BRS Regulatory Process Overview
APHIS regulates the importation, interstate movement, or environmental release (i.e., field trial use) of certain organisms developed using genetic engineering that may pose a plant pest risk.
Under the revised regulations, all regulated activities involving organisms developed using genetic engineering must be authorized through a permit, unless the organism:
Until the RSR process takes effect on April 5, 2021, developers may continue to use permitting, notification, and petition processes in the preexisting regulations. The notification process will be eliminated for all plants on April 5, 2021. More information about these processes can be found below.
Beginning August 17, 2020, the regulatory exemptions and confirmation process in the revised rule take effect. A person can assess whether a plant developed using genetic engineering meets the criteria for a regulatory exemption and has the option of submitting a request for confirmation that the plant is exempt from regulation. If a plant does not meet the exemption criteria, all regulated activities must be authorized through a permit unless the plant completes a regulatory status review (RSR) that results in a finding that the plant is not regulated. Until the exemption process takes effect, please follow the preexisting permitting and notification process.
APHIS issues permits to authorize the importation, interstate movement, or environmental release of organisms developed using genetic engineering that may pose a plant pest risk, including plants, insects, or microbes. Applications for permits include scientific information for APHIS to review before APHIS issues the permit. Once the exemption process takes effect, a permit is not required for any plant that meets the exemption criteria. Until the regulatory status review (RSR) process takes effect on April 5, 2021, developers may continue to use the notification processes in the preexisting regulations for certain plants.
Under the preexisting rule, developers could submit a petition requesting an agency determination that a plant developed using a plant pest is unlikely to pose a plant pest risk, and, therefore, is no longer subject to APHIS’ biotechnology regulations.
Under the revised rule, developers have the option of requesting a permit or a regulatory status review (RSR) of a plant developed using genetic engineering that has not been previously reviewed and determined to be nonregulated. Developers can continue to use the preexisting petition process until the new RSR process is implemented on April 5, 2021 for certain crops, and fully implemented on October 1, 2021 for all crops.
On April 5, 2021, APHIS transitioned from ePermits to APHIS eFile. All applicants are required to use APHIS eFile to apply for permits for organisms developed using genetic engineering. Any applications submitted in the retired ePermits system through April 4, 2021, will complete processing in ePermits. Compliance reports related to these applications must also be submitted in ePermits. BRS will reject any applications submitted in ePermits on or after April 5, 2021.