Peer Review of the Draft Health Effects Documents for Perfluorooctanoic Acid and Perfluorooctane Sulfonate-Interim List of Potential Peer Reviewers, 24419-24425 [2014-09888]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Pages 24419-24425]
From the Federal Register Online via the Government Printing 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: https://peerreview.versar.com/epa/pfoa/interim-list.html.
     Email: peerreview@versar.com (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 
peerreview@versar.com (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: donohue.joyce@epa.gov.

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 
(https://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 
https://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: https://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: https://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 (https://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: https://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