Healthnotes Newswire (February 15, 2007)—The US Food and Drug Administration (FDA) has announced that meat and milk from clones of adult cattle, pigs, and goats, and their offspring, are as safe to eat as food from conventionally bred animals. When the agency formally approves food from cloned animals, which is expected later this year, it will require no special labeling. Consumer advocacy groups have expressed concern regarding the ethics of animal cloning, the accuracy of the FDA’s safety findings, and the public’s right to know the source of its food products.

“Based on FDA’s analysis of hundreds of peer-reviewed publications and other studies on the health and food composition of clones and their offspring, the draft risk assessment has determined that meat and milk from clones and their offspring are as safe as food we eat every day,” said Stephen F. Sundlof, DVM, PhD, director of FDA’s Center for Veterinary Medicine. “Cloning poses no unique risks to animal health when compared to other assisted reproductive technologies currently in use in US agriculture.”

An animal clone is a genetic copy of a donor animal, similar to identical twins but born at different times. No long-term safety studies of food from cloned animals have been done. The FDA’s position—that food products derived from the progeny of clones pose no additional risks—is based on general assumptions about biology, preliminary experimental evidence, and some practical observations.

But many food experts and advocacy groups disagree with this assessment. The Center for Food Safety (CFS), a nonprofit public interest and environmental advocacy membership organization, points out that animal cloning is a new technology with potential food safety risks. “Defects in clones are common,” said Andrew Kimbrell, executive director of CFS. “Cloning scientists have warned that even small imbalances in clones could lead to hidden food safety problems in clones’ milk or meat.”

Those hidden problems could include higher levels of hormones and antibiotics that are often used with cloned animals, resulting in higher levels in the food products, and greater risk of food-borne infections due to the compromised immune systems of cloned offspring.

Despite its draft safety assessment, the agency is requesting producers and breeders wait to introduce food from clones into the food supply.

While questions regarding the long-term safety of food from cloned animals cannot soon be resolved, the issue of disclosure to consumers may already be settled. Although meat and milk from cloned animals are not slated to get special warning labels in the conventional meat industry, consumers won’t be left completely in the dark. The National Organic Program (NOP), a branch of the United States Department of Agriculture (USDA), oversees standards for organic agricultural products in the United States. On January 31, 2007, the NOP issued a statement saying that cloning as a production method is incompatible with the Organic Foods Production Act and is prohibited under NOP regulations. In other words, consumers can avoid products from cloned animals by choosing only certified organic meat and milk.

At the end of 2006, the FDA issued three documents on the safety of animal cloning: a draft risk assessment, a proposed risk management plan, and a draft guidance for industry. FDA is seeking comments from the public on the three documents until April 2, 2007. To submit electronic comments on the three documents, visit their Web site (http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.html?AGENCY=FDA).

Comments may also be addressed in writing to Division of Docket Management HFA-305, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. Include FDA docket number 2003N-0573.

(United States Food and Drug Administration. Center for Veterinary Medicine. A Risk-Based Approach to Evaluate Animal Clones and Their Progeny–DRAFT. http://www.fda.gov/cvm/CloneRiskAssessment.htm [Accessed 2/3/07])

(Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology, Committee on Agricultural Biotechnology, Health, and the Environment, National Research Council. Animal Biotechnology: Science Based Concerns. National Academies Press, 2002.)