[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Pages 24419-24425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09888]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OW-2014-0138; FRL-9910-21-OW]
Peer Review of the Draft Health Effects Documents for
Perfluorooctanoic Acid and Perfluorooctane Sulfonate--Interim List of
Potential Peer Reviewers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice; request for public comments.
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SUMMARY: Environmental Protection Agency (EPA) requests public comments
on the interim list of candidates being
[[Page 24420]]
considered as peer reviewers for the contractor-managed external peer
review of the draft documents entitled, ``Health Effects Document for
Perfluorooctanoic Acid'' and ``Health Effects Document for
Perfluorooctane Sulfonate.'' This notice provides the names,
professional affiliations, expertise, education, and professional
experience of the candidate reviewers. The public is requested to
provide relevant information or documentation on the candidates who are
being evaluated by the contractor (Versar, Inc.). Once the public
comments on the interim list of candidates have been reviewed and
considered, Versar will select the final six to seven peer reviewers
who, collectively, best provide expertise spanning the multiple subject
matter areas covered by the draft documents and, to the extent
feasible, best provide a balance of perspectives.
DATES: The public comment period on the interim list of peer reviewers
begins on April 30, 2014 and ends on May 21, 2014.
ADDRESSES: Any interested person or organization may submit comments on
the interim list of peer reviewers. Public comments should be submitted
to the EPA contractor, Versar, Inc., no later than May 21, 2014, by one
of the following methods:
Online: http://peerreview.versar.com/epa/pfoa/interim-list.html.
Email: [email protected] (subject line: PFOA/PFOS Peer
Review).
Mail: Versar, Inc., 6850 Versar Center, Springfield, VA
22151 (ATTN: Betzy Colon).
Please be advised that public comments are subject to release under
the Freedom of Information Act.
FOR FURTHER INFORMATION CONTACT: Questions concerning the comment
process or Web site should be directed to the EPA contractor, Versar,
Inc., at 6850 Versar Center, Springfield, VA 22151; by email
[email protected] (subject line: PFOA/PFOS Peer Review); or by
phone: (703) 642-6727 (ask for Betzy Colon). For additional information
concerning the health effects documents, please contact Joyce Donohue
at U.S. EPA, Office of Water, Health and Ecological Criteria Division
(Mail Code 4304T), 1200 Pennsylvania Avenue NW., Washington, DC 20460;
telephone: (202) 566-1098; or email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background Information on the Draft Health Effects Documents
EPA has prepared draft health effects documents for
Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) for
purposes of public comment (scientific views) and peer review. EPA will
consider any public comments and peer reviewer comments submitted in
accordance with the Federal Register notice dated February 24, 2014
(http://www.gpo.gov/fdsys/pkg/FR-2014-02-28/pdf/2014-04455.pdf) when
finalizing the documents. Once the health effects documents are
finalized, they will be utilized to develop lifetime health advisory
values for each chemical. PFOA and PFOS are listed on the third
contaminant Candidate List (CCL3) \1\ and both chemicals are currently
being monitored under the third Unregulated Contaminant Monitoring Rule
(UCMR3) \2\. The draft documents are available through
www.regulations.gov (docket ID number EPA-HQ-OW-2014-0138) and at
http://peerreview.versar.com/epa/pfoa.
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\1\ CCL3 is a list of contaminants that are currently not
subject to any proposed or promulgated national primary drinking
water regulations, that are known or anticipated to occur in public
water systems, and which may require regulation under the Safe
Drinking Water Act (SDWA). Additional information about the CCL3 can
be found at the following Web site: http://water.epa.gov/scitech/drinkingwater/dws/ccl/ccl3.cfm.
\2\ EPA uses the Unregulated Contaminant Monitoring (UCM)
program to collect data for unregulated contaminants suspected to be
present in drinking water. Results from UCMR3 can be examined as
they become available at the following Web site: http://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucmr3/.
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II. Process of Obtaining Candidate Reviewers
On February 24, 2014, EPA released the draft health effects
documents on PFOA and PFOS for the purposes of public comment and peer
review. Consistent with guidelines for the peer review of highly
influential scientific assessments, EPA tasked a contractor (Versar,
Inc.) to assemble six to seven scientific experts to evaluate the draft
documents. As part of the peer review process, a public nomination
period was held from February 24, 2014 to March 21, 2014, during which
members of the public were able to nominate scientific experts with
knowledge and experience in one or more of the following areas: (1)
Epidemiology, (2) toxicology (liver effects, immunotoxicity,
neurotoxicity, developmental and reproductive toxicology, etc.), (3)
membrane transport, (4) human health risk assessment, (5)
pharmacokinetic models, and (6) mode-of-action for cancer and noncancer
effects. Versar also conducted an independent search for scientific
experts to augment the list of publically-nominated candidates. In
total, Versar evaluated the 29 candidates nominated during the public
nomination period and identified by Versar.
Selection Process: Versar considered and screened all candidates
against the selection criteria described in the Federal Register dated
February 24, 2014 (http://www.gpo.gov/fdsys/pkg/FR-2014-02-28/pdf/2014-04455.pdf), which included having demonstrated expertise in the areas
described above, being free of any conflict of interest, and being
available to participate in-person in a two-day peer review meeting in
the Washington, DC area (exact date to be determined). Following the
screening process, Versar narrowed the list of potential reviewers to
15 candidates. This Federal Register notice is to solicit comments on
the interim list of 15 candidates. The public is requested to provide
relevant information or documentation on the candidates who are being
evaluated by Versar. Once the public comments on the interim list of
candidates have been reviewed and considered, Versar will select the
final six to seven peer reviewers. Additional information on the
scientific peer review process can be found at: http://peerreview.versar.com/epa/pfoa.
Responsibilities of Peer Reviewers: Peer reviewers will be charged
with evaluating and preparing written comments on the draft PFOA and
PFOS health effects documents. Specifically, reviewers will provide
general comments, their overall impressions of the documents, and
respond to 12 charge questions. This includes determining the
appropriateness of the quality, accuracy, and relevance of the data in
the documents. Any public comments submitted to EPA's public docket
(docket ID number EPA-HQ-OW-2014-0138) during each document's 60-day
public comment period will also be provided to the peer reviewers for
their consideration. In addition, peer reviewers will participate in a
two-day peer review meeting to discuss the scientific basis supporting
EPA's draft health effects documents. The meeting will be held in the
Washington, DC metro area and is anticipated to take place in the late
July or August timeframe. Following the peer review meeting, Versar
will provide a peer review summary report to EPA containing the
comments and recommendations from the peer reviewers. The final peer
review report will also be made available to the public. In preparing
the final health effects documents, EPA will consider Versar, Inc.'s
report of the comments and recommendations from the external peer
review meeting, as well as written public comments received through the
official public docket.
[[Page 24421]]
III. Interim List of Peer Reviewers
Following are the names, professional affiliations, expertise,
education, and professional experience of the current candidates being
considered for the external peer review of the draft PFOA and PFOS
Health Effects documents. After review and consideration of any public
comments received, Versar will select from this list the final six to
seven peer reviewers who, collectively, best provide expertise spanning
the multiple areas listed above and, to the extent feasible, best
provide a balance of perspectives. Once the final six to seven peer
reviewers are selected by Versar, a third Federal Register notice will
be published at least 30 days prior to the external peer review meeting
with the names of the final peer reviewers, along with information on
the meeting date, location, and registration details.
1. John C. Bailar III, M.D., Ph.D., University of Chicago
(Emeritus).
i. Expertise: Epidemiology and Human Health Risk Assessment.
ii. Education: Yale University, M.D. (1955) and American
University, Ph.D. in Statistics (1973).
iii. Professional Experience: Dr. Bailar is Professor Emeritus at
the University of Chicago, where he was founding Chair of the
Department of Health Studies. Prior to joining the University of
Chicago, Dr. Bailar was at the U.S. National Cancer Institute from
1956-1980, Harvard University 1980-1988, and McGill University (where
he was Chair of Epidemiology and Biostatistics) 1988-1995. Since he
retired in 2001, Dr. Bailar has been Scholar in Residence at the
National Academies. Dr. Bailar received his M.D. from Yale University
in 1955 and his Ph.D. in Statistics from American University in 1973.
His areas of expertise include statistics, biostatistics, epidemiology,
and environmental and occupational hazards. For many years his
professional interests centered on the causes and prevention of
disease. More recently he has focused on improving quality and
performance in science generally, with a special focus on
communication. Dr. Bailar has served on more than 40 committees at the
National Academies, and served as chair or co-chair of 13 of these
committees. Dr. Bailar has received numerous special/prestigious
honors, awards and recognitions, including MacArthur Fellow 1990-1995,
elected member to both the Institute of Medicine and the International
Statistical Institute, honorary Fellow, American Medical Writers
Association, and most recently an Honored Member of the Board of
Editors in the Life Sciences. In addition, for 11 years, he was the
statistical consultant and a member of the editorial board for The New
England Journal of Medicine. Association memberships of Dr. Bailar
include the American Statistical Association (life member) and Council
of Science Editors (Past President). Dr. Bailar has more than 250
scientific publications including articles in peer reviewed journals,
books, book chapters, and proceedings, and has published widely in the
statistics and epidemiology literature.
2. James V. Bruckner, Ph.D., University of Georgia.
i. Expertise: Toxicology (liver effects, neurotoxicology, and
developmental/reproductive) and Human Health Risk Assessment.
ii. Education: University of Michigan, Ph.D. in Toxicology (1974).
iii. Professional Experience: Dr. Bruckner is currently Professor
of Pharmacology and Toxicology at the University of Georgia College of
Pharmacy. He is also Professor in the Department of Physiology and
Pharmacology at the University of Georgia College of Veterinary
Medicine. He received his Ph.D. in Toxicology from the University of
Michigan in 1974. He has previously held faculty positions at the
University of Kansas and the University of Texas Medical School at
Houston. He is actively engaged in graduate education and in federally-
funded research projects. Dr. Bruckner's research focus is on the
toxicology and toxicokinetics of solvents, drug-solvent interactions at
occupational exposure levels, and toxicokinetic bases for
susceptibility of children to insecticides and other chemicals. Dr.
Bruckner has published more than 200 journal articles, book chapters,
and abstracts. He has also served on a variety of expert panels and
committees for the EPA, National Institutes of Health, National
Aeronautics and Space Administration, Agency for Toxic Substances and
Disease Registry, Food and Drug Administration, and National Academy of
Sciences.
3. Deborah A. Cory-Slechta, Ph.D., University of Rochester School
of Medicine and Dentistry.
i. Expertise: Toxicology (neurotoxicology and developmental/
reproductive) and Human Health Risk Assessment.
ii. Education: University of Minnesota, Ph.D. in Experimental
Psychology (1977).
iii. Professional Experience: Dr. Cory-Slechta is currently a
Professor in the Department of Environmental Medicine and the
Department of Pediatrics at the University of Rochester School of
Medicine and Dentistry, where she also serves as co-director of the
Behavioral Sciences Facility Core and director of the Animal Behavior
Core. Dr. Cory-Slechta received her Ph.D. from the University of
Minnesota in 1977 and worked as a junior staff fellow of the Food and
Drug Administration (FDA) National Center for Toxicological Research
(NCTR) beginning in 1979. She was appointed to the faculty of the
University of Rochester Medical School in 1982 and was appointed Chair
of the Department of Environmental Medicine and Director of the
National Institute of Environmental Health Sciences (NIEHS)
Environmental Health Sciences Center at the University of Rochester in
1998. From 2000 to 2002, she was the Dean for Research and Director of
the AAB Institute for Biomedical Sciences. Following her appointment as
Dean, she served from 2003 to 2007 as the Chair of the Department of
Environmental and Occupational Medicine at Robert Wood Johnson Medical
School and as Director of the Environmental and Occupational Health
Sciences Institute, a joint Institute of the Robert Wood Johnson
Medical School and Rutgers. Dr. Cory-Slechta's research has focused
largely on environmental neurotoxicants as risk factors for behavioral
disorders and neurodegenerative disease. These research efforts have
resulted in over 170 papers and book chapters to date. Dr. Cory-Slechta
has served on numerous national research review and advisory panels,
including committees of the National Institutes of Health, NIEHS, NCTR,
EPA, National Academy of Sciences, Institute of Medicine, and the
Agency for Toxic Substances and Disease Registry, Centers for Disease
Control. In addition, Dr. Cory-Slechta has served on the editorial
boards of several journals including Environmental Health Perspectives,
Neurotoxicology, Toxicology, Toxicological Sciences, Fundamental and
Applied Toxicology, Neurotoxicology and Teratology, and American
Journal of Mental Retardation. She has held the elected positions of
President of the Neurotoxicology Specialty Section of the Society of
Toxicology, President of the Behavioral Toxicology Society, and been
named a Fellow of the American Psychological Association.
4. Jamie C. DeWitt, Ph.D., East Carolina University.
i. Expertise: Toxicology (immunotoxicology, neurotoxicology, and
developmental).
ii. Education: Indiana University, Ph.D. in Environmental Science
and Neural Science (2004).
[[Page 24422]]
iii. Professional Experience: Dr. DeWitt is an Assistant Professor
in the Department of Pharmacology and Toxicology at the Brody School of
Medicine at East Carolina University (ECU). She is affiliated with The
Harriet and John Wooten Laboratory for Alzheimer's and
Neurodegenerative Diseases Research and holds an adjunct appointment in
the ECU Department of Public Health. Dr. DeWitt received her Ph.D. in
Environmental Science and Neural Science from the School of Public and
Environmental Affairs and Program in Neural Science at Indiana
University in 2004. She also completed postdoctoral training in
Developmental Cardiotoxicity at Indiana University-Bloomington and in
Immunotoxicology at EPA through a cooperative training agreement with
the University of North Carolina at Chapel Hill. Dr. DeWitt's main
research focus is on how toxicants found in the environment can lead to
neurodevelopmental and neurodegenerative disorders via disruption of
the developing immune system. Much of her past research has involved
the immunotoxicity of PFOA and related polyfluoroalkyl substances
(PFASs). Dr. DeWitt has published seven peer reviewed research
articles, three review papers and two book chapters that address the
biological effects of PFOA, as well as one paper on the effects of PFOS
on immune function. Her publications describe effects as well as
underlying mechanisms following adult and developmental exposure. Her
research experience and publication record (more than 25 peer reviewed
manuscripts, 6 review articles, 9 book chapters) extend beyond the
effects of perfluoroalkyl acids and working with rodent models. She is
currently editing a book on the general toxicity of PFASs and is a
current member of the mechanistic working group for Monograph 110 of
the International Agency for Research on Cancer, which will include an
assessment of PFOA. She is on the editorial boards of the Journal of
Immunotoxicology and the Journal of Environmental Toxicology and Health
and has reviewed grants for the U.S. Department of Defense and the
National Institute of Occupational Safety and Health (NIOSH). She has
also been a manuscript reviewer for more than 20 journals. Dr. DeWitt
is the current president of the North Carolina chapter of the Society
of Toxicology (SOT) and the Junior Councilor for the Immunotoxicology
Specialty Section of the SOT. She also was awarded the Outstanding
Young Investigator Award from the Immunotoxicology Specialty Section in
2013.
5. Neeraja K. Erraguntla, Ph.D., DABT, Texas Commission on
Environmental Quality.
i. Expertise: Toxicology (liver effects, neurotoxicology,
immunotoxicology, and developmental/reproductive) and Human Health Risk
Assessment.
ii. Education: Louisiana State University, Ph.D. in Physiology,
Pharmacology, & Toxicology (1998).
iii. Professional Experience: Dr. Erraguntla is currently a Senior
Toxicologist/Project Manager at the Texas Commission on Environmental
Quality (TCEQ). She is also an Adjunct Assistant Professor at Texas A&M
School of Public Health. Dr. Erraguntla received her Ph.D. in
Physiology, Pharmacology, and Toxicology from Louisiana State
University in 1998. Prior to joining TCEQ, Dr. Erraguntla served as a
Scientific Advisor at Life Technologies (2001-2004) and as a Research
Fellow/Research Associate at the University of Texas Southwestern
Medical Center (1998-2001). Dr. Erraguntla was board-certified as a
Diplomate of the American Board of Toxicology in 2012. Her work focuses
on air toxics, multimedia risk assessment, and development of toxicity
factors for various industrial chemicals. This involves general review
of toxicological studies, weight-of-evidence (WOE) analysis by the
integration of science along multiple lines of evidence (epidemiology,
in vivo & in vitro experimental toxicology, and human clinical studies)
and advising staff on hazard classification. Dr. Erraguntla is also a
team leader working on developing a framework for conducting systematic
reviews and determining WOE for toxicity factors. Dr. Erraguntla has
been an invited speaker at over eight national and state/regional
meetings. She is currently a member of EPA's Science Advisory Board
Environmental Justice Technical Guidance Panel and has been a member of
EPA's Acute Exposure Guideline Levels Committee. Dr. Erraguntla has
also been a full member of the Society of Toxicology (SOT) since 2011
and has supported SOT's Specialty Sections and Special Interest Groups.
6. Penelope A. Fenner-Crisp, Ph.D., DABT, Independent Consultant.
i. Expertise: Human Health Risk Assessment and Mode-of-Action.
ii. Education: University of Texas Medical Branch, Ph.D. in
Pharmacology (1968).
iii. Professional Experience: Dr. Fenner-Crisp has over 35 years of
experience in human health and ecological risk assessments and is
currently an independent consultant after retiring from her position as
the Executive Director of the International Life Sciences Institute
(ILSI) Risk Science Institute (2000-2004). Prior to joining ILSI, Dr.
Fenner-Crisp was employed by EPA, where she served in a variety of
capacities for over 22 years (1978-2000) including Senior Science
Advisor to the Director and Deputy Director of the Office of Pesticide
Programs, Director of the Health Effects Division of the Office of
Pesticide Programs, Director of the Health and Environmental Review
Division of the Office of Pollution Prevention and Toxic Substances,
and Senior Toxicologist in the Health Effects Branch of the Office of
Drinking Water. She was a charter member of EPA's Risk Assessment Forum
(RAF), a group of EPA senior scientists who are experts in all areas of
human, ecological, and exposure assessment, and served as the RAF chair
from 1998 until her retirement from EPA in 2000. Dr. Fenner-Crisp
received her Ph.D. in Pharmacology from the University of Texas Medical
Branch in Galveston in 1968 and completed a Postdoctoral Fellowship in
Pharmacology at Georgetown University Schools of Medicine and Dentistry
(1971-1976), with an emphasis on reproductive endocrinology. Her 35
years of experience includes hands-on practice, and management
oversight, of all components of both human health and ecological risk
assessments related to drinking water contaminants, industrial
chemicals, pesticides and foodborne pathogens. Dr. Fenner-Crisp has
served on numerous committees and panels including expert panels
charged with the review of EPA Integrated Risk Information System
documents, EPA Advisory Committees, EPA Science Advisory Board Drinking
Water Committee, and several World Health Organization Panels, to name
a few. She has also played a key role in the development of many EPA
science policies, including the policy guidance for use of Monte Carlo
analyses in exposure assessment, the cumulative risk conceptual
framework, implementation of the cancer guidelines, and those relevant
to implementation of the 1996 Food Quality Protection Act. Dr. Fenner-
Crisp is a member of the Society of Toxicology since 1983, and the
Society for Risk Analysis (SRA) since 1981, where she was the recipient
of the SRA's first Risk Practitioner award. She has been a Diplomate of
the American Board of Toxicology since 1984 and served a four-year term
on its Board of Directors from 2001-2005. Dr. Fenner-Crisp has
[[Page 24423]]
been an invited speaker at over 100 national and international meetings
and workshops, and has authored or co-authored over 40 publications,
including peer-reviewed journal articles, reports, and book chapters.
7. Jeffrey W. Fisher, Ph.D., U.S. Food and Drug Administration.
i. Expertise: Toxicology (developmental/reproductive), Human Health
Risk Assessment, and Pharmacokinetic Models.
ii. Education: Miami University of Ohio, Ph.D. in Zoology/
Toxicology (1987).
iii. Professional Experience: Dr. Fisher is currently a Research
Toxicologist at the U.S. Food and Drug Administration (FDA), National
Center for Toxicological Research. He was formerly a Professor in the
Department of Environmental Health Science, College of Public Health at
the University of Georgia (UGA). He joined UGA in 2000 and served as
Department Head of the Department of Environmental Health Sciences from
2000 to 2006 and Director of the Interdisciplinary Toxicology Program
from 2006-2010. Prior to joining UGA, he spent most of his career at
Wright Patterson Air Force Base, where he was Principal Investigator
and Senior Scientist in the Toxics Hazards Division and Technical
Advisor for the Operational Toxicology Branch. Dr. Fisher's research
interests are in the development and application of biologically based
mathematical models to ascertain health risks from environmental, food-
borne and occupational chemical exposures. Dr. Fisher's modeling
experience includes working with chlorinated and non-chlorinated
solvents, fuels, pesticides, perchlorate and bisphenol A. He has
developed physiologically-based pharmacokinetic (PBPK) models for use
in cancer risk assessment, estimating lactational transfer of solvents,
understanding in utero and neonatal dosimetry, quantifying metabolism
of solvent mixtures and developing biologically motivated models for
the hypothalamic-pituitary-thyroid axis in rodents and humans. Dr.
Fisher has published over 140 papers on pharmacokinetics and PBPK
modeling in laboratory animals and humans. He has served on several
national panels and advisory boards for the U.S. Department of Defense,
Agency for Toxic Substances and Disease Registry, EPA and non-profit
organizations. He was a U.S. delegate for the North Atlantic Treaty
Organization. Dr. Fisher served on the International Life Sciences
Institute Steering Committee, which evaluated chloroform and
dichloroacetic acid using EPA-proposed Carcinogen Risk Guidelines. He
is Past President of the Biological Modeling Specialty Section of the
Society of Toxicology, reviewer for several toxicology journals, and
was Co-Principal Investigator on a National Institutes of Health-
supported workshop on Mathematical Modeling at the University of
Georgia in the fall of 2003. Dr. Fisher was also a member of the
National Academy of Sciences subcommittee on Acute Exposure Guideline
Levels from 2004-2010 and for the EPA Science Advisory Board (SAB)
(2007-2010). He is an ad hoc EPA SAB member for dioxin and perchlorate.
Dr. Fisher is a Fellow of the Academy of Toxicological Sciences, an
associate editor for Toxicological Sciences, and on the editorial board
of Journal of Environmental Science and Health Part C Environmental
Carcinogenesis & Ecotoxicology Reviews.
8. William L. Hayton, Ph.D., The Ohio State University.
i. Expertise: Membrane Transport, Pharmacokinetic Models, and Mode-
of-Action.
ii. Education: State University of New York, Ph.D. in Pharmaceutics
(1971).
iii. Professional Experience: Dr. Hayton is a Professor Emeritus in
the College of Pharmacy at The Ohio State University. Dr. Hayton
received a Ph.D. in Pharmaceutics from the State University of New York
at Buffalo in 1967. He was a member of the Washington State University
College of Pharmacy faculty for 19 years, rising to Chair of the
Pharmacology/Toxicology Graduate Program in 1982 and Acting Dean at the
College of Pharmacy in 1987. In 1990, he transferred to the Ohio State
University as Chair of the Division of Pharmaceutics, where he later
served as Associate Dean for the Graduate Programs and Research until
his retirement in 2010. Dr. Hayton's expertise is pharmacokinetics,
particularly construction and validation of mathematical models that
describe or explain the kinetics of complex biological systems. One
recent research interest is characterization of the Fc receptor-
mediated transport and catabolism of albumin and IgG in wild type and
FcR knockout mice. A second recent project is the quantitative modeling
of the female hypothalamus-pituitary-gonad (HPG) axis in the female
rainbow trout (Oncorhynchus mykiss). The model is based on and
integrates the biology of gonadotropin, estrogen, androgen and
maturational hormone signaling systems, and it includes key
intermediate steps in the signaling pathways; viz., gonadotropin and
sex steroid synthesis, hormone receptors and their corresponding mRNA
levels. Dr. Hayton's expertise extends to interspecies scaling of
pharmacokinetic model parameter values and xenobiotic metabolism. Dr.
Hayton is author or co-author of over 100 peer-reviewed scientific
publications and has held peer-reviewed grant support from the National
Institutes of Health, EPA, U.S. Air Force Office of Scientific
Research, U.S. Food and Drug Administration, and U.S. Fish and Wildlife
Service. He previously served on the EPA Science Advisory Board
Perfluorooctanoic Acid Risk Assessment Review Panel.
9. Matthew P. Longnecker, Sc.D, M.D., National Institute of
Environmental Health Sciences.
i. Expertise: Epidemiology and Pharmacokinetic Models.
ii. Education: Harvard School of Public Health, Sc.D. in
Epidemiology (1989); Dartmouth Medical School, M.D. (1981).
iii. Professional Experience: Dr. Longnecker, M.D., Sc.D., is the
head of the Biomarker-based Epidemiology Group at the National
Institute of Environmental Health Sciences (NIEHS). Dr. Longnecker
received an M.D. from Dartmouth Medical School and completed a
residency in internal medicine at Temple University Hospital in
Philadelphia. After receiving a Sc.D. in Epidemiology from Harvard
School of Public Health in 1989, he served as an Assistant Professor in
the Department of Epidemiology at the University of California, Los
Angeles, School Of Public Health. Since 1996, Dr. Longnecker has served
as Adjunct Professor/Associate Professor in the Department of
Epidemiology, School of Public Health, University of North Carolina at
Chapel Hill. He came to the NIEHS Epidemiology Branch in 1995, as a
tenure-track investigator. Dr. Longnecker's research program is focused
on the health effects of persistent organic pollutants (e.g., the DDT
metabolite p,p'-DDE, and polychlorinated biphenyls). He is particularly
interested in the effects of intrauterine exposure to persistent
organic pollutants in relation to intrauterine growth, preterm birth,
birth defects, neurologic findings at birth, growth, neurodevelopment,
intelligence, and hearing. Recently, Dr. Longnecker has completed and
has ongoing a series of studies on perfluorinated alkyl substances in
relation to reproductive and pediatric outcomes. In addition, he has
begun studying the effects of early, low-level exposure to the
nonpersistent pollutants, bisphenol A and organophosphate pesticides.
Dr. Longnecker's research efforts have resulted in over 180 papers and
book chapters to date. He has served as a
[[Page 24424]]
leader for numerous national and international committees, such as for
the Society for Epidemiologic Research and the International Society
for Environmental Epidemiology, and has been on numerous national and
international scientific advisory boards, including the EPA Science
Advisory Board for the Perfluorooctanoic Acid Risk Assessment Review.
10. Julie Melia, Ph.D., DABT, SRC, Inc.
i. Expertise: Toxicology (neurotoxicology, developmental/
reproductive, liver effects), Human Health Risk Assessment, and Mode-
of-Action.
ii. Education: Northeastern University, Ph.D. in Biomedical
Sciences/Toxicology (1990).
iii. Professional Experience: Dr. Melia is currently a Senior
Toxicologist at SRC, Inc. where she has served as Program Manager and
provided toxicological support for several EPA programs and offices.
She is also an Adjunct Scientist and member of the Maine Center for
Toxicology and Environmental Health at the University of Southern
Maine. She received her Ph.D. in Biomedical Sciences/Toxicology from
Northeastern University in 1990 and has 24 years of experience in the
design and management of chemical toxicity evaluations and human health
and ecological risk assessments. Prior to joining SRC in 2003, Dr.
Melia was employed in the private sector, where she managed
multidisciplinary project teams and contributed to more than 50
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA), Resource Conservation and Recovery Act (RCRA), and state-
directed risk assessments. Dr. Melia was board-certified as a Diplomate
of the American Board of Toxicology in 2004 and has expertise in the
critical review of mechanistic toxicology studies and the evaluation of
chemical-specific modes of action. Dr. Melia has addressed complex
toxicological issues related to human exposure to many chemicals
including, phthalates, PAHs, polychlorinated biphenyls (PCBs),
pesticides (DDT, kepone), chlorinated solvents, brominated
trihalomethanes, 1,4-dioxane, and ethanol. She has demonstrated
innovative approaches to addressing challenging technical issues
related to chemical toxicology and risk assessment and has significant
experience in the critical review of epidemiology, toxicology, and
mechanistic studies and the development of quantitative toxicity
values. Dr. Melia has presented information to the EPA Science Advisory
Board and has served as an external peer reviewer for Agency for Toxic
Substances and Disease Registry Toxicological Profiles. She is a member
of the Society of Toxicology, and the International Society of
Regulatory Toxicology and Pharmacology.
11. Andy L. Nong, Ph.D., Health Canada.
i. Expertise: Pharmacokinetic Models.
ii. Education: Universit[eacute] de Montr[eacute]al, Ph.D. in
Public Health (Toxicology) (2007).
iii. Professional Experience: Dr. Nong is currently a Research
Scientist at the Environmental Health Sciences and Research Bureau at
Health Canada. He is also an Affiliate at the R. Samuel McLaughlin
Centre for Population Health Risk Assessment within the University of
Ottawa. He received his Ph.D. in Public Health from the
Universit[eacute] de Montr[eacute]al in 2007 and holds a Master's
degree in Pharmaceutical Sciences (2001). Prior to joining Health
Canada, Dr. Nong served as Research Investigator (2008-2009) and
Postdoctoral Fellow (2005-2008) at The Hamner Institutes for Health
Sciences. His work has been recognized, in particular, for
pharmacokinetics and biological modeling approaches in risk assessment.
Specifically, his research program explores the use of biological
computer models to simulate and interpret the fate and effects of
chemical exposure. This work has led to deriving drinking water dose
estimates, evaluating chemical mixture exposure, interpreting
biomonitoring and exposure surveys, and investigating models for
toxicity screening approaches for human equivalent chemical exposures.
Dr. Nong is a member of the expert panel for Genome Canada's
Bioinformatics and Computational Biology roadmap. His international
involvement includes a partnership with the EPA National Center for
Computational Toxicology and Toxicity Forecaster (ToxCast\TM\) program,
providing technical support for documents on PBPK modeling in risk
assessment for EPA and the World Health Organization/International
Program on Chemical Safety. Dr. Nong has authored and co-authored
several publications, including peer-reviewed articles and book
chapters, and served on the Board of Editors of the Journal of Applied
Toxicology.
12. Stephen M. Roberts, Ph.D., University of Florida.
i. Expertise: Toxicology (liver effects and immunotoxicology) and
Human Health Risk Assessment.
ii. Education: University of Utah, Ph.D., Department of
Pharmacology (1973).
iii. Professional Experience: Dr. Roberts is a Professor at the
University of Florida with joint appointments in the College of
Veterinary Medicine, College of Medicine, and College of Public Health
and Health Professions. He also serves as Director of the Center for
Environmental & Human Toxicology at the University of Florida. Dr.
Roberts received a Ph.D. from the University of Utah College of
Medicine Department of Pharmacology in 1973. After a National
Institutes of Health postdoctoral fellowship in pharmacokinetics at
SUNY Buffalo (1977-1980), he served on the faculties of the University
of Cincinnati College of Pharmacy (1980-1986) and the College of
Medicine at the University of Arkansas for Medical Sciences (1986-
1989). Dr. Roberts has been a faculty member at the University of
Florida since 1989. His research addresses mechanisms of toxicity,
particularly involving the liver and immune system. Dr. Roberts also
has an active research program in toxicokinetics, especially involving
bioavailability of environmental toxicants, as well as approaches to
evaluation of potential toxicity of nanomaterials. His teaching
responsibilities at the University of Florida include graduate courses
in toxicology and risk assessment, as well as invited lectures in other
graduate and professional courses. Dr. Roberts' research efforts have
resulted in over 100 papers and book chapters to date, as well as over
100 published abstracts and letters. Dr. Roberts has served on numerous
national advisory panels, including for the EPA, Department of Health
and Human Services, and the Food and Drug Administration. He is
currently the Associate Editor for Nanotoxicology and is currently or
recently on the Editorial Boards of Toxicology and Applied Toxicology,
Human and Ecological Risk Assessment, and Dose-Response.
13. Angela L. Slitt, Ph.D., University of Rhode Island.
i. Expertise: Toxicology (liver effects) and Membrane Transport.
ii. Education: University of Connecticut, Ph.D. in Pharmacology and
Toxicology (2000).
iii. Professional Experience: Dr. Slitt is currently an Associate
Professor in the Department of Biomedical and Pharmaceutical Sciences
at the University of Rhode Island. Dr. Slitt received her Ph.D. in
Pharmacology and Toxicology from the University of Connecticut in 2000,
and then served until 2004 as a postdoctoral fellow at the University
of Kansas Medical Center. Dr. Slitt has been a faculty member at the
University of Rhode
[[Page 24425]]
Island since 2006. Dr. Slitt's graduate and postdoctoral training was
heavily focused on liver biology and health, with a focus in the area
of toxicology, and included research in nuclear receptors,
biotransformation, and transporter expression. Her current research
interests focus on how (1) expression of drug transporters affects
chemical disposition and toxicity, (2) nutrition and intake of dietary
antioxidants affects the expression of drug transporters, (3) liver
disease (i.e., diabetes, cholestasis, and ethanol cirrhosis) affects
transporter expression and chemical disposition, and (4) transporter
expression affects cholesterol transport and susceptibility to
gallstone formation. She has also recently investigated the effect of
PFOS on caloric restriction in mice. Dr. Slitt is presently on the
Editorial Board of BMC Pharmacology and Toxicology, Journal of
Biochemical and Molecular Toxicology, and Toxicology Methods and
Mechanism, and is an ad-hoc reviewer for numerous other journals. She
is author or co-author of over 50 peer-reviewed scientific
publications, and was recently awarded the University of Rhode Island
Early Career Faculty Research Excellence Award.
14. Calvin C. Willhite, Ph.D., Risk Sciences International and
McLaughlin Centre for Population Health Risk Assessment.
i. Expertise: Toxicology (developmental/reproductive) and Human
Health Risk Assessment.
ii. Education: Dartmouth Medical School, Ph.D. in Pharmacology
(1980).
iii. Professional Experience: Dr. Willhite has more than 30 years
of experience in the fields of toxicology and human health risk
assessment. He is currently employed as a Contract Toxicologist for
Risk Sciences International and McLaughlin Centre for Population Health
Risk Assessment at the University of Ottawa, where he performs
chemical-specific human health risk assessments for Health Canada and
European Union REACH. Prior to his present employment, Dr. Willhite
also conducted chemical specific risk assessment as a Toxicologist for
the National Sanitation Foundation (2005-2012) and for the State of
California (1985-2011). He received his Ph.D. in Pharmacology from the
Dartmouth Medical School in 1980. Dr. Willhite has more than 100
publications in basic and applied toxicology and human health risk
assessment. He has experience with many types of compounds including
chemicals in occupational, submarine and ambient air; drugs in
dermatology; endocrine-active drugs and environmental chemicals;
inorganic elements; and dietary supplements. His editorial
responsibilities include serving on the Editorial Board and/or as
Reviewer of many peer reviewed toxicology journals. He is currently
serving on the Editorial Board of Toxicology and Applied Toxicology,
Journal of Toxicology, Journal of Toxicology and Environmental Health
Part A, and the International Journal of Toxicology. He has been a
member of the National Academy of Sciences Committee on Toxicology, EPA
National Advisory Committee, American Conference of Industrial
Hygienists, International Agency for Research on Cancer, Society of
Toxicology, and National Institutes of Health advisory committees.
15. Raymond G. York, Ph.D., DABT, Fellow-ATS, RG York and
Associates, LLC.
i. Expertise: Toxicology (developmental/reproductive and
neurotoxicology).
ii. Education: University of Cincinnati, Ph.D. in Toxicology
(1982).
iii. Professional Experience: Dr. York is a board-certified
Toxicologist and operates his own consulting company, RG York and
Associates, LCC. Dr. York received his Ph.D. in Toxicology at the
University of Cincinnati Medical Center in 1982 and completed a two-
year postdoctoral fellowship at the Children's Hospital Research
Foundation in Cincinnati in the area of developmental toxicology. He
has previously served as Senior Scientific Director at WIL Research
Laboratories (2008-2011), Associate Director of Research/Program
Manager at Charles River Laboratories (1995-2008), and Director of
Reproductive Toxicology and Neurotoxicology at International Research
and Development Corporation (now MPI Research) (1989-1995). Dr. York
was board-certified as a Diplomate of the American Board of Toxicology
in 1986 and served four years on its Board of Directors. His work focus
is in the field of toxicology, particularly reproductive and
developmental toxicology. Dr. York has served as a study director on
over 700 safety evaluation studies, published over 100 manuscripts,
review articles, book chapters and abstracts, and has been an invited
speaker at international conferences. He is currently on the EPA
Science Advisory Board for trimethylbenzene. Dr. York has also been a
member of the Society of Toxicology (SOT) since 1985 and the American
College of Toxicology since 1998. He is currently President of the
Reproductive and Developmental Toxicology Specialty Section of SOT. In
addition, Dr. York has been a member of the Teratology Society since
1984, and served as the President for both the Midwest Teratology
Association (1989) and the Middle Atlantic Reproduction and Teratology
Association (2004). He has served as a reviewer for Toxicology and
Applied Pharmacology and International Journal of Toxicology and as a
member of the Editorial Board of Fundamental and Applied Toxicology.
Dated: April 22, 2014.
Nancy K. Stoner,
Acting Assistant Administer, Office of Water.
[FR Doc. 2014-09888 Filed 4-29-14; 8:45 am]
BILLING CODE 6560-50-P