The responses to the questions provided in this document represent the FDA's view in light of the conclusions and recommendations outlined in the Animal Cloning Risk Assessment, Risk Management Plan, and Guidance for Industry #179.

What is the Animal Cloning Risk Assessment?

What is the Risk Management Plan?

What is the Guidance for Industry?

What are animal clones?

Are there long-term studies on the consumption of food from clones?

If there are no long-term studies on the consumption of food from clones, why is FDA concluding that it is safe to consume these cloned animals and their offspring?

Are there any substantive differences between the conclusions in the draft and final versions of the cloning risk assessment regarding the consumption of food from clones?

If FDA thinks food from livestock clones is safe, why does FDA continue to recommend that food from sheep clones be kept out of the food supply?

How soon will meat or milk from clones be on the market?

Is meat or milk from clones safe for pets?

Is cloning the same as genetic engineering?

Why are livestock producers interested in cloning? Don't the more conventional means of producing animals work?

Is FDA considering the ethics of animal cloning?

Would food from clones be labeled?

Is animal cloning allowed in other countries? Can food products from these animals be sold for human consumption in other countries?

Additional Information

What is the Animal Cloning Risk Assessment?

It's a report written by scientists in the Food and Drug Administration's Center for Veterinary Medicine. Agency scientists analyzed data from hundreds of published reports and other detailed information about clones of livestock animals. The report provides FDA's conclusions on the risks to the health of animals involved in the cloning process, and on the safety of food from animal clones and their offspring.

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What is the Risk Management Plan?

The Risk Management Plan takes into account the risks to animals identified in the Risk Assessment, and suggests how those risks could be managed.

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What is the Guidance for Industry?

It explains FDA's recommendations for industry on the use of clones and their offspring for human food and animal feed.

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What are animal clones?

An animal clone is a genetic copy of a donor animal. Clones are similar to identical twins, just born at a different time. Cloning could be thought of as an extension of the assisted reproductive technologies that livestock breeders have been using for centuries. These include artificial insemination, and more recently, embryo transfer, embryo splitting, and in vitro fertilization.

Cloning is the newest and most complex form of assisted reproductive technology, and has been around for more than 20 years in various forms. The form used most frequently today is known as Somatic Cell Nuclear Transfer, or SCNT. With SCNT, the genes of the donor animal are inserted into an egg cell that has had its nucleus removed, and after a few steps in the lab is implanted into a surrogate dam where it develops just like any other embryo. (Dam is a term that livestock breeders use to refer to the female parent of an animal.)

You can learn more about the cloning process by going to our "Cloning Primer." You may also ask for single printed copies of these documents from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. If you make this request, please enclose a self-addressed, adhesive label. Doing so will help that office respond to your request more effectively.

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Are there long-term studies on the consumption of food from clones?

Cloning doesn't put any new substances into an animal, so there's no "new" substance to test. Feeding milk or meat from clones to lab animals as part of a regular diet wouldn't let us tell whether any negative outcomes observed were due to the food from clones or from something else the lab animals were exposed to. It isn't possible to have someone (or even lab animals) eat only meat or drink only milk. Doing so would not provide a healthful diet and would likely cause illness.

Food scientists, toxicologists, and regulators have faced this problem before and decided that long term feeding trials of whole foods don't give meaningful results.

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If there are no long term studies on the consumption of food from clones, why is FDA concluding that it is safe to consume these cloned animals and their offspring?

Cloning doesn't put any new substances into an animal, so there's no "new" substance to test. Feeding milk or meat from clones to lab animals as part of a regular diet wouldn't let us tell whether any negative outcomes observed were due to the food from clones or from something else the lab animals came across. It isn't possible to have someone (or even lab animals) eat only meat or drink only milk. Doing so would not provide a healthful diet and would likely cause illness.

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Are there any substantive differences between the conclusions in the draft and final versions of the cloning risk assessment regarding the consumption of food from clones?

Not really. As we stated in the Draft Risk Assessment, FDA has no concerns about the safety of food from cattle, swine (pig) or goat clones, or food from the progeny of a clone of a species traditionally consumed as food. Our conclusions were strengthened by the data that we evaluated since the publication of the draft. We did not, however, get more information that would allow us to make decisions regarding food from sheep clones or other species, and we do ask that producers continue to voluntarily keep food from clones of other species (e.g., sheep) out of the food supply.

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If FDA thinks food from livestock clones is safe, why does FDA continue to recommend that food from sheep clones be kept out of the food supply?

At the time of the risk assessment, the agency felt it did not have sufficient information to make a decision on food consumption risks from clones of species other than cattle, swine, and goats.

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How soon will meat or milk from clones be on the market?

It's highly unlikely that you will see meat from clones at the supermarket any time soon. We anticipate that clones would be used as elite breeding animals rather than as food themselves. Instead, the sexually reproduced offspring of animal clones would be the animals intended to produce food. Milk from cow clones may enter the food supply once clones are bred and have their calves (cows don't make milk until after they have calves). It's important to remember, however, that at this time there are only a few hundred cattle clones, most of which are not dairy cows, so again, it's highly unlikely that there will be much milk from dairy cow clones in the food supply.

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Is meat or milk from clones safe for pets?

Yes. We believe it is safe for meat or milk from clones to be used in making pet food.

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Is cloning the same as genetic engineering?

No, cloning is not the same as genetic engineering. Genetic engineering involves adding, taking away, or modifying genes, while cloning does not change the gene sequence.

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Why are livestock producers interested in cloning? Don't the more conventional means of producing animals work?

Livestock producers will continue to use the more conventional means of breeding food animals. The point of cloning is to increase the number of breeding animals with naturally occurring desirable traits. This will allow for the more rapid spread of these characteristics through the herd, such as disease resistance or higher quality meat.

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Is FDA considering the ethics of animal cloning?

FDA recognizes that animal cloning for agricultural purposes raises moral, religious, and ethical issues that are important to some members of the public. The relevant issues in this context for the agency are limited to the animal health and food safety issues. The agency is not charged with addressing moral, religious, or ethical issues related to animal cloning for agricultural purposes. We are also aware that these ethical concerns can become intertwined with, and amplify concerns about, food safety. We have participated, and will continue to participate in discussions on the ethical issues to ensure that people have the correct facts in order to make informed decisions about clones.

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Would food from clones be labeled?

No. FDA is not requiring any additional measures relating to food derived from adult clones of cattle, swine, and goats, and the offspring of clones of any species traditionally consumed as food, including labeling. Under our current laws, FDA may require specific food labeling if there are any safety concerns, or if there is a material difference in the composition of food. We have not identified any food safety concerns, and we have found no material difference in food from clones as compared to food from conventionally bred animals. For example, 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. Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading.

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Is animal cloning allowed in other countries? Can food products from these animals be sold for human consumption in other countries?

Scientists in many other countries are using cloning technology. "Dolly the sheep," the first mammal to be successfully cloned from an adult cell, was from Scotland. Several countries have been actively engaged in agricultural cloning, including Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Japan, New Zealand, South Korea, and the United Kingdom. At this time, we can not confirm whether or not food from clones is being sold in other countries.

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Additional Information

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