March 22, 2005, Colin Macilwain, Nature via
CropChoice.com: Some US corn fields have been
sown with a different transgenic strain to the one that
A strain of genetically modified corn that does not
have regulatory approval has been distributed by accident
over the past four years, Nature has learned.
Syngenta, one of the world's largest agricultural biotechnology
companies, revealed the mistake to US regulators at
the end of last year. Although the crop is believed
to be safe, the fact that it was sold for years by accident
raises serious questions about how carefully biotechnology
firms are controlling their activities, critics say.
The corn (maize) was modified with a gene from the
soil bacterium Bacillus thuringiensis (Bt), which is
inserted into the crop to act as a pesticide. Syngenta
has approval to sell a variety of the transgenic crop
called Bt11, which has been used successfully for many
years in the United States and elsewhere. The strain
has been approved for consumption in the European Union,
for example, and may be one of the first food crops
approved for cultivation there.
But between 2001 and 2004, Syngenta inadvertently produced
and distributed several hundred tonnes of Bt10 corn
- a different genetic modification that has not been
Since the release was discovered in late 2004, US government
scientists have assessed the Bt10 corn - which differs
from Bt11 by only a handful of nucleotides on a section
of the gene that does not code for the protein toxin
- and have concluded that it is safe to eat and poses
no environmental threat.
"What makes this somewhat unique is that Bt10
and Bt11 are physically identical and the proteins are
identical," says Jeff Stein, head of regulatory
affairs at Syngenta in Research Triangle Park, North
Sarah Hull, a spokeswoman for the company in Washington
DC, adds that Syngenta promptly reported the mistake
to regulators after the discovery. She says this shows
that the system is working as it should do. Company
officials also note that the release was relatively
small. About 150 square kilometres of the crop was planted
over the four years, they say, which is 0.01% of all
corn planted in the United States during that period.
As Bt corn seed has to be bought every year, rather
than being gathered from the previous year's crop, the
problem should not escalate.
Hard to swallow
But Michael Rodemeyer, director of the Pew Initiative
on Food and Biotechnology, a think-tank in Washington
DC, says that the release reflects the absence of a
thorough monitoring system for genetically modified
products in the US food supply. "This will raise
questions in the minds of countries that import food
from the United States about whether we have adequate
controls in place," Rodemeyer says. "It will
provide ammunition for critics of genetically modified
food - and it may provide incentives for countries to
look at non-genetically modified varieties."
Syngenta discovered the mistake when one of its seed
manufacturers, which was attempting to use the corn
seeds in plant-breeding experiments, informed it that
the seed was not Bt11.
Syngenta then told the Environmental Protection Agency
(EPA), the Food and Drug Administration and the US Department
of Agriculture (USDA), which are jointly responsible
for approving genetically modified crops. Regulators
and the company have since been involved in months of
discussions over what should be done about the error,
and how and when information should be released to the
White House officials have also been involved in these
sensitive talks, partly because the United States and
the European Union are locked in a fierce trade dispute
over whether tough European rules to trace the flow
of genetically modified crops are scientifically necessary.
Syngenta officials declined to list the countries that
accidentally received the Bt10 seed.
In a statement released to Nature on March 14, the
EPA says that regulatory agencies are "conducting
investigations to determine the circumstances surrounding
and extent of any violations of relevant laws and regulations".
The EPA says that it is investigating whether the Federal
Insecticide, Fungicide, and Rodenticide Act has been
breached, and that the USDA is looking at possible violations
of the Plant Protection Act. "The US government
is also communicating with our major trading partners
to ensure they understand there are no food safety or
environmental concerns," it adds.
The last major, unintended release of a genetically
modified crop in the United States occurred in 2000,
when a Bt corn known as StarLink was inadvertently planted
for human consumption. Because of possible allergic
reactions, StarLink had been approved for use only in
animal feed. Recall of StarLink corn cost the food industry
an estimated US$1 billion, according to Rodemeyer, and
lent impetus to global concerns about the safety of
genetically modified food.