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from only 4 clones and 242 offspring of clones. For goats, FDA had data on neither milk nor meat composition of clones nor their offspring. These data—on only a few dozen animals in some categories, and no animals at all in other categories, are completely inadequate on which to base a conclusion about cloned food. The safety of millions of meat dinners and glasses of milk cannot be assessed just on the basis of 59 cloned cows and five cloned pigs.

Critical Biological Systems Approach Not Scientific

Given the paucity of data that directly address the safety of milk and meat from cloned animals (such as compositional data on meat and milk) and clone progeny compared to that of non-clone comparators and offspring of non-clone comparators, respectively, the FDA used indirect measures of food safety, primarily data on the health of the clones at different life stages.

Use of these indirect measures is justified by a highly questionable and un- scientific framework/assumption—the Critical Biological Systems Approach—which assumes healthy animals must be safe to eat. As FDA states, “the Critical Biological Systems Approach, (CBSA) is based on the hypothesis that a healthy animal is likely to produce safe food products” (FDA, 2006). The CBSA breaks down the life of the animals into 5 developmental stages—gestation and giving birth; perinatal period, juvenile development, reproductive development, post-puberty (e.g. adulthood)—and then looks at the health of the animals at each stage. The CBSA assumes that if an animal has health problems at a early developmental stage and survives to a later developmental stage, then those health problems will often resolve themselves.

This is not a valid approach to evaluating safety. In fact, many diseases, like cancer and diabetes, show up later in life rather than earlier. A particular concern would be if cloned animals looked healthy but carried bacteria that could make human sick, such as Salmonella or E. coli 0157:H7.

FDA Should Not Assume Unhealthy Animals Removed at Slaughter

A large percentage of clones (a majority in some studies) have such serious birth defects that they do not survive to adulthood. FDA assumes the deformed or sick animals that result from cloning will not enter the food supply because they will be discovered at antemortem inspection. The Risk Assessment therefore need only consider clones that “appear to be healthy” or that are exhibiting subtle health effects. Since the majority of health problems and/or birth defects have been seen in younger animals, the FDA just assumes these animals won’t make it into the human food supply because “local, state, and federal regulations . . . exclude frankly malformed, diseased, and otherwise unhealthy animals from the human food supply” (FDA, 2006). Since FDA excludes these animals from their Risk Assessment, FDA places its emphasis on identifying “subtle health effects” that could have arisen by the process of SCNT cloning.

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