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SCNT clones has been adequately studies; at present there are no studies that directly address this question.

In addition, as the National Research Council pointed out, the “stress from these developmental problems might result in shedding of pathogens in fecal material, resulting in a higher load of undesirable microbes on the carcass, [so that] the food safety of products, such as veal, from young somatic cell cloned animals, might indirectly present a food safety concern” (NRC, 2002: 65). Thus, the stressed SCNT clones could be carrying or shedding dangerous pathogens such as E. coli 0157:H7, Campylobacter, or Salmonella which can all cause serious food safety problems.

Overall, FDA fails, in this Risk Assessment to assess the risk resulting form clones being more sickly and requiring drugs to stay alive. FDA risk assessment must assess whether cloned animals may be more likely to carry or shed pathogens such as E. coli 0157:H7, Campylobacter, or Salmonella which can all cause serious food safety problems. It must also assess the issue of increased antibiotic and other drug use, whether this will result in more risks of drug residues in milk and meat, and whether this will exacerbate the problem of antibiotic resistance.

FDA Fails to Conclude that SCNT is Unsafe for Animals

FDA requires new animal drugs to be proven safe for human, and the environment before they are allowed in the environment. Although cloning is a new reproductive technique rather than a new drug, we think FDA should hold it to the same standard.

FDA fails to draw conclusions as to whether cloning is safe for animals. The data cited show that it is not—it results in high rates of sickness, deformities and death. The Risk Assessment should be revised to assess the safety of cloning to animals.

For cattle, most clones die before they’re born and a lot are born dead (stillborn) or have to be euthanized for deformities and other abnormalities. The Cyagra data set contains information on 134 clones. Some 18.6% of these clones (25 of 134) were born dead or euthanized that day. Eleven of the 25 clones that died the day they were born were stillborn; the others were euthanized for various problems such as “abnormal development,” “severe contracture,” and “abnormal deliver.”

For survival to 6 months of age, FDA identified 25 studies, including the Cyagra data set and 6 that involved transgenic and SCNT animals (Table V-1, FDA 2006). Pooling the data from all 25 studies yield data on 718 live born clones. Of the 718 live born cow clones, some 488, or 68% are still live after 6 months. If we only include data on SCNT clones and not include animals that are transgenic as well, the survival rate to 6 months decreases slightly to 66.1% (353 of 534). Thus, approximately one-third of all the SCNT cow clones die between birth and 6 months of age. Data from USDA’s own National Animal Health Monitoring Service (NAHMS) show that only 3% of beef cattle

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