Producer FAQs

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.

Does FDA support animal cloning?

FDA neither supports nor opposes the cloning of food-producing animals for agricultural purposes. FDA’s job is to protect the public health. While FDA worked to complete the final Animal Cloning Risk Assessment process, it asked producers to voluntarily keep food from clones out of the food supply until we had assessed its safety. Because the agency has insufficient information to determine its safety, FDA continues to ask producers to voluntarily keep food from clone species other than cattle, swine, and goats (e.g., sheep) out of the food supply.

What do the Animal Cloning Risk Assessment, Risk Management Plan (RMP), and Guidance for Industry (GFI) cover?

The documents address risks to animal health associated with cloning and the safety of foods derived from animal clones; actions within the agency’s purview to manage the risks associated with animal cloning; and the agency’s current thinking on the use of edible products from clones or their progeny for human food or animal feed.

According to FDA’s recommendations, does FDA have any concerns about the use of any clone of any species

• for breeding stock for food production?
  No.
• to produce feed products for animals?
  No, as long as using that species in feed is under the same controls applied to any animal that is the product of sexual reproduction.
• to produce food for humans?
  FDA does not have concerns about food from clones of cattle, swine, and goats. Food from these clones would be subject to the same food safety systems that exist to ensure the safety of foods from other animals, and FDA is not recommending any additional measures. FDA recommends that clones of other species (e.g., sheep) not be used as food for humans.

According to the recommendations, does FDA have any concerns about the use of progeny of clones of any species

• for breeding stock for food production?
  No.
• to produce feed products for animals?
  No.
• to produce food for humans?
  No.

According to FDA’s recommendations, does FDA have any concerns about the use of sheep clones

• for breeding stock?
  No.
• to produce feed products for animals?
  No, subject to the same requirements as for conventionally bred sheep.
• to produce food for humans?
  Yes. Due to the lack of information on sheep clones FDA recommends that sheep clones not be used as food for humans.

Then why doesn’t FDA have any concerns about the use of the progeny of sheep clones as food?

The agency’s assessment of the current science concludes that progeny of clones of any species traditionally consumed as food are just like any other sexually produced offspring of those species.

What if my cow clone delivers a dead calf? Do I have to dispose of it differently from another dead animal?

No. The calf is the same as any other calf and requires no special handling. For example, rendering may be an option in your area. FDA’s policy on rendering your dead calf from an animal clone for use in animal feed is the same as for any other dead calf. For more information on the use of rendered products in animal feed, please refer to Compliance Policy Guide 7126.24, entitled “Rendered Animal Feed Ingredients.”

Do I have to consult with FDA before I slaughter my clones?

No. Contacting FDA is not necessary.

I’ve heard that newborn clones require special care. What measures will be in place to assure their welfare?

Commercially available clones will be born at facilities operated by clone producers with considerable expertise in assisted reproductive technologies and animal husbandry. In order to assure that all clone producers have access to the best sources of information on the care of these animals, FDA/CVM will continue to work with clone producers and scientific and professional organizations dedicated to animal health and the care of food-producing animals in order to develop care standards for newborn clones and their surrogate dams.

Why is FDA/CVM involved in animal cloning? Do you have the legal authority to regulate these products?

FDA/CVM has broad authority to regulate the safety of our food supply. In order to ensure that food from clones doesn’t pose any consumption risks, the agency designed a science-based regulatory approach to identify and manage any potential risks. The resulting Risk Assessment, Risk Management Plan, and Guidance for Industry set out our findings that food from cattle, swine, and goat clones and the progeny of all clones does not present any additional risk when compared to conventionally bred animals. These documents also set out our recommendations regarding the use of clones and their progeny as human food and animal feed. Furthermore, the Guidance for Industry discusses FDA 's intent to exercise enforcement discretion to the extent that any parts of animal cloning or animal clones based on being derived from somatic cell nuclear transfer (SCNT), meet the requirements for regulation as new animal drugs.

I operate an organic dairy. Can I use clones or their progeny in my herd? FDA does not administer the National Organic Program, which is run by the U.S. Agriculture Department. According to a statement released on January 31, 2007 by the USDA’s Agricultural Marketing Service (AMS), which administers the National Organic Program, food products from animal clones cannot be considered organic. AMS and the National Organic Standards Board (NOSB) are currently examining the issue of whether food products from the progeny of animal clones can be considered organic. To follow up on this issue, please contact the AMS directly at 202-720-8998. The AMS statement can be viewed on USDA’s Web site at National Organic Program.

Is it true that the use of cloning is primarily to produce breeding animals?

Yes. The interest in clones is primarily as breeding stock. Using conventional selective breeding efforts, animals of exceptional quality are produced only rarely. Copying these exceptional animals will permit the more rapid distribution of their naturally occurring desirable qualities to the herds of many animal producers.

Will food derived from animal clones be common in the marketplace?

No, not in the foreseeable future. Clones produce meat or milk only incidentally to their primary purpose as breeding stock. Almost all of the food from animals derived from cloning would come from the sexually reproduced offspring of clones and their descendents, and not from the clones themselves.

Is animal cloning allowed in other countries? Can products from these animals be sold for human consumption in other countries? If not, why not?

Animals are being cloned for agricultural purposes in many countries including Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Japan, New Zealand, South Korea, and the United Kingdom. At this time, we cannot confirm whether or not food from clones is being sold in other countries. Some countries, such as New Zealand, have issued position papers indicating that there is no need for specific regulation of food from clones, and that food from clones is as safe as food from non-clones. The European Food Safety Authority issued a draft scientific opinion on the safety of food from clones and their progeny on January 11, 2008 , which supports those conclusions drawn by the FDA in its Risk Assessment.

Would animal cloning be bad for the gene pool?

Cloning is just another tool in the animal breeders’ toolbox. Like other assisted reproductive technologies, the effects of cloning on the gene pool will depend on responsible use of the technology by animal breeders.

When do FDA’s recommendations in its guidance go into effect?

The guidance goes into effect immediately.