2070-AK54 201910 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 2070 Office of Chemical Safety and Pollution Prevention OCSPP 2000 Environmental Protection Agency EPA 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.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 40 CFR 150-180 21 U.S.C. 346a, Federal Food, Drug, and Cosmetic Act 7 U.S.C. 136 et seq., Federal Insecticide Fungicide and Rodenticide Act Yes

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.

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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).

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

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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.

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

]]> NPRM 02/00/2020 No Businesses None No No No No Eric Bohnenblust 2070 Office of Chemical Safety and Pollution Prevention OCSPP 703 347-0426 bohnenblust.eric@epa.gov Mail Code 7505P, 1200 Pennsylvania Ave NW, Washington DC 20460 Cameo Smoot 2070 Office of Chemical Safety and Pollution Prevention OCSPP 703 305-5454 smoot.cameo@epa.gov 7506P, Washington DC 20460