From: gtlinc@teleport.com
Sent: Sunday, March 25, 2001 12:56 PM
To: fdadockets@oc.fda.gov
Subject: comments on proposed GE regulations

Docket 00N-1396 & Docket 00D-1598
   Dockets Management Branch (HFA-305)
   Food and Drug Administration
   5630 Fishers Lane, Room 1061
   Rockville, MD 20852

Dear FDA:

Due to your short deadline for responding I am unable to compile a thorough comment. I believe you will find thorough comments from various consumer protection groups that generally get the point across that you need to adjust your proposed regulations regarding GE food approval & labeling.

I know many of you want the GE foods to go forward as important progress in our agricultural industry. But the most basic scientific criteria cannot be satisfied by the pro-GE arguments.  Please take note of just these two simple concepts:

1. Pro-GE arguments proffer that the changes in DNA are only additions of the same types of amino acids that already exist in all DNA, and thus the human body will likely be able to metabolize them as completely as any other amino acids. This pro-GE argument is based on blissful ignorance of how the human body metabolizes amino acids. If the FDA thinks for one millisecond that the pro-GE amino acid argument is sound, then the FDA must not recognize that Mad Cow Disease clearly disproves the pro-GE argument. Mad Cow Disease is known to come from preons, protein fragments, amino acid fragments, or some similar substance that in its complete form was not harmful but in its fragmented form (without its own complete DNA structure) cannot be safely metabolized by cows nor humans. Just this single observation should motivate the FDA to issue a permanent ban on all GE foods and development.

2. Why does the FDA calmly accept the pro-GE presentation that the insertion of a gene is only to provide one specific function (for instance, resistance to a plant fungus). Does the FDA actually think for one millisecond that a gene carries out only one function??? The pro-GE argument does not even understand the additional functions of the genes that they want to insert, nor the effects of those functions (unregulated by now-missing companion genes) in the human physiology. I have worked with safety testing protocols in toxicology and there is no protocol that could ever safely test this effect in humans. If the FDA puts forth testing requirements for GE-foods, the test could not include the aforementioned effects on humans; and the FDA test would simply allow an unsafe GE food to be presented as safe and meeting FDA standards. 

Please please please as human beings: do not allow the money that comes from the GE manufacturers and is promised to put US agriculture ahead of the would .....please please please do not let that override your duty as a human being to protect human life on earth. Please do not issue regulations that allow GE foods into the food chain and distribution chain. And if you think that there are people who want to eat this food, then you must have very strict labeling laws to protect the educated people who would never knowingly eat such food.

Thank you for considering this comment as support for consumer group comments that address the specific wording of your proposed regulations.

Richard E. Morris, J.D.