Bush Backs Streamlining of Biotech Review Process

In a boost to the biotechnology industry, President Bush on Tuesday endorsed guidelines urging elimination of “unnecessary regulatory burdens” that slow review and approval of genetically engineered products.

The president’s Council on Competitiveness, chaired by Vice President Quayle, issued four principles that, in essence, state that regulatory reviews should focus on the product and not on the process by which it was created or manufactured.

“Products developed through biotechnology processes do not per se pose risks to human health and the environment, . . . (and) biotechnology products that pose little or no risk should not be subject to unnecessary regulatory review during testing and commercialization,” the council said in its statement.

Many critics of genetic engineering have insisted that products of biotechnology demand special attention because of the way in which they were created. But the biotechnology industry--which is really a collection of disparate companies using genetic engineering technologies--for years has been campaigning to deflect attention from the technology and toward the products.

Tuesday’s announcement, however, may have more symbolism than clout; implementation of the guidelines still rests with the federal agencies that review, regulate and approve biotech products. The difficulty may lie in “translating a set of principles into action within the bureaucracy,” said Roger Salquist, chief executive of Calgene. Salquist’s company, headquartered in Davis, Calif., is a leader in genetically engineered agricultural products.

The principles also state that reviews of low-risk biotech products should be expedited and--in what some have interpreted as a gentle slap at interagency bickering--that jurisdictions should be clarified and conflicting policies standardized. Many products face overlapping reviews by the agencies, which include the Food and Drug Administration, the Environmental Protection Agency and the Department of Agriculture.

“There is not much new here,” said Michael Picker of the Sacramento office of the National Toxics Campaign, a group that has opposed genetic engineering of herbicide-resistant plants. “We have in many respects viewed them (the regulatory agencies) as boosters and not too discriminating in the past.”

The final two principles suggest that regulations for the industry be based on performance and not design standards. For example, in a field test of genetically engineered organisms, the ideal regulations would set standards for restricting spread of the organisms within specified concentrations, rather than tell the company to build tall fences or cover-up domes.