81 FR 35760 - Request for Nominations for Peer Reviewers for EPA's Draft Biologically Based Dose-Response (BBDR) Model for Perchlorate, Draft Model Support Document and Draft Approach for Deriving a Maximum Contaminant Level Goal (MCLG) for Perchlorate in Drinking Water

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 107 (June 3, 2016)

The Environmental Protection Agency (EPA) is expanding the scope of the request for nominations announced in the Federal Register on March 1, 2016. Requested nominations are for an external peer review of the draft Biologically Based Dose-Response model and the draft model support document for perchlorate in drinking water. The expanded scope will include the review of the application of the draft Biologically Based Dose-Response Model to develop a perchlorate maximum contaminant level goal. EPA is combining the two panels to achieve efficiency and transparency in evaluating the development and application of key scientific products for analyzing perchlorate in drinking water. EPA invites the public to nominate scientific experts for the peer review. Persons nominated during the previous nomination period requested in the March 1, 2016, Federal Register notice do not need to be renominated under this notice and will be considered for selection for the interim and final list of peer reviewers.

[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35760-35761]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12724]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2009-0297; FRL-9947-20-OW]


Request for Nominations for Peer Reviewers for EPA's Draft 
Biologically Based Dose-Response (BBDR) Model for Perchlorate, Draft 
Model Support Document and Draft Approach for Deriving a Maximum 
Contaminant Level Goal (MCLG) for Perchlorate in Drinking Water

AGENCY: Environmental Protection Agency (EPA).

ACTION: Request for nominations for peer reviewers.

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SUMMARY: The Environmental Protection Agency (EPA) is expanding the 
scope of the request for nominations announced in the Federal Register 
on March 1, 2016. Requested nominations are for an external peer review 
of the draft Biologically Based Dose-Response model and the draft model 
support document for perchlorate in drinking water. The expanded scope 
will include the review of the application of the draft Biologically 
Based Dose-Response Model to develop a perchlorate maximum contaminant 
level goal. EPA is combining the two panels to achieve efficiency and 
transparency in evaluating the development and application of key 
scientific products for analyzing perchlorate in drinking water. EPA 
invites the public to nominate scientific experts for the peer review. 
Persons nominated during the previous nomination period requested in 
the March 1, 2016, Federal Register notice do not need to be 
renominated under this notice and will be considered for selection for 
the interim and final list of peer reviewers.

DATES: The nomination period for scientific experts begins on June 3, 
2016 and ends on July 5, 2016.

ADDRESSES: Any interested person or organization may nominate 
scientific experts to be considered as peer reviewers. Nominations 
should be submitted in time to arrive no later than July 5, 2016. Self-
nominations will also be accepted. Nominations should be submitted to 
the EPA contractor, Versar, Inc., using the following email address: 
[email protected] (the subject line should read: BBDR Model Peer 
Review and Peer Review of Approach for Deriving a Perchlorate MCLG). 
Nominations will also be accepted via the U.S. Postal Service mail or 
by an overnight/priority mail service. Mailed nominations should be 
addressed to Versar, Inc., 6850 Versar Center, Springfield, VA 22151 
(Attention: David Bottimore). Nominations should include all nominee 
information outlined in section II of the SUPPLEMENTARY INFORMATION 
section of this document.

FOR FURTHER INFORMATION CONTACT: Questions concerning the nomination 
process should be directed to the EPA contractor, Versar, Inc., at 6850 
Versar Center, Springfield, VA 22151; by email to 
[email protected] (the subject line should read: BBDR Model Peer 
Review and Peer Review of Approach for Deriving a Perchlorate MCLG); or 
by phone: (703) 642-6815 (ask for David Bottimore). For additional 
information concerning the draft Biologically Based Dose-Response 
Model, the draft Model Support Document and the draft approach for 
deriving a perchlorate MCLG, please contact Russ Perkinson at the U.S. 
Environmental Protection Agency, Office of Ground Water and Drinking 
Water, Standards and Risk Management Division, (Mail Code 4607M), 1200 
Pennsylvania Avenue NW., Washington, DC 20460; telephone: 202-564-4901; 
or email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Information on the Draft Biologically Based Dose-Response (BBDR) 
Model, the Draft Model Support Document for Perchlorate and the Draft 
Approach for Deriving a Perchlorate Maximum Contaminant Level Goal 
(MCLG)

    EPA has begun the process for developing a National Primary 
Drinking Water Regulation (NPDWR) for Perchlorate in accordance with 
the requirements under the Safe Drinking Water Act (SDWA). Among these 
requirements are that the agency must request comment from EPA's 
Science Advisory Board (SAB) prior to proposal of an MCLG and a NPDWR. 
42 U.S.C. 1412(e). For additional background information, refer to the 
March 1, 2016, Federal Register notice (81 FR 10617).
    Based on the SAB's recommendations, EPA, with contributions from 
Food and Drug Administration (FDA) scientists, developed a draft BBDR 
model to determine under what conditions of iodine nutrition and 
exposure to perchlorate across sensitive life stages low serum free and 
total thyroxine would result. The draft BBDR model integrates 
physiologically-based pharmacokinetic models for perchlorate with 
iodine models for thyroid hormones in formula-fed and nursing infants, 
as well as lactating women. The draft model predicts the effects of 
perchlorate on serum thyroid hormone concentrations in infants exposed 
via

[[Page 35761]]

ingestion of formula mixed with contaminated drinking water or breast 
milk.
    EPA is considering deriving a perchlorate MCLG by linking BBDR 
model output to alterations in thyroid hormone status that result in 
alterations in neurodevelopment. The draft approach for deriving a 
perchlorate MCLG outlines an assessment of the literature linking 
alterations in thyroid hormone status to alterations in 
neurodevelopment. Based on the results of this literature review, the 
report describes potential approaches to set the MCLG based on the 
availability of the current literature and the output of the BBDR 
model, predicting the effects of perchlorate on serum thyroid hormone 
concentrations in infants exposed via ingestion of formula mixed with 
contaminated drinking water or breast milk (see 81 FR 10617, March 1, 
2016). The draft approach will be approximately 100 pages in length 
with approximately 7-10 figures and 10-15 tables. The draft approach 
describes application of the BBDR model to the development of a 
perchlorate MCLG and the appropriateness of the process under SDWA 
guidelines.
    EPA anticipates releasing the draft BBDR model, draft model support 
document, and draft approach for peer review and public comment in the 
near future (the exact date to be determined).

II. How To Submit Nominations for Peer Reviewers

    Expanded Expertise Sought: EPA is seeking candidates who are 
nationally and/or internationally recognized scientific experts to 
serve as external peer reviewers for the draft BBDR model, the draft 
model support document, and the draft approach to derive a perchlorate 
MCLG. Nominees should possess and demonstrate background knowledge and 
experience in one or more of the following areas of risk assessment to 
include: An understanding of thyroid function (preferably in the 
sensitive life stages of interest), the importance of maternal thyroid 
hormone homeostasis in each stage of gestation, hypothyroxinemia, 
neurodevelopmental assessment indices for young children including the 
Bayley's Scale, the toxicity of perchlorate, epidemiological assessment 
techniques, and statistics.
    Expanded Selection Criteria: Selection criteria for individuals 
nominated to serve as external peer reviewers of the draft BBDR model, 
draft model support document, and draft approach to derive an MCLG for 
perchlorate include the following: (1) Demonstrated expertise through 
relevant peer reviewed publications, (2) professional accomplishments 
and recognition by professional societies, (3) demonstrated ability to 
work constructively and effectively in a committee setting, (4) absence 
of financial conflicts of interest, (5) no actual conflicts of interest 
or the appearance of lack of impartiality, (6) willingness to commit 
adequate time for the thorough review of the draft BBDR model, the 
draft model support document and the draft approach for deriving a 
perchlorate MCLG, commencing approximately during the summer of 2016 
(exact date to be determined), and (7) availability to participate in 
person in a two-day peer review meeting in the Washington, DC metro 
area, projected to occur during the fall of 2016 (exact date will be 
published in the Federal Register at least 30 days prior to the 
external peer review meeting). Further logistical information regarding 
the external peer review meeting will be announced at a later date in 
the Federal Register.
    Expanded Required Nominee Information: To receive full 
consideration, the following information should be submitted to Versar 
([email protected]) (the subject line should read: BBDR Model Peer 
Review and Peer Review of Approach for Deriving a Perchlorate MCLG): 
(1) Contact information for the person making the nomination; (2) 
contact information for the nominee; (3) the disciplinary and specific 
areas of expertise of the nominee; (4) the nominee's curriculum vitae; 
and (5) a biographical sketch of the nominee indicating current 
position, educational background, past and current research activities, 
recent service on other advisory committees, peer review panels, 
editorial boards or professional organizations, sources of recent grant 
and/or contract support and other comments on the relevance of the 
nominee's expertise to this peer review topic. Compensation for non-
federal peer reviewers will be provided by Versar.
    Expanded Selection Process: EPA's contractor, Versar, will notify 
candidates of selection or non-selection. Versar may also conduct an 
independent search for candidates to assemble a balanced group 
representing the expertise needed to fully evaluate EPA's draft BBDR 
model, draft model support document for perchlorate, and draft approach 
for deriving a perchlorate MCLG. The contractor will consider and 
screen all candidates against the criteria previously listed. Following 
the screening process, the contractor will narrow the list of potential 
reviewers to approximately 12-18 interim candidates. Prior to selecting 
the final peer reviewers, a Federal Register notice will be published 
(exact date to be determined) to solicit comments on the interim list 
of candidates. In that notice, the public will be requested to provide 
relevant information or documentation on the nominees within 30 days of 
the announcement of the interim list of candidates. Once the contractor 
has considered the public comments on the interim list of candidates, 
the contractor will select the final list of peer reviewers based on 
who, collectively, will best provide expertise spanning the disciplines 
listed above and (to the extent feasible) best provide a balance of 
perspectives.

    Dated: May 23, 2016.
Joel Beauvais,
Deputy Assistant Administrator.
[FR Doc. 2016-12724 Filed 6-2-16; 8:45 am]
 BILLING CODE 6560-50-P