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January 9, 2023

APHIS Announces Final Regulatory Status Review Guide

Lynn L. Bergeson Carla N. Hutton

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a plant developed using genetic engineering that APHIS has not previously reviewed. Developers may submit a request for an RSR when they believe a modified plant is not subject to regulation. APHIS will review the modified plant and consider whether it might pose an increased plant pest risk compared to a nonregulated plant. If its review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS will post the request, its response letter, the plant, trait, and a general description of the Mechanism of Action (MOA) on its website. The posting of plant, trait, and MOA combinations provides a growing range of modifications that are eligible for exemption from regulation. Alternatively, if APHIS is unable to make such a finding, the modified plant is subject to regulation.