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FDA further assumes “that if clones were to pose food consumption risks, the only mechanism by which those risks could arise would be from inappropriate epigenetic reprogramming . . . Progeny of animal clones, on the other hand, are not anticipated to pose food safety concerns, as natural mating resulting from the production of new gametes by the clones is expected to reset even those residual epigenetic reprogramming errors that could persist in healthy, reproducing clones” (FDA, 2006: ??). Thus, one needs to look for subtle health effects in the clones, as these effects are not expected to be passed to the next generation. FDA further argues that such “inappropriate epigenetic reprogramming” that may occur with SCNTs lead to results that are not different than what is seen with artificial reproductive technologies (ARTs), although their frequency might be higher in SCNTs.

There is a profound fallacy in FDA’s assumption that antemortem inspection will catch all these potentially sick and deformed animals. The meat inspectors already face an overwhelming task and the USDA’s Food Safety Inspection Service is moving more toward having plant employees do the inspection, while the Federal inspectors simply oversee the paperwork. Problems have already arisen with USDA inspections. For example, take enforcement of USDA’s rule mandating the removal of specified risk materials (SRMs) form cattle over 30 months of age from entering the human food chain. The consumer group Public Citizen issued a report in August, 2005 that demonstrated there were 829 documented violations, from January 2004 through March 2005, of USDA’s rules on ensuring removal of SRMs from animals over 30 months of age (Public Citizen, 2005). Given the lapses in USDA’s inspection program when it comes to potentially very serious threat of mad cow disease, it cannot be assumed that USDA inspection will effectively ensure that all animals that are sick or unwell would be effectively removed.

Unique Risks Exist and Require Assessment

As for the notion that there are no “unique risks” posed by SCNTs clones, FDA has failed to consider the that there are quantitative differences between the risks posed by SCNT clones compared to other ARTs, with the risks being far more frequent, often by ten-fold or more, in the former compared to the latter. Thus quantitative differences are important. However, there are also qualitative differences in risks posed by SCNT compared to other ARTs. A unique risk posed by SCNTs, but not by other ARTs had to due with the potential for abnormal nuclear-mitochondrial interaction, with SCNTs often having mtDNA from both parents (e.g. donor and recipient cells), while embryos produced using other ARTs only have mtDNA from one parent (e.g. the mother). Since dysfunctional mitochondria can wreak havoc on an organism and lead to many types of health problems, this important and unique risk deserves further scrutiny before any milk and meat from SCNTs are allowed on the market.

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