2004D-0369 - Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use;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 : EC384
Submitter : Ms. Kathleen Hill Date & Time: 02/06/2005 04:02:23
Organization : DS-n-SP-CAF(TM)
International Public Citizen
Category :
Issue Areas/Comments
RE: Docket No. 2004D-0369
Dear Commissioner Crawford,

I am writing to express my concern at the misguided 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."

The ostensible purpose of this guidance document is to set up a voluntary mechanism for evaluating the potential health risks from contamination of the food supply with material from genetically engineered (GE) plants being field tested out-of-doors. In fact, the guidance will reduce, not increase, the safety of our food, for the following reasons:

1) The proposed "safety evaluation" is totally inadequate.
a) 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.
b) 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.
c) 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 desire.

2) The FDA presumes that any contamination that occurs will be at low levels, lessening concern. Yet "low level" is never defined. Permissible contaminant levels are in principle unlimited. Two considerations suggest that contamination may often be higher than anticipated.
a) in some cases the transgenes responsible for novel proteins can cross over to related weed species or compatible cultivars, which can act as a genetic
reservoir for the persistence and amplification of the transgene, which could be transferred back to food cultivars in the future.
b) by negating the existing de facto zero tolerance standard for experimental transgenic proteins in the food supply, GE crop field trial operators will have less incentive to strictly adhere to gene confinement protocols, resulting in more, not less, contamination.

In Summary: Clearly, the true purpose of this initiative has nothing to do with food safety. As stated by FDA Commissioner Lester Crawford in a recent speech, the goals are to "enhance public confidence" and "avoid product recalls" when such contamination occurs. This is also why the Biotechnology Industry Organization regards the initiative as "enormously important".

I urge you to reject this misconceived policy. The FDA should be devising rules and procedures to STOP contamination of the food supply with experimental transgenic proteins, not give rubber stamp approval to such contamination when it occurs.

Finally, I urge the FDA to replace its current non-rigorous "voluntary consultation" process with a mandatory, science-based review process designed to ensure food safety rather than, as at present, "enhance public confidence" in inadequately tested and potentially hazardous GE foods.