May 25, 2020

Agriculture Biotechnology Regulations

USDA updates agricultural biotechnology regulations

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) finalized the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE Rule). SECURE Rule is the first comprehensive revision of APHIS’ biotechnology regulations since it was established in 1987. The revisions enable APHIS to regulate organisms developed using genetic engineering for plant pest risk with greater precision and reduces regulatory burden for developers of organisms that are unlikely to pose plant pest risks.

“Under President Trump’s leadership, USDA is implementing the first significant update to our plant biotechnology regulations in more than three decades,” said Secretary Perdue in a press release. “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, which will help us continue to Do Right and Feed Everyone – safely.” 

The previous regulations determined whether a plant pest was used in the development of a plant using genetic engineering and required an extensive deregulation process for those plants that did not pose increased pest risk. After 30 years of experience, USDA’s APHIS regulatory scientists are aware that using a plant pest in the development of a plant does not cause a risk to plant health. This information is what led to the final rule, which 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.

The U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA) are working with USDA to achieve shared goals. “Alongside the USDA as they work to implement the SECURE rule, the FDA is committed to encouraging innovation in agricultural biotechnology while utilizing scientific risk-based approaches in our regulatory approach,” said FDA Commissioner Stephen Hahn, M.D. “FDA is dedicated to making sure that American consumers have confidence in the safety of the food they feed their families.” 

“The SECURE rule strikes the right balance of protecting plant health while positioning U.S. agriculture at the forefront of innovation,” said House Agriculture Committee ranking member Michael Conaway (R-Texas). Conaway also said he looks forward to “updates on the regulatory framework for gene-edited animals that ends the misguided regulation that inaccurately defines animals as drugs. USDA’s expertise and vision will lend credibility to what is currently an anti-innovation status quo.”

The SECURE Act will be published on the Federal Register on May 18, 2020. Read the unofficial version of the final rule here.