A White House task force has determined that no new rules or laws are needed to regulate the emerging biotechnology industry, but it has called for the creation of a "biotechnology science board" to advise federal agencies on how to assess new products.
The interagency task force recommendation essentially leaves intact a variety of existing mechanisms, ranging from the National Institutes of Health's genetics research guidelines to the Environmental Protection Agency's Toxic Substances Control Act, to regulate the flow of new biotechnology products into the marketplace.
The task force's report, which represents the views of 17 executive branch groups with interests in biotechnology, will be published in the Dec. 31 issue of the Federal Register.
"One of the purposes of this document is to assemble in one place all the applicable regulations affecting biotechnology at each step of the process, from research to marketing to disposal of materials," said Bruce Abell, a spokesman for the White House Office of Science and Technology Policy. " The panel did not recommend new legislation."
Biotechnology -- especially that allowing scientists to create different forms of life by altering a cell's genetic code -- has sparked a great deal of public concern. Various groups have expressed fears about the release of potentially dangerous genetically engineered organisms into the environment, and about "genetic tampering" with life. Some organizations have called for stringent regulation of genetic engineering research and the products it produces, but congressional attempts to enact restrictions have met with failure.
The task force has concluded, however, that the existing regulatory structure is adequate to deal with concerns about the new technology.
The report's findings, which had been expected, came as a relief to many biotech corporations, which feared that new regulations might inject uncertainty into the market and further delay the introduction of new products.
"Our feeling has been all along that existing statutory authority has been sufficient," said Alan R. Goldhammer, a technology associate at the Industrial Biotechnology Association. "We are very supportive of the existing agencies . . . . I think the report is going to clarify where a lot of these new biotechnology products are going to fall."
Some agencies already have clear authority over biotechnology products. For example, genetically engineered pharmaceuticals such as insulin would fall under the jurisdiction of the Food and Drug Administration.
Other products apparently fall into overlapping regulatory zones. A genetically engineered micro-organism designed to help plants fight insects would be regulated by either EPA, the Department of Agriculture, or both.
The report said that establishing a biotechnology science board would assure that the evaluation of new products is consistent from agency to agency. A separate interagency working group should be maintained to help clarify jurisdictional confusion, the report said.
The agencies most concerned with biotechology -- FDA, EPA and the Agriculture Department -- plan to release policy statements outlining how they intend to use their current regulatory authority.