EPA sends biotech industry a warning to obey federal rules. Agency cracks down on firm that illegally tested bacteria
The US Environmental Protection Agency has sent a message to the budding genetic-engineering industry: It ``is not going to tolerate any infraction'' of pesticide regulations. That message was delivered earlier this week when the EPA proposed $20,000 in fines for Advanced Genetic Sciences (AGS) of Oakland, Calif. The small company wanted to be the first to market a genetically engineered bacteria that might reduce frost damage on plants.
In addition to the fine, the EPA suspended the company's experimental-use permit for field testing its bacteria. The EPA's move came a week after the Monterey (Calif.) County Board of Supervisors extended a February ban on tests of the bacteria, which AGS had planned to conduct in a strawberry patch there.
The EPA's action stems from a probe into the company's admission that it violated EPA rules by testing a genetically engineered bacteria on trees that were on the roof of its building instead of in an enclosed greenhouse. The EPA requires that it be notified before such a test is done outdoors so that it can decide whether an experimental-use permit is needed.
One tree developed a canker, and failure to mention it on the company's application for a subsequent experimental-use permit meant it ``knowingly falsified'' its application, the EPA said.
``EPA is not going to tolerate any infraction of its regulations that govern the biogenetic industry's pesticide efforts,'' said Jack Moore, assistant administrator for pesticides and toxic substances.
The agency said it was suspending the experimental permit until the tree tests are repeated indoors. This requires no permit and the company already has pledged to repeat the test.
Joseph Bouckaert, president of Advanced Genetic Sciences, expressed the company's regret at the EPA announcement, but said it remains confident its experimental efforts will eventually pay off.
Referring to the EPA ruling, David Jones, the company's chief financial officer, said, ``It'll certainly mean we'll apply stricter protocols and controls in future experiments.''
The nation's best-known critic of biotechnology, activist Jeremy Rifkin, was jubilant. ``EPA was right to throw the book at them,'' he said.
EPA regulates only a small part of the new genetic-engineering industry. Drugs come under the Food and Drug Administration, and two genetically engineered drugs are already on the market. Plants may be genetically engineered -- perhaps to resist a pesticide -- and they come under the Agriculture Department. The National Institutes of Health oversees basic research, some of it voluntarily put under NIH guidelines.
Richard Godown, executive director of the chief industry trade group, the Industrial Bio-Technology Association, said EPA's action was ``very stiff,'' but it was noteworthy that ``they did not throw up their hands . . . and said it wasn't reconcilable.''
``The overwhelming lesson from this is, `When in doubt, call EPA,' '' Mr. Godown said.