Frankenfish and the FDA

A new threat to wild Atlantic salmon is lurking in the offices of Food and Drug Administration headquarters in Maryland. Aqua Bounty Farms, a Prince Edward Island company, and its Massachusetts affiliate, A/F Protein, have applied for FDA approval of a genetically engineered salmon that grows up to six times faster than normal fish. Sebastian Belle, executive director of the Maine Aquaculture Association, states that “none of our members has ever indicated an interest in using GMO products,” but the Association has not formally opposed GE fish, for fear that Maine industry will be at a “competitive disadvantage” vis a vis others who grow the superfish.

Having the initial decision for legalization of GE superfish in the hands of the FDA is troubling (other agencies will later pass on licensing of GE aquaculture locations). The FDA has long cast a benign eye on GE plant foods. It opposes GE labeling and argues that these foods are the “substantial equivalent” of traditional foods and hence don’t require safety testing. In the Jan-Feb 2001 issue of the FDA Consumer, FDA staff writer Carol Lewis writes glowingly that “for fish farmers, raising these so-called transgenic fish could be faster and cheaper because it takes less feed and about half the time to produce a crop,” and that “making a transgenic animal is deceptively simple, especially when compared to traditional breeding approaches.”

Deceptive, yes. Simple, no. FDA staff should study the article just published by Barry Commoner (Harper’s, Feb. 2002) which reveals that genetic engineering is, if anything, deceptively, and dangerously, complex. The drive for commercialization of genetically engineered products has distorted normal scientific processes, resulting in adherence to a genetics model that has long been refuted by research. The relationship between genetic sequencing and plant or animal traits is far more complex than industry claims, and subject to more variability and risk. Genetic engineering creates new proteins that we are unable to predict, and that industry is not required to identify or test for: “[I]n that alien genetic environment [of the host organism], alternative splicing of the bacterial gene might give rise to multiple variants of the intended protein – or even to proteins bearing little structural relationship to the original one, with unpredictable effects on ecosystems and human health.”

More fish farm escapees are trapped in some Downeast rivers than native endangered wild salmon. Aqua Bounty proposes to farm only sterile females but, as acknowledged by Aqua Bounty’s own scientists, there can be no guarantee of sterility. In Sutterlin et al., “Environmental Risks in Using GH Transgenic Atlantic Salmon” [www.nbiap.vt.edu/brarg/brasym96/sutterlin96.htm], lead authors Sutterlin and Fletcher are employed by Aqua Bounty and A/F Protein, respectively. The authors admit that “Present sterility techniques will probably be adequate for some species in most circumstances, but may not sufficiently reduce risks (or be commercially viable) for other species under other conditions. Considering the lack of present understanding of the fitness (behavioral, physiological and genetic) of such transgenic fish, it may be exceedingly difficult to predict impacts in many situations.” Cold comfort for endangered cold water fish.

The FDA is conducting its environmental review of transgenic fish under its authority to regulate “new animal drugs” – a vestige of the Reagan-era decision that the feds would write no new statutes to deal with issues of genetic engineering, just squeeze review of the new life forms into pigeonholes of existing regulations. The Maine Commission to Study Genetic Engineering, in its 1996 final report, identified as one of three major “areas of concern” the need for “an effective system of federal legislation…to assess the risks of environmental release [of genetically engineered fish] and regulation to address those risks.”

Two years ago, the Interior Department did an analysis of the effectiveness of laws to address the risks of environmental release of GE plants and animals. The conclusion, in the words of then Science Advisor to Secretary Bruce Babbitt, was that “the laws currently applied to review of transgenic organisms that may escape into the environment, reproduce and spread…are woefully deficient for this purpose – filled with gaps, nearly incomprehensible, and stretched beyond legal credibility by the agencies that implement them.” (William Brown, “Promise and Peril,” The Environmental Forum, Sept/Oct 2001) Interior Department staff specifically reviewed, and found significant problems with, the FDA’s regulation of transgenic salmon. They proposed a legislative overhaul of the process of licensing and risk assessment for GE products. The FDA and the USDA opposed it.

FDA procedures for new animal drug approval are confidential – to protect “trade secrets” – and have no provision for public input. Nevertheless, you can send your concerns about the issue to the FDA and to our Congressional delegation by logging on to www.centerforfoodsafety.org.

Sharon S. Tisher, J.D. teaches environmental law at the University of Maine.