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,
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 approved.
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 Carolina.
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 public.
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.