FIFRA Scientific Advisory Panel; Notice of Public Meetings and Request for Nominations of Ad Hoc Expert Reviewers, 36580-36583 [2020-13010]
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Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
of prohibited and exempt off-the-record
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Order No. 607 (64 FR 51222,
September 22, 1999) requires
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make or receive a prohibited or exempt
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Unless the Commission determines that
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respond to any facts or contentions
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having made a prohibited off-the-record
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Exempt off-the-record
communications are included in the
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unless the communication was with a
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CFR 1501.6, made under 18 CFR
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The following is a list of off-therecord communications recently
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due to the proclamation declaring a
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issued by the President on March 13,
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Docket No.
File date
Prohibited:
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Exempt:
RP20–859–000
5–27–2020
Presenter or
requester
U.S. Congress 1
1 U.S.
Senators John Hoeven, Kevin Cramer, and
U.S. Representative Kelly Armstrong.
Dated: June 9, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020–13014 Filed 6–16–20; 8:45 am]
BILLING CODE 6717–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2020–0263; FRL–10009–83]
FIFRA Scientific Advisory Panel;
Notice of Public Meetings and Request
for Nominations of Ad Hoc Expert
Reviewers
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
There will be a 4-day public
peer review meeting of the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) Scientific Advisory Panel
(SAP) to consider and review the use of
new approach methodologies (NAMs) to
derive extrapolation factors and
evaluate developmental neurotoxicity
for human health risk assessment.
Preceding the public peer review
meeting, there will be a public
preparatory virtual meeting, conducted
via teleconference and webcast, to
consider the scope and clarity of the
draft charge questions for this peer
review. In addition, EPA is requesting
nominations of prospective candidates
for service as ad hoc reviewers to assist
the FIFRA SAP with this review. Any
interested person or organization may
nominate qualified individuals to be
considered as prospective candidates for
this review by following the instructions
provided in this notice.
DATES:
Nominations: Submit nominations of
candidates to serve as ad hoc reviewers
on or before July 2, 2020.
Preparatory Virtual Meeting: The
preparatory virtual meeting will be held
on August 25, 2020, from 1:00 p.m. to
approximately 4:00 p.m. (EDT). You
must register online on or before August
SUMMARY:
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25, 2020, to receive the webcast meeting
link and audio teleconference
information. You must submit your
written comments or request time to
present oral comments for the
preparatory virtual meeting on or before
noon, August 21, 2020.
Peer Review Meeting: The 4-day
public peer review meeting will be held
September 15–18, 2020, from 9:00 a.m.
to approximately 5:00 p.m. (EDT) (as
needed, updated times for each day may
be provided in the meeting agenda that
will be posted in the docket at https://
www.regulations.gov and the FIFRA
SAP website at https://www.epa.gov/
SAP). To make oral comments during
the peer review meeting and be
included on the meeting agenda, please
register by noon on September 9, 2020.
Any written comments submitted for
the peer review meeting on or before
September 9, 2020, will be provided to
the FIFRA SAP for their consideration
before the meeting. Comments received
after September 9, 2020, and prior to the
oral public comment period during the
meeting will be available to the FIFRA
SAP for their consideration during the
meeting.
Special accommodations: Requests
for special accommodations should be
submitted on or before August 25, 2020,
to allow EPA time to process these
requests.
ADDRESSES:
Nominations: Submit your
nominations of candidates to the
Designated Federal Official (DFO) listed
under FOR FURTHER INFORMATION
CONTACT.
Preparatory Virtual Meeting:
Registration is required to participate
during the public preparatory virtual
meeting. Please refer to the FIFRA SAP
website at https://www.epa.gov/sap for
information on how to register.
Peer Review Meeting: The location of
the 4-day public peer review meeting
will be announced on the FIFRA SAP
website at https://www.epa.gov/sap. You
may also subscribe to the following
listserv for alerts regarding this and
other SAP-related activities: https://
public.govdelivery.com/accounts/
USAEPAOPPT/subscriber/new?topic_
id=USAEPAOPPT_101. This peer
review meeting may also be viewed via
webcast. Please refer to the FIFRA SAP
website at https://www.epa.gov/sap for
information on how to access the
webcast.
Special accommodations: For
information on access or services for
individuals with disabilities, and to
request accommodation for a disability,
please contact the DFO listed under FOR
FURTHER INFORMATION CONTACT.
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Comments: Submit requests to present
oral comments to the DFO listed under
FOR FURTHER INFORMATION CONTACT.
Submit written comments, identified
by docket identification (ID) number
EPA–HQ–OPP–2020–0263, through the
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not electronically submit any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
Additional information on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets. For additional
instructions related to this meeting, see
SUPPLEMENTARY INFORMATION.
Please note that due to the current
COVID–19 public health emergency the
EPA Docket Center (EPA/DC) and
Reading Room were closed to public
visitors on March 31, 2020. Our EPA/DC
staff will continue to provide customer
service via email, phone, and webform.
For further information on EPA/DC
services, docket contact information and
the current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets. For questions
about this docket, you may also contact
the DFO listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
Tamue Gibson, DFO, Office of Science
Coordination and Policy (7201M),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–7642; email address:
gibson.tamue@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. Where can I access information about
the FIFRA SAP and this meeting?
Information about the FIFRA SAP and
this meeting is available on the FIFRA
SAP website at https://www.epa.gov/
scipoly/sap and in the docket for this
meeting, identified by docket ID number
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EPA–HQ–OPP–2020–0263, at https://
www.regulations.gov.
C. 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 Tips for Effective
Comments at https://www.epa.gov/
dockets/comments.html.
II. Background
A. What is the purpose of the FIFRA
SAP?
The FIFRA SAP serves as one of the
primary scientific peer review
mechanisms of EPA’s Office of
Chemical Safety and Pollution
Prevention (OCSPP) and is structured to
provide independent scientific advice,
information and recommendations to
the EPA Administrator on pesticides
and pesticide-related issues as to the
impact of regulatory actions on human
health and the environment. The 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 I).
The 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 (NSF).
The FIFRA established a Science
Review Board consisting of at least 60
scientists who are available to the
FIFRA SAP on an ad hoc basis to assist
in reviews conducted by FIFRA SAP. As
a scientific peer review mechanism, the
FIFRA SAP provides comments,
evaluations, and recommendations to
improve the effectiveness and quality of
analyses made by Agency scientists.
Members of the FIFRA SAP are
scientists who have sufficient
professional qualifications, including
training and experience, to provide
expert advice and recommendation to
the Agency.
B. What is the purpose of this public
meeting?
In 2007, the National Research
Council (NRC)’s report on Toxicity
Testing in 21st Century: A Vision and a
Strategy was published which
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encouraged a new paradigm in toxicity
testing that reduces the reliance on
laboratory animals while moving
towards in vitro and in silico predictive
approaches that are more efficient and
human relevant. EPA’s Office of
Pesticide Programs (OPP) has developed
a strategic vision for implementing the
2007 NRC report that has multiple
components involving a combination of
computational and predictive modeling
approaches, in vitro techniques, and
limited, targeted in vivo testing.
EPA is actively engaged in numerous
activities with respect to reducing
laboratory animal use and implementing
in vitro and computational approaches.
As NAMs can provide human relevant
information that may be challenging to
obtain with whole animal testing. EPA
is also interested in using in vitro and
computational approaches for reducing
the reliance on default assumptions for
risk assessment, including the
application of 10X uncertainty factors
for inter- and intra-species
extrapolation.
In recent years, EPA began
collaborative work with academia, and
industry to use organophosphate
pesticides (OPs) as a case study for the
development of NAMs for purposes of
using data to inform extrapolation/
uncertainty and safety factors in lieu of
reliance on default factors.
The Agency is interested in using in
vitro data to derive extrapolation factors
and evaluate developmental
neurotoxicity for human health risk
assessment. Specifically, the Agency is
seeking advice and recommendation
from the FIFRA SAP on scientific issues
associated with the evaluation and
utility of NAMs as part of a weight of
evidence evaluation of developmental
neurotoxicity potential and the use of in
vitro acetylcholinesterase inhibition
data to develop interspecies and/or
intraspecies data-derived extrapolation
factors for organophosphate pesticides.
C. How can I access the FIFRA SAP
documents and meeting minutes?
EPA’s background paper, the
supporting materials, and draft charge/
questions provided to the FIFRA SAP
will be available by late-June as
described in Unit I.B. The Agency will
provide additional background
documents (e.g., the meeting agenda) as
the materials become available. In
addition, the FIFRA SAP will prepare
meeting minutes summarizing its
recommendations to the Agency
approximately 90 days after the
meeting. The meeting minutes will also
be made available as described in Unit
I.B.
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III. Nominations for Ad Hoc Expert
Reviewers
A. How do I nominate someone to be
considered as an ad hoc expert reviewer
to assist the FIFRA SAP in this peer
review?
As part of a broader process for
developing a pool of candidates for each
review, FIFRA SAP staff routinely
solicits the stakeholder community for
nominations of prospective candidates
for service as ad hoc reviewers. Any
interested person or organization may
nominate qualified individuals to be
considered as prospective candidates for
a specific topic. Nominees should be
identified by name, occupation,
position, address, email address, and
telephone number. The Agency will
consider all nominations of prospective
candidates for this review that are
received on or before the deadline
identified in the DATES section. Final
selection of ad hoc reviewers is a
discretionary function of the Agency.
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B. Who can I nominate to be considered
as an ad hoc expert reviewer to assist
the FIFRA SAP in this peer review?
Individuals nominated for this
meeting should have expertise in one or
more of the following areas: (i) Data
derived extrapolation factors; (ii)
Development and implementation of
new approach methodologies; (iii)
Statistics; (iv) Developmental
neurotoxicity; (v) In vitro to in vivo
extrapolation; and (vi) Organophosphate
pesticides. Nominees should be
scientists who have sufficient
professional qualifications, including
training and experience, to provide
expert comments on the scientific issues
for this review.
C. How will EPA select ad hoc expert
reviewers to assist the FIFRA SAP in this
peer review?
The selection of scientists to serve on
a FIFRA SAP review 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 reviewer to
fully participate in the Panel’s review,
absence of any conflicts of interest or
appearance of loss of impartiality,
independence with respect to the
matters under review, and lack of bias.
Although financial conflicts of interest,
the appearance of loss of impartiality,
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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 a
FIFRA SAP review. Numerous qualified
candidates are identified for each
review; 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 charge for this review, the
Agency anticipates selecting
approximately twelve ad hoc scientists.
FIFRA SAP members and ad hoc
reviewers are subject to the provisions
of the Standards of Ethical Conduct for
Employees of the Executive Branch at 5
CFR part 2635, conflict of interest
statutes in Title 18 of the United States
Code and related regulations. In
anticipation of these requirements,
prospective candidates for service on
the FIFRA SAP will be asked to submit
confidential financial information
which shall fully disclose, among other
financial interests, the candidate’s
employment, stocks, 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 loss 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.
EPA plans to make a list of candidates
under consideration as prospective ad
hoc panelists for this meeting available
for a 15-calendar day public comment
period in July 2020. The list of the
FIFRA SAP members and ad hoc
reviewers participating at this meeting
will be available as described in Unit
I.B.
Those who are selected from the pool
of prospective candidates will be asked
to attend the preparatory and peer
review 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 final report.
IV. Public Participation
A. How may I participate in the public
peer review meeting?
You may participate in the public
peer review meeting by following the
instructions in this unit. To ensure
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proper receipt of comments,
nominations or other requests by EPA,
it is imperative that you identify docket
ID number EPA–HQ–OPP–2020–0263 in
the subject line on the first page of your
request.
1. Written comments. The Agency
encourages written comments for the
peer review meeting be submitted using
the instructions in ADDRESSES and Unit
I.B. and C, on or before the date set in
the DATES section. Comments received
after this date and prior to the end of the
oral public comment period during the
meeting will still be provided to the
FIFRA SAP for their consideration.
Anyone submitting written comments
after this date, should contact the DFO
listed under FOR FURTHER INFORMATION
CONTACT. Anyone submitting written
comments during the meeting should
email the DFO prior to the meeting to
arrange for distribution of their
comments to the FIFRA SAP.
2. Oral comments. The Agency
encourages each individual or group
wishing to make brief oral comments to
the FIFRA SAP during the peer review
meeting to submit their request to the
DFO listed under FOR FURTHER
INFORMATION CONTACT on or before the
date set in the DATES section in order to
be included on the meeting agenda.
Requests to present oral comments will
be accepted until the date of the peer
review meeting and, to the extent that
time permits, the Chair of the FIFRA
SAP may permit the presentation of oral
comments at the peer review meeting by
interested persons who have not
previously requested time.
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. Oral comments before the
FIFRA SAP during the peer review
meeting are limited to 5 minutes unless
arrangements have been made prior to
the date set in the DATES section. In
addition, each speaker should email a
copy of his/her comments to the DFO
prior to the meeting for distribution to
the FIFRA SAP.
3. Webcast. This meeting may also be
viewed via webcast. Please refer to the
FIFRA SAP website at https://
www.epa.gov/sap for information on
how to access the webcast.
B. How may I participate in the
preparatory virtual meeting?
Registration for the preparatory
virtual meeting is required. To
participate by listening or making a
comment during this meeting, please
visit: https://www.epa.gov/sap to register.
Registration online will be confirmed by
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email that will include the webcast
meeting link and audio teleconference
information.
1. Written comments. Written
comments for the preparatory virtual
meeting should be submitted, using the
instructions in ADDRESSES and Unit I.B.
and C, on or before the date set in the
DATES section.
2. Oral comments. Registration is
required to participate in the
preparatory virtual meeting. Please visit
the FIFRA SAP website at https://
www.epa.gov/sap to register online.
Each individual or group wishing to
make brief oral comments to the FIFRA
SAP during the preparatory virtual
meeting should submit their request
when registering online or with the DFO
listed under FOR FURTHER INFORMATION
CONTACT on or before the date set in the
DATES section. Oral comments before the
FIFRA SAP during the preparatory
virtual meeting are limited to
approximately 5 minutes due to the
time constraints of this meeting.
3. Webcast. The preparatory meeting
will be webcast only. Please refer to the
FIFRA SAP website at https://
www.epa.gov/sap for information on
how to access the webcast. Registration
is required.
Authority: 5 U.S.C. App. I; 7 U.S.C. 136 et
seq.; 21 U.S.C. 301 et seq.
Dated: June 8, 2020.
Hayley Hughes,
Director, Office of Science Coordination and
Policy.
[FR Doc. 2020–13010 Filed 6–16–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2020–0060; FRL–10010–41]
Cancellation Order for Certain
Pesticide Registrations and
Amendments To Terminate Uses
This notice announces EPA’s
order for the cancellations and
amendments to terminate uses,
voluntarily requested by the registrants
and accepted by the Agency, of the
products listed in Table 1, Table 1A,
Table 1B and Table 2 of Unit II,
pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA). This cancellation order follows
an April 17, 2020 Federal Register
Notice of Receipt of Requests from the
registrants listed in Table 3 of Unit II to
voluntarily cancel and amend to
terminate uses of these product
registrations. In the April 17, 2020
notice, EPA indicated that it would
issue an order implementing the
cancellations and amendments to
terminate uses, unless the Agency
received substantive comments within
the 30-day comment period that would
merit its further review of these
requests, or unless the registrants
withdrew their requests. The Agency
received 5 public comments on the
notice, but they did not merit its further
review of the requests. Further, the
registrants did not withdraw their
requests. Accordingly, EPA hereby
issues in this notice a cancellation order
granting the requested cancellations and
amendments to terminate uses. Any
distribution, sale, or use of the products
subject to this cancellation order is
permitted only in accordance with the
terms of this order, including any
existing stocks provisions.
DATES: The cancellations and
amendments are effective June 17, 2020.
FOR FURTHER INFORMATION CONTACT:
Christopher Green, Information
Technology and Resources Management
Division (7502P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (703) 347–0367; email address:
green.christopher@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
A. Does this action apply to me?
This action is directed to the public
in general and may be of interest to a
wide range of stakeholders including
environmental, human health, and
agricultural advocates; the chemical
industry; pesticide users; and members
of the public interested in the sale,
distribution, or use of pesticides. Since
others also may be interested, the
Agency has not attempted to describe all
the specific entities that may be affected
by this action.
B. How can I get copies of this document
and other related information?
The docket for this action, identified
by docket identification (ID) number
EPA–HQ–OPP–2020–0060, is available
at https://www.regulations.gov or at the
Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please note
that due to the public health emergency
the EPA Docket Center (EPA/DC) and
Reading Room was closed to public
visitors on March 31, 2020. Our EPA/DC
staff will continue to provide customer
service via email, phone, and webform.
For further information on EPA/DC
services, docket contact information and
the current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets.
II. What action is the Agency taking?
This notice announces the
cancellations and amendments to
terminate uses, as requested by
registrants, of products registered under
FIFRA section 3 (7 U.S.C. 136a). These
registrations are listed in sequence by
registration number in Tables 1, 1A, 1B
and 2 of this unit.
TABLE 1—PRODUCT CANCELLATIONS
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Registration
No.
Company
No.
Product name
Active ingredients
264–612 ........
264–615 ........
279–3564 ......
279–3570 ......
1258–1270 ....
264
264
279
279
1258
Nortron E.C ........................................
Nortron G.S ........................................
Tackle Herbicide .................................
Tackle II Herbicide .............................
Densil CA ...........................................
2693–170 ......
2693
Fiberglass Bottomkote with Biolux II—
Black.
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Ethofumesate.
Ethofumesate.
Glyphosate-isopropylammonium & Imazethapyr.
Glyphosate-isopropylammonium & Imazethapyr.
Chlorothalonil & 1,3,5-Triazine-2,4-diamine, N-cyclopropyl-N’-(1,1dimethylethyl)-6-(methylthio)-.
1,3,5-Triazine-2,4-diamine, N-cyclopropyl-N’-(1,1-dimethylethyl)-6(methylthio)- & Cuprous oxide.
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]]>Agencies
[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36580-36583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13010]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2020-0263; FRL-10009-83]
FIFRA Scientific Advisory Panel; Notice of Public Meetings and
Request for Nominations of Ad Hoc Expert Reviewers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: There will be a 4-day public peer review meeting of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific
Advisory Panel (SAP) to consider and review the use of new approach
methodologies (NAMs) to derive extrapolation factors and evaluate
developmental neurotoxicity for human health risk assessment. Preceding
the public peer review meeting, there will be a public preparatory
virtual meeting, conducted via teleconference and webcast, to consider
the scope and clarity of the draft charge questions for this peer
review. In addition, EPA is requesting nominations of prospective
candidates for service as ad hoc reviewers to assist the FIFRA SAP with
this review. Any interested person or organization may nominate
qualified individuals to be considered as prospective candidates for
this review by following the instructions provided in this notice.
DATES:
Nominations: Submit nominations of candidates to serve as ad hoc
reviewers on or before July 2, 2020.
Preparatory Virtual Meeting: The preparatory virtual meeting will
be held on August 25, 2020, from 1:00 p.m. to approximately 4:00 p.m.
(EDT). You must register online on or before August 25, 2020, to
receive the webcast meeting link and audio teleconference information.
You must submit your written comments or request time to present oral
comments for the preparatory virtual meeting on or before noon, August
21, 2020.
Peer Review Meeting: The 4-day public peer review meeting will be
held September 15-18, 2020, from 9:00 a.m. to approximately 5:00 p.m.
(EDT) (as needed, updated times for each day may be provided in the
meeting agenda that will be posted in the docket at https://www.regulations.gov and the FIFRA SAP website at https://www.epa.gov/SAP). To make oral comments during the peer review meeting and be
included on the meeting agenda, please register by noon on September 9,
2020. Any written comments submitted for the peer review meeting on or
before September 9, 2020, will be provided to the FIFRA SAP for their
consideration before the meeting. Comments received after September 9,
2020, and prior to the oral public comment period during the meeting
will be available to the FIFRA SAP for their consideration during the
meeting.
Special accommodations: Requests for special accommodations should
be submitted on or before August 25, 2020, to allow EPA time to process
these requests.
ADDRESSES:
Nominations: Submit your nominations of candidates to the
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION
CONTACT.
Preparatory Virtual Meeting: Registration is required to
participate during the public preparatory virtual meeting. Please refer
to the FIFRA SAP website at https://www.epa.gov/sap for information on
how to register.
Peer Review Meeting: The location of the 4-day public peer review
meeting will be announced on the FIFRA SAP website at https://
www.epa.gov/sap. You may also subscribe to the following listserv for
alerts regarding this and other SAP-related activities: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101. This peer review meeting may also be
viewed via webcast. Please refer to the FIFRA SAP website at https://
www.epa.gov/sap for information on how to access the webcast.
Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation for a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT.
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Comments: Submit requests to present oral comments to the DFO
listed under FOR FURTHER INFORMATION CONTACT.
Submit written comments, identified by docket identification (ID)
number EPA-HQ-OPP-2020-0263, through the Federal eRulemaking Portal:
https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not electronically submit any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
Additional information on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets. For additional instructions related to this
meeting, see SUPPLEMENTARY INFORMATION.
Please note that due to the current COVID-19 public health
emergency the EPA Docket Center (EPA/DC) and Reading Room were closed
to public visitors on March 31, 2020. Our EPA/DC staff will continue to
provide customer service via email, phone, and webform. For further
information on EPA/DC services, docket contact information and the
current status of the EPA/DC and Reading Room, please visit https://www.epa.gov/dockets. For questions about this docket, you may also
contact the DFO listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Tamue Gibson, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-7642; 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. Where can I access information about the FIFRA SAP and this meeting?
Information about the FIFRA SAP and this meeting is available on
the FIFRA SAP website at https://www.epa.gov/scipoly/sap and in the
docket for this meeting, identified by docket ID number EPA-HQ-OPP-
2020-0263, at https://www.regulations.gov.
C. 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 Tips for Effective Comments at https://www.epa.gov/dockets/comments.html.
II. Background
A. What is the purpose of the FIFRA SAP?
The FIFRA SAP serves as one of the primary scientific peer review
mechanisms of EPA's Office of Chemical Safety and Pollution Prevention
(OCSPP) and is structured to provide independent scientific advice,
information and recommendations to the EPA Administrator on pesticides
and pesticide-related issues as to the impact of regulatory actions on
human health and the environment. The 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 I). The 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 (NSF). The FIFRA established a Science Review Board
consisting of at least 60 scientists who are available to the FIFRA SAP
on an ad hoc basis to assist in reviews conducted by FIFRA SAP. As a
scientific peer review mechanism, the FIFRA SAP provides comments,
evaluations, and recommendations to improve the effectiveness and
quality of analyses made by Agency scientists. Members of the FIFRA SAP
are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency.
B. What is the purpose of this public meeting?
In 2007, the National Research Council (NRC)'s report on Toxicity
Testing in 21st Century: A Vision and a Strategy was published which
encouraged a new paradigm in toxicity testing that reduces the reliance
on laboratory animals while moving towards in vitro and in silico
predictive approaches that are more efficient and human relevant. EPA's
Office of Pesticide Programs (OPP) has developed a strategic vision for
implementing the 2007 NRC report that has multiple components involving
a combination of computational and predictive modeling approaches, in
vitro techniques, and limited, targeted in vivo testing.
EPA is actively engaged in numerous activities with respect to
reducing laboratory animal use and implementing in vitro and
computational approaches. As NAMs can provide human relevant
information that may be challenging to obtain with whole animal
testing. EPA is also interested in using in vitro and computational
approaches for reducing the reliance on default assumptions for risk
assessment, including the application of 10X uncertainty factors for
inter- and intra-species extrapolation.
In recent years, EPA began collaborative work with academia, and
industry to use organophosphate pesticides (OPs) as a case study for
the development of NAMs for purposes of using data to inform
extrapolation/uncertainty and safety factors in lieu of reliance on
default factors.
The Agency is interested in using in vitro data to derive
extrapolation factors and evaluate developmental neurotoxicity for
human health risk assessment. Specifically, the Agency is seeking
advice and recommendation from the FIFRA SAP on scientific issues
associated with the evaluation and utility of NAMs as part of a weight
of evidence evaluation of developmental neurotoxicity potential and the
use of in vitro acetylcholinesterase inhibition data to develop
interspecies and/or intraspecies data-derived extrapolation factors for
organophosphate pesticides.
C. How can I access the FIFRA SAP documents and meeting minutes?
EPA's background paper, the supporting materials, and draft charge/
questions provided to the FIFRA SAP will be available by late-June as
described in Unit I.B. The Agency will provide additional background
documents (e.g., the meeting agenda) as the materials become available.
In addition, the FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will also be made available as described in Unit
I.B.
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III. Nominations for Ad Hoc Expert Reviewers
A. How do I nominate someone to be considered as an ad hoc expert
reviewer to assist the FIFRA SAP in this peer review?
As part of a broader process for developing a pool of candidates
for each review, FIFRA SAP staff routinely solicits the stakeholder
community for nominations of prospective candidates for service as ad
hoc reviewers. Any interested person or organization may nominate
qualified individuals to be considered as prospective candidates for a
specific topic. Nominees should be identified by name, occupation,
position, address, email address, and telephone number. The Agency will
consider all nominations of prospective candidates for this review that
are received on or before the deadline identified in the DATES section.
Final selection of ad hoc reviewers is a discretionary function of the
Agency.
B. Who can I nominate to be considered as an ad hoc expert reviewer to
assist the FIFRA SAP in this peer review?
Individuals nominated for this meeting should have expertise in one
or more of the following areas: (i) Data derived extrapolation factors;
(ii) Development and implementation of new approach methodologies;
(iii) Statistics; (iv) Developmental neurotoxicity; (v) In vitro to in
vivo extrapolation; and (vi) Organophosphate pesticides. Nominees
should be scientists who have sufficient professional qualifications,
including training and experience, to provide expert comments on the
scientific issues for this review.
C. How will EPA select ad hoc expert reviewers to assist the FIFRA SAP
in this peer review?
The selection of scientists to serve on a FIFRA SAP review 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
reviewer to fully participate in the Panel's review, absence of any
conflicts of interest or appearance of loss of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of loss
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 a FIFRA SAP review. Numerous
qualified candidates are identified for each review; 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 charge for this review, the
Agency anticipates selecting approximately twelve ad hoc scientists.
FIFRA SAP members and ad hoc reviewers are subject to the
provisions of the Standards of Ethical Conduct for Employees of the
Executive Branch at 5 CFR part 2635, conflict of interest statutes in
Title 18 of the United States Code and related regulations. In
anticipation of these requirements, prospective candidates for service
on the FIFRA SAP will be asked to submit confidential financial
information which shall fully disclose, among other financial
interests, the candidate's employment, stocks, 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 loss 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.
EPA plans to make a list of candidates under consideration as
prospective ad hoc panelists for this meeting available for a 15-
calendar day public comment period in July 2020. The list of the FIFRA
SAP members and ad hoc reviewers participating at this meeting will be
available as described in Unit I.B.
Those who are selected from the pool of prospective candidates will
be asked to attend the preparatory and peer review 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 final report.
IV. Public Participation
A. How may I participate in the public peer review meeting?
You may participate in the public peer review meeting by following
the instructions in this unit. To ensure proper receipt of comments,
nominations or other requests by EPA, it is imperative that you
identify docket ID number EPA-HQ-OPP-2020-0263 in the subject line on
the first page of your request.
1. Written comments. The Agency encourages written comments for the
peer review meeting be submitted using the instructions in ADDRESSES
and Unit I.B. and C, on or before the date set in the DATES section.
Comments received after this date and prior to the end of the oral
public comment period during the meeting will still be provided to the
FIFRA SAP for their consideration. Anyone submitting written comments
after this date, should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments during the
meeting should email the DFO prior to the meeting to arrange for
distribution of their comments to the FIFRA SAP.
2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments to the FIFRA SAP during the peer
review meeting to submit their request to the DFO listed under FOR
FURTHER INFORMATION CONTACT on or before the date set in the DATES
section in order to be included on the meeting agenda. Requests to
present oral comments will be accepted until the date of the peer
review meeting and, to the extent that time permits, the Chair of the
FIFRA SAP may permit the presentation of oral comments at the peer
review meeting by interested persons who have not previously requested
time.
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. Oral comments before
the FIFRA SAP during the peer review meeting are limited to 5 minutes
unless arrangements have been made prior to the date set in the DATES
section. In addition, each speaker should email a copy of his/her
comments to the DFO prior to the meeting for distribution to the FIFRA
SAP.
3. Webcast. This meeting may also be viewed via webcast. Please
refer to the FIFRA SAP website at https://www.epa.gov/sap for
information on how to access the webcast.
B. How may I participate in the preparatory virtual meeting?
Registration for the preparatory virtual meeting is required. To
participate by listening or making a comment during this meeting,
please visit: https://www.epa.gov/sap to register. Registration online
will be confirmed by
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email that will include the webcast meeting link and audio
teleconference information.
1. Written comments. Written comments for the preparatory virtual
meeting should be submitted, using the instructions in ADDRESSES and
Unit I.B. and C, on or before the date set in the DATES section.
2. Oral comments. Registration is required to participate in the
preparatory virtual meeting. Please visit the FIFRA SAP website at
https://www.epa.gov/sap to register online. Each individual or group
wishing to make brief oral comments to the FIFRA SAP during the
preparatory virtual meeting should submit their request when
registering online or with the DFO listed under FOR FURTHER INFORMATION
CONTACT on or before the date set in the DATES section. Oral comments
before the FIFRA SAP during the preparatory virtual meeting are limited
to approximately 5 minutes due to the time constraints of this meeting.
3. Webcast. The preparatory meeting will be webcast only. Please
refer to the FIFRA SAP website at https://www.epa.gov/sap for
information on how to access the webcast. Registration is required.
Authority: 5 U.S.C. App. I; 7 U.S.C. 136 et seq.; 21 U.S.C. 301
et seq.
Dated: June 8, 2020.
Hayley Hughes,
Director, Office of Science Coordination and Policy.
[FR Doc. 2020-13010 Filed 6-16-20; 8:45 am]
BILLING CODE 6560-50-P
