2004D-0369 - Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use;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 : EC201
Submitter : Miss. Kiira Mancasola Date & Time: 02/05/2005 12:02:22
Organization : Stanford University
Category :
Issue Areas/Comments

Dear Commissioner Crawford,

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."

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.

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

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. First, 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. Secondly, 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.

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.


Kiira Mancasola
Stanford Unviersity Student
Stanford, CA