Genetic Engineering’s Morass
Animal husbandry and crop breeding have been going on for centuries and have benefited humanity by making more food available to feed more people. This is a form of genetic engineering, but there is little, if any, government regulation of such activity.
In the last decade or so scientists have extended their genetic-engineering skills to the molecular level, producing a variety of organisms that promise to be at least as beneficial to humanity. Study after study by reputable and conscientious researchers have concluded that these altered organisms pose no new threat to the environment or to other life on Earth. Nonetheless, a regulatory morass has developed around genetic engineering that at best delays the use of these organisms and could threaten the financial viability of the nascent biotechnology industry that is creating them.
No fewer than five federal agencies have regulatory jurisdiction over various aspects of genetic engineering. The Environmental Protection Agency can review proposed tests of new organisms; the U.S Department of Agriculture can pass judgment on their use; so can the Food and Drug Administration; the National Institutes of Health regulates researchers, and the Occupational Safety and Health Administration oversees the plants at which drugs and chemicals are produced.
Sometimes these agencies adopt and enforce different standards. Sometimes they squabble among themselves over who has the right to regulate a new product. When Genentech--the San Francisco-based biotechnology pioneer--sought to test an interferon vaccine for cows, the Department of Agriculture and the Food and Drug Administration fought for a year over who had control. The Department of Agriculture regulates “veterinary biologics” while the FDA has the say-so over “new animal drugs.” Meanwhile, the drug was not tested, Genentech incurred substantial additional expense and the public lost the ben-efit of healthier cows.
The amount of regulation and the delays that it entails have forced some American researchers to conduct their tests abroad, which defeats the purpose of the regulation in the first place and potentially undercuts this country’s worldwide lead in biotechnology. Most important, more regulation is being applied to these new products than they need.
This is a purely political problem, not a scientific one. At the beginning of the genetic-engineering revolution, biologists were rightly concerned about the potential consequences of their work. They even voted a moratorium on this research until they could determine what the real risks were. This was the first time in history that scientists voluntarily agreed to forgo research because of possible dangers.
But the issue is now resolved. All reputable scientists, including a panel of the National Academy of Sciences, have concluded that the imagined risks are all but non-existent. It is time for Congress to streamline the regulation of genetic engineering while maintaining adequate safeguards. Researchers and entrepreneurs should not be hindered from developing these products and bringing them to market.
