[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.

[[Page 9308]]


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

[[Page 9309]]

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

[[Page 9310]]

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]
 BILLING CODE 6560-50-P


