F.D.A.: No more testing needed for StarLink
April 30, 2008
by Eric Schroeder
WASHINGTON — The Food and Drug Administration on April 25 withdrew its guidance for testing shipments of yellow corn and dry-milled yellow corn intended for human food use for the presence of Cry9C protein residues. The F.D.A. withdrew its guidance in response to an Environmental Protection Agency (E.P.A.) "white paper" and to an independent assessment of StarLink exposure, both of which found the U.S. corn supply is essentially free of StarLink.
In the E.P.A. paper, details of which were published in the April 25 issue of the Federal Register, the agency concluded that Cry9C has been "sufficiently removed from the human food supply to render the level or risk low enough that continued testing for the protein in yellow corn at dry mills and masa production facilities provided no additional human health protection."
The announcement was applauded by the North American Millers’ Association, which has worked for years to bring mandatory testing of StarLink to conclusion.
"We’re delighted that the recent actions by the E.P.A. and F.D.A. have validated our long felt conviction on the safety and wholesomeness of all milled grain products," said Rick Schwein, Grain Millers, Inc., and chairman of NAMA.
The StarLink corn variety, bioengineered with the Cry9C insecticidal protein, was discovered in the food supply in 2000. At that time, StarLink had been approved for use as animal feed but not as a food grain. Aventis CropScience had been required to make agreements with farmers to ensure the corn was kept separate from grain that is approved for food use, an arrangement that failed. Since then, the E.P.A., F.D.A. and U.S. Department of Agriculture have tested more than 4 million corn samples, and no samples have been found to contain Cry9C protein in more than four years.
NAMA said that from the beginning millers followed the F.D.A. guidance, acknowledging the need to show quality assurance procedures were in place and working. In addition, NAMA said millers remained confident throughout the process that a science-based risk assessment by the E.P.A. would conclude further testing for Cry9C was not necessary. There has not been a single incident of a human health affect from Cry9C.
"As it turns out, there never was any real health or safety issue," said Don Sullins, PhD, ADM Milling Co. and chairman of NAMA’s Technical Committee. "Plus, since the last StarLink was grown in 2000 the U.S. has emptied and refilled its grain silos with seven harvests — a total of more than 75 billion bushels. It’s time to move on."