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EPA/OCSPP RIN: 2070-AK54 Publication ID: Spring 2023 
Title: Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived From Newer Technologies 

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 plant-incorporated protectant (PIP) products 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. EPA is reviewing the comments received and is planning to issue a final rule.

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: 7 U.S.C. 136 et seq. Federal Insecticide, Fungicide and Rodenticide Act    21 U.S.C. 346a, Federal Food, Drug, and Cosmetic Act   
Legal Deadline:  None
Action Date FR Cite
Notice  08/20/2020  85 FR 51395   
NPRM  10/09/2020  85 FR 64308   
Notice  05/09/2023  88 FR 29835   
Final Rule  05/31/2023  88 FR 34756   
Final Rule Effective  07/31/2023 
Additional Information: 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.
RIN Information URL:  
Sectors Affected: 111 Crop Production; 325320 Pesticide and Other Agricultural Chemical Manufacturing 
RIN Data Printed in the FR: No 
Agency Contact:
Michael Mendelsohn
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW, Mail Code 75117,
Washington, DC 20460
Phone:202 566-2395

Amanda Pierce
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
Mail Code 7511M, 1200 Pennsylvania Avenue NW,
Washington, DC 20460
Phone:202 566-1470