81 FR 67347 - 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

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 190 (September 30, 2016)

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.

[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67347-67348]
From the Federal Register Online  [www.thefederalregister.org]
[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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