05-10763. 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 one new member to serve on the panel as a result of a membership term 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 member.

DATES:

Comments, identified by docket ID number OPP-2005-0136, must be received on or before July 1, 2005.

ADDRESSES:

Comments may be submitted electronically (preferred), through hand delivery/courier, or by mail. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Steven Knott, Assistant Executive Secretary, FIFRA SAP Staff, 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. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket ID number OPP-2005-0136. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4:00 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to submit or view public comments, to access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments in hard copy that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments?

You may submit comments electronically (preferred), through hand delivery/courier, or by mail. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/​edocket/​, and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPP-2005-0136. The system is an “ anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by e-mail to [e-mail], Attention: Docket ID Number OPP-2005-0136. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you deliver as described in Unit I.C.2 or mail to the address provided in Unit I.C.3. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP-2005-0136. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1.

3. By mail. Due to potential delays in EPA's receipt and processing of mail, respondents are strongly encouraged to submit comments either electronically or by hand delivery or courier. We cannot guarantee that comments sent via mail will be received prior to the close of the comment period. If mailed, please send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0136.

II. Background

Amendments to FIFRA enacted November 28, 1975, include a requirement under section 25(d) that notices of intent to cancel or reclassify pesticide registrations pursuant to section 6(b)(2), as well as proposed and final forms of regulations pursuant to section 25(a), be submitted to a Scientific Advisory Panel prior to being made public or issued to a registrant. In accordance with section 25(d), the Scientific Advisory Panel is to have an opportunity to comment on the health and environmental impact of such actions. The Panel shall also make comments, evaluations, and recommendations for operating guidelines to improve the effectiveness and quality of analyses made by Agency scientists.

In accordance with the statute, the SAP is composed of a permanent panel of seven members, selected and appointed by the Deputy Administrator of EPA from nominees submitted by both the National Science Foundation and the National Institutes of Health. The Agency is, at this time, selecting one new member to serve on the panel as a result of a membership term that will expire this year. The Agency requested nominations of experts to be selected from the field of toxicology (especially animal studies used in human health risk assessment). Nominees should be well published and current in their fields of expertise. The statute further stipulates that we publish the name, address, professional affiliation, and a brief biographical sketch of each nominee in the Federal Register and solicit public comments regarding the candidates nominated.

III. Charter

A Charter for the FIFRA Scientific Advisory Panel dated October 25, 2004 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

Members are scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments as to the impact on health and the environment of regulatory actions under sections 6(b) and 25(a) of FIFRA. No persons shall be ineligible to serve on the Panel by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency (except the EPA). The Deputy Administrator appoints individuals to serve on the Panel for staggered terms of 4 years. Panel members are subject to the provisions of 40 CFR part 3, subpart F, Standards of Conduct for Special Government Employees, which include rules regarding conflicts of interest. Each nominee selected by the Deputy Administrator, before being formally appointed, is required to submit a confidential statement of employment and financial interests, which shall fully disclose, among other financial interests, the nominee's sources of research support, if any.

In accordance with section 25(d) of FIFRA, the Deputy Administrator shall require all nominees to the Panel to furnish information concerning their professional qualifications, educational background, employment history, and scientific publications. The Agency is required to publish in the Federal Register the name, address, and professional affiliations of each nominee and to seek public comment on the nominees.

B. Applicability of Existing Regulations

With respect to the requirements of section 25(d) of FIFRA that the Administrator promulgate regulations regarding conflicts of interest, the Charter provides that EPA's existing regulations applicable to Special Government Employees, which include advisory committee members, will apply to the members of the Scientific Advisory Panel. These regulations appear in 40 CFR part 3, subpart F. In addition, the Charter provides for open meetings with opportunities for public participation.

C. Process of Obtaining Nominees

In accordance with the provisions of section 25(d) of FIFRA, EPA, in February 2005, requested the National Institutes of Health (NIH) and the National Science Foundation (NSF) to nominate scientists to fill one vacancy occurring on the Panel. The Agency requested nominations of experts in the field of toxicology (especially animal studies used in human health risk assessment). NIH and NSF responded by letter, providing the Agency with a total of 11 nominees. Copies of these letters, with the listed nominees, are available in the public docket referenced in unit I.B.1. of this notice. Six of the 11 nominees are interested and available to actively participate in SAP meetings.

IV. Nominees

The following are the names, addresses, professional affiliations, and selected biographical data of nominees being considered for membership on the FIFRA Scientific Advisory Panel. The Agency will select one of the nominees to fill a vacancy occurring this year.

1. Nominee. Blumberg, Bruce, Ph.D., Associate Professor, Departments of Developmental and Cell Biology and Biomedical Engineering, University of California, Irvine, CA.

i. Expertise. Molecular endocrinology, developmental biology.

ii. Education. A.B., Biology, Rutgers University; Ph.D., Biology, University of California, Los Angeles.

iii. Professional Experience. Dr. Bruce Blumberg is Associate Professor of Developmental and Cell Biology with a joint appointment in Biomedical Engineering at the University of California, Irvine (UCI). He received the Ph.D. from the University of California, Los Angeles in 1987 in Biology and completed postdoctoral fellowships at the University of Medicine and Dentistry of New Jersey (biochemistry) and at the University of California, Los Angeles Medical School (biochemistry, embryology). He joined the Gene Expression Laboratory headed by Dr. Ronald M. Evans at the Salk Institute as a Staff Scientist in 1992. While at Salk, Dr. Blumberg led the effort to identify ligands for orphan nuclear receptors and was codiscoverer of the steroid and xenobiotic receptor, SXR, which is the key mediator of the vertebrate response to many hormonally active dietary and xenobiotic compounds. He joined the faculty at the University of California, Irvine in 1998 and has an active research program funded by the EPA, DOD, and NIH to examine the role of nuclear hormone receptors in development and disease. His teaching responsibilities at UCI include undergraduate and graduate courses in genomics and the regulation of gene expression. Dr. Blumberg is the director of the UCI Cancer Center Program in the Developmental Biology of Cancer and the Program Leader for Functional Genomics in the UCI Institute for Genomics and Bioinformatics.

2. Nominee. Bucher, John, Ph.D., Deputy Director, Environmental Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC.

i. Expertise. Toxicology, chronic rodent bioassays.

ii. Education. B.A., Biology, Knox College; M.S., Biochemistry, University of North Carolina at Chapel Hill; Ph.D., Pharmacology, University of Iowa.

iii. Professional Experience. Dr. John Bucher is Deputy Director of the Environmental Toxicology Program and Chief of the Toxicology Operations Branch, Environmental Toxicology Program, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health. He received his Ph.D. in Pharmacology from the University of Iowa in 1981 and was then an NIH Postdoctoral Fellow in the Department of Biochemistry and Center for Environmental Toxicology at Michigan State University. In 1983, he joined the NIEHS as a staff toxicologist working with the National Toxicology Program (NTP). Dr. Bucher's research interests include characterization of the toxic and carcinogenic potential of a wide variety of substances of interest to the NTP. He has expertise in issues relating to the design and interpretation of chronic rodent bioassays, including technical and policy matters. Other research interests include examination of strategies to characterize the toxicity and carcinogenicity of chemicals using non-traditional methods, such as genetically modified mice, and the development of noninvasive techniques, such as assessment of expired breath volatiles, in chemical toxicity studies. Recently he initiated studies to examine the novel toxicities of manufactured nanomaterials. At the NIEHS, Dr. Bucher has administrative oversight for the NTP Toxicology and Carcinogenesis Testing Programs, the NTP Report on Carcinogens, and NIEHS activities associated with the Interagency Coordinating Committee for the Validation of Alternative Methods. Dr. Bucher has served in an advisory capacity to the FDA, EPA, NIOSH, WHO (IPCS and IARC) among others.

3. Nominee. Cory-Slechta, Deborah, Ph.D., Director, Environmental and Occupational Health Sciences Institute, A joint institute of the Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey and Rutgers University, Piscataway, NJ.

i. Expertise. Neurotoxicology, behavioral toxicology.

ii. Education. B.S. (magna cum laude), Psychology, Western Michigan University; M.A. (with honors), Experimental Psychology, Western Michigan University; Ph.D., Experimental Psychology, University of Minnesota.

iii. Professional Experience. Dr. Deborah Cory-Slechta is the Director of The Environmental and Occupational Health Sciences Institute (EOHSI) as well as the Chair of the Department of Environmental and Occupational Medicine at the UMDNJ-Robert Wood Johnson Medical School. She received her Ph.D. degree from the University of Minnesota in 1977 and worked as a junior staff fellow at the National Center for Toxicological Research before moving to the University of Rochester in 1979. She subsequently served as Chair of the Department of Environmental Medicine and Director of the NIEHS Environmental Health Sciences Center and Dean for Research and Director of the Aab Institute for Biomedical Sciences at the University of Rochester. Dr. Cory-Slechta has served on numerous national research review and advisory panels, including committees of the National Institutes of Health, the National Institute of Environmental Health Sciences, the Food and Drug Administration, the National Center for Toxicological Research, the Environmental Protection Agency, the National Academy of Sciences, the Institute of Medicine, and the Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention. In addition, Dr. Cory-Slechta has served on the editorial boards of the journals Neurotoxicology, Toxicology, Toxicological Sciences, Fundamental and Applied Toxicology, Neurotoxicology and Teratology, and American Journal of Mental Retardation. She has held the elected positions of President of the Neurotoxicology Specialty Section of the Society of Toxicology, President of the Behavioral Toxicology Society, and been named a Fellow of the American Psychological Association. Her research has focused largely on the relationships between neurotransmitter systems and behavior, and how such relationships are altered by exposures to environmental toxicants, particularly the role of environmental neurotoxicants in developmental disabilities and neurodegenerative diseases. These research efforts have resulted in over 100 papers and book chapters to date.

4. Nominee. Klaunig, James, Ph.D., Director, Division of Toxicology, Department of Pharmacology and Toxicology, Indiana University School of Medicine, Indianapolis, IN.

i. Expertise. Toxicology, carcinogenesis, mode of action.

ii. Education. B.S., Biology, Ursinus College; M.A., Biology, Montclair State University; Ph.D., Experimental Pathology/Toxicology, University of Maryland School of Medicine.

iii. Professional Experience. Dr. James E. Klaunig is Professor and Director of Toxicology in the Department of Pharmacology and Toxicology at Indiana University School of Medicine. He also serves as the Program Director of the Molecular Carcinogenesis Program for the Indiana University Cancer center. He received his B.S. degree from Ursinus College in Collegeville Pa., an M.A. from Montclair State University, Montclair, NJ, and his Ph.D. from the University of Maryland in Baltimore, MD. He is a Fellow of the Academy of Toxicological Sciences and serves on its Board of Directors. He has received numerous awards including the Otis R. Bowen, Distinguished Leadership Award, Indiana University School of Medicine, the Indiana University Trustee Teaching Excellence Award, the Kenneth P. DuBois Award from the Midwest Society of Toxicology (SOT) and the Sagamore of the Wabash from the Governor of Indiana for service to the State. He recently stepped down as Associate Editor of Toxicological Sciences and is currently the Editor in Chief of Toxicologic Pathology. He has served as a Member of the NIH/NIEHS National Toxicology Program Board of Scientific Counselors and is currently a Member of the USEPA SAB. He also has served as President of the Carcinogenesis Specialty Section, President of the Ohio Valley SOT, Member and Chair of the SOT Education Committee, and Member of the Finance and Program Committees of the SOT. He was recently the Treasurer as well as a member of the Executive Council of the SOT. He also served the State of Indiana as the Director of Toxicology and the State Toxicologist from 1991 to 2003 as well as service on the Indiana Pesticide Review Board, the Governor's Council on Impaired and dangerous driving and on the Indiana Controlled Substances Advisory Board. He has trained over 50 graduate students and postdoctoral fellows and has published over 170 peer reviewed manuscripts. His research interests are dedicated to understanding the mechanisms of chemically induced carcinogenesis, specifically the mode of action of nongenotoxic carcinogens, role of oxidative stress in carcinogenesis and cell injury, and understanding of the multistage nature of the cancer process.

5. Nominee. Maglia, Anne, Ph.D., Assistant Professor, Department of Biological Sciences, University of Missouri-Rolla, Rolla, MO.

i. Expertise. Developmental biology, bioinformatics, animal ecology.

ii. Education. B.S., Zoology, Ohio University; M.S., Biological Science, East Tennessee State University; Ph.D., Ecology and Evolutionary Biology, University of Kansas.

iii. Professional Experience. Dr. Anne Maglia is an assistant professor in the Department of Biological Sciences and an investigator in the Environmental Research Center for Emerging Contaminants at the University of Missouri-Rolla. She received her Ph.D. in Biological Sciences from the University of Kansas in 2000, and subsequently completed a postdoctoral fellowship in Bioinformatics at the University of Kansas. Dr. Maglia has an active research program in amphibian developmental biology, including studies on the effects of environmental contaminants on frog developmental processes and population viability. In addition, she and a colleague have developed an online database of interactive 3D visualizations of animal anatomy that is being used to compare normal and malformed anatomies. Her teaching responsibilities at the University of Missouri-Rolla include graduate and undergraduate courses in developmental biology, comparative anatomy, and bioinformatics. Dr. Maglia has served on the Board of Directors of the MidSouth Computational Biology and Bioinformatics Society and is the director of a regional amphibian population monitoring program in conjunction with the Missouri Department of Conservation.

6. Nominee. Relyea, Rick, Ph.D., Assistant Professor, Department of Biological Sciences, University of Pittsburgh, Pittsburgh, PA.

i. Expertise. Aquatic ecology, ecotoxicology.

ii. Education. B.S., Environmental and Forest Biology, State University of New York; M.S., Wildlife Science, Texas Tech University; Ph.D., Biology, University of Michigan.

iii. Professional Experience. Dr. Rick Relyea is an Assistant Professor at the University of Pittsburgh where he teaches undergraduate and graduate courses in ecology. He received his Ph.D. from the University of Michigan in 1998 and subsequently performed post-doctoral work at the University of Missouri-Columbia where he conducted research in aquatic toxicology. During his six years at the University of Pittsburgh, Dr. Relyea has emerged as a world leader in the study of aquatic ecology and ecotoxicology. He has an active research program funded through the National Science Foundation, spanning the range from controlled, laboratory experiments to natural wetlands. His areas of research include: (1) Long-term research on the biodiversity of aquatic ecosystems, (2) the impacts of stress on animal performance, and (3) the effects of pesticides on aquatic organisms and communities. From 2001-2005, he published 30 articles in top-tier scientific journals and his research has received coverage in the popular press, including American Scientist and Science. Based on his highly productive research program and empirical discoveries, Dr. Relyea was named the Chancellor's Distinguished Researcher at the University of Pittsburgh in 2005.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: May 23, 2005.

Clifford J. Gabriel,

Director, Office of Science Coordination and Policy.