82_FR_26193 82 FR 26086 - FIFRA Scientific Advisory Panel; Notice of Public Meeting; Request for Ad Hoc Expert Nominations

82 FR 26086 - FIFRA Scientific Advisory Panel; Notice of Public Meeting; Request for Ad Hoc Expert Nominations

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 107 (June 6, 2017)

Page Range26086-26089
FR Document2017-11697

There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review physiologically based pharmacokinetic modeling to address pharmacokinetic differences between and within species.

Federal Register, Volume 82 Issue 107 (Tuesday, June 6, 2017)
[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Notices]
[Pages 26086-26089]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11697]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0180; FRL-9962-78]


FIFRA Scientific Advisory Panel; Notice of Public Meeting; 
Request for Ad Hoc Expert Nominations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: There will be a 4-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review physiologically based pharmacokinetic modeling to 
address pharmacokinetic differences between and within species.

DATES: The meeting will be held on October 24, 2017 to October 27, 
2017, from approximately 9 a.m. to 5 p.m.
    Comments. Written comments should be submitted on or before 
September 11, 2017. FIFRA SAP may not be able to fully consider written 
comments submitted after September 11, 2017. Requests to make oral 
comments should be submitted on or before September 25, 2017 by 
contacting the Designated Federal Official (DFO) listed under FOR 
FURTHER INFORMATION CONTACT. For additional instructions, see Unit I.C. 
of the SUPPLEMENTARY INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members 
of FIFRA SAP for this meeting should be provided on or before July 21, 
2017.
    Webcast. This meeting may be webcast. Please refer to the FIFRA SAP 
Web site at https://www.epa.gov/sap for information on how to access 
the webcast. Please note that the webcast is a supplementary public 
process provided only for convenience. If difficulties arise resulting 
in webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT at least 10 days prior to the meeting to allow EPA time to 
process your request.

ADDRESSES: Meeting: The meeting will be held at the Environmental 
Protection Agency, Conference Center, Lobby Level, One Potomac Yard 
(South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2017-0180, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online

[[Page 26087]]

instructions for submitting comments. Do not submit electronically any 
information you consider to be Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.
    Nominations, requests to present oral comments, and requests for 
special accommodations. Submit nominations to serve as ad hoc members 
of FIFRA SAP, requests for special accommodations, or requests to 
present oral comments to the DFO listed under FOR FURTHER INFORMATION 
CONTACT.

FOR FURTHER INFORMATION CONTACT: Dr. Marquea D. King, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 
telephone number: (202) 564-3626; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may 
be of interest to persons who are or may be required to conduct testing 
of chemical substances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA) and FIFRA. Since other entities may also be interested, the 
Agency has not attempted to describe all the specific entities that may 
be affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through 
regulations.gov or email. If your comments contain any information that 
you consider to be CBI or otherwise protected, please contact the DFO 
listed under FOR FURTHER INFORMATION CONTACT to obtain special 
instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

C. How may I participate in this meeting?

    You may participate in this meeting by following the instructions 
in this unit. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-OPP-2017-0180 in the subject line 
on the first page of your request.
    1. Written comments. Written comments should be submitted, using 
the instructions in ADDRESSES and Unit I.B., on or before September 11, 
2017, to provide FIFRA SAP the time necessary to consider and review 
the written comments. FIFRA SAP may not be able to fully consider 
written comments submitted after September 11, 2017.
    2. Oral comments. The Agency encourages each individual or group 
wishing to make brief oral comments to FIFRA SAP to submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or 
before September 25, 2017, in order to be included on the meeting 
agenda. Requests to present oral comments will be accepted until 
September 25, 2017 and, to the extent that time permits, the Chair of 
FIFRA SAP may permit the presentation of oral comments at the meeting 
by interested persons who have not previously requested time. Oral 
comments before FIFRA SAP are limited to approximately 5 minutes unless 
arrangements have been made prior to September 25, 2017. The request 
should identify the name of the individual making the presentation, the 
organization (if any) the individual will represent, and any 
requirements for audiovisual equipment. In addition, each speaker 
should bring 15 copies of his or her oral remarks and presentation 
slides (if required) for distribution to FIFRA SAP at the meeting by 
the DFO.
    3. Seating at the meeting. Seating at the meeting will be open and 
on a first-come basis.
    4. Request for nominations to serve as ad hoc expert members of 
FIFRA SAP for this meeting. As part of a broader process for developing 
a pool of candidates, both U.S. citizens and permanent residents who 
can demonstrate that they are actively seeking U.S. citizenship will be 
considered. For each meeting, FIFRA SAP staff routinely solicits the 
stakeholder community for nominations of prospective candidates for 
service as ad hoc members of FIFRA SAP. Any interested person or 
organization may nominate qualified individuals to be considered as 
prospective candidates for a specific meeting. Individuals nominated 
for this meeting should have expertise in one or more of the following 
areas: Physiologically-based pharmacokinetic (PBPK) modeling, 
pharmacokinetics, pharmacodynamic (PD) modeling, in vitro to in vivo 
extrapolation, human health risk assessment, neurotoxicity, 
organophosphate pesticides, pyrethroids pesticides, N-methyl carbamate 
pesticides, fungicides, acetylcholinesterase inhibition, and exposure 
assessment. Nominees should be scientists who have sufficient 
professional qualifications, including training and experience, to be 
capable of providing expert comments on the scientific issues for this 
meeting. Nominees should be identified by name, occupation, position, 
address, email address, and telephone number. Nominations should be 
provided to the DFO listed under FOR FURTHER INFORMATION CONTACT on or 
before July 21, 2017. The Agency will consider all nominations of 
prospective candidates for this meeting that are received on or before 
that date. However, final selection of ad hoc members for this meeting 
is a discretionary function of the Agency.
    The selection of scientists to serve on FIFRA SAP is based on the 
function of the Panel and the expertise needed to address the Agency's 
charge to the Panel. No interested scientists shall be ineligible to 
serve by reason of their membership on any other advisory committee to 
a Federal department or agency or their employment by a Federal 
department or agency, except EPA. Other factors considered during the 
selection process include availability of the potential Panel member to 
fully participate in the Panel's review, absence of any conflicts of 
interest or appearance of lack of impartiality, independence with 
respect to the matters under review, and lack of bias. Although 
financial conflicts of interest, the appearance of lack of 
impartiality, lack of independence, and bias may result in 
disqualification, the absence of such concerns does not assure that a 
candidate will be selected to serve on FIFRA SAP. Numerous qualified 
candidates are identified for each Panel. Therefore, selection 
decisions involve carefully weighing a number of factors including the 
candidates' areas of expertise and professional qualifications and 
achieving an overall balance of different scientific perspectives on 
the Panel. In order to have the collective breadth of experience needed 
to address the Agency's peer review charge for this meeting, the Agency 
anticipates selecting approximately 13 ad hoc scientists.

[[Page 26088]]

    FIFRA SAP members are subject to the provisions of 5 CFR part 
2634--Executive Branch Financial Disclosure, Qualified Trusts, and 
Certificates of Divestiture, as supplemented by EPA in 5 CFR part 6401. 
In anticipation of this requirement, prospective candidates for service 
on FIFRA SAP will be asked to submit confidential financial information 
which shall fully disclose, among other financial interests, the 
candidate's employment, stocks, and bonds, and where applicable, 
sources of research support. EPA will evaluate the candidate's 
financial disclosure form to assess whether there are financial 
conflicts of interest, appearance of a lack of impartiality, or any 
prior involvement with the development of the documents under 
consideration (including previous scientific peer review) before the 
candidate is considered further for service on FIFRA SAP. Those who are 
selected from the pool of prospective candidates will be asked to 
attend the public meetings and to participate in the discussion of key 
issues and assumptions at these meetings. In addition, they will be 
asked to review and to help finalize the meeting minutes and the final 
meeting report. The list of FIFRA SAP members participating at this 
meeting will be posted on the FIFRA SAP Web site at https://www.epa.gov/sap or may be obtained from the OPP Docket at http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of 
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is 
structured to provide scientific advice, information and 
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the 
environment. FIFRA SAP is a Federal advisory committee established in 
1975 under FIFRA that operates in accordance with requirements of the 
Federal Advisory Committee Act (5 U.S.C. Appendix). FIFRA SAP is 
composed of a permanent panel consisting of seven members who are 
appointed by the EPA Administrator from nominees provided by the 
National Institutes of Health and the National Science Foundation. The 
FIFRA SAP is assisted in their reviews by ad hoc participation from the 
Science Review Board (SRB). As a scientific peer review mechanism, 
FIFRA SAP provides comments, evaluations, and recommendations to 
improve the effectiveness and quality of analyses made by Agency 
scientists.

B. Public Meeting

    The 2009 National Research Council's report ``Science and 
Decisions'' recommends that the EPA use the best, most current science 
to support or revise the default assumptions in risk assessment. In 
addition, the 2013 Institute of Medicine's report on ``Environmental 
Decisions in the Face of Uncertainty'' further recommends that 
replacing default uncertainty factors with data-derived extrapolation 
factors (DDEFs) that delineate the differences between species would 
reduce uncertainty in risk assessment. Such inter- and intra-species 
extrapolation factors can be derived using a PBPK modeling approach to 
organize mechanistic data on properties that determine the absorption, 
distribution, metabolism, and excretion (ADME) of chemicals that enter 
the body. In the 2006 document on ``Approaches for the Application of 
Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data 
in Risk Assessment'', the Agency recognizes that PBPK model analysis is 
a scientifically sound approach that allows for estimating the internal 
dose of a chemical or its metabolite at a target site, and can act as a 
means to evaluate and describe the uncertainty in a risk assessment.
    PBPK models incorporate the relevant physiology, chemistry, 
biochemistry that determines the ADME processes, and thus, they are 
useful for predicting internal dosimetry related to a certain chemical 
within and outside the testing conditions (e.g., species, dose ranges). 
PBPK models have been used to assist high-to-low dose, route-to-route, 
aggregation of exposure from multiple routes, and inter-species 
extrapolations that are necessary for estimating human health risks 
based on the results of animal toxicity studies. The physiological 
structure of PBPK models also allows for examining the effects of 
changing physiology, such as aging, early life-stage, or pregnancy. The 
temporal change in the dose metric simulated by a PBPK model can also 
be linked to a PD model to predict quantitative changes in biological 
effects, such as acetylcholinesterase (AChE) inhibition.
    Several registrants, including the Council for the Advancement of 
Pyrethroid Human Health Risk Assessment (CAPHRA), Tessenderlo Kerley 
Inc. (TKI), FMC/Cheminova, and Syngenta, are developing PBPK (or PBPK-
PD) models for the chemicals: Acibenzolar, carbaryl, deltamethrin, 
dimethoate, malathion, and permethrin. All six models will include 
life-stage physiological changes from birth to adulthood, so that dose 
metrics can be predicted at any age. These life-stage models, however, 
will not include gestation and lactational phases, therefore; it is not 
expected that these models will have the capability to predict dose 
metrics in pregnant women or fetuses or breastfeeding exposures. These 
models are intended as a means to estimating inter- and intra-species 
data derived extrapolation factors and/or human points of departure 
(PoD) for various exposure scenarios (e.g., routes of exposure). For 
dimethoate, malathion, and carbaryl, the PBPK models will be coupled 
with PD models to predict AChE inhibition in red blood cells (RBCs) and 
other tissues (e.g., brain).
    The purpose of the October 2017 SAP will be to review five PBPK or 
PBPK-PD models (carbaryl, deltamethrin, dimethoate, malathion, and 
permethrin) for the purposes of model structures, mathematical 
representations, parameter estimations, computer implementations, 
variability and uncertainty analysis, and model predictive 
capabilities, as well as the appropriateness of their applications in 
human health risk assessments. The details for each model, including 
their inputs, parameters and associated distributions, and the model 
code, written in software program acslX or R, will be provided for five 
(not including acibenzolar) chemicals as part of the background 
materials for the meeting. The agency will solicit comments from the 
SAP members on the evaluation of these PBPK (or PBPK-PD) models 
regarding their capability to predict appropriate internal dose metrics 
in humans. In addition, the SAP members will be asked to evaluate the 
appropriateness of using these models for intended risk assessment 
purposes, such as deriving chemical-specific DDEFs to replace default 
uncertainty factors, or estimating human PoDs for various exposure 
scenarios (e.g., dietary, drinking water, and worker exposures). 
Finally, the SAP members will be asked to comment on the potential for 
using these models as a basis for extrapolation to other chemicals 
within the same chemical class.
    For the sixth PBPK model (acibenzolar), developed in Simcyp, 
details including inputs, parameters and associated distributions, will 
be provided as background materials. The SAP members, however, will not 
be asked to review the Simcyp model code. Instead, the agency will 
solicit comments from the SAP members as a consultation on this model 
as primarily

[[Page 26089]]

a proof-of-concept study, highlighting newer in vitro and in silico 
based approaches. This model is not anticipated to be used in a risk 
assessment by the Agency.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, charge/questions to FIFRA SAP, and related 
supporting materials will be available on or before August 11, 2017. In 
addition, a list of candidates under consideration as prospective ad 
hoc panelists for this meeting will be available for public comment by 
mid to late August (see link for listing of nominees to appear in mid 
to late August at https://www.epa.gov/sap). Comments should be provided 
to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before 
the deadline listed on the Web site given above. Your comments will be 
placed in the public docket by the DFO. You may obtain electronic 
copies of most meeting documents, including FIFRA SAP composition 
(i.e., members and ad hoc members for this meeting) and the meeting 
agenda, at http://www.regulations.gov and the FIFRA SAP Web site at 
https://www.epa.gov/sap.
    FIFRA SAP will prepare meeting minutes summarizing its 
recommendations to the Agency approximately 90 days after the meeting. 
The meeting minutes and final report will be posted on the FIFRA SAP 
Web site or may be obtained from the OPP Docket at http://www.regulations.gov.

    Authority: 7 U.S.C. 136 et. seq.; 21 U.S.C. 301 et seq.

    Dated: May 25, 2017.
Stanley Barone Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 2017-11697 Filed 6-5-17; 8:45 am]
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                                                  26086                           Federal Register / Vol. 82, No. 107 / Tuesday, June 6, 2017 / Notices

                                                  the scientific and technical basis for                  as it develops advice for the EPA.                     ENVIRONMENTAL PROTECTION
                                                  Agency positions and regulations. The                   Interested members of the public may                   AGENCY
                                                  SAB is a Federal Advisory Committee                     submit relevant written or oral
                                                                                                                                                                 [EPA–HQ–OPP–2017–0180; FRL–9962–78]
                                                  chartered under the Federal Advisory                    information on the topic of this advisory
                                                  Committee Act (FACA), 5 U.S.C., App.                    activity, and/or the group conducting                  FIFRA Scientific Advisory Panel;
                                                  2. The SAB will comply with the                         the activity, for the SAB to consider                  Notice of Public Meeting; Request for
                                                  provisions of FACA and all appropriate                  during the advisory process. Input from                Ad Hoc Expert Nominations
                                                  SAB Staff Office procedural policies.                   the public to the SAB will have the most
                                                  Pursuant to FACA and EPA policy,                                                                               AGENCY: Environmental Protection
                                                                                                          impact if it provides specific scientific
                                                  notice is hereby given that the SAB will                                                                       Agency (EPA).
                                                                                                          or technical information or analysis for
                                                  hold a public meeting to discuss and                                                                           ACTION: Notice.
                                                                                                          SAB to consider or if it relates to the
                                                  deliberate on the topics below.
                                                     (1) As part of the EPA’s effort to                   clarity or accuracy of the technical                   SUMMARY:   There will be a 4-day meeting
                                                  routinely inform the SAB about                          information. Members of the public                     of the Federal Insecticide, Fungicide,
                                                  proposed and planned agency actions                     wishing to provide comment should                      and Rodenticide Act Scientific Advisory
                                                  that have a scientific or technical basis,              follow the instructions below to submit                Panel (FIFRA SAP) to consider and
                                                  the agency provided notice to the SAB                   comments. Oral Statements: In general,                 review physiologically based
                                                  that the Office of Management and                       individuals or groups requesting an oral               pharmacokinetic modeling to address
                                                  Budget published the ‘‘Unified                          presentation on a public teleconference                pharmacokinetic differences between
                                                  (Regulatory) Agenda’’ on the Web on                     will be limited to three minutes. Each                 and within species.
                                                  November 17, 2016 available at https://                 person making an oral statement should                 DATES: The meeting will be held on
                                                  www.reginfo.gov/public/do/                              consider providing written comments as                 October 24, 2017 to October 27, 2017,
                                                  eAgendaMain.                                            well as their oral statement so that the               from approximately 9 a.m. to 5 p.m.
                                                     (2) The SAB convened a Work Group                    points presented orally can be expanded                   Comments. Written comments should
                                                  to review information provided in the                   upon in writing. Interested parties                    be submitted on or before September 11,
                                                  agency’s Fall 2016 regulatory agenda                                                                           2017. FIFRA SAP may not be able to
                                                                                                          should contact Mr. Thomas Carpenter,
                                                  regarding EPA planned actions and their                                                                        fully consider written comments
                                                                                                          DFO, in writing (preferably via email) at
                                                  supporting science. The SAB will                                                                               submitted after September 11, 2017.
                                                                                                          the contact information noted above by                 Requests to make oral comments should
                                                  discuss recommendations and
                                                                                                          June 22, 2017, to be placed on the list                be submitted on or before September 25,
                                                  information developed by the Work
                                                  Group regarding the adequacy of the                     of public speakers. Written Statements:                2017 by contacting the Designated
                                                  science supporting the planned actions.                 Written statements should be supplied                  Federal Official (DFO) listed under FOR
                                                  Information about this advisory activity                to the DFO via email at the contact                    FURTHER INFORMATION CONTACT. For
                                                  can be found on the Web at https://                     information noted above by June 22,                    additional instructions, see Unit I.C. of
                                                  www.epa.gov/sab/ Briefings from SAB                     2017, so that the information may be                   the SUPPLEMENTARY INFORMATION.
                                                  members on current activities and                       made available to the SAB members for                     Nominations. Nominations of
                                                  committee and panels developing                         their consideration. It is the SAB Staff               candidates to serve as ad hoc members
                                                  advisory reports.                                       Office general policy to post written                  of FIFRA SAP for this meeting should
                                                     Pursuant to FACA and EPA policy,                     comments on the Web page for the                       be provided on or before July 21, 2017.
                                                  notice is hereby given that the Chartered               advisory meeting or teleconference.                       Webcast. This meeting may be
                                                  SAB will hold a public teleconference to                Submitters are requested to provide an                 webcast. Please refer to the FIFRA SAP
                                                  discuss information provided by the                     unsigned version of each document                      Web site at https://www.epa.gov/sap for
                                                  EPA on planned actions in the Fall 2016                 because the SAB Staff Office does not                  information on how to access the
                                                  semi-annual regulatory agenda and their                 publish documents with signatures on                   webcast. Please note that the webcast is
                                                  supporting science. The Chartered SAB                   its Web sites. Members of the public                   a supplementary public process
                                                  will comply with the provisions of                      should be aware that their personal                    provided only for convenience. If
                                                  FACA and all appropriate SAB Staff                                                                             difficulties arise resulting in webcasting
                                                                                                          contact information, if included in any
                                                  Office procedural policies.                                                                                    outages, the meeting will continue as
                                                                                                          written comments, may be posted to the
                                                     Availability of Meeting Materials:                                                                          planned.
                                                                                                          SAB Web site. Copyrighted material will                   Special accommodations. For
                                                  Prior to the meeting, the review
                                                                                                          not be posted without explicit                         information on access or services for
                                                  documents, agenda and other materials
                                                  will be accessible on the SAB Web site                  permission of the copyright holder.                    individuals with disabilities, and to
                                                  at https://www.epa.gov/sab/.                               Accessibility: For information on                   request accommodation of a disability,
                                                     Procedures for Providing Public Input:               access or services for individuals with                please contact the DFO listed under FOR
                                                  Public comment for consideration by                     disabilities, please contact Mr. Thomas                FURTHER INFORMATION CONTACT at least
                                                  the EPA’s federal advisory committees                   Carpenter at the contact information                   10 days prior to the meeting to allow
                                                  and panels has a different purpose from                 provided above. To request                             EPA time to process your request.
                                                  public comment provided to the EPA                      accommodation of a disability, please                  ADDRESSES: Meeting: The meeting will
                                                  program offices. Therefore, the process                 contact Mr. Carpenter preferably at least              be held at the Environmental Protection
                                                  for submitting comments to a federal                    ten days prior to each meeting to give                 Agency, Conference Center, Lobby
                                                  advisory committee is different from the                the EPA as much time as possible to                    Level, One Potomac Yard (South Bldg.),
                                                  process used to submit comments to an                                                                          2777 S. Crystal Dr., Arlington, VA
mstockstill on DSK30JT082PROD with NOTICES




                                                                                                          process your request.
                                                  EPA program office.                                                                                            22202.
                                                     Federal advisory committees and                        Dated: May 9, 2017.                                     Comments. Submit your comments,
                                                  panels, including scientific advisory                   Christopher S. Zarba,                                  identified by docket identification (ID)
                                                  committees, provide independent                         Director, EPA Science Advisory Staff Office.           number EPA–HQ–OPP–2017–0180, by
                                                  advice to the EPA. Members of the                       [FR Doc. 2017–11688 Filed 6–5–17; 8:45 am]             one of the following methods:
                                                  public can submit comments for a                        BILLING CODE 6560–50–P
                                                                                                                                                                    • Federal eRulemaking Portal: http://
                                                  federal advisory committee to consider                                                                         www.regulations.gov. Follow the online


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                                                                                  Federal Register / Vol. 82, No. 107 / Tuesday, June 6, 2017 / Notices                                            26087

                                                  instructions for submitting comments.                   C. How may I participate in this                       following areas: Physiologically-based
                                                  Do not submit electronically any                        meeting?                                               pharmacokinetic (PBPK) modeling,
                                                  information you consider to be                             You may participate in this meeting                 pharmacokinetics, pharmacodynamic
                                                  Confidential Business Information (CBI)                 by following the instructions in this                  (PD) modeling, in vitro to in vivo
                                                  or other information whose disclosure is                unit. To ensure proper receipt by EPA,                 extrapolation, human health risk
                                                  restricted by statute.                                  it is imperative that you identify docket              assessment, neurotoxicity,
                                                    • Mail: OPP Docket, Environmental                     ID number EPA–HQ–OPP–2017–0180 in                      organophosphate pesticides, pyrethroids
                                                  Protection Agency Docket Center (EPA/                   the subject line on the first page of your             pesticides, N-methyl carbamate
                                                  DC), (28221T), 1200 Pennsylvania Ave.                   request.                                               pesticides, fungicides,
                                                  NW., Washington, DC 20460–0001.                            1. Written comments. Written                        acetylcholinesterase inhibition, and
                                                    • Hand Delivery: To make special                      comments should be submitted, using                    exposure assessment. Nominees should
                                                  arrangements for hand delivery or                       the instructions in ADDRESSES and Unit                 be scientists who have sufficient
                                                  delivery of boxed information, please                   I.B., on or before September 11, 2017, to              professional qualifications, including
                                                  follow the instructions at http://                      provide FIFRA SAP the time necessary                   training and experience, to be capable of
                                                  www.epa.gov/dockets/contacts.html.                      to consider and review the written                     providing expert comments on the
                                                    Additional instructions on                                                                                   scientific issues for this meeting.
                                                                                                          comments. FIFRA SAP may not be able
                                                  commenting or visiting the docket,                                                                             Nominees should be identified by name,
                                                                                                          to fully consider written comments
                                                  along with more information about                                                                              occupation, position, address, email
                                                                                                          submitted after September 11, 2017.
                                                  dockets generally, is available at http://                                                                     address, and telephone number.
                                                                                                             2. Oral comments. The Agency
                                                  www.epa.gov/dockets.                                                                                           Nominations should be provided to the
                                                                                                          encourages each individual or group
                                                    Nominations, requests to present oral                                                                        DFO listed under FOR FURTHER
                                                                                                          wishing to make brief oral comments to
                                                  comments, and requests for special                                                                             INFORMATION CONTACT on or before July
                                                                                                          FIFRA SAP to submit their request to
                                                  accommodations. Submit nominations                                                                             21, 2017. The Agency will consider all
                                                                                                          the DFO listed under FOR FURTHER
                                                  to serve as ad hoc members of FIFRA                                                                            nominations of prospective candidates
                                                                                                          INFORMATION CONTACT on or before
                                                  SAP, requests for special                                                                                      for this meeting that are received on or
                                                                                                          September 25, 2017, in order to be
                                                  accommodations, or requests to present                                                                         before that date. However, final
                                                                                                          included on the meeting agenda.
                                                  oral comments to the DFO listed under                                                                          selection of ad hoc members for this
                                                                                                          Requests to present oral comments will
                                                  FOR FURTHER INFORMATION CONTACT.                                                                               meeting is a discretionary function of
                                                                                                          be accepted until September 25, 2017
                                                  FOR FURTHER INFORMATION CONTACT: Dr.                                                                           the Agency.
                                                                                                          and, to the extent that time permits, the
                                                  Marquea D. King, DFO, Office of                         Chair of FIFRA SAP may permit the                         The selection of scientists to serve on
                                                  Science Coordination and Policy                         presentation of oral comments at the                   FIFRA SAP is based on the function of
                                                  (7201M), Environmental Protection                       meeting by interested persons who have                 the Panel and the expertise needed to
                                                  Agency, 1200 Pennsylvania Ave. NW.,                     not previously requested time. Oral                    address the Agency’s charge to the
                                                  Washington, DC 20460–0001; telephone                    comments before FIFRA SAP are limited                  Panel. No interested scientists shall be
                                                  number: (202) 564–3626; email address:                  to approximately 5 minutes unless                      ineligible to serve by reason of their
                                                  king.marquea@epa.gov.                                   arrangements have been made prior to                   membership on any other advisory
                                                  SUPPLEMENTARY INFORMATION:                              September 25, 2017. The request should                 committee to a Federal department or
                                                  I. General Information                                  identify the name of the individual                    agency or their employment by a
                                                                                                          making the presentation, the                           Federal department or agency, except
                                                  A. Does this action apply to me?                        organization (if any) the individual will              EPA. Other factors considered during
                                                     This action is directed to the public                represent, and any requirements for                    the selection process include
                                                  in general. This action may be of                       audiovisual equipment. In addition,                    availability of the potential Panel
                                                  interest to persons who are or may be                   each speaker should bring 15 copies of                 member to fully participate in the
                                                  required to conduct testing of chemical                 his or her oral remarks and presentation               Panel’s review, absence of any conflicts
                                                  substances under the Federal Food,                      slides (if required) for distribution to               of interest or appearance of lack of
                                                  Drug, and Cosmetic Act (FFDCA) and                      FIFRA SAP at the meeting by the DFO.                   impartiality, independence with respect
                                                  FIFRA. Since other entities may also be                    3. Seating at the meeting. Seating at               to the matters under review, and lack of
                                                  interested, the Agency has not                          the meeting will be open and on a first-               bias. Although financial conflicts of
                                                  attempted to describe all the specific                  come basis.                                            interest, the appearance of lack of
                                                  entities that may be affected by this                      4. Request for nominations to serve as              impartiality, lack of independence, and
                                                  action.                                                 ad hoc expert members of FIFRA SAP                     bias may result in disqualification, the
                                                                                                          for this meeting. As part of a broader                 absence of such concerns does not
                                                  B. What should I consider as I prepare                  process for developing a pool of                       assure that a candidate will be selected
                                                  my comments for EPA?                                    candidates, both U.S. citizens and                     to serve on FIFRA SAP. Numerous
                                                    1. Submitting CBI. Do not submit CBI                  permanent residents who can                            qualified candidates are identified for
                                                  information to EPA through                              demonstrate that they are actively                     each Panel. Therefore, selection
                                                  regulations.gov or email. If your                       seeking U.S. citizenship will be                       decisions involve carefully weighing a
                                                  comments contain any information that                   considered. For each meeting, FIFRA                    number of factors including the
                                                  you consider to be CBI or otherwise                     SAP staff routinely solicits the                       candidates’ areas of expertise and
                                                  protected, please contact the DFO listed                stakeholder community for nominations                  professional qualifications and
                                                  under FOR FURTHER INFORMATION                           of prospective candidates for service as               achieving an overall balance of different
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                                                  CONTACT to obtain special instructions                  ad hoc members of FIFRA SAP. Any                       scientific perspectives on the Panel. In
                                                  before submitting your comments.                        interested person or organization may                  order to have the collective breadth of
                                                    2. Tips for preparing your comments.                  nominate qualified individuals to be                   experience needed to address the
                                                  When preparing and submitting your                      considered as prospective candidates for               Agency’s peer review charge for this
                                                  comments, see the commenting tips at                    a specific meeting. Individuals                        meeting, the Agency anticipates
                                                  http://www.epa.gov/dockets/                             nominated for this meeting should have                 selecting approximately 13 ad hoc
                                                  comments.html.                                          expertise in one or more of the                        scientists.


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                                                  26088                           Federal Register / Vol. 82, No. 107 / Tuesday, June 6, 2017 / Notices

                                                     FIFRA SAP members are subject to                     effectiveness and quality of analyses                  All six models will include life-stage
                                                  the provisions of 5 CFR part 2634—                      made by Agency scientists.                             physiological changes from birth to
                                                  Executive Branch Financial Disclosure,                                                                         adulthood, so that dose metrics can be
                                                                                                          B. Public Meeting
                                                  Qualified Trusts, and Certificates of                                                                          predicted at any age. These life-stage
                                                  Divestiture, as supplemented by EPA in                     The 2009 National Research Council’s                models, however, will not include
                                                  5 CFR part 6401. In anticipation of this                report ‘‘Science and Decisions’’                       gestation and lactational phases,
                                                  requirement, prospective candidates for                 recommends that the EPA use the best,                  therefore; it is not expected that these
                                                  service on FIFRA SAP will be asked to                   most current science to support or                     models will have the capability to
                                                  submit confidential financial                           revise the default assumptions in risk                 predict dose metrics in pregnant women
                                                  information which shall fully disclose,                 assessment. In addition, the 2013                      or fetuses or breastfeeding exposures.
                                                  among other financial interests, the                    Institute of Medicine’s report on                      These models are intended as a means
                                                  candidate’s employment, stocks, and                     ‘‘Environmental Decisions in the Face of               to estimating inter- and intra-species
                                                  bonds, and where applicable, sources of                 Uncertainty’’ further recommends that                  data derived extrapolation factors and/
                                                  research support. EPA will evaluate the                 replacing default uncertainty factors                  or human points of departure (PoD) for
                                                                                                          with data-derived extrapolation factors                various exposure scenarios (e.g., routes
                                                  candidate’s financial disclosure form to
                                                                                                          (DDEFs) that delineate the differences                 of exposure). For dimethoate,
                                                  assess whether there are financial
                                                                                                          between species would reduce                           malathion, and carbaryl, the PBPK
                                                  conflicts of interest, appearance of a
                                                                                                          uncertainty in risk assessment. Such                   models will be coupled with PD models
                                                  lack of impartiality, or any prior
                                                                                                          inter- and intra-species extrapolation                 to predict AChE inhibition in red blood
                                                  involvement with the development of
                                                                                                          factors can be derived using a PBPK                    cells (RBCs) and other tissues (e.g.,
                                                  the documents under consideration                       modeling approach to organize
                                                  (including previous scientific peer                                                                            brain).
                                                                                                          mechanistic data on properties that                      The purpose of the October 2017 SAP
                                                  review) before the candidate is                         determine the absorption, distribution,                will be to review five PBPK or PBPK–
                                                  considered further for service on FIFRA                 metabolism, and excretion (ADME) of                    PD models (carbaryl, deltamethrin,
                                                  SAP. Those who are selected from the                    chemicals that enter the body. In the                  dimethoate, malathion, and permethrin)
                                                  pool of prospective candidates will be                  2006 document on ‘‘Approaches for the                  for the purposes of model structures,
                                                  asked to attend the public meetings and                 Application of Physiologically Based                   mathematical representations,
                                                  to participate in the discussion of key                 Pharmacokinetic (PBPK) Models and                      parameter estimations, computer
                                                  issues and assumptions at these                         Supporting Data in Risk Assessment’’,                  implementations, variability and
                                                  meetings. In addition, they will be asked               the Agency recognizes that PBPK model                  uncertainty analysis, and model
                                                  to review and to help finalize the                      analysis is a scientifically sound                     predictive capabilities, as well as the
                                                  meeting minutes and the final meeting                   approach that allows for estimating the                appropriateness of their applications in
                                                  report. The list of FIFRA SAP members                   internal dose of a chemical or its                     human health risk assessments. The
                                                  participating at this meeting will be                   metabolite at a target site, and can act               details for each model, including their
                                                  posted on the FIFRA SAP Web site at                     as a means to evaluate and describe the                inputs, parameters and associated
                                                  https://www.epa.gov/sap or may be                       uncertainty in a risk assessment.                      distributions, and the model code,
                                                  obtained from the OPP Docket at http://                    PBPK models incorporate the relevant                written in software program acslX or R,
                                                  www.regulations.gov.                                    physiology, chemistry, biochemistry                    will be provided for five (not including
                                                                                                          that determines the ADME processes,                    acibenzolar) chemicals as part of the
                                                  II. Background
                                                                                                          and thus, they are useful for predicting               background materials for the meeting.
                                                  A. Purpose of FIFRA SAP                                 internal dosimetry related to a certain                The agency will solicit comments from
                                                                                                          chemical within and outside the testing                the SAP members on the evaluation of
                                                     FIFRA SAP serves as the primary                      conditions (e.g., species, dose ranges).               these PBPK (or PBPK–PD) models
                                                  scientific peer review mechanism of                     PBPK models have been used to assist                   regarding their capability to predict
                                                  EPA’s Office of Chemical Safety and                     high-to-low dose, route-to-route,                      appropriate internal dose metrics in
                                                  Pollution Prevention (OCSPP) and is                     aggregation of exposure from multiple                  humans. In addition, the SAP members
                                                  structured to provide scientific advice,                routes, and inter-species extrapolations               will be asked to evaluate the
                                                  information and recommendations to                      that are necessary for estimating human                appropriateness of using these models
                                                  the EPA Administrator on pesticides                     health risks based on the results of                   for intended risk assessment purposes,
                                                  and pesticide-related issues as to the                  animal toxicity studies. The                           such as deriving chemical-specific
                                                  impact of regulatory actions on health                  physiological structure of PBPK models                 DDEFs to replace default uncertainty
                                                  and the environment. FIFRA SAP is a                     also allows for examining the effects of               factors, or estimating human PoDs for
                                                  Federal advisory committee established                  changing physiology, such as aging,                    various exposure scenarios (e.g., dietary,
                                                  in 1975 under FIFRA that operates in                    early life-stage, or pregnancy. The                    drinking water, and worker exposures).
                                                  accordance with requirements of the                     temporal change in the dose metric                     Finally, the SAP members will be asked
                                                  Federal Advisory Committee Act (5                       simulated by a PBPK model can also be                  to comment on the potential for using
                                                  U.S.C. Appendix). FIFRA SAP is                          linked to a PD model to predict                        these models as a basis for extrapolation
                                                  composed of a permanent panel                           quantitative changes in biological                     to other chemicals within the same
                                                  consisting of seven members who are                     effects, such as acetylcholinesterase                  chemical class.
                                                  appointed by the EPA Administrator                      (AChE) inhibition.                                       For the sixth PBPK model
                                                  from nominees provided by the National                     Several registrants, including the                  (acibenzolar), developed in Simcyp,
                                                  Institutes of Health and the National                   Council for the Advancement of                         details including inputs, parameters and
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                                                  Science Foundation. The FIFRA SAP is                    Pyrethroid Human Health Risk                           associated distributions, will be
                                                  assisted in their reviews by ad hoc                     Assessment (CAPHRA), Tessenderlo                       provided as background materials. The
                                                  participation from the Science Review                   Kerley Inc. (TKI), FMC/Cheminova, and                  SAP members, however, will not be
                                                  Board (SRB). As a scientific peer review                Syngenta, are developing PBPK (or                      asked to review the Simcyp model code.
                                                  mechanism, FIFRA SAP provides                           PBPK–PD) models for the chemicals:                     Instead, the agency will solicit
                                                  comments, evaluations, and                              Acibenzolar, carbaryl, deltamethrin,                   comments from the SAP members as a
                                                  recommendations to improve the                          dimethoate, malathion, and permethrin.                 consultation on this model as primarily


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                                                                                  Federal Register / Vol. 82, No. 107 / Tuesday, June 6, 2017 / Notices                                                  26089

                                                  a proof-of-concept study, highlighting                  Washington has adopted regulations                     revisions-to-the-total-coliform, or by
                                                  newer in vitro and in silico based                      analogous to the Environmental                         writing or calling Ricardi Duvil, Ph.D. at
                                                  approaches. This model is not                           Protection Agency’s Revised Total                      the address below.
                                                  anticipated to be used in a risk                        Coliform Rule. EPA has determined that                 FOR FURTHER INFORMATION CONTACT:
                                                  assessment by the Agency.                               these revisions are no less stringent than             Ricardi Duvil, Ph.D., EPA Region 10,
                                                                                                          the corresponding federal regulations.                 Drinking Water Unit, 1200 Sixth
                                                  C. FIFRA SAP Documents and Meeting
                                                                                                          Therefore, EPA intends to approve these                Avenue, Suite 900, OWW–193, Seattle,
                                                  Minutes
                                                                                                          State program revisions. By approving                  Washington 98101, telephone (206)
                                                     EPA’s background paper, charge/                      these rules, EPA does not intend to                    553–2578, email at duvil.ricardi@
                                                  questions to FIFRA SAP, and related                     affect the rights of federally recognized              epa.gov.
                                                  supporting materials will be available                  Indian tribes within ‘‘Indian country’’ as
                                                                                                                                                                 SUPPLEMENTARY INFORMATION:
                                                  on or before August 11, 2017. In                        defined by 18 U.S.C. 1151, nor does it
                                                  addition, a list of candidates under                    intend to limit existing rights of the                   Authority: Section 1413 of the Safe
                                                  consideration as prospective ad hoc                     State of Washington.                                   Drinking Water Act, as amended (1996), and
                                                  panelists for this meeting will be                                                                             40 CFR part 142 of the National Primary
                                                                                                          DATES: All interested parties may
                                                  available for public comment by mid to                                                                         Drinking Water Regulations.
                                                                                                          request a public hearing. A request for
                                                  late August (see link for listing of                    a public hearing must be submitted by                   Dated: May 10, 2017.
                                                  nominees to appear in mid to late                       July 6, 2017 to the Acting Regional                    Michelle L. Pirzadeh,
                                                  August at https://www.epa.gov/sap).                     Administrator at the EPA address                       Acting Regional Administrator, Region 10.
                                                  Comments should be provided to the                      shown below. Frivolous or insubstantial                [FR Doc. 2017–11705 Filed 6–5–17; 8:45 am]
                                                  DFO listed under FOR FURTHER                            requests for a hearing may be denied by                BILLING CODE 6560–50–P
                                                  INFORMATION CONTACT on or before the                    the Acting Regional Administrator.
                                                  deadline listed on the Web site given                   However, if a substantial request for a
                                                  above. Your comments will be placed in                  public hearing is made by July 6, 2017,                ENVIRONMENTAL PROTECTION
                                                  the public docket by the DFO. You may                   a public hearing will be held. If no                   AGENCY
                                                  obtain electronic copies of most meeting                timely and appropriate request for a                   [FRL–9962–28–Region 3]
                                                  documents, including FIFRA SAP                          hearing is received and the Acting
                                                  composition (i.e., members and ad hoc                   Regional Administrator does not elect to               Notice of Tentative Approval and
                                                  members for this meeting) and the                       hold a hearing on his own motion, this                 Opportunity for Public Comment and
                                                  meeting agenda, at http://                              determination shall become final and                   Public Hearing for Public Water
                                                  www.regulations.gov and the FIFRA                       effective on July 6, 2017. Any request                 System Supervision Program Revision
                                                  SAP Web site at https://www.epa.gov/                    for a public hearing shall include the                 for Virginia
                                                  sap.                                                    following information: (1) The name,
                                                    FIFRA SAP will prepare meeting                        address, and telephone number of the                   AGENCY:   Environmental Protection
                                                  minutes summarizing its                                 individual, organization, or other entity              Agency (EPA).
                                                  recommendations to the Agency                           requesting a hearing; (2) a brief                      ACTION: Notice of approval and
                                                  approximately 90 days after the                         statement of the requesting person’s                   solicitation of requests for public
                                                  meeting. The meeting minutes and final                  interest in the Acting Regional                        hearing.
                                                  report will be posted on the FIFRA SAP                  Administrator’s determination and a
                                                  Web site or may be obtained from the                    brief statement of the information that                SUMMARY:    Notice is hereby given that
                                                  OPP Docket at http://                                   the requesting person intends to submit                the Commonwealth of Virginia is
                                                  www.regulations.gov.                                    at such hearing; (3) the signature of the              revising its approved Public Water
                                                                                                          individual making the request, or, if the              System Supervision Program. Virginia
                                                    Authority: 7 U.S.C. 136 et. seq.; 21 U.S.C.
                                                  301 et seq.                                             request is made on behalf of an                        has adopted drinking water regulations
                                                                                                          organization or other entity, the                      for the Revised Total Coliform Rule. The
                                                    Dated: May 25, 2017.                                                                                         U.S. Environmental Protection Agency
                                                  Stanley Barone Jr.,                                     signature of a responsible official of the
                                                                                                          organization or other entity.                          (EPA) has determined that Virginia’s
                                                  Director, Office of Science Coordination and                                                                   Revised Total Coliform Rule meets all
                                                  Policy.                                                 ADDRESSES: All documents relating to
                                                                                                                                                                 minimum federal requirements, and that
                                                                                                          this determination are available for
                                                  [FR Doc. 2017–11697 Filed 6–5–17; 8:45 am]                                                                     it is no less stringent than the
                                                                                                          inspection between the hours of 9:00
                                                  BILLING CODE 6560–50–P                                                                                         corresponding federal regulation.
                                                                                                          a.m. and 4:00 p.m., Monday through
                                                                                                                                                                 Therefore, EPA has tentatively decided
                                                                                                          Friday, at the Washington Department
                                                                                                                                                                 to approve the State program revisions.
                                                  ENVIRONMENTAL PROTECTION                                of Health, Drinking Water Program, P.O.
                                                                                                          Box 47820, Olympia, Washington 98504                   DATES: Comments or a request for a
                                                  AGENCY                                                                                                         public hearing must be submitted by
                                                                                                          and between the hours of 9:00 a.m.–
                                                  [FRL–9963–09–Region 10]                                 12:00 p.m. and 1:00–4:00 p.m. at the                   July 6, 2017. This determination shall
                                                                                                          EPA Region 10 Library, 1200 Sixth                      become final and effective on July 6,
                                                  Public Water Supply Supervision                                                                                2017, if no timely and appropriate
                                                                                                          Avenue, Seattle, Washington 98101.
                                                  Program; Program Revision for the                                                                              request for a hearing is received, and the
                                                                                                          Copies of the documents which explain
                                                  State of Washington                                                                                            Regional Administrator does not elect to
                                                                                                          the rule can also be obtained at EPA’s
                                                                                                          Web site at: https://www.federalregister.              hold a hearing on his own motion, and
                                                  AGENCY: Environmental Protection
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                                                                                                          gov/articles/2013/02/13/2012-31205/                    if no comments are received which
                                                  Agency (EPA).
                                                                                                          national-primary-drinking-water-                       cause EPA to modify its tentative
                                                  ACTION: Notice of tentative approval.                                                                          approval.
                                                                                                          regulations-revisions-to-the-total-
                                                  SUMMARY:   Notice is hereby given that                  coliform-rule and https://www.federal                  ADDRESSES:  Comments or a request for
                                                  the State of Washington has revised its                 register.gov/articles/2014/02/26/2014-                 a public hearing must be submitted to
                                                  approved State Public Water Supply                      04173/national-primary-drinking-water-                 the U.S. Environmental Protection
                                                  Supervision Primacy Program.                            regulations-minor-corrections-to-the-                  Agency, Region III, 1650 Arch Street,


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Document Created: 2017-06-06 06:21:01
Document Modified: 2017-06-06 06:21:01
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.
DatesThe meeting will be held on October 24, 2017 to October 27, 2017, from approximately 9 a.m. to 5 p.m.
ContactDr. Marquea D. King, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
FR Citation82 FR 26086 

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