2003N-0573 Draft Animal Cloning Risk Assessment
FDA Comment Number : EC1031
Submitter : Mr. Gilbert Thompson Date & Time: 01/04/2007 12:01:52
Organization : Mr. Gilbert Thompson
Category : Individual Consumer
Issue Areas/Comments
Somatic Cell Nuclear Transfer (SCNT) is a technology "early" in its development. As stated in Docket 2003N-0573, based on currently available data, "there do not appear to be any anomalies . . . that would have a direct impact . . . based on the "apparent" normal status of the clinical measurements . . ." on use of edible products from animal clones or their progeny for human food or animal feed. What about data which will appear years later that may show inappropriate reprogramming of the nucleus of donor cells that could result in epigenetic changes creating subtle hazards that eventually prove food consumption risks? We have enough trouble with our current food supply from the use of hormones and antibiotics causing subtle hazards that have proven of risk. Your risk assessment, like all risk assessments, has enough qualifiers to facilitate reaching any conclusion desired based on "currently available data". As an example it is stated in Docket 2003N-0573 the goal of a comprehensive risk assessment/management process is that concerns have been minimized to levels considered "acceptable". What about all the additional issues unaddressed, i.e., potential allergenicity, microbiological effects, unanticipated effects, technology changes, how much data is enough. As a consumer I do not feel that the risks have been minimized to levels considered "acceptable". If animal cloning is approved by the FDA, which is likely inevitable, as a MINIMUM the guidance for industry must include labeling of all such food/feed products as cloned so that consumers can make informed choices in consumption of same for THEIR control of their future health risk. Without such labeling you are eliminating such choice which is our right as U.S. citizens. Individual choice is the final defense in preventive health decisions under current circumstances. It would be criminal to remove that choice in light of the brave new world of cloning.