On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of the AquAdvantage Salmon, a genetically modified Atlantic salmon. In approving the NADA, FDA concluded, among other things, that the AquAdvantage Salmon is as safe to eat as any non-genetically modified Atlantic salmon. King & Spalding has represented the sponsor of the NADA, AquaBounty Technologies, Inc., since 2009.

Since the early 1980s, FDA has been a leader in developing meaningful scientific criteria and employing a flexible interpretation of the statutory requirements to ensure that the use of biotechnology in producing FDA-regulated products does not pose a risk to consumers. In regulating biotechnology products, FDA has not sought any additional statutory authority and has persuasively taken the position that its existing statutory authorities for regulating drugs, medical devices, food, and animal drugs are sufficient to ensure the safe and appropriate use of any such product derived from biotechnology.¹

Over the years, FDA has successfully overseen and regulated the marketing of numerous genetically modified drugs and plant foods. Not until now, however, has it authorized the marketing of a genetically modified animal. In large part, this gap may be attributed to the rigor FDA has applied in regulating the use of biotechnology in this context. FDA defines “genetically engineered animals” as those animals modified by Ribosomal DNA (rDNA) techniques, including all progeny that contain the modification. In FDA’s view, the term “genetically engineered animal” can refer both to animals with a heritable rDNA construct and to an animal with a non-heritable rDNA construct (e.g., a construct intended as therapy for a disease in that animal).  FDA regulates modified animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act. In light of the fact that Section 201(g) of the Act defines “drugs,” in part, as “articles (other than food) intended to affect the structure or any function of the body of man or other animals,” FDA has concluded that any rDNA construct in the resulting modified animal meets this definition. Thus, the modified animal itself is not a drug, the animal is just “along for the ride” with the rDNA construct being the “drug.”

With respect to food-producing animals, the safety of the food derived from a modified animal must be evaluated just as the safety of any food-producing animal on the receiving end of a new animal drug must be evaluated. The food safety evaluation FDA employs focuses on whether the food from the modified animal poses any risk to humans or animals consuming edible products from the modified animal compared to the edible products from appropriate non-transgenic comparators. FDA divides the food safety risk questions into two overall categories. First, it asks whether there is any direct toxicity, including allergenicity, associated with the expression product of the construct or components of the construct. Second, FDA focuses on any potential indirect toxicity associated with both the transgene and its expression product (i.e., will the expression of the transgene affect the physiological processes and the resulting animal so that unintended food consumption hazards are created or existing food consumption risks are exacerbated or increased). Natural adverse outcomes are identified by determining whether there are any biologically relevant changes to physiology in the animal, and whether reasons for toxicological concern are suggested by any biologically relevant changes in the composition of edible products from the modified animal compared with those from the appropriate non-transgenic comparator.

AquaBounty’s NADA was before FDA for nearly 20 years. The genetic modifications involved are both straightforward and limited: the insertion of a gene from the Pacific Chinook salmon and a gene from the Ocean Pout (an eel-like fish). The effect, too, is straightforward: the modified Atlantic salmon reaches market weight in half the time of an unmodified Atlantic salmon. The fish will be raised in land-based facilities (as opposed to off-shore net pens or cages) outside of the United States. The modified salmon are all female, and are all sterile. The facilities in which the fish will be raised are secure and have multiple redundant forms of physical containment that have been verified and validated by FDA.

With respect to the labeling of marketed AquAdvantage Salmon, FDA has determined that the term “Atlantic salmon” is the appropriate common or usual name of the food. FDA reached this conclusion based on the fact that the AquAdvantage Salmon does not differ materially or significantly from its counterpart—non-modified farm-raised Atlantic salmon. Moreover, FDA has concluded that the modified salmon is as safe and nutritious as its non-modified counterpart. Accordingly, FDA has concluded that there is no legal basis to require that the AquAdvantage Salmon be labeled as “modified,” “genetically engineered,” “GMO,” or any similar appellation. 

The approval is controversial. Consumer and environmental groups have made no secret of their distrust of the technology, and of the agency. The key factor underlying these concerns, however, is likely not with the AquAdvantage Salmon, the safety of which is firmly established, but rather with the fact that now, with this approval, there is a clear signal that the new animal drug approval system, complicated as it is, works and as a result, an array of other authorizations for modified food-producing animals may soon follow.

Author: Frederick H. Degnan, Partner, Washington, D.C., +1 202 626 3742, fdegnan@kslaw.com.

¹ See, for example, State of Policy for Regulating Products of Biotechnology, 51 Fed. Reg. 23309 (June 26, 1986).