Bush Loosens Controls on Biotech Industry
President Bush on Monday loosened federal regulatory control of the $4-billion biotechnology industry, saying that will help it grow to a $50-billion giant by the end of the decade.
Biotechnology uses new and sometimes unproven techniques to manipulate genes. The processes hold vast promise of changes to agriculture, medicine and pharmaceuticals, energy, manufacturing and environmental restoration.
The Administration’s new policy, in effect, would require federal agencies to prove that a new, genetically engineered product poses an environmental or health risk before asserting their oversight authority.
Environmentalists criticized the change as risky. “It’s a little different from allowing chemicals to escape,” said D. Douglas Hopkins, a senior attorney with the Environmental Defense Fund. “Organisms reproduce. You can release a few and end up with many millions.”
Reaction from the biotechnology industry was mixed, in part because details of the Bush Administration initiative were not widely known.
Peter Jensen, executive director of the California Industrial Biotechnology Assn., expressed hope that the move would boost investment in the industry, which employs about 34,000 workers in the state.
Jensen said that many investors have been put off by the years it has taken to bring biotechnology products to market. “In principle, anything we can do to remove the regulatory impediments is great,” he said.
But Roger H. Salquist, chairman and chief executive of Calgene Inc. in Davis, Calif., countered that “loosening the regulations per se is a nonsense issue. . . . The system is working.”
Salquist added, however, that only recently have a number of biotechnology products gotten close to hitting the market. If the Bush Administration is simply directing regulators not to impose unnecessary delays on these products, he said, the new policy could be helpful.
Jeff Nesbit, spokesman for the President’s Council on Competitiveness, said the new policy is meant to streamline the regulatory process and to ensure that “agencies won’t add extra layers of regulations because of the products involved.”
Eventually, the Administration hopes to produce a “road map” to direct biotechnology firms toward the right regulatory agency, Nesbit said.
Now, he said, “if you’ve got a tomato genetically engineered to have pesticide protection, it is conceivable that three different agencies will want to regulate it: Department of Agriculture as produce, the Environmental Protection Agency as a pesticide and the Food and Drug Administration because it regulates pesticide residue on food products.”
Bush told a meeting sponsored by the U.S. Chamber of Commerce that “the rewards we reap include new medicines, safer ways to clean up hazardous wastes and a revolution in agriculture.”
The Council on Competitiveness, headed by Vice President Dan Quayle, said the action will put in place “a scientifically sound, risk-based policy” that will allow federal agencies wide discretion in their oversight of biotechnology use.
But the Environmental Defense Fund’s Hopkins warned that the effect will be to make it easier for researchers to release genetically engineered organisms into the environment. “It puts a heavy burden on federal agencies to demonstrate unreasonable risk before the agency can exercise oversight,” he said.
Biotechnology now concentrates almost entirely on pharmaceuticals. The Administration plan envisions growth in agriculture, manufacturing and environmental restoration.
