| 2004D-0369 - Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use;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 :||EC488|
|Submitter :||Mr. William Fry||Date & Time:||02/08/2005 05:02:37|
|Organization :||HEB Grocery Co LP|
| HEB is a privately-owned chain of over 300 stores which have been serving the people of Texas for 100 years. In keeping with our goal of offering our customers the safest possible food, HEB would like to offer the following comments about Docket 2004D-0369, 'Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal proteins Produced by Bioengineered Plants Intended for Food Use.'
1. We are concerned that compliance with the guidance is voluntary. We would prefer rules that require bioengineering companies to prove that neither toxicity nor allergenicity to humans result from the bioengineering procedure prior to them being permitted to begin field testing. We believe compulsory rules would enhance the confidence our customers have in the safety of the Nation?s food supply.
2. We object to the bioengineering of plants that are commonly used for food when the purpose of that bioengineering is to produce proteins that have no food use, i.e. proteins that have only industrial or pharmaceutical uses. The Draft Guidance appears to permit this practice. The basis of this concern is the inability of current regulations and practices to prevent cross-contamination with non-bioengineered plants of the same variety. Cross-contamination can occur through many pathways. When a food is found to contain a product of bioengineering that is not approved for food, it is food retailers, wholesales and manufacturers who must pay the price of removing that product from the market. Starlink corn is an example of the ease with which cross contamination of food can occur.
William G. Fry
Quality Assurance and Environmental Affairs