This original announcement was published by the EPA on August 4, 2023. Click here for more information.
The U.S. Environmental Protection Agency (EPA) is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIPs) exemption rule. These resources are available on EPA’s public website, https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated-0 and include the following:
- Fact sheet and background information on PIPs rule
- Examples of genetic modifications that are exempt under the rule
- Description of how to submit a self-determination or a request for EPA confirmation of exemption under the rule
- Sample documents for submitting a self-determination or request for confirmation
The PIPs Exemption Final Rule went into effect on July 31, 2023.
In May 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting two categories 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 human health and the environment are protected while reducing costs for the regulated community, consistent with the September 2022 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, and reduced use of conventional pesticides.
The 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 exempts PIPs derived through genetic engineering from FIFRA registration and FFDCA tolerance requirements in cases where the PIPs are essentially equivalent to those exempted by the 2001 rule.
The rule contains conditions for exempting:
1) PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption; and
2) Loss-of-function (LoF) PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect. For this category of PIP, biotechnology developers can make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.
EPA also indicated in the preamble to the rule that EPA would consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements and expanding the categories of PIPs that are allowed the option to self-determine and do not require EPA confirmation of eligibility for the exemption.
The resources mentioned above, as well as the final rule and additional information, including EPA’s response to comments, are available on EPA’s website https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated-0.