While it may have an odd sounding name — “genetically engineered salmon” — you may now have a new lunch or dinner option.  The FDA announced last week that it issued the first approval for a genetically engineered animal intended for food, the AquAdvantage Salmon by AquaBounty Technologies, Inc.  At the same time, the FDA issued two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from genetically engineered or non-genetically engineered sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from genetically engineered plants.

All of the AquAdvantage approval documents are available here.  Such FDA approval was necessary because the FDA regulates genetically engineered animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the “FDCA”).  Here, the recombinant DNA (rDNA) construct introduced into the animal to make it grow faster meets the definition of a “drug.” As the FDA explained in its press release, the agency undertook a “comprehensive analysis of the scientific evidence” and made several determinations, including:

  • AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the FDCA;
  • food from the fish is safe to eat;
  • the rDNA construct (the piece of DNA that makes the salmon grow faster) is safe for the fish itself;
  • the AquAdvantage Salmon meets the sponsor’s claim about faster growth;
  • food from AquAdvantage Salmon is as safe to eat and as nutritious as food from other non-genetically engineered Atlantic salmon;
  • there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.

The FDA’s approval also contained several limitations and constraints:

  • The AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in Canada and Panama — AquAdvantage Salmon may not be bred or raised in the United States;
  • No other facilities or locations, in the United States or elsewhere, are authorized for breeding or raising AquAdvantage Salmon that are intended for marketing as food to U.S. consumers;
  • Measures must be taken to contain the fish and prevent their escape and establishment in the environment (including physical barriers in the tanks and in the plumbing that carries water out of the facilities to prevent the escape of eggs and fish). (The FDA noted that the AquAdvantage Salmon are reproductively sterile so that even if they escape a tank, they would be unable to interbreed or establish populations in the wild).

For its part, AquaBounty Technologies issued a press release, noting that “AquAdvantage Salmon 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. Using land-based aquaculture systems, this rich source of protein and other nutrients can be farmed close to major consumer markets in a more sustainable manner.”  The press release further states that “Through greater efficiency and localized production, AquaBounty’s AquAdvantage Salmon increases productivity while reducing costs and the environmental impacts associated with current salmon farming operations. Land-based aquaculture systems can provide a continuous supply of fresh, safe, traceable, and sustainable AquAdvantage Salmon to communities across the U.S. and do it with a reduced carbon footprint. Importantly, it offers an alternative approach to fish farming that does not exploit the oceans.”

Recognizing “that some consumers are interested in knowing whether food ingredients are derived from genetically engineered sources,” the FDA also published two guidance documents explaining how food companies that want to voluntarily label their products can do so.

The first guidance document provides guidance to assist food manufacturers that wish to voluntarily label their food products or ingredients (for humans or animals) derived from Atlantic salmon as either containing or not containing products from genetically engineered Atlantic salmon.  The document also provides guidance on voluntary statements that may be appropriate for species of salmon that have no genetically engineered counterparts.

For example, manufacturers may state that their fish is “not genetically engineered” or “not genetically modified through the use of modern biotechnology.”  They may also state that they “do not use Atlantic salmon produced using modern biotechnology.” The FDA’s “main concern” is that the “labeling be truthful and not misleading.”

On the other hand, manufacturers of food products or food ingredients derived from AquAdvantage Salmon may label their products as “genetically engineered” or state that “this salmon patty was made from Atlantic salmon produced using modern biotechnology.”  They may also include an explanation that is not likely to be misleading, such as “This Atlantic salmon was genetically engineered so it can reach market weight faster than its non-genetically engineered counterpart.”

The second FDA guidance addresses the voluntary labeling of plant-derived foods with information concerning whether the food was or was not produced using genetic engineering.  Again, the “FDA’s main concern … is that such voluntary labeling be truthful and not misleading.”  Examples of generally permissible statements include:

  • “Not bioengineered.”
  • “Not genetically engineered.”
  • “Not genetically modified through the use of modern biotechnology.”
  • “We do not use ingredients that were produced using modern biotechnology.”
  • “This oil is made from soybeans that were not genetically engineered.”
  • “Our corn growers do not plant bioengineered seeds.”

For foods that are derived from genetically engineered plants, the guidance includes examples of permitted statements such as:

  • “Genetically engineered”;
  • “This product contains cornmeal from corn that was produced using modern biotechnology.”;
  • “Some of our growers plant soybean seeds that were developed through modern biotechnology to be drought tolerant.”

The FDA summarized its work on the genetically engineered salmon in a “Fact Sheet” available here.

As technology continues to improve, we can expect to see more activity in the area of genetically engineered animals.  As the FDA itself notes, “While conventional breeding methods have long been used to produce more desirable traits in animals, genetic engineering is a much more targeted and powerful method of introducing desirable traits into animals.”  Here at the Monitor, we will keep a close on genetically engineered developments — including whether and how genetically engineered products are approved by the FDA and any consumer litigation with respect to how they are labeled.