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  • Executive Summary
    The U.S. Food and Drug Administration (FDA) requested technical assistance from the Centers for Disease Control and Prevention (CDC) in investigating adverse event reports of human illnesses that were potentially associated with consumption of genetically modified corn products ...more
  • Background
    Prior to reports of human illnesses, a protein named Cry9c had been inserted into genetically modified StarLink™ corn.  This protein has pesticidal properties  ...more
  • Epidemiological Investigation
    An epidemiological investigation was initiated to determine if FDA adverse event reports were consistent with allergic reactions to food and whether Cry9c needed to be investigated ...more
  • Research Protocol
    CDC developed a protocol for collection of serum from affected individuals and FDA developed a test method for detecting Cry9c-specific antibodies in serum ...more
  • Interpretation of ELISA Results
    Serum from affected individuals and from unaffected controls were analyzed and data is presented  ...more
  • Summary and Recommendations
    Summaries of results and recommendations are given ...more
  • Figures and Tables
    View figures and tables from the report ...more
  • Appendix A
    Consent to participate and related materials ...more
  • Appendix B
    FDA procedure for detection of antibodies to Cry9C ...more

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