Biotech Companies Lobby for Federal Regulation THE FIRST PRODUCTS of the brave new world of agricultural biotechnology--crop plants genetically engineered to resist plant pathogens and herbicides--are almost ready to move into full-scale testing. But whether U.S. farmers will actually be able to plant any of the new varieties of these novel crops in the next few years may depend as much on the federal government as on the companies developing them.
Six years after the Reagan Administration began trying to hammer out regulations governing outdoor testing and marketing of organisms produced with recombinant DNA technology, federal agencies have yet to agree on such basic issues as how to determine which plants and microorganisms should be subject to special review, and which should be exempt.
Part of the holdup has been that six of the biggest federal agencies--three on a side--have taken conflicting views of whether genetically engineered organisms should be singled out for special regulation. But the wrangling may finally be coming to an end: The White House says it will be stepping in to resolve the controversy and that a basic agreement may be hashed out within a month.
At present, the Environmental Protection Agency (EPA) and the U.S. Department of Agriculture (USDA) are approving small-scale field trials involving genetically engineered plants and microorganisms on a case-by-case basis. But there are no overall rules governing large-scale testing and it's unclear what companies will have to do to gain approval to market some biological products.
Consequently, many companies are unable to make long-range plans because they cannot predict how much time and money it will take to get a new crop variety or biological pesticide on the market. Some, such as Eastman Kodak, have even decided to avoid using any recombinant DNA technology that might get a potential product stuck in regulatory quicksand. "Without knowing what is going to be required," says Kodak's director of agriculture, Zenas B. Noon, Jr., "you can risk losing millions of dollars."
Others are nervously hoping that their competitors will not steal a march on them while they wait for agencies to provide written guidance or regulations mapping the route to commercial production. Pioneer Hi-Bred International, for example, is concerned that regulatory delays may prevent it from marketing seeds for genetically modified sunflowers, soybeans, and corn ahead of its competitors. Rod Townsend, regulatory affairs manager for Pioneer, says some of these crop varieties may be overtaken by hybrids produced through...