81 FR 10617 - Request for Nominations for Peer Reviewers for EPA's Biologically Based Dose-Response (BBDR) Model for Perchlorate in Drinking Water

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 40 (March 1, 2016)

The U.S. Environmental Protection Agency (EPA) invites the public to nominate scientific experts to be considered as peer reviewers for the contractor-managed, external peer review of the draft Biologically Based Dose-Response model for perchlorate in drinking water and the draft model support document. The draft model predicts changes in thyroid hormones in sensitive life stages exposed to different dietary iodide and perchlorate levels. EPA has been working with scientists at the Food and Drug Administration to develop the model recommended by EPA's Science Advisory Board for the derivation of a maximum contaminant level goal for perchlorate in drinking water. The model integrates previous perchlorate and iodine models for thyroid hormones in formula-fed and nursing infants, as well as lactating women. The model predicts the effects of perchlorate on serum thyroid hormone concentrations in infants exposed via ingestion of formula mixed with contaminated drinking water or breast milk. EPA anticipates releasing the draft model and draft model support document for peer review and public comment in the near future (the exact date to be determined).

[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10617-10618]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04449]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2009-0297; FRL-9942-98-OW]


Request for Nominations for Peer Reviewers for EPA's Biologically 
Based Dose-Response (BBDR) Model for Perchlorate in Drinking Water

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for nominations for peer reviewers.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) invites the 
public to nominate scientific experts to be considered as peer 
reviewers for the contractor-managed, external peer review of the draft 
Biologically Based Dose-Response model for perchlorate in drinking 
water and the draft model support document. The draft model predicts 
changes in thyroid hormones in sensitive life stages exposed to 
different dietary iodide and perchlorate levels. EPA has been working 
with scientists at the Food and Drug Administration to develop the 
model recommended by EPA's Science Advisory Board for the derivation of 
a maximum contaminant level goal for perchlorate in drinking water. The 
model integrates previous perchlorate and iodine models for thyroid 
hormones in formula-fed and nursing infants, as well as lactating 
women. The model predicts the effects of perchlorate on serum thyroid 
hormone concentrations in infants exposed via ingestion of formula 
mixed with contaminated drinking water or breast milk. EPA anticipates 
releasing the draft model and draft model support document for peer 
review and public comment in the near future (the exact date to be 
determined).

DATES: The nomination period for scientific experts begins on March 1, 
2016 and ends on March 31, 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 March 31, 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). Nominations will also be accepted via 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); or by phone: (703) 642-6815 (ask for David Bottimore). For 
additional information concerning the draft BBDR model and draft model 
support document, 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 and Draft Model Support Document for Perchlorate in Drinking 
Water

    EPA is 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 the EPA's Science Advisory Board (SAB) 
prior to proposal of a maximum contaminant level goal (MCLG) and a 
NPDWR (42 U.S.C. 1412(e)).
    In 2012, EPA sought guidance from the SAB on how best to consider 
and interpret life stage information, epidemiologic and biomonitoring 
data, physiologically based pharmacokinetic (PBPK) analyses and the 
totality of perchlorate health information to derive an MCLG for 
perchlorate. The MCLG is the maximum level of a contaminant in drinking 
water at which no known or anticipated adverse effect on the health of 
persons would occur, and which allows an adequate margin of safety. 
MCLGs are non-enforceable public health goals.
    In 2013, the SAB recommended that, ``. . . EPA derive a perchlorate 
MCLG that addresses sensitive life stages through physiologically-based 
pharmacokinetic/pharmacodynamic (PBPK/PD) modeling based upon its mode 
of action rather than the default MCLG approach using the reference 
dose and specific chemical exposure parameters'' (see Advice on 
Approaches to Derive a Maximum Contaminant Level Goal for Perchlorate, 
EPA-SAB-13-004). The SAB found that ``. . . this data-driven approach 
represents a more rigorous way to address differences in biology and 
exposure between adults and sensitive life stages than is possible with 
the default approach for deriving an MCLG.''
    Based on the SAB's recommendations, EPA and Food and Drug 
Administration (FDA) scientists developed a BBDR (also known as a PBPK/
PD) 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. EPA is considering deriving a perchlorate 
MCLG by linking BBDR model output to information from literature to 
account for adverse health outcomes.

II. How to Submit Nominations for Peer Reviewers

    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 and draft model support 
document for

[[Page 10618]]

perchlorate in drinking water. Nominees should possess and demonstrate 
background knowledge and experience in one or more of the following 
areas: (1) PBPK, PBPK/PD and/or 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.
    Selection Criteria: Selection criteria for individuals nominated to 
serve as external peer reviewers of the draft BBDR model and draft 
model support document 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 and draft model support document, 
commencing approximately in June 2016 (exact date to be determined), 
and (7) availability to participate in-person in a one-day peer review 
meeting in the Washington, DC metro area, projected to occur in 
approximately August 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.
    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): (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.
    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 and draft 
model support document for perchlorate in drinking water. Versar will 
consider and screen all candidates against the criteria previously 
listed. Following the screening process, Versar will narrow the list of 
potential reviewers to approximately 10-15 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 Versar has considered the public comments on the 
interim list of candidates, Versar will select the final list of peer 
reviewers, based on who, collectively, will best provide expertise 
spanning the disciplines previously listed and (to the extent feasible) 
best provide a balance of perspectives.

    Dated: February 21, 2016.
Joel Beauvais,
Deputy Assistant Administrator.
[FR Doc. 2016-04449 Filed 2-29-16; 8:45 am]
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