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FDA Claims Controversial Corn is Not Allergenic

FDA Claims Controversial Corn is Not Allergenic

June 14, 2001
New York Times

U.S. Finds No Allergies to Altered Corn
By ANDREW POLLACK

Government scientists said yesterday that they had found no evidence that any
people had had allergic reactions to the genetically modified StarLink corn.

The findings could dispel public concern that the corn, which spread through
the nation's food supply even though it was never approved for human
consumption, represents a threat to public health.

The results, announced by the Centers for Disease Control and Prevention,
could also clear the way for the Environmental Protection Agency to permit
small amounts of the corn to be present in food without leading to recalls,
something that would greatly relieve the farmers, grain processors and food
companies.

The C.D.C. and the Food and Drug Administration tested the blood of 17
people who had reported suffering allergic reactions ranging from upset
stomachs to potentially fatal anaphylactic shock after eating products they
thought contained StarLink corn.

The agencies looked to see if the blood contained antibodies to the protein
in the corn that was considered the possible allergen. No such antibodies
were found, an indication that none of the people had had immune reactions
to the corn protein.

"We do not have any positive results whatsoever," said Carol S. Rubin, a
research scientist at the National Center for Environmental Health at the
C.D.C. Still, the report prepared by the centers says that there is some
possibility that people could be allergic without having antibodies in their
blood.

StarLink contains a bacterial gene that permits the corn to produce a
protein that kills the corn borer, a major pest. But that protein, known as
Cry9C, has some characteristics of an allergen, mainly that it is not
digested easily in the stomach.

Because of those concerns, the corn was approved for use as animal feed but
not for human consumption. But it leaked into the human food supply, causing
huge recalls of taco shells and other products, hurting American grain
exports, forcing grain elevators and food companies to test incoming
shipments of corn, and raising new concerns about the possible health
effects of genetically engineered foods.

Now, the biotechnology industry, which said all along that there was little
threat to public health from the corn, may breathe a bit easier. "We are
pleased, but not the slightest bit surprised," said L. Val Giddings, vice
president for food and agriculture of the Biotechnology Industry
Organization, a trade group.

Critics of genetically modified food said the testing was insufficient.
"These tests are not proof that StarLink corn is safe for human
consumption," said Matt Rand, a spokesman for Genetically Engineered Food
Alert, a coalition of environmental groups. "This is not a thorough
investigation."

He said the government did not test the hundreds of people who complained to
food companies about reactions instead of to the F.D.A. He also said it
appeared that the test might have been performed using Cry9C made by
bacteria, which might be different from the protein made in the corn.

Dr. Rubin said she could not comment on the specifics of the antibody test
because it was designed by the F.D.A. An F.D.A. spokeswoman said her agency
would not comment.

Dr. Marc E. Rothenberg, the section chief for allergy and immunology at
Children's Hospital in Cincinnati and an adviser to the E.P.A. on this
issue, said that antibody tests were more likely to report false positives
than false negatives. Just because a person has antibodies to a protein does
not mean she suffered an allergic reaction, he said. But if there are no
antibodies, he said, there is only a tiny chance that the person had an
allergic reaction.

The results of the blood tests will be used by the E.P.A. to decide whether
to permit small amounts of StarLink in human food. Aventis CropScience, the
company that developed StarLink, has asked the agency to permit such a small
presence for four years, so the food industry would be spared the costs and
disruptions of testing and food recalls. The E.P.A. has scheduled a meeting
of its scientific advisory panel for next month to discuss the issues.

Aventis, which declined to comment on the results announced yesterday, has
asserted that since most of the StarLink grown has been collected by the
company and the government, there is so little in the food supply that it
would not cause any public health problems even if Cry9C were found to be an
allergen.

The C.D.C. and the F.D.A. reviewed the cases of 51 people who had told the
agency about allergic reactions they thought were connected to StarLink. Of
those, 28 people were considered to have had some sort of allergic reaction,
while the rest were judged to have had some other health problem.

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