Biotech rules receive scrutiny.

Biotech rules receive scrutiny

A new Reagan administration policy governing the release of biotechnology products provides "a workable system of review" for rleasing genetically engineered organisms into the environment, says Rep. Harold Volkmer (D-Mo.), who chairs the House Subcommittee on Investigations and Oversight, one of three subcommittees that participated in a hearing on the policy last week. But some scientists question the ability of the new guidelines to adequately protect the environment, while other scientists argue that they improperly exempt from rigorous review some potentially hazardous organisms.

Under the expanded guidelines, which went into effect June 26, products derived from disease-inducing organisms, products to be newly introduced into an ecosystem and products with altered nonregulatory DNA sequences would received particularly close scrutiny. Products with alterations to regulatory DNA coding sequences, products created by deleting a gene and products created by combining the genes of organisms within the same genus would receive brief review, under the assumption that such products are better understood and pose little risk.

Elliott Norse of the Ecological Society of America in Washington, D.C., sees in the new policy a "tilt toward minimizing safeguards" that could allow the release of potentially dangerous organisms. "There is currently no definitive way to predict what the [engineered] product will be -- that is, what an organism will do when modified and released into the environment," he said at the hearing.

Another problem with the rules, according to Monica Riley of the Washington, D.C.-based American Society for Microbiology, is the distinction they make between manipulating regulatory and nonregulatory DNA sequences in engineered organisms. Regulatory sequences control nonregulatory DNA sequences, which affect the functioning of an organism, such as the production of an enzyme. In exempting such altered organisms from in-depth review, she says, the new policy fails to appreciate the power of regulatory sequences to affect an organism's ability to compete and survive in a new environment.

Volkmer also expresses concern that the agencies affected by the new policy have yet to agree on the definitions of crucial terms such as "environmental release" and "containment facility," leading to confusion in the biotechnology industry. Says Volkmer, "It is difficult to implement release guidelines if there is confusion about when a release has occurred."