2004D-0369 - Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use;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

  
EC447
  



  

  

  



  

  
Submitter : 
  

  
Dr. Gloria Adduci
  

  
Date & Time: 
  

  
02/06/2005 05:02:57
  



  

  
Organization : 
  

  
Genetic Rights Council
  



  

  
Other Organization
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 It seems to us that the guidance document will reduce the safety of food.

The proposed 'safety evaluation' is inadequate. 

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. 

It excludes standard toxicological testing procedures such as animal feedings trials, and proposes absolutely no assay to detect unintended effects of the genetic engineering process.

It sets non limits on the amount of contamination allowed in foods. 

Indeed, the digestive stability and amino acid homology tests proposed in the guidance cannot exclude a novel protein's toxicity or allergenicity*.



*Fu, T-J., Abbott, U.R., Hatzos, C., 2002. Digestibility of food allergens and non allergenic proteins in simulated gastric fluid and simulated intestinal fluid ? a comparative study. J. Agric. Food Chem.; 50(24): 7154-60.