81 FR 67350 - Request for Public Comments To Be Sent to EPA on Peer Review Materials To Inform the Safe Drinking Water Act Decision Making on Perchlorate

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 will undergo expert peer review in support of the EPA's Safe Drinking Water Act decision making on perchlorate. This request is one of two Federal Register notices being published concurrently, seeking public comment on two separate sets of peer review materials. The Agency requests comment on both 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.'' These materials will be reviewed by an expert peer review panel and the panelists will consider the public comments received. A companion notice published on this date requests comments on the interim list of peer reviewers and draft peer review charge questions to be sent to EPA's contractor, Versar, Inc.

[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67350-67351]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23606]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2016-0438; FRL-9953-44-OW]


Request for Public Comments To Be Sent to EPA on Peer Review 
Materials To Inform the Safe Drinking Water Act Decision Making on 
Perchlorate

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 will undergo expert 
peer review in support of the EPA's Safe Drinking Water Act decision 
making on perchlorate. This request is one of two Federal Register 
notices being published concurrently, seeking public comment on two 
separate sets of peer review materials. The Agency requests comment on 
both 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.'' These 
materials will be reviewed by an expert peer review panel and the 
panelists will consider the public comments received. A companion 
notice published on this date requests comments on the interim list of 
peer reviewers and draft peer review charge questions to be sent to 
EPA's contractor, Versar, Inc.

DATES: Comments on the draft Biologically Based Dose-Response (BBDR) 
model and draft report must be received by EPA on or before November 
14, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2016-0438, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting 
comments. Once submitted, comments cannot be edited or withdrawn. The 
EPA may publish any comment received to its public docket. Do not 
submit electronically any information you consider to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Multimedia submissions (audio, video, etc.) must 
be accompanied by a written comment. The written comment is considered 
the official comment and should include discussion of all points you 
wish to make. The EPA will generally not consider comments or comment 
contents located outside of the primary submission (i.e., on the web, 
cloud, or other file sharing system). For additional submission 
methods, the full EPA public comment policy, information about CBI or 
multimedia submissions, and general guidance on making effective 
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: For additional information concerning 
the draft BBDR model and the draft report, please contact Russ 
Perkinson at U.S. EPA, 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 EPA's Biologically Based Dose-Response (BBDR) Model 
for Perchlorate in Drinking Water

    EPA has begun development of a national primary drinking water 
regulation (NPDWR) for perchlorate, in accordance with the requirements 
of the Safe Drinking Water Act (SDWA). One statutory requirement is 
that the Agency must request comment from EPA's Science Advisory Board 
(SAB) prior to proposal of a maximum contaminant level goal (MCLG) and 
a NPDWR.
    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.
    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'' (Advice on Approaches 
to Derive a Maximum Contaminant Level Goal for Perchlorate, EPA-SAB-13-
004).
    Based on the SAB's recommendations, EPA, with contributions from 
Food and Drug Administration scientists, developed a BBDR (also known 
as a PBPK/PD) model. The BBDR model was developed by integrating PBPK 
models for perchlorate and iodide with BBDR models for thyroid hormones 
to predict the effect of perchlorate on the thyroid gland in formula-
fed and breast-fed infants for the postnatal period from days 7 to 90, 
as well as lactating women. The draft model is focused on the condition 
of hypothyroxinemia as an indicator of the potential adverse health 
effects. This integrated draft model predicts the effects of 
perchlorate on serum thyroid hormone concentrations in the pregnant and 
lactating mother exposed to perchlorate in the diet and in infants 
exposed via ingestion of perchlorate in formula or breast milk.

II. How To Obtain the Draft BBDR Model and Draft Reports

    EPA's 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'' is 
available electronically and can be accessed using the Public Docket at 
http://www.regulations.gov (Docket ID No. EPA-HQ-OW-2016-0438). The 
draft BBDR model code files can be accessed at https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/3352518. All written 
comments must be submitted during the public comment period.

[[Page 67351]]

III. Exclusion for Peer Review Candidates

    Important: Anyone wishing to be considered as an expert peer 
reviewer must not submit comments during the public comment period. 
Candidates on the interim list not selected for the panel peer review 
(see companion Peer Review Federal Register notice, published on 
September 30, 2016 will be given a limited opportunity to submit public 
comments once the final peer reviewers are selected by Versar, Inc., 
the EPA contractor managing this peer review process.

    Dated: September 23, 2016.
Joel Beauvais,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2016-23606 Filed 9-29-16; 8:45 am]
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