New York Times / October 4, 2000 / By Andrew Pollack
A federal judge has upheld the Food and Drug Administration's policy on genetically modified food, throwing out a lawsuit by biotechnology opponents that sought to require that such foods be labeled and tested for safety.
The decision represents a victory for the F.D.A. at a time when the agency is under fire from biotechnology critics for not regulating bio-engineered foods strictly enough. That criticism has increased in the last two weeks after environmental groups discovered a genetically engineered corn that was not approved for human consumption in taco shells.
In the taco case, meanwhile, a man who said he developed severe hives and stomach problems after eating the shells filed a lawsuit, the first known formal claim that anyone had actually been hurt by the corn.
The dismissed lawsuit was not directly related to the taco shell incident.
It was filed in 1998 challenging the F.D.A.'s fundamental policy on genetically engineered foods.
In its policy statement, issued in 1992, the agency said genetically modified foods were generally recognized as safe and would not be regulated as food additives. It set up voluntary, not mandatory, consultations for companies wanting to market such foods. It also said labeling was not required because genetic engineering did not change food in a "material" way.
The lawsuit, filed by the Alliance for Bio-Integrity and by some scientists and clergy members, said that lack of labeling and mandatory safety testing violated food safety laws. The suit also asserted that the F.D.A. had not allowed for proper public comment or filed an environmental impact statement on the new policy. And it said the lack of labeling violated the religious rights of people who did not want to eat such foods on moral grounds.
But Judge Colleen Kollar-Kotelly of the United States District Court in Washington granted summary judgment to the F.D.A., ruling that the agency "was not arbitrary and capricious in its finding that genetically modified foods need not be labeled because they do not differ `materially' from nonmodified foods." The decision was issued Friday but the parties involved did not receive copies until late Monday.
Judge Kollar-Kotelly also said that the government did not have to follow procedures for public notice and comment or file an environmental impact statement because the 1992 announcement was a policy statement, not a formal regulation.
The plaintiffs snatched some measure of victory from that reasoning. "It's a court ruling that there hasn't been any regulation on genetic engineering from the F.D.A.," said Joseph Mendelson III, a lawyer for the International Center for Technology Assessment, a Washington public interest group that was one of the plaintiffs. An F.D.A. spokeswoman said only that the agency was pleased by the decision.
Mr. Mendelson said the plaintiffs would not appeal because the F.D.A. is now changing its regulations. Those new regulations, while tougher, do not go far enough and could be the subject of a new lawsuit, he said.
In the taco shell incident, meanwhile, the F.D.A. said it had confirmed that StarLink corn was in the Taco Bell brand taco shells and had instituted a formal recall, although Kraft Foods, a unit of Philip Morris, which sold the shells, has already voluntarily recalled them. The F.D.A. also said it would now test other processed corn products.
Wallace Wasson of Chicago stated in a lawsuit that he suffered a severe stomachache, diarrhea, headache and hives after eating the Kraft taco shells. Mr. Wasson joined a class- action suit yesterday that had been filed last week against Kraft and Azteca Milling, which made the corn flour used in the shells.
StarLink was not approved for human consumption because of concerns that it could cause allergies. But there is no proof that it actually does cause allergies and some experts have said the chances of this are small.
The environmental groups that first detected the StarLink in the taco shells said they had received numerous calls from people believing they had suffered reactions to the shells. But even these biotechnology opponents said that many of the claims were dubious and that none had been confirmed.
An F.D.A. spokeswoman said the agency had received a few complaints of adverse reactions and was investigating them.
According to the complaint filed in Illinois state court in Chicago, Mr. Wasson ate some taco shells on the evening of Sept. 20 and awoke in pain at 3 a.m. the next morning. On Sept. 22, hearing the news about the tainted taco shells, he called the toll-free number listed on the taco shell box and was referred to a doctor, who assured him the shells were safe.
