From: myra perala [myra@aracnet.com]
Sent: Tuesday, April 03, 2001 10:23 PM
To: fdadockets@oc.fda.gov
Subject: Docket 00N-1396 & Docket 00D-1598
 Docket 00N-1396 & Docket 00D-1598 
 Dockets Management Branch (HFA-305) 
 Food and Drug Administration 
 5630 Fishers Lane, Room 1061 
 Rockville, MD 20852

 Food and Drug Administration:

Despite overwhelming consumer demand, the FDA has failed to require health and ecological safety testing or mandatory labeling, and thus puts my health (and ALL AMERICAN’S) AS WELL AS our environment at risk and deprives us of the right to know or choose what we are eating.

The proposed rules:

Do not require mandatory pre-market safety testing
Do not require pre-market environmental review
Do not require mandatory labeling of GE foods
Restrict voluntary labeling of non-GE foods
Require a mere letter of notification prior to the  marketing of a GE food 
Fail to ensure public access to adequate information for independent review
Are supported by industry and opposed by consumer groups


The FDA must 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. 

The FDA must 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. 

The FDA must 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. 

The FDA must end its cozy relationship with the industries it purports 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 FDA advisory committee meetings had at least one conflict of interest. 

DO THE RIGHT THING!!  PROTECT THE HEALTH OF AMERICANS AS YOUR CHARTER REQUIRES.

Myra Perala
2229 SE Market Street
Portland, OR 97214