Safe Food_ Bacteria, Biotechnology, and Bioterrorism - Marion Nestle [112]
From such examples, it should be evident that questions about the relative risks and relative benefits of genetically modified foods cannot be answered without further research and experience. As I explain in chapter 7, the industry and its sympathetic government regulators decided in advance—using a strictly science-based approach to risk assessment—that the foods were safe and that few precautions were necessary, and they assumed that any unanticipated consequences of transgenic foods could be handled appropriately by existing regulations. As it turned out, unexpected consequences revealed the inadequacies of this approach. Some examples follow.
THE POLITICS OF UNEXPECTED CONSEQUENCES
Critics of food biotechnology insist that without prior experience, transgenic foods raise safety issues that are difficult to define, predict, or quantify but that nevertheless should be taken seriously and evaluated in advance—before the foods are grown extensively and enter the food supply. They invoke the precautionary principle (discussed in the introduction). As support for the need for precaution, they cite the examples to which we now turn. These examples explain why safety issues—especially those that cannot easily be resolved by scientific studies—become matters of politics. A precautionary approach threatens the economics of the entire agricultural biotechnology enterprise.
Toxic Contaminants: Tryptophan Supplements
The classic case of the unanticipated consequences of nutritional—if not food—biotechnology concerns supplements of the amino acid tryptophan. Like all amino acids, tryptophan is a component of proteins in all organisms. Supplements of tryptophan have been used for years as self-medication for insomnia and neurological conditions. In the 1980s, companies began to genetically engineer bacteria to produce larger amounts of tryptophan so that this amino acid would be easier to collect and purify. In 1989, tryptophan supplements produced by a Japanese petrochemical company, Showa Denko, caused eosinophilia-myalgia syndrome (EMS), an unusual constellation of symptoms of muscle pain, weakness, and increased blood levels of white cells (eosinophils). Eventually, more than 1,500 people who had taken the supplements became ill, and about 40 died. The FDA prevented further marketing of the supplement, and the company stopped making it.40
This example might just indicate that genetic techniques sometimes lead to unexpected problems, but this particular situation had additional implications. Because tryptophan is a normal component of body proteins, investigators did not think that the genetic engineering processes were at fault. Instead, they suspected that a toxic substance emerged during the manufacturing process, and they attempted to identify it. Victims, however, sued Showa Denko for about $2 billion, thereby introducing liability as an intervening factor. The company not only refused to cooperate with FDA investigations but also tried to discredit the scientists who had linked the syndrome to its product. Showa Denko demanded prepublication copies of the studies under the Freedom of Information Act (most scientists would find this intimidating as well as a nuisance) and used a carefully selected advisory committee to argue that