http://www.washingtonpost.com/wp-dyn/articles/A62091-2001Jul27.html

EPA Rejects Biotech Corn as Human Food

By Marc Kaufman
Washington Post Staff Writer
Saturday, July 28, 2001; Page A02

The federal government's investigation into whether StarLink corn causes
allergic reactions failed to establish that the genetically engineered corn
was safe to eat, according to an expert panel convened by the Environmental
Protection Agency.

While the panel did not conclude the modified corn causes allergies, it said
that months of study by federal agencies "do not eliminate the possibility
of such a reaction."

Based on the panel's recommendations, the EPA yesterday announced that it
would continue its policy against permitting even trace amounts of StarLink
in foods -- turning down a request to change that position from Aventis
CropSciences, which developed the corn.

The unapproved presence of Starlink has required hundreds of food recalls
and costly international trade problems, and food industry officials said
yesterday they were disappointed in the EPA's refusal. But critics of
biotechnology said they were pleased by the decision, which they said
vindicated their concerns about the potential risks of some genetically
modified products.

Stephen Johnson, of the EPA's Office of Prevention, Pesticides and Toxic
Substances, said the agency had no choice but to turn down the Aventis
application. "Some of the world's leading experts on allergenicity and food
safety told us there was not enough data to conclude with reasonable
certainty that there was an acceptable level of [StarLink corn] that people
could eat," he said. "That leaves us no room" to allow StarLink.

The EPA approved StarLink as animal feed in 1998, but did not allow it for
human use because of concerns that it contained a protein that broke down
slowly and could cause dangerous allergic reactions. A public interest group
found StarLink's genetically modified protein in taco shells last fall, and
it has been at the center of the often contentious international debate over
crop biotechnology ever since.

Johnson said the agency was studying how it might respond to the panel's
recommendation that it expand its study of possible allergic reactions to
StarLink. The panel said the federal government should ask specialists to
report suspicious reactions to corn -- which is not a common cause of
allergic reactions -- and should expand research into the entire field of
genetically improved crops and food allergies.

In addition, the panel said that "every attempt" should be made to further
test two people who reported severe reactions and who have offered to
undergo skin testing and to eat StarLink products under medical supervision.

One of the two, Florida optometrist Keith Finger, told the panel that he
sought out StarLink corn after his initial reaction last fall, and had
received some anonymously in the mail. After running a test that showed it
was in fact StarLink, he ate some and went to a local hospital several hours
later with itchy rashes over his body and fast-rising blood pressure.

During two days of testimony in mid-July, Food and Drug Administration
officials said that blood tests on 17 people who reported possible allergic
reactions to StarLink, including Finger, did not show any signs of an actual
physical reaction.

But the expert panelists raised questions about the validity of the testing
process and the size of the sample. They said that the tests decreased the
probability that people had suffered allergic reactions to StarLink, but did
not rule it out.

Johnson said yesterday it "would require many months or years of continued
scientific evaluation to answer the question of allergenicity."

An Aventis official said that the company was not surprised by the panel
conclusions and the EPA decision. She also said that there is no way to
conclusively determine if the Cry9C protein in StarLink -- which protects
the corn against the European corn borer -- can cause allergic reactions.

In a statement, the company emphasized its commitment to directing all corn
with the StarLink Cry9C protein to livestock and industrial uses. "We will
continue to support the grain handlers and millers with their testing
programs," the company said. "We are proud of the progress we have made in
containing StarLink corn."

In its report, the expert panel concluded that the amount of StarLink in the
food supply was significantly less than predicted in the fall, and that
there is a "low probability of allergenicity" in the population based on
levels of StarLink in the U.S. diet. Aventis has been buying back StarLink
corn, and corn commingled with StarLink, and virtually all is expected to be
out of the food supply after the fall harvest.

During the panel meeting, officials from the Agriculture Department reported
the agency will spend between $13 million and $17 million to also buy back
seed for growing corn that had been contaminated with StarLink.

The modified corn, which was planted on only 320,000 acres last year but has
spread well beyond that, has created problems for U.S. corn exporters
because some foreign buyers avoided all U.S. corn. The grain and food
industries have supported the Aventis request for allowing trace amounts of
the corn, saying low levels of many genetically modifed proteins can be
found in virtually all corn.

"The food industry is disappointed by the EPA decision today on StarLink,"
said Gene Grabowski of the Grocery Manufacturers of America. "It means
continued uncertainty and anxiety in the food market . . . and eventually
will result in price increases. It's a situation that should not be allowed
to continue."

But Bill Freese of Friends of the Earth, an environmental group, said the
panel report "shows that the EPA and FDA need to begin more seriously
regulating genetically engineered foods to protect public health."