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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Releases Animal Cloning Draft Risk Assessment; Finds Food as Safe as Conventionally Produced Foods

FDA Veterinarian Newsletter 2006 Volume XXI, No V

On December 28, 2006, the Food and Drug Administration (FDA) released a draft risk assessment that concluded meat and milk derived from adult cattle, pig, and goat clones or their progeny are as safe to eat as food already available.

During a 90-day comment period concluding April 2, 2007, FDA is encouraging comments from the public regarding the science of the cloning process. Until it has reviewed all comments, FDA is continuing to ask producers and breeders to voluntarily refrain from introducing food products from animal clones or their progeny into commerce, according to Dr. Stephen Sundlof, Director of FDA’s Center for Veterinary Medicine (CVM). CVM initiated the voluntary moratorium in 2001, when the livestock industry started to investigate the use of a type of cloning that appeared to have commercial -applicability.

FDA’s conclusion about the safety of meat and milk from animal clones and progeny came after FDA scientists reviewed many studies that compared food from adult cattle, pig, and goat clones and their progeny to food from conventionally bred animals, and found no differences in safety. FDA did not make a recommendation regarding the safety of food from sheep clones, due to the limited information currently available.

Dr. Sundlof noted that, even without the voluntary moratorium, the overwhelming majority of meat and milk in the food supply would still come from conventional means, rather than through cloning. The value of these relatively expensive animal clones will be in their genetics, not in the food they produce. Instead, animal clones will be bred by conventional means to produce animals for food. Some animal clones may be used for milk production if the moratorium is lifted. (See the related article in this issue, “A Primer on Cloning and its use in Livestock -Operations.”)

In addition to food safety, the draft risk assessment also addressed the health of the animals involved in cloning. Scientists consider animal cloning to be an “assisted reproductive technology,” like others that are widely used today, such as artificial insemination, embryo transfer, and in vitro fertilization. Like these other technologies, and even natural breeding done through mating, cloning can carry risks to the animals involved. No new risks were noted as a result of cloning, however.

The draft risk assessment is approximately 800 pages long and contains data FDA scientists reviewed in reaching their conclusions about food safety and animal health with regard to cloning. Scientists outside FDA examined the draft risk assessment in a peer-review process before the document was publicly released.
FDA’s findings echo the National Academy of Sciences’ conclusions on animal biotechnology, published in 2002. FDA has reviewed extensive studies and data that have become available since the NAS review and reached similar conclusions.

Risk management plan and draft guidance for industry

FDA released a proposed risk management plan with the draft risk assessment. The proposed risk management plan outlines measures FDA might take to address any risks, such as working with scientific and professional socie-ties that have expertise in animal health and reproduction to develop standards of care for animals involved in the cloning process. FDA also proposed utilizing international scientific organizations to develop a database of information about the health of animal clones and their offspring, as well as the composition of meat and milk derived from the animals.

FDA also released a draft Guidance for Industry that contains FDA’s -recommendations on the use of clones and their progeny for human and animal food.

Although FDA is a science-based Agency and has no authority to address ethical issues with regard to animal cloning, it has offered to provide scientific expertise to interested parties working on ethics issues.

FDA is seeking comments from the public for 90 days following the release of the documents. To submit electronic comments, visit http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received by April 2, 2007, and should include the docket number 2003N-0573.