EPA is Backed into a Corner on StarLink/Allergy Issue

US panel unconvinced of StarLink bio-corn safety
By Julie Vorman

WASHINGTON, Dec 5 (Reuters) - An independent panel of U.S. scientists on
Tuesday dealt a blow to Aventis SA's (AVE.N) bid to win temporary approval
of StarLink bio-corn for human food by finding that the corn had a "medium
likelihood" of causing allergic reactions.

The group of physicians, chemists and other scientists concluded that there
were still many unanswered questions about the safety of StarLink, a type of
corn engineered to repel pests.

The Environmental Protection Agency, which appointed the panel, said it
would use the 28-page, highly technical report to guide its decision on the
Aventis request.

"EPA will continue its evaluation of the scientific information and develop
the appropriate regulatory approach" to protect public health, Stephen
Johnson, EPA deputy assistant administrator, said in a statement.

A spokeswoman for Aventis, the giant Franco-German pharmaceutical maker and
seed company, said the firm had no immediate comment.

The EPA landed in the middle of the controversy over StarLink corn because
of its 1998 decision to approve the corn for use as animal feed -- but not
for human food because of lingering concerns about health and safety.

In September, traces of StarLink were found in taco shells purchased at a
Washington, D.C. area grocery store, setting off a massive recall of more
than 300 kinds of taco shells, chips, cornmeal and other foods by U.S.

Investigators determined that a portion of the 80 million bushel StarLink
crop this year was accidentally commingled with vast amounts of conventional
corn by farmers, grain elevators and shippers. Aventis launched a $100
million corn buy-back program, but the company's costs could soar much
higher due to potential liability related to recalls by food processors and
expenses by grain handlers.

A Washington law firm last week filed a class action lawsuit against
Aventis, claiming the contamination has frightened away some foreign buyers
like Japan and South Korea and depressed already-low corn prices. The
lawsuit seeks an undetermined amount of damages for cleaning grain
elevators, farm equipment, storage bins, railcars and trucks.


The science panel's report raised more questions about StarLink safety,
suggesting it may be to blame for rashes, diarrhea and other allergic
reactions reported by some 44 Americans. As many as 14 of those illnesses
may have been caused by StarLink, but further investigation is needed to
rule out other allergens, the report said.

The science panel concluded there was a "medium likelihood" that StarLink's
unique Cry9C protein is a potential allergen, based on the chemical
properties of the protein. More data is needed, however, to analyze
allergenicity, the report said.

Based on the best available estimates of StarLink residue in the U.S. diet,
there is a "low probability" of allergic reactions, the scientists said.
"There is need for a better evaluation of the amount of StarLink corn that
could be in the food chain," the report said.

The panel also said it was "highly doubtful" that much more StarLink corn
would contaminate the U.S. food supply now that seedmaker Aventis has
withdrawn the corn from the market.

The report dismissed many of the arguments Aventis made in seeking a
four-year temporary approval for the corn so that all contaminated supplies
can work their way through food processors, distribution channels and
consumers' pantries. The company contends that StarLink is safe, but even if
it carried a small risk of allergic reactions, only a tiny amount is present
in the overall U.S. food chain.


Environmentalists said the science panel's report would make it difficult
for the EPA to approve the Aventis request.

"This gives the EPA plenty of ammunition to delay a decision or to deny
Aventis' petition outright," said Becky Goldburg, a biotech expert with
Environmental Defense.

"The overall risk is probably fairly low, but there is just uncertainty
after uncertainty about whether StarLink corn is an allergen," she added.
"The information is not there for EPA to make a sound scientific decision at
this time."

Larry Bohlen, a spokesman for Genetically Engineered Food Alert, a coalition
of anti-biotech activist groups, said the panel also emphasized that the
U.S. Centers for Disease Control should aggressively investigate the 44
self-reported illnesses by consumers who ate foods with corn ingredients.
The consumers reported symptoms ranging from itchiness to breathing problems
requiring emergency hospital treatment.

Foodmakers pointed to the panel's determination that only tiny amounts of
StarLink were in the food supply.

"The food industry welcomes the EPA finding that there is such a modest
amount of StarLink corn in the system that there is a low probability that
consumers could develop an allergy to the corn," said Gene Grabowski, vice
president of the Grocery Manufacturers of America, a trade group that
represents some of the nation's biggest food companies.

"We urge federal regulators to come to an expeditious and appropriate
conclusion on this matter," he added.

The EPA said it was working with the Food and Drug Administration and the
U.S. Agriculture Department to monitor the U.S. food supply and detect any
more StarLink corn.

The trio of government regulators are also evaluating what impact food
processing has on StarLink residue and new methods to measure StarLink
contamination in processed foods.

17:56 12-05-00


Scientists Urge Biotech Corn Study

.c The Associated Press

WASHINGTON (AP) - A variety of gene-altered corn shows a ``medium
likelihood'' of causing allergic reactions, but so little is in the food
supply that consumers are unlikely to have developed sensitivities to it, a
panel of scientists told the government Tuesday.

The panel that advises the Environmental Protection Agency said more
research on the biotech corn is needed and urged the government to find out
whether the corn was the cause of allergic reactions that have been reported
to the Food and Drug Administration.

StarLink corn was withdrawn from the market after its discovery in the food
supply in September spawned nationwide recalls of taco shells.

The EPA is deciding whether to grant temporary food-use approval for the
corn to prevent further recalls and disruptions in food processing and grain
handling. The panel's report virtually ensured that the decision won't come
for at least several weeks.

The agency ``will continue its evaluation of the scientific information, and
develop the appropriate regulatory approach in response to the StarLink
situation to ensure protection of public health and continued consumer
confidence in the safety and integrity of the food supply,'' said Stephen
Johnson, EPA's deputy assistant administrator.

EPA regulates use of the biotech corn because it was genetically modified to
produce its own pesticide.

EPA had approved the corn only for animal feed and industrial uses because
of unresolved questions about whether it can cause allergic reactions. The
corn's developer, Aventis CropScience, has asked the EPA to temporarily
approve the corn for food use to avoid further recalls.

Aventis, which says it doesn't believe the corn is an allergen, declined
comment on the report.

Some 34 people have contacted the government this fall with health
complaints that they thought might be caused by StarLink. Of those, 7 to 14
merit further study because they appear to involve allergic reactions of
some kind and ``represent a real opportunity'' to determine whether StarLink
is an allergen, the panel said.

The scientists said there is a ``low probability'' that people have
developed allergies to the corn ``because of the apparent low level'' of the
corn entering the human diet. However, the pesticidal protein in the corn,
Cry9C, has several characteristics of allergens, including its molecular
weight and its relative resistance to heat and gastric juices.

Critics of the biotech industry have urged EPA to deny the food-use
approval, saying it would unfairly relieve Aventis of financial and legal
responsibility for the corn.

``It looks like science is going to win out over expediency,'' said Rebecca
Goldburg, a scientist with Environmental Defense, an advocacy group.

``It would be inappropriate to leap to retroactively approve StarLink corn
for the convenience of Aventis. Clearly a much better course is to develop
the proper methodology and information in order to make a real determination
about the safety.''

The StarLink problem has become an embarrassment to the biotech industry and
a headache for farmers, grain handlers and food processors.

EPA already knows enough about the corn to grant food-use approval, or
temporary tolerance, for the StarLink that has gotten into the food supply,
said Lisa Dry, a spokeswoman for the Biotechnology Industry Organization.
``We do believe there is enough data there to be confident that there is no
health issue,'' she said.

Gene Grabowski, a spokesman for the Grocery Manufacturers of America, said
the food industry wants EPA to make ``an expeditious and appropriate''
decision on StarLink ``so that consumers can be once again assured that the
food supply is safe.''

A group of farmers filed suit against Aventis last week in Illinois federal
court, claiming that the company failed to warn growers adequately of
restrictions on use of the corn. Farmers have said they were unaware that it
could not be sold for food use.

``We've been getting reports from a number of farmers across the country who
are having extraordinary difficulty selling their corn crops,'' said
attorney Elizabeth Cronise.

StarLink was grown on about 0.4 percent of the nation's corn acreage this

On the Net:

Aventis site: http://www.starlinkcorn.com

Report by EPA's scientific advisory panel: http://www.epa.gov/scipoly/sap

FDA site: http://www.fda.gov

AP-NY-12-05-00 1843EST

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