The following editorial appeared in Saturday's Washington Post:
The ecosystem may or may not be ready for the first genetically engineered salmon, but the regulatory system emphatically is not. It is stuck in the legacy of decisions about biotech regulation made in the mid-1980s, when food was food, drugs were drugs and a lot of people thought most biotech products were going to be microbes. The creatures and products that have come along instead -- corn that makes its own pesticide, animals that make drugs, goats that carry a spider gene and make silk --are straining that simple model.
The case of the salmon shows how badly the framework needs updating. A coalition of 60 consumer and environmental groups recently asked the Food and Drug Administration (FDA) to block importation and marketing of the souped-up salmon, which reaches full size faster because of genetically stepped-up production of growth hormone. The fish have been under development under controlled conditions in Canada, but they have not been commercially marketed. No significant health issues have been raised about humans eating the fish. But environmentalists fear that if the altered fish escape from the ocean pens in which commercial fish are typically grown, they could mate with wild salmon and wreck ecological balances. That issue is unlikely to get the best possible airing at the FDA, which has classified the genetic enhancement as a drug for animals. That technically means the main task of its review will not be to look at the effects of the fish on the environment or the fish on the consumer, but to study the effect of the growth hormone on the fish.
Environmental issues will be covered, the FDA promises. But the environmental and marine specialists who could best address them are housed at other agencies. Even the Environmental Protection Agency gets involved only under narrow circumstances. It was able to regulate Starlink, the bioengineered corn that found its way into the food supply after being denied a permit for human consumption, only because the corn was classified as containing a pesticide. Consumers can benefit hugely from these products, but only if whatever needs checking is being checked. Those producing these organisms likewise need to have a reliable notion of what sort of hurdles they face. The opposite situation now obtains: Most checking is voluntary, especially for foods, but the coalition that petitioned the FDA on the salmon has also filed the request with the Departments of Agriculture, Commerce, Interior (which houses the Fish and Wildlife Service) and Defense (the Army Corps of Engineers). Any of these could theoretically claim jurisdiction under statutes ranging from the Endangered Species Act to laws governing the control of exotic foreign species.
A better way is mapped out in legislation being drafted by Rep. Peter DeFazio, D-Ore.. It would require approval of new genetically modified organisms through a single "address," probably an assistant EPA administrator for biotech, who would then be required to consult with experts in other agencies depending on each organism's properties. The exact address is less important than the idea of a process flexible enough to keep up with bioengineers' limitless ingenuity.
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