APHIS Proposes Amendment to Biotechnology Regulation Exemptions

  • On August 5, 2021
  • APHIS, Biotechnology, biotechnology regulation, biotechnology regulation exemptions, plant breeding, USDA APHIS

On July 16, APHIS published for public comment a proposal to amend the list of exemptions under its biotechnology regulation. The proposal would add three additional modifications that plants may contain. APHIS views these modifications as similar to those that could be achieved through conventional breeding. The three additional modifications are:

  1. 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;
  2. A contiguous deletion of any size generated using an externally provided repair template, on one or two homologous chromosomes; and
  3. A change resulting from 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 an insertion of DNA in the absence of a repair template.

The Federal Register noticed can be viewed and comments can be submitted here. The public comment period ends on August 18. ASTA is developing comments regarding the public comment request through its Plant Breeding Innovation Working Group. If you have any questions, contact Fan-Li Chou.