FIFRA Scientific Advisory Panel; Notice of Public Meeting; Request for Ad Hoc Expert Nominations, 26086-26089 [2017-11697]
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26086
Federal Register / Vol. 82, No. 107 / Tuesday, June 6, 2017 / Notices
the scientific and technical basis for
Agency positions and regulations. The
SAB is a Federal Advisory Committee
chartered under the Federal Advisory
Committee Act (FACA), 5 U.S.C., App.
2. The SAB will comply with the
provisions of FACA and all appropriate
SAB Staff Office procedural policies.
Pursuant to FACA and EPA policy,
notice is hereby given that the SAB will
hold a public meeting to discuss and
deliberate on the topics below.
(1) As part of the EPA’s effort to
routinely inform the SAB about
proposed and planned agency actions
that have a scientific or technical basis,
the agency provided notice to the SAB
that the Office of Management and
Budget published the ‘‘Unified
(Regulatory) Agenda’’ on the Web on
November 17, 2016 available at https://
www.reginfo.gov/public/do/
eAgendaMain.
(2) The SAB convened a Work Group
to review information provided in the
agency’s Fall 2016 regulatory agenda
regarding EPA planned actions and their
supporting science. The SAB will
discuss recommendations and
information developed by the Work
Group regarding the adequacy of the
science supporting the planned actions.
Information about this advisory activity
can be found on the Web at https://
www.epa.gov/sab/ Briefings from SAB
members on current activities and
committee and panels developing
advisory reports.
Pursuant to FACA and EPA policy,
notice is hereby given that the Chartered
SAB will hold a public teleconference to
discuss information provided by the
EPA on planned actions in the Fall 2016
semi-annual regulatory agenda and their
supporting science. The Chartered SAB
will comply with the provisions of
FACA and all appropriate SAB Staff
Office procedural policies.
Availability of Meeting Materials:
Prior to the meeting, the review
documents, agenda and other materials
will be accessible on the SAB Web site
at https://www.epa.gov/sab/.
Procedures for Providing Public Input:
Public comment for consideration by
the EPA’s federal advisory committees
and panels has a different purpose from
public comment provided to the EPA
program offices. Therefore, the process
for submitting comments to a federal
advisory committee is different from the
process used to submit comments to an
EPA program office.
Federal advisory committees and
panels, including scientific advisory
committees, provide independent
advice to the EPA. Members of the
public can submit comments for a
federal advisory committee to consider
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as it develops advice for the EPA.
Interested members of the public may
submit relevant written or oral
information on the topic of this advisory
activity, and/or the group conducting
the activity, for the SAB to consider
during the advisory process. Input from
the public to the SAB will have the most
impact if it provides specific scientific
or technical information or analysis for
SAB to consider or if it relates to the
clarity or accuracy of the technical
information. Members of the public
wishing to provide comment should
follow the instructions below to submit
comments. Oral Statements: In general,
individuals or groups requesting an oral
presentation on a public teleconference
will be limited to three minutes. Each
person making an oral statement should
consider providing written comments as
well as their oral statement so that the
points presented orally can be expanded
upon in writing. Interested parties
should contact Mr. Thomas Carpenter,
DFO, in writing (preferably via email) at
the contact information noted above by
June 22, 2017, to be placed on the list
of public speakers. Written Statements:
Written statements should be supplied
to the DFO via email at the contact
information noted above by June 22,
2017, so that the information may be
made available to the SAB members for
their consideration. It is the SAB Staff
Office general policy to post written
comments on the Web page for the
advisory meeting or teleconference.
Submitters are requested to provide an
unsigned version of each document
because the SAB Staff Office does not
publish documents with signatures on
its Web sites. Members of the public
should be aware that their personal
contact information, if included in any
written comments, may be posted to the
SAB Web site. Copyrighted material will
not be posted without explicit
permission of the copyright holder.
Accessibility: For information on
access or services for individuals with
disabilities, please contact Mr. Thomas
Carpenter at the contact information
provided above. To request
accommodation of a disability, please
contact Mr. Carpenter preferably at least
ten days prior to each meeting to give
the EPA as much time as possible to
process your request.
Dated: May 9, 2017.
Christopher S. Zarba,
Director, EPA Science Advisory Staff Office.
[FR Doc. 2017–11688 Filed 6–5–17; 8:45 am]
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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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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: https://
www.regulations.gov. Follow the online
SUMMARY:
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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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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:
king.marquea@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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
https://www.epa.gov/dockets/
comments.html.
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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 firstcome 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
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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.
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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 https://
www.regulations.gov.
II. Background
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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
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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.
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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
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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 https://
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 https://
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]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9963–09–Region 10]
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Public Water Supply Supervision
Program; Program Revision for the
State of Washington
Environmental Protection
Agency (EPA).
ACTION: Notice of tentative approval.
AGENCY:
Notice is hereby given that
the State of Washington has revised its
approved State Public Water Supply
Supervision Primacy Program.
SUMMARY:
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Washington has adopted regulations
analogous to the Environmental
Protection Agency’s Revised Total
Coliform Rule. EPA has determined that
these revisions are no less stringent than
the corresponding federal regulations.
Therefore, EPA intends to approve these
State program revisions. By approving
these rules, EPA does not intend to
affect the rights of federally recognized
Indian tribes within ‘‘Indian country’’ as
defined by 18 U.S.C. 1151, nor does it
intend to limit existing rights of the
State of Washington.
DATES: All interested parties may
request a public hearing. A request for
a public hearing must be submitted by
July 6, 2017 to the Acting Regional
Administrator at the EPA address
shown below. Frivolous or insubstantial
requests for a hearing may be denied by
the Acting Regional Administrator.
However, if a substantial request for a
public hearing is made by July 6, 2017,
a public hearing will be held. If no
timely and appropriate request for a
hearing is received and the Acting
Regional Administrator does not elect to
hold a hearing on his own motion, this
determination shall become final and
effective on July 6, 2017. Any request
for a public hearing shall include the
following information: (1) The name,
address, and telephone number of the
individual, organization, or other entity
requesting a hearing; (2) a brief
statement of the requesting person’s
interest in the Acting Regional
Administrator’s determination and a
brief statement of the information that
the requesting person intends to submit
at such hearing; (3) the signature of the
individual making the request, or, if the
request is made on behalf of an
organization or other entity, the
signature of a responsible official of the
organization or other entity.
ADDRESSES: All documents relating to
this determination are available for
inspection between the hours of 9:00
a.m. and 4:00 p.m., Monday through
Friday, at the Washington Department
of Health, Drinking Water Program, P.O.
Box 47820, Olympia, Washington 98504
and between the hours of 9:00 a.m.–
12:00 p.m. and 1:00–4:00 p.m. at the
EPA Region 10 Library, 1200 Sixth
Avenue, Seattle, Washington 98101.
Copies of the documents which explain
the rule can also be obtained at EPA’s
Web site at: https://www.federalregister.
gov/articles/2013/02/13/2012-31205/
national-primary-drinking-waterregulations-revisions-to-the-totalcoliform-rule and https://www.federal
register.gov/articles/2014/02/26/201404173/national-primary-drinking-waterregulations-minor-corrections-to-the-
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revisions-to-the-total-coliform, or by
writing or calling Ricardi Duvil, Ph.D. at
the address below.
FOR FURTHER INFORMATION CONTACT:
Ricardi Duvil, Ph.D., EPA Region 10,
Drinking Water Unit, 1200 Sixth
Avenue, Suite 900, OWW–193, Seattle,
Washington 98101, telephone (206)
553–2578, email at duvil.ricardi@
epa.gov.
SUPPLEMENTARY INFORMATION:
Authority: Section 1413 of the Safe
Drinking Water Act, as amended (1996), and
40 CFR part 142 of the National Primary
Drinking Water Regulations.
Dated: May 10, 2017.
Michelle L. Pirzadeh,
Acting Regional Administrator, Region 10.
[FR Doc. 2017–11705 Filed 6–5–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9962–28–Region 3]
Notice of Tentative Approval and
Opportunity for Public Comment and
Public Hearing for Public Water
System Supervision Program Revision
for Virginia
Environmental Protection
Agency (EPA).
ACTION: Notice of approval and
solicitation of requests for public
hearing.
AGENCY:
Notice is hereby given that
the Commonwealth of Virginia is
revising its approved Public Water
System Supervision Program. Virginia
has adopted drinking water regulations
for the Revised Total Coliform Rule. The
U.S. Environmental Protection Agency
(EPA) has determined that Virginia’s
Revised Total Coliform Rule meets all
minimum federal requirements, and that
it is no less stringent than the
corresponding federal regulation.
Therefore, EPA has tentatively decided
to approve the State program revisions.
DATES: Comments or a request for a
public hearing must be submitted by
July 6, 2017. This determination shall
become final and effective on July 6,
2017, if no timely and appropriate
request for a hearing is received, and the
Regional Administrator does not elect to
hold a hearing on his own motion, and
if no comments are received which
cause EPA to modify its tentative
approval.
SUMMARY:
Comments or a request for
a public hearing must be submitted to
the U.S. Environmental Protection
Agency, Region III, 1650 Arch Street,
ADDRESSES:
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Agencies
[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Notices]
[Pages 26086-26089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
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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: https://www.regulations.gov.
Follow the online
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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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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: king.marquea@epa.gov.
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 https://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.
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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 https://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
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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 https://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 https://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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