EPA Exempts Categories of Genetically Engineered Plant-Incorporated Protectants from Regulatory Requirements

On May 31, 2023, EPA published a final rule exempting two categories of plant-incorporated protectants (PIPs) created using genetic engineering from certain Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration requirements and from food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA).  In addition to reducing regulatory burden, EPA stated in a press release that the final rule may result in increased research and development in this sector and provide more pest control options for farmers, ultimately reducing the use of conventional pesticides.

PIPs are defined (in part) at 40 CFR 174.3 as “pesticidal substance[s] that [are] 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.”  In 2001, EPA exempted PIPs derived through conventional plant breeding from FIFRA registration and FFDCA food tolerance requirements, but did not exempt PIPs created using biotechnology.  Because of recent scientific advances, however, EPA writes that PIPs “can now be created through genetic engineering that are virtually indistinguishable from those created through conventional breeding.”  The final rule adds exemptions for the following two categories of genetically engineered PIPs, which EPA states pose no greater risk than PIPs created through conventional breeding:

  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.
  2. Loss-of-function 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 either 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.

Exempted PIPs are still subject to the adverse effects reporting requirements at 40 CFR 174.71 and recordkeeping requirements.

In the preamble to the final rule, EPA established that the Agency is open to considering additional PIP category exemptions and expanding the categories of PIPs that are allowed to self-determine without EPA confirmation of their eligibility exemption.