Biotech Updates

USDA APHIS Proposes Exemption of Gene Modifications Similar to Conventional Breeding from Biotech Regulations

July 21, 2021

The US Department of Agriculture's Animal and Plant Health Inspection Service (USDA APHIS) is soliciting comments on their proposal to exempt some gene modifications in plants from biotech regulations.

According to USDA, the three modifications are similar and functionally equal to modifications that can be achieved through conventional breeding. These include the following:

  1. the same or distinct loss of function mutations in the paternal and maternal alleles of a single gene resulting from the repair of a targeted DNA break in the same location on two homologous chromosomes in the absence of a repair template;
  2. a contiguous deletion or any size generated using an externally provided repair template, on one or two homologous chromosomes; and
  3. a change resulting from the repair of two targeted double-strand breaks on a chromosome, or at the same location on two homologous chromosomes, when the repair results in a contiguous deletion of any size in the presence or absence of a repair template, or in a contiguous deletion of any size combined with insertion of DNA in the absence of a repair template. 

Read the USDA APHIS proposal and the Federal Register Notice for more details.


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