FDA GUIDANCE FOR INDUSTRY 67 
This guide replaces those parts of Guidance for Industry 60, June 17, 1997, that applied to renderers. 
 
SMALL ENTITIES COMPLIANCE GUIDE 
FOR RENDERERS 
(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.  
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
February 1998  WHAT IS THE PURPOSE 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. However, certain products are exempt from the regulation: 
  The following protein products derived from mammals are  
exempt: 
  Blood and blood products P  
  Gelatin 
  Milk products (milk and milk proteins) 
  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 you are not required to comply 
with the provisions of this regulation. This material is referred to as nonprohibited material 
throughout this guide. 
All other mammalian protein will be referred to as prohibited material throughout this guide. 
If you receive and process this material, you must comply with the provisions of 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 a renderer as any firm or individual that processes slaughter byproducts, 
animals unfit for human consumption, or meat scraps. This definition includes: 
  establishments traditionally considered to be renderers; 
  those who collect slaughter by-products, animals unfit for human consumption, or meat 
scraps, and subject them to minimal processing; 
  those who collect and distribute slaughter by-products, animals unfit for human 
consumption, or meat scraps, to firms other than renderers; and 
  renderers that also blend animal protein products. The Small Entities Compliance Guide 
for Protein Blenders, Feed Manufacturers, and Distributors, FDA Guidance for Industry 
68, applies to protein blending operations. The distribution activities of renderers are 
included in this regulation. 
A slaughterhouse, dealer, hauler, or anyone else who supplies you with product to be rendered is 
not subject to specific requirements under this regulation. However, if you separate prohibited 
from nonprohibited material, you may wish to have assurance from your supplier of 
nonprohibited material about the products contents. This could include a certification from the 
supplier, or specification of source in a business contract. 
Even if you fall within the definition of renderer, you are not subject to the regulation if you do 
not receive and process any prohibited material. 
If you obtain raw materials from a variety of sources, and may not be able to determine the 
species of some incoming material, the material is considered prohibited material because it 
"contains or may contain" prohibited products. Prohibited materials also includes products 
sold by renderers that may be able to determine the species of all their incoming materials, but 
choose not to separate prohibited from nonprohibited materials. 
There are two categories of renderers that process prohibited material - 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 Do Not Separate Prohibited and Nonprohibited Material 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 by the FDA. 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 Have Three Additional Requirements: 
4. Obtain non-prohibited material (including pure pork and pure equine) only from single species 
slaughter facilities. Single species slaughter facilities are those that are dedicated solely to the 
slaughter of a single species of animal. 
5. Provide for measures to avoid commingling or cross-contamination of prohibited and 
nonprohibited materials. 
6. 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. 
  The cautionary 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 cautionary 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?    This requirement does not anticipate the creation of 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 products 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. 
  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 PROVIDE FOR MEASURES TO 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 materials. This could be entirely 
separate buildings, rooms, or other locations; or separate storage containers for incoming 
material and finished product, and separate manufacturing lines. 
  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 volume 
of clean-out flush material was determined; and a description of how clean-out flush 
material is handled. 
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 latter). 
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 shipment of finished products. 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. 
WHAT ARE SOME EXAMPLES OF MEASURES THAT I COULD FOLLOW TO 
PREVENT COMMINGLING AND CROSS CONTAMINATION? 
EXAMPLE PROCESSING OPTION #1 
This example is a single plant with two or more totally segregated processing lines. This 
includes all process functions from raw material receiving through and including finished 
product load-out. 
Suggested Procedures for Processing Option 1 
No clean-out procedures are necessary for this processing situation, because the lines are 
completely separate. This type of plant should have the ability to process prohibited and non-
prohibited products from the same plant so long as procedures are in place to assure total 
segregation. These procedures should be part of the plant's written procedures specifying 
measures the firm is taking to prevent commingling and cross contamination and should be 
available for inspection and FDA review for compliance purposes. 
EXAMPLE PROCESSING OPTION #2 
This example is a single plant which has two or more segregated raw material receiving, 
grinding, cooking, and pressing lines but shares finished product conveying, grinding, and load-
out systems. 
Suggested Procedures for Processing 0ption 2 
The suggested procedures to prevent commingling and cross contamination for this type of plant 
deal specifically with the meal grinding (and screening), storage, and load-out systems. It is 
assumed that this type of plant would have separate storage facilities for prohibited versus non-
prohibited product. It may have separate or common load-out facilities. 
STEP #1 - The first step in the clean-out and flushing procedure should be to empty all transport 
and process equipment from the first point of commonality of products to the final load-out 
device.  STEP #2 The system should then be flushed with a sufficient volume of nonprohibited product 
to accomplish one complete change of operating volume of the entire system (exclusive of 
separate meal storage facilities). The flush material should be considered prohibited product and 
treated as such. 
STEP #3 - Once the system has been flushed, all subsequent material processed would be non-
prohibited material. Specific operating procedures should be part of the plant's written 
procedures specifying the procedures to prevent commingling and cross contamination and 
available for inspection and FDA review for compliance purposes. 
EXAMPLE PROCESSING OPTION #3 
This example is a single plant with separate raw material receiving and grinding, common 
cooking and pressing, and common or separate finished product handling. 
Suggested Procedures for Processing Option 3 
The procedures to prevent commingling and cross contamination for this type of plant deal 
specifically with the cooking and pressing systems. The meal grinding, storage, and load-out 
systems should be cleaned and flushed according to the guidance in processing option 2 above. It 
is also assumed that this type of plant would have separate storage facilities for prohibited versus 
non-prohibited finished meal. It may have separate or common load-out facilities. 
STEP #1 - The first step should be to empty all transport and process equipment (including the 
cooker) from the first point of commonality of raw material to the meal grinding system. 
STEP #2 - The system should then be cleaned and/or flushed with sufficient nonprohibited raw 
material to accomplish the following changes of the operating volume of the cooker: 
  In the case of a continuous cooker with a bottom discharge (to provide positive cooker clean-
out), raw material equal to at least one half the operating volume of the cooker; 
  In the case of a continuous cooker without a bottom discharge, raw material equal to at least 
the operating volume of the cooker; or  
  In the case of a batch cooker system, raw material equal to at least one half the operating 
volume of the cooker for each batch cooker. In general, the volume of material required to 
flush the cooking system should provide an adequate flush of the meal grinding, storage and 
load-out system, as well. The flush material should be considered prohibited product and 
treated as such. All subsequent material processed should be considered non-prohibited 
product. Specific operating procedures should be documented and verified, should be part of 
the plant's written procedures specifying the procedures utilized to prevent commingling and 
cross contamination, and should be available for inspection and FDA review for compliance 
purposes. 
EXAMPLE PROCESSING OPTION #4  This example is for a single plant with one processing line handling both prohibited and non-
prohibited material. This includes all process functions from raw material receiving through and 
including product load-out. 
Suggested Procedures for Processing Option 4 
The procedures to prevent commingling and cross contamination for this type of plant deal with 
the complete plant process. It is assumed that this type of plant would have adequate storage 
facilities to separate prohibited from non-prohibited finished product. It may have separate or 
common load-out facilities. 
The procedures should include measures to empty and clean and/or flush all transport and 
process equipment including the raw material receiving hoppers, conveyors, grinders, and cooker 
from the first point of commonality of raw material through the load-out system. As a guideline, 
the volume of flushing material should be equal to the operating volume of the process and 
transport equipment, including the cookers. 
The flush material should be considered prohibited product and treated as such. All subsequent 
material processed should be considered non-prohibited product. Specific operating procedures 
should be documented and verified, should be part of the plant's written procedures specifying 
the procedures utilized to prevent commingling and cross contamination, and should be available 
for inspection and FDA review for compliance purposes. 
Due to the degree of variability among rendering systems, a Hazard Analysis and Critical 
Control Points (HACCP)-based approach of process controls would be helpful in implementing 
any of the above procedures. This will enable differences to be addressed on a site-specific basis. 
Renderers could follow the above clean-out procedures by determining their plant's individual 
characteristics and apply appropriate time and volume requirements for flushing material to 
accomplish the intent of the procedures. Individual clean-out procedures, including time and 
volume calculations, should be part of the plant's written procedures specifying the procedures 
utilized to prevent commingling and cross-contamination and should be available for inspection 
and FDA review for compliance purposes. 
WHAT OTHER INFORMATION DO I NEED TO KNOW TO HELP ME COMPLY 
WITH THIS REGULATION? 
SINGLE SPECIES SLAUGHTER FACILITIES 
  Single species slaughter facilities are those that are dedicated solely to the 
slaughter of a single species of animal. That means any facilities slaughtering 
different species on different days, different shifts, or on different processing 
lines, even if done only occasionally, are not single species facilities. 
  Product received from different single species slaughter facilities may be 
combined or blended at the renderer and it may be commingled with other protein 
products as long as the requirements of the regulation are met.  PRODUCTS FOR IMPORT 
  All mammalian protein product imported into the U.S. is 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 
regulation. 
PRODUCTS FOR EXPORT 
  Prohibited protein product destined for export should be marked "FOR 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 for the country 
of destination. 
  Any prohibited protein product destined for export which 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 prohibited protein products 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. 
  Product consisting only of nonprohibited protein has no requirements under this 
regulation. 
ARE THERE ANY PROVISIONS FOR PROHIBITED PRODUCTS TO BE EXEMPTED 
FROM THIS REGULATION? 
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. 
The regulation provides for two levels of exemption from the cautionary statement and records 
requirements: 
1) Renderers can be exempted from both the cautionary statement and records requirements if 
they do any one of three things: 
a) Use exclusively a manufacturing method that has been validated by the FDA to deactivate the 
agent that causes transmissible spongiform encephalopathy (TSE) (BSE is a TSE) and whose 
design has been made available to the public;  b) Use routinely a test method that has been validated by the FDA to detect the presence of the 
agent that causes TSE's and whose design has been made available to the public. Products found 
by such test to contain the agent that causes TSE's shall be labeled "Do not feed to cattle or other 
ruminants." Records of the test results shall be made available for inspection by the FDA; or 
c) Use exclusively a method for controlling the manufacturing process that minimizes the risk of 
the TSE agent entering the product and whose design has been made available to the public and 
validated by FDA. 
2) Renderers can be exempted from the records requirement alone if they use a permanent 
method, approved by FDA, to make a mark indicating the presence of the mammalian materials. 
If the marking is by the use of an agent that cannot be detected on visual inspection, the renderer 
must use an agent whose presence can be detected by a method that has been validated by the 
FDA and whose design has been made available to the public.