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Summary and Recommendations

Table 1 [opens in new window] summarizes the results of the various samples that were analyzed using the Cry9c IgE-specific ELISA test. This table displays the nonreactivity of all of the human samples to the Cry9c protein, while also showing the ability of the test to react to known allergens and to hyperimmune goat serum. Cry9c-specific-IgE was not detected in any of the human serum specimens using an ELISA that was capable of detecting IgE to other allergens in people with known hypersensitivity to them. This table also points out that there was no positive human control for this test method.

Although the study participants may have experienced allergic reactions, based upon the results of this study alone, we cannot confirm that a reported illness was a food-associated allergic reaction. Although our results do not provide any evidence that the allergic reactions experienced by the people who filed AERs were associated with hypersensitivity to Cry9c protein, we cannot completely rule out this possibility, in part because food allergies may occur without detectable serum IgE to the allergens (Ogura 1993). We recommend that the study participants share the study results with their health care providers.

Evaluating the public health implications from the inadvertent introduction of StarLink™ corn into the human food supply posed a challenging retrospective task. The difficulties of this investigation highlight the importance of evaluating the allergic potential of genetically modified foods before they become available for human consumption.


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