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‘Frankenfish’ Salmon Can Be Overseen by FDA Despite Concerns (1)

Dec. 20, 2019, 4:27 PMUpdated: Dec. 20, 2019, 9:36 PM

The Food and Drug Administration can regulate salmon that’s genetically engineered to grow faster, according to a decision in a California federal court case over concerns about so-called frankenfish.

Fishing, consumer, and environmental groups that challenged the FDA’s approval of such salmon from AquaBounty Technologies Inc. failed to convince the court that the agency lacks authority to regulate the fish. The U.S. District Court for the Northern District of California Dec. 19 sided with the FDA, leaving to a later date a decision on whether the regulator failed to consider potential risks.

AquaBounty won the FDA’s first greenlight for changing the genetic makeup of an animal destined for the dinner table. The case could have implications for similar modifications in the works for fish like tilapia and trout or other animals down the line, according to the Center for Food Safety, one of the groups that sued.

“That’s why we were so concerned about this approval,” said Amy van Saun, a senior attorney at the center. “We want to make sure people and the environment are protected.”

Genetically engineered salmon are meant as an alternative to endangered wild salmon. AquaBounty plans to harvest its salmon starting in late 2020.

The FDA put restrictions on how and where its salmon are grown to reduce risks that engineered salmon will mix with normal salmon. AquaBounty’s salmon will also have to be labeled as modified.

“We fully support the robust regulatory process and comprehensive work done by FDA in its approval of AquaBounty’s genetically engineered salmon,” AquaBounty president and CEO Sylvia Wulf said in a Dec. 20 statement. The firm declined to comment on the ongoing lawsuit.

The suit challenged FDA authority over genetically engineered salmon and the way the agency went about regulating the fish as a drug, not a food. The court sided with the FDA, pointing out that otherwise there would be “a regulatory void” where companies could genetically engineer animals without oversight.

Genetic material used to modify an animal may not seem like a drug in the traditional medical context, but the legal definition is broader than the ordinary meaning of the word, the court said.

A hearing in May 2020 will address another argument from the Institute for Fisheries Resources, the Center For Food Safety, and the other groups that FDA approval of the salmon failed to fully consider its environmental impacts.

AquaBounty’s genetically engineered salmon has faced resistance from Alaska Sen. Lisa Murkowski (R) because it poses competition to wild salmon from her state. Murkowski recently called for a delay on the salmon’s sale, after a ban on its import was lifted earlier this year.

Earthjustice represented the Institute for Fisheries Resources and other groups. The Justice Department represented the FDA.

The case is Institute for Fisheries Resources v. Hahn, N.D. Cal., No. 3:16-cv-01574, 12/19/19.

(Updated with additional reporting throughout)

To contact the reporters on this story: Julie Steinberg in Washington at jsteinberg@bloomberglaw.com; Andrea Vittorio in Washington at avittorio@bloomberglaw.com

To contact the editors responsible for this story: Jo-el J. Meyer at jmeyer@bloomberglaw.com; Laura D. Francis at lfrancis@bloomberglaw.com; Rob Tricchinelli at rtricchinelli@bloomberglaw.com

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