| 2004D-0369 - Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use;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 :||EC458|
|Submitter :||Dr. Jim Hanson||Date & Time:||02/06/2005 05:02:40|
|Organization :||Hanson Medical Systems, Inc.|
| I am very concerned and displeased that your draft will actually REDUCE, not increase, the safety of our food. The draft only applies to experimental GE crop varities that generate non-pesticidal proteins. The draft excludes standard toxicological testing procedures. Test conditions are not specified (i.e digestive stability and amino acid homology, a novel protein's toxicity or allergenicity) which allow for applicants to just create and get the results they might desire. "Low levels" of "contamination" are never defined.
It appears that this initiative has nothing to do with science and common sense, but just has to do with politics, keeping things quiet from the public, and to appease corporations and possible recalls. This is not good ethics nor good science.