WASHINGTON - The U.S. Food and Drug Administration (FDA) is expected later this week to release a preliminary safety assessment that clears the way for marketing of meat and dairy products from cloned animals for human consumption. The assessment and the agency's expected endorsement of cloned food comes despite widespread concern among scientists and food safety advocates over the safety of such products. The move to market cloned milk and meat also flies in the face of dairy and food industry concern and recent consumer opinion polls showing that most Americans do not want these experimental foods.

"Instead of doing its job, the Bush FDA has ignored the science and fast-tracked this decision for the benefit of a few cloning companies,"said Joseph Mendelson, Legal Director for the Center for Food Safety (CFS). "This is a lose-lose situation for consumers and the dairy industry."

The FDA action follows the recent news that the agency has refused to investigate health problems in animal clones on a U.S. dairy farm. Greg Wiles, whose Williamsport Maryland "Futuraland 2020"dairy was the first farm in the nation to have cloned cows, told FDA that one of his two cow clones was suffering from unexplained health problems. Wiles told Food Chemical News that the clone "just stopped growing...she just looks terrible," but says that when he reported the problems to FDA and other federal officials, he was "paddled around like a tennis ball from agency to agency."CFS has asked the Agriculture Department to intervene in the case to stop any sale and prohibit the slaughter of clones and their progeny for food.

In October, CFS, joined by a coalition of consumer, environmental and animal welfare organizations, filed a legal petition with the FDA seeking a moratorium on foods produced from cloned animals and establishment of mandatory rules for pre-market food safety and environmental review of cloned foods (see the petition HERE). The petition also requested that the Department of Health and Human Services establish a federal review committee to advise FDA on the ethical issues raised by animal cloning.

Recent opinion polls also show that Americans are overwhelmingly concerned about animal cloning for food production. A November 2006 food industry poll conducted by the International Food Information Council showed that 58% of Americans surveyed would be unlikely to buy meat or milk from animal clones even if FDA found such products to be safe. In the same poll, only 16% of Americans had a favorable opinion of animal cloning. A December 2006 poll by the Pew Initiative found that 64% of those polled were uncomfortable with animal cloning, with 43% saying that cloned food is unsafe, while another 36% felt unsure about cloned food safety.

The FDA's action also follows growing opposition to the use of clones and their progeny for food products on Capitol Hill. In November, Senator Barbara Mikulski sent a letter to the FDA requesting a complete overview of how the agency came to its decision of using clones in food.  In early December, a bi-partisan group of seven senators led by Senator Patrick Leahy asked FDA to reconsider its assessment of cloned animals.   The International Dairy Foods Association, representing major dairies and food makers including Kraft, Nestle and others, also has opposed allowing products from cloned animals into the food supply at this time.

Cloning scientists have acknowledged that genetic abnormalities are common in clones, yet FDA failed to address how food safety and animal welfare concerns could be managed if cloning is widely adopted by the livestock industry. Some of the health and safety problems in animal cloning include:

    * Surrogate mothers are treated with high doses of hormones; clones are often born with severely compromised immune systems and frequently receive massive doses of antibiotics. This opens an avenue for large amounts of veterinary pharmaceuticals to enter the human food supply;
    * Imbalances in clones' hormone, protein, and/or fat levels could compromise the quality and safety of meat and milk;
    * The National Academy of Sciences warned that commercialization of cloned livestock for food production could increase the incidence of food-borne illnesses, such as E. coli infections;
    * Cloning commonly results in high failure rates and defects such as intestinal blockages; diabetes; shortened tendons; deformed feet; weakened immune systems; dysfunctional hearts, brains, livers, and kidneys; respiratory distress; and circulatory problems.

"There is widespread concern among Americans, and scientific concern that cloned food may not be safe and that cloning will increase animal cruelty,"said Mendelson. "We intend to pursue our legal action to compel FDA to address the many unanswered questions around cloned food."

Notes:
Center for Food Safety's Legal Petition and background documents are available HERE

Letter from Senator Patrick Leahy, et al  to Dept of Health and Human Services at
http://leahy.senate.gov/press/200612/Leahy%20Letter%20to%20Sec.%20Leavitt.pdf

The International Food Information Council poll report and results are at http://ific.org/research/upload/2006%20Biotech%20Consumer%20Research%20Report.pdf

The Pew Initiative on Food and Biotechnology poll and results are at http://pewagbiotech.org/research/2006update/