New USDA rule updates plant biotechnology regulations

U.S. Secretary of Agriculture Sonny Perdue has announced a final rule updating and modernizing the U.S. Department of Agriculture’s (USDA) biotechnology regulations under the Plant Protection Act. According to the USDA, the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule removes duplicative and antiquated processes to facilitate the development and availability of these technologies through a “transparent, consistent, science-based, and risk-proportionate regulatory system.”

The USDA’s previous regulations focused on whether a plant pest was used in the development of a plant using genetic engineering and required a lengthy deregulation process for those plants that did not pose increased pest risk. After 30 years of experience, USDA’s Animal Plant Health Inspection Service (APHIS) regulatory scientists know that simply using a plant pest in the development of a plant does not necessarily cause the plant to pose a risk to plant health. Thus, the final rule puts in place a more efficient process to identify plants that would be subject to regulation, focusing on the properties of the plant rather than on its method of production.

APHIS will evaluate plants developed using genetic engineering for plant pest risk under a new process called a regulatory status review, regulating only those that plausibly pose an increased plant pest risk. This updated process aligns with President Trump’s executive order for modernizing biotechnology and the coordinated framework for biotechnology and will ensure the regulations keep pace with the latest science and technological advances, reduce regulatory burdens for developers of plants developed using genetic engineering that are unlikely to pose plant pest risks, and ensure that agency resources are better focused on the prevention of plant pest risk.

“USDA’s SECURE rule will streamline and modernize our regulatory system, facilitate science-based innovations, and provide our farmers with the tools they need to produce the world’s safest, most abundant, and most affordable food supply,” said Perdue.

“Alongside the USDA as they work to implement the SECURE rule, the FDA [U.S. Food and Drug Administration] is committed to encouraging innovation in agricultural biotechnology while utilizing scientific risk-based approaches in our regulatory approach,” said Stephen Hahn, FDA commissioner.