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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and recommendations outlined in the Draft Animal Cloning Risk Assessment, Proposed Risk Management Plan, and Draft Guidance for Industry #179.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 is the Draft Animal Cloning Risk Assessment?
It’s a draft 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 on clones of livestock animals. The draft 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.
What is the Proposed Risk Management Plan?
It takes into account the risks identified in the Draft Risk Assessment, and suggests how those risks could be managed.
What is the Draft Guidance for Industry?
It explains FDA’s draft recommendations on the use of clones and their offspring for human food and animal feed.
What are animal clones?
An animal clone is an exact genetic copy of a donor animal. Clones are similar to identical twins, just born at a different time. Cloning can 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” at
http://www.fda.gov/cvm/CloningRA_Primer.htm. 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.
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 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.
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.
Is it safe to feed meat or milk from clones to my pets?
Yes. We believe it is safe for meat or milk from clones to be used in making pet food.
Is cloning the same as genetic engineering?
No, cloning is not the same as genetic engineering. Genetic engineering involves adding or taking away genes, while cloning does not change the gene sequence.
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.
Is FDA considering the ethics of animal cloning?
FDA recognizes that animal cloning raises ethical issues that are important to some members of the public. The agency’s jurisdiction, however, is limited to health and safety issues, and does not extend to ethical issues related to animal cloning. We are also aware that ethical concerns can become intertwined with, and amplify concerns about food safety. We plan to participate in discussions on the ethical issues posed by animal cloning to provide our scientific expertise.
Would food from clones be labeled?
No. FDA is not recommending any additional measures relating to food derived from adult clones and their offspring, including labeling. 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.
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 was from Scotland. There are a number of livestock clones in Australia, Canada, France, Italy, Japan, New Zealand, and South Korea, and other animals have been cloned in other countries (e.g., horses in Italy). It is our understanding, however, that no country has yet allowed food from animal clones in their food supplies.
Do findings in the Draft Risk Assessment for cloning animals further lead to cloning humans?
FDA does not believe so. FDA believes that there are major unresolved safety questions and scientific issues pertaining to the use of cloning technology to create a human being. FDA’s authorities and processes value and prioritize human life in medical research, as the Public Health Service Act and Food, Drug, and Cosmetic Act offer protections for human subject research. The findings in the draft risk assessment do not alter FDA’s position on the safety risks to cloning humans. Additionally, there are unresolved issues regarding the broader social and ethical implications of the use of cloning for humans.
I have an opinion on cloning and would like to voice it to FDA. How can I do that?
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 electronic comments 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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