The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on February 27, 2025, that it will begin to accept petitions for nonregulated status according to APHIS biotechnology regulations at 7 C.F.R. Part 340 (2019) on March 3, 2025. APHIS notes that its biotechnology regulations enable developers to petition for a determination that an “article” is not regulated. The petition process applies only to plants that meet the regulatory definition of “regulated article.” APHIS states that, in general, “a regulated article is an organism or product that has been altered or produced using genetic engineering (1) that has one or more of its components derived from a plant pest or an unclassified or unknown organism; or (2) that APHIS determines is a plant pest or has reason to believe is a plant pest.” In contrast, according to APHIS, “a genome edited organism (e.g., plant, microbe, insect) that is not a plant pest or likely to be a plant pest is not subject to 7 CFR part 340 (2019), unless the organism retains DNA sourced from a plant pest. Similarly, a transgenic organism that is not a plant pest and not likely to be a plant pest and does not contain DNA sourced from a plant pest is not subject to 7 CFR part 340 (2019).”
Developers whose modified plant meets the definition of “regulated article” can petition for nonregulated status by providing relevant information, data, and publications that substantiate that the modified plant is unlikely to pose a greater plant pest risk than the unmodified plant from which it was derived. APHIS has published a February 2025 “Petition User Guide with Reference To 7 CFR Part 340 — Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests” that provides more information on the specific requirements and instructions on how to apply. APHIS “encourage[s] developers to request a pre-submission consultation to review the information APHIS needs to evaluate a petition and reach a decision.” Requests for a pre-submission consult may be sent to BRS.Petitions@usda.gov.”
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