In the first-ever product recall of a food because of its genetically engineered ingredients, Taco Bell brand taco shells are being pulled from supermarket shelves after tests confirmed the presence of an ingredient not approved for human consumption.
The Taco Bell restaurant chain also said that, as a precautionary measure, it has begun substituting taco shells sold in its 7,000 locations nationwide.
The Kraft Foods unit of Philip Morris Co., which distributes the Taco Bell brand shells in supermarkets, said Friday it is recalling the shells and discontinuing their production until it can ensure that the product is free of the genetically modified ingredient.
The taco shells contain a type of bioengineered corn, StarLink, that "was approved for animal use, not for use in food," said Kathy Knuth, a Kraft spokeswoman. "On that basis alone, it should not be eaten."
Although there have been no reported incidents of illness from the corn, consumers who have purchased the products are urged not to eat them and to return them to the stores where they were purchased for full refunds.
Most bioengineered corn and soybeans are considered safe for humans, but StarLink contains a pest-repelling protein, Cry9C, that may be hard for humans to digest. It is unclear whether this protein was in the taco shells.
The recall will cost the food giant millions of dollars. The Taco Bell shells accounted for about half of the $100 million in sales generated by Kraft's Taco Bell brand products last year.
Irvine-based Taco Bell, which buys its taco shells from the same manufacturer that Kraft uses, says it is still testing its shells for the presence of StarLink corn. Meanwhile, it is continuing to sell the shells at its restaurants for the next several days while it awaits shipments from new suppliers of the corn flour used in these products.
"We're unaware of any known health risk associated with this corn variety, nor have we received a single consumer complaint," said Taco Bell Vice President Jonathan Blum. "Nonetheless, we're taking the matter seriously and continue to cooperate with the [Food and Drug Administration] and do the responsible thing to make sure the health and safety of our customers is safeguarded."
The restaurant chain said the taco shell problem will have no effect on its licensing agreement with Kraft.
How the Starlink animal feed corn got mixed in with corn for human consumption is not clear. Taco Bell brand taco shells are made for Kraft by chip maker Sabritas at a plant in Mexicali, Mexico, with corn flour from a mill in Texas. A Kraft spokesman said the corn bought by the Texas miller came from farmers in six states, and that the miller had ordered a conventional form of corn.
The incident underlines the difficulty food manufacturers have in ensuring that their processed products are free of genetically altered ingredients. Bioengineered corn and soy are not segregated at most grain elevators, allowing corn such as StarLink to slip into other products.
"The whole U.S. corn and soybean system is based on commodities," said Sano Shimoda, president of BioScience Securities, a biotech securities research firm. "This demonstrates the need for segregated systems with testing and information control so that the right product can get to the right consumer."
The case also illustrates, analysts say, how unprepared government regulators are to deal with unapproved bioengineered crops that slip into the food supply. Although the FDA and the Environmental Protection Agency, two agencies with oversight of genetically modified crops, are investigating the matter, they have yet to even test the product.
Indeed, the FDA is still setting up its own testing facility to ensure that it can perform these genetic tests on processed food, according to Jim Maryanski, the FDA's biotechnology coordinator. In a sense, Maryanski says, this is a test case for the system.
"It's certainly the first time we've had a reason to run tests on a corn product produced through bioengineering," he said. Currently, he said, the FDA's labs can test for specific DNA only in crops, not in processed food.
The presence of the StarLink corn in the taco shells was first reported this week by the environmental group Friends of the Earth, which had the shells tested by an independent lab.
Friends of the Earth, a member of the coalition known as Genetically Engineered Food Alert, commissioned the tests out of concern that StarLink was not being segregated from other corn at grain elevators. Altogether, 23 food items made from corn were sampled, including frozen food, cereal and tortilla chips. However, only the Taco Bell taco shells were found to contain the bioengineered corn and only 1% of the sample tested contained the StarLink corn.
"It's unfortunate that an environmental group like Friends of the Earth should have to serve as watchdogs of the food supply," said Mark Helm, a Friends of the Earth spokesman. "That's the FDA's job."
Biotechnology proponents applauded Kraft's move and said regulators need to work together to find ways to ensure that this doesn't happen again.
"In order for consumers to be confident in the safety of the food supply, they need to know that stuff that's not approved isn't getting in there," said Val Giddings, a geneticist and vice president of the Biotechnology Industry Organization.
To protect consumers and manufacturers from another incident like this one, Kraft asked regulators to consider several reforms, including the discontinuing of approvals for bioengineered crops intended for animal use only, mandatory pre-market review of new bioengineered crops and the establishment of a validated testing procedure so bioengineered products can be detected easily in processed food.
Maryanski noted that food contamination isn't a problem unique to bioengineered crops. However, he said, this case will help the FDA "look at what it needs to do differently in the future."
The EPA, which grants licenses for biopesticide crops, said it has not decided whether to revoke the license on StarLink and is still investigating the matter.
Times staff writer Leslie Earnest contributed to this report.