Regulatory Exemptions and Confirmations
On Dec. 2, 2024, the United States District Court for the Northern District of California, vacated the U.S. Department of Agriculture (USDA) final rule (7 CFR part 340) issued in May 2020 for organisms developed using genetic engineering. Regulatory Status Review responses, Confirmation Request responses, and active permits that USDA issued prior to Dec. 2, 2024, remain valid. APHIS is determining next steps and will provide additional guidance to stakeholders.
Developers can request a confirmation from APHIS that a modified plant qualifies for an exemption and is not subject to the regulations in 7 CFR part 340.
Under APHIS biotechnology regulations, certain categories of modified plants are exempt from regulation because they could otherwise have been developed through conventional breeding techniques and thus are unlikely to pose an increased plant pest risk compared to conventionally bred plants. Plants that have a plant-trait-mechanism of action combination that has been previously reviewed and determined by APHIS to be unlikely to pose a plant pest risk and therefore to be not regulated are also exempt from the regulations.
When developers request a confirmation from APHIS, we will provide a written response (“confirmation letter”) within 120 days of receiving a sufficiently detailed confirmation request. APHIS will post both the confirmation requests and the issued confirmation letters on its website, with redactions to protect Confidential Business Information and Personal Identifying Information, as appropriate.
*As part of 2020 revisions to the regulations, “Am I Regulated?” responses issued under the legacy regulations that indicated the nonregulated status of specific plants are considered valid exemptions from the current regulations for the particular requestor and specific plant(s).
Plants that are exempt from the regulations
Plants that contain the following types of modifications that could otherwise be achieved through conventional breeding:
- (b)(1): A change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template
- (b)(2): A targeted single base pair substitution
- (b)(3): The introduction of a gene known to occur in the plant’s gene pool; or changes in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool
- (AM1): An indel or contiguous deletion of any size, made at a targeted location, with or without insertion of DNA if generated without using a repair template, or without insertion of DNA if generated using a repair template
- (AM2): A plant with up to twelve (12) modifications, made simultaneously or sequentially, if each modification individually qualifies for exemption and occurs in a different gene
APHIS can expand the exemptions related to modifications that could otherwise be achieved through conventional breeding to ensure the regulations remain current with technology and science. Stakeholders can also request expansion through a process that provides public notice and comment.
Plants that contain a plant-trait-mechanism of action (MOA) combination that APHIS has already evaluated under the legacy or current regulations and determined are not subject to the regulations.
- BRS Guide for Requesting a Confirmation of Exemption (1.28 MB)
- Guide for Submitting Confidential Business Information (492.34 KB)
- Guidance for Preparing Proposals to Exempt Plants with Additional Modifications from Regulation Pursuant to 7 CFR § 340.1(b)(4) (431.95 KB)
- Table of Confirmation Letters
- Plant-Trait-Mechanism of Action (MOA) Table
- Submit a Confirmation Request
- Submit a Question About Confirmations