Federal Court Says It's OK That FDA Hasn't Been
Testing or Labeling GE Foods

Center for Foor Safety, Washington, D.C.
For Immediate Release: Contact: Andrew Kimbrell
October 3, 2000 Joseph Mendelson




Washington D.C.-- On Monday, October 2, 2000, a federal court held that the
Food and Drug Administration's (FDA) current, 1992 policy on genetically
engineered foods "does not have a binding effect" on GE food producers. In
dismissing a May 1998 lawsuit on the FDA's 1992 policy, the court equated
the current policy to agency "inaction" and therefore found it immune from
challenge under a number of statutes. FDA has announced that it will publish
new rules on the testing and labeling of GE foods this fall.

The Court also refused to judge the current controversy over the safety and
labeling of GE foods declaring that the agency's 1992 policy can only be
assessed with the information that was available at that time. While
acknowledging plaintiffs have produced information "showing significant
disagreement among scientific experts" concerning the safety of such food,
the court stated it could not consider such information because it has been
presented after 1992. The ruling leaves questions regarding the creation of
actual regulations addressing the safety, environmental review and labeling
of genetically foods unresolved.

Commenting on today's decision, Center for Food Safety Executive Director
Andrew Kimbrell stated, "This court decision means that for almost a decade
these novel foods have gone virtually unregulated in the United States.
American consumers have been used as unknowing guinea pigs for the safety of
these foods."

As a result of the court assessing only issues concerning GE foods prior to
1992, the ruling will have no effect on the safety and environmental issues
concerning GE foods that have come to light since the issuance of the
policy. On May 3, 2000, the FDA announced plans to substantially modify its
1992 policy rendering the court's determination irrelevant to the agency's
expected new regulations.

The Center for Food Safety and 53 environmental, farming, and consumer
organizations legally petitioned the FDA earlier this year detailing the new
science that supports mandatory pre-market safety testing, environmental
review and labeling of all GE foods. The FDA has not formally answered the
coalition's legal petition as of yesterday's court ruling.

"We can only hope that FDA's response to our petition and the new
regulations scheduled to be released this fall ensure adequate pre-market
testing and mandatory labeling for all GE foods," stated Joseph Mendelson,
Center for Food Safety Legal Director and attorney in the case.

"Clearly another legal battle may be in the offing should the FDA's new
regulations fail to protect consumers and the environment," Mendelson


New York Times, October 4, 2000

Judge Upholds F.D.A. Policy on Genetically Altered Foods

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"

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

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.

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