[Federal Register Volume 83, Number 43 (Monday, March 5, 2018)]
[Notices]
[Pages 9307-9310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04418]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2017-0617; FRL-9971-35]
FIFRA Scientific Advisory Panel; Notice of Public Meeting and
Request for Nomination of Ad Hoc Expert Members
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 4-day, in-person meeting of the Federal
Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel
(FIFRA SAP) to consider and review the Resistance of Lepidopteran Pests
to Bacillus thuringiensis (Bt) Plant Incorporated Protectants in The
United States: EPA's Analysis of Scientific Uncertainties Related to
Resistance Management and Options to Enhance the Current Insect
Resistance Management Program. Preceding the in-person meeting, there
will be a half-day virtual preparatory meeting, conducted via webinar
using Adobe Connect, to consider and review the clarity and scope of
the meeting's draft charge questions. Registration is required to
attend this virtual meeting. The date and registration instructions
will be on the FIFRA SAP website http://www.epa.gov/sap by mid-March to
early April.
DATES: The virtual preparatory meeting will be announced in a future
Federal Register Notice and on http://www.epa.gov/sap. The 4-day, in-
person meeting will be held July 17 to July 20, 2018, from
approximately 9 a.m. to 5 p.m.
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ADDRESSES: Meeting: The location of the 4-day, in-person meeting will
be announced in a future Federal Register Notice and on http://www.epa.gov/sap. The virtual meeting will be webcast. Please refer to
the following website for information on how to access the webcast:
http://www.epa.gov/sap.
Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0617, by one of the following methods:
Federal eRulemaking Portal: http://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.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
How to submit nominations, requests to present oral comments, and
requests for special accommodations. Submit nominations of candidates
to serve as ad hoc members of the FIFRA SAP Meeting, requests for
special accommodations, or requests to present oral comments to the DFO
listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Tamue L. 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].
Comments. Written comments should be submitted for both the virtual
preparatory meeting and the in-person meeting on or before May 10,
2018. FIFRA SAP may not be able to fully consider written comments
submitted after May 10, 2018. Requests to make oral comments should be
submitted on or before May 24, 2018 by contacting the Designated
Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.
You may also subscribe to the following listservs to be notified when
notices regarding this and other SAP related activities are published.
https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101, https://public.govdelivery.com/accounts/USAEPAOPPT/subscribers/qualify. 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 review should be provided on or before April 4,
2018. More information can be found under unit I.C.4., Request for
nominations to serve as ad hoc expert members of FIFRA SAP for this
meeting.
Webcast. The virtual preparatory meeting will be webcast only and
registration is required. Please refer to the following website for
information on how to access the webcast: http://www.epa.gov/sap. The
4-day, in-person SAP meeting may also be webcast. You may refer to the
FIFRA SAP website at http://www.epa.gov/sap for information on how to
access the webcast. Please note that the webcast for the in-person
meeting is a supplementary public process provided only for
convenience. If difficulties arise resulting in webcasting outages, the
in-person meeting will continue as planned.
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 at least 10 days prior to the meeting to allow EPA time to
process your request.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general. This action may
be of interest to persons who are or may be required to conduct testing
of chemical substances under the Federal Food, Drug, and Cosmetic Act
(FFDCA) and FIFRA. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact the DFO
listed under FOR FURTHER INFORMATION CONTACT to obtain special
instructions before submitting your comments.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
C. How may I participate in both meetings?
You may participate in both meetings 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-2017-0617 in the subject line on the first page of
your request.
1. Written comments. Written comments for both the in-person and
virtual meetings should be submitted, using the instructions in
ADDRESSES and Unit I.B., on or before May 10, 2018, 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 May 10, 2018.
2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments to FIFRA SAP during the in-person
or virtual meetings to submit their request to the DFO listed under FOR
FURTHER INFORMATION CONTACT on or before May 24, 2018, to be included
on the meeting agenda. Requests to present oral comments during the in-
person meeting will be accepted until the date of the meeting 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 during the virtual
meeting are limited to approximately 5 minutes due to the time
constraints of this webcast. Oral comments during the 4-day, in-person
meeting are limited to approximately 5 minutes unless arrangements have
been made prior to May 24, 2018. 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 in-person 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 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
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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:
Field entomologists with expertise in the southern United States (U.S.)
corn and cotton systems who are either corn earworm/bollworm (both
systems), fall armyworm, and/or western bean cutworm experts; pesticide
resistance modelers with a strong background in entomology, ecology,
and population biology; insect resistance management experts;
population biologists understanding the life-history of corn earworm/
bollworm, fall armyworm, and/or western bean cutworm; corn breeders,
molecular biologists in the field of entomology with an understanding
of the agricultural system in the southern U.S.; social scientists with
expertise in resistance management issues and understanding of dynamics
in the agricultural U.S. (e.g., human and market factors); and
economists with expertise in the U.S. agricultural system and Bt
technology-related issues. Nominees should be scientists who have
sufficient professional qualifications, including training and
experience, to provide 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 April 4, 2018. 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 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 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.
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 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. 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 final
report. The list of FIFRA SAP members participating at this meeting
will be posted on the FIFRA SAP website at http://www.epa.gov/scipoly/sap or may be obtained from the OPP Docket at http://www.regulations.gov.
II. Background
A. Purpose of 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. 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). 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 (NIH) and the National
Science Foundation (NSF). FIFRA established a Science Review Board
(SRB) consisting of at least 60 scientists who are available to FIFRA
SAP on an ad hoc basis to assist in reviews conducted by FIFRA SAP. 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. Members of FIFRA SAP are
scientists who have sufficient professional qualifications, including
training and experience, to provide expert advice and recommendation to
the Agency.
B. Public Meeting
The purpose of the July 2018 SAP is for the Agency to present major
risk factors believed responsible for expediting lepidopteran
adaptation to Bt toxins in the U.S. and associated scientific
uncertainties. Furthermore, the Agency will discuss identified
shortcomings of the current insect sampling methodologies, rearing and
resistance testing of populations and the feasibility of successful
mitigation when resistance is confirmed. In addition, the meeting
serves to assess whether it is warranted scientifically to develop a
resistance management plan for western bean cutworm. The overall goal
of the meeting is to receive recommendations that reduce the resistance
risks for lepidopteran pests, increase the longevity of currently
functional Bt traits and future technologies, and improve the current
insect resistance management program for lepidopteran pests of Bt corn
and cotton.
Lepidopteran resistance to Bacillus thuringiensis (Bt) traits of
corn and cotton were published by academic scientists for the
continental U.S. in 2014 for the fall armyworm (Spodoptera frugiperda),
in 2016 for the corn earworm (Helicoverpa zea), and in 2017 for the
western bean cutworm (Striacosta albicosta). Likewise, industry
reported resistance for the southwestern corn borer (Diatraea
grandiosella) in their resistance monitoring reports to the U.S. EPA in
2016. The Agency identified several risk factors that may have had the
greatest impact on these resistance
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developments. Some of these are: (1) Lack of high dose traits; (2) use
of single modes of action possible year-after-year; (3) corn seed
blends in the southern U.S.; (4) poor refuge compliance for Bt corn in
southern states; (5) continuous selection with same traits expressed in
Bt corn and Bt cotton in a given year; (6) methodological approaches
with monitoring for resistant field populations; and (7) challenges
with identifying resistance using diet bioassays for non-high-dose
pests. The Agency will discuss its analysis of identified risk factors
underlying lepidopteran resistance development in the U.S. as well as
associated scientific uncertainties. Furthermore, the Agency will
discuss its analysis of methodological issues with collecting insects
from the field, rearing and testing populations for resistance, and the
feasibility of mitigating field resistance for Lepidopteran pests.
C. FIFRA SAP Documents and Meeting Minutes
EPA's background paper, charge/questions to FIFRA SAP, and related
supporting materials will be available by mid to late March 2018. In
addition, a list of candidates under consideration as prospective ad
hoc panelists for this meeting will be available for a 15-day public
comment period by late March to early April 2018. You may obtain
electronic copies of most meeting documents, including FIFRA SAP
composition (i.e., members and ad hoc members for this meeting) and the
meeting agenda, at http://www.regulations.gov and the FIFRA SAP website
at http://www.epa.gov/scipoly/sap.
FIFRA SAP will prepare the meeting minutes and final report
approximately 90 calendar days after the in-person meeting. The meeting
minutes and final report will be posted on the FIFRA SAP website:
https://www.epa.gov/sap and may be accessed in the docket at https://www.regulations.gov.
Authority: 7 U.S.C. 136 et. seq.; 21 U.S.C. 301 et seq.
Dated: February 21, 2018.
Stanley Barone Jr.,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2018-04418 Filed 3-2-18; 8:45 am]
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