81_FR_67540 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

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)

Page Range67350-67351
FR Document2016-23606

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 Issue 190 (Friday, September 30, 2016) 
[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.

-----------------------------------------------------------------------

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:perkinson.russ@epa.gov.

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]
BILLING CODE 6560-50-P

67350 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices identification to enter the building. will be reviewed by an expert peer proposal of a maximum contaminant Attendees are encouraged to arrive at review panel and the panelists will level goal (MCLG) and a NPDWR. least 15 minutes prior to the start of the consider the public comments received. In 2012, EPA sought guidance from meeting to allow sufficient time for A companion notice published on this the SAB on how best to consider and security screening. Proposed agenda date requests comments on the interim interpret life stage information, items for the meeting include, but are list of peer reviewers and draft peer epidemiologic and biomonitoring data, not limited to, the following: Overview review charge questions to be sent to physiologically-based pharmacokinetic of materials provided to the EPA’s contractor, Versar, Inc. (PBPK) analyses and the totality of subcommittee; Update on ORD’s Air, DATES: Comments on the draft perchlorate health information to derive Climate, and Energy Research Program; Biologically Based Dose-Response an MCLG for perchlorate. Review of charge questions; (BBDR) model and draft report must be Presentations on research efforts related received by EPA on or before November In 2013, the SAB recommended that, to social science; and Subcommittee 14, 2016. ‘‘. . . EPA derive a perchlorate MCLG discussion. ADDRESSES: Submit your comments, that addresses sensitive life stages Information on Services for identified by Docket ID No. EPA–HQ– through physiologically-based Individuals with Disabilities: For OW–2016–0438, to the Federal pharmacokinetic/pharmacodynamic information on access or services for eRulemaking Portal: http:// (PBPK/PD) modeling based upon its individuals with disabilities, please www.regulations.gov. Follow the online mode of action rather than the default contact Tim Benner at (202) 564–6769 instructions for submitting comments. MCLG approach using the reference or benner.tim@epa.gov. To request Once submitted, comments cannot be dose and specific chemical exposure accommodation of a disability, please edited or withdrawn. The EPA may parameters’’ (Advice on Approaches to contact Tim Benner, preferably at least publish any comment received to its Derive a Maximum Contaminant Level ten days prior to the meeting, to give the public docket. Do not submit Goal for Perchlorate, EPA–SAB–13– EPA as much time as possible to process electronically any information you 004). your request. consider to be Confidential Business Based on the SAB’s Dated: September 26, 2016. Information (CBI) or other information recommendations, EPA, with Fred S. Hauchman, whose disclosure is restricted by statute. contributions from Food and Drug Director, Office of Science Policy. Multimedia submissions (audio, video, Administration scientists, developed a [FR Doc. 2016–23687 Filed 9–29–16; 8:45 am] etc.) must be accompanied by a written BBDR (also known as a PBPK/PD) comment. The written comment is model. The BBDR model was developed BILLING CODE 6560–50–P considered the official comment and by integrating PBPK models for should include discussion of all points perchlorate and iodide with BBDR ENVIRONMENTAL PROTECTION you wish to make. The EPA will models for thyroid hormones to predict AGENCY generally not consider comments or the effect of perchlorate on the thyroid comment contents located outside of the gland in formula-fed and breast-fed [EPA–HQ–OW–2016–0438; FRL–9953–44– primary submission (i.e., on the web, OW] infants for the postnatal period from cloud, or other file sharing system). For days 7 to 90, as well as lactating women. additional submission methods, the full Request for Public Comments To Be The draft model is focused on the EPA public comment policy, Sent to EPA on Peer Review Materials condition of hypothyroxinemia as an information about CBI or multimedia To Inform the Safe Drinking Water Act indicator of the potential adverse health submissions, and general guidance on Decision Making on Perchlorate effects. This integrated draft model making effective comments, please visit predicts the effects of perchlorate on AGENCY: Environmental Protection http://www2.epa.gov/dockets/ serum thyroid hormone concentrations Agency (EPA). commenting-epa-dockets. in the pregnant and lactating mother ACTION: Notice of request for public FOR FURTHER INFORMATION CONTACT: For exposed to perchlorate in the diet and comment. additional information concerning the in infants exposed via ingestion of draft BBDR model and the draft report, perchlorate in formula or breast milk. SUMMARY: The U.S. Environmental please contact Russ Perkinson at U.S. Protection Agency (EPA) is announcing EPA, Office of Ground Water and II. How To Obtain the Draft BBDR the release of materials for public Drinking Water, Standards and Risk Model and Draft Reports comment that will undergo expert peer Management Division (Mail Code review in support of the EPA’s Safe 4607M), 1200 Pennsylvania Avenue EPA’s draft model report entitled Drinking Water Act decision making on NW., Washington, DC 20460; telephone: ‘‘Biologically Based Dose Response perchlorate. This request is one of two 202–564–4901; or Models for the Effect of Perchlorate on Federal Register notices being email:perkinson.russ@epa.gov. Thyroid Hormones in the Infant, Breast published concurrently, seeking public SUPPLEMENTARY INFORMATION: Feeding Mother, Pregnant Mother, and comment on two separate sets of peer Fetus: Model Development, Revision, review materials. The Agency requests I. Information on EPA’s Biologically and Preliminary Dose-Response comment on both the draft Biologically Based Dose-Response (BBDR) Model for Analyses’’ is available electronically Based Dose-Response Model and an Perchlorate in Drinking Water and can be accessed using the Public accompanying draft model report EPA has begun development of a Docket at http://www.regulations.gov mstockstill on DSK3G9T082PROD with NOTICES entitled ‘‘Biologically Based Dose- national primary drinking water (Docket ID No. EPA–HQ–OW–2016– Response Models for the Effect of regulation (NPDWR) for perchlorate, in 0438). The draft BBDR model code files Perchlorate on Thyroid Hormones in the accordance with the requirements of the can be accessed at https://hero.epa.gov/ Infant, Breast Feeding Mother, Pregnant Safe Drinking Water Act (SDWA). One hero/index.cfm/reference/details/ Mother, and Fetus: Model Development, statutory requirement is that the Agency reference_id/3352518. All written Revision, and Preliminary Dose- must request comment from EPA’s comments must be submitted during the Response Analyses.’’ These materials Science Advisory Board (SAB) prior to public comment period. VerDate Sep<11>2014 20:49 Sep 29, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\30SEN1.SGM 30SEN1

Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices 67351 III. Exclusion for Peer Review any penalty for failing to comply with requests. The notice to subscribers must Candidates a collection of information subject to the be mailed no later than thirty calendar Important: Anyone wishing to be PRA that does not display a valid OMB days from the date the request waiver considered as an expert peer reviewer control number. was filed with the Commission, and must not submit comments during the DATES: Written PRA comments should cable operators must inform the public comment period. Candidates on be submitted on or before November 29, Commission in writing, as soon as the interim list not selected for the 2016. If you anticipate that you will be possible, of that notification date. The panel peer review (see companion Peer submitting comments, but find it notification to subscribers must state: Review Federal Register notice, difficult to do so within the period of On (date of waiver request was filed published on September 30, 2016 will time allowed by this notice, you should with the Commission), (cable operator’s be given a limited opportunity to submit advise the contact listed below as soon name) filed with the Federal public comments once the final peer as possible. Communications Commission a request reviewers are selected by Versar, Inc., for waiver of the rule prohibiting ADDRESSES: Direct all PRA comments to the EPA contractor managing this peer scrambling of channels on the basic tier Cathy Williams, FCC, via email PRA@ review process. of service. The request for waiver states fcc.gov and to Cathy.Williams@fcc.gov. (a brief summary of the waiver request). Dated: September 23, 2016. FOR FURTHER INFORMATION CONTACT: For A copy of the request for waiver is on Joel Beauvais, additional information about the file for public inspection at (the address Deputy Assistant Administrator, Office of information collection, contact Cathy of the cable operator’s local place of Water. Williams at (202) 418–2918. business). [FR Doc. 2016–23606 Filed 9–29–16; 8:45 am] SUPPLEMENTARY INFORMATION: Individuals who wish to comment on BILLING CODE 6560–50–P OMB Control Number: 3060–0667. this request for waiver should mail Title: Section 76.630, Compatibility comments to the Federal with Consumer Electronics Equipment; Communications Commission by no FEDERAL COMMUNICATIONS Section 76.1621, Equipment later than 30 days from (the date the COMMISSION Compatibility Offer; Section 76.1622, notification was mailed to subscribers). Consumer Education of Equipment Those comments should be addressed to [OMB 3060–0667 and 3060–1104] Compatibility. the: Federal Communications Information Collections Being Form Number: Not applicable. Commission, Media Bureau, Type of Review: Extension of a Washington, DC 20554, and should Reviewed by the Federal currently approved collection. include the name of the cable operator Communications Commission Respondents: Business or other for- to whom the comments are applicable. AGENCY: Federal Communications profit entities. Individuals should also send a copy of Commission. Number of Respondents and their comments to (the cable operator at ACTION: Notice and request for Responses: 8,250 respondents; 66,501 its local place of business). Cable comments. responses. operators may file comments in reply no Estimated Time per Response: .017 later than 7 days from the date SUMMARY: As part of its continuing effort hours-3 hours. subscriber comments must be filed. to reduce paperwork burdens, and as Frequency of Response: 47 CFR 76.1621 states a cable system required by the Paperwork Reduction Recordkeeping and third party operators that use scrambling, Act (PRA) of 1995 (44 U.S.C. 3501– disclosure requirements; On occasion encryption or similar technologies in 3520), the Federal Communications reporting requirement. conjunction with cable system terminal Commission (FCC or Commission) Obligation to Respond: Required to devices, as defined in § 15.3(e) of this invites the general public and other obtain or retain benefits. The statutory chapter, that may affect subscribers’ Federal agencies to take this authority for this collection is contained reception of signals shall offer to supply opportunity to comment on the in Section 4(i) and Section 632 of the each subscriber with special equipment following information collections. Communications Act of 1934, as that will enable the simultaneous Comments are requested concerning: amended. reception of multiple signals. The whether the proposed collection of Total Annual Burden: 17,353 hours. equipment offered shall include a single information is necessary for the proper Total Annual Cost: $1,355. terminal device with dual descramblers/ performance of the functions of the Privacy Act Impact Assessment: No decoders and/or timers and bypass Commission, including whether the impact(s). switches. Other equipment, such as two information shall have practical utility; Nature and Extent of Confidentiality: independent set-top terminal devices the accuracy of the Commission’s There is no need for confidentiality with may be offered at the same time that the burden estimate; ways to enhance the this collection of information. single terminal device with dual tuners/ quality, utility, and clarity of the Needs and Uses: 47 CFR 76.630(a) descramblers is offered. For purposes of information collected; ways to minimize states a cable system operator shall not this rule, two set-top devices linked by the burden of the collection of scramble or otherwise encrypt signals a control system that provides information on the respondents, carried on the basic service tier. This functionality equivalent to that of a including the use of automated requirement is subject to certain single device with dual descramblers is collection techniques or other forms of exemptions explained below. Requests considered to be the same as a terminal information technology; and ways to for waivers of this prohibition, which device with dual descramblers/ mstockstill on DSK3G9T082PROD with NOTICES further reduce the information are allowed under 47 CFR 76.630(a)(2), decoders. collection burden on small business must demonstrate either a substantial (a) The offer of special equipment concerns with fewer than 25 employees. problem with theft of basic tier service shall be made to new subscribers at the The FCC may not conduct or sponsor a or a strong need to scramble basic time they subscribe and to all collection of information unless it signals for other reasons. As part of this subscribers at least once each year (i.e., displays a currently valid OMB control showing, cable operators are required to in subscriber billings or pre-printed number. No person shall be subject to notify subscribers by mail of waiver information on the bill). VerDate Sep<11>2014 20:49 Sep 29, 2016 Jkt 238001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\30SEN1.SGM 30SEN1


Document Created: 2018-02-09 13:34:07
Document Modified: 2018-02-09 13:34:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of request for public comment.
DatesComments on the draft Biologically Based Dose-Response (BBDR) model and draft report must be received by EPA on or before November 14, 2016.
ContactFor 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]
FR Citation81 FR 67350 
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