Yesterday, USDA formally announced that it “does not regulate or have any plans to regulate plants” created using new breeding techniques, such as gene editing, as long as such plants “are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.” The announcement provides an affirmative statement regarding the Agency’s regulatory approach with respect to plant breeding innovation, a position that had for a time become less clear after the Agency’s withdrawal in November 2017 of its January 2017 proposed revisions to Part 340, the regulations under which plant biotechnology products are evaluated by USDA.
USDA explained that “scientists can now create new plant varieties that are indistinguishable from those developed through traditional breeding methods.” These varieties “may protect crops against threats like drought and diseases, increase nutritional value, and eliminate allergens.” According to the US Secretary of Agriculture, USDA’s approach “seeks to allow innovation when there is no risk present.”
Gene editing is a process that makes targeted, precise changes to an organism’s own genome, in most cases without relying on transgenic technology, which involves the introduction of a foreign gene into an organism (e.g., inserting a bacterial gene into a plant to impart insect resistance). USDA’s announcement makes clear that while many gene edited plants will not be regulated, transgenic plants will continued to be regulated.
The USDA’s action follows recommendations by the Interagency Task Force on Agriculture and Rural Prosperity to develop a “streamlined, science-based regulatory policy for biotechnology” and “reduce barriers to commercialization.” We reported on the Task Force’s report in a Client Alert this past January.