Advocacy groups want FDA, not USDA, to regulate genetically engineered animals

A wide-ranging collection of advocacy groups have sent letters to the U.S. Health and Human Services Department and U.S. Department of Agriculture, urging the leadersof the federal agencies to maintain regulatory authority over genetically engineered food animals within the U.S. Food and Drug Administration.

The push for FDA control is in response to a Trump administration proposal that sought to withdraw most of the FDA’s regulatory authority over genetically engineered animals, including fish, and transfer that authority to USDA’s Animal and Plant Health Inspection Service.

“Despite concerns that FDA still needs to develop final regulations on genetically engineered animals, FDA possesses the scientific and administrative capacities to regulate these animals better than USDA,” Center for Food Safety Policy Director Jaydee Hanson said. “President Biden has said that his administration will be science-based. Leaving genetically engineered animal regulation to the FDA is the science-based approach here.”

The administrative action took the form of a memorandum of understanding between the USDA and FDA that broke down a new approach to GE animals – namely that the USDA would develop a new program for the pre-market evaluation of "agricultural amenable species developed using genetic engineering" with FDA consultation. The FDA would continue to regulate dairy products, table and shell eggs, certain meat products, and animal feed derived from genetically engineered species.

The memorandum of understanding was signed and posted on the USDA’s Animal and Plant Health Inspection Service, but not on any FDA website.

On 11 January, then-FDA Commissioner Stephen Hahn told Health and Human Services Department leadership that he refused to sign the MoU, according to Politico, “amid concerns about its legality and the potential health repercussions of relaxing oversight of certain genetically altered products.”

According to the Center for Food Safety, the groups behind the letters shared Hahn’s concerns and are urging current U.S. Health and Human Services Secretary Xavier Becerra to ask U.S. Agriculture Secretary Tom Vilsack to instruct USDA officials to remove the MoU from the APHIS website, since it is not in effect. The groups are also urging Becerra to order the HHS Office of the General Counsel to evaluate the legality of the MoU in the context of FDA’s statutory authorities and scientific capacity to regulate and conduct pre-market and post-market risk assessment of genetically engineered animals and fish.

Currently, only one commercial entity is pursuing the sale of genetically modified seafood - Maynard, Massachusetts, U.S.A.-based AquaBounty Technologies, which is nearing the first commercial harvest and sale of its genetically engineered AquAdvantage salmon.


“Genetically engineered animals are a significant new threat to our food system. With the GMO salmon company AquaBounty looking for buyers, the FDA must urgently strengthen its regulations to fully evaluate GMO animals for public health and environmental safety,” Friends of the Earth Program Manager Dana Perls said. “Handing authority over to the USDA will dilute the already-weak GMO animal regulations and exacerbate harm to farmers and the environment.”

Institute for Agriculture and Trade Policy analyst Steve Suppan said the shifting of responsibility could erode the reputation of U.S. exports.

“If importing country authorities believe that USDA has usurped FDA authority over genetically engineered animals, the reputation and sales of U.S. agricultural exporters will likely suffer,” he said.

Public debates between regulatory bodies is something no company wants on the brink of a major product release, but AquaBounty executives said they are unphased by efforts to shift regulatory responsibility one way or another.

“As the company that produced the first bioengineered animal approved for food use, we worked closely with FDA throughout the almost 20-year review process for our salmon, as FDA is the federal agency currently charged with primary oversight over most seafood and foods developed using bioengineering. After a comprehensive review, FDA determined that our salmon met the agency’s rigorous statutory requirements for safety and effectiveness,” AquaBouty CEO and President Sylvia Wulf told SeafoodSource. “Regardless of which agency is charged with oversight moving forward, FDA regulates the majority of seafood under its longstanding statutory authority, so our salmon will remain under its purview, as noted in the recent proposals.”

Wulf said AquaBounty supports efforts to make sure the regulatory process is rigorous.  

“We strongly support a thorough, predictable, and science-based regulatory framework and believe both USDA and FDA are capable of establishing an improved approach to oversight,” she said. “And we are encouraged by this renewed interest in ensuring that the regulatory system provides rigorous oversight while also fostering innovation that will safely diversify and strengthen the global food supply. “

The thirteen groups that signed the letters are Center for Food Safety, A Greener World, American Anti-Vivisection Society, Animal Legal Defense Fund, Animal Welfare Institute, Food and Water Watch, Food Animal Concerns Trust, Friends of the Earth, Institute for Agriculture and Trade Policy, International Center for Technology Assessment, National Family Farm Coalition, Northwest Atlantic Marine Alliance, and World Animal Protection.