USDA and FDA to Revise Regulation of Agricultural Biotechnology

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 agricultural biotechnology.

On June 29, 2018 the USDA’s Animal and Plant Health Inspection Service (APHIS) 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.

APHIS’s review of its regulations is part of a broader federal effort to examine federal oversight of biotechnology-derived products to address advances in biotechnology.  In June, the FDA announced “new steps” in its approach to the regulation of biotechnology-derived products, including the formation of a new Biotech Working Group and forthcoming release of an Action Plan to ensure a “flexible regulatory framework” focused on (i) advancing and protecting public and animal health, (ii) strengthening public outreach and communication, and (iii) increasing engagement with domestic and international partners.