From: christine wilson [chris1@inteliport.com]
Sent: Thursday, March 29, 2001 12:04 PM
To: fdadockets@oc.fda.gov
Subject: Re: Docket OON-1396 and Docket OOD-1598

Dear FDA personnel,                                                                                         March 29, 2001
 
                               As a consumer, I am alarmed to learn that the FDA's proposed new rules concerning genetically engineered (GE) foods fail to require mandatory pre-market safety and environmental review, mandatory labeling, and public access to sufficient information for independent review.  I am dismayed also that these new proposed rules would restrict voluntary labeling of non-GE foods and require nothing but a letter of notification prior to the marketing of a GE food.
     I believe it is critical, to ensure the health and safety of consumers, that the FDA:
(1) require mandatory pre-market comprehensive review of all GE products, both foods and pharmaceuticals.  The unique and potentially hazardous new substances that may end up in GE products, such as a certain protein in the engineered Starlink corn, are a cause for serious concern, as the long-term consequences of their consumption are unknown.  Again, the potential ecological impact of GE crops and organisms released into the environment cannot, I feel, be established with any degree of probability without rigorous and comprehensive testing beforehand.  Moreover, unlike other toxic or potentially toxic substances, genetic pollution can be self-replicating (through the reproduction of the GMOs), can contaminate wild gene pools, and can therefore be difficult, if not impossible, to recall or contain once released. 
(2) require mandatory labeling of GE products.  Without such disclosure, both consumers and health professionals would be at a loss to determine whether any allergic or toxic reactions were the result of a GE product.  Thus consumers would be denied knowledge critical to their holding food producers liable should any of their genetically modified products prove hazardous.  Again, it also seems reasonable that consumers be able to be informed as to exactly what they are buying with their money.
     It is my sincere hope and expectation that, as the agency responsible for overseeing the safety of foods and pharmaceuticals, that the FDA will put the well-being of consumers first, and not simply bow to the interests of the biotech industry.
                                                                                                                  Thankyou,
                                                             
                                                                                                                   Paul Quandt 
                                                                                                                   1307-F Eastway Dr. 
                                                                                                                    Elizabeth City, NC  
                                                                                                                    27909