FDA 'cherry picked' evidence to push cloned animal foods

A watchdog group is challenging the US government's stance on food from cloned animals, accusing regulators of downplaying evidence of health risks in order to serve industry interests. A report released on Mar. 21 by the Center for Food Safety, a research and advocacy organization that supports a federal ban on cloning livestock, says the US Food and Drug Administration (FDA) has selectively applied the research tying cloning to genetic abnormalities. With the biotech industry pushing to introduce clones to the country's food supply, the FDA is finalizing a favorable "risk assessment" for products derived from animal-cloning technology. While requesting that agricultural producers refrain for now from selling food generated through cloning, the agency declared in December that current research "has not identified any food-consumption risks or subtle hazards in healthy clones of cattle, swine or goats." But the Center for Food Safety argues the FDA's official safety claims are based on skewed interpretations of sparse or inconsistent scientific data. For instance, the FDA's review of available research relied heavily on studies that looked not at consumption of clone-derived food specifically, but rather at the physiology of cloned animals. The agency's methodology assumed a link between animals' health and the safety of the food produced from them. The Center for Food Safety also criticized the FDA's focus on data provided by the biotech firms Viagen and Cyagra, which have a financial stake in cloning for agriculture. At the same time, the FDA noted several studies showing relatively high rates of large-offspring syndrome in newborn cloned animals. The syndrome, according to the agency, typically involves excess body weight, "abnormalities of the lungs and other parts of the body, and… cardiovascular and respiratory problems." But the agency stressed that "clones that reach reproductive age appear to be normal… and appear to give rise to healthy, apparently normal progeny." The agency also said genetic "errors" related to the cloning process would not pass on to subsequent generations developed through conventional breeding. The Center for Food Safety, however, pointed to a 2003 study, not cited in the FDA assessment, by researchers at the University of Sydney in Australia, suggesting that cloned animals could in fact transfer such traits to offspring. Despite the FDA's uniformly optimistic conclusions, some of the studies it cited displayed contrasting outcomes. According to the FDA's survey of research on cloned cows since the mid-1990s, survival rates past birth ranged from zero to 100 percent. Research submitted to the FDA by Cyagra showed that of 134 cloned animals in its study, at the time the data was collected in 2003, only half were still alive. Causes of death among the clones included developmental defects, circulatory problems, and euthanasia due to "failure to thrive." Similarly, in examining the nutritional composition of clone-derived meat and milk–based on Viagen and Cyagra's own datasets alongside other published and unpublished research–the FDA discerned no "significant differences" between cloned and non-cloned animal products. But the Center for Food Safety's analysis of the studies found that the studies did cite various discrepancies between the cloned and non-cloned animals in fat and protein composition. "From the very start, the FDA narrowed the terms of their risk assessment," said Charles Margulis, author of the Center's report. The Center blasted the risk assessment for not even broaching some of the deeper issues surrounding cloning: animal welfare and ethics, for example, or how overall biodiversity and the environment could be impacted by large-scale genetic manipulation of animal populations. The agency's "cherry picking of the data," Margulis argued, is framed around conclusions that support the interest of biotechnology firms, which stand to gain from the commercialization of cloned and genetically altered livestock, bred to produce food with more profitable qualities. The FDA, which refused to comment on the Center's report, will close the public-comment period for its risk assessment on Apr. 2. In the meantime, the agency is calling for a non-binding moratorium on marketing food developed from clones. Yet it has rejected calls for consumer-labeling for such products, arguing that they are essentially identical to their non-clone counterparts.