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Animal and Plant Health Inspection Service
U.S. Department of Agriculture

Regulatory Exemptions

This process takes effect on August 17, 2020 

OVERVIEW
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 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. On August 17, 2020, the exemptions and confirmation process will replace 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). 

Qualifications for Exemption
A developer may review the regulations to assess whether a plant belongs to one of the exempt categories.   

A plant that contains a single modification of a type in one of the following three categories is exempt from regulation:

  1. A change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template; or
  2. A targeted single base pair substitution; or
  3. Introduction of a gene known to occur in the plant’s gene pool, or a change in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool.    

A plant that contains a plant-trait-mechanism of action (MOA) combination that APHIS has already evaluated under the previous or revised regulations and determined by APHIS not to be regulated.  

Note:  BRS will post a list plant-trait-mechanism of action (MOA) combinations that are eligible for exemption. 

Expansion of Exemptions
APHIS can expand the exemptions related to modifications that could otherwise be achieved through conventional breeding to ensure the regulations remain current with technology and science. Stakeholders can also request expansion through a process that provides public notice and comment.  

Confirmation of Exemptions
Developers may seek confirmation from APHIS that a plant meets an exemption and is not subject to the regulation in 7 CFR part 340.  

Learn More About the Confirmation Request Process

View Previous AIR Letters of Inquiry and APHIS Responses 

Learn More About the SECURE Rule

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