The Food and Drug Administration has released a draft executive summary of a document that assesses the safety of food products derived from animal clones. The risk assessment also evaluates the risks to animals involved in the cloning process.

Among other conclusions, the FDA determined that there were no differences in overall behavior and health of juvenile and adult animal clones and conventional animals, even at the level of blood chemistry. Although there were risks to animals involved in the cloning process, the agency concluded that cloning technology does not present any type of risk that is not present with other forms of reproduction. Adverse outcomes may occur at a higher frequency with cloning, however, than with other assisted reproductive technologies now in common use, such as in vitro fertilization or embryo transfer.

The draft risk assessment, which was discussed at a meeting of the FDA-CVM's Veterinary Medicine Advisory Committee in early November, builds on the findings of a National Academy of Sciences study that determined that food products derived from animal clones and their offspring are likely to be as safe to eat as food from their nonclone counterparts, on the basis of all available data. Most of the data came from cattle, pig, and goat clones.

The FDA's draft risk assessment does not address ethical issues or make recommendations about the potential need for rules on marketing food from animal clones. These subjects will be addressed at a later date.

Until the FDA makes any final decisions on cloned animals, the agency will continue to request that producers withhold these products from the market. Thus far, the FDA believes that no animal clones have entered the food supply.

To read the executive summary, visit www.fda.gov/cvm/index/cloning/CLRAES.doc.