FDA GUIDANCE FOR INDUSTRY 68 
This guide replaces those parts of Guidance for Industry 60, June 17, 1997, that applied to protein blenders, 
feed manufacturers, and distributors. 
 
 
SMALL ENTITIES COMPLIANCE GUIDE 
FOR PROTEIN BLENDERS, FEED MANUFACTURERS, 
AND DISTRIBUTORS 
(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 made from cattle. However, certain 
products are exempt from the regulation: 
  The following protein products derived from mammals are exempt: 
  Blood and blood products 
  Milk products (milk and milk proteins)  
  Gelatin  
  Pure porcine (pork) or pure equine (horse) protein 
  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: 
  poultry 
  marine (fish) 
  vegetable 
  The following are also exempt because they are not protein or tissue: 
  Grease 
  Fat 
  Amino acids 
  Tallow 
  Oil 
  Dicalcium phosphate 
If you receive and process ONLY the above exempted products (or only products containing the 
exempted products) you are not required to comply with this regulation. We refer to this material 
as nonprohibited material. 
All other mammalian protein will be referred to as prohibited material throughout this guide. If 
you receive and process this material or products containing this material, you must comply with 
this regulation. 
Ruminant animals are any animals with a four-chambered stomach including cattle, sheep, goats, 
buffalo, elk, and deer. 
IS MY FIRM AFFECTED BY THIS REGULATION? 
This regulation defines blenders, feed manufacturers, and distributors as follows -    "Blender" means any firm or individual which obtains processed animal protein from 
more than one source or from more than one species, and subsequently mixes (blends) or 
redistributes an animal product. "Blenders" under the regulation are protein blenders, 
which are intermediaries between renderers and feed manufacturers. 
  "Feed manufacturer" includes manufacturers and mixers of complete and intermediate 
feeds intended for animals. It includes on-farm feed mixing operations; however, those 
with on-farm mixers should refer to the separate guide for feeders of ruminant animals 
with on-farm feed mixing operations (FDA Guidance for Industry 69). The term includes 
pet food manufacturers. 
  "Distributor" includes persons who distribute or transport feeds or feed ingredients 
intended for animals. This includes retailers of feed and feed products; the 
distribution activities of blenders and feed manufacturers; and independent haulers. 
* Even if you fall within the definition of blender, feed manufacturer, or distributor, you 
are not subject to the regulation if you do not receive, process and distribute any prohibited 
material or products containing prohibited material. 
If you know or have reason to know that an incoming product contains or may contain prohibited 
material, you are subject to the regulation. Renderers may not be able to determine the species of 
incoming material; rendered product from such material is considered prohibited material 
because it "contains or may contain" prohibited material. You may wish to have assurance from 
your raw material supplier about the products contents. This could include a certification from 
the supplier, or specification of source in a business contract. 
The regulation provides procedures for two general categories of blenders, feed manufacturers, 
and distributors that are subject to the regulation: those that do NOT separate prohibited material 
from nonprohibited material, and those that do. 
HOW DO I COMPLY WITH THE NEW REGULATION? 
A. Firms That Handle Only Prohibited Material, or Handle Both Prohibited and 
Nonprohibited Material But Do Not Separate Them Need to: 
1. Label all outgoing products that contain or may contain prohibited material with the following 
cautionary statement: 
Do not feed to cattle or other ruminants. 
2. Maintain records sufficient to track the materials throughout their receipt, processing, and 
distribution, and make the records available for inspection and copying. Invoices or similar 
documents for incoming and outgoing products will satisfy this requirement. The records should 
contain information normally expected to be included in such documents - 
   Date of the receipt or purchase and sale or delivery 
   Name and address of the seller 
  Name and address of the consignee    Identification of the product 
  Quantity 
3. Maintain the records for a minimum of one year. 
B. Firms That Do Separate Prohibited from Nonprohibited Materials Have Two Additional 
Requirements: 
4. Provide for measures to avoid commingling or cross-contamination of prohibited and 
nonprohibited materials. 
5. Maintain written procedures that document the measures you adopt to prevent commingling or 
cross-contamination. 
WHAT DO I NEED TO KNOW ABOUT THE CAUTIONARY STATEMENT? 
  The term label means a display of written, printed, or graphic matter on the immediate 
container of any product. The term labeling means all labels and other written, printed, 
or graphic matter (1) upon any article or any of its containers or wrappers, or (2) 
accompanying such article. 
  The cautionary statement is required only if the products contain or may contain 
prohibited material. 
  This requirement does NOT apply to pet food products that are sold or intended for sale 
at retail or to feeds for nonruminant laboratory animals. If the pet food products or 
laboratory animal feeds are sold or are intended for sale as distressed or salvage items, 
then the cautionary statement is required. Distressed or salvage items may be fed to or 
become components of feed for other animals including ruminants. 
  Labeling for all other animal feeds is required to contain the cautionary statement, 
including feeds intended for nonruminant animals. 
  The statement must be placed prominently on the label or labeling. It should be 
conspicuous compared with other statements on the labeling. It should be placed on the 
labeling so that it is likely to be read and understood by the ordinary individual under 
usual conditions of purchase and use. 
  FDA suggests that the cautionary statement have a different type size or color from other 
labeling, or that you use some other means of highlighting the statement so that it is 
easily noticed by the purchaser. 
  For products shipped in bulk, the cautionary statement should appear on the invoice or 
other document, and placard or any other labeling that physically accompanies the 
shipment. 
  For products that are shipped in bags or other small containers, the cautionary statement 
should appear on the product labels. The labels can be attached to or be part of the bag or 
other container. 
  The statement should be included on any other labeling for the products. This can include 
leaflets, brochures, and other labeling materials whether or not they physically 
accompany the shipment of the products. An example might be a sales brochure that you 
mail to current and potential customers.  WHAT DO I NEED TO KNOW ABOUT THE RECORD KEEPING REQUIREMENT? 
  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 and/or your company. 
  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. 
  The records can be maintained for a shipment as a whole and do not have to be 
maintained for each individual container within a shipment. 
  Records need to identify the product: 
  Use of the product's common or usual name on the invoice or similar sales 
document will satisfy, in part, the "records" requirement of the regulation as well 
as the legal requirement that the product label bear its common or usual name. 
The common or usual names of rendered products typically are those included in 
definitions published by the Association of American Feed Control Officials 
(AAFCO), such as "meat and bone meal." 
  FDA regulations permit feed labels to contain collective terms, rather than 
common or usual names, in certain circumstances. For example, "animal protein 
products" can be used where the product contains certain ingredients such as meat 
and bone meal. The agency will not object to continued use of collective terms, 
provided that feed intended for ruminants does not contain protein from 
prohibited material, or the product contains the cautionary statement. 
  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. 
HOW CAN I AVOID COMMINGLING OR CROSS-CONTAMINATION? 
1. Separation 
  You could have separate equipment or facilities for the manufacture, processing, 
blending, 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. Cleanout 
  Cleanout 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. Cleanout 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 cleanout is 
implemented - who is responsible, how clean-out is monitored and verified; how volume 
of clean-out flush material was determined; and a description of how cleanout flush 
material is handled. OR 
3. Combination of Separation and Cleanout 
An example would be use of some separate and some common equipment (clean-out would be 
required for the latter). 
You need written procedures, whether you use separation, cleanout, or a combination: 
  Written procedures should include the procedures followed from the time of receipt of 
incoming material until the time of shipment 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 inspector should be able to easily identify operations that are 
described in the written procedures. 
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 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, flushing, sequencing or other equally effective techniques may be used. 
Under these methods, the equipment is cleaned through use of a nonprohibited 
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 facilities, feedmills should determine their facilities 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? 
  Products containing only nonprohibited material have no requirements under this 
regulation. 
  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 
  Dried Meat Solubles 
  Fleshings Hydrolysate 
  Meat Meal 
  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 
  Animal Digest 
  Cooked Bone Marrow 
  Leather Hydrolysate 
  Meat Protein Isolate 
  Mechanically Separated Bone Marrow 
  Bone Meal, cooked  
  Bone Meal, steamed  
  Stock 
  Dehydrated Garbage 
  Dehydrated Food-Waste 
PRODUCTS FOR IMPORT  
  All mammalian protein products imported into the U.S. are subject to the same 
requirements under this regulation as mammalian protein obtained from domestic 
sources. Persons responsible for importing mammalian protein should determine the 
origin and species of the imported product to be assured any prohibited material is 
handled in compliance with this regulation. NOTE: Importation of certain animal protein 
products from certain countries is prohibited by USDA regulations. 
PRODUCTS FOR EXPORT    Product containing prohibited material that is destined for export should be markedFOR 
EXPORT ONLY on the shipping containers if appropriate and on documents 
accompanying the shipment. No other labeling would be required for purposes of this 
regulation but there may be additional labeling requirements imposed by the country of 
destination. 
  Any product containing prohibited material that is destined for export and is diverted 
back to domestic commerce for any reason (salvage, quality, etc.), will be subject to all 
of the requirements of the regulation. This will include the requirement to label the 
product with the cautionary statement Do not feed to cattle or other ruminants. 
  Responsibility for these products containing prohibited material rests with the owner of 
the goods (holder of the title to the goods). The owner is responsible for assuring that 
they are not diverted back to domestic commerce unless they meet the requirements of 
the regulation, including the cautionary labeling statement. 
ARE THERE ANY PROVISIONS FOR PROHIBITED PRODUCTS TO BE EXEMPTED 
FROM THIS REGULATION? 
The regulation provides for two kinds of exemptions for prohibited products from the cautionary 
statement or records requirements: 
NOTE: The FDA has not validated any methods that would meet the requirements for any of the 
above exemptions. If and when the agency does so, it will provide additional guidance as needed 
for the implementation of such exemptions. 
1) Protein blenders, feed manufacturers, and distributors can be exempted from both the 
cautionary statement and records requirements if, among other things, they: 
a) Purchase animal protein products from renderers that certify compliance with a validated 
manufacturing method to deactivate the agent that causes transmissible spongiform 
encephalopathy (TSE) (BSE is a TSE), who routinely use a validated test method to detect the 
presence of the agent that causes TSEs, or who use exclusively a validated method for 
controlling the manufacturing process that minimizes the risk of the TSE agent entering the 
product; or 
b) Comply themselves with these exempting provisions. 
2) Protein blenders, feed manufacturers, and distributors can be exempted from the records 
requirement alone if, among other things, they: 
a) Purchase animal protein products that are marked by a permanent method, approved by FDA, 
indicating the presence of the prohibited materials; or 
b) Comply themselves with this marking requirement.