APHIS Announces Final Regulatory Status Review Guide

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is posting its final Regulatory Status Review (RSR) guide. It details the information requirements and process for submitting a RSR request under the revised biotechnology regulations at 7 CFR part 340.

Previously, developers submitted a petition to APHIS requesting deregulation of a modified organism if sufficient information was available to determine whether the organism was unlikely to pose a plant pest risk. Organisms that are unlikely to pose a plant pest risk are not subject to APHIS’ biotechnology regulations. APHIS discontinued the petition process on October 1, 2021.

Under the revised regulations, developers may request a permit and/or a regulatory status review of a plant developed using genetic engineering that the Agency has not previously reviewed. Developers may submit a request for a regulatory status review when they believe a modified plant is not subject to regulation. We review the modified plant and considers whether it might pose an increased plant pest risk compared to a nonregulated plant. If our review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, we will post the request, our response letter, and the plant, trait, and a general description of the Mechanism of Action (MOA) on our website. The posting of plant, trait, and MOA combinations provides a growing range of modifications that are eligible for exemption from regulation. Alternatively, if we are unable to make such a finding, the modified plant is subject to regulation.

If you have additional questions regarding RSR requests, please contact us at RSRrequests@usda.gov.