FDA's cloned food risk assessment flawed, claims review

By Lorraine Heller

- Last updated on GMT

The US Food and Drug Administration's (FDA) risk assessment on meat
and milk from cloned animals is based on "flawed assumptions
and misrepresented findings", according to an independent
review released yesterday.

The new report, issued by the Center for Food Safety (CFS), claims that FDA found virtually no scientific evidence to support the commercial release of these experimental foods. According to the report, FDA found no peer-reviewed studies on meat from cloned cows or on milk or meat from the offspring of cow clones. The group also said the agency found just three peer-reviewed studies on milk from cloned cows, adding that all three studies showed differences in milk from clones that should have prompted further research. In addition, it noted that there were no peer-reviewed studies on meat from cloned pigs and goats or their offspring. "FDA's flawed approach falls far short of providing the kind of rigorous scientific assessment that Americans deserve before these experimental animals are allowed into the food supply,"​ said Andrew Kimbrell, executive director of CFS. The group added that "despite FDA's claim that there is 'no difference' between food from clones and their progeny and food from naturally-bred animals, most of the studies they reviewed found troubling abnormalities and defects in animal clones which could pose food safety risks". ​The report was released during a public comment period on FDA's planned approval of food from cloned animals. ​A CFS spokesperson told FoodNavigator-USA.com that "the 3,900 comments received thus far by FDA is a huge undercount, this only represents comments they have posted online. But, for example, CFS has emailed about 9,000 comments forwarded from our supporters, and I know that about a half dozen other groups are collecting comments as well."​ The non-profit public interest group has already called for the regulatory agency to extend its public comment period on its draft risk assessment of animal cloning, which is due to close on April 2 2007. Together with a number of other organizations, CFS said a 90-day extension to the comment period is necessary to allow enough time for an in-depth review and analysis of the extensive information. The draft risk assessment alone, it said, is 678 pages long, most of which includes complicated science-based methodology and reasoning. "As FDA is not facing any statutory requirement to proceed within a specific timetable, we respectfully request that FDA extend the comment period - commensurate with the scope and complexity of the documents being commented on and the time it took FDA to prepare them - to allow adequate time to analyze the information necessary to prepare a thorough response to the request for comments and to participate fully in the rulemaking process,"​ wrote a letter to the Commissioner of the FDA earlier this month. The letter, which said it is "in the public interest of the agency to take the time needed to 'get it right'",​ was sent by groups including the American Bakers Association, the American Frozen Food Institute, the Food Marketing Institute, GMA/FPA, the International Dairy Foods Association, the National Milk Producers Federation, the National Restaurant Association and the Snack Food Association. The concerns of these groups are part of a general backlash in response to FDA's controversial decision to approve cloning for food production, announced earlier this year. Because the introduction of cloned food into the US food supply is such groundbreaking action, the industry has added its voice to the usual and expected clamor from public health groups. A number of food firms have publicly made a stance against cloned products, including leading US dairy Dean Foods. Additionally, in a January 23 letter to its coop members, California's largest dairy processor, California Dairies, stated that it "will not accept milk from cloned cows, effective immediately."​ Another California dairy, Clover Stornetta announced its ban on milk from clones early in January. According to a statement published by Dean Foods, its decision to reject cloned products is based on the desire and expectations of its customers. "We see no consumer benefit from this technology,"​ said the firm. "If the FDA does approve the sale ofmilkfrom cloned cows, we will work with our dairy farmers to implement protocols to ensure that the milk they supply Dean Foods does not comes from cloned cows," it added. To view the full CFS report,Not Ready for Prime Time: FDA's Flawed Approach to Assessing the Safety of Food from Animal Clones,​ click here​.

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