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)

Page Range		35760-35761
FR Document		2016-12724

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 Issue 107 (Friday, June 3, 2016)

[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

35760 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices

385.214) on or before 5:00 p.m. Eastern ENVIRONMENTAL PROTECTION Springfield, VA 22151 (Attention: David
time on the specified comment date. AGENCY Bottimore). Nominations should include
Protests will be considered by the all nominee information outlined in
[EPA–HQ–OW–2009–0297; FRL–9947–20–
Commission in determining the section II of the SUPPLEMENTARY
OW]
appropriate action to be taken, but will INFORMATION section of this document.
not serve to make protestants parties to Request for Nominations for Peer FOR FURTHER INFORMATION CONTACT:
the proceeding. Any person wishing to Reviewers for EPA’s Draft Biologically Questions concerning the nomination
become a party must file a notice of Based Dose-Response (BBDR) Model process should be directed to the EPA
intervention or motion to intervene, as for Perchlorate, Draft Model Support contractor, Versar, Inc., at 6850 Versar
appropriate. Such notices, motions, or Document and Draft Approach for Center, Springfield, VA 22151; by email
protests must be filed on or before the Deriving a Maximum Contaminant to perchlorate@versar.com (the subject
comment date. Anyone filing a motion Level Goal (MCLG) for Perchlorate in line should read: BBDR Model Peer
to intervene or protest must serve a copy Drinking Water Review and Peer Review of Approach
of that document on the Petitioner. for Deriving a Perchlorate MCLG); or by
AGENCY: Environmental Protection phone: (703) 642–6815 (ask for David
The Commission encourages Agency (EPA). Bottimore). For additional information
electronic submission of protests and ACTION: Request for nominations for concerning the draft Biologically Based
interventions in lieu of paper, using the peer reviewers. Dose-Response Model, the draft Model
FERC Online links at http:// Support Document and the draft
www.ferc.gov. To facilitate electronic SUMMARY: The Environmental Protection approach for deriving a perchlorate
service, persons with Internet access Agency (EPA) is expanding the scope of MCLG, please contact Russ Perkinson at
who will eFile a document and/or be the request for nominations announced the U.S. Environmental Protection
listed as a contact for an intervenor in the Federal Register on March 1, Agency, Office of Ground Water and
must create and validate an 2016. Requested nominations are for an Drinking Water, Standards and Risk
eRegistration account using the external peer review of the draft Management Division, (Mail Code
Biologically Based Dose-Response 4607M), 1200 Pennsylvania Avenue
eRegistration link. Select the eFiling
model and the draft model support NW., Washington, DC 20460; telephone:
link to log on and submit the
document for perchlorate in drinking 202–564–4901; or email:
intervention or protests.
water. The expanded scope will include perkinson.russ@epa.gov.
Persons unable to file electronically the review of the application of the draft
should submit an original and 5 copies SUPPLEMENTARY INFORMATION:
Biologically Based Dose-Response
of the intervention or protest to the Model to develop a perchlorate I. Information on the Draft Biologically
Federal Energy Regulatory Commission, maximum contaminant level goal. EPA Based Dose-Response (BBDR) Model,
888 First Street NE., Washington, DC is combining the two panels to achieve the Draft Model Support Document for
20426. efficiency and transparency in Perchlorate and the Draft Approach for
The filings in the above proceeding evaluating the development and Deriving a Perchlorate Maximum
are accessible in the Commission’s application of key scientific products for Contaminant Level Goal (MCLG)
analyzing perchlorate in drinking water. EPA has begun the process for
eLibrary system by clicking on the
EPA invites the public to nominate developing a National Primary Drinking
appropriate link in the above list. They
scientific experts for the peer review. Water Regulation (NPDWR) for
are also available for review in the
Persons nominated during the previous Perchlorate in accordance with the
Commission’s Public Reference Room in nomination period requested in the
Washington, DC. There is an requirements under the Safe Drinking
March 1, 2016, Federal Register notice Water Act (SDWA). Among these
eSubscription link on the Web site that do not need to be renominated under
enables subscribers to receive email requirements are that the agency must
this notice and will be considered for request comment from EPA’s Science
notification when a document is added selection for the interim and final list of
to a subscribed docket(s). For assistance Advisory Board (SAB) prior to proposal
peer reviewers. of an MCLG and a NPDWR. 42 U.S.C.
with any FERC Online service, please DATES: The nomination period for
email FERCOnlineSupport@ferc.gov. or 1412(e). For additional background
scientific experts begins on June 3, 2016 information, refer to the March 1, 2016,
call (866) 208–3676 (toll free). For TTY, and ends on July 5, 2016. Federal Register notice (81 FR 10617).
call (202) 502–8659.
ADDRESSES: Any interested person or Based on the SAB’s
Comment Date: 5:00 p.m. Eastern time organization may nominate scientific recommendations, EPA, with
on June 3, 2016. experts to be considered as peer contributions from Food and Drug
Dated: May 26, 2016. reviewers. Nominations should be Administration (FDA) scientists,
Nathaniel J. Davis, Sr.,
submitted in time to arrive no later than developed a draft BBDR model to
July 5, 2016. Self-nominations will also determine under what conditions of
Deputy Secretary. be accepted. Nominations should be iodine nutrition and exposure to
[FR Doc. 2016–13064 Filed 6–2–16; 8:45 am] submitted to the EPA contractor, Versar, perchlorate across sensitive life stages
BILLING CODE 6717–01–P Inc., using the following email address: low serum free and total thyroxine
perchlorate@versar.com (the subject line would result. The draft BBDR model
should read: BBDR Model Peer Review integrates physiologically-based
mstockstill on DSK3G9T082PROD with NOTICES

and Peer Review of Approach for pharmacokinetic models for perchlorate
Deriving a Perchlorate MCLG). with iodine models for thyroid
Nominations will also be accepted via hormones in formula-fed and nursing
the U.S. Postal Service mail or by an infants, as well as lactating women. The
overnight/priority mail service. Mailed draft model predicts the effects of
nominations should be addressed to perchlorate on serum thyroid hormone
Versar, Inc., 6850 Versar Center, concentrations in infants exposed via

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Document Created: 2018-02-08 07:29:36
Document Modified: 2018-02-08 07:29:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Request for nominations for peer reviewers.
Dates		The nomination period for scientific experts begins on June 3, 2016 and ends on July 5, 2016.
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]
FR Citation		81 FR 35760