Statements in the press that the plaintiffs would not appeal came from a release that was issued by only one of the plaintiff organizations stating its own decision not to appeal. There are dozens of plaintiffs, and the decision of one does not affect the ability of the others to appeal. Further, that press release did not explain all the weaknesses in the court's decision. The following release provides important information and perspective, and reveals why there are strong grounds on which to appeal.

US Court Confirms Bioengineered Foods are Unregulated Finds FDA "Inaction" is Technically Legal Despite "Significant" Safety Dispute. Says Political Appointees had Leeway to Ignore Warnings of Staff Scientists About Unique Health Hazards

Although acknowledging that “significant” scientific dispute exists about the safety of genetically engineered (GE) foods, a federal court has ruled that the U.S. Food and Drug Administration's decision not to regulate them is technically legal. On October 2, the U.S. District Court for the District of Columbia delivered a ruling that the policy of “inaction” adopted in 1992 is entitled to stand, despite the fact that scientists currently disagree about the safety of these new foods and that the FDA’s own experts had repeatedly warned about their unique health hazards. Accordingly, it dismissed a lawsuit filed against the FDA in May, 1998 by a coalition of public interest groups, eminent scientists, and religious leaders. Doing so, it affirmed FDA policy does “not impose any … obligations” on the biotech industry.

The suit challenged the FDA’s presumption that GE foods are safe and its refusal to require they be safety tested and labeled. In an unprecedented step, nine well-credentialed scientists joined the suit as plaintiffs to emphasize the extent to which FDA’s presumption of safety is scientifically unsound. While noting that plaintiffs had introduced many statements from experts explaining that genetic engineering is “inherently risky” and that “genetically modified plants could have high levels of toxins,” the court said it could only consider evidence within the FDA’s written record when the agency made its policy decision in 1992.

Further, although the court recognized there were numerous statements in the relevant record from the FDA’s own scientists “warning” about unintended harmful side effects and “criticizing” the lack of scientific basis for the FDA’s policy, it held that the agency’s political appointees were legally entitled to disregard such expert input.

“The court’s decision is based on technical aspects of U.S. administrative law and in no way rules that GE foods are safe,” states Steven Druker, executive director of the Alliance for Bio-Integrity, the public interest organization that coordinated the suit and is the lead plaintiff. “Rather, the court has said that FDA’s 1992 policy to allow unregulated marketing of GE foods is entitled to judicial deference even though there is major scientific disagreement about their safety. This gives the biotech industry nothing to brag about; but it does give all consumers something to be very concerned about.”

Druker continues: “The decision is badly flawed, and it fails to address key facts emphasized by the plaintiffs. First, shortly before the FDA issued its policy statement claiming that GE foods are generally recognized as safe, its biotechnology coordinator wrote to a Canadian health official that there was no scientific consensus about safety. Second, the political appointees did not just ignore their experts’ input; they lied about it. They claimed they were ‘not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way.’ Third, as the court recognized, the law requires that each GE food be demonstrated safe through ‘technical evidence’; but there is no such evidence for any of the GE foods on the market."

Druker concludes: “This decision is clearly unsound. The Alliance for Bio-Integrity intends to appeal it, reverse it, and reinstate reason and responsibility in FDA policy.”

Contact: Steven Druker (641) 472-5554