The Agriculture Department's program to regulate genetically engineered products and research is inadequate and confused, the General Accounting Office said yesterday.
The program is so confused, the GAO said, that two almost identical proposals were sent to two different agencies inside the department. The GAO investigators said that some applications to approve gene-engineered products already have been submitted, and many more are expected, but that USDA is not prepared for the increased flow.
After a year's study of biotechnology regulation at the department, the GAO reached three main conclusions:
*The main biotechnology committee at Agriculture -- the Agriculture Recombinant DNA Research Committee -- has almost no authority, meets infrequently, has no budget, and its meeting records show confusion about what the committee should do.
*The department has no clear policy about who should review biotechnology proposals, and what rules should be applied. "Different agencies in USDA have been jockeying for regulatory control, and USDA officials have expressed uncertainty as to which agency is responsible for different activities," the report said.
*USDA has done little to communicate to Congress and the public the benefits and risks of biotechnology.
As the GAO report was released, Jeremy Rifkin of the Foundation on Economic Trends, a longtime activist on biotechnology matters, sent a petition to the department demanding revocation of a license for a live-virus vaccine. Rifkin said the vaccine was a product of gene engineering but did not receive the special environmental studies necessary before releasing such an organism into the field.
The vaccine is is probably the first live gene-engineered organism to be deliberately released into the field. USDA issued a marketing license on Jan. 20 to TechAmerica Group Inc. of Omaha. The vaccine is intended to inoculate pigs and cattle against a painful and fatal disease called Pseudorabies.
The licensing occurred without any special review about its impact on the environment, said David Espeseth, senior staff veterinarian at USDA. He said the vaccine was considered to be a simple gene alteration of a live organism, and not harmful. So, as a matter of policy, it was not passed on to the USDA's main biotechnology committee.
Espeseth's policy statement clashed with USDA comments in the GAO report. GAO investigators said they were told by a USDA microbiologist that "the expected use of live organisms" would receive "more caution and some regulatory or procedural changes."
Rifkin said USDA is required by law to follow the standard federal guidelines issued by the National Institutes of Health until USDA issues its own guidelines. Those guidelines demand a special review for "deliberate-release" experiments.
USDA's Espeseth also acknowledged that the department did not know the vaccine was a gene-engineered product until the licensing procedure was well underway. Documents released by Rifkin showed that the states where vaccine testing was done were not notified that the product was genetically engineered until long after approval was given for field experiments.
The situation "represents gross incompetence at USDA, or blatant disregard of regulations, or both," Rifkin said.