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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA’s Animal Cloning Documents Underscore Safety of Meat and Milk From Cloned Animals

by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No VI

Meat and milk from clones of adult cattle, pigs, goats, and their offspring are as safe to eat as food from conventionally bred animals, according to three documents the Food and Drug Administration released on January 15, 2008. The release of these documents - a risk assessment, a risk management plan, and a guidance for industry - constitutes FDA’s position with respect to the effect of cloning on animal and food safety, and describes the Agency’s enforcement posture.

How clones are made

An animal clone is a genetic copy of a donor animal, similar to identical twins but born at a different time. Most cloning today uses a process called somatic cell nuclear transfer (SCNT). Just as with in vitro fertilization, scientists take an immature egg from a female animal (often from ovaries obtained at the slaughterhouse). But instead of combining it with sperm, they remove the nucleus (which contains the egg’s genes). This leaves behind the other components necessary for an embryo to develop. Scientists then add the nucleus containing the desirable traits from a cell obtained from the animal the farmer wishes to copy. After a few other steps, the donor nucleus and egg fuse, start dividing, and an embryo begins to form. The embryo is then implanted in the uterus of a surrogate dam (again the same as with in vitro fertilization), which carries it to term. (“Dam” is a term that livestock breeders use to refer to the female parent of an animal). The clone is delivered just like any other baby animal.

Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence. Clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding. Because cloned animals are intended to be used for breeding, they are not expected to enter the food supply in any significant numbers. Instead, their sexually reproduced offspring will be used for producing meat and milk for the marketplace. FDA is currently recommending that food from clones of species other than the three mentioned in the risk assessment be kept out of the food and feed chain because sufficient information to make a decision on the food consumption risks is not available.

Risk assessment

The risk assessment that was released in mid-January finds that meat and milk from clones of cattle, pigs, and goats, and food from the sexually reproduced offspring of clones pose no increased food consumption risks relative to comparable products from conventionally bred animals. The risk assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health, and they agreed with the methods used by FDA to evaluate the data and the conclusions presented in the document.

Also included in the risk assessment is an overview of assisted reproductive technologies widely used in animal agriculture, the scientific information available on the health of animal clones and their sexually reproduced offspring, and an assessment of whether food from clones or their sexually reproduced offspring could pose food consumption risks that are different from the potential risks presented by food from conventionally bred animals. The conclusions drawn all agree with those contained in a 2002 report released by the National Academy of Sciences.

Risk management plan

The risk management plan addresses such topics as the risks to animal health and potential remaining uncertainties associated with food and feed from animal clones and their offspring. These risks have been observed in other assisted reproductive technologies already in use in common agricultural practices in the United States. FDA is collaborating with professional and scientific societies with expertise in animal health and reproduction to develop a set of care standards for animals involved in the cloning process.

Guidance for industry

The guidance for industry, which went into effect upon publication in the Federal Register, addresses the use of food and feed products derived from clones and their offspring. It is directed at clone producers, livestock breeders, ranchers, and farmers who purchase clones. It provides FDA’s current thinking on the use of clones and their offspring in human food or animal feed, and concludes that food products from the offspring of clones from any species traditionally used for food are suitable to enter the food and feed supply.

The Agency does not recommend any special measures in the guidance that relate to the use of products from cattle, swine, or goat clones as human food or animal feed. However, the guidance does recommend that edible products from sheep and any other clones not be introduced into the human food supply, because sufficient information was not avail-able in order to make a decision on the food consumption risks.

The guidance also notes that, because of their cost and rarity, clones will be used as any other specialized breeding stock are - to pass on naturally occurring, desirable traits such as disease resistance and higher quality meat to production herds. Almost all of the food that comes from the cloning process is expected to be from sexually reproduced descendants of clones, not the clones themselves. The U.S. Department of Agriculture supports the FDA’s conclusions regarding the safety of food from cattle, swine, and goat clones, but is encouraging the cloning industry to continue the voluntary moratorium on putting these foods into the food supply. The purpose of this moratorium is to allow for a sufficient period of time to bring stakeholders together in order to discuss efforts to provide a smooth and orderly market transition, as industry determines next steps with respect to marketing foods from clones.

The guidance also sets forth FDA’s enforcement position with respect to cloning as follows: “Assuming that any part of SCNT or animal clones, based on being derived from SCNT, meet the statutory definition of new animal drug under the Federal Food, Drug, and Cosmetic Act, at this time, FDA does not intend to regulate any such new animal drugs. This intent not to regulate (i.e., the intent to exercise enforcement discretion) applies to both non-food and food-producing species.”

Labeling

FDA is not recommending any additional measures relating to food derived from adult clones and their offspring, including labeling. Under the Agency’s current laws, the only grounds for labeling food are if there are any safety concerns or if there is a material difference in the composition of food. FDA has not identified any food safety concerns and has not found any material difference in food from clones as food from conventionally bred animals. For instance, FDA scientists found that the milk components from dairy clones were of the same type and present in the same amounts as milk sold every day. Therefore, there is no science-based reason to use labels to distinguish between milk derived from clones and that from conventional animals.

Availability of the documents

The full text of FDA’s cloning risk assessment, the risk management plan, and the guidance for industry, along with other pertinent information on cloning, are all available on FDA’s Web site.

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Additional Information

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