Field-test ups and downs.

Field-test ups and downs 

The path to governmental permission for field tests of genetically engineered microbes has been far rougher than the scientific development of the organisms. But a long-awaited report of the President's Office of Science and Technology Policy (OSTP), now awaiting the President's approval, is expected to smooth out some of the rough areas for the biotechnology industry. Meanwhile, critics of genetic engineering continue to erect blockades.

A proposal to field-test microbes genetically engineered to protect corn against root cutworms has taken a major detour. The Environmental Protection Agency (EPA) deferred action on the request by the Monsanto Co. of St. Louis for an experimental use permit. EPA asked Monsanto for "better data' to indicate that the release of the two genetically altered strains of bacteria wil present "minimal risk' to the environment. Because the bacteria were to be applied to seeds during the spring planting season, the EPA action rules out a field test of these organisms this year, the company says.

This EPA decision counters the recommendation last month of its scientific advisory panel. The panel said that although there were deficiencies in some of the studies Monsanto submitted, the available data were sufficient to show that the risks presented by a field test are minimal.

While Monsanto has had a major setback, the University of California at Berkeley has received permission to field-test a genetically engineered microbe, a bacterium altered to prevent it from triggering frost damage in crops. But opposition to the field test has been raised in the neighborhood of the proposed test sites. The university says it will delay the testing to address local concerns.

The university proposes to test the same organism that was about to be field-tested by Advanced Genetic Sciences of Oakland, Calif. That company recently had its testing permit revoked by EPA when the agency reported violations of rules regulating greenhouse tests (SN:3/8/86, p. 148). Before approving the University of California proposal, EPA undertook extra investigation steps, inspecting the test sites and examining the university scientists' laboratory records.

As a new tactic in his continuing opposition to biotechnology field tests, Jeremy Rifkin of the Washington, D.C.-based Foundation on Economic Trends recently petitioned EPA to withhold experimental use permits for such experiments until the agency addresses the issue of insurance liability. He says companies and universities are being denied field-test coverage by insurance companies. "No research institution or corporation in the United States,' Rifkin says, "has the financial reserves to cover the liability claims for one genetic engineering accident of the scale of a spreading chestnut blight or dutch elm disease.'

Specifics of how the various federal agencies should divide up the task of regulating the fruits of biotechnology now are described in an OSTP report. The delegation of authority recommended follows the general scheme currently in place: EPA would handle microbial products; the Department of Agriculture would regulate animal vaccines and genetically engineered plants; and the Food and Drug Administration would deal with pharmaceuticals and human vaccines. But the report provides "considerable details' that will make the pattern of authority "much more visible to the biotechnology community,' says one government official.

A category of genetically engineered products, those from which a gene has been deleted, would not be required to face as rigorous a review as those to which genes have been added, according to other government officials. But a spokesperson for OSTP refused to confirm that report. Scientists disagree on whether the deletion of a gene is necessarily less risky.