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EPA/OCSPP RIN: 2070-AK54 Publication ID: Spring 2021 
Title: Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived From Newer Technologies 
Abstract:

In 2020, EPA proposed regulations that would allow for an exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) for certain PIPs that are created in plants using biotechnology, as long as their pesticidal substances are found in plants that are sexually compatible with the recipient plant and meet the proposed exemption criteria, ensuring their safety. The current exemption for PIPs is limited to PIPs that are moved through conventional breeding. EPA's proposed rule would allow certain PIPs created through biotechnology to also be exempt under existing regulations, in cases where those PIPs 1) pose no greater risk than PIPs that meet EPA safety requirements, and 2) could have otherwise been created through conventional breeding. The proposed rule also includes a process through which developers of PIPs based on sexually compatible plants created through biotechnology submit either a self-determination letter or request for EPA confirmation that their PIP meets the criteria for exemption. For increased flexibility in bringing PIPs to market, a developer can also submit both. This action is intended to implement section 4(b) of Executive Order 13874 (84 FR 27899, June 11, 2019) on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

 
Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 174   
Legal Authority: 21 U.S.C. 346a, Federal Food, Drug, and Cosmetic Act 7 U.S.C. 136 et seq. Federal Insecticide Fungicide and Rodenticide Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/09/2020  85 FR 64308   
Final Rule  12/00/2021 
Additional Information: Docket #:EPA-HQ-OPP-2019-0508
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
Sectors Affected: 111 Crop Production; 325320 Pesticide and Other Agricultural Chemical Manufacturing 
RIN Data Printed in the FR: No 
Agency Contact:
Amanda Pierce
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
Mail Code 7511P, 1200 Pennsylvania Avenue NW,
Washington, DC 20460
Phone:703 347-0561
Email: pierce.amanda@epa.gov

Wiebke Striegel
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
Mail Code 7511P, 1200 Pennsylvania Avenue NW,
Washington, DC 20460
Phone:703 347-0556
Email: striegel.wiebke@epa.gov