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Industry Reps Welcome New Biotech Regulations

June 24, 1986

WASHINGTON (AP) _ Representatives of the fast-growing biotechnology industry on Tuesday welcomed new federal regulations that they said allowed more latitude to commercialize new developments.

″I was struck by the regard for commercial interests″ in Friday’s announcement that outlined the Reagan administration’s new regulatory framework, said Roger Kleese, vice president for plant research of Molecular Genetics, a Minnesota firm developing herbicide-resistant corn plants.

″The guidelines are strict but workable,″ said Richard Godown, director of the Industrial Biotechnology Association, a trade group. ″They provide a much more definitive road map from the laboratory to the market.″

And Jerry Caulder, president of Mycogen Corporation, which is developing microbial pesticides at its San Diego, Calif., laboratories, said the new regulations would make it easier for the United States to retain its world leadership in biotechnology.

The officials, speaking at an industry-sponsored briefing, said they were reacting to general descriptions of the new policy provided last week by the administration.

More detailed regulations are to be published soon.

President Reagan’s approval of the new plan last week generally eased federal oversight of products being developed through gene-splicing techniques, giving five government agencies different regulatory roles.

The National Institures of Health will retain their role as monitor of genetic engineering research, while product testing and development will be overseen by the Food and Drug Administration, the Environmental Protection Agency, the Agriculture Department and the Occupational Safety and Health Administration.

The regulations designate categories of organisms that are believed to pose the most risk to the environment, singling them out for more rigorous treatment, and expediting the review of those deemed of less concern.

Hundreds of potential new products are being developed using the new processes that let scientists alter the genetic makeup of living cells. Among them are new drugs and vaccines, more productive farm animals and plants that can resist pesticides or even produce their own pesticides.

There has been public concern about the booming new field, however, which some believe holds the potential for a disastrous environmental accident because of the chance for human error in redesigning plant and animal genes.

The industry spokesmen said they were confident the new regulations left no room for error and that their primary regulatory problem now was dealing with public doubts about safety which they said were not founded on scientific truth.

″Scientific literacy in the United States is pretty low,″ said Caulder, who criticized ″pseudo-scientists″ he said were stirring up public fears. ″We’re not putting the bull in the china shop. We’re just changing one handle on a teacup,″ he said.

″There is a realization in the industry that there are some uncertainties, whether natural or created, in the minds of the public,″ Godown said. ″The public has a right to have their concerns addressed,″ and that is the role of the new regulations, he said.

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