2004D-0369 - Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC312
  



  

  

  



  

  
Submitter : 
  

  
Mrs. Theresa  fitzpatrick
  

  
Date & Time: 
  

  
02/06/2005 03:02:45
  



  

  
Organization : 
  

  
friends of the earth
  



  

  
Food Industry
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 RE: Docket No. 2004D-0369' 



Dear Commissioner Crawford,



I am writing to express my disappointment at the FDA's draft

'Guidance for Industry: Recommendations for the Early Food

Safety Evaluation of New Non-Pesticidal Proteins Produced by New

Plant Varieties Intended for Food Use.' 



The ostensible purpose of this guidance document is to set up a

voluntary mechanism for evaluating the potential health risks

from contamination of the food supply with material from

genetically engineered (GE) plants being field tested

out-of-doors. In fact, the guidance will reduce, not increase,

the safety of our food, for the following reasons.



The proposed 'safety evaluation' is totally inadequate. First,

it applies only to experimental GE crop varieties that generate

non-pesticidal proteins, by definition excluding the growing

number of trials involving metabolic manipulations rather than

novel proteins. Secondly, by negating the existing de facto zero

tolerance standard for experimental transgenic proteins in the

food supply, GE crop field trial operators will have less

incentive to strictly adhere to gene confinement protocols,

resulting in more, not less, contamination.



The true purpose of this initiative has nothing to do with food

safety. As stated by FDA Commissioner Lester Crawford in a

recent speech, the goals are to 'enhance public confidence' and

'avoid product recalls' when such contamination occurs. This is

also why the Biotechnology Industry Organization regards the


  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 initiative as 'enormously important'.



I urge you to reject this misconceived policy. The FDA should be

devising rules and procedures to STOP contamination of the food

supply with experimental transgenic proteins, not give rubber

stamp approval to such contamination when it occurs. 



Finally, I urge the FDA to replace its current non-rigorous

'voluntary consultation' process with a mandatory, science-based

review process designed to ensure food safety rather than, as at

present, 'enhance public confidence' in inadequately tested and

potentially hazardous GE foods.



Sincerely,

Terri Fitzpatrick