A live-virus vaccine made by genetic engineering has been pulled from the market in the United States, while the Agriculture Department performs a hurried environmental assessment of the product's impact.
The license suspension is another significant blow to the biotechnology industry's attempt to market products. Only two gene-engineered products using live microbes have been approved by regulatory agencies, and the licenses for both have been suspended.
Yesterday, the USDA suspended for at least two weeks the license of TechAmerica Group Inc. to sell its vaccine. The action followed acknowledgments by department officials that its licensing procedure was incorrect. The vaccine was licensed without review by the department's gene engineering review committee, USDA officials said.
Jeremy Rifkin, head of the Foundation for Economic Trends, triggered the USDA action when he filed a petition demanding suspension of TechAmerica's license.
He said the USDA failed to follow guidelines of its review group, called the Recombinant DNA Research Committee, and also failed to produce an environmental assessment on the risk of putting the engineered vaccine into the field.
The vaccine, marketed by Biologics Corp., a subsidiary of TechAmerica, is intended to combat pseudorabies, a painful and sometimes fatal disease that attacks pigs and other livestock.
The disease is caused by a virus, from which researchers deleted one gene to prevent the virus from causing disease while allowing it to stimulate the animal's defenses.
Rifkin said suspension of the license was "a major victory because it gets the product off the market and the department will have to do an environmental assessment. The action acknowledges that the department was violating the law in licensing a product it hadn't fully reviewed."
Bert W. Hawkins, administrator of the Animal and Plant Health Inspection Service, said the suspension will remain in effect for only two weeks "to better document our administrative procedures under" the National Environmental Protection Act (NEPA). "We want to make a paper trail . . . . "
He said the USDA did not "document" the environmental analysis that was done "because we felt the product was not significantly different from products already on the market. In fact, it was a safer product. But we should have documented it for the public perception."
Hawkins said the issue would not go to the department's gene engineering review committee because the matter is "past that stage." He said that panel had been informed of the vaccine's existence.
Rifkin said the idea that an environmental assessment can be done after licensing and in two weeks "is ridiculous. NEPA requires that before licensing you must have documents showing you did an environmental assessment."
"You can't now put together a hurried little paper and call it an environmental assessment. That's what you call cheating," Rifkin said.
Michael J. Bartkoski Jr., vice president of operations for Biologics Corp., said the company followed all federal regulations but agreed to suspension of its license "to clear up any questions or misconceptions about whether any procedures were not followed by USDA" in the licensing.
"Not even Jeremy Rifkin has raised a question about the vaccine and its safety. We are not talking about a question of safety, just about a question of procedure," Bartkoski said.
He said the suspension would cause loss of sales and potential loss of prestige in the marketplace for the company.
"It's a loss for the American farmer. It is taking away from the American farmer an excellent vaccine that is safer than others . . . when they need it," he said.
Pseudorabies has been a growing problem among midwestern swine herds, costing farmers millions of dollars annually.
The other license suspension involved testing of Frostban, produced by Advanced Genetic Sciences Inc., and designed to retard frost formation as live gene-engineered microbes are sprayed on the blossoms of fruit plants.
While the microbe was supposed to be kept in a laboratory or greenhouse, the firm tested it on trees in the open air of its rooftop.