U.S. Environmental Protection Agency (EPA) finalizes rule to accelerate use of plant-incorporated biotechnologies to protect against pests

Date:06-05-2023

Recently, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIPs) created using genetic engineering from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). This rule ensures that public health and the environment are protected while reducing costs for the regulated community, consistent with Executive Order 14081 on advancing biotechnology. The rule may also result in increased research and development activities, commercialization of new pest control options for farmers (particularly in minor crops such as grapes and cucumbers), and reduced use of conventional pesticides.

All plants naturally contain mechanisms to help them withstand pathogens and other pests. In its regulations, EPA uses the term ″PIP″ to describe these pesticidal traits. EPA has regulated PIPs for over 25 years, with the majority of PIPs registered under FIFRA being genetically engineered with beneficial traits derived from other organisms. PIPs are one of the safest methods to control pests because of their narrow activity spectrum, and their use can greatly reduce the need for conventional pesticides. Advances in science and technology now enable the modification of plants’ genomes such that PIPs created using genetic engineering can be indistinguishable from those found in conventionally bred plants.

The final rule will allow PIPs to be exempt from FIFRA registration and FFDCA tolerance requirements in cases where they both pose no greater risk than PIPs that EPA has already concluded meet safety requirements, and when they could have otherwise been created through conventional breeding. Today’s final rule reflects the biotechnological advances made since 2001, when the Agency first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements but did not at that time exempt PIPs created through biotechnology.

Specifically, the final rule includes:

• Exemptions from FIFRA registration and FFDCA tolerance requirements for:

• PIPs in which genetic engineering has been used to insert or modify a gene to match a gene found in a sexually compatible plant; and,

• Loss-of-function PIPs in which the genetically engineered modification reduces or eliminates the activity of a gene, which then helps makes the plant resistant to pests.

• A required notification process to increase transparency and public confidence in these products. Developers of PIPs in the first exempted category additionally require an EPA confirmation that their PIP is eligible for the exemption, whereas developers of PIPs in the second exempted category can determine on their own whether the exemption applies.

In the future, as biotechnology advances further, the Agency intends to consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements as well as by adding categories of exempted PIPs to the list of categories that do not require EPA confirmation of eligibility.

Upon publication of the federal register notice, the final rule and additional information, including EPA’s response to comments will be available in docket EPA-HQ-OPP-2019-0508 at www.regulations.gov.