Glowing in the Dark: How America's First Transgenic Animal Escaped Regulation
42 Pages Posted: 9 Jun 2005 Last revised: 12 Nov 2012
This article tells the story of the GloFish, America's first commercially available transgenic (or genetically modified GMO, also called living modified or LMO). Beginning with the scientific research that produced this transgenic fish, the article traces the GloFish through development, marketing and regulation in order to extract whatever lessons can be learned from this initial experience with a transgenic animal. I assert that the tale is a cautionary one - with agency reluctance to regulate jeopardizing public and environmental safety. Rather than engaging in heightened or even ordinary regulatory scrutiny, the Food and Drug Administration (FDA), the lead agency for regulating transgenic animals, instead announced in 2003 that it would permit GloFish to enter into interstate commerce wholly unregulated. This announcement that the FDA would not to regulate GloFish meant that no federal agency was exercising any oversight over the first commercially-available transgenic animal. Proponents of other novel transgenic organisms are already claiming that the GloFish's regulatory path sets a precedent for regulating transgenic organisms. Since the FDA is currently considering a proposal to approve widespread aquaculture of transgenic salmon, the FDA's approach to GloFish raises immediate and pressing concerns about the environmental risks likely to flow from inadequate regulation of this new biotechnology.
This article measures FDA's decision not to regulate against the applicable statutory mandates and regulatory policies. To that end, the article describes the New Animal Drug approval process and measures what the FDA actually did in the GloFish case against the statutory requirements for approving a new animal drug under the federal Food Drug and Cosmetics Act (FDCA). The Article then compares the FDA's GloFish Declaration with the FDA's responsibilities under the National Environmental Policy Act (NEPA). I argue that, in its GloFish decision, the FDA inappropriately substituted substantial equivalence, an administrative policy developed to coordinate agency oversight of biotechnology, for the applicable statutory standards under the FDCA and NEPA. Finally, the article ends by exploring the possible fallout from this decision for the FDA's pending consideration of a NAD application for transgenic salmon. In particular, this section identifies some sui generis environmental concerns associated with aquaculture of transgenic salmon and considers what the FDA's GloFish decision may tell us about the FDA's willingness to fully consider these questions.
Keywords: biotechnology, transgenic, aquaculture, GMO, LMO, FDA, Food Drug and Cosmetics Act, FDCA, regulation, NEPA, New Animal Drug, Coordinated Framework, transgenic salmon, risk assessment, precautionary principle, GloFish, genetically modified organism, GM
JEL Classification: I19, K1, K19, K23, K32, Q1, Q18
Suggested Citation: Suggested Citation