BRUSSELS, Belgium, April 4, 2005 (ENS):
Syngenta's unintended distribution across the European
Union of a genetically modified corn variety that was
not approved has got EU officials and environmental
groups demanding answers from the biotechnology company
and from the U.S. government. European officials were
alarmed to learn from company representatives on Thursday
that the unauthorized corn carries a gene that confers
resistance to a widely used antibiotic.
Up to 1,000 metric tons of the engineered corn, or
maize, was exported to the EU over a four year period
between 2001 and 2004.
The European Commission said Friday that officials
have written to the U.S. authorities and to Syngenta
requesting clarification regarding Bt10, the unauthorized
transgenic strain of maize developed by the company.
Bt10 is engineered to include a gene from the soil
bacterium Bacillus thuringiensis (Bt), which is inserted
into the plant genome as a pesticide. A different variety
of the engineered maize, called Bt11, is approved for
sale in the European Union and in the United States.
The Commission said it has learned from Syngenta that
up to 10 kilograms (22 pounds) of Bt10 seed may have
been exported inadvertently as Bt11 for research purposes
to Spain and France. The resulting materials have all
In addition, the Commission said an estimated 1,000
metric tons of Bt10 food and feed products may have
entered the EU through the Bt11 export channels since
European officials are concerned about the health effects
of Bt10. At a meeting Thursday with representatives
of Syngenta, representatives of the European Commission
were informed that "Bt10 included the gene conferring
resistance to the antibiotic ampicillin," the Commission
Ampicillin is a penicillin drug used to treat bacterial
The Commission was first informed by the U.S. Mission
to the European Union on March 22 about an inadvertent
release in the U.S. of a nonauthorized genetically modified
maize line called Bt10.
But the U.S. authorities did not inform the Commission
that Bt10 contains the gene conferring resistance against
the antibiotic ampicillin. It was only on March 31 that
this information was given officially to the Commission
According to the advice of the European Food Safety
Authority, the ampicillin resistance gene should not
be present in crops grown commercially. According to
Syngenta, this gene is inactive in Bt10.
"The European Commission deplores the fact that
a GMO which has not been authorized through the EU’s
comprehensive legislative framework for GMOs, nor by
any other country, has been imported into the EU,"
said EU Health and Consumer Protection Commissoner Markos
"We are writing to the U.S. authorities asking
them to guarantee, by taking the appropriate measures,
that present and future exports of maize to the EU do
not contain GMOs which are not authorized for the EU
market, including Bt10," he said.
"This case again shows the importance of the European
Union’s comprehensive framework for traceability
and labeling of GMOs," Kyprianou said. The EU traceability
and labeling laws took effect in April 2004.
In the UK, Friends of the Earth has written to the
Food Standards Agency demanding "an urgent investigation"
into whether unapproved genetically modified maize has
been illegally imported into the UK.
Over 16 thousand metric tons of U.S. maize was imported
into the UK last year.
"The British public will be concerned that this
unapproved GM ingredient may have found its way into
food and animal feed, and will demand answers. The Food
Standards Agency needs to urgently reassure us that
this maize was not imported into the UK. And if it was
it must ensure that any contaminated products are withdrawn
Friends of the Earth's GM Campaigner Clare Oxborrow
said, "This is an industry out of control. For
four years Syngenta failed to notice that they were
selling farmers an unapproved GM seed. How are consumers
and farmers supposed to trust them to produce our food
in the future?
This case makes a complete mockery of the U.S. regulatory
system for GM crops. To make matters worse the US government
has known about this accident for months and together
with Syngenta decided to keep it a secret until now."
Syngenta found out about the mixup from one of its
seed manufacturers. The researchers were trying to use
engineered maize seeds to breed experimental plants
when they discovered the seed was not Bt11.
Syngenta has not said when it was informed of the error.
In a statement dated March 21, the company said it "recently
discovered" the "unintended event."
The European Commission informed the 25 EU member states
without delay via the Rapid Alert System for food and
feed. The Commission is asking all member states to
stop the entry of Bt10 into their countries and to report
any of the unauthorized crop that they detect.
EU Environment Commissioner Stavros Dimas said, “In
order to avoid any adverse effect on human and animal
health or the environment of such an accidental release,
the Commission has asked member states to carry out
appropriate control measures to stop Bt10 entering their
"Member states should also notify the state of
play regarding past or current national experimental
releases of Bt11, and implement any necessary monitoring
and surveillance measures in the surrounding areas where
these releases took place,” Dimas said.
The Commission has asked the Bush administration for
"the full safety information about Bt10 at its
disposal without delay, including the full risk assessments
upon which it is based as well as for an urgent audit
and an official view as to the quantities exported,
including the channels they may have taken in the EU."
The Commission has also asked Syngenta, the developer
of the Bt10 crop, to release the full information about
the molecular characterization of Bt10 and its distinction
from Bt11, as well as the specific detection method
and adequate reference materials to trace Bt10.
Syngenta said, "The Bt protein produced by these
lines is identical to that produced by the commercialized,
fully approved Bt11 varieties. Therefore, there is no
change to the food, health and environmental profile
of the corn."
The Commission also has asked Syngenta to confirm that
all Bt10 plantings and seed stock in the United States
have been destroyed or isolated for further destruction.
Syngenta has committed to provide that information this
The U.S. government has given reassurance that "no
food, feed or environmental concerns are associated
with the inadvertent release of this nonauthorized genetically
modified crop," based on the fact that the Bt protein
in Bt10 is similar to the one in Bt11, which is fully
authorized in the U.S. and which the EU has authorized
for use in food and feed.
Regulators and the company have been involved in "months
of discussions over what should be done about the error,
and how and when information should be released to the
public," according to an article in the journal
"Nature" published March 22.
The issue is particularly sensitive because the United
States and the European Union are at odds over whether
the new European rules on traceability and labeling
of genetically modified crops are required scientifically.
In the United States, three agencies have oversight
of transgenic foods. The U.S. Department of Agriculture
takes the position that genetically modified crops are
safe and do not require special attention.
The U.S. Food and Drug Administration believes that
genetically engineered foods are “substantially
equivalent” to traditional foods and does not
give them special scrutiny.
The U.S. Environmental Protection Agency regulates
the pesticide, but not the plant. In the case of corn
genetically engineered to produce Bt, the agency regulates
the Bt toxin, but the USDA regulates the genetically
engineered corn. The EPA does not subject plants that
are engineered with traits other than pesticide resistance,
such as herbicide tolerance, to environmental review.
The European Union takes the position that environmental
risk assessments are needed for each new genetically
modified organism before it is marketed to identify
and evaluate potential adverse effects.
"These include direct or indirect, immediate or
delayed effects, taking into account any cumulative
and long term effects on human health and the environment
which may arise from the deliberate release or placement
on the market," the EU states in its position paper
of the regulation of transgenic organisms.
The European environmental risk assessment procedure
requires evaluation in terms of how the genetically
modified organism was developed and examines the potential
risks associated with the new gene products produced
by the organism - such as toxic or allergenic proteins
- and the possibility of gene-transfer of antibiotic
Copyright Environment News Service (ENS) 2005. All