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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.

Statement of Need:

This rule implements the policy goals articulated by multiple administrations to improve, clarify, and streamline regulations of biotechnology, beginning with the White House Office of Science and Technology Policy in a policy statement in 1986 on the “Coordinated Framework for the Regulation of Biotechnology” (51 FR 23302; June 26, 1986), the update to the Coordinated Framework in 2017, and, more recently, the June 11, 2019, Executive Order 13874 (84 FR 27899) on “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.” This rulemaking is intended to further implement section 4(b) of Executive Order 13874.

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).

Alternatives:

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 action is provided in greater detail in the economic analysis that will accompany the final rule.  As described for the proposed rule, the primary benefits to society associated with the exemptions of these PIPs from FIFRA and FFDCA requirements are the reduction of overall registration costs (fees plus data requirement costs) to developers of PIPs exempted in the rulemaking with a per-product cost saving estimated to range from $472,000 - $886,000 using a 3% discount rate on future maintenance fees. These exemptions may also result in increased commercialization of new pest control options for farmers, particularly in minor crops, and reduced use of conventional pesticides, which could provide environmental benefits.

Risks:

EPA did not identify any risks to humans or the environment as a result of this action.