The U.S. Department of Agriculture (USDA) today (June 6) published a new proposed rule for the regulation of plant-based agricultural biotechnology products.
Under the proposed rule, USDA’s Animal and Plant Health Inspection Service (APHIS) – which has authority to determine whether agricultural biotech traits pose a plant pest or noxious weed risk to the environment – would exempt most crops developed with gene-editing techniques from regulation. APHIS said these plants can be produced through traditional breeding techniques, making them unlikely to pose a greater plant pest risk than conventionally bred crops.
The APHIS proposal also would empower crop developers to make a “self-determination” that their plant is exempt from APHIS regulatory oversight. They would have the option to request written confirmation from APHIS that their self-determination is valid.
USDA’s proposed rule does not affect the separate biotech regulatory oversight policies of the U.S. Food and Drug Administration and Environmental Protection Agency, both of which still are developing their approaches with respect to gene-edited traits.
USDA Undersecretary for Marketing and Regulatory Programs Greg Ibach said the new APHIS approach “would enable APHIS to evaluate GE organisms for plant pest risk with greater precision than the current rule allows, ensuring oversight and risk are based on the best available science.”
APHIS first published in January 2017 its proposal to revise its plant biotechnology regulation, known as “Part 340,” addressing the importation, interstate movement and environmental release of certain genetically engineered organisms. The NGFA had urged the agency to withdraw that proposal, arguing that it needed to better assess its impacts on the marketability of biotech-enhanced commodities given the lack of international regulatory alignment regarding APHIS’s proposed new approach. In a joint statement authored by NGFA and submitted on the APHIS proposal, the NGFA, joined by the Corn Refiners Association, North American Export Grain Association, North American Millers Association and National Oilseed Processors Association, recommended that USDA develop an effective international- and state-engagement strategy to build alignment and acceptance around a new science-and risk-based regulatory approach to address new plant breeding innovations. The agency later withdrew its January 2017 proposal.
APHIS’s new proposed rule was developed following issuance of a 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.”
The NGFA is reviewing the new proposal and intends to partner with like-minded agribusiness associations to submit official comments to the agency before the Aug. 5 deadline on the public comment period.