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Date:

September 17, 2000

Subject:

Aventis Statement on AllegationsAbout Unapproved

 

(Note: See below for the Washington Post article that triggered this press
release.....CSP)
--------
Aventis CropScience Statement on Allegations
About Unapproved StarLink™ Corn Use in Food Product

September 18, 2000

Aventis CropScience is deeply concerned by the claims of a group that some
of our company’s StarLink™ corn -- not approved for food use -- was
allegedly found in store-bought taco shells. Our StarLink™ corn is
approved for domestic feed and non-food industrial uses only at this time.

Our company is cooperating with the food company that produced the taco
shells, the U.S. Food and Drug Administration (FDA) and the US
Environmental Protection Agency (EPA) to have an independent third-party
laboratory conduct an analysis to confirm whether StarLink™ corn was
present in the corn used to make the taco shells.

Until a thorough analysis is carried out, it would be premature and
speculative to make any claims about the presence of StarLink™ corn in
food products.

StarLink™ provides insect protection for hybrid corn through the use of
Cry9C protein. We understand the claims about detection of Cry9C DNA in
taco shells have been made by Genetic ID. Past experience with Genetic ID
for other products is that similar allegations were discovered to be
incorrect when more thoroughly reviewed. Nonetheless we take this
allegation very seriously.

The StarLink™ Stewardship Program was instituted in 1998 to ensure that
growers direct the grain only to approved markets. The Stewardship Program
has been well publicized in the corn industry and all information to date
indicates that the program is responsible and appropriate. This was
undertaken not for any specific food safety concern but reflects
unresolved scientific questions about the protein’s potential to be a food
allergen. That research is continuing.

Our company will work with regulatory agencies and responsible food
companies until this matter is resolved in an appropriate manner.

Questions and Answers

What are you doing about the allegation of unapproved corn being found in
food products?
We are working simultaneously on several fronts. First we are doing
everything we can to facilitate having an independent, third-party lab
repeat the testing. Secondly, we are working with the food company
concerned (Kraft) to track the grain in question based on our knowledge of
where StarLink™ corn has been grown. Most importantly, we are maintaining
a close dialogue with FDA and EPA on our progress.

What testing is available for the food industry to ensure their products
do not contain StarLink™ corn?
We are in close communication with the Grocery Manufacturers Association
and others to address the concerns of the food processing industry. We
are making our Stewardship Program available to them to help understand
what steps we have in place to ensure StarLink™ corn is directed into the
proper channels.

Why is this corn not yet approved for food use?
No negative effects have been associated with StarLink™ corn. The Cry9C
protein which protects this corn from insects is under continued review to
determine if it has the potential to be a food allergen. The most recent
public discussion by experts concluded that "there is no evidence to
indicate that Cry9C is or is not a potential food allergen." We are
working closely with EPA and FDA to resolve this lack of clarity as soon
as possible. No similar protein has ever been associated with a food
allergen response.

What will you do if StarLink™ corn has been used in food?
It is premature to discuss further action at this time. Our company will
work with regulatory agencies and responsible food companies until this
matter is resolved in an appropriate manner.

What is your past experience with Genetic ID?
In the past Genetic ID has claimed to have detected unapproved corn from
Aventis CropScience (as well as another company) in Japan. On further
investigation by the government of Japan, this claim was found to be
baseless. In that case too, we were skeptical because we had done our
utmost to properly "steward" the corn in the U.S.

Media Inquiries: Rick Rountree 919-549-2310

Technical and Industry : Margaret Gadsby 919-549-2233

=============
Lisa J. Dry
Director of Communications BIO
Biotechnology Industry Organization
1625 K St., NW, Suite 1100
Washington, DC 20006

Phone 202-857-0244
Fax 202-857-0237
email ldry@bio.org
www.bio.org

BIO represents more than 900 biotechnology companies, academic
institutions, state biotechnology centers and related organizations in all
50 U.S. states and more than 27 other nations. BIO members are involved in
the research and development of health care, agricultural, industrial and
environmental biotechnology products.
==========================================================
http://www.washingtonpost.com/wp-dyn/articles/A24834-2000Sep17.html

Biotech Critics Cite Unapproved Corn in Taco Shells


A form of biotech corn not allowed in food because of concerns it could
trigger allergies has been detected in grocery store Taco Bell taco
shells, a coalition of biotech critics will report Tuesday.

The type of corn, produced by Aventis Corp. and called StarLink, was
approved by federal authorities in 1998 as an animal feed. But because the
corn has been genetically modified in a way that makes it more difficult
to break down in the human gut, the agencies have refused to approve it
for human use.

The possibility that the modified corn made it into food products anyway
has federal officials concerned, with several calling the development
"very serious" if confirmed by further testing.

"If there has been a violation of our licensing process, then we would
have a very great concern," said Stephen Johnson, an assistant
administrator for pesticides at the Environmental Protection Agency.
"Likewise, we would want to make sure we are completely protecting the
public health."

Officials at the Food and Drug Administration, who called the possible
presence of StarLink corn in human food "unlawful," said yesterday that
the agency has already started an investigation.

If the tests are confirmed, they will surely raise the volume in the
already contentious debate over biotech foods, which in recent years have
become commonplace in American grocery stores. While most of the country's
political, scientific and commercial establishment has embraced
biotechnology as safe and useful, activists continue to raise questions
about its use and hope to inspire the kind of widespread backlash now
present in Europe.

The group that had the taco shells tested--the Genetically Engineered Food
Alert--has asked the FDA to recall the products immediately.

"This corn is absolutely not supposed to be in our food, but an
independent lab found it there anyway," said Larry Bohlen of Friends of
the Earth, a member of the coalition. "This shows a major regulatory
failure and raises some real human health concerns."

The group said this first finding was potentially "the tip of an iceberg,"
and that it could be in many other products as well. Samples of taco
shells from Taco Bell restaurants will also be tested soon, group members
said.

The taco shells tested were manufactured in Mexico for Taco Bell and were
distributed by Kraft Foods Inc. Michael Mudd, Kraft's vice president for
corporate affairs, said that the corn was bought by a Texas miller from
farmers in six states, and that the miller had ordered a conventional form
of corn.

"This is a serious issue and Kraft is doing everything we can to confirm
whether or not this material is present in the product," Mudd said. "If it
is confirmed, we will immediately take--in consultation with the FDA--all
appropriate steps."

Biotech industry officials, however, also questioned the testing
techniques of Genetic Id, the Iowa company that concluded the unapproved
corn was in the taco shells. At least on! ce before, the company came to
conclusions about the presence of genetically modified materials that were
later proven inaccurate. Officials of Genetic Id, which does substantial
testing of American products being shipped to Europe, have in the past
been publicly skeptical about biotechnology.

Industry officials also said that testing for the protein is "not at all
simple, and it is easy to get a false positive."

Aware of the sensitivity of the issue, the company repeated the tests on
the taco shells, according to Genetic Id vice president Jeffrey Smith. He
said that company policy is to duplicate each test, so the taco shell
sample was actually tested four times using a process called polymerase
chain reaction. Each time, he said, researchers found 1 percent of the
corn DNA to be from the unapproved corn, and found the presence of other
biotech material as well.

"Our specialty is to help agriculture and the food industry with issues of
[genetically modified organism] ident! ification and segregation," Smith
said. "This is a very controversial field, and our findings have been
attacked before. But we have all the necessary documentation to show what
we did and what we found." He also said that some of the sample remained.

Bohlen of Friends of the Earth said that he hoped the FDA or EPA would
quickly test the shells to settle the issue. "We've been saying for a long
time that federal authorities should be doing this testing, but so far
it's been left to groups like us," he said.

The StarLink corn is genetically modified to contain the plant pesticide
Bacillus thuringienis, or Bt, which kills the destructive European corn
borer. While there are many varieties of Bt corn now, StarLink is the only
one that contains the Cry9C protein. That substance, which Aventis
officials say provides a useful alternative to other more commonly used Bt
corn varieties, is what federal officials have concluded might cause
allergies in some people.

The issue of food allergies caused by biotech products is a very sensitive
one in the industry and is among the top health concerns raised about
biotechnology. In an often discussed case, researchers in 1995 spliced a
Brazil nut gene into soybeans in an effort to create a more nutritious
soybean. But that protein turned out to be a major cause of Brazil nut
allergies, and could have caused real harm to those who avoid the nut.
That form of soybean never came to market because of the allergy concerns.

StarLink corn is the only biotech variety allowed for animals but not
approved for human use, FDA officials said. Company officials have been
trying to win federal approval for human use, but a special EPA science
panel concluded in July that "there is no evidence to indicate that Cry9C
is or is not a potential food allergen." There is no previous history of
human dietary exposure to the Cry9C protein to guide researchers.

Aventis officials said that StarLink corn is not widely used now, and that
farmers who grow it must learn how to handle the corn.

"We have difficulty imagining how our corn could end up in the human food
supply," said Aventis spokeswoman Margaret Gadsby. "We have in place a
stewardship program that is focused on keeping the corn in the proper
channels, and it has had the full participation of the corn industry. We
have every indication it is working well."

Although biotech crops are widespread, there have been only a few
documented instances of their inappropriate presence. Early this year, for
instance, some unapproved varieties of biotech canola were found growing
in Europe. Critics say more examples have not been found because no
government agencies are charged with finding them.

Rep. Dennis J. Kucinich (D-Ohio,) a biotech skeptic, said discovery of the
unapproved corn shows that genetically engineered ingredients are not well
regulated.

In a release from the Genetically Engineered Food Alert, Kucinich said,
"It concerns me and should concern American consumers that this is a
glimpse of things to come as genetically engineered products are rushed to
store shelves without real mandatory safety testing and labeling programs
in place."