#158 
 
Guidance for Industry 
 
Use of Material from Deer and Elk 
in Animal Feed 
 
This version of the guidance replaces the version made available September15, 2003. 
This document has been revised to update the docket number, contact information, and 
standard disclosures. 
 
Submit comments on this guidance at any time.  Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD  20852.  All comments should be identified with the Docket No. FDA-2003-D-
0432 (formerly 03D-0186). 
 
For further information regarding this guidance, contact Burt Pritchett, Center for Veterinary 
Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 
20855, 240-402-6276, E-mail: burt.pritchett@fda.hhs.gov. 
 
Additional copies of this guidance document may be requested from the Policy and Regulations 
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish 
Place, Rockville, MD 20855, and may be viewed on the Internet at either 
http://www.fda.gov/AnimalVeterinary/default.htm or http://www.regulations.gov. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
March 2016 
    Contains Nonbinding Recommendations 
Guidance for Industry 
 
Use of Material from Deer and Elk 
in Animal Feed 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA office 
responsible for this guidance as listed on the title page. 
 
I.  Introduction 
 
Under FDAs BSE feed regulation (21 CFR 589.2000) most material from deer and elk is 
prohibited for use in feed for ruminant animals.  This guidance document describes FDAs 
recommendations regarding the use in all animal feed of all material from deer and elk that are 
positive for Chronic Wasting Disease (CWD) or are considered at high risk for CWD.  The 
potential risks from CWD to humans or non-cervid animals such as poultry and swine are not 
well understood.  However, because of recent recognition that CWD is spreading rapidly in 
white-tailed deer, and because CWDs route of transmission is poorly understood, FDA is 
making recommendations regarding the use in animal feed of rendered materials from deer and 
elk that are CWD-positive or that are at high risk for CWD. 
 
In general, FDAs guidance documents 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. 
 
II.  Background 
 
CWD is a neurological (brain) disease of farmed and wild deer and elk that belong in the animal 
family cervidae (cervids).  Only deer and elk are known to be susceptible to CWD by natural 
transmission.  The disease has been found in farmed and wild mule deer, white-tailed deer, 
North American elk, and in farmed black-tailed deer.  CWD belongs to a family of animal and 
human diseases called transmissible spongiform encephalopathies (TSEs).  These include 
bovine spongiform encephalopathy (BSE or mad cow disease) in cattle; scrapie in sheep and 
goats; and classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in humans.  There 
is no known treatment for these diseases, and there is no vaccine to prevent them.  In addition, 
although validated postmortem diagnostic tests are available, there are no validated diagnostic 
tests for CWD that can be used to test for the disease in live animals. 
   
2  Contains Nonbinding Recommendations 
III. Use in animal feed of material from CWD-positive deer and elk 
 
Material from CWD-positive animals may not be used in any animal feed or feed ingredients. 
Pursuant to Sec. 402(a)(5) of the Federal Food, Drug, and Cosmetic Act, animal feed and feed 
ingredients containing material from a CWD-positive animal would be considered adulterated.  
FDA recommends that any such adulterated feed or feed ingredients be recalled or otherwise 
removed from the marketplace. 
 
IV. Use in animal feed of material from deer and elk considered at high risk for CWD 
 
Deer and elk considered at high risk for CWD include: (1) animals from areas declared by State 
officials to be endemic for CWD and/or to be CWD eradication zones; and (2) deer and elk that 
at some time during the 60-month period immediately before the time of slaughter were in a 
captive herd that contained a CWD-positive animal. 
 
FDA recommends that materials from deer and elk considered at high risk for CWD no longer 
be entered into the animal feed system.  Under present circumstances, FDA is not 
recommending that feed made from deer and elk from a non-endemic area be recalled if a State 
later declares the area endemic for CWD or a CWD eradication zone.  In addition, at this time, 
FDA is not recommending that feed made from deer and elk believed to be from a captive herd 
that contained no CWD-positive animals be recalled if that herd is subsequently found to contain 
a CWD-positive animal. 
 
V.  Use in animal feed of material from deer and elk NOT considered at high risk for 
CWD 
 
FDA continues to consider materials from deer and elk NOT considered at high risk for CWD 
to be acceptable for use in NON-RUMINANT animal feeds in accordance with current agency 
regulations, 21 CFR 589.2000.  Deer and elk not considered at high risk include: (1) deer and 
elk from areas not declared by State officials to be endemic for CWD and/or to be CWD 
eradication zones; and (2) deer and elk that were not at some time during the 60-month period 
immediately before the time of slaughter in a captive herd that contained a CWD-positive 
animal. 
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