*EPF411 06/14/01
Text: CDC Report on Genetically Engineered StarLink Corn
(Corn did not cause allergies in people, research finds) (840)
U.S. health officials report that genetically engineered StarLink corn did not cause the reactions that occurred in people who reported allergic responses after eating tacos and other corn products last year.
According to a June 13 release that describes the findings of a report by the U.S. Centers for Disease Control and Prevention (CDC), blood tests failed to find any signs of antibodies to the protein in the genetically engineered corn, indicating none of those tested had experienced an allergic reaction to the corn.
StarLink, developed by Aventis CropSciences of Research Triangle, North Carolina, is a variety of corn engineered to contain a protein, called Cry9c, that can protect crops against several insects. The U.S. Environmental Protection Agency (EPA) approved StarLink only for use in animal feed corn, and not for human consumption, because the Cry9c protein shared molecular properties with proteins that are known food allergens.
The StarLink corn protein nonetheless inadvertently entered the human food supply last year, triggering the recall of about 300 commercial corn products. More than 50 people reported experiencing adverse reactions between July and November 2000 after StarLink was found in a variety of products made with cornmeal. The CDC tested the blood of 17 of those people who agreed to provide a blood sample.
Aventis has asked the EPA for retroactive approval to allow small amounts of StarLink corn in food for people. The latest tests by the CDC were requested by an EPA scientific advisory panel to help determine whether to issue that approval. The advisory panel is set to meet again on the StarLink issue in July.
The full CDC report can be found at the following Web site: http://www.cdc.gov/nceh
Following is the text of the press release:
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Centers for Disease Control and Prevention
Office of Communication
June 13, 2001
CDC Involvement In Investigating Adverse Health Effects
Associated with Eating Corn Products Potentially
Contaminated with the Cry9C Protein In Starlink(tm) Corn
In May 1998, the U.S. Environmental Protection Agency (EPA) granted a limited license for the production of StarLink(tm) corn containing the protein Cry9c. This protein has pesticidal properties and was inserted into StarLink(tm) corn to protect the crop against several insects. The EPA did not license StarLink(tm) for use in food intended for human consumption because the Cry9c protein shared several molecular properties with proteins that are known food allergens.
In response to a request from EPA in October of 2000 the U.S. Food and Drug Administration (FDA) requested assistance from the Centers for Disease Control and Prevention (CDC) in investigating possible adverse health effects among people who had reported to FDA that they may have had an allergic reaction to eating corn products contaminated with the Cry9c protein in StarLink(tm) corn.
CDC's investigation did not find any evidence that hypersensitivity to the Cry9c protein was responsible for the self-reported allergic responses that people experienced last fall.
Our field investigation included the following:
1. Reviewing the adverse event reports (AERs) that FDA/Center for Food Safety and Applied Nutrition received from consumers in the United States or its territories who reported adverse health events between July 1, 2000, and November 30, 2000, and involving a product suspected of containing corn meal contaminated with StarLink(tm) corn.
2. Contacting persons who gave permission to the FDA for CDC to speak with them. CDC field investigators asked basic questions about food consumption and signs and symptoms that each person recalled experiencing when they consumed corn products. CDC obtained medical records and collected blood specimens from each person for later laboratory tests.
An FDA laboratory developed a laboratory method to detect the type of antibody (IgE) that would indicate hypersensitivity to the Cry9c protein that was inserted into StarLink(tm) corn.
CDC asked FDA to evaluate the case report samples as well as other reference samples using this developmental method. To avoid bias in the laboratory analysis, all samples were provided to FDA with just a simple code number.
FDA returned the data to CDC and CDC analyzed it to compare case values with control values.
Although the study participants may have experienced allergic reactions, based upon the results of this study alone, we cannot conclude that a reported illness was a Cry9c allergic reaction.
An independent laboratory analyzed the same set of coded samples that CDC sent to FDA and confirmed the results.
CDC reviewed this data and issued individual reports to the study participants. CDC has also sent a report of the investigation and study results to FDA, and FDA will provide this information to EPA. EPA will consider the results of the CDC study and other data as it makes recommendations about the use of Cry9c.
CDC is continuing to work with FDA to evaluate the AER system for identifying potential health outcomes.
To access the full report, log onto http://www.cdc.gov/nceh.
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(Distributed by the Office of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)
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