SPECIAL SESSION: Beneficial Microbes: From Isolation to Product Registration and the Regulatory Process
USDA Regulation of Genetically Engineered Plants and Microorganisms
Patricia de Sa Snow - USDA APHIS BRS.
Biotechnology Regulatory Services (BRS) is an operational program unit within USDA’s Animal and Plant Health Inspection Service (APHIS) that implements regulations for certain genetically engineered (GE) organisms that may pose a risk to plant health. These regulations are codified in Title 7 Code of Federal Regulations part 340, with statutory authority derived from the Plant Protection Act (PPA), a part of the larger Agricultural Risk Protection Act of 2000. APHIS BRS issues authorizations (permits and notifications) for interstate movement, importation and release of GE organisms that pose a plant pest risk, including plants, invertebrates, or microbes. Developers can petition APHIS to determine that a GE plant is no longer regulated under the plant pest provisions of the PPA or the regulatory requirements of 7 CFR 340. The developer must provide data, often from APHIS regulated confined field tests, to help inform the determination of whether the GE plant poses no more of a plant pest risk than its non-GE comparator. Developers that are not sure if the GE plant they developed meets the definition of a regulated article may seek a confirmation of regulatory status by submitting an “Am I Regulated” (AIR) inquiry to BRS. Potential plant pest and weediness risks and environmental impacts of GE organisms are assessed by APHIS scientists who review applications for authorizations, petitions, AIR inquiries, potential non-compliance issues and proposed regulatory changes, and who establish permit conditions to ensure containment and field confinement of regulated GE organisms.