From: Dennis [d2@ncplus.com]
Sent: Sunday, April 01, 2001 12:51 AM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598
RE:  Docket 00N-1396, Proposed Rule on Premarket Notice Concerning Bioengineered Foods

I have the following comments on the proposed rules:

1) The FDA should require that any entity proposing to commercially distribute bioengineered foods provide objective, scientifically valid pre-market heath-testing for long-term effects of those foods.   

2)  The FDA must conduct, or ensure that any entity proposing to commercially produce and distribute bioengineered foods conducts, a rigorous, objective, and comprehensive environmental review of the potential effects of producing such food.   

3)  Bioengineered foods must be clearly labelled as such on the store shelf.  This labelling must be mandatory.  Consumers must be informed about the food products they may purchase.  By not requiring this disclosure on the label of such foods you are depriving the consumer of making informed choices in the marketplace.   These choices can affect the health of the individual purchaser, their children, their environment and future generations.  

4)  The pre-market advance submission of information to the FDA of 120 days that is proposed for any bioengineered foods is far too short for adequate evaluation by the FDA.   The  final rule should require that this information be provided to the FDA at least one-year in advance of planned distribution.  The 120-days is inadequate to evaluate the potential risks to public health.  The proposed short notice will encourage FDA officials to conduct only cursory evaluations in an attempt to meet the product market deadline.  

5)  The pre-market advance submission should be an application for approval, not simply a notice that the product will be commercially produced and sold.  FDA should require approval of these products, rather than just notice.

We, the public, the taxpayers who fund the FDA, have seen the Rezulin tragedy.  We don't want FDA officials caving in to industry demands.   Your duty is to protect the American public, not provide "customer service" to big industry.   We expect and demand the highest ethical standards in your work.

Sincerely,

Diane Steeck
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