USDA releases overhaul of biotech regulations

U.S. Secretary of Agriculture Sonny Perdue announced May 14 a final rule updating and modernizing the U.S. Department of Agriculture’s biotechnology regulations under the Plant Protection Act. The new rule “marks the first comprehensive revision of the regulations since they were established in 1987.” The new rule’s provisions become effective on key dates over the next 18 months.

Critics say the new rules fail to make any use of USDA’s authority to regulate “noxious weeds”—which they say was the impetus for updating the regulations to begin with—and fail to address several critical issues involving genetically modified organisms. “USDA’s new rules avoid confronting the serious problems caused by GMO agriculture—epidemics of weeds resistant to weed-killers, massive herbicidal drift damage and GMO contamination undercutting organic and non-GMO producers,” said Bill Freese, a science policy adviser at the Center for Food Safety.

The new rules are collectively called The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient, or SECURE rule, and the USDA says they will “bring USDA’s plant biotechnology regulations into the 21st century by removing duplicative and antiquated processes in order to facilitate the development and availability of these technologies through a transparent, consistent, science-based, and risk-proportionate regulatory system.”

“Under President Trump’s leadership, USDA is implementing the first significant update to our plant biotechnology regulations in more than three decades,” said Perdue. “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 Environmental Protection Agency) applauds USDA’s efforts to finalize the SECURE rule that will support our nation’s farmers,” said EPA Administrator Andrew Wheeler. “EPA is continuing our own efforts to safely reduce unnecessary regulations and further break down barriers to support advancements in biotechnology. We plan to issue our proposed rule early this summer.”

“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 Ha. “FDA is dedicated to making sure the American consumers have confidence in the safety of the food they feed their families.”

Functional definition

The USDA says the new rules risk replaces the mere determination that gene editing was used to determine whether a plant should be regulated with a comprehensive risk assessment. “After 30 years of experience, USDA’s Animal Plant Health Inspection Service 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.

A plant whose traits are developed using gene-editing, or even one in which foreign DNA is introduced, might be exempted from regulation, provided that the traits could have been developed using conventional means.

But the new rules leave biotech companies to make that determination, said Freese, in effect allowing the companies to regulate themselves. “The real issue is not whether or not foreign [genetic] material is introduced into a plant,” he said. “All genetic engineering techniques including gene editing have unintended and potentially harmful effects, and so all GMOs should be regulated.”

The National Academy of Sciences recommended in 2002 that all GMOs should fall under USDA regulation, he said, but the agency for years denied that it had that broad authority.

The USDA said its updated process aligns with the president’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. 

The USDA said it carefully considered thousands of comments received during several comment and review processes.

David Murray can be reached at [email protected].