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®: CRE Regulatory Action of the Week

FDA Withdraws STARLINK Corn Testing Guidance

On April 25, 2008, the U.S. Food and Drug Administration announced that it is withdrawing a guidance document with the mellifluous title "FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues." FDA summarized its original reason for producing this guidance document:

"Cry9C is a pesticidal protein in the STARLINK variety of yellow corn that makes the corn more resistant to certain types of insects. EPA authorized STARLINK corn only for use in animal feed. EPA did not authorize the use of STARLINK corn in human food because of unresolved questions about the allergenic potential of the Cry9C protein. Although restricted to animal food use, some STARLINK corn was commingled with yellow corn intended for human use. In addition, in certain limited cases, the Cry9C protein was also detected in corn seeds of a non-STARLINK variety of corn or in corn from such seeds."

The FDA guidance document recommended a testing/screening regime intended to minimize the production of human food products with corn containing the Cry9c protein.

The FDA is withdrawing its STARLINK guidance document in response to an EPA document entitled "White Paper Concerning Dietary Exposure to Cry9C Protein Produced by Starlink Corn and the Potential Risks Associated with Such Exposure." This EPA White Paper is available in the same Federal Register as the FDA announcement.

The EPA White Paper "concludes that the protein has been sufficiently removed from the human food supply to render the level of risk low enough that continued testing for the protein in yellow corn at dry mills and mass production facilities provides no added public health protection."

  • Click here to read FDA notice withdrawing guidance document
  • Click here to read EPA notice of white paper