FDA Approves Genetically Modified Salmon

from FDA

Last Thursday after years of review, the Food and Drug Administration (FDA) approved the sale of genetically engineered salmon called the AquaAdvantage salmon in the United States. Not only will genetically engineered salmon be able to be sold in the United States, the law does not require food containing ingredients derived from these salmon to be labeled as genetically engineered or genetically modified.

After a long and rigorous scientific review, the FDA arrived at the decision that AquAdvantage salmon is as safe and nutritious to eat as any non-genetically engineered farmed Atlantic salmon. AquAdvantage Salmon has been genetically engineered to grow more rapidly than its non-genetically engineered farm-raised Atlantic salmon counterpart. It does so because it contains an rDNA construct that is composed of the growth hormone gene from Chinook salmon under the control of a promoter (a sequence of DNA that turns on the expression of a gene) from another type of fish called an ocean pout. This allows the salmon to grow to market size faster than non-genetically engineered farm-raised Atlantic salmon with less feed.

As part of its evaluation, the FDA examined data comparing three groups of fish: non-genetically engineered farm-raised Atlantic salmon from both the company’s salmon farm and from a different commercial salmon farm, and AquAdvantage Salmon. This study compared key hormones (including estradiol, testosterone, 11-ketotestosterone, T3, T4 and insulin-like growth factor 1 (IGF1)) and found no biologically relevant differences. The FDA found the salmon to be equivalent. According to the FDA, the reviewed data also showed 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 company’s claim about faster growth.

The FDA reported that after analyzing the potential environmental impact that an approval of the AquAdvantage Salmon would have. Under the approval, AquAdvantage Salmon are subject to stringent conditions to prevent the possibility of escape into the wild. The salmon cannot be raised in ocean net pens: instead, the approval allows for them to be grown only at two specific land-based facilities: one in Canada, where the breeding stock are kept, and Panama, where the fish for market will be grown out using eggs from the Canada facility. In addition, both the Canada and Panama facilities have multiple and redundant physical barriers to prevent eggs and fish from escaping, including metal screens on tank bottoms, stand pipes, and incubator trays to prevent the escape of eggs and fish during hatching or rearing. The fish to be produced for food in Panama will be all-female fish that have been sterilized by a process that may not be 100% effective.

Nonetheless, based on the multiple forms of physical and biological containment proposed by AquaBounty Technologies in the application, the FDA found that the AquAdvantage Salmon would not cause a significant impact on the environment of the United States. This finding is based on the extremely low likelihood that AquAdvantage Salmon could escape from the Canada and Panama facilities and survive in an ocean or waterway to interbreed with wild Atlantic salmon. Based on the agency’s conclusion in the final Environmental Assessment, the agency issued a Finding of No Significant Impact.

Though it is likely that consumers would want to know whether the Atlantic salmon they buy is the product of genetic engineering, the FDA determined that no additional labeling of food from AquAdvantage Salmon is required because the data showed that food derived from AquAdvantage Salmon is not materially different from food derived from other Atlantic salmon. The FDA only requires additional labeling of foods, including foods from genetically engineered sources, when the food products are materially different from their conventional counterparts.

According to FDA standards material differences include changes in features like nutritional profile, and functional properties. The fact that a food is produced through the use of genetic engineering alone does not constitute a material fact requiring additional labeling under the law. Under a draft Guidance released in conjunction with the approval for the genetically engineered salmon, manufacturers who wish to voluntarily label their food products as containing or not containing genetically engineered Atlantic salmon may do so as long as such labeling is truthful and non-misleading. The FDA draft Guidance that the term genetically modified organism, the familiar GMO, is overly broad and inaccurate and should not be used on food labeling and packaging. The FDA prefers the terms non-biologically engineered or non-genetically engineered. You can review the Guidance and comment starting today, Monday, November 23, 2015 by submitting comments at www.regulations.gov.

It will take a year or two before genetically engineered salmon are being sold in groceries or served on menus. As it stands now, this fish will not have to be labeled. To be certain you are avoiding genetically engineered salmon you will have to avoid all farmed fish or look for companies that use the approved FDA terms. This approval will not change anything for me. Though salmon is one of my favorite foods eaten several days a week, I never eat farmed Atlantic salmon or Atlantic salmon. I will not eat farmed fish and I prefer the leaner wild coho salmon.