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]


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

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:[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]
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 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR