2004D-0369 - Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use; Availability
FDA Comment Number : EC468
Submitter : Mr. Christian Crowley Date & Time: 02/08/2005 05:02:46
Organization : The George Washington University Economics Dep't
Category :
Issue Areas/Comments
Dear Sir or Madam,

I am concerned about the new draft guidelines to
deal with the growing problem of genetically engineered plants
contaminating food crops. The guidelines may allow contamination of the American food supply with experimental genetically(GE) material that escapes
from GE crop test plots. The proposed policy sets out loose safety assessment
guidelines under which companies may voluntarily consult with
the FDA to have their experimental biotech traits deemed
"acceptable" as contaminants in food.

The proposed "safety assessment" is based on paperwork and two
inadequate tests that FDA estimates will take companies just 20
hours to complete. The review would NOT involve safety tests in
animals, and it excludes testing for unintended effects caused
by genetic engineering. It also sets NO LIMITS on the amount of
contamination allowed in foods. While presented as a food safety
measure, both FDA Commissioner Lester Crawford and Michael
Phillips, vice president of the Biotechnology Industry
Organization, have acknowledged that these new rules would
provide legal cover to companies whose novel crops contaminate
the food supply.

Many of the genes spliced into these experimental GE crops are
hidden from the public as trade secrets. Experiments we know of
include crops engineered to survive dousing with chemical
herbicides or produce their own insecticides. Others have
sterile pollen or seeds, radically altered nutritional content
for use as animal feed, or anti-fungal compounds that resemble
food allergens.

Let us redirect our attention to finding ways to reduce and prevent contamination of the food supply, including contamination with engineered traits.

Thank you for your attention,
Christian Crowley
Department of Economics
The George Washington University
Washington, D.C.