THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

28 March 2005

Dear Friends and colleagues,

RE: UNAPPROVED GM CORN INADVERTENTLY RELEASED

We wish to bring to your attention a worrying development with regard to the release of an experimental and unapproved GM corn into the food chain.

Between 2001 and 2004, Syngenta inadvertently produced and distributed several hundred tonnes of an unapproved corn (Bt10). About 150 square kilometres of the crop were planted over the four-year period in the USA.

According to the US Environmental Protection Agency, regulatory agencies are "conducting investigations to determine the circumstances surrounding and extent of any violations of relevant laws and regulations". The Department of Agriculture and the Food and Drug Administration are also investigating, and the company reportedly faces a fine of up to $500,000.

Syngenta officials have however declined to list the countries that have accidentally received the unapproved seed. It was reported that the EU could have been one of the importing parties which has received the Bt10 corn. The EU, like many countries around the world, has zero tolerance for unapproved GMOs.

The Japanese Health Ministry has announced that inspection offices at Japan's ports will start testing samples of corn cargoes from the US to determine whether they contain Bt10 corn. If cargoes contain the unapproved variety, the importer will be asked to destroy the cargo or to ship it back to the US. 

This incident raises many questions regarding the adequacy of regulatory oversight, disclosure of information in the interest of protecting public health and the environment, detection, testing and monitoring, as well as on ensuring compliance with domestic regulations on unapproved GMOs and penalties in the event of contravention. 

We urge countries to seek clarification and disclosure of the countries which might have inadvertently imported this unapproved GM corn so that appropriate action can be taken.  

With best wishes,

Lim Li Ching and Chee Yoke Heong
Third World Network
121-S Jalan Utama
10450 Penang
Malaysia
Email: twnet@po.jaring.my
Website

REF: Doc.TWN/Biosafety/2005/J

Item 1

US launches probe into sales of unapproved transgenic corn
Colin Macilwain
NATURE, 22 March 2005
http://www.nature.com/news/2005/050321/full/nature03570.html

Syngenta admits 150 square kilometres accidentally sown with wrong seeds. Some US corn fields have been sown with a different transgenic strain to the one that was approved.

PunchstockA 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 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 bout 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 14 March, 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.

Item 2

Tons of experimental biotech corn inadvertently sent to farmers
By PAUL ELIAS
AP Biotechnology Writer

Swiss biotechnology company Syngenta AG said Tuesday it mistakenly sold to farmers an experimental corn seed genetically engineered to resist bugs that was never approved by U.S. regulators, bolstering critics' claims that the industry needs tighter government scrutiny.

Hundreds of tons of the genetically engineered seeds and resulting corn crop were shipped in the United States and overseas between 2001 and 2004. Federal investigators said there was no health or environmental risk because of the seed's similarity to another Syngenta product already approved for sale and consumption.

"While there are no safety concerns, the regulatory agencies are conducting investigations to determine the circumstances surrounding and extent of any violations of relevant laws and regulations," said Cynthia Bergman, an Environmental Protection Agency spokeswoman. "The U.S. government is also communicating with our major trading partners to ensure they understand there are no food safety or environmental concerns that could affect trade."

The Department of Agriculture and the Food and Drug Administration are also investigating, and the company faces a fine of up to $500,000, USDA spokesman Jim Rogers said.

In trading Tuesday, U.S.-traded Syngenta shares fell 39 cents, or 1.8 percent, to close at $21.45 on the New York Stock Exchange. The stock has traded in a 52-week range of $13.93 to $23.26.

Biotechnology critics say the fact that hundreds of tons of unapproved corn were planted in open fields for four years before Syngenta acknowledged the mistake shows that regulators and the industry can't now be trusted to keep genetically engineered organisms from contaminating the food supply.

They also complain that current government regulations are particularly lax once a genetically engineered crop has been approved for consumption.

Nearly half the nation's corn approved for market by the Department of Agriculture is genetically modified, but many consumers want their groceries to be biotechnology-free, and are willing to pay a premium for food they trust to be organic.

Syngenta also acknowledged Tuesday that some of the unapproved corn may have been shipped overseas to countries that allow imports of either the genetically engineered seed or of products made with the genetically modified corn.

The United States and the European Union are in a bitter trade dispute over how strictly to regulate U.S. biotechnology imports. Syngenta spokeswoman Sarah Hull would not say whether EU countries have received the unapproved corn.

"Instead of building international confidence in genetic engineering, the industry continues to shoot itself in the foot," said Greg Jaffe, biotech director for the nonprofit Center for Science in the Public Interest in Washington D.C. "It proves this technology is hard to control and we have an industry that is not as diligent as we would like."

The corn in question is spliced with bacteria genes to resist bugs without the need for pesticides. It differs from Syngenta's approved seeds only in terms of where the foreign genetic material is placed in the plant's genome, said Jeff Stein, head of Syngenta's U.S. regulatory affairs.

Syngenta also did not say where in the United States the corn was grown, other than to say it sprouted on a total of 37,000 acres in four states - representing less than 1 percent of all U.S. corn. Still, the mislabeled corn amounted to several hundred tons shipped over the last four years.

In 2000, the inadvertent planting and distributing of genetically engineered corn not approved for human consumption - so-called StarLink - cost the food industry an estimated $1 billion in recalled products.

No recalls for this wrongly shipped corn are planned, Hull said, because the government has declared the corn poses no health or environmental risks. But all unapproved plants and seeds Syngenta still had have been destroyed, she said. She declined to say how much the incident might cost the company.

Hull said the Swiss-based company discovered the mistake in mid-December and reported it immediately as required by law to federal authorities. Syngenta and the USDA said they didn't publicize the situation because of the ongoing investigation. The science journal Nature first reported the mishap on its Web site Tuesday.

Item 3

Unapproved GM corn found in US food chain
http://www.newscientist.com/article.ns?id=dn7188
23 March 2005
NewScientist.com news service
Kurt Kleiner

A Swiss company accidentally sold unapproved genetically modified seed corn in the US for four years. The mistake resulted in about 133 million kilograms of the corn making its way into the food chain.

Officials for the company, Syngenta, and the US Environmental Protection Agency insist there is no danger to human health. But the EPA and the US Department of Agriculture are investigating to see if any laws or regulations were broken. The EPA confirmed the investigation was underway in a statement to the journal Nature.

Between 2001 and 2004, Syngenta accidentally sold an unapproved corn variety called Bt 10, mistaking it for the approved variety Bt 11. Both varieties produce a bacterial toxin that kills insects, using the same inserted gene and producing the same protein. The only difference is the location of the inserted gene, Syngenta says.

The company says it discovered the mistake for itself when it switched to a new quality control system that tests for DNA directly. Previously it had tested only for proteins, which meant the two varieties appeared identical.

In all, about 15,000 hectares in four US states were planted with the unapproved variety. This amounts to about 0.01% of the corn grown in the US over those four years. On average, about 70% of corn in the US is fed to animals, while the other 30% is consumed directly by people.

Allergic reactions

In 2000 a GM corn variety called Starlink was discovered in the human food supply, even though it was approved only for use in animal feed because of possible allergic reactions in humans. That discovery prompted a massive recall and new methods for segregating GM and non-GM corn. It also raised concerns among overseas buyers of US corn.

Critics say the Bt 10 release demonstrates that regulations and methods for controlling GM crops are still faulty.

"This really makes us wonder what else is in corn that has not been approved but that has been field tested. It seems that companies either won't or can't control it," says Jane Rissler, a senior scientist at the Union of Concerned Scientists in Washington, DC, US.

The Starlink contamination was originally discovered by the environmental group Friends of the Earth and Bill Freese, an FoE research analyst, says regulators should not assume the unapproved variety is harmless without further testing.

"The US government should immediately institute a testing programme, at Syngenta's expense, to remove Bt 10-contaminated grain, seed stocks and processed foods from the food chain," he adds.