Comment on Morphing U.S. Biotechnology Regulations

The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the opportunity to influence government policy regarding federal and international biotechnology regulations that will affect anyone sourcing or manipulating genetic material. We expect these policies to be particularly salient for developers in the food, agriculture, and pharmaceutical industries. Comments will be considered by the applicable agencies and will ultimately shape the regulatory compliance and intellectual property landscape in the United States and around the world for genetic-centric innovations.

• The USDA Animal and Plant Health Inspection Service (APHIS) Is Seeking Comments by December 15, 2023, on Five Additional Proposed Exemptions to the Revised Biotechnology Regulations (7 C.F.R. Part 340). By December 14, 2023, nearly 3,000 comments were submitted, and APHIS announced that it would reopen the comment period for an additional 21 days to encourage submission of additional comments.

• APHIS proposes five additional exemptions for plants with modifications that could be achieved through conventional breeding, expanding the category of modified plants that are not subject to regulation.

• From the inception of the SECURE Rule, the agency planned to add additional exemptions, but this is the first instance of concrete proposals, originating from internal evaluations and public comments on Regulatory Status Review (RSR) requests. The Federal Register notice was published on November 15, 2023, and comments may be submitted here until December 15, 2023.

• At a meeting for stakeholders on November 15, APHIS representatives outlined the proposed exemptions and described how the three current exemptions in 7 CFR § 340.1(b)(1)–(3) (regarding a genetic change caused by cellular repair of a targeted, single double-stranded break; a targeted single base pair substitution; and the introduction of certain types of known sequences) are to be expanded. The five proposed exemptions include the following:

  • certain combinations of loss-of-function modifications at a single locus;
  • certain types of contiguous deletions of any size;
  • certain autopolyploid plants containing modifications described in the current exemptions;
  • certain plants with up to four simultaneous or sequential modifications at different loci that would individually qualify for exemption; and
  • certain further modifications to plants containing modifications that have already been confirmed exempt via voluntary review.

• Further, APHIS representatives indicated that the exemptions could potentially be further expanded if APHIS is provided literature showing that additional categories of modifications could be accomplished by conventional breeding. Additional information on the proposed exemptions may be found here.

• USPTO Is Seeking Comments by January 22, 2024, on Potential Intellectual Property and Genetic Resources Treaty.

• Nagoya at the Patent Office? The USPTO is seeking comments to inform U.S. government participation in international negotiations relating to the proposed “International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources.” Comments may be submitted until January 22, 2024.

• The United States is not a party to the Nagoya Protocol and does not currently enforce access and benefit-sharing provisions related to genetic resources, but upcoming negotiations may result in Nagoya-like protections that, according to the USPTO’s request for comments, “may result in changes to requirements for filing patent applications and for challenging patent rights.”

• USDA Is Requesting Comments by March 8, 2024, on Specialty Crops Competitiveness Initiative.

• USDA announced a new initiative to revamp its support of the U.S. specialty crops industry to increase its competitiveness in foreign markets, enhance domestic marketing, and improve production and processing practices. Feedback is requested for any and all of the wide-ranging efforts of the agency related to specialty crops, including the Specialty Crop Block Grant Program and the National Organic Program.

• More information on the initiative can be found here and comments may be submitted until March 8, 2024.

Finally, a recent interagency publication illustrates the benefit of robust stakeholder-agency dialogue through comment submission. In response to industry concerns about lack of clarity regarding the regulation of activities spanning the respective jurisdictions of the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and USDA, the agencies provided a useful orientation tool to the Coordinated Framework for Biotechnology Products:

• The (Increasingly) Coordinated Framework: E.O. 14081 Implementation Forges Ahead.

• An FDA-EPA-USDA joint publication was released on November 9, 2023 on the Unified Website for Biotechnology Regulation with informative case studies, addressing previous comments asking the agencies to clarify the “who, what, when” of the interagency framework as applied to cutting-edge applications of biotechnology. The publication provides case study examples of biomanufacturing (e.g., “intergenic yeast modified for ethanol production”), genetically altered non-food animals (e.g., “Self-limiting mosquito”), and cellular agriculture (e.g., “Pig”).

If you are considering submitting comments in response to any of the agency requests above, we recommend consulting with counsel who are knowledgeable about the U.S. biotechnology framework and the agencies’ actions to date.