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Biotech firm suspends sale of corn seeds after recall

September 27
Washington Post

A biotechnology company yesterday voluntarily suspended sales of seeds for the genetically engineered corn that prompted the recall of millions of taco shells nationwide.

The move marks the first time that a genetically modified crop has been withdrawn from the market because of regulatory and safety considerations. It is the latest setback for the biotech industry, which has been struggling to convince the public that its products are safe and well regulated.

Aventis CropScience of Research Triangle Park, N.C., said it is instructing seed distributors to stop sales of its StarLink brand corn seed to farmers for next year's planting season. In announcing the move, the company acknowledged it had lost the public's confidence that it could keep the corn out of the human food supply. The seed was only approved for use in animal feed because of concerns that it might trigger dangerous allergic reactions in people.

The company's admission that it is having difficulty guaranteeing the seed's segregation underscores one of the major problems facing genetically engineered food: Consumers, especially in Europe, are demanding that they be able to know which foods contain engineered products and which do not.

The Clinton administration is establishing rules for voluntary labeling of genetically modified products, but they all depend on the proper flow of engineered or conventional crops to the right grain elevators and processing plants. Evidence is mounting that that may not have occurred with StarLink corn.

"We have a stewardship program in place to make sure StarLink corn remains in the proper channel," said Aventis spokesman Richard Rountree. "Is it perfect? Perhaps not. Do we want to make it closer to perfect? Absolutely."

As a result, the company also announced yesterday that it will "enhance" its program with StarLink growers to make sure that the corn now in their fields does not enter the human food chain. Aventis is arguing that corn should still be allowed to reach market.

The corn was found last week in Taco Bell taco shells sold by Kraft Foods in grocery stores. Aventis maintains that the testing so far has not conclusively found the presence of StarLink in the taco shells, but both Kraft and the group of biotech critics that first raised the issue have lab test results showing its presence.

The Aventis decision came while the Food and Drug Administration and the Environmental Protection Agency--which perform much of the regulation of biotech crops--continue to struggle over how to perform their own tests of the taco shells. The agencies have come under criticism for the slow pace of their testing, compared with that commissioned by Kraft and the biotech critics.

EPA officials have said that if the corn is found in any foods, the agency will revoke Aventis's license to sell the corn--even if it turns out that a farmer was responsible for selling the animal corn for human use.

"The way this license agreement is set up is that even if a grower were to mess up, we're not going after that grower," an EPA official said. "We go after the company. We hold the company responsible, and the company knows this."

The official said the EPA had strongly recommended that Aventis be "proactive" regarding StarLink, and that the agency considered yesterday's withdrawal to be "prudent."

Aventis was also under industry pressure to withdraw the StarLink corn. The National Corn Growers Association urged the move on Monday and the Grocery Manufacturers of America said yesterday that "we think the Aventis action was necessary to reassure the public that this kind of problem can never occur again."

Aventis officials said that StarLink corn, approved by the EPA in 1998 for animal feed, is planted on about 325,000 acres of the 73 million that grow corn nationally. The company plans to continue efforts to win EPA approval for human use, and also has applications pending to market the corn in Japan, Canada and the European Union.

Supporters of biotech emphasize that there have been no reports of adverse reactions to any genetically modified products, which are now widely distributed worldwide. But critics such as the group that first found the StarLink corn in taco shells, the Genetically Engineered Food Alert, said that may be because there has been no testing or reporting of possible problems.

StarLink corn is genetically modified to produce a protein that gives corn protection against the European corn borer. That protein, however, breaks down relatively slowly in the human body, raising concerns that it could cause allergic reactions in people.

Companies act to keep bioengineered corn out of food -- 

September 27
New York Times

Moving to address safety concerns, agribusiness companies took steps yesterday to limit the chances that a strain of bioengineered corn not approved for human consumption could end up in food products.

The corn, approved for use only in animal feed, was found last week in a sampling of taco shells sold in stores under the Taco Bell brand, prompting Kraft Foods to recall the more than 2.5 million boxes of the product believed to be in distribution.

Yesterday, Aventis CropScience, which engineered the corn to make it more pest-resistant and marketed the technology under the StarLink name, told seed companies not to sell any of the corn for planting next year.

Affirming a policy adopted Monday by the Biotechnology Industry Organization, a Washington-based trade group, Aventis also said it would no longer market bioengineered products for any use until they had been cleared for use in food.

"We agree that it's prudent," said David Witherspoon, president of the Garst Seed Company, Aventis's biggest licensee. Mr. Witherspoon said Garst, based in Slater, Iowa, would store StarLink corn seed harvested this year on the assumption that StarLink would eventually be cleared for food use.

While it has not been established that the StarLink corn poses a risk to human health, tests have found it to carry a protein that has some characteristics of allergens.

Mr. Witherspoon said Garst would direct farmers who want next year's crops engineered to fend off the corn borer, a common pest, to use corn strains based on Monsanto's YieldGuard technology, which has government clearance for food uses.

Aventis said yesterday that the company and regulators were discussing the fate of the 315,000 acres planted with StarLink this year. Aventis said it was close to announcing new measures developed in consultation with farmers to confine the current crop to approved uses. Aventis said that containing this year's crop should not be a major challenge since it represented much less than one-half of 1 percent of the 73 million acres planted in corn this year.

As Aventis moved to halt sales of the corn seed, the company that milled the corn in the taco shells moved yesterday to halt further shipments of yellow corn products from its mill in Plainview, Tex. The company, Azteca Mills of Dallas, said it was testing for evidence of the unapproved corn and expected to resume full production within a week. The Plainview mill has been identified as the source of the corn meal for the Kraft taco shells, which were made at a plant in Mexico owned by PepsiCo.

Kraft said yesterday that as far as it could determine, all Taco Bell shells were off the shelves. "We will not destroy the products that are being returned until we hear from the Food and Drug Administration what it wants to do with them," said Michael Mudd, a company spokesman.

The recall will cost Kraft millions of dollars at a minimum, but the final figure, including lost sales, will not be known until Kraft finds a new mill to make the shells and starts producing them again, Mr. Mudd said. In any event, the losses are not expected to hurt the earnings of Philip Morris, Kraft's parent.

The Taco Bell restaurant chain, meanwhile, said that tests had turned up "no reason to believe" that the unapproved corn had found its way into the shells used in its restaurants. Taco Bell's suppliers include the PepsiCo plant in Mexico, although its shells use a different recipe than Kraft's.

The restaurant chain, a subsidiary of Tricon Global Restaurants in Louisville, Ky., said all shells now being shipped had been made from corn grown in regions other than the Plainview area as an added precaution.

Biotechnology critics said that even with the corporate steps being taken to deal with the episode, a thorough government investigation was in order.

"You can't identify a solution until you have a better understanding of the problem," said Margaret Mellon, senior scientist at the Union of Concerned Scientists in Washington.

The case was mentioned several times yesterday during a Senate committee hearing on biotechnology. Joseph A. Leavitt, director of the Center for Food Safety and Applied Nutrition at the Food and Drug Administration, commended Kraft for "acting responsibly" in the taco shell recall. He told the committee that the incident reinforced the need for vigilance by federal authorities and "other interested parties" to make sure that "the rules pertaining to bioengineered foods are being fully adhered to."

The StarLink corn is a latecomer among the several first-generation biotechnology products that use genes from the Bacillus thuringiensis, or Bt, family of bacteria, to produce a protein deadly to corn borers. It was approved for use in corn for animal feed or industrial products in 1998.

The StarLink protein attaches to a different part of the insect gut than those produced by other Bt-engineered plants. Evidence suggesting that it might cause allergies because it is not so easily broken down in the human digestive system led the Environmental Protection Agency to demand more tests before clearing it for use in food corn.

Identifying which altered corn has the StarLink gene can be tricky. Aventis yesterday endorsed a test developed by Strategic Diagnostics. But even that test cannot pick out processed foods made from StarLink corn because the Bt protein typically is broken down by heating and other food processing.

Call for detailed studies on genetically modified foods

September 27
The Hindu

Dr. Arpad Pusztai, whose findings unleashed controversy over the safety of Genetically-Modified (GM) foods two years ago, has said that detailed studies into the effects of GM foods were essential before they were permitted into the food chain.

Dr. Pusztai had carried out research into the effects of GM potatoes on rats at the Rowett Research Institute in Scotland. He found that the rats fed on these potatoes suffered from intestinal damage and impaired immune systems. He went public with his findings in mid-1998. The resulting outcry and publicity played an important role in creating public opinion against GM foods in Europe.

Dr. Pusztai was in Bangalore for the two-day International Seed Tribunal organized by a number of NGOs and farmers' organizations. In his talk here on Monday, he explained his research findings and the importance of further studies.

The potatoes had been genetically modified to produce a chemical, called `Lectin', which would inhibit certain pests from feeding on the plant. Laboratory tests had shown it to be safe even at high concentrations. Growing rats were fed with ordinary potatoes, the GM potatoes and ordinary potatoes with the lectin added.

The detrimental effects were noticed in the rats which were fed the GM potatoes, he said. The damage could not be attributed to lectin; it was the result of the genetic modification method used and the unpredictable disturbances caused to the plant's own genes.

Though GM foods did not create acute toxicity, they could have a cumulative effect after 20 to 30 years of consumption. Rigorous, independent and transparent studies, involving biological and chemical tests, were needed to take a rational decision on whether it was safe to allow GM foods into the food chain. Very few studies had been carried out so far and no money was available, even from governments, for such work, Dr. Pusztai pointed out.

The Delhi-based Research Foundation for Science, Technology and Ecology, headed by Dr. Vandana Shiva, has been demanding a 10- year moratorium on genetically engineered foods and crops in India. It has also been calling for labeling to identify foods containing GM material.

In another talk, Ms. Hope Shand, Research Director of the North American NGO, the Rural Advancement Foundation International (RAFI), spoke about the growing consolidation and power of the ``gene giants''. A few giant corporations, whose aim was to retain their monopoly, were in a position to make critical decisions concerning agriculture and health. The new patent regimes were only strengthening their control, Ms. Shand said.

Genetically engineered foods causing some concerns

September 26
CNN

As a U.S. Senate committee heard testimony on biotechnology and consumer confidence in food Tuesday, Aventis CropScience suspended sales of the genetically engineered corn product found to have been mistakenly used in the manufacture of some taco shells sold in grocery stores.

Kraft Foods recalled millions of packages of the shells Friday after tests showed that some were made with an Aventis corn known as StarLink. The corn contains a bacterium gene that makes it toxic to the corn bore pest. It is approved for use only in animal feed because of a concern that it could cause allergic reactions in humans.

"Today, we simply don't have a system to catch the illegal use of genetically engineered ingredients," U.S. Sen. Barbara Boxer, a Democrat from California, said during the Health, Education, Labor and Pensions Committee hearing. "We don't even have a system that requires mandatory safety tests, Mr. Chairman, to make sure that genetically engineered products, when they are used properly, are safe."

Aventis spokesman Rick Rountree said company officials felt that "until we can get all this resolved, the fairest thing for food companies and the consuming public is to stop sales." The company also will see that corn being harvested this season does not get into food channels, he said.

The recalled taco shells are being sold under the Taco Bell name. Taco Bell Corp. officials said the company will be replacing all of the shells used in their restaurants later this week. There are 7,000 Taco Bell restaurants in the United States.

Although StarLink is under review for approval as human food, the mix-up "should not have happened," Lester Crawford, director of the Center for Food and Nutrition Policy, told CNN. "The American public should expect swift action from its regulatory agencies -- USDA, FDA and EPA -- in a concerted effort to try to get this off the market and find out what happened, because irrespective of what the risk is, which is low, this should not be in human food."

The Center for Food and Nutrition Policy is a non-partisan food-safety advocacy group based at Georgetown University.

Federal oversight

A majority of foods -- particularly processed foods -- made with corn and soybeans probably contain bioengineered ingredients because of increasing use of genetic engineering in those commodities, Crawford said. "But I would emphasize that these have been tested and approved by the EPA," he added.

Still, the Kraft recall "illustrates how full of holes federal oversight of genetically engineered foods is," said Rebecca Goldburg, a biologist with Environmental Defense.

In a letter to federal regulators on Monday, the Biotechnology Industry Organization agreed that farmers shouldn't be allowed to grow a crop that isn't approved for food use. Kraft made this recommendation, as well as three others, to the federal Food and Drug Administration on Friday when it announced the recall.

The biotech group, which represents more than 900 companies, research institutions and other groups, said "consumer confidence in the safety of all food products must be our first and only priority."

FDA officials said they are considering Kraft's recommendations, but are confident that existing regulations are working to protect public health. They have said there is no known health risk from the corn used in the recalled taco shells.

U.S. Agriculture Secretary Dan Glickman said the recall showed that the government must improve its efforts to ensure that genetically engineered food products remain separate from other foods.

"We've got to do a better job of segregating those commodities to make sure that ... we basically protect people from things that haven't been approved," Glickman said. "The FDA is monitoring the situation very closely, very carefully. I don't think there is any public health and safety issue here, but the fact is the product has not been approved for human consumption. It should not be served."

The federal Department of Agriculture, the Food and Drug Administration and the Environmental Protection Agency share the responsibility of regulating biotech foods. The FDA is now finalizing rules regarding new varieties of genetically engineered products and voluntary product labeling.

U.S. Rep. Dennis Kucinich, an Ohio Democrat, has sponsored legislation to require labeling and safety testing of such foods. Other countries, such as the United Kingdom, do require such foods to be labeled as containing genetically altered ingredients.

Aventis halts sale of corn seeds linked to Kraft recall

September 26
Reuters

The U.S. unit of European pharmaceuticals giant Aventis SA on Tuesday halted the sale of its gene-altered corn seed variety not approved for human consumption in the latest fallout from Kraft Foods nationwide recall of taco shells made from the corn.

Life science company Aventis Cropscience said it has ordered distributors to stop the sale of Starlink corn seeds to ensure they do not enter the food chain.

The move comes on the heel of a voluntary recall by Kraft Foods, the biggest U.S. food manufacturer and unit of Philip Morris Cos, of Taco Bell Home Originals taco shells because some samples contained Starlink corn.

It was the first time a U.S. food product containing genetically-modified organisms (GMOs) not approved for human consumption has been pulled back.

The United States is the world's largest producer of genetically modified (GM) crops, which are spliced with genes to make them resistant to pesticide and deadly to pests, in a GM food industry worth about $4 billion a year.

Gene-modified crops have prompted a storm of protest in Europe but until the Kraft recall U.S. food companies had been largely insulated from the controversy.

Tests performed by an independent laboratory found, in certain samples, the presence of Starlink corn that Kraft had not specified for the taco shells and which is not approved for use in food because of concerns it might be an allergen.

All other Bt corn hybrids grown and sold in the United States have governmental approval for both food and feed use, the National Corn Growers Association said.

Bt corn is a type of GMO crop that, through the addition of the natural Bt soil bacterium, has a built-in defense against the European corn borer, an insect that has caused millions of dollars in crop losses over the years.

The U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) said this week they were jointly investigating allegations by an anti-biotech coalition that a variety of unapproved genetically spliced corn had slipped into Taco Bell shelss sold in a Maryland grocery store.

``Sales will not resume until the company receives a food clearance from the U.S. Environmental Protection Agency,'' Aventis said in a statement.

Aventis spokesman Rick Rountree said Starlink corn hybrid seeds were planted in less than 10,000 acres when introduced in 1998. Plantings have grown to 315,000 acres this year but still constitute less than one percent of total corn seedings.

He said the company was taking several measures to ensure that corn grown from Starlink seeds do not end up in food channels, but declined to say if it would involve price incentives for farmers to store them separately.

Rountree said that it was unlikely that farmers had purchased seeds for plantings next year, but added that Aventis distributors would take back seeds that were sold.

Lynn Jensen, president of the National Corn Growers Association, welcomed the move by Aventis to stop the sale of Starlink. ``It's a very appropriate action,'' he said.

Jensen said the taco shell recall highlighted the need to segregate Starlink corn from other varieties in the grain handling process to ensure it does not enter the food chain.

``A lot of farmers know what is going on, but in the heat of harvest they can forget,'' he added. ``There is going to be some sort of financial incentive to get farmers to segregate.''

Democrats: recall shows need for firm biotech rules

September 26
Reuters

The recall of Taco Bell shells containing unapproved gene-spliced corn was seized upon by Democratic senators on Tuesday as proof that U.S. biotech regulations must be tightened while Republicans said the only change needed is more public education.

The voluntary recall by Kraft Foods has sparked a fresh debate over the safety of bioengineered foods at a time when the Food and Drug Administration is preparing new rules aimed at boosting consumer confidence without making any major changes.

``The irony of this controversy is a growing wariness on the part of consumers about food that, to date, government, academia and some consumer groups have declared safe,'' said Sen. James Jeffords, a Vermont Republican and chair of the Senate Health committee. The panel held a hearing on Tuesday to look at consumers' concerns.

Kraft, a unit of Philip Morris Cos. Inc., announced the recall Friday after it confirmed the presence of StarLink gene-altered corn in some packages of taco shells. The company also urged the government to take somewhat stricter measures in approving future biotech crops.

StarLink is one of several so-called Bt corn varieties engineered to repel pests before being harvested for animal feed. But it is the only one that the Environmental Protection Agency refused to approve for human food use because agency scientists suspected some people might be allergic to it.

The EPA, FDA and U.S. Agriculture Department share responsibility for regulating gene-spliced foods.

FDA SAYS BIOTECH FOODS SAFE

Joe Levitt, director of the FDA's Center for Food Safety and Applied Nutrition, defended the agency's regulations.

``While the FDA investigation is still continuing, Kraft's rapid response was a prudent action that clearly put the interests of consumers first,'' he told the panel.

The FDA is preparing to publish regulations that would convert its voluntary consultation process for biotech developers into a mandatory one. The agency also is working on guidelines that food manufacturers can use if they want to label a product as containing or being free of a genetically altered ingredient.

Both measures are aimed at boosting consumer confidence in the FDA's procedures, rather than significantly changing any rules, Levitt said. ``The FDA stands behind the safety of these products and wants the public to have the same confidence we do,'' he said.

Mandatory labels on biotech foods would not have prevented the Taco Bell contamination, Levitt said.

Government-mandated labels -- like those required in the European Union, Japan, China, New Zealand and other nations -- have been fiercely opposed by foodmakers as costly and implying the foods are less safe.

CONGRESS DISAGREES ON ACTION

Two Democrats -- Barbara Boxer of California and Dick Durbin of Illinois -- said it was time for stricter rules to prevent another unapproved biotech ingredient from slipping into the food supply.

``We simply don't have a system in place to catch the misuse of genetically modified ingredients,'' Boxer told the panel. ``We don't even have a system that requires mandatory safety tests.''

Her legislation would require biotech companies to perform prescribed safety tests and to indicate on a food label if it contained genetically-altered ingredients. The bill has little chance of passage this year with Congress hurrying to complete its work during the next two weeks.

Durbin said he planned to introduce a bill that would require the FDA to monitor foods from the farm to store shelves to ensure that biotech foods were not ``inappropriately'' entering the food supply.

``We should not have to rely on public interest groups to conduct this screening for us,'' Durbin said, referring to the environmental group Friends of the Earth, which initially detected StarLink in taco shells.

Republicans on the panel said existing FDA, EPA and USDA regulations already work well to protect consumers.

They endorsed the biotech industry's $50 million campaign now underway to educate Americans about the safety of the food through brochures, Web sites and television advertising.

``As we have seen in Europe, the public's lack of knowledge about this technology can create a reactionary, anti-biotech sentiment based more on alarmist rhetoric than sound science,'' said Senator Tim Hutchinson, an Arkansas Republican.

Senator Christopher Bond, a Republican from the farm state of Missouri, said environmental and activist groups were trying to eliminate biotech foods, not just make them safer.

``Please do not underestimate the sophistication of the activists because they are smart enough to know that labeling kills the technology,'' Bond told the panel.

Food firms scour supply chain after Kraft recall

September 26
Reuters

Chicago - Food companies are reexamining their supply chains and banning the gene-modified variety of corn known as Starlink following the recall of Kraft Foods taco shells from U.S. grocery stores after the unapproved grain was found in samples.

``This development has changed some of the ways we are purchasing corn,'' Mark Dollins, Quaker Oats Co.'s director of corporate communications, told Reuters Tuesday.

The Kraft recall is the first of a U.S. food product containing a gene-modified ingredient not approved for human consumption. Starlink corn gained approval from U.S. regulators for use in animal feed only and had been on the market for less than two years.

There is no evidence of health problems linked to the Starlink strain, which is spliced with a pesticide known as bacillus thuringiensis. But U.S. regulators withheld approval of the corn for human use amid concerns a protein it contains might be an allergen.

Kraft, in announcing the recall on Friday, said it was suspending production of its Taco Bell brand taco shells until it could ensure the ingredients it receives from suppliers are in compliance with federal rules.

On Tuesday, the U.S. unit of European pharmaceuticals giant Aventis SA, maker of the Starlink corn, said it was halting sale of the seeds to ensure they do not enter the food supply. The company said plantings of Starlink hybrid seeds made up less than 1 percent of total corn seedings this year.

``This is not a label issue. This is not a biotech issue. This is an error in the food safety system. The food company and the seed company have taken the proper steps,'' said Gene Grabowski, spokesman for the Grocery Manufacturers of America trade group.

The U.S. Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) said last week they were investigating allegations by an anti-biotech coalition that a variety of unapproved genetically altered corn had slipped into Taco Bell shells sold in a Maryland grocery store.

The FDA is finalizing rules that will mandate consultations between agency scientists and food companies developing new varieties of bioengineered products and is also working on guidelines for food manufacturers who want to indicate on labels whether a food contains gene-altered ingredients.

Quaker Oats said on Tuesday it was now specifying to suppliers that it would not accept Starlink corn and requiring they provide genetic identification for the grains Quaker buys following the Kraft recall.

Other companies are likely to follow suit in tightening policies to help prevent a similar mistake from occurring, said a food industry source who asked not to be named.

``A number of companies are considering steps to tighten the supply chain,'' said the source.

ConAgra Inc. spokeswoman Karen Savinski said the company earlier this year began notifying growers and suppliers that it would not accept the Starlink variety at its corn processing plant in Kansas.

ConAgra's Casa de Oro food service unit, which supplies taco shells for Taco Bell restaurants, switched its corn flour buying to a mill in Indiana from one in Texas at the request of the fast-food chain, Savinski said.

The Taco Bell chain, operated by Tricon Global Restaurants Inc., said on Friday it directed suppliers to purchase corn flour from plants outside Texas as a precaution after Kraft identified a plant in Plainview, Texas, as the source of the Starlink-tainted corn.

Some food companies said that while they could be fairly confident no Starlink corn found its way into their products, they would continue to watch the situation closely.

``This appears to be an isolated incident involving an uncommon type of corn, but we are monitoring the issue,'' Kellogg Co. said in a statement.

Companies concede it is virtually impossible to guarantee grain supplies that are completely free of unwanted materials because of the chances crops can cross-pollinate or become mingled at shipment or delivery points.

Kraft, which is owned by Philip Morris Co., called for the discontinuation of partial regulatory approvals of new bioengineered seed varieties among other proposals it suggested to help ensure the safety of the food supply.