17 April 2002

FIVE YEARS OF MONSANTO'S RIGOROUS QUALITY CONTROL

Genetic engineering is a precision technology under rigorous quality control by the producers of genetically engineered seeds - companies like Aventis CropScience and Monsanto.

A Monsanto spokesperson was reported this week as saying, 'The company's rigorous testing program was designed to find any possible contamination problems and stop them' (item 1). "The ultimate goal of the quality assurance program is to make sure that [contamination] never gets in there."

In the meantime, as the St. Louis Post-Dispatch reports, "A genetically modified variety of canola (oilseed rape) made by Monsanto Co., yet to be approved for sale in the United States, may have entered the American food supply." (item 1)

Thanks to Monsanto's rigorous quality assurance, back in May 2001 there was a seed recall over the very same problem. Monsanto promised a "thorough investigation", admitting 'Nobody knows how the gene ended up in a variety where it wasn't supposed to be.' (item 3)

Yet, despite the fact that in May 2001, "Monsanto says it discovered in the nick of time a problem with one of the genetically modified canola crops it pioneered", as far back as 1997:

'According to the St. Louis POST-DISPATCH, Monsanto, the St. Louis chemical and biotechnology giant, last month announced it had recalled "small quantities" of a genetically engineered canola seed containing an unapproved gene that had gotten into the product by mistake...

Putting the wrong gene into a commercial product by mistake is precisely the kind of error that opponents of genetic engineering have been predicting for a decade. Proponents of genetic engineering have said it could never happen because of rigorous quality-assurance by the industry itself and tight regulation by governments. ' (item 2)

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1. MONSANTO SAYS GENE-ALTERED CANOLA MAY BE IN U.S. FOOD;
CONSUMER GROUP SEEKS CRIMINAL PROBE OF HOW THE VARIETY SPREAD ? April 16, 2002
2. GENETIC ENGINEERING ERROR - June 5, 1997
3. Monsanto says it discovered canola problem in the nick of time ? May 3, 2001

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1. MONSANTO SAYS GENE-ALTERED CANOLA MAY BE IN U.S. FOOD; CONSUMER GROUP SEEKS CRIMINAL PROBE OF HOW THE VARIETY SPREAD

Tina Hesman, St. Louis Post-Dispatch, April 16, 2002

A genetically modified variety of canola made by Monsanto Co., yet to be approved for sale in the United States, may have entered the American food supply.

While there are no human health concerns associated with the canola, the company's disclosure -- made in a letter to the U.S. Department of Agriculture -- is once again raising environmental fears over how safely biotech companies can control their genetically engineered crops.

The biotech industry is still smarting from the StarLink debacle of less than two years ago, in which an insect-resistant corn that was approved only for animal feed was found in human food. The incident caused StarLink's maker, Aventis CropScience, to pull the corn from the market and recall more than 300 food products containing corn. The Center for Food Safety, a Washington-based consumer group that opposes genetically engineered crops, asked the Agriculture Department Monday to start a criminal investigation of Monsanto and Aventis, which also has developed genetically engineered canola. The two companies knew for years that an unapproved genetic modification could be contaminating canola crops in the United States but didn't report it to the government, the group's petition said.

That's a clear violation of the law, said Joseph Mendelson III, the legal director for the Center for Food Safety. But even more worrisome is the companies' own admissions that they cannot keep unapproved varieties of biotech crops out of commercial supplies, he said.

"They can't control the genetic pollution," Mendelson said.

Monsanto says it has done nothing wrong and the company's commitment to quality control will keep biotech crops in check.

Monsanto is asking the Agriculture Department to approve the canola in question even though it has no plans to sell that variety. Similarly, Aventis is applying for registration of two of its herbicide-tolerant canola varieties.

Agriculture Department approval could help avoid costly recalls if any U.S. canola crops are found to be contaminated. Canola is a modified version of oilseed rape. Canadian scientists removed some oils and proteins from the rapeseed to make it easier to digest. Now more than 12 million acres of canola are grown in Canada and 1.5 million acres in the United States. Canola oil is widely used for cooking and in processed foods.

In 1997, Monsanto recalled 60,000 bags of canola seed produced by Limagrain Canada Seeds Inc., because small amounts of its GT200 canola DNA was detected in canola seed sold in three Canadian provinces. Monsanto also paid two farmers in Alberta to plow under the fields they had planted with the contaminated seeds.

The GT200 canola variety is genetically engineered to be resistant to glyphosate, the active ingredient in Monsanto's Roundup herbicide.

The variety didn't have full approval in Canada at the time of the contamination. A few months later, GT200 was cleared for sale by the Canadian Food Inspection Agency. But Monsanto never commercialized the variety.

Last year, Monsanto's GT200 canola was found in commercial strains of Quest canola, distributed by Agricore and Saskatchewan Wheat Pool in western Canada. That time, Monsanto's own seed testing measures caught the error, said Monsanto spokesman Loren Wassel.

Although only a "very few" of the lots of Quest canola tested were tainted with GT200, Monsanto decided to replace all of the seed - hundreds of tons - because the variety was not approved yet for sale in Japan, Wassel said. Canada exports much of its canola to Japan, Mexico and the United States.

Monsanto has since applied for, and gotten, permission to sell GT200 and its other herbicide-resistant canola varieties in Japan. But the company does not yet have full consent to use the variety in the United States. The Environmental Protection Agency already has cleared the variety for use in human food, but it is not yet registered with the Agriculture Department.

It's ironic that Monsanto's extra effort to get full regulatory approval for a variety of canola it never intends to market should be pointed to as a problem, Wassel said.

The company's rigorous testing program was designed to find any possible contamination problems and stop them, he said.

"The ultimate goal of the quality assurance program is to make sure that it never gets in there," Wassel said.

But it did contaminate Canadian canola - twice.

The problem in 1997 was that tiny amounts of GT200 seeds were mixed with Monsanto's commercial Roundup Ready canola strain, called GT73. It was an isolated incident, and Monsanto dealt with it fully, Wassel said.

He declined to speculate about how GT200 invaded the commercial canola last year.

"After an extensive investigation, we concluded that it would be more productive to focus on our quality assurance program," Wassel said.

No contamination was found in Canada in intervening years, and Monsanto has no evidence that canola in the United States is tainted, Wassel said.

But it's the fact that Monsanto can't say exactly how a non-commercial variety of canola keeps contaminating commercial seeds that has some activists bothered.

"This is living material. It breeds. It cross-pollinates, and it can get out there even if we don't want it to," said Mendelson.

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2. GENETIC ENGINEERING ERROR

RACHEL'S ENVIRONMENT & HEALTH WEEKLY #549, USA,
by Peter Montague, June 5, 1997

According to the St. Louis POST-DISPATCH, Monsanto, the St. Louis chemical and biotechnology giant, last month announced it had recalled "small quantities" of a genetically engineered canola seed containing an unapproved gene that had gotten into the product by mistake. Canola is a crop grown for livestock feed, and for oil consumed by humans. The canola-recall story, only 84 words long, was buried in the POST-DISPATCH April 18, under a confusing headline, deep in a news-wrapup column on the business page.[1]

Putting the wrong gene into a commercial product by mistake is precisely the kind of error that opponents of genetic engineering have been predicting for a decade. Proponents of genetic engineering have said it could never happen because of rigorous quality-assurance by the industry itself and tight regulation by governments. The recall was reportedly initiated by Monsanto Canada Ltd., and by Limagrain Canada Seeds, Inc., of Saskatoon, Saskatchewan, which was selling the seed under license from Monsanto.

The recalled canola seed was "Roundup ready" --meaning it had been genetically engineered to withstand dousing with Monsanto's herbicide, glyphosate, which is marketed under the trade name Roundup. Since February, 1996, Monsanto has been marketing various genetically-engineered crops that are "Roundup-ready" in an effort to boost sales of Roundup, the herbicide responsible for a large proportion of Monsanto's annual profits.[2] (See REHW #521.) The idea is to douse Roundup-ready crops with Roundup to kill weeds, leaving the genetically-engineered crop intact. According to the Associated Press, Monsanto refused to disclose how much genetically misengineered canola seed is being recalled, but said the amount was "small."[1]

Canadian government officials say the quantity being recalled is not small. Brewster and Cathleen Kneen, publishers of the RAM'S HORN, a Canadian newsletter devoted to analysis of the food system, said that, in mid-April, Monsanto reported to the Evaluation Branch of the Biotechnology Strategies and Coordination Office of the Canadian government that it was recalling 60,000 bag units of two types of canola seeds (types LG3315 and LG3295) because one or both types contained the wrong gene.[3] Thus the amount recalled is sufficient to seed 600,000 to 750,000 acres of land. According to RAM'S HORN, some of the seed had already been planted when Monsanto discovered the mistake.

The MANITOBA CO-OPERATOR,  a Canadian agricultural newspaper, quoted Ray Mowling, a Monsanto spokesperson, saying, "In some recent quality assurance testing by us, we've identified that there's a possible variety contamination."[4]

Brewster Kneen of RAM'S HORN points out that it takes a long time to produce enough Roundup Ready seed for 600,000 acres, so this error went undetected for a substantial period.

Under Canadian law, there are three levels of approval for genetically engineered crops: environmental (meaning the crop can be planted), livestock (the resulting crop can be fed to livestock), and human (the resulting crop can be fed to humans).

Two Roundup-resistant canola genes, RT-73 and RT-200, had been approved for planting, but only RT-73 was approved for livestock and humans. It was the unapproved RT-200 that somehow ended up in the seed that had to be recalled.

"The preliminary testing showed it to be the wrong configuration, as opposed to the one approved," Monsanto's Mowling said.

Canola oil is used in low-fat foods, pharmaceuticals, nutritional supplements, confectionery products, margarine and shortening, personal care products, lubricants, soaps, and detergents. The presence of the unapproved canola gene in a commercial product reveals, at a minimum, that Monsanto's quality-assurance programs failed in this instance, and that the biotechnology regulatory system in Canada is ineffective. The regulatory system in the U.S. is more lax than Canada's.

Limagrain's Gary Bauman said his company will try to discover how the mistake occurred. However, he said it will be difficult to trace exactly where in the process it happened because the seeds available for testing now are progeny (offspring) of the original seeds. "We may never know how it happened," he said. Bauman later seemed to lay the blame squarely on Monsanto. He said only Monsanto has the expertise to detect genetic differences between seeds. "The apparent contamination, discovered by Monsanto, is something only they are able to detect. We are not even allowed to try to investigate how to look at and discover this gene within our own varieties," Bauman said.[5]

--Peter Montague (National Writers Union, UAW Local 1981/AFL-CIO)

[1] "Argosy Names Perry New Chief Executive," ST. LOUIS POST-DISPATCH April 18, 1997, pg. C1.
[2] Robert Steyer, "Monsanto Makes a Bestseller Better," ST. LOUIS POST-DISPATCH January 21, 1996, pg. D1.
[3] Brewster Kneen, "Monsanto's Claims Overturned," RAM'S HORN No. 147 (April 1997), pg. 1. RAM'S HORN is available each month (11 months each year) for $20 per year from: Box 3028, Mission, B.C. V2V 4J3 Canada. Checks should be made out to THE RAM'S HORN. [This is one of the most interesting newsletters I have seen in a long time.--P.M.] Mr. Kneen also quoted Sheri Haas with the Evaluation Branch of the Biotechnology Strategies and Coordination Office of Agriculture Canada, a federal agency: Room 3369, 59 Camelot Drive, Nepean, Ontario K1A OY9; telephone (613) 225-2342 ext. 4175; internet: shaas@em.agr.ca.
[4] Laura Rance, "Registration Suspended; Genetic mixup prompts recall of Roundup Ready canola," MANITOBA CO-OPERATOR April 24, 1997. The MANITOBA CO-OPERATOR is published weekly by Manitoba Pool Elevators, 220 Portage Avenue, P.O. Box 9800, Sta. Main, Winnipeg, Manitoba R3C 3K7, Canada. Telephone: (204) 934-0401. Our thanks to Cathleen Kneen of RAM'S HORN for a copy of Laura Rance's story.
[5] Brewster Kneen, "Misguided Canola--Update," RAM'S HORN No. 148 (May 1997) quoting Mary MacArthur, a reporter for the WESTERN PRODUCER, which is published weekly by Western Producer Publications, P.O. Box 2500, Saskatoon, Saskatchewan S7K 2C4, Canada. Telephone: (306) 665-3500.

Environmental Research Foundation
P.O. Box 5036, Annapolis, MD 21403
Fax (+1-410) 263-8944
erf@rachel.clark.net

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3. Monsanto takes steps to recover Quest canola

Monsanto says it discovered in the nick of time a problem with one of the genetically modified canola crops it pioneered

Western Producer, Canada, by Sean Pratt
http://www.producer.com/articles/20010503/news/20010503news01a.html
May 3, 2001

The company, along with its marketing partners Agricore and Saskatchewan Wheat Pool, have implemented a recall of Quest, a herbicide tolerant variety of canola. The recall comes weeks before farmers will be out in the fields in full force. Producers in Alberta have already seeded 8,000 acres of the variety, while in Saskatchewan a "negligible" amount has been sown. While the sellers of the seed are pleased the recall happened before seeding was in full swing, some groups wonder why it happened at all.

"This seed has been in the pipeline for more than a year, maybe more than two years," said Darrin Qualman, executive director of the National Farmers Union. "And they didn't find it until after hundreds of bags had been sold to the farmers and thousands of acres had been seeded. It doesn't seem to indicate a very timely testing on the part of the manufacturer."

Quest is a Roundup Ready variety that was created by Monsanto Canada and produced, multiplied and sold to farmers by Agricore and Sask Pool.

Routine quality assurance tests conducted by the pool earlier this spring unveiled "trace levels" of an unwanted gene in the genetically modified crop. Monsanto confirmed the problem on April 16 and immediately notified the federal government that the variety was being recalled. Monsanto spokesperson Trish Jordan stressed that the GM canola is being recalled because of trade implications, not for food safety reasons. She said the GT-200 gene that was discovered in the variety is "almost identical" to the GT-73 gene that makes Quest resistant to the Roundup Ready herbicide. Monsanto developed both genes simultaneously, but chose to commercialize GT-73 rather than GT-200.

The canola industry is being careful to differentiate between this incident and the StarLink case, which made headlines around the world last year. StarLink was a gene-spliced corn made by Aventis and introduced in the United States. It was eventually found in human food, even though it had only been approved for livestock feed. Jordan said people have nothing to fear about the GT-73 and GT-200 genes.

"They're both approved for food, feed and environmental release in Canada and that's why it's not a safety issue." She said the problem with the GT-200 gene is that while it has been approved in Canada, it hasn't been approved in importing countries. Nobody knows how the gene ended up in a variety where it wasn't supposed to be. Right now, Monsanto and its marketing partners are focusing on getting the Quest seed back and providing farmers with replacement seed. When that is done, they will start a "thorough investigation."

Agricore sold the variety to 826 farmers, 120 of whom took delivery. Twenty-nine farmers who took delivery have planted the canola. Sask Pool's numbers aren't as specific. Len Posyniak, vice-president of human resources and communication, said typically between 2,000 and 2,500 customers would book the variety. Only 500 tonnes of product were delivered to farmers and a "negligible" amount of that has been seeded. Both companies are offering to replace the Quest seed with more expensive versions of Roundup Ready canola at no extra cost.

The few growers who have planted the crop will have to plow it down or kill it with 2-4D. They will not be allowed to reseed the field with a Roundup Ready crop, but they can choose another herbicide tolerant canola system or a different crop like wheat or barley. Agricore and
Sask Pool will help farmers with the costs of plowing the crop under, reseeding it and spraying the field with herbicide.

Eugene Dextrase, president of the Canadian Canola Growers Association, is pleased with how the situation has been handled. "I haven't heard complaints from anyone. I think Agricore and Saskatchewan Wheat Pool are making a real effort to make this as smooth as possible so that the farmers are properly compensated." Agricore said "99.9 percent" of its Quest seed has already been retrieved and is safely stored in a warehouse. The pool expects most of its seed will have been returned by the end of this week.