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GUIDANCE FOR INDUSTRY 
SMALL ENTITIES COMPLIANCE GUIDE FOR FEEDERS OF 
RUMINANT ANIMALS WITHOUT ON-FARM FEED MIXING 
OPERATIONS 
 (This version of the guidance replaces the version that was made available in February 1998. 
This guidance document has been revised to update contact information and provide new 
requirements regarding the use of tallow in ruminant feed.)  
Submit comments on this guidance at any time.  Submit written comments 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.   
For questions regarding this guidance document, contact Shannon Jordre, Division of 
Compliance (HFV-230), U.S. Food and Drug Administration, Center for Veterinary Medicine, 
7519 Standish Place, MPN-4, Rockville, MD 20855, (240) 276-9229. 
Additional copies of this guidance document may be requested from the Communications Staff, 
HFV-12, Center for Veterinary Medicine, U.S. Food and Drug Administration, 7519 Standish 
Place, Rockville, MD  20855, and may be viewed on the Internet at 
http://www.fda.gov/AnimalVeterinary/default.htm.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
July 13, 2009 
  CONTAINS NON-BINDING RECOMMENDATIONS 
Guidance for Industry 
SMALL ENTITIES COMPLIANCE GUIDE FOR FEEDERS OF RUMINANT 
ANIMALS WITHOUT ON-FARM FEED MIXING OPERATIONS1 
 
This guidance document represents the Food and Drug Administrations (FDAs) 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 alterative 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.    
 
Introduction 
On April 25, 2008, FDA published a final rule in the Federal Register, entitled Substances 
Prohibited from Use in Animal Food or Feed (73 FR 22719).  See also 73 FR 18626; April 24, 
2009.  This final rule established a new regulation at 21 CFR 589.2001 entitled, Cattle 
Materials Prohibited in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform 
Encephalopathy.  21 CFR 589.2001 prohibits the use of certain cattle materials in the feed of all 
animals and is aimed primarily at rendering operations.  This new rule also amended the 
previously existing BSE regulation, 21 CFR 589.2000 entitled, Animal Proteins Prohibited in 
Ruminant Feed, which addresses only the feeding of ruminant animals. 
The Food and Drug Administration (FDA) has prepared this Small Entities Compliance Guide in 
accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 
1996. (Public Law 104-121). This guidance document represents the agency's current thinking 
on compliance with the regulation 21 CFR 589.2000 "Animal Proteins Prohibited in Ruminant 
Feed", as amended during the recent rule-making process, and how the regulation impacts 
livestock producers feeding ruminant animals.  
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. 
What Is The Purpose And Scope Of This Regulation, 21 CFR 589.2000? 
This regulation is designed to prevent the establishment and amplification of Bovine Spongiform 
Encephalopathy (BSE), sometimes referred to as Mad Cow Disease, through animal feed. The 
                                                 
1 This guidance has been prepared by the Office of Surveillance and Compliance in the Center for Veterinary 
Medicine. 
  2 CONTAINS NON-BINDING RECOMMENDATIONS 
regulation prohibits the use of certain proteins derived from mammalian tissue in feeding 
ruminant animals. An example is meat and bone meal derived from cattle. However, certain 
products are exempt from this regulation. 
  The following protein products derived from mammals are exempt: 
o  Blood and blood products  
o  Gelatin  
o  Milk products (milk and milk proteins) 
o  Pure porcine (pork) or pure equine (horse) protein products 
o  Inspected meat products, such as plate waste, which have been cooked and 
offered for human food and further heat processed for animal feed 
  The following nonmammalian protein products are exempt: 
o  Poultry 
o  Marine (fish) 
o  Vegetable 
  The following products are also exempt because they are not protein or tissue: 
o  Grease 
o  Tallow that contains no more than 0.15% insoluble impurities2 
o  Fat3 
o  Amino acids 
o  Vegetable oil 
o  Dicalcium phosphate 
We refer to the exempted products throughout this guide as nonprohibited material. We refer 
to all mammalian protein that is not exempted as prohibited material. 
Prohibited material and/or feeds containing prohibited material cannot be fed to ruminant 
animals. Ruminant animals are any animals with a four-chambered stomach including cattle, 
sheep, goats, buffalo, elk, and deer. 
Is My Operation Affected By 21 CFR 589.2000? 
  This regulation applies to livestock feeding operations that feed ruminants. The 
regulation applies to "establishments and individuals that are responsible for feeding 
ruminants" to make it clear that all responsible persons, in both large and small feeding 
operations, are subject to the regulation. 
  Examples include dairies, cattle feed lots, calf and lamb raising operations, cattle, sheep, 
and goat grazing operations. 
                                                 
2 Tallow is defined by 21 CFR 589.2001(b)(5) as the rendered fat of cattle. Tallow that contains more that 0.15% 
insoluble impurities is considered to be an animal protein prohibited in ruminant feed in 21 CFR 589.2000(a)(1). 
Such tallow should be labeled with the cautionary statement Do Not Feed to Cattle or Other Ruminants. 
3 Excludes tallow that contains more than 0.15% insoluble impurities.  
  3 CONTAINS NON-BINDING RECOMMENDATIONS 
  If a feed product intended for ruminants contains animal protein, the protein can consist 
only of nonprohibited material. 
  The Association of American Feed Control Officials (AAFCO) has identified the 
following ingredients listed in its Official Publication as prohibited material: 
o  Meat 
o  Meat By-Products 
o  Animal Liver 
o  Dried Meat Solubles  
o  Fleshings Hydrolysate  
o  Meat Meal 
o  Meat and Bone Meal  
o  Animal By-Product Meal  
o  Meat Meal Tankage 
o  Meat and Bone Meal Tankage  
o  Hydrolyzed Leather Meal  
o  Hydrolyzed Hair 
o  Glandular Meal and Extracted Glandular Meal  
o  Stock/Broth 
o  Animal Digest  
o  Cooked Bone Marrow  
o  Leather Hydrolysate 
o  Meat Protein Isolate  
o  Mechanically Separated Bone Marrow 
o  Unborn Calf Carcasses  
o  Bone Meal, cooked  
o  Bone Meal, steamed 
o  Dehydrated Garbage  
o  Dehydrated Food-Waste 
o  Salvage Pet Food 
o  Distressed Pet Food 
  Feed and feed ingredients not containing animal proteins are not subject to the regulation. 
  Persons who feed prohibited material to ruminants would be subject to regulatory action 
under the Federal Food, Drug, and Cosmetic Act. Regulatory action could include seizure 
of inventory, injunction against feeding prohibited material to ruminants, or prosecution. 
Note: If you mix your own feed for your ruminant animals, you are subject to additional 
requirements. Consult the Small Entities Compliance Guide for Feeders of Ruminant Animals 
with On-Farm Feed Mixing Operations, FDA Guidance for Industry 69. 
How Do I Comply With 21 CFR 589.2000? 
  4 CONTAINS NON-BINDING RECOMMENDATIONS 
1. Do not feed products labeled with the caution statement Do not feed to cattle 
or other ruminants to your ruminant animals4. 
2. Maintain copies of all purchase invoices for ALL feeds received that contain 
animal protein. 
3. Maintain copies of labeling for ALL feeds received containing animal protein 
products. 
4. Keep invoices and labeling available for inspection and copying. 
5. Maintain the records for a minimum of one year. 
What Other Information Do I Need To Know To Help Me Comply With 21 CFR 589.2000? 
  Renderers, protein blenders, and feed manufacturers are required to label products 
containing prohibited materials with the cautionary statement Do not feed to cattle or 
other ruminants. 
o  If you intend to feed only ruminant animals, products with this caution 
statement should not be available for use in your operation. If the feed does not 
bear the caution statement but you suspect that it contains prohibited material, do 
not use it until you are sure that it does not contain such materials. 
o  If you intend to use a feed containing prohibited material for nonruminant 
animals, take steps to ensure that the feed will not be fed to ruminants. 
  Labeling And Record Keeping 
o  For bulk shipments it is common practice to provide labeling information on the 
invoice.  In such cases, retaining the invoice is sufficient documentation. 
o  If the only labeling for a bulk product is on a placard, the placard for each 
shipment should be retained. 
o  Feed may also be received in bags or other containers that have attached labeling. 
In those instances, the labeling should be removed and retained. However, 
maintenance of only one such labeling piece from each shipment that 
represents a different product is necessary. 
o  If the labeling cannot be removed from the bag or other container, it is acceptable 
to retain a representative bag or a transposed copy of the labeling information 
from a container that cannot feasibly be stored. 
o  The records should be legible and readily retrievable.  
                                                 
4 If the product label bears the Do Not Feed to Animals statement, take steps to ensure that it is not fed to animals. 
This product should not have been introduced into the animal feed chain because it is prohibited from use in any 
animal feed by another rule titled SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED 
and codified in 21 CFR 589.2001. This rule published on April 25, 2008, with an effective date of April 27, 2009. 
  5 CONTAINS NON-BINDING RECOMMENDATIONS 
o  The one year requirement for maintenance of records means one year from the 
date of the receipt of the product. 
  Inspections 
o  On-farm inspections will be limited but will be needed on a selective basis to 
trace prohibited material to verify that it is not being shipped to ruminant 
producers and fed to ruminant animals. For example, on-farm inspection 
might be necessary as a follow up to a feed mill inspection, to verify that feed 
not labeled with the cautionary statement is in fact being fed to nonruminant 
animals. 
  
 
 
 
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