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Given the paucity of data that directly address the safety of meat and milk from cloned animals, the FDA used indirect measures of food safety, primarily data on the health of the clones at different life stages. The operating hypothesis is the notion that an animal that appears healthy must be safe to eat (e.g. the Critical Biological Systems Approach). This approach is not scientific—this is reasoning by inference, not from data. Furthermore, FDA has bent over backward to interpret data from cloning companies in a way that minimizes the potential problems raised by SCNTs. Both of these problems need to be remedied in the final Risk Assessment.

We also strongly disagree with the notion FDA put forward in media materials and elsewhere that clones are simply “identical twins” born at different times and that clones (e.g. somatic cell nuclear transplants, SCNTs) show no “unique hazards” compared with other artificial reproductive technologies (ARTs). Scientifically speaking, SCNT clones are not “identical twins” and the problem of aberrant nuclear-mitochondrial interaction (due in part to the presence of mitochondria from two parents) is a “unique hazard” for SCNTs compared to other ARTs.

We believe that FDA should require safety testing of the products of cloned animals before they are placed on the market. In addition, we believe that FDA should require labeling of the meat and milk from cloned animals.

Food Safety Assessment: Insufficient Data

The data presented in the new FDA Draft Animal Cloning Risk Assessment are too scanty and are not of sufficient quality to draw valid conclusions about the safety of meat and milk from cloned animals and their offspring. FDA’s Risk Assessment should assure that milk and meat is not only safe, but as nutritious as conventional.

The compositional data on milk and meat from clones and non-clone comparators on which FDA bases its conclusions ranges from poor to non-existent. In the case of cows, the FDA was able to find only seven published studies on milk parameters that collectively involved only 43 cow clones—27 Holstein, 9 Freisen, 1 Brown Swiss, 4 Jersey, and 2 HolsteinXJersey. For meat, there are only two peer-reviewed studies that collectively involved only 5 cloned Japanese Black Beef cattle. FDA also reviewed meat composition data for 11 cows supplied it by Cyagra, a company that produces cloned cattle. There are no compositional studies on milk and meat from offspring of cloned cattle.

In the case of pigs, there are no peer-reviewed data comparing meat composition of clones and non-clone comparators, nor of offspring of clones and offspring of non- clones. FDA relies on data submitted by a company, Viagen, that compares the meat composition of 5 clones as well as meat composition data from 242 offspring of clones. The meat composition data of offspring of clones and non-clones was published in the scientific literature after the FDA released their Draft Animal Cloning Risk Assessment

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