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.

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: perchlorate@versar.com (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 perchlorate@versar.com (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 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).