U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) is sharing its final notice describing additional modifications plants can have and qualify for exemption from the regulations at 7 CFR part 340 because the modifications could be achieved through conventional breeding. This notice becomes effective upon publication in the Federal Register on November 13, 2024. APHIS has also updated its guide to assist developers with requesting a confirmation of exemption from regulation.
APHIS received and considered nearly 6,500 comments on the proposal it published in November 2023, and is now finalizing two additional modifications that: provide additional flexibilities in how developers can use biotechnology to create modified plants that could have been achieved through conventional breeding; and increase the number of modifications a plant can contain, from one modification to as many as twelve modifications, and qualify for exemption from regulation.
This notice brings APHIS' biotechnology regulations up to date with advances in science, technology, and conventional breeding techniques. It ensures that plants with similar characteristics are treated similarly from a regulatory perspective.
APHIS anticipates that expanding the scope of modifications that plants can contain and be exempt from its regulations will foster innovation, enable a larger number of smaller businesses and academic institutions to engage in innovative agricultural product development and expand the number and variety of new crops being developed through biotechnology.
Under 7 CFR part 340, developers can review our exemptions to determine if their modified plant meets the criteria for regulatory exemption. They can also voluntarily request that APHIS confirm their modified plant meets the criteria for regulatory exemption. To learn more about these additional modifications plants can contain and qualify for exemption from regulation, please consider registering to attend our stakeholder meeting on November 14.