5 Separate Agencies Remain but Review Period Speeded Up : New Ground Rules on Biotech Products Put Into Effect

A new Reagan Administation formula for regulating genetically engineered products continues to allow five separate agencies to decide which products get licensed, but it provides consistent regulatory ground rules expected to speed up research and product approval.

The policy, which went into effect Friday, reduces the review period for some genetically engineered products and declares that not all forms of biotechnology need special scrutiny.

“What we’re saying here is that a given product is regulated as a product, not by the technique by which it is developed,” said David T. Kingsbury, who headed a White House scientific group that produced the new guidelines. “We are simply relying on existing regulatory statutes instead of imposing a new structure because the technology is different.”

Industry representatives praised the new rules, saying they do not change the existing regulatory process for most biogenetic products but clarify the process for the most controversial of them. Critics on Capitol Hill and in the environmental community condemned the formula as too cumbersome, yet too lenient in review requirements.

Sen. Albert Gore (D-Tenn), a member of the Commerce, Science and Transportation Committee, complained that the new regulatory framework fails to resolve “the bureaucratic muddle” surrounding the industry and exempts some kinds of engineered products from special review.

But Kingsbury said that the product type will determine which agency has jurisdiction and that companies will have “no choice of shopping agencies.”

Under the rules, the products and research will be overseen by the Food and Drug Administration, the Environmental Protection Agency, the Department of Agriculture, the Occupational Safety and Health Administration and the National Institutes of Health. For example, the EPA will continue to regulate pesticides and the FDA will keep its jurisdiction over drugs.

In the past, regulatory scrutiny has varied widely from agency to agency, with the FDA’s reviews considered the most stringent and the USDA’s the least. The new formula spells out which agency reviews which product and relies on a committee of agency representatives to ensure equal levels of stringency monitoring.

The rules also distinguish between different forms of genetic modifications. If the product requires addition of genetic information to an organism, it will be subject to regulation as a biogenetic product, Kingsbury said. If it alters genetic information in a single organism, it will be reviewed like a similar product made by non-bioengineering techniques, he said.

Kingsbury and industry leaders said special regulation in cases of a single organism is unnecessary because products are never made more dangerous by the process. One such product is a vaccine for pseudorabies, in which a gene is deleted from the virus. The remaining substance is used to inoculate pigs against the disease. Industry officials cite the vaccine, made by Omaha-based Biologics Corp., as an example of a helpful product that was delayed by excessively rigorous regulatory review and then held up because of charges made by industry critic Jeremy Rifkin.

Rifkin, president of the Washington-based Foundation on Economic Trends, contends that products altered in such a way do pose threats and must be regulated differently. Rifkin said he will file a lawsuit next week seeking to rescind the new rules.

“They have given the industry everything they wanted,” Rifkin said. “The White House has made it clear that the environment be damned.”

Although the guidelines will not change regulatory procedures for most companies, they help clarify the process for a small segment of the burgeoning biotechnology industry--those that deal in the release of genetically engineered plants and organisms into the environment.

With the guidelines, “a lot of uncertainties have been cleared up . . . uncertainties over which agency to go to” in the regulatory process, said Alen Goldhammer of the Maryland-based Industrial Biotechnology Assn. “For 95% of all products, there has been no real uncertainty--they go to the FDA,” he said.

But for the other products, most of which are still in the research stage, the guidelines clarify the route for regulatory approval. Agricetus, the Madison, Wis.-based joint venture of Cetus and W. R. Grace, recently gained USDA approval for a test project on genetically improved tobacco plants. Had the new regulatory formula been in effect two years ago, it would have simplified the venture’s efforts, said Robert Fildes, president of Agricetus and chief executive of Emeryville, Calif.-based Cetus, the No. 2 biotechnology company.

The plants, which have no commercial value, were planted a couple of weeks ago in Wisconsin and are being used as a model to test a genetic engineering technique to make plants more disease resistant. If the technique works for the tobacco plants, said Fildes, it could then be used on other agricultural products, including important cash crops such as corn and cotton.

“It took us a couple of years just to find our way through all of this--just finding out which agency,” Fildes said.

Maura Dolan reported from Washington and Donna K. H. Walters from Los Angeles.