From: David Krag, M.D. [dkrag@salus.med.uvm.edu]
Sent: Monday, March 26, 2001 11:04 AM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598

Dear FDA,
Regarding Docket 00N-1396 & Docket 00D-1598:

I am a physician scientist that conducts human and in vitro experiments
with recombinant DNA. I am well aware of the potential problems that can
occur with rearrangement of DNA. It is incredibly clear that we know very
little about the translation products of DNA. We know even less about the
interactions of these products with other biological substances. 
The products of genetically engineered cannot be recalled. With this fact
in mind, even a minor detrimental outcome becomes not only permanent but
widespread.
Although the general public was introduced to the concept of genetically
engineered foods as a method to solve worldwide starvation by introducing
critical amino acids to corn or other grain products to make complete
protein, this is clearly not the only goal of industry.
Upon us now is a worldwide crisis of ineffective antibiotics due to
emergence of resistant strains of microorganisms. They have emerged due to
a selection process of overuse of antibiotics.
The crisis of ineffective antibiotics due to prior and current overuse of
antibiotics is relevant to genetically engineered plants. Strains of plants
genetically engineered to be tolerant to or overly sensitive to synthetic
or biologically endogenous chemicals may allow that strain to overgrow all
other species. The imbalance of this factor cannot be predicted.
The imperative to push through policies which may put at permanent risk
living plants, insects, and animals is difficult to justify.
I am requesting that all such foods be subjected to rigorous and fully
disclosed review prior to approval.
Thank you very much




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David Krag, M.D.
SD Ireland Professor of Surgical Oncology
University of Vermont
Given Bldg Rm E309
Burlington, Vermont
05405