Genetically Engineered Salmon Debate

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.

Genetically engineered salmon are safe and edible

Attorney Sharon Tisher’s attack on the U.S. Food and Drug Admini-stration’s long history of safe and effective food regulation (BDN, Feb. 15) obviously aims to influ-ence debate in the Legislature as a bill banning genetically advanced salmon moves toward introduc-tion. Tisher serves up a suggestive mixture of lurking bureaucrats, Canadian corporations, threatened salmon, collusive regulation, de-ceptive and dangerous science, unpredictable effects, fish farms, the Reagan era and trade secrets. With her helpful addition of Frankenfish to the headline, could any reader doubt that a perfect storm is brewing up out there on the fringes of science.

The FDA regulation that so troubles Tisher is actually the gold standard of human and animal safety testing that Americans have relied on for safe and effective medicines since 1917. Genetically engineered salmon are being tested under a proven process that has developed over the past 85 years to regulate the safety of pharmaceuti-cal products for humans, animals and for the environment. It re-quires that products be safe, manu-factured to an exacting standard, consistent in performance and that they work.

FDA is also the agency that regulates seafood safety, bringing a great deal of “in-house” expertise to its examination of transgenic fish. Under the National Environ-mental Policy Act and the Endan-gered Species Act, the FDA also taps the expertise of the National Marine Fisheries Service and U.S. Fish and Wildlife Service help con-struct an environmental risk as-sessment of transgenic fish and to evaluate the results. Regardless of how the FDA process plays out, the fisheries agencies will have the final say over what kind of salmon can actually be grown in Maine.

Tisher attacks the principle of “substantial equivalence” as an FDA argument to dodge the need for food safety testing. In fact, it is what Tisher calls “traditional foods” that are exempt from safety testing — not because they are safe, but because people have been eating them for thousands of years with no apparent ill effect.

This is an important point. The only foods that are safety tested are those that have been developed through the process of gene splic-ing. More than 3,000 peer-reviewed studies in scientific journals and 15 years of safe consumption of food and pharmaceutical products sup-port the safety of the technique. Contrast this record with the com-pletely untested genetic modifica-tions developed through chemical and radiologic mutation, embryo salvage, tissue culture and wide crossing that plant breeders have developed in the past 50 years. Po-tatoes and tomatoes, whether or-ganic “heirlooms” or modern hy-brids, are untested glycoalkaloid factories that carry dozens of known toxins (both are members of the deadly nightshade family), while grapefruits are laboratory creations that could never have been bred by nature alone. Do we fear these wholesome foods, even though they have never been evaluated for safety, or do we use common sense to recognize that whatever theoretical risk they might pose has never risen to the level of causing actual harm in our diets.

Engineered foods and medicines have a similar record of safe con-sumption dating, in some cases back to the 1970s. Millions of Americans take genetically engi-neered insulin to control diabetes, eat cheese (even French camem-bert) made with engineered chy-mosin, drink beer fermented with engineered yeasts, eat meats fed on engineered feeds, foods made with modified soy, corn and canola, pa-payas engineered to resist ring spot virus and drink milk pro-duced with the help of engineered proteins. Scientific testing and common sense both tell us what the Clinton administration’s Un-dersecretary of Commerce, David Aaron, said in 1999, “Thirteen years of experience with biotech products in the U.S. have shown us that biotech foods developed and used in the U.S. present no safety risk beyond those of their ‘natural’ counterparts. Not a single ailment has been attributed to biotech foods. Not one. Not a sneeze, not a rash, not a headache.”

In the face of overwhelming sci-entific evidence of safety, Tisher resorts to quoting Barry Com-moner’s article in Harper’s, in which the venerable green icon resurrects his 1960s debate with James Watson, the Nobel Prize winning discoverer of the DNA double helix, to claim again that proteins, not genes, are the blue-print for life. Commoner lost that argument — and his credibility in the scientific community — in peer review journals nearly 40 years ago. His sad attempt to recover his scientific reputation in the pages of a mass media magazine says more about advancing age than about the advancement of science.

Finally, Tisher trots out Bill Brown’s critique of federal bio-technology regulation that was endorsed by the Clinton admini-stration in 1999. In his Environ-mental Forum article, Brown de-scribed the Interior Department as “an odd-person-out … a disruptive presence” inside the administra-tion, which put forth a plan to out-law the possession of genetically engineered materials for any pur-pose, including private research. Interior’s plan was rejected by the White House, the Department of Agriculture and the Environ-mental Protection Agency, as well as the FDA.

But while Interior accepted the better judgment of its agency peers, Brown did not. Instead, he moved to the National Audubon Society when he left government and began promoting the aban-doned plan in activist circles. Two years later, it surfaces in Maine in an activist’s attempt to confuse legislators into passing a law sup-ported, not by science, but only by fear itself.

Joseph McGonigle is vice president at Aqua Bounty Farms, a Massachusetts biotechnology company. He has rep-resented the aquaculture industry in Maine, served on the Senate presi-dent’s staff and was executive director of the Commission on Maine's Fu-ture.

Sharon Tisher Responds:

McGonigle also refers to "more than 3,000 peer-reviewed studies in scientific journals" that "support the safety of [gene splicing]." Again, the reader is invited to infer that these are studies of food safety. Wrong again. In a report in the June 9, 2000 issue of Science, Jose Domingo performed a comprehensive search of journal databases to identify published reports on the safety of genetically engineered food. Domingo found a wealth of opinions and comments, but an absolute paucity - only eight - published reports of experimental data on safety testing. Asks Domingo: "If…safety and toxicity studies of GM foods have been carried out by [biotechnology] companies, why have the results not been subjected to the judgment of the international scientific community, as would be the course if such research were published in reputed journals?"

If, as McGonigle concedes, no less than the U.S. Interior Department finds something fundamentally awry with our system of biotech regulation, we should listen. Hostility to adequate regulation is a ticket to consumer distrust and ecological disaster. On the major point of my commentary, moreover - the ecological risks of the fish McGonigle's firm manufactures - McGonigle is uncharacteristically silent.