FDA Proclaims Genetically Engineered Salmon Safe

By Dave Fusaro, Editor in Chief

Nov 19, 2015

The FDA on Nov. 19 ruled the genetically engineered (GE) AquAdvantage salmon, created by AquaBounty Technologies, is as safe to eat as any non-GE Atlantic salmon, and also as nutritious. Whether it needs a special label is still undecided.

"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 FDA wrote in its announcement. "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. That’s because the multiple containment measures the company will use in the land-based facilities in Panama and Canada make it extremely unlikely that the fish could escape and establish themselves in the wild."

The science is not likely to persuade opponents of GE foods. There's a significant pushback on plants grown from genetically engineered seeds; a first-generation, genetically engineered animal appears destined for even more criticism.

In 2013, while the salmon was still under review by the federal agency, Whole Foods Market, Trader Joe’s, Aldi and some regional chains vowed to never carry the GE fish.

As for whether or not any resulting products need to be labeled as GE, FDA apparently is leaving that up to food processors.

"Although the law does not require food containing ingredients derived from these salmon to be labeled as GE, FDA recognizes that many consumers are interested in this information, and some food manufacturers will want to make the distinction," the FDA wrote.

"FDA is releasing two guidance documents detailing the agency’s current thinking on labeling—a draft guidance for labeling of food derived from Atlantic salmon that has or has not been genetically engineered and a final guidance for labeling of food that has or has not been derived from GE plants—to help those manufacturers who wish to voluntarily make the distinction on the labeling of their food products."

The public is invited to provide comments on the draft guidance (see final paragraph below).

AquaBounty Technologies has had the salmon under development for several years. The Maynard, Mass., biotechnology company, now majority-owned by Intrexon Corp., developed and patented the (mostly) Atlantic salmon with genes from faster-growing chinook salmon and a sea eel. As a result, the genetically modified AquAdvantage salmon grows to maturity twice as fast as an Atlantic salmon.

In addition to claiming the GE salmon is more environmentally friendly, AquaBounty notes: "The U.S. currently imports over 90% of all the seafood, and more specifically over 95% of the Atlantic salmon, it consumes. AquAdvantage Salmon will offer the opportunity for an economically viable domestic aquaculture industry while providing consumers a fresh and delicious product."

To comment on the draft guidance on voluntary labeling of products from the GE salmon, anyone can read the Draft Guidance (at www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm469802.htm) and, starting Nov. 23, submit comments on the draft guidance at www.regulations.gov.

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