The FDA Approves First Genetically Modified Animal for Human Consumption

Published December 9, 2015

The Food and Drug Administration (FDA), the federal agency charged, in part, along with the Department of Agriculture, with ensuring the nation’s food supply is safe to eat, approved a genetically engineered salmon as fit for consumption.

The AquaAdvantage Salmon created by AquaBounty Technologies, is the first genetically altered animal to be cleared by FDA for sale in American supermarkets, having determined it was safe for human consumption. The FDA’s approval came after a long process of study beginning in the 1990s, making AquaAdvantage possibly the, longest studied most thoroughly tested and vetted food product in the FDA’s history.

Salmon Found ‘Safe and Nutritious’

Concerning the approval the FDA’s website states:

After an exhaustive and rigorous scientific review, FDA has arrived at the decision that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious.

The FDA scientists rigorously evaluated extensive data submitted by the manufacturer, AquaBounty Technologies, and other peer-reviewed data, to assess whether AquAdvantage salmon met the criteria for approval established by law; namely, safety and effectiveness. The data demonstrated that the inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor’s claim about faster growth. 

In addition, FDA assessed the environmental impacts of approving this application and found that the approval would not have a significant impact on the environment of the United States. 

Opposition and Support for Decision

The approval of the salmon was stridently opposed by some consumer and environmental groups, who argued, despite evidence to the contrary and near universal sanction by every major scientific body, studies demonstrating the safety of genetically modified foods are inadequate. By contrast, William Muir, a professor of animal sciences at Purdue University, said there is “no credible evidence,” these salmon pose a risk to human health or the environment and could actually reduce the overharvest of wild salmon. “[T]he current practice of using wild caught salmon as a food source is not sustainable; our oceans are overfished,” Muir was quoted in by Reuters as stating 

Within hours of the agency’s decision on Thursday, one consumer advocacy group, the Center for Food Safety, said it and other organizations would file a lawsuit challenging the approval. 

The AquAdvantage salmon is an Atlantic salmon genetically modified using a growth hormone gene from the Chinook salmon and a genetic switch from the ocean pout, an eel-like creature, that keeps the transplanted gene continuously active, so it grows to market size in as little as half the time as a non-engineered farmed salmon. AquAdvantage salmon also consume 25 percent less feed to reach maturity.

“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty regarding the AquAdvantage salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” said Bernadette Dunham, director of the agency’s Center for Veterinary Medicine, in a statement to the New York Times.

The FDA has decided AquaBounty’s product will not require special labeling because it is nutritionally equivalent to conventional farm-raised Atlantic salmon.

Questions Over Why Decision Was Delayed

Despite actually determining AquAdvantage salmon was safe for human consumption and the environment more than five years ago, FDA withheld approval until November 19, 2015, saying the process took so long because it was the first approval of its kind. John Entine of the Genetic Literacy Project has indicated the Obama administration delayed approval because it was wary of a political backlash.  Indeed, Ronald Stotish, the chief executive of AquaBounty told the Times he was delighted and somewhat surprised by the approval after all this time. “We had no indication that approval was imminent,” he said in an interview. 

Stotish told Reuters, “the approval is “a game-changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats.”

H. Sterling Burnett, Ph.D., ([email protected]) is the managing editor of Environment & Climate News.