As reported in our December 5, 2024, blog item, on December 4, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it acknowledges the U.S. District Court for the Northern District of California’s December 2, 2024, ruling prospectively vacating USDA’s May 2020 final rule for organisms developed using genetic engineering. National Family Farm Coalition, et al. v. Vilsack (No. 3:21-cv-05695-JD). As reported in our May 18, 2020, memorandum, the final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule amended the regulations regarding the movement of certain genetically engineered organisms in response to advances in genetic engineering and APHIS’s understanding of the plant pest risk posed by genetically engineered organisms. APHIS announced on December 10, 2024, that it is re-establishing the regulatory and non-regulatory processes under the pre-May 2020 framework, 7 C.F.R. Part 340 (2019), “including pathways for authorizing regulated activities, commercializing products, and providing compliance oversight for products of biotechnology.” In keeping with its pre-2020 approach, APHIS will restart the Am I Regulated process. If stakeholders are unsure whether an organism developed using genetic engineering meets the definition of a “regulated article,” they may submit an “Am I Regulated” inquiry. APHIS states that “in the coming days,” it will resume issuing permits under 7 C.F.R. Part 340 (2019). Stakeholders who have already submitted a permit application and wish to remove constructs that do not meet the definition of a “regulated article” and, thus, are not subject to regulation, may withdraw the permit application and resubmit it. APHIS notes that the APHIS eFile system “enables permit holders to easily clone an application, copy constructs, and then delete those that are not necessary.” Instructions can be found in the APHIS eFile Job Aid on pages 45-46. APHIS intends to provide additional information on resuming the notification process in the coming weeks.