[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: 
[email protected].

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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