Historic posts are reprinted verbatim from their original source.
Source: Andrew Pollack, The New York Times, December 4, 2000
A federal advisory panel concluded yesterday that there was a “medium likelihood” that the genetically engineered corn known as StarLink is a potential allergen, a finding that could hurt the food industry’s quest to have the corn temporarily approved for human consumption.
But the panel of outside scientific experts also concluded that there was only a low probability of significant allergy problems arising in the American population because there is little StarLink in the food supply.
The advisory panel report is intended to help the Environmental Protection Agency decide whether to allow StarLink to be in human food for four years. Until now the corn has been approved only for animal use because of concerns it might cause allergies.
But the corn has been found in taco shells, setting off recalls and causing millions of dollars in losses for farmers, grain elevators, flour mills and food companies. So Aventis CropScience, the developer of StarLink, is seeking temporary approval so the food industry can avoid further recalls and will not have to test its corn so extensively for the presence of StarLink.
The advisory panel, which conducted a 12-hour public hearing last week, was not asked to make a recommendation, only to answer scientific questions. It concluded that there are many uncertainties — about whether the protein is an allergen, about the level of exposure to an allergen needed to cause a reaction, and about the amount of the protein actually in foods made from corn.
Those uncertainties, as well as the panel’s judgment of the medium likelihood that the protein, known as Cry9C, is a potential allergen, could make it more difficult for the E.P.A. to satisfy the necessary standard for approval, which is that there be “reasonable certainty of no harm.”
At the least, the 28-page report could delay any approval because it calls for more studies, which the E.P.A. said yesterday that it was undertaking. In particular the report said the government should test the blood of 7 to 14 of the people who complained of allergic reactions from products containing StarLink to see if they are in fact allergic to it.
Still, people on both sides of the debate claimed victory.
The panel “has clearly agreed that there is a low risk to public health,” Gene Grabowski, a spokesman for the Grocery Manufacturers of America, which represents food companies, said in a statement.
But Richard Caplan, environmental advocate for the U.S. Public Interest Research Group, said that even a low risk is too high. “If you are the one with an allergic reaction you don’t want it to be in the `low’ category, you want it to be as close to `no’ as possible,” he said. “My reading of this document is that E.P.A. should deny the petition.”
StarLink has a bacterial gene that allows it to produce Cry9C, a toxin that kills the corn borer, a common pest. Since this bacterial protein is not known to have been in the food supply before, there is no easy way to know if people are allergic to it.
Another E.P.A. advisory panel earlier this year concluded that there was no evidence to indicate whether Cry9C is or is not an allergen. But Aventis put forth new evidence intended to show that the protein was not an allergen. It also argued that even if the protein were an allergen, people would not be exposed to enough to become sensitized and develop allergic reactions. That is because the corn was not widely planted and will not be grown in the future, even for animal feed, since Aventis has canceled its license for the seed.
The advisory panel, made up mainly of academic allergy and agricultural experts, said “there can be no final proof that Cry9C is or is not a food allergen.” But it said the protein had, to some degree, several characteristics of allergens. It dismissed Aventis’s new evidence as unconvincing. But it said that because of low levels in the diet, there is a “low likelihood” that people have been sensitized to the protein.