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Div. of Media Relations
1600 Clifton Road
MS D-14
Atlanta, GA 30333
(404) 639-3286
Fax (404) 639-7394 |
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June 13, 2001
Contact: CDC, Division of Media Relations
(404) 639–3286
Backgrounder
CDC involvement in investigating adverse health effects associated with eating corn
products potentially contaminated with the Cry9C Protein in StarLink™ corn
- In May 1998, the U.S. Environmental Protection Agency (EPA) granted a limited license
for the production of StarLink™ corn containing the protein Cry9c. This protein has
pesticidal properties and was inserted into StarLink™ corn to protect the crop against
several insects. The EPA did not license StarLink™ 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™ 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:
- 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™ corn.
- 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™
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/ehhe/Cry9cReport/.
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