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EPA/OCSPP RIN: 2070-AK54 Publication ID: Fall 2019 
Title: ●Protectants (Pips) To Reflect Newer Technologies 

EPA is considering proposing to update the existing exemptions from regulation under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) for certain plant incorporated protectants (PIP) products to reflect newer technologies, i.e., the exemptions are from the requirements to obtain a pesticide registration under FIFRA and establish a tolerance or tolerance exemption for residues in or on food commodities under FFDCA. EPA regulations (40 CFR 174.3) define a PIP as a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant or produce thereof. EPA currently regulates all PIPs except those exempted by regulation at 40 CFR 174.25 and 174.508.

Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 40 CFR 150-180     (To search for a specific CFR, visit the Code of Federal Regulations.)
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

Statement of Need:

This action fulfills the requirement in section 4(b) of Executive Order 13874, entitled Modernizing the Regulatory Framework for Agricultural Biotechnology Products (84 FR 27899, June 14, 2019), which directs the EPA Administrator to use existing statutory authority, as appropriate, to exempt low-risk products of agricultural biotechnology from undue regulation to the extent consistent with law and the principles set forth in section 3 of the Executive order.

Summary of the Legal Basis:

This action is being developed under the authority of sections 3, 5, 10, 12 and 25 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 and 136y), and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).


The main alternative is to continue to consider individual requests for exempting these PIPs on a case-by-case basis.

Anticipated Costs and Benefits:

An assessment of the incremental impacts of this update will be provided in greater detail in the economic analysis that will accompany the proposal, and is only briefly summarized here, The primary benefits to society associated with the proposed exemptions of these PIPs from FIFRA and FFDCA requirements are the reduction in the regulatory barriers to the development and production of this category of PIPs and in barriers to adoption by growers. These exemptions also save Agency resources that would be spent evaluating these products if individual registration and establishment of tolerances/exemptions were required. In providing exemptions from existing requirements, without imposing any new requirements, the incremental impacts of this proposal involve savings from the costs associated with the existing requirements.


These PIPs are formed when genetic material is transferred using bioengineering technology between plants that could otherwise transfer the genetic material by natural interbreeding.

Action Date FR Cite
NPRM  02/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Eric Bohnenblust
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
Mail Code 7505P, 1200 Pennsylvania Ave NW,
Washington, DC 20460
Phone:703 347-0426

Cameo Smoot
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
Washington, DC 20460
Phone:703 305-5454