[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Notices]
[Pages 55448-55450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19779]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2019-0682; FRL-10013-29]
EPA Draft Proposal To Improve Lepidopteran Resistance Management;
Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is making available for public comment a proposal to
improve current resistance management strategies for certain
Lepidopteran pests of Bacillus thuringiensis (Bt) plant-incorporated
protectants (PIPs) in corn and cotton. EPA is soliciting input from all
affected stakeholders such as corn and cotton growers, crop
consultants, industry, academia, non-governmental organizations and the
general public.
DATES: Comments must be received on or before November 9, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2019-0682, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
[[Page 55449]]
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Anne Overstreet, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are a
registrant or manufacturer of Bt PIPs, grow Bt corn or cotton PIPs for
crop or animal production, serve as a corn agronomist, crop consultant
or extension specialist, or conduct insect resistance management-
related research. The following list of North American Industrial
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
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 can I get copies of this document and other related information?
A copy of the proposal, titled ``EPA Draft Proposal to Address
Resistance Risks to Lepidopteran Pests of Bt Following the July 2018
FIFRA Scientific Advisory Panel Recommendation'' is available in the
docket under docket identification (ID) number EPA-HQ-OPP-2019-0682.
II. What action is the Agency taking?
EPA is making available for public comment a proposal to improve
current resistance management strategies for certain Lepidopteran pests
of Bacillus thuringiensis (Bt) plant-incorporated protectants (PIPs) in
corn and cotton. EPA's proposal contains measures designed to delay
lepidopteran development of resistance to Bt corn and cotton PIPs in
response to multiple reports of Bt resistance among some pests. The
proposal was informed by advice received by the Agency from the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory
Panel and from unsolicited comments received from several stakeholder
groups. EPA believes that the proposed measures will prolong the
effectiveness of Bt PIPs for Lepidopteran pest control. This goal has
significance, given the long safety record of Bt PIPs. If used
properly, Bt PIPs greatly reduce the need for conventional pesticides
and the risks they may present to human health and the environment. EPA
is soliciting comments from all affected stakeholders, including corn
and cotton growers, crop consultants, industry, academia, and the
general public.
As part of its regulation of Bt corn and cotton PIPs, EPA requires
measures to delay the development of resistance among target pests.
These measures include the use of non-Bt PIP refuges to provide
susceptible insects (to dilute any resistance genes in the population),
annual monitoring to detect resistance in pest populations, mitigation
steps if resistance develops, a refuge compliance program, and grower
education.
EPA is concerned about recent cases of Bt resistance among corn
and/or cotton pests that have been documented by academic and industry
researchers. Bt resistance has been reported for corn earworm, fall
armyworm, western bean cutworm, and southwestern corn borer. In a white
paper prepared for the SAP meeting, EPA identified a number of risk
factors that likely contributed to these resistance cases and could
lead to more widespread resistance incidents in the future. These risk
factors include a lack of ``high dose'' toxin expression in Bt PIPs for
some of the Lepidopteran target pests, cross resistance between
different Bt PIPs, cross-pollination of Bt and refuge plants in Bt corn
seed blend products, poor compliance with non-PIP refuge requirements,
and ineffective resistance monitoring methods. Seeking guidance on
these concerns, the Agency convened a FIFRA SAP meeting in July 2018.
The panel was tasked with evaluating the reported cases of resistance
and EPA's identified risk factors and providing guidance on potential
improvements to the current resistance management program. Meeting
materials, including EPA's white paper, the charge to the panel, and
the SAP's final report, are available in docket number EPA-HQ-OPP-2017-
0617.
Following the SAP meeting, EPA developed a proposal to bolster
current resistance management strategies for Lepidopteran target pests
of Bt corn and cotton PIPs. EPA's proposal addresses the following
aspects of resistance management:
A proposed new resistance definition for ``non-high dose''
Lepidopteran pests, based on unexpected injury (UXI) levels in Bt corn
and cotton;
Enhanced resistance monitoring using sentinel plots in
regions at high risk of resistance and investigations of UXI cases with
standardized pest damage thresholds;
Improved resistance mitigation for cases of confirmed
resistance by implementing best management practices (BMPs) once UXI
has been detected;
Increased communications among stakeholders to provide
``early warnings'' on potential cases of resistance to Bt PIPs;
Industry reporting to EPA on UXI investigations and BMP
implementation.
EPA believes these proposed enhancements are consistent with the
SAP's guidance and will prolong the effectiveness of Bt corn and cotton
PIPs by reducing selection pressure for resistance, improving
resistance monitoring, and better mitigating populations that do
develop resistance. The Agency's goals are to prolong the durability of
Bt corn and cotton PIPs while maintaining the environmental benefits of
these management tools.
In addition to the above elements, EPA has identified three further
[[Page 55450]]
measures for public comment, but will not take a position on them until
it has reviewed all stakeholder input:
Phase down of single traits and non-functional pyramids;
Increasing percent refuge in seed blend products; and
Measures to improve refuge compliance.
The Agency is seeking input on the proposal from potentially
affected entities and other stakeholders, including (but not limited
to) registrants of Bt PIPs, corn and cotton growers, crop consultants/
agronomists, commodity groups, extension entomologists, academic
researchers, and the general public. Commenters are also encouraged to
provide input on the specific recommendations of the SAP, including
alternate approaches or counter proposals towards addressing the issues
raised by the panel and the Agency's resistance management goals.
During the comment period, EPA will seek to further engage affected
entities and other stakeholders through webinars in late July and
August to discuss the proposal and answer questions.
Authority: 7 U.S.C. 136 et seq.
Dated: August 19, 2020.
Jean Overstreet,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2020-19779 Filed 9-4-20; 8:45 am]
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