FDA GUIDANCE FOR INDUSTRY 69 
This guide replaces those parts of Guidance for Industry 60, June 17, 1997 that 
applied to feeders of ruminant animals with on-farm feed mixing operations. 
 
SMALL ENTITIES COMPLIANCE GUIDE 
FOR FEEDERS OF RUMINANT ANIMALS 
WITH ON-FARM FEED MIXING OPERATIONS 
(October 19, 2010, this guidance document was revised to update contact information and to correct 
broken internet links) 
 
This document is intended to provide guidance for ANIMAL PROTEINS PROHIBITED 
FROM USE IN RUMINANT FEED, Title 21, Code of Federal Regulations, Part 589.2000, 
Effective Date: August 4, 1997. 
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 Division of Compliance (HFV-230), 
U.S. Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Place, 
MPN-4, Rockville, MD 20855, (240) 276-9200. 
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.  
The Food and Drug Administration (FDA) has prepared this guide in accordance with section 212 of the Small 
Business Regulatory Enforcement Fairness Act. This guidance document represents the agency's current thinking on 
compliance with the regulation 21 CFR 589.2000 "Animal Proteins Prohibited from Ruminant Feed." It does not 
create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the applicable statute, regulations or both. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
February 1998  WHAT IS THE PURPOSE AND SCOPE OF THIS REGULATION? 
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 
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.: 
  Blood and blood products 
  Milk products (milk and milk proteins) 
  Pure porcine (pork) or pure equine (horse) protein products 
  Inspected meat products, such as plate waste, which have been cooked and offered 
for human food and further heat processed for animal feed 
  Gelatin 
  The following nonmammalian protein products are exempt: 
  Poultry 
  Marine (fish) 
  Vegetable 
  The following products are also exempt because they are not protein or tissue: 
  Grease 
  Fat 
  Amino acids 
  Tallow 
  Oil 
  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 THIS NEW REGULATION? 
  This provision applies to livestock feeding operations that feed ruminants and that also 
mix their own feed. 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. 
  If a feed intended for ruminants contains animal protein, the protein can consist only of 
nonprohibited material.  
  Feed and feed ingredients not containing animal proteins are not subject to the regulation. 
  Renderers who sell meat and bone meal or other animal protein products to you or your 
supplier may not be able to determine the species of their incoming materials. Such 
material is considered prohibited material because it contains or may contain 
prohibited material. 
  Persons who mix ruminant feed containing prohibited material, or feed prohibited 
material to ruminant animals 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. 
  The Association of American Feed Control Officials (AAFCO) has identified the 
following ingredients listed in their Official Publication as prohibited material: 
  Meat  
  Meat By-Products  
  Animal Liver 
  Stock 
  Dried Meat Solubles 
  Fleshings Hydrolysate 
  Meat Meal 
  Animal Digest 
  Meat and Bone Meal 
  Animal By-Product Meal 
  Meat Meal Tankage 
  Meat and Bone Meal Tankage 
  Hydrolyzed Hair 
  Hydrolyzed Leather Meal 
  Glandular Meal and Extracted Glandular Meal 
  Unborn Calf Carcasses 
  Cooked Bone Marrow 
  Leather Hydrolysate 
  Meat Protein Isolate 
  Mechanically Separated Bone Marrow 
  Dehydrated Food-Waste 
  Bone Meal, cooked 
  Bone Meal, steamed 
  Dehydrated Garbage 
NOTE: If you also have a commercial feed operation, that is, you sell feed in addition to mixing 
feed for your own animals (or animals produced on contract), you are subject to additional 
requirements. Consult the Small Entities Compliance Guide for Protein Blenders, Feed 
Manufacturers, and Distributors, FDA Guidance For Industry 68.  HOW DO I COMPLY WITH THE NEW REGULATION? 
1. Do not mix feed for ruminant animals using feed ingredients labeled with the caution 
statement Do Not Feed To Cattle or Other Ruminants. 
2. If you mix feed for both ruminant and nonruminant animals, and you use prohibited material 
for the nonruminant animal feed: 
  Provide for measures to avoid commingling and cross contamination of prohibited and 
nonprohibited materials by following separation or clean-out procedures. 
  Maintain written procedures that you develop and implement to prevent commingling 
and cross contamination. 
  Maintain records sufficient to track the prohibited materials throughout their receipt, 
processing, and distribution, and make the records available for inspection and copying. 
The records should contain dates of receipt or purchase of prohibited material or feed 
ingredients containing prohibited material; name and address of the seller; identification 
of the product; and quantity. You should also maintain records of the delivery of the 
finished feed to your feeding operation. Production records will suffice if they contain the 
required information. 
3. If any of the feed that you mix for nonruminant animals contains prohibited material and does 
not remain within your immediate control (e.g., for example, it is shipped to a contract 
grower): 
  Label the outgoing product with the cautionary statement Do not feed to cattle or other 
ruminants. 
  Maintain records of the delivery of finished feed which should include the date of 
delivery, the name and address of both you and your recipient, identification of the 
product, and quantity. 
4. If you also purchase complete feed (feed that you do not mix before feeding): 
  Maintain copies of all purchase invoices and labeling (e.g., one bag or feed tag) for ALL 
feed received that contains animal protein products. 
  Keep invoices and labeling available for inspection and copying. 
5. Maintain the records for a minimum of one year. 
HOW CAN I AVOID COMMINGLING OR CROSS-CONTAMINATION? 
1. Separation 
  You could have separate equipment or facilities for the mixing or storage of prohibited 
and nonprohibited product. This could be entirely separate buildings, rooms, or other 
locations; or separate storage containers for incoming material and finished product, and 
separate mixers and handling equipment.    Separate equipment for prohibited material should be clearly identified to help ensure that 
prohibited material is not mistakenly added to product intended to contain nonprohibited 
material only. OR 
2. Clean-out 
  Clean-out could be physical cleaning, flushing, sequencing or other means, either alone 
or in combination with separation measures, that are adequate to prevent carryover of 
prohibited material into nonprohibited material. Clean-out procedures should be used on 
all equipment and conveyances that handle both prohibited and nonprohibited material. 
  Documentation for clean-out should include a description of how clean-out is 
implemented; who is responsible; how clean-out is monitored and verified; how the 
volume of clean-out flush material was determined; and a description of how clean-out 
flush material is handled. OR 
3. Combination of Separation and Clean-out 
An example would be use of some separate and some common equipment (cleanout would be 
required for the common equipment). 
You need written procedures, whether you use separation, clean-out, or a combination: 
  Written procedures should include the procedures followed from the time of receipt of 
incoming material until the time of distribution of finished product. They should reflect 
what actually happens in your operation. 
  Written procedures should have enough detail to provide a clear understanding of your 
actual procedures. An investigator should be able to easily identify operations that are 
described in the written procedures. 
NOTE: These requirements also apply to transportation equipment. 
WHAT ARE SOME CLEAN-OUT MEASURES THAT I COULD USE? 
Include one or more of the following, or other equally effective procedures. These procedures are 
adapted from the FDAS Current Good Manufacturing Practice for Medicated Feed regulations, 
Title 21, Code of Federal Regulations, Part 225. 
  Use cleaning by physical means, e.g. vacuuming, sweeping, washing, etc. 
  Alternatively, you may use flushing, sequencing or other equally effective techniques. 
Under these methods, the equipment is cleaned through use of a non-prohibited product, 
e.g., a feed that does not contain prohibited material. 
  The volume of flushed material should be sufficient to prevent carryover of products that 
contain or may contain prohibited material. Due to the degree of variability among feed 
mixing systems, feed mixers should determine their equipments individual 
characteristics and apply appropriate time and volume requirements for flushing material 
to accomplish the intent of the procedures. The volume used should be stated in the  written procedures, and should be based on a documented analysis or test of the firms 
system. 
  Nonprohibited material used in the cleaning should be considered prohibited and should 
be identified, stored, and handled so that it does not become incorporated in feed for 
ruminant animals. 
  Sequencing should be done on a predetermined basis and be designed to prevent unsafe 
contamination of ruminant feeds. An appropriate example would be producing a swine 
feed containing prohibited material, followed by a swine or poultry feed containing 
nonprohibited material, followed by a ruminant feed containing nonprohibited material. 
WHAT OTHER INFORMATION DO I NEED TO KNOW TO HELP ME COMPLY 
WITH THIS REGULATION? 
  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 mix feed for and feed only ruminant animals, products with this 
caution statement should not be available for use in your operation. If a feed 
ingredient or feed does not bear the caution statement but you suspect that they 
contain prohibited material, do not use them until you are sure that they do not 
contain such materials. 
o  If you intend to mix or use a feed containing prohibited material for nonruminant 
animals, take steps to ensure that the feed will not be fed to ruminants. 
o  If you mix feed only for ruminant animals and do not use prohibited 
material, this regulation does not require you to keep any records or labeling. 
However, if you mix medicated feed for your own animals, you are required by 
the Current Good Manufacturing Practice for Medicated Feeds regulations to 
keep records identifying the formulation and date of mixing for all medicated feed 
you mix, whether or not the feed contains prohibited material. 
RECORD KEEPING 
  You are not required to create a new set of records. The information should be available 
in normal and customary business records maintained by you. 
  The information could be maintained in several different documents including invoices, 
receiving tickets, receiving logs, disbursement records, weight tickets, purchase orders, 
or other business records or documents. Feed production records may be used if they 
contain the necessary information. 
WHAT OTHER INFORMATION DO I NEED TO KNOW TO HELP ME COMPLY 
WITH THIS REGULATION? (Continued) 
  The records must be maintained so that they are available for inspection and copying. 
They should be maintained in a condition that keeps them legible and readily retrievable.    Records must be maintained for one year, which means one year from the date of 
shipment of the product that you mix, or one year from the date of receipt for complete 
feeds containing animal protein products. 
LABELING - For Feeds That You Mix: 
  The cautionary statement is required only if the products contain or may contain 
prohibited material. 
  The cautionary statement must be placed prominently on the label or labeling. 
  Since bulk shipments of feed are commonplace, and labeling information typically is 
contained in the invoices for bulk shipments, the cautionary statement may be placed on 
the invoice and maintenance of the invoice is sufficient documentation. 
LABELING - For Feeds That You Purchase: 
  If the only labeling for a bulk product is on a placard, the placard for each shipment 
should be retained. 
  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. 
  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.