Environmental Protection Agency (EPA).
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, at this time, anticipates selecting two new members to serve on the panel as a result of membership terms that will expire next year. Public comments on the nominations are invited, as these comments will be used to assist the Agency in selecting the new chartered Panel members.
Comments, identified by docket ID number EPA-HQ-OPP-2011-0550, must be received on or before August 29, 2011.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2011-0550, 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 Start Printed Page 45556(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 (703) 305-5805.
Instructions. Direct your comments to docket ID number EPA-HQ-OPP-2011-0550. If your comments contain any information that you consider to be CBI or otherwise protected, please contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting your comments. 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 Web site 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 (703) 305-5805.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address: email@example.com.End Further Info End Preamble Start Supplemental 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?
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.
The FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) 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 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.
In accordance with the statute, the SAP is composed of a permanent panel of seven members, selected and appointed by the Administrator of EPA from nominees submitted by both the NSF and the NIH. The Agency, at this time, anticipates selecting two new members to serve on the panel as a result of membership terms that will expire next year. The Agency requested nominations of experts to be selected from the fields of pharmacology, immunotoxicology, toxicology risk assessment, environmental toxicology and/or biostatistics with demonstrated experience and expertise in all phases of the risk assessment process 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 field of expertise. The statute further stipulates that we publish the name, address and professional affiliation in the Federal Register.Start Printed Page 45557
A Charter for the FIFRA SAP dated October 22, 2010, 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 of pesticides on health and the environment. 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)(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 SAP. 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, on February 24, 2011, requested that the NIH and the NSF nominate scientists to fill vacancies occurring on the Panel. The Agency requested nominations of experts in the fields of pharmacology, immunotoxicology, toxicology risk assessment, environmental toxicology and/or biostatistics with demonstrated experience and expertise in all phases of the risk assessment process 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 38 nominees. Copies of these letters, with the listed nominees, are available in the public docket referenced in Unit I.B.1., of this notice. Of the 38 nominees, 20 are interested and available to actively participate in SAP meetings (see Unit IV. Nominees). The following 18 nominees are not available:
1. Kim Boekelheide, PhD, Brown University, Providence, RI.
2. Paul W. Brandt-Rauf, DrPH, MD, ScD, University of Illinois, Chicago, IL.
3. Patricia A. Buffler, PhD, MPH, University of California, Berkeley, CA.
4. John Cashman, PhD, Human Biomolecular Research Institute, San Diego, CA.
5. Deborah A. Cory-Slechta, PhD, University of Rochester School of Medicine & Dentistry, Rochester, NY.
6. Carlos Davidson, PhD, San Francisco State University, San Francisco, CA.
7. Elaine Faustman, PhD, University of Washington, Seattle, WA.
8. Clement Furlong, PhD, University of Washington, Seattle, WA.
9. John P. Giesy, PhD, University of Sasketchewan, Saskatoon, Saskatchewan, Canada.
10. Anumantha Kanthasamy, PhD, Iowa State University, Ames, IA.
11. Stephen A. McCurdy, M.D., M.P.H., University of California-Davis, Davis, CA.
12. Marie Lynn Miranda, PhD, Duke University, Durham, NC.
13. James J. Pestka, PhD, Michigan State University, East Lansing, MI.
14. Walter J. Rogan, M.D., National Institute of Environmental Health Sciences, Research Triangle Park, NC .
15. Jason Rohr, PhD, University of South Florida, Tampa, FL.
16. Anthony Scialli, M.D., Tetra Tech Services, Arlington, VA.
17. Lester G. Sultatos, PhD, University of Medicine & Dentistry of New Jersey, Newark, NJ.
18. Stephen C. Waring, DVM, PhD, Marshfield Clinic Research Foundation, Marshfield, WI.
The following are the names, addresses, professional affiliations, and selected biographical data of nominees being considered for membership on the FIFRA SAP. The Agency anticipates selecting two of the nominees to fill vacancies occurring next year.
1. Daniel W. Anderson, PhD, University of California Davis, Davis, CA.
i. Expertise: Ecotoxicology.
ii. Education: B.S., in Zoology from North Dakota State University; M.S., in Wildlife Ecology and PhD, in Wildlife Ecology and Zoology from University of Wisconsin.
iii. Professional Experience: Dr. Daniel Anderson is Professor Emeritus at the University of California Davis, where he was Director and co-founder of the Marine Bird Ecology and Ecotoxicology Project, and former Chair of the UC Davis Department of Wildlife, Fish, and Conservation Biology. He joined the faculty of UC Davis in 1976, and is continuing his research efforts on environmental contaminants and their effects on seabird populations, ecology, habitat, migration and related areas. While at UC Davis, he taught undergraduate courses in Wildlife Ecotoxicology, Avian Biology, and Field Biology Techniques; as well as graduate seminars in Ecotoxicology and Avian Ecology, and also served as founder and Chairperson of the Ecotoxicology “area of emphasis” in the Ecology Graduate Group at UC Davis. Prior to that, while at University of Wisconsin, he was instrumental in hypothesizing and documenting a specific link between the DDT-metabolite, DDE, and widespread eggshell thinning in susceptible species of birds. In late 1970, Dr. Anderson served as a Research Biologist for the U.S. Fish and Wildlife Service, working on pesticide contaminants in wildlife of California and Mexico, primarily to study and document contaminant changes in seabirds and raptors, in particular, the decline of DDE and associated beginnings of the recovery of the Brown Pelican. Dr. Anderson and his co-workers also published papers on the dynamics and effects of agricultural contaminants in migratory waterbirds. Dr. Anderson retired from teaching and administration in 2009, but continues his life-long commitment to ecotoxicology, seabird biology, and conservation. Dr. Anderson's current research involves studies of contamination effects, distribution, and dynamics of organic and inorganic materials in birds from California and Baja California coastal and wetland environments. Dr. Anderson is also actively involved in the conservation and management of avian populations and their habitats.
2. John C. Bailar, III, M.D., PhD, The University of Chicago, Chicago, IL.
i. Expertise: Statistics, epidemiology & risk assessment.Start Printed Page 45558
ii. Education: B.A. in Chemistry from the University of Colorado; M.D. in Medicine from Yale University; PhD in Statistics from the American University.
iii. Professional Experience: Dr. John Bailar is Professor Emeritus at the University of Chicago and founding Chair of the University's Department of Health Studies. His professional interests have centered for years on the causes and prevention of disease. More recently he has focused on improving quality and performance in science generally. He was at the U.S. National Cancer Institute 1956-1980, Harvard University 1980-1988, and McGill University 1988-1995, before he went to Chicago. At present he is Scholar in Residence at the National Academies. He was a MacArthur Fellow 1990-1995. He has published widely in the statistics and epidemiology literature, including, recently, the health effects of air pollution. His areas of expertise include statistics, epidemiology and risk assessment. He has chaired over 20 National Academy committees and served on numerous others and has also served as monitor of more than 20 Academy reports.
3. Kenneth Barry Delclos, PhD, U.S. Food and Drug Administration (FDA), Jefferson, AR.
i. Expertise: Toxicology, pharmacology, endocrine disruption.
ii. Education: A.B. in Biochemistry from Cornell University; PhD in Pharmacology from Harvard University; Postdoctoral work at McArdle Laboratory for Cancer Research, University of Wisconsin.
iii. Professional Experience: Dr. K. Barry Delclos is a Research Pharmacologist in the Division of Biochemical Toxicology at the FDA's National Center for Toxicological Research since 1985, where he has conducted research in diverse areas. Earlier efforts focused largely on chemical carcinogenesis, but more recently his focus has been on toxicities associated with endocrine active agents. He continues to serve as Principal Investigator on a series of studies conducted under an Interagency Agreement between the FDA and the National Toxicology Program to evaluate aspects of the hypothesis that exposure to low levels of hormonally active agents, particularly during development, adversely affects human health, including reproductive function and carcinogenesis. He has served on interagency committees evaluating carcinogens and endocrine active agents, including several EPA advisory panels relating to endocrine active chemicals.
4. Russell L. Carr, PhD, Mississippi State University, Mississippi State, MS.
i. Expertise: Developmental neurotoxicology.
ii. Education: B.S. in Biology and Chemistry from Delta State University; M.S. in Zoology and PhD in Animal Physiology from Mississippi State University; Postdoctoral work at Mississippi State University.
iii. Professional Experience: Dr. Russell Carr is an Associate Professor in the Center for Environmental Health Sciences, in the College of Veterinary Medicine at Mississippi State University. Prior to serving in his current faculty position, Dr. Carr completed postdoctoral training (1995) and served as a Research Toxicologist (1995-1999) at Mississippi State. Dr. Carr's primary research interests are in the area of developmental neurotoxicology with emphasis on environmental chemicals. One focus is investigating the mechanisms by which developmental organophosphorus insecticide exposure alters the neurochemistry of the brain and induces long-term changes in behavior. Another focus is the development of a short lived aquatic vertebrate model to study the lifetime effects of developmental exposure. Dr. Carr is currently the Research Coordinator/Evaluator for the Indianola Promise Community of the Delta Health Alliance. He is active in both the national and local chapters, the Society of Toxicology (SOT). Dr. Carr has served as an ad hoc panel member on several U.S. EPA FIFRA SAP's.
5. Marion Ehrich, PhD, Virginia-Maryland Regional College of Veterinary Medicine, Blacksburg, VA.
i. Expertise: Pharmacology and toxicology.
ii. Education: B.S. in Pharmacy from South Dakota State University; M.S. in Pharmacology/Toxicology from the University of Chicago; and PhD in Pharmacology/Toxicology from the University of Connecticut at Storrs.
iii. Professional Experience: Dr. Marion Ehrich is a Professor at the Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM) in Blacksburg, VA, and VT Carilion School of Medicine in Roanoke, VA. In addition to teaching pharmacology and toxicology to medical, veterinary and graduate students, her professional responsibilities include service in the Veterinary Medical Teaching Hospital Pharmacy and in the Toxicology Diagnostic Laboratory. She has been teaching at VMRCVM since 1980, when she also became a member of the Society of Toxicology (SOT) and a Diplomate of the American Board of Toxicology. She was elected a fellow of the Academy of Toxicological Sciences in 1999. Dr. Ehrich's primary research activities are associated with the comparative neurotoxicities of antiesterase pesticides, with both in vivo and in vitro models used for study. Dr. Ehrich was the 2003-2004, President of the SOT and their 2010 Merit Awardee. She served as Treasurer for the Board of Directors of the American Board of Toxicology (1985-89), Secretary for the SOT (1992-94), and Treasurer for the Academy of Toxicological Sciences (2006-09). She has also chaired SOT's Education Committee (1990-92), SOT's Regulatory Affairs and Legislative Action Committee (1997-98), SOT's Neurotoxicology Specialty Section (2008-2009), and the Toxicology Education Foundation (2000-2001). In addition, she served on the Executive Board of the Council for Scientific Society Presidents. She currently serves on the National Research Council's Committee on Toxicology and editorial boards for the International Journal of Toxicology, the Journal of Applied Toxicology, and NeuroToxicology.
6. Jay Gan, PhD, University of California, Riverside, CA.
i. Expertise: Environmental chemistry.
ii. Education: PhD in Pesticide Chemistry from Zhejiang University (Hangzhou, China); Postdoctoral fellow with IAEA's Laboratories in Seibersdorf, Austria (1990-1991) and University of Minnesota in St. Paul, MN (1991-1993).
iii. Professional Experience: Dr. Jianying (Jay) Gan is currently a Professor of Environmental Chemistry, in the Department of Environmental Sciences at the University of California (UC) Riverside, where he served as the Department Chair from 2007 to 2010. He joined the UC Riverside faculty in 2001, following 8 years service as a Research Scientist with the (USDA) Agricultural Research Service Laboratory in Riverside, CA. His research is related to environmental fate, transport, and risk assessment of pesticides, wastewater trace pollutants, and persistent organic pollutants, with an emphasis on water quality and risk mitigation. To date he has authored over 175 technical journal articles, and edited four pesticide books through American Chemical Society. Dr. Gan, currently supervises five PhD students majoring in Environmental Sciences or Environmental Toxicology. He teaches “Fate and Transport of Contaminants in Soil” to undergraduate students and “Environmental Organic Chemistry” to graduate students. Dr. Gan, was elected a Fellow of American Association for the Advancement of Science (AAAS) in 2008, a Fellow of American Society of Agronomy (ASA) Start Printed Page 45559in 2006, and a Fellow of Soil Science Society of America (SSSA) in 2010.
7. Ellen Gold, PhD, University of California Davis School of Medicine, Davis, CA.
i. Expertise: Epidemiology, effects of environmental exposures on women's health, endocrine function and reproductive health.
ii. Education: B.A. in Bacteriology and M.A. in Zoology from the University of California—Los Angeles; PhD in Epidemiology from The Johns Hopkins University School of Hygiene and Public Health.
iii. Professional Experience: Dr. Ellen Gold is the current Chair of the Department of Public Health Sciences and Chief of the Division of Epidemiology, in that Department in the University of California Davis School of Medicine and former Chair of the Graduate Group in Epidemiology. After receiving her PhD she became a faculty member at The Johns Hopkins University until she moved to the UC Davis faculty in 1988. She has been principal investigator on a number of NIH-funded, peer-reviewed grants and has had continuous NIH research grant funding for over 20 years. These research grants have largely focused over the past 30 years on lifestyle and environmental factors that affect women's reproductive health and cancer risk and include her work for the past 15 years studying the natural history of the menopausal transition, including hormonal and symptomatic changes, in a longitudinal study of a large, multi-racial/ethnic national cohort. She has also authored or co-authored over 150 peer-reviewed publications. She has mentored numerous graduate students and junior faculty and has received a number of outstanding faculty and mentoring awards, as co-director of the UC Davis Building Interdisciplinary Research Careers in Women's Health program and is a Fellow in the American Association for the Advancement of Science.
8. Pertti (Bert) J. Hakkinen, PhD, National Institutes of Health, Bethesda, MD.
i. Expertise: Toxicology.
ii. Education: B.A. in Biochemistry and Molecular Biology from the University of California—Santa Barbara; PhD in Comparative Pharmacology and Toxicology from the University of California, San Francisco, CA.
iii. Professional Experience: Dr. Pertti (Bert) Hakkinen is the Senior Toxicologist and Toxicology and Environmental Health Science Advisor in the Division of Specialized Information Services at the National Library of Medicine (NLM), National Institutes of Health (NIH). He provides leadership on the development of new resources in toxicology, exposure science, and risk assessment, and enhancements to existing NLM resources in these fields. Dr. Hakkinen is the project leader for the Wireless Information System for Emergency Responders (WISER) and Chemical Hazards Emergency Medical Management (CHEMM) tools, represents NLM on various committees, and provides leadership for NLM's participation in national and international efforts in toxicology-, exposure-, and risk assessment-related information. He also is the co-director of a Public Health Informatics course offered since 2009, at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland, and is the vice-chair of the SAP for the Mickey Leland National Urban Air Toxics Research Center (NUATRC) in Houston, Texas. During his career, Dr. Hakkinen has held numerous leadership positions in the field of toxicology and risk assessment. Before joining the NIH in 2008, Dr. Hakkinen served for several years on the auxiliary staff of the European Commission (EC) at the EC's Institute for Health and Consumer Protection, Joint Research Centre, in Italy. He has also held positions with Toxicology Excellence for Risk Assessment (TERA) and Gradient Corporation in the United States and at the Procter and Gamble Company in the United States and Japan. Dr. Hakkinen is a member of the Society of Toxicology (SOT) and a charter member of the Society for Risk Analysis (SRA) and the International Society of Exposure Science (ISES). He is a co-editor and co-author of the latest edition of the Encyclopedia of Toxicology, and of the last two editions of the Information Resources in Toxicology book. Dr. Hakkinen has authored and co-authored numerous other publications.
9. Dale Hattis, PhD, Clark University, Worcester, MA.
i. Expertise: Risk assessment methodology.
ii. Education: B.A. in Biochemistry from the University of California, Berkeley, CA. PhD in Genetics from Stanford University.
iii. Professional Experience: Dr. Dale Hattis is Research Professor with the George Perkins Marsh Institute at Clark University. For the past 35 years 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 research has explored PBPK-based dosimetry for chlorpyrifos based on observations of blood levels in pregnant women and their newborn infants, quantitative analysis of uncertainties for cancer and non-cancer health risks of dioxin, 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, PBPK modeling of acrylamide dose in rats and humans, and mechanism-based dose response modeling of carcinogenic effects from ionizing radiation. He is a leader in efforts to replace the current system of uncertainty factors with distributions based on empirical observations. He has been a member of the Environmental Health Committee of the EPA Science Advisory Board, and for several years he has served as a member of the FQPA Science Review Board. 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 Councilor and is a Fellow of the Society for Risk Analysis.
10. David Hawthorne, PhD, University of Maryland, College Park, MD.
i. Expertise: Entomology.
ii. Education: B.S. in Biology and Economics from Kent State University; M.S. in Entomology from North Carolina State University; PhD in Entomology from Cornell University; Postdoctoral training at the University of Oregon and Cornell University.
iii. Professional Experience: Dr. David J. Hawthorne is an Associate Professor at the University of Maryland, College Park, in the Department of Entomology, College of Computational, Mathematical and Natural Sciences, where he has served on the faculty since 1997. At Cornell University, Dr. Hawthorne did his thesis work on insect adaptation to resistant crop cultivars, focusing on quantitative genetics approaches to understanding that process. His post-doctoral training was done at the University of Oregon and at Cornell University. At the University of Oregon, he worked on molecular genetics of variation in anthocyanin expression in maize. At Cornell he developed markers and populations that would result in the first genetic linkage map of Colorado potato beetle and the mapping of resistance in that insect to the insecticide esfenvalerate. The Hawthorne lab investigates the genetic Start Printed Page 45560and ecological factors underlying responses of insects to novel host plants and agricultural pesticides. This work has been applied to increase understanding of the processes of speciation and the risk assessment and management of pesticide responses by both pest and beneficial insects. Dr. Hawthorne has an active collaboration at the United States Department of Agriculture/Agricultural Research Service (USDA/ARS) at Beltsville, MD, on the effects of chronic exposure of pesticides to honey bees and on the effects of pesticide combinations on honey bee health. He has authored 21 articles on insect molecular ecology and genetics, has served on several grant review committees for the USDA and the NIH, and on review panels for development of resistance-preventing strategies and re-registration of Bt corn for the EPA. Research in Dr. Hawthorne's laboratory is currently funded by grants from the USDA.
11. Lawrence Kapustka, PhD, SLR Consulting, Calgary, Alberta, Canada.
i. Expertise: Environmental & ecological risk assessment.
ii. Education: B.S.Ed in Biology and M.S. in Botany from the University of Nebraska; PhD Plant Physiological Ecology from the University of Oklahoma.
iii. Professional Experience: Dr. Lawrence Kapustka has over 35 years of experience in environmental and ecological risk assessment. He began his professional career in academia with 3 years at the University of Wisconsin-Superior and 10 years at Miami University teaching courses, conducting research programs, and advising graduate students in a range of basic and applied subjects including ecology, forestry, plant physiology, microbial ecology, and environmental sciences. He followed that academic start to his career with 3 years at the EPA research laboratory in Corvallis, Oregon where he led the Plant Toxicology and Hazardous Waste research programs. Since 1990, Dr. Kapustka has worked in consulting firms including his own private practice for over 15 years. Dr. Kapustka has gained international recognition for his leadership role in advancing the practice of environmental risk assessment. His contributions have included the development of test methods used to evaluate toxicity of chemicals to ecological receptors and continual refinement of approaches to assess environmental risks. He has collaborated with clients to advance the state-of-the-science employed in risk assessments, including the use of the basics of systems ecology and landscape ecology. Most recently, Dr. Kapustka has been working with colleagues and clients to incorporate spatially-explicit landscape perspectives to achieve integrated holistic risk assessments to inform environmental management decisions. He has helped clients with strategic planning to address environmental challenges, the design of sampling plans to characterize baseline conditions, and design of monitoring plans to track environmental compliance. Dr. Kapustka has worked with industries, public interest groups, and regulators from several jurisdictions (Federal, state/provincial, and international) to develop policies and approaches to meet emerging concerns, including those in the growing field of nanotechnology and radiation ecology. He has provided litigation support pertaining to natural resource damage claims, permitting, and site contamination cases. Dr. Kapustka has been responsible for business development, marketing, project management, and general business operations. He volunteers as a member of the executive committee of the Calgary Chapter of Ducks Unlimited Canada.
12. David J. Kent, PhD, Keller & Heckman LLP, Washington, DC.
i. Expertise: Environmental risk assessment.
ii. Education: B.S. in Biology from University of Bridgeport; M.S. in Environmental Science from Rutgers University; PhD, in Environmental Science and Policy from George Mason University.
iii. Professional Experience: Dr. David Kent has 28 years of consulting experience, primarily in the area of chemical and pesticide regulation for both domestic and international companies. He assists clients in assessing available data, manages consortia, conducts environmental fate and transport modeling, and performs environmental risk assessments. Dr. Kent is a leader in the assessment and management of High Production Volume (HPV), Medium Production Volume (MPV), and Persistent Bioaccumulative and Toxic (PBT) chemicals in both the United States and Europe. He assesses potential risks of chemical and pesticide use and has helped companies in a wide variety of specialty areas, including chemicals, pesticides, and consumer products. Dr. Kent is very active in advising companies in how best to meet their obligations under the European REACH chemical control program, the European Union (EU) classification and labeling regulation, and the EU Biocides Directives and Regulation. He has also prepared numerous data dossiers for client submission to regulatory agencies, including proprietary reports for submission under REACH, FIFRA, BPD, TSCA, HPV, FDA, and other regulatory and voluntary programs. Dr. Kent is actively involved in and commonly speaks at regional, national, and international scientific organizations. He has served as president of regional chapters of both the Society of Environmental Toxicology and Chemistry (SETAC) and the Society for Risk Analysis (SRA). He chaired the Program Committee for the 26th Annual SETAC meeting and routinely participates at trade association-sponsored conferences, often as the moderator for panels. Dr. Kent has authored or co-authored more than 100 scientific articles, presentations, and other documents for both peer-reviewed journals and technical newsletters. Topics have included preparations and requirements for REACH, probabilistic ecological risk assessment of pesticides, the proposed Biocide Products Regulation, ecological risk assessment for wetlands, policy implications of emerging chemical regulations, and the status and trends of the HPV Chemical assessment programs in the United States and Europe.
13. Lynda Lanning, D.V.M., DABT, National Institutes of Health, Bethesda, MD.
i. Expertise: Toxicology and pathology.
ii. Education: B.S. in Animal Science and Zoology from North Carolina State University; D.V.M from Auburn University.
iii. Professional Experience: Dr. Lynda Lanning is a Health Administrator in the Office of Regulatory Affairs, Division of Microbiology and Infectious Disease, National Institute of Allergy and Infectious Disease, National Institutes of Health. She completed a pathology residency at Argonne National Laboratory and is a Diplomate of the American Board of Toxicology. Her expertise is in toxicologic pathology, toxicology, safety assessment and drug development. Dr. Lanning's diverse professional experience as a toxicologic pathologist includes work with the National Toxicology Program, medical device product development, contract research industry nonclinical toxicology, regulatory nonclinical pharmaceutical safety assessment and compound development, and biologic and therapeutic drug development of unique compounds for biodefense, global and orphan diseases. She is responsible for making complex regulatory and drug development recommendations based on the results of nonclinical studies. Dr. Lanning is Start Printed Page 45561involved in the technical design and analysis of nonclinical studies for compounds in early and late stages of development, evaluation of the effectiveness and quality of nonclinical studies and safety assessment of compounds in development. She has authored numerous peer-reviewed publications and book chapters and is an active member of both national and international professional societies related to toxicology and toxicologic pathology.
14. James McManaman, PhD, University of Colorado—Denver, Aurora, CO.
i. Expertise: Biochemistry, neurobiology and reproductive health.
ii. Education: B.S. in Chemistry from University of Northern Colorado; PhD in Biochemistry from University of Colorado—Boulder; Post Doctoral Fellow at Baylor College of Medicine.
iii. Professional Experience: Dr. James McManaman is a Professor of Obstetrics and Gynecology, and Chief of the Division of Reproductive Sciences at the University of Colorado, Anschutz Medical Campus. He joined the Neurology Faculty at Baylor College of Medicine where he worked on motoneuron survival factors. Dr. McManaman was recruited to Synergen Inc., in 1992, as head of their Neuroscience Group. Following the sale of Synergen to Amgen in 1993, Dr. McManaman returned to academics at the University of Colorado's medical campus where he remains. At the University of Colorado, Dr. McManaman developed active interest in mammary gland biology, lipid metabolism, preterm birth and perinatal biology, which are currently his primary research interests. Dr. McManaman is the Research Director of the NIH funded Women's Reproductive Health Research Program at the University of Colorado, and he directs the University's Frontiers in Pregnancy Research Symposia, a nationally recognized symposia that focuses on biological, psychosocial and clinical research related to pregnancy and perinatal biology. Dr. McManaman is also the co-director of the Adipose Biology Program of the University of Colorado's Obesity Research Initiative. He has served on a number of advisory panels including being a regular member of the Integrated Clinical Endocrinology and Reproduction (ICER) Study Section at NIH from 2005-2009, and an ad hoc reviewer for a variety of other NIH Study Sections.
15. Prakash Nagarkatti, PhD, University of South Carolina School of Medicine, Columbia, SC.
i. Expertise: Immunotoxicology.
ii. Education: B.Sc. in Botany and Chemistry and M.Sc. in Microbiology from Karnatak University; PhD, in Immunology from Jiwaji University/Defense R & D Establishment, India; Postdoctoral research in Immunology at McMaster University and University of Kentucky School of Medicine.
iii. Professional Experience: Dr. Prakash Nagarkatti is currently a South Carolina Distinguished Professor and Associate Dean for Basic Science at the School of Medicine, University of South Carolina (USC), as well as the Director of the NIH-supported Center of Research Excellence in Inflammatory and Autoimmune Diseases. From 2005 to 2010, he also served as an advisor to the vice president for research at USC. He joined Virginia Tech as an assistant professor in 1986, and rose to become full professor. In 2000, Dr. Nagarkatti joined the Department of Pharmacology and Toxicology at the Medical College of Virginia, Virginia Commonwealth University as Wazeter Distinguished Professor and Director, Immunotoxicology. Dr. Nagarkatti's research has been continuously supported by numerous grants from NIH, NSF/EPA, and American Cancer Society totaling more than $21 million. Currently, he serves as the Director and Principal Investigator on a $6 million NIH Interdisciplinary Center of Research Excellence in Inflammatory and Autoimmune Diseases. Dr. Nagarkatti has published over 150 scientific papers in high-impact journals and has won numerous awards nationally and internationally including those for teaching and scholarly activity. He has chaired and served as a member on numerous NIH Study Sections and has been invited to give keynote/plenary talks at international meetings. Dr. Nagarkatti has also served on a number of advisory and review panels nationally and internationally, for Federal government and private foundations. Dr. Nagarkatti is one of the pioneers in the area of immunotoxicology, having published papers in this field from early 1980s. Currently, his lab has been investigating the effect of a wide range of environmental contaminants, endocrine disruptors, drugs, and botanicals on the immune response. His laboratory was instrumental in demonstrating for the first time that dioxin (TCDD) triggers apoptosis in immune cells through activation of AhR receptor. His research in immunotoxicology has received recognition and awards from the Society of Toxicology. More recently, Dr. Nagarkatti has been working on the impact of epigenetic regulation on the immune system and testing the “fetal basis of adult disease” hypothesis using endocrine disruptors. His research has provided evidence to support this concept by demonstrating how exposure to endocrine disruptors during pregnancy alters T cell development in the fetus and how this impacts the immune response and susceptibility to immunological disorders, infections and cancer, during adult life.
16. Harry M. Ohlendorf, PhD, CH2M HILL, Inc., Sacramento, CA.
i. Expertise: Ecological risk assessment & fisheries/wildlife ecotoxicology.
ii. Education: B.S. in Wildlife Management, M.S. in Wildlife Science and PhD, in Wildlife Science from Texas A&M University.
iii. Professional Experience: Dr. Harry Ohlendorf is Technology Fellow at CH2M Hill, Inc., and has more than 39 years of experience in evaluating the impacts of environmental contaminants on wildlife in aquatic and terrestrial ecosystems, including more than 21 years at CH2M Hill and more than 18 years with U.S. Fish and Wildlife Service (USFWS). He began his career in 1971, as a Wildlife Research Biologist with the USFWS Patuxent Wildlife Research Center, in Laurel, Maryland, where he served as Assistant Director for 7 years and remained actively involved in pollution ecology research. In 1980, he became the leader of the USFWS Pacific Coast Research Station in Davis, California, and studied the occurrence and impacts of contaminants in aquatic and terrestrial ecosystems until 1990 when he joined CH2M HILL. Dr. Ohlendorf's experience there includes a wide variety of environmental projects, particularly focusing on ecological risk assessment and risk management, for which he provides firm-wide technical guidance. Risk assessments have focused on a wide range of contaminants, ecological receptors, and ecosystems. He is a Certified Wildlife Biologist and serves as the Chair of The Wildlife Society's Wildlife Toxicology Working Group. He has been recognized as a “Pioneer of Selenium Research” for his extensive work related to selenium ecotoxicology. Dr. Ohlendorf served on the Editorial Board of the journal Environmental Toxicology and Chemistry in 1987-1989, and 2007-2010, and has authored more than 85 papers in the fields of ecotoxicology and vertebrate ecology (including 12 invited book chapters and 2 books edited/co-edited).
17. Rick Relyea, PhD, University of Pittsburgh, Pittsburgh, PA.
i. Expertise: Biology, ecology and ecotoxicology.Start Printed Page 45562
ii. Education: B.S. in Environmental and Forest Biology (Wildlife Management) from State University of New York—Syracuse; M.S. in Wildlife Science (Wildlife Management) from Texas Tech University; PhD in Biology (Ecology, Evolution and Organismal Biology) from the University of Michigan.
iii. Professional Experience: Dr. Rick A. Relyea is a Professor of Biology at the University of Pittsburgh and Director of the Pymatuning Laboratory of Ecology. Dr. Relyea regularly teaches courses in ecology, evolution, and animal behavior at the undergraduate and graduate levels. For two decades, Dr. Relyea has conducted research on a wide range of topics including community ecology, evolution, disease ecology, and ecotoxicology. He has served on multiple scientific panels for the NSF and has been an associate editor for the journals of the Ecological Society of America. He has authored more than 80 scientific articles and book chapters, and has presented research seminars throughout the world. In 2005, he was named the “Chancellor's Distinguished Researcher” at the University of Pittsburgh.
18. Lee Shugart, PhD, LR Shugart & Associates, Inc., Oak Ridge, TN.
i. Expertise: Biochemistry, environmental sciences, genetic ecotoxicology.
ii. Education: B.S. in Chemistry from East Tennessee State University; M.S. in Biochemistry and PhD in Microbiology from the University of Tennessee.
iii. Professional Experience: Dr. Lee Shugart is President of LR Shugart and Associates, Inc. His research interests are concerned with elucidating the cellular mechanisms of environmental genotoxicants and the development of new methodologies for quantifying the interaction of genotoxicants with DNA and proteins. He has published over one hundred articles in the peer-reviewed, scientific literature on such topics as protein biosynthesis, mechanisms of enzyme action, and nucleic acid biochemistry, and has conducted extensive research on the chemical modification of macromolecules by environmental contaminants in fish, rodents, and humans. He is considered an established authority on the use of the Biomarker Approach for evaluating the effects of contaminants on the health of environmental species. He is the current and founding Editor-in-Chief of the international scientific journal Ecotoxicology, a past member of the editorial board of Biomarkers and an Associate Editor for the 2nd edition of the Encyclopedia of Toxicology. He has served as a Consultant to the Science Advisory Board of the EPA and as a Scientific Assistant to the Deputy Assistant to the Secretary of Defense for Nuclear and Chemical and Biological Matters/Counter Proliferation. Dr. Shugart was a Line Officer in the U.S. Navy and served as a Communication Officer for the Chief of Naval Operation and as a Chief Engineer on a destroyer stationed with the 6th fleet. He is a veteran of the Korean Conflict.
19. Joseph P. Sullivan, PhD, Ardea Consulting, Woodland, CA.
i. Expertise: Pesticide ecotoxicology.
ii. Education: B.A. in Biology from Ripon College; M.S. in Biology/Ecology from Utah State University; PhD in Wildlife Science from Virginia Polytechnic Institute & State University.
iii. Professional Experience: Dr. Joseph Sullivan is Principal Consultant/Owner of Ardea Consulting. His work since graduate school has involved the evaluation of impacts of pesticides on terrestrial wildlife species. His graduate research investigated blood biomarkers indicative of reproductive impacts following exposure to organochlorine insecticides. Immediately following graduate school, he worked for 31/2 years as the avian toxicologist for a pesticide manufacturing company. Dr. Sullivan acted as Study Director conducting EPA guideline ecotoxicology tests according to Good Laboratory Practices. He also spent 3 years conducting field studies evaluating exposure to and impacts of pesticides to wildlife, primarily birds. This experience provided in-depth knowledge and understanding of the testing necessary for the registration of pesticides. In 1997, he established Ardea Consulting which he continues to operate in Woodland, CA, specializing in avian and wildlife biology/toxicology as well as ecological risk assessment. In 2009, Dr. Sullivan co-authored a chapter on impacts of environmental contaminants on wildlife in the six volume compendium General and Applied Toxicology. In Pennsylvania, he served as President of the Pennsylvania Chapter of the Wildlife Society, member of the Pennsylvania Biodiversity Partnership, and Secretary of the Morrisville Environmental Advisory Council. He has served as Treasurer, Secretary and Vice Chair of the Wildlife Toxicology Working Group of The Wildlife Society. Now in California, Dr. Sullivan serves on the Woodland Water Rate Advisory Committee.
20. Vasilis Vasiliou, Ph.D., University of Colorado Denver, Aurora, CO.
i. Expertise: Pharmacology & toxicology.
ii. Education: B.S. in Chemistry, Ph.D. in Biochemistry and postdoctoral training in Pharmacology from University of Ioannina, Greece; Postdoctoral training in Molecular Toxicology from the University of Cincinnati.
iii. Professional Experience: Dr. Vasilis Vasiliou is Professor of Molecular Toxicology at the Departments of Pharmaceutical Sciences and Ophthalmology at the University of Colorado Denver. He is also Director of the Toxicology Graduate Program at the University of Colorado Denver since 2001, a program that has been ranked in the top 10 of the country. Dr. Vasiliou spent his one-year Sabbatical as a Guest Scientist at the National Eye Institute, National Institutes of Health (NIH 2005-2006) in the laboratory of Molecular and Developmental Biology. Dr. Vasiliou's major research interest has been the cellular responses to oxidative stress induced by physical agents (e.g.. UV radiation), metabolism and toxicity of both endogenous and foreign chemicals. Dr. Vasiliou is a world expert in the Aldehyde Dehydrogenases (ALDH) and he maintains the official Web page for the ALDH superfamily. He is a Specialist Advisor for the Human Gene Nomenclature Committee of the Human Genome Organization (HUGO). He is a member of ARVO (Cornea Specialty Section) and Society of Toxicology (Ocular Toxicology & Mechanisms Specialty Section). Dr Vasiliou's research program has been funded since 1997, from NEI/NIH and NIAAA/NIH. He is the author of about 110 original scientific papers and review articles published in peer reviewed international journals as well as a number of book chapters and editorials. Dr. Vasiliou is the editor of the journal Human Genomics and he is a member of the Editorial Board of the Cutaneous and Ocular Toxicology, and The Ocular Surface.
List of Subjects
Environmental protection, Pesticides and pests.Start Signature
Dated: July 21, 2011.
Director, Office of Science Coordination and Policy.
[FR Doc. 2011-19174 Filed 7-28-11; 8:45 am]
BILLING CODE 6560-50-P