By Randy Gordon, President
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) also is planning next spring to propose a major overhaul of its approach to regulating plant biotechnology.
The proposal, which is expected to be issued for public comment as early as March 2019, is intended to revamp the agency’s so-called “Part 340” regulations under which it determines whether plant biotechnology methods – including genome editing – pose a plant pest risk. APHIS has jurisdiction over plant pest risks under the Plant Protection Act.
USDA, the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) each have distinct regulatory authorities and responsibilities under the so-called “Coordinated Framework for the Regulation of Biotechnology Products,” which was updated in September 2016 under the Obama administration. FDA is responsible for regulatory oversight of agricultural biotechnology for human and animal food safety; APHIS determines whether agricultural biotech traits pose a plant pest or noxious weed risk to the environment; and EPA regulates pesticidal proteins that may be incorporated into biotech traits as part of its regulatory jurisdiction over all pesticides marketed and used in the United States to protect human health and the environment.
APHIS’ proposed approach is expected to provide specific criteria under which technology developers will self-determine whether transgenic or genome-edited traits they intend to develop and introduce into the environment are subject to regulatory review by the agency. The criteria are expected to include such factors as whether the technology being utilized is gene-edited (which would not be subject to regulatory oversight if it is not a plant pest or developed using a plant pest) or has been evaluated previously by APHIS and found not to be subject to regulation.
The APHIS proposal comes on the heels of the USDA Statement on Plant Breeding Innovation issued on March 28 by Secretary of Agriculture Sonny Perdue, which stated that USDA “does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests. This includes a set of new techniques (e.g., genome editing) that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods.”
As is the case with FDA’s planned rollout of its new approach for providing regulatory oversight of genome editing, NGFA’s Crop Technology Committee has and will continue to engage with APHIS officials and provide input to the agency focused on impacts on the future marketability of U.S. grains, oilseeds and products derived therefrom.