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 been destroyed.
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 2001.
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 said.
Ampicillin is a penicillin drug used to treat bacterial infections.
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 by Syngenta.
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
"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
"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 week.
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
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
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 resistance
Copyright Environment News Service (ENS) 2005. All Rights Reserved.