FDA and the Future of ‘Frankenfish’

If you've come across one of the ads, newspaper stories, or opinion pieces from Chuck Norris in the past week warning you about frankenfish, you can thank the FDA. In mid-November, the FDA made history by approving the first genetically engineered (GE) animal for human consumption, Atlantic salmon from the company AquaBounty. Not only has the approval process failed to win over skeptics, exposing the weaknesses in the current legal regime that governs plants and animals developed through biotechnology, it raises important questions about the future of food oversight. With emerging genetic technologies on the horizon, can federal agencies continue to exert control over approving genetically altered plants and animals under a legal scheme that never imagined the technologically advanced foods of today and tomorrow? 

AquaBounty created the AquAdvantage salmon by combining the growth gene from the Chinook salmon and a “promoter” gene from another species with the genetic code of the Atlantic salmon. The genetic modification allows the GE salmon to grow to market weight in about half the time it takes wild Atlantic salmon – around two years instead of four. The GE salmon are raised in tanks on land, in Canada and Panama; the Canadian facility contains the breeding stock while the salmon grow to market weight in the Panamanian location. 

The FDA regulated the GE salmon under its authority to review new animal drugs, a fact that illustrates the ill-suited nature of the existing legal framework for giving federal agencies the authority to regulate genetically altered animals. In the case of the AquAdvantage salmon, FDA has explained that the introduction of recombinant DNA (rDNA) into an animal (here, the addition of the Chinook salmon and promoter DNA into Atlantic salmon) meets the definition of an animal drug under the Food, Drug and Cosmetic Act (FDCA). The FDCA defines “drugs” as “articles intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function in the body of man or other animals.” 21 U.S.C. § 301(g)(1). Under this definition, the foreign DNA added to the Atlantic salmon falls under the “drug” definition because it spurs growth in the Atlantic salmon, i.e., affecting the structure or any function in the body of the animal.

FDA approval for GE salmon completes a process begun over a decade ago. AquaBounty approached FDA about selling its GE salmon in 1993 and filed a formal application for approval in 1995. The lengthy approval process involved many steps: FDA approved the salmon under the scheme designed for new animal drugs, requiring AquaBounty to submit years’ long studies of the salmon; AquaBounty completed and submitted those studies in 2009, the process also included a public comment period conducted by FDA and an environmental assessment prepared in consultation with the Fish and Wildlife Service and the National Marine Fisheries Service (NOAA Fisheries). However, the FDA determined that a full-scale environmental impact statement (EIS) was not necessary, a move that has drawn criticism. Even more controversial: the FDA will not require the AquAdvantage salmon to bear a label identifying the product as genetically engineered. Consumer polls indicate a strong preference for labeling, and leading grocers have pledged not to carry the GE salmon.

FDA approval has done little to inspire public acceptance for the GE salmon. In fact, the process itself has given critics plenty of fodder. It is disheartening, then, to consider the future of the government’s role in regulating genetically modified animals. Consider for instance the CRSPR (pronounced “crisper”) method of genetic alteration. Hailed as a major scientific breakthrough, CRSPR allows scientists to selectively edit the genetic code of an animal to produce desirable traits without having to bring in genetic material from a foreign organism. The logic the FDA exercised to regulate the AquAdvantage salmon – that the introduction of genetic material from a different animal constitutes a “drug” – doesn’t apply nearly as neatly when no foreign genetic material is involved. Newer methods of genetic modification, like CRSPR, cannot be as easily enveloped into the existing statutory and regulatory structure as the GE salmon. This problem is not merely theoretical: In 2011, USDA encountered a genetically altered grass from Scott that the agency admitted it did not have the authority to regulate, allowing Scott to skip the environmental testing typically required of genetically modified crops. It is only a matter of time before the same occurs for an animal intended for human consumption.

Government oversight of genetically altered agricultural plants and animals is critical, and this gaping hole in the regulatory framework must be addressed. No matter the method of genetic alteration, plants and animals created through biotechnology should be evaluated for their environmental impacts, the safeguards in place to prevent the genetically altered organisms from escaping or drifting into contact with non-altered organisms, and in the case of animals, the effects on the animals. A regulatory process designed specifically for plant and animal foods created through biotechnology will protect human and environmental health and help inspire consumer confidence in our foods.