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The responses to the questions provided in this document represent the FDA’s view in light of the conclusions and recommendations outlined in the Draft Animal Cloning Risk Assessment, Proposed Risk Management Plan, and Draft Guidance for Industry #179. Based on the comments received in response to these draft documents, FDA may revise its conclusions and recommendations. If such changes are needed, the responses to some of the following questions may also need to be revised. |
Does FDA support animal cloning?
FDA neither supports nor opposes cloning food-producing animals. FDA’s job is to protect the public health. While the livestock industry has been developing cloning for commercial use, FDA has asked producers to voluntarily keep food from clones out of the food supply until we have assessed its safety.
What do the Draft Cloning Risk Assessment, Proposed Risk Management Plan (PRMP), and Draft Guidance for Industry (GFI) cover?
They address food consumption, animal health, and how FDA is approaching the question of ethics for clones and their progeny.
According to FDA’s proposed 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?
Yes, because of the lack of information on sheep clones, FDA recommends that sheep clones not be used as food for humans. With regard to clones of cattle, swine, and goats, FDA does not have concerns about their use as human food. The food from these clones would be subject to the existing food safety systems the same as food from any other animal. FDA is not recommending any additional measures.
According to the proposed 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 proposed 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 conventional sheep.
-to produce food for humans?
Yes, because of 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?
Progeny of clones of any species are just like any other sexually produced offspring.
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 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 would not be necessary, but we still ask that you voluntarily refrain from introducing meat or milk from clones into the food supply until the Draft Risk Assessment, Proposed Risk Management Plan and Draft Guidance for Industry become final.
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, CVM will 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 Draft Risk Assessment, Proposed Risk Management Plan, and Draft Guidance for Industry set out our findings that food from clones and their progeny 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.
Does FDA/CVM support animal cloning?
FDA neither supports nor opposes cloning food-producing animals. FDA’s job is to protect the public health. While the livestock industry has been developing cloning for commercial use, FDA has asked producers to voluntarily keep food from clones out of the food supply until we have assessed its safety.
I operate an organic dairy. Can I use clones or their progeny in my herd?
Probably not. The following answer was provided by USDA's Agricultural Marketing Service (AMS), which administers the National Organic Program:
According to USDA's National Organic Program regulations (7 CFR 205) clones and animals derived from this process would fall under the definition of excluded methods, which are prohibited by organic operations. Excluded methods include, among other things, processes that are not considered compatible with organic production. See 7 CFR 205.2. This should be regarded as an informal opinion issued before AMS has had an opportunity to fully consider this issue, including the information provided by FDA in the Draft Risk Assessment, and other materials being released for comment at this time. You may follow up on this issue at the AMS; contact Dr. Barbara Robinson, Deputy Administrator, T&M Programs.
Is it true that the use of cloning is primarily to produce breeding animals?
Yes. The interest in clones is primarily as breeding stock. Animals of exceptional quality are produced only rarely through selective breeding efforts. 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 clones be common in the marketplace?
No, not for 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 will come from the sexually reproduced offspring of clones and their descendents, and not 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 in many countries. Dolly the sheep was from Scotland. There are a number of livestock clones in Australia, Canada, France, Italy, Japan, New Zealand, and South Korea. It is our understanding, however, that no country has yet allowed food from animal clones in their food supplies.
Won’t cloning be bad for the gene pool?
Cloning is just another tool in the animal breeders’ toolbox. Like other assisted reproductive technologies, animal breeders can use it responsibly or not.
When do FDA’s recommendations in its Draft Guidance go into effect?
After we have considered comments, and issued a final Guidance for Industry along with a final Risk Assessment and final Risk Management Plan.
How can I submit a comment on cloning?
Public comments are invited on the Draft Risk Assessment, the Proposed Risk Management Plan, and Draft Guidance for Industry. You may send written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20852. Submit comments electronically to http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. All written comments should be identified with Docket No. 2003N-0573. Please specify which document your comment addresses.
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