A federal judge in California has vacated USDA’s 2020 rule exempting genetically engineered plants from regulation, which could significantly delay approval of crops engineered with traits to resist herbicides.
The Animal and Plant Health Inspection Service’s so-called SECURE rule did not address concerns raised in scientific papers, including a review by the National Academies of Science, Engineering and Medicine of the risks of GE crops, U.S. District Judge James Donato said.
In particular, Donato said, APHIS did not adequately explain why GE plants that pose the same plant-pest risks as plants created using conventional breeding should be exempt. APHIS relied on a 1989 NAS study but ignored one from 2002, the judge said.
“Nowhere in the final rule does APHIS acknowledge the conflicting scientific evidence concerning the basis on which the exemption is premised,” he said in his order, issued late Monday.
Donato sent the rule back to APHIS for reconsideration and asked the parties to address the impact of the ruling on a recently issued rule that expands the exemptions allowed.
"Our view is that there's no way those exemptions can stand," said Center for Food Safety Co-Executive Director and Legal Director George Kimbrell. "They also are wiped out by the decision because they're a house of cards. They're all predicated on implementing the underlying 2020 rule that the court just struck down, so they have nothing to stand on and they are also eliminated."
In the meantime, provided his ruling stands, the biotech industry would be subject to the pre-2020 regulatory regime, which required APHIS to comply with the National Environmental Policy Act and Endangered Species Act.
“The ruling is a rebuke of the first Trump administration’s efforts to practically eliminate oversight of novel GE technology and instead let industry self-regulate,” the Center for Food Safety, one of the plaintiffs in the case, said. “Previously, nearly all GE plants went through agency approval before experimental planting and again before any commercial use.”
USDA did not respond immediately to a request for comment. The department could seek a stay of the order from the 9th Circuit Court of Appeals.
The Biotechnology Innovation Organization said it and the American Seed Trade Association, which had “joined the lawsuit to highlight the numerous benefits that access to innovative products of biotechnology provides to American farmers, consumers, and the environment, are currently reviewing the court’s ruling.”
The court determined the 2020 rule did not address “a single one” of the issues that APHIS itself had identified earlier in the years-long process that led to the 2020 rule.
“The court also found that the exemption of GE crops was ‘repudiated’ by the ‘scientific evidence in the record,’ specifically the conclusions and recommendations from the National Academies of Science,” CFS said.
Other plaintiffs are the National Family Farm Coalition, Pesticide Action Network, Center for Environmental Health and the Center for Biological Diversity. CFS represented all of them.
