Nominations to the FIFRA Scientific Advisory Panel; Request for Comments, 45555-45562 [2011-19174]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45555-45562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19174]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0550; FRL-8882-2]


Nominations to the FIFRA Scientific Advisory Panel; Request for 
Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice provides the names, addresses, professional 
affiliations, and selected biographical data of persons nominated to 
serve on the Scientific Advisory Panel (SAP) established under section 
25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA). The Panel was created on November 28, 1975, and made a 
statutory Panel by amendment to FIFRA, dated October 25, 1988. The 
Agency, 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.

DATES: Comments, identified by docket ID number EPA-HQ-OPP-2011-0550, 
must be received on or before August 29, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2011-0550, by one of the following methods:
     Federal eRulemaking Portal: https://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

[[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 https://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 https://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 https://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.

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: bailey.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

 I. General Information

 A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to persons who are or may be required to 
conduct testing of chemical substances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of 
1996 (FQPA). Since other entities may also be interested, the Agency 
has not attempted to describe all the specific entities that may be 
affected by this action. If you have any questions regarding the 
applicability of this action to a particular entity, consult the DFO 
listed under FOR FURTHER INFORMATION CONTACT.

 B. What should I consider as I prepare my comments for EPA?

    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 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.

[[Page 45557]]

III. Charter

    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.

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 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.

[[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)

[[Page 45559]]

in 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

[[Page 45560]]

and 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

[[Page 45561]]

involved 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.

[[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 3\1/
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.

    Dated: July 21, 2011.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2011-19174 Filed 7-28-11; 8:45 am]
BILLING CODE 6560-50-P