EPA rejects biotech corn as human food

"We are very pleased, but not surprised that the data released today by the Centers for Disease Control are consistent with the mass of data we already had, showing the safety of StarLink corn... The data are compelling..." - L. Val Giddings, vice president for food and agriculture of the Biotechnology Industry Organization (BIO), June 13 2001

"Oops, they did it again. Biotechnology terrorists started another scare that didn't pan out. The results were not unexpected... Cry9C is not otherwise known to be an allergen. Experts doubted that Cry9C would be an allergen... Sadly, none of this seems to matter to the anti-technology activists and their dupes." Steven Milloy, "At Least the Biotech Terrorists Are Consistent ... They're Always Wrong", June 18 2001 http://www.foxnews.com/story/0,2933,27297,00.html

EXCERPT from item 1: The scientists advising EPA said they believe there is a medium chance that the corn is an allergen...the scientists questioned the reliability of the test that was used [by the Centers for Disease Control and Prevention] and said the government should be contacting doctors to look for possible allergy cases related to StarLink. The search for such cases needs to continue for two years, the report said. "The public would benefit from assurance of the safety of the food supply," the scientists said.

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2 items

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1. Scientists say biotech corn still not safe, recommend mandatory testing, more investigation of health complaints
By PHILIP BRASHER, AP Farm Writer
The Associated Press. July 27, 2001,

WASHINGTON: Scientists advising the government said Friday that genetically altered StarLink corn has not been proven safe for food. The panel of scientists urged mandatory testing of grain and a wider search for people who may have had allergic reactions to the biotech corn.

Discovery of the corn in taco shells last fall spawned nationwide recalls of food products. Developer Aventis CropScience withdrew the corn from the market but has asked the Environmental Protection Agency to allow trace amounts in food in order to avoid further recalls. The scientists advising EPA said they believe there is a medium chance that the corn is an allergen, although there is a low risk that consumers would eat enough corn to develop an allergy to it. The scientists said they could not determine a maximum safe level of the corn "where there would be a reasonable scientific certainty that exposure would not be harmful to public health."

Grain processors have been testing voluntarily for StarLink at the recommendation of the Food and Drug Administration, but the scientists said the testing should be made mandatory, at least until this year's crop clears the market. EPA officials had no immediate comment on the report. "At least for the time being, I don't see how EPA" can approve the Aventis request, "given that the panel feels that there is still a medium risk that Cry9C is an allergen," said Rebecca Goldburg, a scientist with the activist group Environmental Defense. StarLink corn was never approved for human consumption because of questions about whether a special protein it contained, known as Cry9C, was an allergen. The protein breaks down relatively slowly in the digestive system, an indication that it could cause allergic reactions in some people. Aventis wants EPA to set a maximum level for Cry9C in food of 20 parts per billion. That's the equivalent of one StarLink kernel in 800 kernels of corn. EPA says the actual levels of StarLink in U.S. corn supplies range from 0.34 to 8 parts per billion, depending on the method used to make the estimate.

In June, the Centers for Disease Control and Prevention cleared StarLink as the cause of allergic reactions in 17 people who thought they may have been sickened by the corn. However, the scientists questioned the reliability of the test that was used and said the government should be contacting doctors to look for possible allergy cases related to StarLink. The search for such cases needs to continue for two years, the report said. "The public would benefit from assurance of the safety of the food supply," the scientists said. On the Net: Environmental Protection Agency: http://www.epa.gov/scipoly/sap/whatsnew.htm Aventis CropScience: http://www.us.cropscience.aventis.com/

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2. EPA Rejects Biotech Corn as Human Food
By Marc Kaufman
Washington Post Staff Writer
Saturday, July 28, 2001
http://www.washingtonpost.com/wp-dyn/articles/A62091-2001Jul27.html

The federal government's investigation into whether StarLink corn causes allergic reactions failed to establish that the genetically engineered corn was safe to eat, according to an expert panel convened by the Environmental Protection Agency.

While the panel did not conclude the modified corn causes allergies, it said that months of study by federal agencies "do not eliminate the possibility of such a reaction."

Based on the panel's recommendations, the EPA yesterday announced that it would continue its policy against permitting even trace amounts of StarLink in foods -- turning down a request to change that position from Aventis CropSciences, which developed the corn.

The unapproved presence of Starlink has required hundreds of food recalls and costly international trade problems, and food industry officials said yesterday they were disappointed in the EPA's refusal. But critics of biotechnology said they were pleased by the decision, which they said vindicated their concerns about the potential risks of some genetically modified products.

Stephen Johnson, of the EPA's Office of Prevention, Pesticides and Toxic Substances, said the agency had no choice but to turn down the Aventis application. "Some of the world's leading experts on allergenicity and food safety told us there was not enough data to conclude with reasonable certainty that there was an acceptable level of [StarLink corn] that people could eat," he said. "That leaves us no room" to allow StarLink.

The EPA approved StarLink as animal feed in 1998, but did not allow it for human use because of concerns that it contained a protein that broke down slowly and could cause dangerous allergic reactions. A public interest group found StarLink's genetically modified protein in taco shells last fall, and it has been at the center of the often contentious international debate over crop biotechnology ever since.

Johnson said the agency was studying how it might respond to the panel's recommendation that it expand its study of possible allergic reactions to StarLink. The panel said the federal government should ask specialists to report suspicious reactions to corn -- which is not a common cause of allergic reactions -- and should expand research into the entire field of genetically improved crops and food allergies.

In addition, the panel said that "every attempt" should be made to further test two people who reported severe reactions and who have offered to undergo skin testing and to eat StarLink products under medical supervision.

One of the two, Florida optometrist Keith Finger, told the panel that he sought out StarLink corn after his initial reaction last fall, and had received some anonymously in the mail. After running a test that showed it was in fact StarLink, he ate some and went to a local hospital several hours later with itchy rashes over his body and fast-rising blood pressure.

During two days of testimony in mid-July, Food and Drug Administration officials said that blood tests on 17 people who reported possible allergic reactions to StarLink, including Finger, did not show any signs of an actual physical reaction.

But the expert panelists raised questions about the validity of the testing process and the size of the sample. They said that the tests decreased the probability that people had suffered allergic reactions to StarLink, but did not rule it out.

Johnson said yesterday it "would require many months or years of continued scientific evaluation to answer the question of allergenicity."

An Aventis official said that the company was not surprised by the panel conclusions and the EPA decision. She also said that there is no way to conclusively determine if the Cry9C protein in StarLink -- which protects the corn against the European corn borer -- can cause allergic reactions.

In a statement, the company emphasized its commitment to directing all corn with the StarLink Cry9C protein to livestock and industrial uses. "We will continue to support the grain handlers and millers with their testing programs," the company said. "We are proud of the progress we have made in containing StarLink corn."

In its report, the expert panel concluded that the amount of StarLink in the food supply was significantly less than predicted in the fall, and that there is a "low probability of allergenicity" in the population based on levels of StarLink in the U.S. diet. Aventis has been buying back StarLink corn, and corn commingled with StarLink, and virtually all is expected to be out of the food supply after the fall harvest.

During the panel meeting, officials from the Agriculture Department reported the agency will spend between $13 million and $17 million to also buy back seed for growing corn that had been contaminated with StarLink.

The modified corn, which was planted on only 320,000 acres last year but has spread well beyond that, has created problems for U.S. corn exporters because some foreign buyers avoided all U.S. corn. The grain and food industries have supported the Aventis request for allowing trace amounts of the corn, saying low levels of many genetically modifed proteins can be found in virtually all corn.

"The food industry is disappointed by the EPA decision today on StarLink," said Gene Grabowski of the Grocery Manufacturers of America. "It means continued uncertainty and anxiety in the food market . . . and eventually will result in price increases. It's a situation that should not be allowed to continue."

But Bill Freese of Friends of the Earth, an environmental group, said the panel report "shows that the EPA and FDA need to begin more seriously regulating genetically engineered foods to protect public health."