[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45555-45562]
From the Federal Register Online via the Government Publishing 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: 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
[[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.
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 protected].
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