Six groups have filed suit against the Agriculture Department over regulations the Trump administration issued last year to streamline the regulation of gene-edited crop traits and allow companies to decide whether their products need USDA approval. 

The regulations “exempt broad categories of GE organisms from any pre-market approval and pass any assessment duties to the biotech/pesticide companies to ‘self-determine’ whether their products are exempt or regulated,” the Center for Food Safety said in a news release announcing the lawsuit, filed in U.S. District Court for the Northern District of California.

In addition to CFS, the plaintiffs are the National Family Farm Coalition, Pesticide Action Network North America, Center for Environmental Health, Friends of the Earth, and Center for Biological Diversity.

Among the laws violated, according to the complaint: The Endangered Species Act, the National Environmental Policy Act, and the Plant Protection Act. “It also unconstitutionally delegated USDA's statutory responsibilities to self-interested industry,” CFS said.

“This case is about whether or not both experimental and commercialized genetically engineered (GE) organisms will remain regulated by the federal government, or if they will now effectively be left to the devices of their manufacturers, to experiment, plant, and sell them as they self-interestedly see fit, without any further oversight by [USDA), regardless of their agronomic risks to U.S. agriculture or their environmental risks to soils, waterways, native ecosystems, and endangered species,” the lawsuit says.

Under the rule issued in May 2020, “GE organisms will no longer be subject to USDA oversight and approval before open-air experiments and before commercial sale and planting,” the lawsuit says. “Since there will no longer be a USDA final agency approval action under the Administrative Procedure Act (APA), there will not be any analysis or transparency under NEPA or the ESA of GE crops’ agricultural or environmental risks.

“In effect, USDA has attempted to get out of the regulation business entirely in this area,” the suit says.

USDA did not consult with federal wildlife agencies about the rule’s impacts on endangered species, the complaint says. Nor did it carefully look at “reasonable alternatives” as required by NEPA.

Other claims are that USDA — specifically, the Animal and Plant Health Inspection Service — did not comply with the Plant Protection Act’s “noxious weed authority” to examine the risks of GE plants, and that USDA’s exemption of certain classes of GE plants because they could have been developed through conventional breeding “is not grounded in science.”

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The complaint also says USDA’s “elimination of the petition for non-regulated status process means no GE organism will receive the degree of scrutiny it deserves.” GE crops “will be commercialized without consideration of field trial data and observations, which informed deregulation decisions under the old regulations,” which “represents an abdication of its statutory duty to provide meaningful oversight of GE organisms," the lawsuit says. 

Under the “‘self-determination’ scheme, there is no opportunity for the agency to conduct ESA and NEPA analyses, as it formerly had in the old deregulation context, to determine whether cultivation of the GE crop affects endangered species or their habitat,” the lawsuit says.

The Trump administration's biotech rule, finalized in May 2020, marked the first major changes to a USDA regulatory process that was developed in 1987, long before the first genetically engineered seeds would hit the market in the 1990s .

USDA did not immediately respond to a request for comment. The Biden administration has made no move to alter the regulations and is actively considering a separate Trump administration proposal to transfer some regulatory authority for animal biotechnology from the Food and Drug Administration to USDA. 

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