Permit Process Overview
APHIS regulates the importation, interstate movement, or environmental release (i.e., outdoor field trials) of certain organisms developed using genetic engineering (including plants, insects, and microbes) that may pose a plant pest risk. Permit applications, which are carefully reviewed by APHIS regulatory scientists, provide details about the nature of the organism and the conditions that will be used to prevent the spread and establishment of the organism in the environment. A permit may include additional conditions to help prevent unauthorized release into the environment.
Under the revised regulations, certain categories of modified plants are exempt from the regulations because they could otherwise have been developed through conventional breeding techniques and thus are unlikely to pose an increased plant pest risk compared to conventionally bred plants. These exemptions apply only to plants because the long history of plant breeding provides us extensive experience in safely managing associated plant pest risks. In addition, plants that have a plant-trait-mechanism of action combination that is the same as in a plant that has been determined by APHIS to be unlikely to pose a plant pest risk and therefore to be not regulated are exempt from the regulations
Developers can request a confirmation from APHIS that a modified plant qualifies for an exemption and is not subject to the regulations in 7 CFR part 340. This confirmation process replaces the preexisting “Am I Regulated?” (AIR) process. Previous AIR responses indicating nonregulated status of organisms are still considered valid exemptions from the new regulation for the particular requestor and specific plant(s).
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.