View Rule

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.

Statement of Need:

This deregulatory rule would exempt from regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) plant-incorporated protectants (PIP) based on sexually compatible plants created through biotechnology. This rule is intended to further implement section 4(b) ("Regulatory Streamlining") of Executive Order No. 13874, 84 Fed. Reg. 27899 (June 11, 2019), Modernizing the Regulatory Framework for Agricultural Biotechnology Products. This proposed rule provides meaningful burden reduction by exempting PIPs based on sexually compatible plants created through biotechnology from the requirements of registration under FIFRA and from the requirement of a tolerance under FFDCA.

Summary of the Legal Basis:

This action is issued under the authority of section 25 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136w et seq. and section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e).

Alternatives:

The alternative to this rule is that the products proposed to be exempted from FIFRA and FFDCA in this rule would be required to obtain a pesticide registration.

Anticipated Costs and Benefits:

The direct benefit of the proposed rule is the reduced regulatory burden associated with developing and marketing a PIP based on sexually compatible plants created through biotechnology. The agency estimates the cost savings per PIP to be between $444,000 $459,000. The proposed exemption may encourage more research and development in this area of biotechnology and better enable firms of all sizes to engage in the development of these types of PIPs. Entities that support minor crops may not support markets large enough to warrant fixed registration costs. These entities may feel the most regulatory relief as a result of this rule. Crop varieties modified for greater pest and disease resistance could also reduce the usage of externally applied pesticides, which in turn, could provide environmental benefits. Growers may also benefit because they will have more tools available to combat pest pressures. This rule is deregulatory and is not expected to result in any increase in costs to developers, growers or food consumers. EPA expects that risks to human health or the environment of PIPs based on sexually compatible plants created through biotechnology would not be greater than any risks of plant products produced through conventional breeding. Subjecting this type of PIP to FIFRA requirements would provide little or no benefit to society in terms of avoided risks to human health and the environment beyond the types of risks normally associated with agricultural production and agricultural products created by conventional breeding.

Risks:

It is possible there may be risks from PIPs based on sexually compatible plants created through biotechnology coming to market with less scrutiny. However, EPA expects that potential risks to human health or the environment of PIPs based on sexually compatible plants created through biotechnology would not be greater than any risks of plant products produced through conventional breeding.