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 any 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. APHIS will provide a written response (“confirmation letter”) within 120 days of receiving a sufficiently detailed confirmation request. APHIS will post both the confirmation requests and the issued confirmation letters on its website, with redactions to protect Confidential Business Information and Personal Identifying Information, as appropriate. 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).
GUIDANCE FOR SUBMITTING A CONFIRMATION REQUEST