In this document, the reader
will find the report of a new study conducted by Aventis CropSciences,
the registrant of StarLink corn. Aventis conducted this study in part
to provide additional information for the Environmental Protection Agency's
(EPA) scientific assessment of the potential allergenicity of StarLink
corn protein in finished food products. On December 5, 2000, the Scientific
Advisory Panel, a group of independent scientific experts, expressed
the need for additional data to more accurately assess the potential
allergenicity of StarLink corn protein. Specifically, the Panel indicated
that it would need more data on the precise amount of StarLink corn
protein in processed foods, such as taco shells, corn muffins and grits.
When the Panel considered
these issues, analytical methods were not available to detect levels
of StarLink corn protein in processed foods. The validated procedures
available at the time only had the capability of detecting StarLink
corn protein in raw corn, and of detecting the DNA that encodes for
the StarLink corn protein in processed foods. A private laboratory has
developed a new analytical method that, reportedly is more sensitive
than the protein strip test being used for corn grain.
In the attached study,
Aventis examined how two types of corn processing affected the amount
of StarLink protein in processed foods. Wet-milling renders corn into
corn oil, corn syrup, alcohol, and corn starch. Aventis reports that
it has found that the wet-milling process reduces the residues of the
StarLink corn protein in finished food products to a level that is below
the limit of detection for its analytical method. This finding is consistent
with scientific literature, as well as the findings of EPA's recent
assessment of wet-milling. Dry-milling renders corn into corn grits,
corn flour and masa. According to Aventis= findings using test products
made from 100% StarLink corn, the dry-milling and subsequent processing
appear to denature, but not completely eliminate, the presence of the
StarLink corn protein in the finished food products. Aventis reports
that its new data indicate lower exposure estimates than what the Agency
had estimated in its assessment last Fall.
EPA is now reviewing this
study, and will solicit scientific peer review from independent scientists
known for their expertise in this field.