The United States Department of Agriculture and the Food and Drug Administration have recently initiated processes to evaluate and propose revisions to their approaches to the regulation of products of agricultural biotechnology.

On June 29, 2018 the USDA’s Animal and Plant Health Inspection Service released a notice of its intent to prepare an environmental impact statement in connection with potential changes to USDA regulations governing plant biotechnology products. The notice identifies potential issues APHIS will evaluate in the EIS and seeks public comments on the impacts and alternatives the agency should consider. Comments on the notice are due by July 30, 2018.

As part of the Federal Coordinated Framework for Regulation of Biotechnology, APHIS has a robust pre-market program for the regulation of certain biotechnology-derived plants and other organisms that may pose plant pest risks. APHIS carries out this program pursuant to its 7 CFR Part 340 regulations implementing the Plant Protection Act, 7 U.S.C. § 7701 et seq. APHIS issued a proposed rule updating its Part 340 regulations in January 2017, which the Agency withdrew in November 2017, stating that it intended to take a “fresh look” at its approach to regulating plant products of biotechnology. Since that withdrawal, USDA has clarified its regulatory approach with respect to plant breeding innovation, formally announcing in March 2018 that it does not intend to regulate plants created using new breeding techniques, such as gene editing, as long as they are not plant pests or developed using plant pests. APHIS’s latest notice cites the “major advances in the science of biotechnology” during the past 30 years and APHIS’s “considerable experience in assessing the plant health risks” of biotechnology-derived organisms since 1987, giving a clear signal that the agency has re-initiated the process of updating its Part 340 regulations. A new proposed rule is anticipated in the coming months, potentially before the end of the year.

Federal agencies are required under the National Environmental Policy Act, 42 U.S.C. § 4321 et seq. to prepare an EIS examining potential environmental impacts of proposals for major federal actions significantly affecting the environment and alternatives to those actions. Through its June 29 notice, APHIS has alerted stakeholders and the public that it intends to prepare a programmatic EIS in connection with the Part 340 revisions under consideration and lists a number of potential issues to be addressed in the EIS, including US agriculture and forestry production; the use of biotechnology-derived organisms in agriculture and forestry; agronomic practices; aspects of the physical and biological environment; consumer health and worker safety; and animal feed safety and animal health, among others. Upon completion of the draft EIS, the Agency will publish a notice in the Federal Register announcing its availability and initiate a public comment period.

FDA

APHIS’s review of its Part 340 regulations is part of a broader federal effort to examine federal oversight of biotechnology-derived products to address advances in biotechnology in a manner consistent with recommendations issued by the Interagency Task Force on Agriculture and Rural Prosperity earlier this year. In June, the Food and Drug Administration announced “new steps” in its approach to the regulation of biotechnology-derived products, including formation of a new Biotech Working Group and forthcoming release of an Action Plan to ensure a “flexible regulatory framework” focused on three key areas:

First, advancing and protecting public and animal health by promoting innovation through an efficient and predictable science- and risk-based regulatory framework; second, strengthening public outreach and communication through strong, effective and transparent engagement with stakeholders; and third, increasing engagement with domestic and international partners through coordinated and collaborative actions to support regulatory alignment and efficiency.

Conclusion

Given the Administration’s focus on innovation in agriculture, we expect these initiatives to continue taking shape in the coming months and to provide additional and much-needed clarity to stakeholders, including developers who seek to bring new and pioneering agricultural biotechnology products to market.