ASTA Comments on USDA’s Proposed Rule to Update Biotechnology Regulations

  • On August 15, 2019

On August 5, ASTA submitted comments on USDA’s proposed rule to update its biotechnology regulations. USDA’s proposal rightly recognizes that some applications of gene editing result in plant varieties that are essentially equivalent to varieties developed through more traditional breeding methods and would thus treat these varieties in the same way from a policy standpoint. While ASTA supports the exclusion of these specific categories of products from an additional pre-market review under Part 340, the association offered some recommendations relating to the definitions, structure and language of the exemptions.

ASTA provided the following suite of interrelated recommendations: a definition of “genetically engineered organism”; a modification to one of the exemptions to more closely mirror Secretary Perdue’s statement that USDA does not intend to require a pre-market review for new plant varieties that could have been produced through traditional breeding methods; and a companion recommendation for a mandatory process that would provide developers with confirmation that their product meets one of the exemptions, while making information about these products available to stakeholders and the public. See ASTA’s press release for more information.