACA). The FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health (NIH) and the National Science Foundation (NSF). FIFRA, as amended by FQPA, established a Science Review Board consisting of at least 60 scientists who are available to the FIFRA SAP on an ad hoc basis to assist in reviews conducted by the FIFRA SAP. As a peer review mechanism, the FIFRA SAP provides comments, evaluations, and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of the FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency. The Agency is, at this time, selecting two new members to serve on the permanent FIFRA SAP as a result of a membership term that will expire this year and the sudden and unexpected loss of a FIFRA SAP member. The Agency requested nominations of experts to be selected from the field of environmental risk assessment including: planning, scoping, and problem formulation; analysis; and interpretation and risk characterization (including the interpretation and communication of uncertainty). Nominees should be well published and current in their fields of expertise. The statute further stipulates that we publish the names, addresses, and professional affiliations in the Federal Register.

III. Charter

A charter for the FIFRA SAP, dated October 24, 2008, was issued in accordance with the requirements of FACA, Public Law 92-463, 86 Stat. 770 (5 U.S.C. App.).

A. Qualifications of Members

FIFRA SAP members are scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments as to the impact of pesticides on health and the environment. No persons are ineligible to serve on the FIFRA SAP by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency (except the EPA). The EPA Administrator appoints individuals to serve on the FIFRA SAP for staggered terms of 4 years unless the appointment serves to fill an unexpired term for a vacancy that has occurred due to a member resignation or reason other than expiration of a term. The FIFRA SAP members, as Special Government Employees, are subject to the provisions of 5 CFR Part 2635-Standards of Ethical Conduct for Employees of the Executive Branch. Each nominee selected by the EPA Administrator before being formally appointed, is requested to submit a confidential statement of employment and financial interests, which shall fully disclose, among other financial interests, the nominee's sources of research support, if any.

In accordance with section 25(d)(1) of FIFRA, the EPA Administrator shall require all nominees to the FIFRA SAP to furnish information concerning their professional qualifications, educational background, employment history, and scientific publications.

B. Applicability of Existing Regulations

With respect to the requirements of section 25(d) of FIFRA that the Administrator promulgate regulations regarding conflicts of interest, the charter provides that EPA's existing regulations applicable to Special Government Employees, which include advisory committee members, will apply to the members of the FIFRA SAP. These regulations appear in 5 CFR part 2635. In addition, the charter provides for open meetings with opportunities for public participation.

C. Process of Obtaining Nominees

In accordance with the provisions of section 25(d) of FIFRA, EPA, in April 2009, requested that NIH and NSF nominate scientists for consideration to serve on the FIFRA SAP. The Agency requested nominations of experts in the field of environmental risk assessment including: planning, scoping, and problem formulation; analysis; and interpretation and risk characterization (including the interpretation and communication of uncertainty). NIH and NSF responded by letter, providing the Agency with a total of 14 nominees. Seven of the 14 nominees are interested and available to actively participate in FIFRA SAP meetings (see Unit IV.). The following 7 nominees are not available:

1. Blomquist, Gary, Ph.D., University of Nevada, Reno, NV.

2. Greer, Linda, Ph.D., National Resources Defense Council, San Francisco, CA.

3. Haws, Laurie C., Ph.D., DABT, ToxStrategies Inc., Austin, TX.

4. Kim, Amy, Ph.D., DABT, Genentech, Inc., San Francisco, CA.

5. Lanno, Roman P., Ph.D., Ohio State University, Columbus, OH.

6. Thomas, Russell S., MS, Ph.D., The Hamner Institutes for Health Sciences, Research Triangle Park, NC.

7. Tickner, Joel A., ScD, MSc, BA, University of Massachusetts- Lowell, Lowell, MA.

IV. Nominees

The following are the names, addresses, professional affiliations, and selected biographical data of nominees being considered for membership on the FIFRA SAP. The Agency expects to select two of the nominees to fill the vacancies described in this notice.

1. Nominee. Braverman, Michael, Ph.D., Manager, Biopesticide Program—Rutgers University, Princeton, NJ.

i. Expertise. Efficacy and environmental fate of pesticides.

ii. Education. B.S., Agriculture/Biology, Murray State University, KY; M.S., Agronomy (Weed Science), University of Arkansas; Ph.D., Horticulture (Vegetable Crops), University of Florida.

iii. Professional experience. Dr. Michael Braverman is currently a Senior Scientist and Manager of the Biopesticide and Organic Support Program for the IR-4 Project at Rutgers University. He oversees a cooperative research project with the United States Department of Agriculture (USDA), State Agriculture Experimental Station, and industry scientists to develop data to support the registration of biopesticides on specialty crops. Dr. Braverman earned his Ph.D. in Horticulture from the University of Florida with an emphasis on herbicide fate and transport in muck soils. Dr. Braverman has 20 years experience in pesticide research and regulations involving efficacy, laboratory analysis of pesticide residues, herbicide physiology, and environmental fate. Dr. Braverman currently supervises a national efficacy grant program involving the review of research proposals designed to develop efficacy data involving biopesticides. Dr. Braverman has provided education, guidance, and technical expertise in the design, interpretation of research and scientific literature review aligned with EPA Product Chemistry, Residue, Human Health and Non-Target Ecotoxicology Guidelines on behalf of USDA, university scientists from other institutions and small businesses. The emphasis of his program has been in synchronization with EPA's Biopesticides and Pollution Prevention Division. He co-manages and co-reviews research programs with EPA's Office of Pollution Prevention and Toxics to promote the adoption of reduced risk products. He has also been an advisor to USDA's Agricultural Research Service (ARS) in regulation, risk assessment, and monitoring and distribution agreements of Plant Incorporated Protectants (PIPs) developed by USDA researchers. He has served as a panel member on several USDA's Cooperative State Research, Education, and Extension Service research grant review programs as well as editorial reviewer of research in the flagship journals of the Weed Science Society of America and the American Phytopathological Society. He has been a leader of intensive regulatory workshops for Agriculture and Ag Food Canada as well as a participant with EPA in workshops involving biopesticide regulations. He has trained M.S. and Ph.D. level graduate students, one of which currently works in EPA's Environmental Fate and Effects Division performing risk assessments on endangered species. On an international level, under the auspices of USDA's Foreign Agricultural Service, he has conducted regulatory workshops to develop regulatory expertise on how to conduct risk assessments in Benin, Colombia, Egypt, Ethiopia, Kenya, Mali, Nigeria, Senegal, South Africa, Tanzania, and Uganda for natural products, microorganism and biotechnology products. He is currently managing a global residue zoning project in over 20 countries in Africa, Asia, Australia, Europe, the Middle East, and North and South America in cooperation with EPA's Office of Pesticide Programs, Analytical Chemistry Laboratory, Fort Meade, MD.

2. Nominee. Fisher, Jeffrey W., Ph.D., Professor and Director, Interdisciplinary Toxicology Program, University of Georgia, Athens, GA.

i. Expertise. Development and application of biologically based mathematical models to ascertain health risks from environmental and occupational chemical exposures.

ii. Education. B.S., Biology, University of Nebraska at Kearney; M.S., Biology/Ecology, Wright State University, Dayton, OH; Ph.D., Zoology/Toxicology, Miami University of Ohio.

iii. Professional experience. Dr. Jeffrey W. Fisher is a Professor in the Department of Environmental Health Science, College of Public Health at the University of Georgia (UGA) and Director of the Interdisciplinary Toxicology Program. Dr. Fisher's research interests are in the development and application of biologically based mathematical models to ascertain health risks from environmental and occupational chemical exposures. Dr. Fisher’s modeling experience includes working with chlorinated and non-chlorinated solvents, fuels, polychlorinated biphenyls, pyrethroids, and perchlorate. Dr. Fisher has published over 100 papers on computational modeling for dose response analyses in laboratory animals and humans. He has developed physiologically based pharmacokinetic models for use in cancer risk assessment, estimating lactational transfer of solvents, understanding in utero and neonatal dosimetry and quantifying metabolism of solvent mixtures. Over the last 10 years Dr. Fisher has developed systems biology models for the hypothalamic-pituitary-thyroid axis (biologically based dose response (BBDR) models in rodents and humans). He has trained several graduate students and postdoctoral fellows on the concepts and application of physiological and system biology models. Dr. Fisher's laboratory and computational research are funded through grants provided by EPA, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry (ATSDR); Air Force Office of Scientific Research; United States Air Force; Department of Energy; and occasionally subcontracts with nonprofit organizations or trade groups. He has served on several national panels and advisory boards for the Departement of Defense, ATSDR, EPA, and non-profit organizations. He also has been a U.S. delegate for the North Atlantic Treaty Organization. He is currently on the Science Advisory Board for EPA and is associate editor for Toxicological Sciences.

3. Nominee. Hattis, Dale, Ph.D., Research Professor, Center for Technology, Environment, and Development, George Perkins Marsh Institute, Clark University, Worcester, MA.

i. Expertise. Modeling and uncertainty analysis in risk assessment.

ii. Education. B.S., Biochemistry, University of California, Berkeley, CA; Ph.D., Genetics, Stanford University, Stanford, CA.

iii. Professional experience. Dr. Dale Hattis is a Research Professor with the George Perkins Marsh Institute at Clark University. For the past 3 decades he has been engaged in the development and application of methodology to assess the health, ecological, and economic impacts of regulatory actions. His work has focused on approaches to incorporate inter-individual variability data and quantitative mechanistic information into risk assessments for both cancer and non-cancer endpoints. Recent past research has explored age-related differences in sensitivity to carcinogenesis and other effects, a taxonomy of different non-mutagenic modes of action for carcinogenesis with likely differential implications for age-related sensitivity, and physiologically based pharmacokinetic (PBPK) modeling of acrylamide dose in rats and humans, and mechanism-based dose response modeling of carcinogenic effects from ionizing radiation. Current efforts are using PBPK modeling to better assess dose response relationships for human birth weight changes and developmental delays associated with exposure to the insecticide chlorpyrifos during pregnancy. He is a leader in efforts to replace the current system of uncertainty factors for non-cancer effects with distributions based on empirical observations. He is a member of the Clean Air Science Advisory Committee reviewing EPA efforts to reassess the National Ambient Air Quality Criteria for nitrogen oxides and sulfur oxides, and for several years he has served as a member of the Food Quality Protection Act Science Review Board. Until recently he has also been a member of the Environmental Health Committee of the EPA Science Advisory Board. For 2007 he was the Chair of the Dose Response Specialty Group of the Society for Risk Analysis. He has also served as a member of the National Research Council Committee on Estimating the Health-Risk-Reduction Benefits of Proposed Air Pollution Regulations. He has been a counselor and is a Fellow of the Society for Risk Analysis, and serves on the editorial board of its journal, Risk Analysis.

4. Nominee. Hayes, Tyrone B., Ph.D., Professor, University of California, Berkeley, CA.

i. Expertise. Role of steroid hormones in amphibian development and effects of pesticides on amphibian development, growth, reproduction, and immune function.

ii. Education. B.A., Biology, Harvard University, Cambridge, MA; Ph.D., Integrative Biology, University of California, Berkeley, CA.

iii. Professional experience. Dr. Tyrone B. Hayes' research focuses on the role of steroid hormones in amphibian development in laboratory and field studies in Africa and the United States. The two main areas of interest are metamorphosis and sex differentiation, but Dr. Hayes is also interested in growth (larval and adult) and hormonal regulation of reproductive behavior. His work addresses problems on several levels including ecological, organismal, and molecular questions. Studies of metamorphosis examine the effects of temperature on developmental rates, interactions between the thyroid hormones and steroids, and hormonal regulation of skin gland development. Dr. Hayes is also examining the effects of tadpole density on developmental rates and measuring metamorphic rates and hormone levels of tadpoles in the field and in the laboratory. His work on sex differentiation involves the African clawed frog (Xenopus laevis), and several other species for comparison. Studies in African Reedfrogs (Hyperolius spp), for example, examine the role of steroid hormones in both primary sex differentiation and in secondary sex differentiation. Ongoing studies also examine the role of steroids in sex differentiation in reptile species that display genetic sex determination. In all of his research, his main goal is to synthesize ecological/evolutionary, organismal/physiological, and biochemical/molecular studies to learn how an animal translates changes in its external environment to internal changes, how these internal changes are coordinated, what molecular mechanisms are involved, and in turn, how changes at the molecular level affect an animal's ability to adapt to the changes in its external environment.

Most recently, Dr. Hayes' studies have been used as models to develop laboratory and field techniques to examine the effects of endocrine disrupting contaminants on amphibian development. His current research in this area focuses on the effects of pesticides mixtures on larval development and the potential role of pesticides in amphibian declines of laboratory and field studies. This work has also expanded to use human cell lines and to examine the potential role of endocrine-disrupting contaminants in ethnic/racial disparities in cancer outcomes.

5. Nominee. LeBlanc, Gerald A., Ph.D., Professor and Head of the Department of Environmental and Molecular Toxicology, North Carolina State University, Raleigh, NC.

i. Expertise. Environmental endocrine toxicology.

ii. Education. B.S., Biology, University of Massachusetts, North Dartmouth, MA; M.A., Biology, Bridgewater State College, Bridgewater, MA; Ph.D., Biology, University of South Florida, Tampa, FL.

iii. Professional experience. Dr. Gerald A. LeBlanc maintains an active research program in environmental endocrine toxicology. This research involves elucidating processes that contribute to the endocrine regulation of reproduction and development and their disruption by environmental agents. Dr. LeBlanc’s research also has been instrumental in developing modeling approaches for evaluating the toxicity of complex chemical mixtures. Dr. LeBlanc has published over 130 research articles and 12 text book chapters. He has served on numerous Federal and international science advisory committees, panels, and boards, including serving as chairman of the EPA Endocrine Disruptors Methods Validation Advisory Committee.

6. Nominee. Shah, Dilip M., Ph.D., Research Scientist and Principal Investigator, Donald Danforth Plant Science Center, St Louis, MO.

i. Expertise. Molecular biology and agricultural biotechnology.

ii. Education. B.S., Botany and Chemistry, South Gujarat University, India; M.S., Genetics, North Carolina State University, Raleigh, NC; Ph.D., Genetics, North Carolina State University, Raleigh, NC.

iii. Professional experience. Dr. Dilip M. Shah is a Research Scientist and Principal Investigator at the Donald Danforth Plant Science Center in Missouri where his lab is involved in studying the interactions of fungal pathogens with their host plants and developing strategies for the development of disease resistant mycotoxin-free transgenic crops. His lab is investigating the modes of action and biological roles of a group of proteins that act as antifungal agents on a broad-spectrum of fungal pathogens and expressing these proteins in transgenic crops for control of economically important fungal pathogens. Dr. Shah has over 25 years of experience in plant molecular biology and agricultural biotechnology. He has made substantial contributions to the development of herbicide- and virus-resistant crops and led a team of scientists working on fungus-resistant crops during his previous tenure at Monsanto Company. He played a major role in the establishment of Monsanto Company's Research and Development Center in India. He has served on the study section of NIH and has served on the review panel at NSF. He is a co-inventor on a number of patents and his patents on glyphosate-tolerant crops were listed as the “Ten Patents That Changed the World” in 2003 year-end publication of Intellectual Property Worldwide.

7. Nominee. Zacharewski, Timothy R., Ph.D., Professor, Department of Biochemistry and the National Food Safety and Toxicology Center, Michigan State University, East Lansing, MI.

i. Expertise. Mechanistic toxicology.

ii. Education. B.S., Chemistry with microbiology emphasis, University of Guelph, Guelph, Ontario, Canada; Ph.D., Toxicology, Texas A & M University, College Station, TX.

iii. Professional experience. Dr. Timothy R. Zacharewski is a Professor in the Department of Biochemistry and Molecular Biology and member of the Center for Integrative Toxicology and the National Food Safety and Toxicology Center at Michigan State University. He graduated with a Ph.D. in Toxicology in 1990 from Texas A&M University in the laboratory of Dr. Stephen Safe. He received a Medical Research Council of Canada Post Doctoral Fellowship to study with Professor Pierre Chambon in Strasbourg, France from 1990-1992. In 1992, Dr. Zacharewski accepted an Assistant Professor position in the Department of Pharmacology and Toxicology at the University of Western Ontario. In 1997, he relocated to Michigan State University where he has been pursuing research interests in the areas of mechanistic toxicology. More specifically, his research interests include the elucidation of receptor-mediated mechanisms of toxicity using comparative omic and computational approaches in order to inform science-based quantitative risk assessment, identify biomarkers of toxicity, and develop high through-put assays to screen drugs and chemicals for toxicity. He has published more than 100 peer-reviewed research papers, presented at numerous national and international meetings, and participated in various workshops addressing issues related to toxicogenomics, food safety, mixture toxicology, environmental risk assessment, stem cells in toxicology, endocrine disruptors, and mechanisms of toxicology. Dr. Zacharewski has served as a member on two committees for the National Academies of Science (i.e., Emerging Issues in Environmental Health Sciences, Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health), and as a consultant to the National Centers for Toxicogenomics, the Science Advisory Board for EPA, the International Life Sciences Institute/Health and Environmental Sciences Institute Technical Committee on the Application of Genomics to Mechanism-Based Risk Assessment, and the Science Advisory Panel for Chemical Industry Institute of Toxicology Centers for Health Research.

List of Subjects

• Environmental protection

Dated: August 7, 2009.

Frank Sanders,

Director, Office of Science Coordination and Policy.