From: Pam Round [pmround@home.com]
Sent: Thursday, March 29, 2001 2:31 AM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598 

Dear Folks at the FDA,

I am writing to beg you to PLEASE require comprehensive testing of genetically engineered products PRIOR to their release to the public.  I can hardly fathom how long it is taking you to understand how important this is.  The future safety of the citizens of this planet depends on you doing this.  And your resistance indicates that you are being unduly influenced by the lobby of special interests and not learning the lessons history has to share.  

It is also of paramount importance that consumers be informed in advance what they are purchasing or eating via clear, honest labels on all food products.

Please read the points below detailing my beliefs about the approach the FDA should take:

* Require mandatory pre-market comprehensive 
  environmental review. Unlike conventional pollutants, 
  where a given amount of pollutant causes a limited amount 
  of damage, a small number of mutant genes could have a 
  population explosion and reproduce forever, causing 
  unlimited and irreparable damage.

* Require mandatory pre-market long-term health 
  testing. GE products could be toxic, cause allergic 
  responses, have lower nutritional value, and compromise 
  immune responses in consumers.

* Require mandatory labeling of GE products. 
  Without mandatory labeling, neither consumers nor health 
  professionals will know if an allergic or toxic reaction 
  was the result of a genetically engineered food. Consumers 
  would be deprived of the critical knowledge needed to hold 
  food producers liable should any of these novel products 
  be hazardous.

* End your cozy relationship with the industries
  you purport to be regulating. People have been allowed to 
  work for a biotech company, then work for the FDA writing the 
  regulatory rules on that company's product, then go back to
  working for the company.  Ninety-two percent of your advisory 
  committee meetings had at least one conflict of interest.
 
Thank you for reconsidering your decision and choosing a future that will be safe and healthy for all.
 
Pamela M. Round
Seattle, WA
pmround@home.com