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Guidance for Industry 
Use of Animal Clones and Clone Progeny for Human 
Food and Animal Feed 
Comments and suggestions regarding this guidance should be sent to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on 
the Internet at http://www.regulations.gov. All written comments should be identified 
with Docket No. 2003N-0573. 
For questions regarding this guidance, contact Larisa Rudenko, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Place, Rockville, 
MD 20855, 240-276-8245, e-mail: larisa.rudenko@fda.hhs.gov.  
Additional copies of this guidance document may be requested from the Communications 
Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 
Standish Place, Rockville, MD 20855, and may be viewed on the Internet at 
http://www.fda.gov/AnimalVeterinary/SafetyHealth/AnimalCloning/default.htm.  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
January 15, 2008
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Use of Animal Clones and Clone Progeny for 
Human Food and Animal Feed 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic. It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public. You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations. If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance. If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance.  
 
  I.  Introduction 
FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities. Instead, guidances describe the Agencys current 
thinking on a topic and should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited. The use of the word 
should in Agency guidances means that something is suggested or 
recommended, but not required. 
 
FDAs Center for Veterinary Medicine (CVM) recently completed a risk assessment entitled 
Animal Cloning: A Risk Assessment on the potential risks presented by cloning food-
producing animals. Among the goals of the risk assessment were the determination of 
whether somatic cell nuclear transfer (SCNT, the process used to produce the clones being 
considered in the risk assessment) poses any unique risks to animals involved in cloning 
relative to other assisted reproductive technologies (ARTs), and whether foods derived from 
animal clones or their progeny pose consumption risks greater than those posed by foods 
derived from their conventional counterparts. This guidance document describes FDAs 
recommendations regarding the introduction of edible products from animal clones and their 
progeny into the food and feed supply. To the extent any parts of SCNT or animal clones, 
based on being derived from SCNT, meet the requirements for regulation as new animal 
drugs under the Federal Food, Drug, and Cosmetic Act (Act), this guidance also sets out 
FDAs enforcement policy that FDA intends to exercise its enforcement discretion 
 
II.  Background 
In July 2001, FDAs Center for Veterinary Medicine (CVM) issued an Update on 
Livestock Cloning (available at 
http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm130
770.htm ) and proceeded to work with stakeholders to assess potential risks presented by 
cloning food-producing animals. CVM also requested that companies voluntarily refrain 
from introducing meat or milk from animal clones or their progeny into the human or 
animal food supply pending completion of the risk assessment process.  
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The Risk Assessment specifically addresses SCNT, which allows the copying of a 
specific animal without sexual reproduction, and focuses on those domestic livestock that 
have been cloned, i.e., cattle, swine, sheep, and goats. Among the goals of the Risk 
Assessment were the determination of whether SCNT poses any unique risks to animals 
involved relative to other assisted reproductive technologies (ARTs), and whether foods 
derived from animal clones or their progeny pose consumption risks in addition to those 
posed by foods derived from their conventional counterparts. 
 
All of the data evaluated in the Risk Assessment are either available in peer-reviewed 
publications, or in the Risk Assessment itself. In addition, the methodology used to 
evaluate the data, underlying assumptions used by the risk assessors; residual 
uncertainties, including sources of potential bias; and the basis for our conclusions are 
explicitly provided in the Risk Assessment.  
  III.  Animal feed derived from clones 
 
No animal feed risks unique to clones were identified in the Risk Assessment. FDA 
therefore does not have recommendations for any additional measures related to the use 
of clones of any age or species for the production of feed for animals that are based on 
the fact that the animals are derived from cloning. This conclusion applies to rendered 
products from any clones and the use of milk from clones for animal feed. 
  IV.  Human food derived from clones 
 
No unique risks for human food consumption were identified in cattle, swine, or goat clones 
derived via SCNT. No anomalies have been observed in animals produced by cloning that are 
not also observed in animals produced by other assisted reproductive technologies (ARTs) 
and natural mating. The frequency of those anomalies, however, is increased over other 
ARTs and natural mating. As was the case with other ARTs, the success rate is improving 
over time. Further, the results of the Risk Assessment have clearly indicated that cloning falls 
on the continuum of assisted reproductive technologies (ARTs). 
 
Following extensive review, the Risk Assessment did not identify any unique risks for human 
food from cattle, swine, or goat clones, and concluded that there is sufficient information to 
determine that food from cattle, swine, and goat clones is as safe to eat as that from their 
more conventionally-bred counterparts. Because of these reasons, and because food from 
clones would be subject to the same requirements as food from their conventionally bred 
counterparts, we do not believe that meat or milk from cattle, swine, and goat clones would 
require any additional controls compared with meat or milk from cattle, swine, or goats 
currently entering the food supply today.  
 
As stated in the Risk Assessment, insufficient information was available on sheep clones to 
make a decision on food consumption risks and assessments were not conducted for animals 
other than cattle, swine, goat, and sheep. Therefore, at this time, the agency continues to 
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recommend that edible products from clones from animals other than cattle, swine, or goat 
(e.g., sheep) not be introduced into the human food supply. 
 
V.  Animal feed and human food derived from clone progeny of any species    
    traditionally consumed as food or feed  
 
FDA anticipates that most of the food products from SCNT technology will be derived from 
clone progeny, the sexually-reproduced offspring of clones, rather than from the clones 
themselves. Based on our evaluation, which included empirical evaluations, a careful 
assessment of the literature, and congruence with biological assumptions, we agree with the 
findings of the National Academies of Science (NAS 2002) that there are no human food or 
animal feed risks associated with the progeny of any clone of a species traditionally 
consumed for food that are not present in other sexually-reproduced animals of the same 
species. Therefore, the agency believes that food products from progeny of a clone from any 
species currently consumed as food are suitable to enter the food and feed supply under the 
same controls as applied to any animal that is the product of sexual reproduction. FDA does 
not have recommendations for any additional measures related to the use of the progeny of 
clones for the production of food for humans or feed for animals based on the fact that these 
are progeny of clones. 
 
VI. Enforcement discretion for new animal drug requirements applicable to SCNT or  
    animal clones based on being derived from SCNT 
 
Assuming, without here deciding, that any part of SCNT or animal clones, based on being 
derived from SCNT, meet the statutory definition of new animal drug under the 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.  
 
REFERENCE:  
 
NAS 2002. Animal Biotechnology: Science-Based Concerns. The National Academies Press. 
Washington , DC.  
 
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