2004D-0369 - Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use;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 : EC476
Submitter : Mr. Steven Wiener Date & Time: 01/25/2005 04:01:44
Organization : Law Offices of Steven D. Wiener
Food Industry
Category :
Issue Areas/Comments
Please stop the contamination of our food supply with genetically engineered seeds and pollenization.

I am writing to express my disappointment at the FDA's draft
"Guidance for Industry: Recommendations for the Early Food
Safety Evaluation of New Non-Pesticidal Proteins Produced by New
Plant Varieties Intended for Food Use."

Voluntary efforts are useless with our agribusiness companies; and

The proposed "safety evaluation" is totally inadequate. First,
it applies only to experimental GE crop varieties that generate
non-pesticidal proteins, by definition excluding the growing
number of trials involving metabolic manipulations rather than
novel proteins. Second, it excludes standard toxicological
testing procedures such as animal feedings trials, and proposes
absolutely no assay to detect unintended effects of the genetic
engineering process. Third, experts agree that the digestive
stability and amino acid homology tests proposed in the guidance
cannot exclude a novel protein's toxicity or allergenicity,
particularly since test conditions are not specified, giving
applicants ample leeway to devise tests to get the results they