US FDA clarifies it has full jurisdiction over GE animals, including fish

AquaBounty salmon swimming in a growout tank
A recent FDA guidance on genetically engineered animals clarifies its authority on the product, which also clarifies GE salmon producer AquaBounty's rights to sell its products | Photo courtesy of AquaBounty
4 Min

The U.S. Food and Drug Administration (FDA) has issued updated guidance making it the regulatory body with full jurisdiction over genetically engineered animals produced in the country.

In a press release, the FDA announced it signed a memorandum of understanding (MOU) with the U.S. Department of Agriculture (USDA) that clarifies the two agencies’ roles and responsibilities on regulating “intentional genomic alterations,” or genetic engineering, in animals. The MOU has clarified that the FDA will lead all regulatory review of new products featuring genetically engineered animals in consultation with the USDA.

Under current U.S. policy, the USDA is responsible for the oversight of most livestock, including cattle, pigs, and poultry. However, the FDA has jurisdiction over most other animals, including farmed fish. With both categories of animals set for new genetic engineering projects, the MOU establishes the FDA as the authority on advancing regulations on new products.

“We recognize that innovations in animal biotechnology offer tremendous opportunities for advancing human and animal health and that we as an agency need to keep our regulatory approach current with the evolution of the science,” FDA Center for Veterinary Medicine Director Tracey Forfa said. “These updated guidance documents demonstrate our commitment to facilitating innovation while ensuring product safety.”

The FDA overseeing genetically engineered animals is good news for AquaBounty Technologies, the first company to be granted permission to sell genetically modified fish in the U.S.

The FDA originally granted approval for the product in 2015, and in 2019, the agency lifted an import alert clearing the way for the company to begin raising and selling its salmon in the U.S. Then, a ruling by a judge in 2020 forced the FDA to reevaluate its determination on AquaBounty's AquAdvantage salmon – a process which ultimately led to a victory for AquaBounty. Then, in 2022, the FDA once again put AquaBounty’s GE salmon under assessment after a lawsuit by multiple organizations led to yet another court order.

The FDA finally reapproved AquAdvantage salmon in 2023.

AquaBounty recently committed further to its planned Pioneer, Ohio, U.S.A.-based salmon recirculating aquaculture system (RAS) facility by announcing its original RAS in Indiana had been put up for sale. The company's Q1 2024 financial report revealed its losses were mounting and that its cash reserves were low. 

Since that time, the company has secured a USD 10 million (EUR 9.3 million) loan from JMB Capital Partners Lending, with a maturation date of 31 July 2024, to provide working capital. The company offered both of its U.S. farm locations as collateral for the loan, and if the company is successful in selling its Indiana-based facility, the loan will mature earlier.

“As previously announced, AquaBounty has been exploring a wide range of financing alternatives to strengthen its balance sheet and increase its cash position,” AquaBounty Chair and CEO Sylvia Wulf said. “The cash from the loan agreement that was announced today will be used to cover our immediate working capital requirements.”

Wulf said the additional funding will allow the company to continue the sale of its Indiana farm, which will, in turn, help the company finance the construction of its Ohio RAS.

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