Researchers Praise Reagan Biotech Rules

A set of restrictions on the research and products of genetic engineering which the Reagan administration released last Saturday will aid the biotechnology industry by creating a standardized set of federal guidelines, researchers said this week.

The new regulations require biotechnology companies to submit all products by genetic engineers to a review by at least one federal agency. Researchers will need federal approval in order to use genetically altered organisms in the environment.

The genetic restrictions will have little or no effect on basic scientific research done at universities. according to Mark S. Ptashne and Thomas P. Maniatis, professors of biochemistry and molecular biology and the founders of Cambridge's Genetics Institute.

But industrial researchers in biotech firms praised the regulations for "resolving issues on the side of scientific clarity" said Marc E. Goldberg, development manager of the Genetics Institute. "They will regulate products based on their character, not on how they're produced," he said. The Genetics Institute works with recombinant DNA products in the areas of health care, agriculture and specialty chemicals.

Biotechnology is an industry based on the ability to artificially manipulate genetic structures of plants, animals and microbes, these experts said.

Several government agencies have been working to create a set of regulations since genetic engineering techniques were discovered in 1976. Saturday's ruling, which combined the restrictions of individual federal agencies', produced the first complete set of federal guidelines for the biotech industry.

According to a White House statement issued Saturday, "the framework provides a measure of regulatory certainly for industry. Implementation of the policies of the framework will allow U.S. industry to efficiently deal with commercialization and promote increased competitiveness internationally."

Regulatory agencies are primarily concerned with eliminating as many unknowns as possible from genetically engineered products, Goldberg said. "The things closest to traditional products are the most easily marketable," he said. For example, using genetic engineering to produce an animal vaccine results in the same product as that made by other methods, but involves fewer steps.

The creation of these universal regulations will benefit industry because it provides a firm set of guidelines that companies can use in their planning process, said Goldberg. "It clarifies the major concerns of regulatory agencies," he added.