#195 
 
 
GUIDANCE FOR INDUSTRY  
 
SMALL ENTITIES COMPLIANCE GUIDE 
FOR RENDERERSSUBSTANCES PROHIBITED FROM USE IN 
ANIMAL FOOD OR FEED 
 
(This version of the guidance replaces the version that was made available on April 30, 2009.  This 
guidance document has been revised to clarify the compliance date of October 26, 2009.) 
 
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.  All written comments should be identified with Docket No. FDA-
2008-D-0597. 
 
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, Food and Drug Administration, 7519 Standish Place, 
Rockville, MD 20855, and may be viewed on the Internet at 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/d
efault.htm .  
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
May 6, 2009  CONTAINS NON-BINDING RECOMMENDATIONS 
 
 
 
TABLE OF CONTENTS 
 
 
 
 
I.  BACKGROUND........................................................................................................................3 
II. PURPOSE..................................................................................................................................3 
III. AGING CATTLE.....................................................................................................................6 
IV. BRAIN AND SPINAL CORD REMOVAL............................................................................7 
V. RECORDKEEPING..................................................................................................................8 
VI. MARKING REQUIREMENTS.............................................................................................10 
VII. WASTEWATER FROM RENDERING...............................................................................12 
VIII. TALLOW.............................................................................................................................12 
IX. ENFORCEMENT...................................................................................................................14 
X. APPENDIX A.........................................................................................................................16
   
 
Page 2  CONTAINS NON-BINDING RECOMMENDATIONS 
 
GUIDANCE FOR INDUSTRY 
 
SMALL ENTITIES COMPLIANCE GUIDE 
FOR RENDERERSSUBSTANCES PROHIBITED FROM USE IN 
ANIMAL FOOD OR FEED1 
 
 
 
 
This guidance 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 alternative 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 
guidan ce. 
I.  BACKGROUND  
 
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 74 FR 18626; April 
24, 2009, which confirmed the effective date and established a compliance date of October 26, 
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 and, amended the previously existing ruminant feed regulation at 21 CFR 
589.2000 entitled, Animal proteins prohibited in animal feed.  FDA has prepared this Small 
Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Public Law 104-121).  This document is intended to 
provide guidance on the requirements of Title 21, Code of Federal Regulations, new Section 
589.2001, and amended Section 589.2000. 
 
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. 
 
II. PURPOSE 
 
                                                 
1 This guidance has been prepared by the Office of Surveillance and Compliance in the Center for Veterinary 
Medicine at the Food and Drug Administration. 
   
 
Page 3  CONTAINS NON-BINDING RECOMMENDATIONS 
 
WHAT IS THE PURPOSE OF REGULATION 589.2001? 
 
This regulation is designed to further strengthen existing safeguards against 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 cattle 
origin materials in the food or feed of all animals. 
 
The following materials are prohibited in all animal feed by the new rule: 
 
  The entire carcass of BSE-positive cattle; 
 
  The brains and spinal cords from cattle 30 months of age and older; 
 
  The entire carcass of cattle not inspected and passed for human consumption that are 30 
months of age or older from which brains and spinal cords were not effectively removed 
or otherwise effectively excluded; 
 
  Tallow that is derived from other materials prohibited by this rule that contain more than 
0.15 percent insoluble impurities; and 
 
  Mechanically separated beef that is derived from the materials prohibited by this rule. 
 
Throughout the regulation, these materials are referred to as cattle materials prohibited in 
animal feed or CMPAF.  If you (i.e., renderers) receive, manufacture, blend, process, or 
distribute any of these materials, you must comply with the provisions of this regulation (21 
CFR 589.2001(c)(2)). 
 
ARE THERE ANY CATTLE MATERIALS SPECIFICALLY EXEMPTED FROM THIS 
REGULATION? 
 
Yes.  The following materials do not fall under the definition of CMPAF: 
 
  Tallow derivatives (as defined in the regulation (See 21 CFR 589.2001(b)(6)). 
 
  Tallow that is derived from material containing the brains and spinal cords of cattle 30 
months of age and older if such tallow contains no more than 0.15 percent insoluble 
impurities. 
 
  Cattle materials (as defined in the regulation (See 21 CFR 589.2001(b)(vi)(C))) from a 
foreign country that has received designation by FDA as not being subject to the new 
regulation. 
 
 
 
   
 
Page 4  CONTAINS NON-BINDING RECOMMENDATIONS 
 
 
WHAT IS THE DIFFERENCE BETWEEN CATTLE MATERIAL PROHIBITED IN 
ANIMAL FEED (CMPAF) AND SPECIFIED RISK MATERIAL (SRM)? 
 
SRM tissues, which are prohibited for use in human food by USDAs Food Safety and 
Inspection Service (FSIS) (9 CFR 310.22 (a)), consist of (1) the brain, skull, eyes, trigeminal 
ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse 
processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root 
ganglia from cattle 30 months of age and older; and (2) the distal ileum of the small intestine 
and the tonsils from all cattle.  FDA has also prohibited the use of these materials in human 
food (See 21 CFR 189.5(a)(5)).  CMPAF, which is prohibited in all animal feed, includes two 
tissues from this list  the brain and spinal cord from cattle 30 months of age and older, as well 
as materials that contain these tissues.  Unlike SRMs, CMPAF does not include the skull or 
vertebral column if the brain and spinal cord were effectively removed. (21 CFR 589.2001). 
 
IS MY FIRM AFFECTED BY THIS REGULATION? 
 
Under this regulation, no animal feed or feed ingredient can be manufactured from, processed 
with, or contain CMPAF.  As a result, FDA imposes requirements on renderers of specifically 
defined cattle materials.  For purposes of the regulation, FDA defines a renderer as any firm or 
individual that processes slaughter byproducts, animals unfit for human consumption, which 
would include carcasses of dead cattle, or meat scraps.  The definition of renderer includes: 
 
  Persons or firms that collect the materials set forth above and subjects them to 
minimal processing; 
 
  Persons or firms that distribute the materials to firms other than renderers whose 
intended use for the products may include animal feed, industrial use, or other uses; 
and 
 
  Persons or firms that also blend animal protein products.  21 CFR 589.2001(b)(4). 
 
 
I AM A RENDERER WHO PICKS UP CATTLE MORTALITIES FOR RENDERING.  
WHAT DO I NEED TO KNOW IF THE RENDERED MATERIALS FROM THOSE 
CATTLE ARE INTENDED FOR NON-RUMINANT FEED? 
 
The regulation requires you to remove the brain and spinal cord from dead cattle (cattle not 
inspected and passed for human consumption) if the cattle are to be processed for use in non-
ruminant animal feed.  21 CFR 589.2001(c)(2)(i).  However, this is not required if the animal 
can be shown to be less than 30 months of age.  You can decide how best to determine the age 
of an animal, but you must have adequate written procedures explaining how you do the aging 
and make these written procedures available for FDA inspection.  21 CFR 589.2001(c)(2)(ii), 
(vi).  You must also have written procedures explaining how you remove, segregate and 
   
 
Page 5  CONTAINS NON-BINDING RECOMMENDATIONS 
 
dispose of the brain and spinal cord of animals not shown to be less than 30 months of age and 
make these written procedures available for FDA inspection. 
 
HOW DOES THIS NEW REGULATION AFFECT FEEDING CATTLE MATERIAL TO 
MINK? 
 
The rule applies to feed for all animal species.  Therefore, CMPAF must be removed from 
cattle material fed to mink. 
 
III. AGING CATTLE 
 
WHAT IS THE BEST WAY TO DETERMINE THE AGE OF AN ANIMAL? 
 
The best evidence of age is written documentation that includes the name and address of the 
current owner, and identifies the date and location where the animal was born.  Types of 
documents that might contain this information are breed association registrations, production 
records, or animal identification systems.  The documentation should relate identifying devices 
on the animal (such as official calf hood or other ear tags, electronic implants, or brands) with 
information about the age of the animal.   
 
CAN I ACCEPT AN OWNERS STATEMENT THAT AN ANIMAL IS LESS THAN 30 
MONTHS OF AGE? 
 
Yes.  You may choose to accept certification from the owner of the animal that he or she is in 
possession of appropriate written documentation showing that the animal is less than 30 
months of age.  If you accept certification from producers, you may want to specify in your 
written procedures how producers will identify to drivers of collection trucks that an animal is 
certified to be less than 30 months of age.  For example, you may have a pre-arranged 
agreement with producers that animals under 30 months of age will be identified by a certain 
color or type of leg band. 
 
CAN DENTITION (EXAMINATION OF AN ANIMALS TEETH) BE USED TO AGE 
CATTLE?  
 
Yes, dentition can be used to determine if cattle are less than 30 months of age.  Veterinary 
medical textbooks and academic articles indicate that the second set of permanent incisors (i.e., 
third and fourth permanent incisors) come through the gum line when cattle are between 24 
and 30 months of age.  Therefore, cattle would be considered to be less than 30 months of age 
if the third permanent incisor has not yet come through and grown above the gum line.  Please 
refer to Appendix A at the end of this guidance document, which provides diagrams from 
USDAs Food Safety and Inspection Service (FSIS) Notice 5-04 (1/12/04), illustrating how 
   
 
Page 6  CONTAINS NON-BINDING RECOMMENDATIONS 
 
dentition can be used to identify animals under 30 months of age.  The diagrams, as well as 
photographs, are also available on the FSIS Web site.2 
 
WHAT ABOUT CALVES THAT ARE OBVIOUSLY LESS THAN 30 MONTHS OF 
AGE? 
 
Body weight, size, and appearance can be reliable indications of age in very young animals.  
These characteristics could obviate the need for documentation or other means of determining 
the animals age. 
 
ARENT CATTLE FROM FEEDLOTS GENERALLY LESS THAN 30 MONTHS OF 
AGE? 
 
Yes.  Cattle in concentrated feeding programs are often sent to slaughter well before 30 months 
of age.  As a renderer, your written procedures for aging cattle might include a description of 
arrangements made with a feedlot to ensure that dead cattle you receive from that feedlot are 
less than 30 months of age. 
 
WHAT CAN I EXPECT WHEN AN FDA INSPECTOR REVIEWS MY PROCEDURES 
FOR AGING CATTLE? 
 
FDA inspection personnel, including state inspectors working on FDAs behalf, will verify that 
you have adequate written procedures in place, evaluate the adequacy of aging procedures, and 
verify that the procedures are being followed.  If an inspector determines there is no basis to 
question the accuracy and reliability of your aging procedures, the inspector is expected to 
accept those procedures as verification of the age of the cattle.  
 
Conversely, inspectors are expected to investigate further if they believe that your aging 
procedures are incorrectly identifying animals as less than 30 months of age.  Investigators 
may conduct hands-on dentition examinations of animals that they believe to be 30 months of 
age or older.  In resolving discrepancies, written documentation that the inspector believes to 
be valid should be accepted as the final determinant of age.  
 
IV. BRAIN AND SPINAL CORD REMOVAL 
 
WHAT DO I HAVE TO DO IF I WANT TO REMOVE THE BRAIN AND SPINAL 
CORD FROM DEAD CATTLE 30 MONTHS OF AGE OR OLDER SO THAT I CAN 
RENDER THE REMAINDER OF THE CARCASS FOR USE IN NON-RUMINANT 
FEED? 
 
                                                 
2http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OFO/TSC/bse_information.htm 
   
 
Page 7  CONTAINS NON-BINDING RECOMMENDATIONS 
 
You are required to have adequate written procedures explaining your methods for the 
removal, segregation, and disposition of the brain and spinal cord (or material containing the 
brain and spinal cord) and make these written procedures available for FDA inspection.  21 
CFR 589.2001(c)(2)(ii), (vi). 
 
WHAT IS THE BEST METHOD FOR REMOVING THE BRAIN AND SPINAL CORD? 
  
There is no single best method for brain and spinal cord removal.  The choice of methods could 
depend on the layout of the plant, cost of equipment, skill level of employees, availability of 
alternative means of disposing of tissues that surround the brain and spinal cord, and a number 
of other considerations.  Some options for removing the brain are: 
  the use of suction equipment or other tools to remove the brain through the foramen 
magnum (large hole at the base of the skull through which the spinal cord passes); 
  opening the skull to expose the brain cavity; and 
  leaving the brain in place and treating the entire head as CMPAF.  
    
Some options for removing the spinal cord are: 
  removing the hide, eviscerating the carcass (removing the contents of the abdominal 
cavity), and using a saw to split the carcass down the midline to expose the spinal 
canal; 
  using cutting equipment to remove the spinal cord with surrounding vertebral column, 
with or without hide removal or evisceration; and 
  removing skeletal muscle or other parts and leaving the spinal cord in place, treating 
the remainder of the carcass as CMPAF. 
 
WHAT CAN I EXPECT WHEN AN FDA INSPECTOR REVIEWS MY PROCEDURES 
FOR REMOVING BRAIN AND SPINAL CORD? 
 
FDA inspection personnel, including state inspectors working on FDAs behalf, will verify that 
you have adequate written procedures in place and that the procedures are designed to ensure 
effective removal of the brain and spinal cord.  Inspection personnel will verify proper 
execution of procedures by reviewing production records and observing plant employees 
performing the procedures.  Inspectors may also conduct inspections to verify that brain and 
spinal cord have been effectively removed.  
 
V. RECORDKEEPING 
 
WHAT DO I NEED TO KNOW ABOUT THE NEW RECORDKEEPING 
REQUIREMENTS? 
 
The new regulations set forth recordkeeping requirements applicable to all renderers of cattle 
materials.  There are slight differences between the requirements for renderers who handle 
CMPAF, and those who do not:   
   
 
Page 8  CONTAINS NON-BINDING RECOMMENDATIONS 
 
 
  If you are a renderer that receives, manufactures, processes, blends, or distributes 
CMPAF, you are required to establish and maintain records sufficient to track the 
CMPAF to ensure that they are not introduced into animal feed.  21 CFR 
589.2001(c)(2)(vi). 
 
  If you are a renderer that receives, manufactures, processes, blends, or distributes 
any cattle materials, you must meet the recordkeeping requirement as follows: 
 
o  You must establish and maintain records that sufficiently demonstrate that 
materials rendered for use in animal feed do not contain CMPAF. 
o  If these materials were obtained from an establishment that segregates 
CMPAF from other materials, your records must demonstrate that the 
supplier has adequate procedures in place to effectively exclude CMPAF 
from any materials supplied to you.  21 CFR 589.2001(c)(3)(i).  Your 
records will meet this requirement if they include either: 
  Certification or other documentation from the supplier that 
materials supplied do not include CMPAF.  These records must 
include a description of the segregation procedures used, 
documentation that the supplier confirms that such segregation 
procedures were in place prior to supplying the materials, and 
records of your periodic review of the suppliers paperwork, i.e., 
certification or other documentation.  21 CFR 
589.2001(c)(3)(i)(A). 
      OR 
  Documentation of another method acceptable to FDA, such as 
third-party certification, for verifying that the supplier has 
effectively excluded CMPAF from any materials shipped to the 
renderer (see additional discussion below).  21 CFR 
589.2001(c)(3)(i)(B). 
     
*   Normal and customary business records maintained by you and/or your company might 
already contain much of the information required by the rule.  Electronic records are 
acceptable when in compliance with 21 Code of Federal Regulations Part 11. 
 
*  The required records could include invoices, receiving tickets, receiving logs, 
disbursement and distribution records, scale tickets, purchase orders, signed affidavits or 
other written statements from slaughter and processing establishments, or other business 
records or documents. 
 
*  Copies of all records must be made available for inspection and copying.  21 CFR 
589.2001(c)(2)(vi); (c)(3)(i).  Records should be readily retrievable and legible. 
 
   
 
Page 9  CONTAINS NON-BINDING RECOMMENDATIONS 
 
*  Records must be maintained for 1 year.  21 CFR 589.2001(e).  That should be 1 year 
from the date the records were created.  Because renderers handling any cattle materials will 
be relying on certification or other documentation from suppliers, renderers are urged to 
notify their suppliers of the renderers' 1-year record retention requirement.  
 
*  All records (including certificates or other documentation) provided by any party for 
demonstrating compliance with this rule should be accurate and truthful.  The knowing and 
willful making of any false, fictitious or fraudulent statements or representations in any 
manner within the jurisdiction of any department or agency of the United States is a matter 
subject to the provisions of Title 18 of the U.S. Code, Section 1001.   
 
 
FOR PURPOSES OF THE SUPPLIERS DOCUMENTATION DISCUSSED ABOVE, 
HOW WOULD THIRD-PARTY CERTIFICATION WORK? 
 
Third-party certification to verify compliance with regulatory requirements is being used 
widely in both the private and public sectors.  FDA recognizes the usefulness of such services 
and in July 2008 published its Guidance for Industry: Voluntary Third-Party Certification 
Programs for Foods and Feeds.3  Third-party certification is characterized as fee-based, 
voluntary product certification and production/processing verification services.  Such 
certification provides independent assurance that regulatory requirements are met.  Written 
production and manufacturing processes and recordkeeping requirements are typically 
confirmed through third-party audits that follow strict guidelines covering specific areas. 
 
There are several third-party certifiers that provide independent auditing services to help 
ensure compliance with requirements for manufacturing, food safety, and documents and 
records.   
 
If you choose to use third-party certification to verify that suppliers have excluded CMPAF 
from any materials supplied to you, copies of the audits and similar reports produced by the 
third-party certification firm should satisfy the recordkeeping requirement. 
 
 
VI. MARKING REQUIREMENTS 
 
WHAT ARE THE MARKING REQUIREMENTS IN THE NEW RULE? 
 
Once CMPAF has been separated from other cattle materials, renderers are required to mark 
the CMPAF with an agent that can be readily detected on visual inspection.  21 CFR 
589.2001(c)(2)(v).  The marking agent is intended to indicate to all parties in the feed chain 
that the material may not be used in animal feed.  However, if material containing CMPAF is 
                                                 
3 http://www.fda.gov/oc/guidance/thirdpartycert.html  
   
 
Page 10  CONTAINS NON-BINDING RECOMMENDATIONS 
 
to be rendered to salvage tallow, the marking agent may be applied after the rendering process 
(see diagram below).  In this way, tallow containing no more than 0.15% insoluble impurities 
(II) would not have to be marked because it could be used in animal feed.  The marking agent 
would have to be applied only to the solids portion, i.e., the resulting meat and bone meal 
(MBM), and to tallow containing more than 0.15% insoluble impurities.  The rule does not 
require carcasses of animals disposed of on the farm (e.g., by burial or composting) to be 
marked.   
Rendering 
Non-ruminant feed 
No marking 
<_0.15% II 
Ruminant feed 
No marking 
CMPAF*  Tallow 
>0.15% II**
MBM 
Disposal only 
Marking required 
Disposal only 
Marking required 
*materials that contain CMPAF such as entire carcasses of animals 30 months of age or older, brain and spinal cord or animals 
30 months of age or older and other materials that contain or may contain CMPAF, are required to be marked at this point only if 
not intended for rendering 
 
**contains or may contain CMPAF
 
WHAT ARE THE ACCEPTABLE MARKING AGENTS AND HOW DO I APPLY 
THEM? 
 
Acceptable marking agents would include Patent Blue V (E131), approved in Europe for this 
purpose, or the list of agents approved for this purpose by the Canadian Food Inspection 
Agency.4 A marking agent should be applied by spraying, dipping, or some other manner so 
that the agent is visible on all surfaces of such marked CMPAF.  FSIS regulations require that 
slaughter plants mark inedible material to indicate that it is not fit for human consumption.  
Renderers may want to suggest that their slaughter plant suppliers, as part of their segregation 
procedures, mark material containing CMPAF with a different agent, so that it can be readily 
distinguished from the inedible material that is to be rendered for animal feed use.  
 
                                                 
4http://active.inspection.gc.ca/scripts/fssa/reference/refresults.asp?lang=e&cmd=4&cat=13&subcat=60&sub=SUBMIT  
   
 
Page 11  CONTAINS NON-BINDING RECOMMENDATIONS 
 
VII. WASTEWATER FROM RENDERING   
 
AS A RENDERER OR PROCESSOR, HOW SHOULD I HANDLE DISLODGED 
CMPAF AND NON-CMPAF TISSUES RECOVERED FROM WASTEWATER?  
 
Operations that remove CMPAF or render CMPAF should take reasonable precautions and 
employ reasonable methods to contain and collect dislodged CMPAF tissues, including such 
tissues recovered from wastewater.  For example, removing CMPAF from the carcass in a 
designated area, collecting the dislodged CMPAF into a container designated for CMPAF, and 
screening CMPAF from the wastewater collection system.  Inspection personnel will assess the 
adequacy of the methods described in your written procedures for removal of CMPAF.  In 
addition, when removing CMPAF from the carcasses of cattle 30 months of age and older, 
renderers must consider non-CMPAF tissues that are dislodged and comingled with CMPAF in 
wastewater during the removal process to also be CMPAF.  In this situation, all strained solids 
are CMPAF and should be marked as CMPAF as explained in the diagram above. 
 
VIII. TALLOW 
 
WHAT DO I NEED TO KNOW ABOUT THE NEW REQUIREMENTS FOR TALLOW? 
 
The new 21 CFR 589.2001 describes the requirements for tallow intended for use in feed for 
non-ruminant animals.  The 1997 ruminant feed regulation (21 CFR 589.2000) has also been 
revised to add requirements for tallow intended for use in feed for ruminant animals.  The 
overall effect of these two regulations on the use of tallow in animal feed is as follows:  
 
If your tallow meets the impurity standard of no more than 0.15% insoluble impurities, then it 
may be used in feed intended for all animals, regardless of its origin.  Tallow that does not 
meet the 0.15% insoluble impurities standard is prohibited from use in ruminant feed but may 
be used in feed for non-ruminant animals if the tallow is derived from documented CMPAF-
free sources.       
    
Since 21 CFR 589.2000 now requires that tallow used in feed for ruminant animals contain no 
more than 0.15% insoluble impurities, the tallow you distribute should either meet the impurity 
standard or be labeled with the caution statement: Do not feed to cattle or other ruminants.  
If your intent is to meet the impurity standard, you should have a written description of your 
procedures for accomplishing this.  For example, this may include a written tank management 
plan; procedures for load-out of tallow from storage tanks; procedures for sampling 
tanks, containers, or finished loads; and analytical results from a laboratory that uses AOCS 
Official Method Ca 3a-46, or an equivalent method.  
 
Insoluble impurities, by definition, are not soluble in tallow or other fats.  They are particles 
that may be suspended in tallow that has been or is being heated, agitated, or moved.  Over 
time, impurities will migrate toward the bottom of a tank that has not been disturbed.  The rate 
   
 
Page 12  CONTAINS NON-BINDING RECOMMENDATIONS 
 
at which impurities will settle is affected by the size and weight of the particles, viscosity of 
the tallow, and time.  Therefore, when sampling tallow to measure insoluble impurity levels, 
the length of time allowed for impurities to settle and the location in the tank where the sample 
is drawn from will affect the results.  For this reason, your sampling procedures should be 
developed so that test results accurately reflect the insoluble impurity level in tallow that you 
intend to offer into commerce as meeting the impurity standard established in 21 CFR 
589.2001.  Similarly, if an inspector visits your facility to collect a tallow sample, we suggest 
that you explain your sampling procedures to the inspector so the sample they collect is 
representative of the tallow product you offer for distribution.  
 
ARE ALL FATS CONSIDERED TO BE TALLOW? 
 
For purposes of 21 CFR part 589, tallow means the rendered fat of cattle.  All other fats and 
oils not derived from cattle are not subject to this rule.  For example, these would include, but 
not be limited to, fats and oils derived from poultry, pork, sheep, goats, equine, fish, and 
vegetable-based sources.  In addition, recovered cooking oils from restaurants and food 
processors are exempt, because any tallow present in them is from edible sources from which 
CMPAF has already been removed under USDA inspection.   
 
 
ARE FEED MILLS REQUIRED TO CLEAN OUT THEIR TALLOW TANKS BEFORE 
THE COMPLIANCE DATE? 
 
No.  Tallow used in animal feed after the compliance date must meet the new impurity 
standard.  This may be accomplished through physically cleaning the tank, switching to new 
product in advance of the compliance date, or by some other means.  The method used for 
bringing tallow tanks into compliance should be documented to meet the record keeping 
requirement of the new rule.  Examples of such written documentation could include copies of 
invoices of incoming product that meets the impurity standard, equipment maintenance logs, 
lab reports, and tank management plans.    
 
DO I NEED TO PROVIDE A CERTIFICATE OF ANALYSIS (COA) FOR INSOLUBLE 
IMPURITIES FOR EACH SHIPMENT OF TALLOW? 
 
No.  While some customers may request a COA for each load, the new regulation does not 
require that you test or certify each load.  The rule does require, however, that you have written 
procedures for ensuring that your tallow meets the standard if it is to be used in feed for cattle.  
In addition, the ingredient definition established by the Association of American Feed Control 
Officials (AAFCO) for animal fat contains specific information on how tallow is to be 
labeled, including a guarantee for maximum insoluble impurities. 
 
CAN I BE HELD RESPONSIBLE FOR THE IMPURITY LEVEL IN THE TALLOW 
AFTER I DELIVER IT TO MY CUSTOMERS STORAGE TANKS OR OTHER 
EQUIPMENT? 
   
 
Page 13  CONTAINS NON-BINDING RECOMMENDATIONS 
 
 
FDA understands that impurities that have settled in a customers equipment or storage tank 
may be re-suspended when new tallow is added, which could cause a tallow sample collected 
from the tank to exceed the limit on insoluble impurities.  Therefore, it may not be appropriate 
to take enforcement action based solely on a sample from a customers storage tank.  
Compliance will be determined on a case-by-case basis, and all relevant information will be 
considered.  In its training program for FDA inspectors and state inspectors acting on FDA's 
behalf, FDA will emphasize the need to collect tallow samples in a manner that reflects the 
impurity level of the tallow the renderer offered into commerce. 
 
SOME BEEF PROCESSORS PRODUCE EDIBLE TALLOW (TALLOW SUITABLE 
FOR USE AS HUMAN FOOD).  TALLOW FOR HUMAN FOOD MAY EITHER BE 
PRODUCED FROM MATERIAL FREE OF SRMS, OR MEET THE 0.15% IMPURITY 
STANDARD.  WHY DOESNT THE SAME OPTION APPLY TO TALLOW FOR 
CATTLE FEED, THAT IS, THAT IT EITHER BE MADE FROM CMPAF-FREE 
MATERIAL OR CONTAIN NO MORE THAN 0.15% INSOLUBLE IMPURITIES? 
   
The new regulation requires that all tallow intended for use in cattle feed meet the impurity 
standard of no more than 0.15% insoluble impurities because cattle are assumed to be more 
susceptible than humans to the BSE agent.        
 
CAN TALLOW CONTAINING MORE THAN 0.15% INSOLUBLE IMPURITIES BE 
BROUGHT INTO COMPLIANCE WITH THE IMPURITY STANDARD BY FURTHER 
PROCESSING IT TO REMOVE IMPURITIES? 
 
Yes.  However, appropriate controls should be in place during shipping and handling to ensure 
that tallow not meeting the impurity standard does not end up in cattle feed.   
 
DOES THE INSOLUBLE IMPURITIES STANDARD OF NO MORE THAN 0.15% 
INSOLUBLE IMPURITIES APPLY TO BLENDED FATS AND OILS? 
 
FDA regulations do not establish a standard for insoluble impurities in any type of fats or oils 
other than tallow (animal fat from cattle).  The impurity standard in the new regulation would 
apply to tallow that is to be blended with other fats or oils, but would not apply to the blended 
product. 
 
WOULD THE CAUTION STATEMENT DO NOT FEED TO CATTLE OR OTHER 
RUMINANTS BE NEEDED ON THE BLENDED PRODUCT? 
 
No, unless the tallow used in the blended fat product exceeded the impurity standard. 
 
IX. ENFORCEMENT 
 
   
 
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WILL FDA COMMUNICATE WITH STATE INSPECTORS CONDUCTING 
INSPECTIONS ON FDA'S BEHALF REGARDING THE AGENCYS EXPECTATIONS 
ON HOW THE NEW REGULATION SHOULD BE ENFORCED, SO THAT IT IS 
ENFORCED UNIFORMLY? 
 
Yes.  FDA plans to provide training to State inspection personnel conducting inspections for 
FDA, as well as to our own investigators.  Also, the Compliance Program for our BSE 
inspection program will be updated and will address many of these issues.  The Compliance 
Program, guidance documents developed for this rule, as well as the original feed ban, and a 
variety of other information are all public documents available on the CVM website.  These 
documents contain a great deal of information that may be useful to both inspection and 
industry personnel.   
   
 
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FDA GUIDANCE FOR INDUSTRY 195 
X. APPENDIX A 
 
FSIS Notice 5-04 
  
The dentition depicted below represents 
animals less than 30 months of age 
   
   
 
 
 
   
 
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The dentition depicted below represents animals 30 months 
of age or older 
   
   
   
 
   
 
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