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3-Food: Aventis published additional saftey data on StarLink corn



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TITLE:  A) Summary of new StarLink(TM) evaluation
        B) U.S. accounts for most of biotech corn
SOURCE: A) Aventis USA, http://www.us.cropscience.aventis.com/AventisUS/
           CropScience/stage/html/starlinkcorn.htm
        B) Associated Press/Washington Post, USA
           http://washingtonpost.com/wp-dyn/articles/A24479-2000Oct27.html
DATE:   A) October 24, 2000
        B) October 27, 2000

------------------ archive: http://www.gene.ch/genet.html ------------------


A) Summary of New StarLinkTM Evaluation

[check Aventis‘ web page to download the report, for more information go to 
http://www.exnet.iastate.edu/Pages/grain/homepage.html]

On October 25, 2000, Aventis CropScience submitted an addendum to its 
original food tolerance exemption petition for StarLinkTM corn. The 
addendum supports the establishment of a time-limited tolerance exemption 
for the Cry9C protein in food.A time-limited approach is requested and is 
believed to be appropriate since StarLink corn was grown in the 1998 
(10,000 acres), 1999 (250,000 acres) and 2000 (350,000 acres) crop seasons 
and the registration has been voluntarily withdrawn as a mechanism of 
limiting StarLink corn sales beyond this period.

The submission includes two key pieces of new data.New information shows 
that Cry9C protein digests under the same conditions and time frames as 
other food stuffs. In addition, a new study is presented indicating that 
Cry9C protein shows no potential to adversely impact individuals who 
currently suffer from food allergy.

The submission also includes a new safety assessment prepared by Novigen 
Sciences, Inc. on behalf of Aventis.This focuses on the Cry9C protein 
since, according to previous findings of the EPA, Cry9C DNA does not 
require a risk assessment or pose a health risk to humans as it has been 
determined to be "Generally Recognized As Safe”. While the presence of 
Cry9C protein has not been documented in foods to date, the Novigen work 
presents a worst case risk assessment based upon very conservative 
estimates of potential exposure to StarLink corn in food products. In 
addition, for the purposes of comparison the assessment utilizes peanut, as 
one of the most potent known allergens, in estimating exposure levels which 
might sensitize individuals and lead to a later allergic reaction. The 
assessment focuses particularly on subgroups of the population who might be 
considered to be at highest risk (e.g., children and those whose dietary 
patterns may result in high levels of yellow corn consumption).Despite the 
use of extremely conservative estimates, the safety assessment concludes 
that a margin of safety of over 100,000 times exists.

Taken together, this information collectively provides overwhelming support 
for the establishment of a time-limited exemption from the requirement of a 
tolerance for Cry9C protein and the DNA required for its expression in 
StarLink corn.This request is based on a "reasonable certainty of no harm” 
standard as defined by the Food Quality Protection Act.

                               *****


B) U.S. Accounts For Most of Biotech Corn

The government says it has traced all but 1.2 million bushels of the 
unapproved biotech corn that was grown this year and that only a fraction 
of the grain is likely to get into the food supply. The unaccounted-for 
grain represents 1.5 percent of the 80 million bushels of StarLink corn 
grown this year. The Agriculture Department has been trying to track down 
the grain since late September, when StarLink from last year's harvest was 
discovered in major brands of taco shells. The corn, which is genetically 
engineered to be toxic to insect pests, was never approved for human 
consumption. Around 88 percent of this year's StarLink crop remains on the 
farm, where USDA is requiring that it be fed to livestock or sealed in bins 
until it is ready for shipment. The remaining 12 percent, or 9.6 million 
bushels, left the farms before USDA could take control of it, said Keith 
Pitts, a senior USDA official overseeing the department's StarLink 
operation. The crop was never approved for export, and officials say they 
are trying to prevent it from being shipped. However, USDA yesterday lifted 
the export restrictions for shipments that may have been inadvertently 
mixed with trace amounts of StarLink. The corn must be used only for 
nonfood purposes, the department said.



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