USDA Seeks Comment on Proposed Biotechnology Regulations Update

JULY 20, 2021

The USDA Animal and Plant Health Inspection Service (APHIS) is seeking comment on a proposal to add three modifications that plants could contain and be exempt from USDA’s biotechnology regulations, due to similarities to modifications that could otherwise be achieved through conventional breeding.

The three modifications covered by an exemption following the proposed biotechnology regulation changes are:

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