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US Launches Probe Into Sales Of Unapproved Transgenic Corn

By Colin Macilwain
NATURE [doi:10.1038/nature03570]
March 22, 2005

Syngenta admits 150 square kilometres accidentally sown with wrong seeds.

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 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 21 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.


Tons of Experimental Biotech Corn Inadvertently Sent to Farmers

By Paul Elias
AP Biotechnology Writer
March 23, 2005

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.


Government Probes New Corn Variety

Associated Press
March 11, 2005

DES MOINES, Iowa (AP) - The government is investigating a new genetically modified corn to determine whether it is safe for humans.

The corn variety, developed by Pioneer Hi-Bred International and Dow AgroSciences, is resistant to rootworm. The seed contains a protein that takes longer than other proteins to break down in humans - a characteristic that can cause allergic reactions.

The investigation comes five years after a recall of StarLink corn, a variety that hadn't been approved for human consumption but was found in taco shells and corn chips.

Doug Gurian-Sherman, a former scientist of the Environmental Protection Agency, said the new corn variety shouldn't be approved.

"At this stage, any kind of reasonably cautious approach would say hold off on their protein until we get data that is more definitive," Gurian-Sherman, who worked on the StarLink issue while at the EPA, said.

He now is a senior scientist with the Center for Food Safety, a group critical of agricultural biotechnology.

The EPA believes the corn is safe, as does the Food and Drug Administration.

The EPA has formed a panel of scientific advisers who are meeting this week to look into data provided by Pioneer and Dow.

Officials with Pioneer and Dow say there are critical differences between their corn and StarLink, which the EPA approved for animal feed but not human consumption.

The protein in the Pioneer-Dow seed took up to 30 minutes to break down, compared to 30 seconds to five minutes for most similar proteins. By comparison, the protein in StarLink could take several hours to break down.

The Pioneer-Dow product would be the second line of biotech corn that is resistant to rootworm. The EPA approved a Monsanto product that is resistant to rootworm in 2003.

Damage from rootworm costs farmers nationwide about $1 billion a year.

Dave Ahlers, who farms near Flandreau, S.D., said his yields increased by up to 10 bushels an acre with the Monsanto seeds.

"I also like how safe it is to handle, compared to the granular insecticides" that farmers traditionally use, Ahlers wrote the EPA.


Biotech Alfalfa This Year

By Jeanne Bernick
Farm Journal
March 17, 2005

Makers expect to have it on the market this summer

The first-ever perennial crop to be genetically engineered is about to become a commercial reality. Monsanto and Forage Genetics expect to release Roundup Ready alfalfa this summer.

Glyphosate-resistant crops are a key part of U.S. agriculture. In 2004, 13% of corn acres, 85% of soybean acres and 60% of cotton acres were planted with herbicide-resistant varieties. Now, alfalfa, the nation?s third most important crop in economic value, will join the list.

Growers will be able to use Roundup herbicides over the top of biotech alfalfa to control more than 200 species of weeds. But herbicide-tolerance is only the first of several traits targeted for alfalfa, says Mark McCaslin, president of Forage Genetics.

"Improved fiber digestibility and increased bypass protein are two biotech forage quality traits currently under development," McCaslin says.

Mixed emotions.While alfalfa can certainly benefit from traits that will help it compete in production against corn silage and soybeans, there is some fear the hay industry is not ready for biotech alfalfa. In the West, where Roundup Ready alfalfa will be adopted first, hay producers worry about rejection of biotech hay by export markets.

"Some of our Japanese hay customers are asking us to sign documents saying no genetically modified products will be coming over," says Jeff Plourd with El Toro Exports, a hay exporter in El Centro, Calif. About 80% of alfalfa hay exports go to Japan.

It's important to note, however, that Japan already uses biotech-improved soybeans, corn and canola for feed.

Still, only 5% of the U.S. hay crop is exported. Dairies consume the majority of U.S. alfalfa, making consumer acceptance of Roundup Ready hay highly dependent upon acceptance by the dairy industry. Since the industry has already accepted biotech corn and soybeans, most experts don't expect problems.

"No dairies I know of are against it, except for a few organic dairies," says Rick Staas, president of San Joaquin Valley Haygrowers in Tracy, Calif.

But Staas says alfalfa growers want to see more data on the economic advantages before they decide to plant it. Most Western growers already use herbicides and clear-seed their crop, so unless Roundup Ready alfalfa gives them better weed control at a cost comparable to their current weed control program, they won't adopt it, he says.

Added cost.In the Midwest, where broadleaf weeds and grasses are controlled by establishing alfalfa with a nurse crop, Roundup Ready alfalfa could give growers needed flexibility in weed management. Fall treatments appear to be especially effective on perennial weeds. But for many Midwesterners, cost is the concern. Producers must pay technology fees on top of the cost of the proprietary seed and the herbicide itself.

McCaslin recognizes that the special alfalfa is not the solution for every producer. "However, we believe that the benefits associated with the technology will make it an excellent value for many alfalfa growers," McCaslin says.

Alfalfa Status Report

Monsanto is co-developing the biotech alfalfa with Forage Genetics, which licensed the technology from Monsanto.

Forage Genetics inserts the Roundup Ready gene into the alfalfa and, in turn, licenses the technology to other seed companies for development of biotech varieties under different brand names.

The special alfalfa trait is now in the last stages of the regulatory process. While Roundup Ready technology is being regulated, USDA puts constraints on field production practices, which limits how much seed can be produced.

The initial seed released this year likely will be limited to approximately 1 million pounds, Forage Genetics reports.

The company is legally unable to talk about the pricing of the new alfalfa while it is going through the regulatory process. However, regional pricing will be likely.


GMOs 'Can Cause Food Shortages'

By Guardian Reporter
March 19, 2005

Genetically Modified Organisms (GMOs) could lead to food shortages, stakeholders in the agricultural sector have warned.

Tanzania: GMOs reduced small-scale farmers into slaves of big companies which monopolised the technology, thus laying the ground for diminished food production, the stakeholders said in a statement released in Dar es Salaam yesterday.

Besides its adverse side effects on human and animal health and the environment, the technology was likely to impact on small-scale farming, thus worsening food scarcity instead of reducing it.

GMOs technology is seen as an alternative way of ensuring food security in developing countries, including Tanzania.

Although Tanzania has yet to introduce the technology, the government is planning to table a Bill in Parliament to discuss the advantages and disadvantages of GMOs.

The stakeholders have appealed to the government to wait for at least ten years before it allows the technology in order to educate its people on the new phenomenon.

They also want the government to train as many experts as possible on the new technology as well as seeking views from Tanzanians on whether they really needed it.

Research done in 2003 showed that like many developing countries, Tanzania is still ill-equipped in terms of technical capacity to conduct biotechnology and biosafety while safeguarding biodiversity, human health and the environment.

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