EPA Proposes Expanded FIFRA Exemptions for Certain Plant-Incorporated Protectants (PIPs) Created Using Gene Editing

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The US Environmental Protection Agency has proposed to amend its pesticide regulations to exempt from FIFRA, the federal pesticide statute, certain pesticidal substances (PIPs) created in plants using biotechnology, so long as the pesticidal substance is found in plants that are sexually-compatible with the recipient plant, i.e., the plant is equivalent to a plant that could have been created using conventional breeding.

Background

EPA regulates pesticides, defined as substances intended for “preventing, destroying, repelling, or mitigating any pest.” Consistent with this authority, EPA regulates pesticidal substances introduced intentionally into plants for the purpose of providing protection to the plants. EPA refers to these pesticidal substances as plant-incorporated protectants, or PIPs. Unless exempted, EPA must evaluate PIPs before they are sold and distributed in interstate commerce to ensure that their proposed use would not cause unreasonable adverse effects on humans or the environment.

EPA’s regulations at 40 C.F.R. Part 174 outline how it regulates PIPs. The current version of those regulations exempts from regulation under FIFRA PIPs that are moved into a plant through conventional breeding. Residues of conventionally-bred PIPs appearing on food or feed, which would ordinarily be required to obtain either a tolerance (a maximum residue limit) or a tolerance exemption under section 408 of the Federal Food, Drug, and Cosmetic Act, are exempt from those requirements as well. Conventionally-bred PIPs remain subject to FIFRA’s adverse effects reporting requirements, under which pesticide registrants must report to EPA regarding additional factual information regarding a pesticide’s unreasonable adverse effects on the environment. PIPs created using biotechnology, even if produced using advanced breeding methods that render the plant indistinguishable from a plant produced using conventional breeding, are ineligible for the conventional breeding exemption as currently drafted.

How Would the Proposed Rule Change EPA’s Approach?

EPA’s proposed rule would expand the PIPs exemption to include PIPs created through biotechnology, including some applications of gene editing, where the pesticidal substance is found in plants that are sexually-compatible with the recipient plant. To be eligible for the exemption, the PIPs must (i) meet certain safety criteria that ensure that the newly-exempt PIPs “pose no greater risk than the currently exempt sexually compatible PIPs,” and (ii) be able to have been created through conventional breeding. In addition, (iii) developers of such PIPs must either submit a self-determination letter to EPA, ask EPA to confirm that the PIP meets EPA’s exemption criteria, or both. Like conventionally bred PIPs, the newly exempted PIPs would remain subject to FIFRA’s existing adverse effects reporting requirements, along with a newly proposed recordkeeping requirement.

Why Did EPA Expand Its Exemption?

FIFRA provides EPA with authority to exempt any pesticide from some or all of FIFRA’s requirements if the pesticide is of a character that is unnecessary to be subject to all of the requirements of FIFRA, i.e., pesticides that EPA determines (i) pose a low probability of risk to the environment; and (ii) are not likely to cause unreasonable adverse effects to the environment, even in the absence of EPA regulatory oversight, taking into consideration both the risks and benefits of a product.

What's the Current Status of the Rulemaking?

EPA released a “pre-publication” copy of the proposed rule on August 31, 2020, and the proposed rule was published in the Federal Register on October 9, 2020. EPA is accepting comments on the proposed rule for 30 days, until December 8, 2020. Comments can be submitted to the following docket number on Regulations.gov: EPA-HQ-OPP-2019-0508.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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