[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67347-67348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23607]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OW-2016-0439; FRL-9953-43-OW]
Request for Public Comments To Be Sent to Versar, Inc., on an
Interim List of Perchlorate in Drinking Water Expert Peer Reviewers and
Draft Peer Review Charge Questions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of request for public comment.
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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing
the release of materials for public comment that relate to the expert
peer review of documents intended to support the EPA's Safe Drinking
Water Act decision making for perchlorate. This request is one of two
Federal Register notices being published concurrently, seeking public
comment on two separate sets of materials. This notice requests
comments on the interim list of peer review candidates and the draft
charge for the expert peer review panel, to be sent to EPA's
contractor, Versar, Inc. The comments will be considered to help inform
the final selection of expert panelists and the development of the peer
review panel's charge. A companion notice, published today, requests
comments on draft materials to inform the EPA's Safe Drinking Water Act
decision making on perchlorate; those materials are the draft
Biologically Based Dose-Response Model and an accompanying draft model
report entitled ``Biologically Based Dose-Response Models for the
Effect of Perchlorate on Thyroid Hormones in the Infant, Breast Feeding
Mother, Pregnant Mother, and Fetus: Model Development, Revision, and
Preliminary Dose-Response Analyses.'' Versar, Inc., will consider the
comments received on this notice in selecting the final peer review
panel, which will collectively provide appropriate expertise spanning
the subject matter areas covered by the draft model and draft report
and, to the extent feasible, best provide a balance of perspectives.
DATES: Comments on the draft peer review panel charge questions and
interim list of peer review candidates must be received on or before
October 21, 2016.
ADDRESSES: Submit your comments on the interim list of peer review
candidates and draft charge to Versar, Inc., no later than October 21,
2016 by one of the following methods:
Email: [email protected] (subject line: Perchlorate
Peer Review).
Mail: Versar, Inc., 6850 Versar Center, Springfield, VA
22151 (ATTN: David Bottimore).
Please be advised that public comments are subject to release under
the Freedom of Information Act.
FOR FURTHER INFORMATION CONTACT: Questions concerning the interim list
of expert peer review candidates and draft peer review charge questions
should be directed to Versar, Inc., at 6850 Versar Center, Springfield,
VA 22151; by email [email protected] (subject line: Perchlorate
Peer Review); or by phone: (703) 642-6815 (ask for David Bottimore).
SUPPLEMENTARY INFORMATION:
I. Process of Obtaining Candidate Reviewers
Versar, Inc., will assemble a panel of scientific experts to
evaluate the draft BBDR model and draft report. As part of the peer
review process, EPA announced a public nomination period from March 1,
2016, to March 31, 2016, in the Federal Register (81 FR 10617; March 1,
2016), during which members of the public were able to nominate
scientific experts whom have knowledge and experience in one or more of
the following areas: (1) Physiologically-based pharmacokinetic (PBPK),
physiologically-based pharmacokinetic/pharmacodynamic (PBPK/PD) and/or
Biologically Based Dose-Response (BBDR) modeling, (2) fetal and
neonatal thyroid endocrinology (clinical and experimental), (3) iodide
homeostasis, and (4) perchlorate toxicology and mode of action or
adverse outcome pathway.
On June 3, 2016, the Agency announced in the Federal Register (81
FR 35760) that, to achieve efficiency, it was expanding the scope of
the peer review announced in March to include review of a draft
approach for application of the draft BBDR model, to inform the
development of a perchlorate MCLG. EPA has reevaluated that approach in
response to concerns that a simultaneous review of a methodology to
applying the model to develop a perchlorate MCLG would not allow the
Agency or peer reviews to consider peer reviewer comments on the draft
BBDR model prior to evaluating the alternative methodologies to
applying the model to derive an MCLG. Today's notice therefore seeks
input only on the peer review of the model, not its application. EPA
will seek input on a second peer review of methods for applying the
model to inform development of a perchlorate MCLG in a future notice.
Versar, Inc., also conducted an independent search for scientific
experts to augment the list of publically-nominated candidates. In
total, the contractor evaluated 35 candidates, including those
nominated during the public nomination periods and those identified by
the contractor.
Selection Process
Versar, Inc., considered and screened all candidates against the
selection criteria described in the March 1, 2016 Federal Register
notice (81 FR 10617), which included the candidates being free of any
conflict of interest and being available to participate in-person in
the peer review meeting in the Washington, DC area, which will be open
to the public, projected to occur in late 2016 (exact date to be
determined). Following the screening process, the contractor narrowed
the list of potential reviewers to 19 candidates. EPA is now soliciting
comments on this list. EPA requests that the public provide relevant
information or documentation on the experts that
[[Page 67348]]
the contractor should consider in evaluating these candidates. Once the
public comments on the interim list of candidates have been reviewed
and considered, the contractor will select the final list of peer
reviewers.
Responsibilities of Peer Reviewers
Peer reviewers will be charged with evaluating and preparing
written comments on the draft BBDR model and draft report. Versar,
Inc., will provide reviewers with a summary of public comments on the
draft BBDR model and report submitted to EPA's docket (ID number EPA-
HQ-OW-2016-0438) during the 45-day public comment period, for their
consideration. Reviewers will participate in the meeting expected to be
held in the Washington, DC metro area in early 2017 (exact date to be
determined) to discuss the scientific basis supporting these materials.
Following the meeting, Versar, Inc., will provide a report to EPA
summarizing the peer reviewer's evaluation of the scientific and
technical merit of the draft model and draft report and their responses
to the charge questions. EPA will make the final report available to
the public (exact date to be determined). In preparing the final BBDR
model and report, EPA will consider Versar's report as well as the
written public comments submitted to the docket.
II. Interim List of Peer Reviewers
Versar, Inc., is considering the following candidates for the peer
review panel. Biosketches are available through the docket at http://www.regulations.gov (Docket ID No. EPA-HQ-OW-2016-0439). After review
and consideration of public comments, Versar, Inc., will select the
final peer reviewers from this list, who will, collectively, best
provide expertise spanning the previously mentioned areas of knowledge
and experience and, to the extent feasible, best provide a balance of
perspectives. EPA will announce the peer review panel meeting date,
location and registration details along with the final list of peer
reviewers selected by Versar, Inc., at least 30 days prior to the
meeting.
Name of Nominee, Degree, Place of Employment
1. Hugh A. Barton, Ph.D., Pfizer, Inc.
2. Nancy Carrasco, M.D., Yale School of Medicine
3. Jonathan Chevrier, Ph.D., McGill University Faculty of Medicine
4. Claude Emond, Ph.D., University of Montreal
5. John P. Gibbs, M.D., Tronox LLC
6. Dale Hattis, Ph.D., George Perkins Marsh Institute, Clark University
7. William L. Hayton, Ph.D., The Ohio State University/College of
Pharmacy
8. Judy S. LaKind, Ph.D., LaKind Associates, LLC
9. Angela M. Leung, M.D., M.Sc., UCLA David Geffen School of Medicine
10. Paul H. Lipkin, M.D., Johns Hopkins University School of Medicine
11. Michael H. Lumpkin, Ph.D., DABT, Center for Toxicology and
Environmental Health, LLC
12. Elaine A. Merrill, Ph.D., Henry Jackson Foundation for the
Advancement of Military Medicine at Wright-Patterson Air Force Base
13. Elizabeth N. Pearce, M.D., M.Sc., Boston Medical Center/Boston
University School of Medicine
14. Stephen M. Roberts, Ph.D., University of Florida
15. Joanne F. Rovet, Ph.D., The Hospital for Sick Children (Toronto)
16. Craig Steinmaus, M.D., M.P.H., University of California, Berkeley
17. Justin G. Teeguarden, Ph.D., Pacific Northwest National Laboratory
18. Graham R. Williams, Ph.D., Imperial College London
19. R. Thomas Zoeller, Ph.D., University of Massachusetts
III. Draft Peer Review Charge Questions
The draft peer review charge questions are available through the
docket at http://www.regulations.gov (Docket ID No. EPA-HQ-OW-2016-
0439).
Dated: September 23, 2016.
Joel Beauvais,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2016-23607 Filed 9-29-16; 8:45 am]
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