#246 
Hazard Analysis and Risk-Based 
Preventive Controls for Food for 
Animals: Supply-Chain Program 
Guidance for Industry 
Draft Guidance 
This guidance document is being distributed for comment purposes only. 
Submit comments on this draft guidance by the date provided in the Federal Register notice 
announcing the availability of the draft guidance.  Submit electronic comments to 
https://www.regulations.gov/.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.  You should identify your comments with the docket number listed in the notice of 
availability that publishes in the Federal Register. 
For questions regarding this draft document, contact Jenny Murphy, Center for Veterinary 
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Place, Rockville, MD 
20855, 240-402-6246, e-mail:  Jenny.Murphy@fda.hhs.gov. 
Additional copies of this draft guidance document may be requested from the Policy and 
Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 
7500 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at either 
https://www.fda.gov/AnimalVeterinary/default.htm or https://www.regulations.gov/. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
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Table of Contents 
I.  PURPOSE ................................................................................................................................ 4 
II. CONSIDERATIONS TO KEEP IN MIND IF YOU ESTABLISH AND IMPLEMENT A SUPPLY-
CHAIN PROGRAM .................................................................................................................. 4 
III. OVERVIEW OF THE REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM .............................. 5
A.  Applicable Requirements of Part 507 .......................................................................... 5 
B.  Receiving Facilities and Suppliers ....................................................................... 5 
C.  Produce Safety Regulation ........................................................................................... 6 
D.  Foreign Supplier Verification Program Regulation .................................................. 6 
E.  Accredited Third-Party Certification Regulation ...................................................... 7 
IV. UNDERSTAND THE HAZARD .................................................................................................. 7
V.  REQUIREMENT TO ESTABLISH AND IMPLEMENT A SUPPLY-CHAIN PROGRAM (21 CFR
507.105) ................................................................................................................................. 7 
A.  Requirement to Establish and Implement a Supply-Chain Program ...................... 7 
B.  How Your Corporate Parent Can Participate in Establishing and Implementing 
Your Supply-Chain Program ....................................................................................... 8 
C.  Exceptions to the Requirement to Establish and Implement a Supply-Chain 
Program .......................................................................................................................... 9 
D.  Requirement When a Supply-Chain-Applied Control is Applied by an Entity 
Other than the Receiving Facilitys Supplier ........................................................... 10 
E.  Role of the Preventive Controls Qualified Individual in the Supply-Chain 
Program ........................................................................................................................ 11 
VI. GENERAL REQUIREMENTS APPLICABLE TO A SUPPLY-CHAIN PROGRAM (21 CFR
507.110) ............................................................................................................................... 11 
A.  What the Supply-Chain Program Must Include ...................................................... 11 
B.  Appropriate Supplier Verification Activities ........................................................... 12 
C.  Assurance that a Hazard Has Been Significantly Minimized or Prevented .......... 13 
D.  Considerations in Approving Suppliers and Determining the Appropriate 
Supplier Verification Activities and the Frequency with Which They Are 
Conducted .................................................................................................................... 14 
E.  Supplier Nonconformance .......................................................................................... 19 
VII. RESPONSIBILITIES OF THE RECEIVING FACILITY (21 CFR 507.115) ............................... 20
A.  Your Responsibility to Approve Suppliers ............................................................... 20 
B.  Your Responsibility to Determine and Conduct Appropriate Supplier Verification 
Activities ....................................................................................................................... 20 
C.  What You May Not Accept from a Supplier as a Supplier Verification Activity . 21 
D.  Audit Provided by the Supplier ................................................................................. 22 
VIII. USING APPROVED SUPPLIERS (21 CFR 507.120) .............................................................. 22
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A.  Approving Suppliers ................................................................................................... 22 
B.  Written Procedures for Receiving Raw Materials and Other Ingredients ............ 22 
IX.  DETERMINING APPROPRIATE SUPPLIER VERIFICATION ACTIVITIES (INCLUDING 
DETERMINING THE FREQUENCY OF CONDUCTING THE ACTIVITY) (21 CFR 507.125) ... 26 
X.  CONDUCTING SUPPLIER VERIFICATION ACTIVITIES FOR RAW MATERIALS AND OTHER 
INGREDIENTS (21 CFR 507.130) ........................................................................................ 26 
A.  Requirement to Conduct Supplier Verification Activities ...................................... 26 
B.  Specific Requirements When the Hazard Requiring a Preventive Control is a 
SAHCODHA Hazard .................................................................................................. 27 
C.  Alternative Supplier Verification Activity If the Supplier Is a Qualified Facility  
   ............................................................................................................................... 28 
D.  Alternative Supplier Verification Activity If the Supplier is a Certain Type of 
Produce Farm .............................................................................................................. 30 
E.  Alternative Supplier Verification Activity If the Supplier Is a Shell Egg Producer 
That Is Not Subject to the Requirements of 21 CFR Part 118 ................................ 31 
F.  Financial Conflict of Interest ..................................................................................... 32 
XI.  ONSITE AUDIT (21 CFR 507.135) ...................................................................................... 33 
A.  Who Conducts an Onsite Audit? ............................................................................... 33 
B.  Consideration of Food Safety Regulations ................................................................ 35 
C.  Substitution of an Inspection for an Audit ................................................................ 36 
D.  Audits Conducted to Meet the Requirements of Subpart E Do Not Have to 
Comply with the Requirements of the Accredited Third-Party Regulation .......... 37 
XII.  RECORDS DOCUMENTING THE SUPPLY-CHAIN PROGRAM ............................................... 37 
XIII. COMPLIANCE DATES .......................................................................................................... 44 
XIV. REFERENCES ....................................................................................................................... 46 
APPENDIX A  GLOSSARY OF TERMS .......................................................................................... 48 
Definitions Established in 21 CFR 507.3 ......................................................................... 48 
Other Terms Used in This Guidance ............................................................................... 51 
APPENDIX B  TABLE OF ABBREVIATIONS AND ACRONYMS USED IN THIS GUIDANCE ............. 53 
   
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Hazard Analysis and Risk-Based Preventive Controls 
for Food for Animals: Supply-Chain Program 
 
Draft Guidance for Industry 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page. 
 
I.  Purpose 
 
The purpose of this guidance is to help a receiving facility comply with the requirements of 21 
CFR part 507, subpart E of the preventive controls for animal food (PCAF) regulation for 
establishing and implementing a supply-chain program for its suppliers.  See section III.B and 
the list of terms in Appendix A for the definition of a receiving facility.  This guidance also is 
intended to help an entity other than the receiving facility conduct certain activities on behalf of a 
receiving facility, provided that the receiving facility complies with applicable requirements in 
subpart E to review and assess the entitys applicable documentation, and document that review 
and assessment. 
 
In this guidance, we use the term you to refer to a receiving facility, rather than to all 
facilities subject to the PCAF requirements, because the requirements of subpart E apply only to 
receiving facilities. 
 
In general, FDAs guidance documents 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.  Considerations to Keep in Mind if You Establish and Implement a Supply-Chain 
Program 
 
If you are an importer, see section V.C.1 for a discussion of how we have aligned the provisions 
for supplier verification in our regulation entitled Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals (21 CFR part 1, subpart L; the FSVP regulation) 
with the provisions for a supply-chain program in subpart E such that importers and receiving 
facilities do not have to duplicate verification activities.  Importantly, this guidance does not 
address the responsibilities of receiving facilities that import raw materials or other ingredients to 
comply with applicable requirements of the FSVP regulation.  If you are a receiving facility that 
is also an animal food importer, and you choose to comply with the FSVP regulation and have 
appropriate documentation of that compliance rather than conducting supplier verification 
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activities in accordance with subpart E (see 21 CFR 507.105(a)(2)), you should refer to our draft 
guidance on the FSVP regulation (Ref. 1). 
 
III.  Overview of the Requirements for a Supply-Chain Program 
 
A.  Applicable Requirements of Part 507 
 
Subpart C of part 507 requires a facility to conduct a hazard analysis to determine whether there 
are any hazards that require a preventive control (21 CFR 507.33).  Subpart C of part 507 also 
identifies several types of possible preventive controls, including process controls (21 CFR 
507.34(c)(1)), sanitation controls (21 CFR 507.34(c)(2)), and supply-chain controls (21 CFR 
507.34(c)(3)).  The requirements for supply-chain controls are established in subpart E (Supply-
Chain Program).  We list the requirements of subpart E for a supply-chain program in Table 1.  
In the remainder of this guidance, we provide recommendations for how you can comply with 
each of these requirements. 
 
Table 1.  Requirements for a Supply-Chain Program in Subpart E 
 
Section  Description 
507.105  Requirement to establish and implement a supply-chain program 
507.110  General requirements applicable to a supply-chain program 
507.115  Responsibilities of the receiving facility 
507.120  Using approved suppliers 
507.125  Determining appropriate supplier verification activities (including 
determining the frequency of conducting the activity) 
507.130  Conducting supplier verification activities for raw materials and other 
ingredients 
507.135  Onsite audit 
507.175  Records documenting the supply-chain program 
 
B.  Receiving Facilities and Suppliers 
 
Subpart E applies to a receiving facility.  Part 507 defines a receiving facility as a facility 
that is subject to subparts C and E of part 507 and that manufactures/processes a raw material or 
other ingredient that it receives from a supplier.  (See 21 CFR 507.3).  Part 507 defines a 
supplier as the establishment that manufactures/processes the animal food, raises the animal, or 
grows the food that is provided to a receiving facility without further manufacturing/processing 
by another establishment, except for further manufacturing/processing that consists solely of the 
addition of labeling or similar activity of a de minimis nature.  (See 21 CFR 507.3). 
 
Under subpart E, entities such as brokers, food distributors, and cold storage facilities are neither 
receiving facilities that are required to establish a supply-chain program nor suppliers, because 
such entities are not manufacturers/processors.  However, part 507 provides that such entities can 
conduct certain activities specified in subpart E on behalf of a receiving facility.  (See 21 CFR 
507.115). 
 
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Examples of receiving facilities are: 
 
  A facility that receives raw agricultural commodities (RACs) such as corn and then 
manufactures/processes swine food 
 
  A facility that manufactures a complete and balanced extruded dog food using beef, rice, 
vitamin premix, and other ingredients 
 
  A facility that manufactures a vitamin-mineral top dress for livestock food using vitamins, 
minerals, and other ingredients 
 
Examples of suppliers are: 
 
  A farm that grows RACs such as corn that are supplied to a feed mill 
 
  A facility that manufacturers a vitamin premix that is supplied to a facility that 
manufactures a complete and balanced extruded dog food 
 
  A facility that manufactures vitamins that are supplied to a facility that manufactures a 
vitamin-mineral top dress for livestock food 
 
See also section V.D for a discussion of the special circumstance of when a preventive control is 
applied by an entity other than the receiving facilitys supplier (e.g., when a harvesting or 
packing operation applies controls to certain produce (i.e., produce covered by 21 CFR part 112), 
because growing, harvesting, and packing activities are under different management). 
 
C.  Produce Safety Regulation 
 
In part 112 (21 CFR part 112), we have established our regulation entitled Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the produce 
safety regulation; 80 FR 74354, November 27, 2015).  The produce safety regulation sets forth 
procedures, processes, and practices that minimize the risk of serious adverse health 
consequences or death, including those reasonably necessary to prevent the introduction of 
known or reasonably foreseeable biological hazards into or onto produce and to provide 
reasonable assurances that the produce is not adulterated on account of such hazards.  The 
produce safety regulation applies to certain produce farms and does not apply to activities of 
facilities that are subject to part 507. 
 
Some provisions of subpart E (i.e., 21 CFR 507.105(c), 507.110(d)(2)(ii), 507.130(d), and 
507.175(c)(13)) refer to the provisions of the produce safety regulation. 
 
D.  Foreign Supplier Verification Program Regulation 
 
In part 1, subpart L (21 CFR part 1, subpart L), we have established our regulation entitled 
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (the 
FSVP regulation; 80 FR 74226, November 27, 2015).  The FSVP regulation requires importers 
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to establish foreign supplier verification programs to verify that their foreign suppliers are using 
processes and procedures that provide the same level of public health protection as those 
required under the provisions on hazard analysis and risk-based preventive controls and 
standards for produce safety in the FD&C Act that the imported food is not adulterated. 
 
Some provisions of subpart E (i.e., 21 CFR 507.105(a)(2) and 507.175(c)(2)) refer to the 
provisions of the FSVP regulation. 
 
E.  Accredited Third-Party Certification Regulation 
 
In part 1, subpart M (21 CFR part 1, subpart M), we have established our regulation entitled 
Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue 
Certifications (the accredited third-party certification regulation; 80 FR 74570, November 27, 
2015).  The accredited third-party certification regulation provides for accreditation of third-
party certification bodies to conduct food safety audits and to certify that eligible foreign entities 
(including registered foreign food facilities) and food produced by such entities meet applicable 
FDA requirements for purposes of sections 801(q)1 and 8062 of the FD&C Act (certifications 
concerning imported foods and voluntary qualified importer program, respectively). 
 
Some provisions of part 507 (i.e., the definition of qualified auditor in 21 CFR 507.3 and the 
requirements for onsite audits in 21 CFR 507.135(d)) refer to the provisions of the accredited 
third-party certification regulation. 
 
IV.  Understand the Hazard 
 
Part 507 defines supply-chain-applied control as a preventive control for a hazard in a raw 
material or other ingredient when the hazard in the raw material or other ingredient is controlled 
before its receipt.  See 21 CFR 507.3 and the glossary of terms in Appendix A.  For background 
and details about hazards, including hazards that could require a supply-chain-applied control, 
see Chapter 3 of draft guidance #245  Hazard Analysis and Risk-Based Preventive Controls for 
Food for Animals (Ref. 2). 
 
V.  Requirement to Establish and Implement a Supply-Chain Program (21 CFR 507.105) 
 
A.  Requirement to Establish and Implement a Supply-Chain Program 
 
With some exceptions (see 21 CFR 507.105(a)(2) and (a)(3)), subpart E requires a receiving 
facility to establish and implement a risk-based supply-chain program for those raw materials 
                                                 
1 Section 801(q) of the FD&C Act gives FDA the authority to make a risk-based determination to require, as a 
condition of admissibility, that a food imported or offered for import into the United States be accompanied by a 
certification or other assurance that the food meets the applicable requirements of the FD&C Act. 
2 Section 302 of FSMA (Voluntary qualified importer program) amended the FD&C Act to create a new section 806 
with the same name.  Section 806 of the FD&C Act describes a voluntary, fee-based program for the expedited 
review and importation of foods from importers who achieve and maintain a high level of control over the safety and 
security of their supply chains.  This control includes importation of food from facilities that have been certified 
under FDAs third-party certification rule. 
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and other ingredients for which the receiving facility has identified a hazard requiring a supply-
chain-applied control.  See 21 CFR 507.105(a)(1). 
 
The supply-chain program must be written (21 CFR 507.105(b)).  The written supply-chain 
program is part of a receiving facilitys food safety plan (see 21 CFR 507.31(c)(3)).  There is no 
standardized or required format for the written supply-chain program or its records.  You can use 
whatever format works best for your facility, provided that the records include all the required 
information, see section XII. 
 
You are not required to establish and implement a supply-chain program for a particular raw 
material or other ingredient if you will control the hazard at your own facility, regardless of 
whether supplier has also applied one or more preventive controls for that hazard to raw 
materials or other ingredients that your supplier provides to you.  In addition, you are not 
required to implement a preventive control, including a supply-chain applied control, if you 
comply with certain requirements for ensuring a hazard will be controlled by your customer or 
subsequent entity in the distribution chain (see 21 CFR 507.36). 
 
Subpart E does not require you to establish and implement a supply-chain program to control 
hazards associated with animal food-contact substances.  A current good manufacturing practice 
(CGMP) provision requires that animal food-packaging materials are safe and suitable. See 21 
CFR 507.25(a)(3). 
 
B.  How Your Corporate Parent Can Participate in Establishing and Implementing 
Your Supply-Chain Program 
 
As discussed in the final rule establishing part 507, your corporate parent (as the owner, operator, 
or agent in charge) can be active in developing and implementing your food safety plan (see 
Responses 239, 439, and 461 in 80 FR 56170 at 56240, 56297, and 56308, respectively).  For 
example, an individual at the corporate level may be the preventive controls qualified individual 
(PCQI).  See 21 CFR 507.3 and Appendix A for the definition of PCQI. 
 
Further, the responsibilities of the receiving facility (such as approving suppliers) could be 
handled at the corporate level.  For example, your corporate parent could have a team that 
establishes written procedures for supplier approval, determines supplier verification activities, 
conducts supplier verification activities, and maintains required documentation.  In addition, 
your corporate parent could establish and implement a supply-chain program that takes into 
consideration its knowledge of the food safety programs in place at all of the facilities under its 
ownership.  See also the example in section X.B.2 in which a facility that is part of a larger 
corporation determines an alternative to an onsite audit when the supplier is a subsidiary of the 
same corporation.  The records documenting the supply-chain program are subject to the 
requirements, in subpart F, applying to records that must be established and maintained.  Under 
21 CFR 507.208, offsite storage of records (such as storage at the place of business of your 
corporate parent of records documenting the supply-chain program) is permitted if such records 
can be retrieved and provided onsite within 24 hours of request for official review.  If your 
corporate parent establishes and maintains the records for the supply-chain program 
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electronically and you can access applicable records maintained at the corporate level 
electronically, we consider the records to be onsite. 
 
C.  Exceptions to the Requirement to Establish and Implement a Supply-Chain 
Program 
 
Subpart E provides for two exceptions to the requirement to establish and implement a supply-
chain program. 
 
1. Exception for importers 
 
We have aligned the provisions for supplier verification in the FSVP regulation with the 
provisions for a supply-chain program in part 507.  A receiving facility that is an importer, is in 
compliance with the FSVP regulation, and has documentation of verification activities conducted 
under 21 CFR 1.506(e) (which provides assurance that the hazards to be controlled before 
importation for the raw material or other ingredient have been significantly minimized or 
prevented) need not conduct supplier verification activities for that raw material or other 
ingredient.  See 21 CFR 507.105(a)(2).  We are providing separate guidance to help importers 
who are subject to the FSVP regulation to comply with the requirements of the FSVP 
regulation.3 
 
2. Exception for animal food supplied for research or evaluation use 
 
The requirements for a supply-chain program do not apply to animal food that is supplied for 
research or evaluation use, provided that such animal food: 
 
  Is not intended for retail sale and is not sold or distributed to the public (21 CFR 
507.105(a)(3)(i)); 
 
  Is labeled with the statement Animal food for research or evaluation use (21 CFR 
507.105(a)(3)(ii)); 
 
  Is supplied in a small quantity that is consistent with a research, analysis, or quality 
assurance purpose, the animal food is used only for this purpose, and any unused quantity 
is properly disposed of (21 CFR 507.105(a)(3)(iii)); and 
 
  Is accompanied with documents, in accordance with the practice of the trade, stating that 
the animal food will be used for research or evaluation purposes and cannot be sold or 
distributed to the public (21 CFR 507.105(a)(3)(iv)). 
 
You should take steps to ensure that the label statement Animal food for research or evaluation 
use remains securely attached to the animal food until the animal food is used for research or 
evaluation. 
                                                 
3 Even if you implement a supply-chain program in accordance with subpart E for a raw material or other ingredient 
you import, you will need to ensure that you are identified as the FSVP importer of the raw material or other 
ingredient in accordance with 21 CFR 1.509. 
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The quantity of the animal food should be limited to the amount anticipated to be needed to 
perform the research, analysis, or quality assurance procedures.  The amount of animal food used 
in research or for evaluation can vary based on the type of animal food, the nature of the research 
or evaluation, and other factors such as the number of repetitions required for the research or 
evaluation process.  For example, a few ounces of a color additive may be needed for research, 
10 pounds of an animal food ingredient could be a small quantity for performing a laboratory 
analysis for pesticides, and 200 pounds of an animal food ingredient may be needed if 
conducting a feeding study in cattle.  Any unused portion must be properly disposed of (21 CFR 
507.105(a)(3)(iii)). 
 
The exemption for research or evaluation would apply to a raw material or other ingredient used 
in feeding studies that involve a discrete set of test subjects for the research or evaluation 
purposes.  For example, the exemption would apply if the animal food raw material or other 
ingredient is incorporated into a pet food and is to be fed to pets as part of a palatability study of 
a pet food.  The raw material or other ingredient must be supplied in a small quantity consistent 
with the research purpose and meet the other requirements for the exemption described in 21 
CFR 507.105(a)(3). 
 
D.  Requirement When a Supply-Chain-Applied Control is Applied by an Entity 
Other than the Receiving Facilitys Supplier 
 
When a supply-chain-applied control is applied by an entity other than the receiving facilitys 
supplier (e.g., when such an entity applies controls to certain produce (i.e., produce covered by 
part 112)), because growing, harvesting, and packing activities are under different management), 
the receiving facility must: (1) verify the supply-chain-applied control; or (2) obtain 
documentation of an appropriate verification activity from another entity, review and assess the 
entitys applicable documentation, and document that review and assessment.  See 21 CFR 
507.105(c). 
 
An example of where this requirement could apply is included as an example in the requirement, 
i.e., when the supplier is a farm and growing, harvesting, and packing activities are under 
different management.  The definition of supplier specifies that the supplier is the establishment 
that grows the food.  However, harvesting and packing operations that are conducted by a 
business entity separate from the grower do not fall within the definition of supplier, even 
though harvesting and packing operations include some supply-chain-applied controls, such as 
maintaining wash water temperature adequate to minimize infiltration of microorganisms and 
establishing and following water-change schedules for recirculated water.  A receiving facility 
has an obligation to identify and implement preventive controls to provide assurances that any 
hazards requiring a preventive control will be significantly minimized or prevented and the food 
manufactured, processed, packed, or held by the facility will not be adulterated under section 402 
of the FD&C Act (21 U.S.C. 342).  That obligation includes responsibilities for raw materials 
and other ingredients when a supply-chain-applied control is applied by an entity (such as a 
harvesting or packing operation) other than the receiving facilitys supplier (the grower). 
 
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In the final rule establishing part 507, we noted that 21 CFR 507.105(c) may have limited 
applicability to raw material and other ingredients used in animal food (80 FR 56170 at 56298).  
The previous example is not representative of animal food production and is used to illustrate 
how the requirement in 21 CFR 507.105(c) may be implemented. 
 
We do not expect the receiving facility to follow all of the requirements of subpart E applicable 
to approving suppliers and conducting supplier verification when verifying control by a non-
supplier in the supply chain (e.g., a harvesting or packing operation).  Instead, the receiving 
facility must verify the supply-chain-applied control or obtain documentation of an appropriate 
verification activity from another entity, review and assess the documentation, and document that 
review and assessment (see 21 CFR 507.105(c)). 
 
E.  Role of the Preventive Controls Qualified Individual in the Supply-Chain 
Program 
 
The supply-chain program in subpart E is a preventive control (see 21 CFR 507.34(c)(3)), and 
preventive controls must be written (21 CFR 507.34(b)).  The preventive controls are part of 
your food safety plan (21 CFR 507.31(c)(2)), and your food safety plan must be prepared, or its 
preparation overseen by, a PCQI (21 CFR 507.31(b) and 507.53(a)(1)). 
 
VI.  General Requirements Applicable to a Supply-Chain Program (21 CFR 507.110) 
 
A.  What the Supply-Chain Program Must Include 
 
Subpart E includes a list of the general requirements for what the supply-chain program must 
include, and provides a cross-reference to where you can find the specific requirements.  As 
specified in 21 CFR 507.110(a), the general requirements are: 
 
  Using approved suppliers as required by  507.120 (21 CFR 507.110(a)(1)); 
 
  Determining appropriate supplier verification activities (including determining the 
frequency of conducting the activity) as required by  507.125 (21 CFR 507.110(a)(2)); 
 
  Conducting supplier verification activities as required by  507.130 and 507.135 (21 CFR 
507.110(a)(3)); 
 
  Documenting supplier verification activities as required by  507.175 (21 CFR 
507.110(a)(4)); and 
 
  When applicable, verifying a supply-chain-applied control applied by an entity other than 
the receiving facilitys supplier and documenting that verification as required by  
507.175, or obtaining documentation of an appropriate verification activity from another 
entity, reviewing and assessing that documentation, and documenting the review and 
assessment as required by  507.175 (21 CFR 507.110(a)(5)). 
   
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B.  Appropriate Supplier Verification Activities 
 
Section 21 CFR 507.110(b) of subpart E specifies four appropriate supplier verification activities 
for raw materials and other ingredients.  We discuss these in sections VI.B.1 through VI.B.4. 
 
1.  Onsite audits (21 CFR 507.110(b)(1)) 
 
See 21 CFR 507.130(b), 21 CFR 507.135, 21 CFR 507.175(c)(7) for details about the 
requirements for onsite audits, and sections X.B, XI, and XII for our recommendations for how 
to comply with those requirements. 
 
2.  Sampling and testing of the raw material or other ingredient (21 CFR 
507.110(b)(2)) 
 
Subpart E provides that sampling and testing of a raw material or other ingredient is an 
appropriate supplier verification activity (see 21 CFR 507.110(b)(2)).  Such sampling and testing 
can be on a periodic basis or on a lot-by-lot basis.  We recommend that you establish the 
frequency of such testing by first conducting the sampling and testing on a relatively frequent 
basis (e.g., monthly) until the supplier establishes a good history of supplying an acceptable raw 
material or other ingredient, after which time you could sample and test less frequently, such as 
quarterly. 
 
If you choose to use sampling and testing as a supplier verification activity, you should use 
scientifically-based sampling plans that provide reasonable assurance that the hazard has been 
significantly minimized or prevented and that address known limitations of sampling and testing 
animal food as a verification activity.  For example, your sampling plan should take into 
consideration whether a hazard is homogeneously distributed throughout the lot, and your 
selection of an analytical method should consider whether animal food components could 
interfere with the method of analysis as well as whether the method is sensitive enough to detect 
a hazard that is present at low concentrations.  To address such limitations, we recommend that 
you obtain samples that are representative of the lot, use a testing method that has been shown to 
provide reliable results when the analyte of interest is within the animal food matrix you will be 
testing, and use a method that has a sensitivity appropriate to detect that hazard. 
 
See 21 CFR 507.175(c)(8) and section XII for a list of required documentation when you 
conduct sampling and testing as a supplier verification activity.  See section VII.B.2 for a 
discussion of the flexibility the regulation provides for your supplier to conduct and document 
sampling and testing of raw materials and other ingredients, for the hazard it controls, and to 
provide such documentation (such as in a Certificate of Analysis (COA)) to you in lieu of your 
conducting such sampling and testing yourself. 
 
3.  Review of the suppliers relevant food safety records (21 CFR 507.110(b)(3)) 
 
In general, by relevant food safety records we mean any records that will provide sufficient 
documentation that your supplier is following the procedures your supplier established to control 
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a hazard and that the hazard has been controlled.  Many such records relate to a particular lot of a 
raw material or other ingredient provided to you, such as the record created when a preventive 
control measure was applied.  For example, if you produce extruded cat food using meat meal 
and rely on your supplier (the renderer making the meat meal) to control metal in the meat meal 
that you will use to produce the extruded cat food, you could obtain copies of the monitoring 
records for the preventive control that the renderer uses to control metal in meat meal. 
 
Relevant food safety records also include records demonstrating that your supplier has verified 
control of a hazard by its own supplier, when applicable.  Such records could include records of 
your suppliers audit of its suppliers food safety activities.  For example, if you produce a 
complete sheep food and obtain a mineral premix from your supplier, you could obtain a copy of 
your suppliers records documenting the audits of the facilities supplying the individual minerals. 
 
See 21 CFR 507.175(c)(9) and section XII for a list of required documentation when you 
conduct a review of the suppliers relevant food safety records as a supplier verification activity. 
 
4.  Other appropriate supplier verification activities based on supplier 
performance and the risk associated with the raw material or other ingredient 
(21 CFR 507.110(b)(4)) 
 
Subpart E provides that you could conduct (and document) or obtain documentation of other 
supplier verification activities that are appropriate based on your suppliers performance and the 
risk posed by the raw material or other ingredient.  This means that you could specify and design 
risk-based activities (other than an onsite audit, sampling and testing, and review of relevant food 
safety records) that can provide effective supplier verification. 
 
As one example, you could develop and use a fact-specific questionnaire or consider information 
applicable to a suppliers certification to a specific audit scheme, and you could use such 
activities alone or in combination with other supplier verification activities.  As another example, 
if you determine and document that you would audit this supplier on a biennial rather than 
annual basis as provided by 21 CFR 507.130(b)(2), you could review the records demonstrating 
the results of the suppliers environmental monitoring program (if applicable) during the year 
that you do not conduct an audit. 
 
See 21 CFR 507.175(c)(10) and section XII for recommended documentation when you conduct 
a supplier verification activity other than an onsite audit, sampling and testing, or review of the 
suppliers relevant food safety records. 
 
C.  Assurance that a Hazard Has Been Significantly Minimized or Prevented 
 
The supply-chain program in subpart E is a type of preventive control and, thus, must comply 
with the requirements applicable to preventive controls in 21 CFR 507.34.  Under 21 CFR 
507.34(a), a preventive control provides assurance that any hazards requiring a preventive 
control will be significantly minimized or prevented.  To make this clear, 21 CFR 507.110(c) 
specifies that the supply-chain program must provide assurance that a hazard requiring a supply-
chain-applied control has been significantly minimized or prevented.  Suppliers that are subject 
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to the PCAF requirements in part 507 are required to develop and implement a food safety plan 
that will significantly minimize or prevent hazards associated with the animal food 
manufactured, processed, packed or held by the facility (see 21 CFR 507.31) and to document 
they are following their plan (see 21 CFR 507.55). 
 
D.  Considerations in Approving Suppliers and Determining the Appropriate 
Supplier Verification Activities and the Frequency with Which They Are 
Conducted 
 
As noted in section VI.A, subpart E specifies that you must approve suppliers and determine 
appropriate supplier verification activities (including determining the frequency of conducting 
the activity).  See 21 CFR 507.110(a)(1) and 21 CFR 507.110(a)(2).  Section 21 CFR 
507.110(d)(1) specifies factors that you must consider in approving suppliers and determining 
appropriate supplier verification activities (including determining the frequency of conducting 
the activity).  We discuss these factors in sections VI.D.1 through VI.D.4.  With one exception, 
the requirement to consider each of these factors applies every time you approve a supplier for a 
raw material or other ingredient, and every time that you determine the appropriate supplier 
verification activity for an animal food received from that supplier.  See a discussion of the 
exception in 21 CFR 507.110(d)(2) and in section VI.D.5. 
 
As noted in sections VII.A and VII.B, only you can approve suppliers, but subpart E provides 
some flexibility for another entity in the distribution chain to conduct certain other activities 
related to supplier verification, and to provide you with applicable documentation of those 
activities, to help you do so. 
 
1. Hazard analysis 
 
The first factor that you must consider in (1) approving suppliers, (2) determining appropriate 
supplier verification activities, and (3) determining the frequency of conducting those activities 
is the hazard analysis of the animal food, conducted in accordance with 21 CFR 507.33.  See 21 
CFR 507.110(d)(1)(i).  To do so, you must consider the nature of the hazard controlled before 
receipt of the raw material or other ingredient.  See 21 CFR 507.110(d)(1)(i).  In the following 
paragraph, we explain the requirements of part 507 for a hazard analysis and provide 
recommendations for how to consider the hazard analysis in approving suppliers, determining 
appropriate supplier verification activities, and determining the frequency of those activities. 
 
Part 507 requires that you conduct a hazard analysis to identify and evaluate, based on 
experience, illness data, scientific reports, and other information, known or reasonably 
foreseeable hazards for each type of animal food manufactured, processed, packed, or held at 
your facility to determine whether there are any hazards requiring a preventive control.  See 21 
CFR 507.33(a).  If you determine that there are any hazards that require a preventive control, 
with few exceptions part 507 further requires that you must identify and implement a preventive 
control.  See 21 CFR 507.34(a).  When the preventive control will be applied to a raw material or 
other ingredient before receipt, part 507 requires that you establish and implement a risk-based 
supply-chain program for that raw material or other ingredient.  See 21 CFR 507.105. 
 
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As part of your hazard analysis, you would evaluate the hazard to assess the severity of the 
illness or injury to humans or animals if the hazard were to occur and the probability that the 
hazard will occur in the absence of preventive controls.  See 21 CFR 507.33(c)(1).  The outcome 
of this aspect of the hazard evaluation impacts the type of verification activity you use (as well as 
the frequency of conducting the activity).  For example, when the hazard is one for which there 
is a reasonable probability that exposure to the hazard will cause serious adverse health 
consequences or death to humans or animals (SAHCODHA), in general you must conduct an 
annual onsite audit before using the raw material or other ingredient from the supplier and at 
least annually thereafter.  See 21 CFR 507.130(b) and the discussion in section X.B.  For other 
hazards, the determination of supplier verification activities, and the frequency of conducting 
those activities, also should be risk-based, i.e., the greater the risk presented by the hazard, the 
more robust the verification activity and the greater the frequency of the verification. 
 
As part of your hazard analysis, you also would evaluate environmental pathogens whenever an 
animal food is exposed to the environment prior to packaging and the packaged food does not 
receive a treatment or otherwise include a control measure (such as a formulation lethal to the 
pathogen) that would significantly minimize the pathogen.  See 21 CFR 507.33(c)(2).  If, for 
example, you are purchasing a flavor enhancer that will be applied to a pet food post heat 
treatment, and you expect that a sanitation control will be applied to address the environmental 
pathogen Salmonella, you could ask to review the flavor enhancer producers written procedures 
for the environmental monitoring it does to verify the sanitation controls.  See 21 CFR 
507.49(b)(3).  You also could periodically verify your suppliers controls by sampling and 
testing the flavor enhancer for Salmonella.  Because Salmonella is a hazard for which there is a 
reasonable probability that exposure to the hazard will cause serious adverse health 
consequences or death to humans or animals, you also would conduct an annual onsite audit to 
verify that your supplier controls Salmonella when it manufactures the flavor enhancer by using 
a kill step such as heat treatment of liver digest used to make the flavor enhancer and sanitation 
controls to significantly minimize contamination from Salmonella in the environment, with 
environmental monitoring to verify controls for Salmonella. 
 
For all hazards that require a supply-chain-applied control, we recommend that you use the 
outcome of your hazard analysis to help you determine the extent of what you do to consider 
supplier performance as required by 21 CFR 507.110(d)(1)(iii) (see the discussion in section 
VI.D.3).  The greater the risk presented by the hazard, the more stringently you should assess 
supplier performance as a mechanism to reduce the risk presented by the hazard. 
 
2. Entity controlling the hazard 
 
The second factor that you must consider in (1) approving suppliers, (2) determining appropriate 
supplier verification activities, and (3) determining the frequency of conducting those activities 
is the entity or entities that will be applying controls for the hazards requiring a supply-chain-
applied control.  See 21 CFR 507.110(d)(1)(ii).  For example, the entity that applies the 
appropriate preventive control could be your direct supplier or your suppliers supplier.  If the 
control is not applied by your direct supplier, you would direct your verification activities to your 
suppliers supplier, but there is flexibility in how you could do this.  For example, 21 CFR 
507.110(a)(5) allows you to verify a control applied by your suppliers supplier, or, to obtain 
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documentation from another entity (such as your direct supplier) that shows that your suppliers 
supplier is applying the control. 
 
In determining whether to approve a supplier that relies on its own supplier to control the hazard 
requiring a supply-chain-applied control, we recommend you consider the robustness of the 
entitys supplier approval process and supplier verification activities. 
 
3. Supplier performance 
 
The third factor that you must consider in (1) approving suppliers, (2) determining appropriate 
supplier verification activities, and (3) determining the frequency of conducting those activities 
is supplier performance.  See 21 CFR 507.110(d)(1)(iii).  Considering supplier performance 
includes: 
 
  The suppliers procedures, processes, and practices related to the safety of the raw material 
and other ingredients (21 CFR 507.110(d)(1)(iii)(A)); 
 
  Applicable FDA food safety regulations and information relevant to the suppliers 
compliance with those regulations, including an FDA warning letter or import alert relating 
to the safety of animal food and other FDA compliance actions related to animal food 
safety (or, when applicable, relevant laws and regulations of a country whose food safety 
system FDA has officially recognized as comparable or has determined to be equivalent to 
that of the United States, and information relevant to the suppliers compliance with those 
laws and regulations) (21 CFR 507.110(d)(1)(iii)(B)); and 
 
  The suppliers food safety history relevant to the raw materials or other ingredients that the 
receiving facility receives from the supplier, including available information about results 
from testing raw materials or other ingredients for hazards, audit results relating to the 
safety of the animal food, and responsiveness of the supplier in correcting problems (21 
CFR 507.110(d)(1)(iii)(C)). 
 
As noted in section VI.D.1 regarding your hazard analysis as the first factor to consider, the 
greater the risk presented by the hazard, the more stringently you should assess supplier 
performance as a mechanism to reduce the risk presented by the hazard. 
 
Suppliers procedures, processes, and practices 
 
Understanding the suppliers procedures, processes, and practices related to the safety of the raw 
material and other ingredients can help you understand the suppliers strengths and weaknesses.  
Mechanisms to do so include: 
 
  Conducting a supplier pre-assessment questionnaire or survey to gather information 
about the suppliers operation, covering topics such as product information (e.g., 
regulatory compliance information) and the suppliers food safety programs (e.g., a 
sanitation control program, or a mycotoxin control program); 
 
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  Asking the supplier to provide documents such as an animal food safety plan and third-
party food safety and good manufacturing practice audit results; 
 
  Conducting a pre-approval site visit to assess programs and process capabilities; and 
 
  A system with defined metrics to evaluate supplier performance, examples may include 
compliance to specifications, third-party audit scores, number of recalls, mock recall 
performance, material rejections/complaints, and issue response time (e.g., the suppliers 
timeframe for resolving an animal food safety issue). 
 
Applicable food safety regulations 
 
You should determine what FDA food safety regulations a potential supplier is subject to, such 
as the CGMP and PCAF requirements in 21 CFR part 507, the produce safety regulation (21 
CFR part 112), the requirements applicable to low-acid canned foods (21 CFR 500.23, 500.24, 
and parts 108 and 113), CGMPs for medicated feeds (21 CFR part 225), or other relevant food 
safety provisions.  In evaluating the suppliers compliance with the relevant regulations, you 
should consider whether the supplier is the subject of an FDA warning letter, import alert, or 
other FDA compliance action related to food safety (e.g., mandatory recall).  See our website 
Supplier Evaluation Resources for resources that are available to help you evaluate the 
suppliers compliance with relevant FDA regulations (Ref. 3). 
 
Having an understanding of applicable FDA food safety regulations and information relevant to 
the suppliers compliance with those regulations can help you determine whether the supplier has 
a demonstrable history of supplying acceptable products and meeting regulatory requirements.  
Mechanisms to do so include: 
 
  Asking the supplier to provide documentation of any recent regulatory inspections on file; 
 
  Searching our online databases for warning letters, import alerts, import refusals, recalls, 
and inspections.  All of these databases are available to the public from our website 
Supplier Evaluation Resources (Ref. 3); and 
 
  Searching for actions that we publicize, such as animal food recalls, updates on foodborne 
illness outbreaks, and suspension of a facilitys registration.  We generally make these 
available from our animal and veterinary homepage (Ref. 4). 
 
You should use this information to inform your decisions about whether you will approve a 
supplier, the type of verification activity you would use if you do approve the supplier, and the 
frequency of conducting the verification activity.  Being subject to an FDA compliance action 
such as a warning letter or an import alert should not necessarily disqualify a supplier.  However, 
you should consider carefully the actions a supplier has taken as a result of regulatory 
compliance issues along with how it impacts your approval of that supplier and your verification 
activities. 
 
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Part 507 includes several provisions that reflect that some suppliers operate in a foreign country.  
See, e.g., the definition of qualified auditor in 21 CFR 507.3 and the provisions of 21 CFR 
507.105(a)(2), 507.130(c), 507.135(c)(1)(ii), 507.135(c)(2), and 507.175(c)(15).  When the 
supplier is in a foreign country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent to that of the United States, you may, when 
applicable, consider relevant laws and regulations of that country, and information relevant to the 
suppliers compliance with those laws and regulations.  See 21 CFR 507.110(d)(1)(iii)(B).  Thus, 
having an understanding of applicable laws and regulations in a foreign country can help you 
consider supplier performance when FDA has officially recognized that countrys food safety 
system as comparable or determined it is equivalent to that of the United States.  For example, 
just as you could ask a domestic supplier to provide documentation of any recent regulatory 
inspections, you could ask a foreign supplier that is in a foreign country whose food safety 
system FDA has officially recognized as comparable or determined to be equivalent to that of the 
United States to provide documentation of an inspection conducted by the applicable food safety 
authority. 
 
As of the date of this draft guidance, we have not developed a systems recognition process for 
animal food.  Therefore, there are no signed systems recognition arrangements with any foreign 
food safety authority related to animal food.  The currently existing systems recognition 
arrangements relate solely to human food and do not apply to animal food. 
 
Suppliers food safety history 
 
Before you became subject to the requirements of subpart E, you could already have established 
a relationship with your suppliers and have information related to audits, or have the results of 
sampling and testing that provide a history of how the supplier has met your specifications.  If 
so, you already could be aware of past problems with raw materials or other ingredients provided 
by the supplier, and the steps the supplier took to address such problems.  You may consider 
such prior relationships as part of your consideration of the suppliers food safety history.  
Likewise, as time goes on and you conduct appropriate supplier verification activities to comply 
with the requirements of subpart E, you would consider this same type of information for 
suppliers that you approve in compliance with subpart E. 
 
You should focus your consideration of the suppliers food safety history on the hazard that the 
supplier is controlling because that is the most relevant information.  However, you should also 
consider other information about the supplier, e.g., information regarding recalls or regulatory 
actions.  For example, you obtain a meat meal for use in pet food from a supplier that is 
controlling biological hazards (e.g., Salmonella) and become aware that meat meal from this 
supplier has been associated with a physical hazard (e.g., large bone fragments).  You should 
consider whether you should implement verification activities related to the control of physical 
hazards to prevent bone fragments in the meat meal you receive for a period of time adequate to 
demonstrate that problems that could lead to the presence of bone fragments have been resolved. 
   
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4.  Other factors 
 
Section 507.110(d)(1)(iv) specifies that you must consider any other factors as appropriate and 
necessary, such as storage and transportation practices, in (1) approving suppliers, (2) 
determining appropriate supplier verification activities, and (3) determining the frequency of 
conducting those activities.  For example, if you are receiving raw materials or other ingredients 
that need temperature control during transportation to ensure their safety, you should consider 
the ability of the supplier to ensure control of temperature during transportation if the supplier 
will be responsible for that activity.  As another example, if you are obtaining a raw material or 
other ingredients from a facility that is owned by your corporate parent, you may consider your 
knowledge of corporate-wide animal food safety procedures, processes, and practices in 
determining the type of supplier verification activity and the frequency with which it is 
conducted.  See also the discussion in section V.B of a circumstance where an individual at the 
corporate level is the PCQI for the purposes of the supply-chain program. 
 
5.  Exception to the full requirements for considerations for approving suppliers 
and determining appropriate supplier verification activities 
 
Section 507.110(d)(2) provides that considering supplier performance can be limited to the 
suppliers compliance history (as required by 21 CFR 507.110(d)(1)(iii)(B)), if the supplier is: (i) 
A qualified facility as defined by 21 CFR 507.3; (ii) a farm that grows produce and is not a 
covered farm under 21 CFR part 112 in accordance with 21 CFR 112.4(a), or in accordance with 
21 CFR 112.4(b) and 112.5; or (iii) a shell egg producer that is not subject to the requirements of 
21 CFR part 118 because it has less than 3,000 laying hens. 
 
E.  Supplier Nonconformance 
 
Section 507.110(e) specifies that if you determine through auditing; verification testing; 
document review; relevant consumer, customer, or other complaints; or otherwise that the 
supplier is not controlling hazards that you have identified as requiring a supply-chain-applied 
control, you must take and document prompt action in accordance with 21 CFR 507.42 
(Corrective actions and corrections) to ensure that raw materials or other ingredients from the 
supplier do not cause animal food that you manufacture or process to be adulterated under 
section 402 of the FD&C Act. 
 
We recommend that you establish processes and procedures to handle supplier nonconformance 
situations.  The appropriate actions you take in response to nonconformance will depend on the 
circumstances and the specific root cause of the nonconformance and could include: 
 
  Discontinuing use of the supplier until the cause or causes of nonconformance or 
adulteration are adequately addressed; 
 
  Notifying the supplier of the problem and requesting documentation of corrective actions 
taken by the supplier; 
 
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  Assisting the suppliers efforts to correct and prevent recurrence of the problem; 
 
  Revising your supply-chain program; and 
 
  Conducting, or working with your supplier to conduct, a recall of an adulterated animal 
food. 
 
VII.  Responsibilities of the Receiving Facility (21 CFR 507.115) 
 
Section 507.115 describes your responsibilities as a receiving facility.  As noted in section III.B, 
subpart E includes provisions that provide for an entity other than you to conduct certain 
activities, provided that you review and assess the entitys applicable documentation, and 
document that review and assessment.  Section 507.115 both specifies this flexibility provided 
by subpart E and places some bounds on that flexibility.  We discuss this flexibility and its 
bounds in sections VII.A through VII.D. 
 
A.  Your Responsibility to Approve Suppliers 
 
Section 507.115(a)(1) specifies that the receiving facility must approve suppliers.  Although 21 
CFR 507.115(a)(2) through (a)(4) provide some flexibility for other entities to determine and 
conduct appropriate supplier verification activities (see section VII.B), ultimately the receiving 
facility is responsible for its supply-chain program (see the discussion in the final rule 
establishing part 507, Response 430 in 80 FR 56170 at 56294).  See section VI.D for 
considerations in approving suppliers.  See section VIII for the requirement to approve suppliers 
before receiving raw materials and other ingredients from those suppliers and the requirement to 
establish written procedures for receiving raw materials and other ingredients. 
 
As noted in section III.B, the definition of supplier in part 507 means that a broker or 
distributor is not a supplier; the supplier is the establishment that manufactures/processes the 
animal food, raises the animal, or grows the food.  Thus, if you buy raw materials or other 
ingredients from a broker or distributor, you should ask the broker or distributor to provide you 
with information that allows you to approve the establishment that manufactures/processes the 
animal food, raises the animal, or grows the food as a supplier of the animal food that you 
purchase from that broker or distributor. 
 
B.  Your Responsibility to Determine and Conduct Appropriate Supplier Verification 
Activities 
 
Section 507.115(a)(2) requires that the receiving facility must determine and conduct appropriate 
supplier verification activities, and satisfy all documentation requirements of subpart E.  
However, sections 507.115(a)(3) and (4) provide some flexibility for other entities to determine 
and conduct supplier verification activities on behalf of the receiving facility.  See section VI.D 
for considerations in determining appropriate supplier verification activities and the frequency of 
conducting them. 
 
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1.  Flexibility for another entity to determine, conduct, and document appropriate 
supplier verification activities 
 
Under 21 CFR 507.115(a)(3), an entity other than the receiving facility may do any of the 
following, provided that the receiving facility reviews and assesses the entitys applicable 
documentation, and documents that review and assessment: 
 
  Establish written procedures for receiving raw materials and other ingredients by the entity 
(21 CFR 507.115(a)(3)(i)); 
 
  Document that written procedures for receiving raw materials and other ingredients are 
being followed by the entity (21 CFR 507.115(a)(3)(ii)); and 
 
  Determine, conduct, or both determine and conduct the appropriate supplier verification 
activities (21 CFR 507.115(a)(3)(iii)), with appropriate documentation. 
 
Although we specify that these activities are your responsibility, subpart E accounts for one or 
more entities in the supply chain between you and your supplier by providing some flexibility for 
these entities to perform certain activities. 
 
2.  Supplier verification activities that the supplier can conduct and document 
 
Under 21 CFR 507.115(a)(4), the supplier may conduct and document sampling and testing of 
raw materials and other ingredients, for the hazard controlled by the supplier, as a supplier 
verification activity for a particular lot of product and provide such documentation to the 
receiving facility.  However, 21 CFR 507.115(a)(4) also requires that you review and assess that 
documentation, and document that review and assessment.  An example of documentation of the 
results of sampling and testing is a COA, whether of periodic testing or lot-by-lot testing of the 
raw material or ingredient. 
 
We recommend that a COA document that major analytical parameters for the specific animal 
foods, or lots, contained in a specific shipment have been met.  Sampling and testing can be 
performed by the suppliers in-house laboratory or contracted to an outside testing laboratory.  
The laboratory conducting the testing should use scientifically valid laboratory methods and 
procedures that can provide reliable, accurate test results. 
 
C.  What You May Not Accept from a Supplier as a Supplier Verification Activity 
 
Section 507.115(b) specifies that a receiving facility may not accept any of the following as a 
supplier verification activity from its supplier: 
 
  A determination by its supplier of the appropriate supplier verification activities for that 
supplier (21 CFR 507.115(b)(1)); 
 
  An audit conducted by its supplier of that supplier (21 CFR 507.115(b)(2)); 
 
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  A review by its supplier of that suppliers own relevant food safety records (21 CFR 
507.115(b)(3)); or 
 
  The conduct by its supplier of other appropriate supplier verification activities for that 
supplier (see 21 CFR 507.115(b)(4)). 
 
The only supplier verification activities in which the supplier can play a role are sampling and 
testing (see section VII.B.2) and providing an audit of the supplier conducted by a third party 
(see section VII.D). 
 
D.  Audit Provided by the Supplier 
 
Under 21 CFR 507.115(c), your responsibilities as a receiving facility do not prohibit you from 
relying on an audit provided by your supplier when the audit of the supplier was conducted by a 
third-party qualified auditor in accordance with the requirements of subpart E applicable to 
audits (i.e., 21 CFR 507.130(f) and 507.135).  We discuss these requirements applicable to audits 
in sections X.F and XI, respectively. 
 
VIII. Using Approved Suppliers (21 CFR 507.120) 
 
As noted in sections VI.A and VII.A, subpart E requires that a receiving facility approve 
suppliers.  See 21 CFR 507.110(a)(1) and 507.115(a)(1). 
 
A.  Approving Suppliers 
 
Section 507.120(a) specifies that the receiving facility must approve suppliers in accordance with 
the requirements of 21 CFR 507.110(d), and document that approval, before receiving raw 
materials and other ingredients from those suppliers.  As discussed in section VI.D, 21 CFR 
507.110(d) specifies factors that you must consider in approving suppliers and determining 
appropriate supplier verification activities and provides for an exception to the full requirements 
for considering these factors. 
 
B.  Written Procedures for Receiving Raw Materials and Other Ingredients 
 
Section 507.120(b) specifies that: 
 
  Written procedures for receiving raw materials and other ingredients4 must be established 
and followed (21 CFR 507.120(b)(1)); 
 
                                                 
4 As noted in the glossary of terms in Appendix A, 21 CFR 507.3 defines the term written procedures for receiving 
raw materials and other ingredients to mean written procedures to ensure that raw materials and other ingredients 
are received only from suppliers approved by the receiving facility (or, when necessary and appropriate, on a 
temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate 
verification activities before acceptance for use).  We defined this term to simplify the provisions discussing these 
procedures. 
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  The written procedures for receiving raw materials and other ingredients must ensure that 
raw materials and other ingredients are received only from approved suppliers (or, when 
necessary and appropriate, on a temporary basis from unapproved suppliers whose raw 
materials or other ingredients are subjected to adequate verification activities before 
acceptance for use) (21 CFR 507.120(b)(2)); and 
 
  Use of the written procedures for receiving raw materials and other ingredients must be 
documented (21 CFR 507.120(b)(3)). 
 
You have flexibility to design appropriate written procedures for receiving raw materials and 
other ingredients that are tailored to your facility and operations.  The goal of these written 
procedures is to ensure that you can accurately identify approved suppliers and incorporate 
changes to your suppliers in a timely and accurate way (e.g., addition of new approved suppliers, 
deletion of suppliers no longer deemed approved, and criteria to approve temporary suppliers).  
Written procedures to ensure that raw materials or ingredients are only received from approved 
suppliers allow consistent implementation of the supplier program by personnel who order raw 
materials and other ingredients, personnel who receive raw materials and other ingredients, and 
personnel who conduct supplier verification activities.  Such procedures also can be part of 
training of personnel who will have responsibility for receiving raw materials and other 
ingredients. 
 
The use of written procedures for receiving raw materials and other ingredients is particularly 
important in light of the flexibility subpart E provides for an entity other than you (such as an 
entity in the supply chain between you and the supplier) to conduct this activity (see 21 CFR 
507.115(a)(3)).  A written procedure is appropriate to help ensure you are receiving raw 
materials and other ingredients only from an approved supplier.  If you purchase from a broker 
or distributor, you must approve the suppliers of the raw materials or other ingredients you buy 
from the broker/distributor (see sections VII.A and VIII.A), but the broker/distributor could 
document that written procedures are being followed to ensure that the raw materials and other 
ingredients provided to you only come from suppliers that you have approved.  The 
broker/distributor would provide this documentation to you (e.g., in documents accompanying 
the shipment) for you to review and assess.  Thus, if you rely on a broker/distributor to ensure 
that the raw materials and other ingredients provided to you only come from suppliers that you 
have approved, you and the broker/distributor you buy from should agree on the written 
procedures for how the broker/distributor will document that raw materials or other ingredients 
are received only from suppliers approved by you.  For example, the broker/distributor could 
have a checklist that an employee dates and initials after reviewing the invoice from the supplier, 
and send a copy of that dated checklist to you together with the invoice for the raw materials or 
other ingredients.  You could use an electronic system or specific supply-chain management 
software to document receipt of the raw material or other ingredient and review the checklist 
from the broker/distributor at the time of receipt.  In the following paragraphs, we discuss the use 
of checklists and computer systems in more detail. 
 
One approach to a written procedure for ensuring that raw materials and other ingredients are 
only received from approved suppliers is to maintain and use an actual approved supplier list to 
ensure that only suppliers from the lists are used for the purchase of raw materials or ingredients 
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(Ref. 5).  One example of this approach is a simple paper system where the receiving personnel 
or quality control/assurance personnel check the origin of the purchased materials and refer to a 
list of approved suppliers to verify that the raw material or ingredient is received from an 
approved supplier (e.g., put a check mark on the receiving document if the supplier is an 
approved supplier) (Refs. 6 and 7). 
 
Another approach to a written procedure for ensuring that raw materials and other ingredients are 
only received from approved suppliers is a computer system or specific supply-chain 
management software that manages the procurement, receipt, and usage of raw materials and 
other ingredients.  An example of this approach is for authorized personnel from the receiving 
facility or its corporate headquarters to enter approved suppliers and approved raw materials and 
other ingredients into the computerized system.  When raw materials and other ingredients are 
delivered to a facility, the receiving personnel cross reference the purchase order number, 
supplier name, material received, and the quantity of material received with the information 
previously entered into the computer system to verify the materials are from an approved 
supplier and the order is correct.  Typically, the computer system would also have a safeguard 
mechanism to prevent the acceptance of a raw material or other ingredient from an unapproved 
supplier.  On an as needed basis, a facility or its corporate headquarters can use the computer 
system to generate a list of the approved suppliers and approved raw materials or ingredients in 
real time. 
 
Another approach to a written procedure for ensuring that raw materials and other ingredients are 
only received from approved suppliers is use of computer programs that link inputs on items 
received with the list of approved suppliers for that item and flag discrepancies.  You could 
either use your existing receiving record system or modify your existing receiving record system 
to record information regarding receipt from approved suppliers. 
 
Subpart E accounts for emergency situations in which you would need to receive raw materials 
or other ingredients on a temporary basis from an unapproved supplier.  See 21 CFR 
507.120(b)(2) and (Ref. 7).  Examples of such situations are disruptions in delivery of raw 
materials and other ingredients from approved suppliers due to: 
 
  An environmental incident (e.g., an earthquake) or weather-related crisis (e.g., a tornado or 
severe drought or flooding in the area where the supplier is located); 
 
  A major equipment breakdown at the facility of a sole supplier of an animal food; 
 
  The emergence of a contamination problem at your suppliers facility; or 
 
  Your supplier ceases operations without giving you advance notification. 
 
For an unapproved supplier that you plan to use on a temporary basis, we recommend that you 
conduct at least a minimal review of the supplier.  For example, we suggest that you review 
FDAs website to determine whether the potential supplier has received a warning letter or is 
listed on an import alert.  In addition, if you need to use an unapproved supplier under such 
unexpected circumstances, you must subject the applicable raw materials or other ingredients to 
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adequate verification activities before acceptance for use.  See 21 CFR 507.120(b)(2).  For 
example, if you are receiving a raw material or ingredient such as poultry by-product meal and 
your temporary supplier controls Salmonella, you could sample and test each shipment of food 
from the temporary supplier for Salmonella using a statistically-based sampling plan.  
Alternatively, you could obtain and review records of the process that the temporary supplier 
uses to kill Salmonella in the poultry by-product meal. 
 
You should use unapproved suppliers only on a temporary basis until you are able to fully 
evaluate and approve a different supplier, or until the problem with your previously approved 
supplier has been corrected and, as appropriate, you reevaluate your approval of that supplier.  
An appropriate time period for use of an unapproved supplier on a temporary basis might vary, 
depending on the circumstances, from a few weeks to a few months.  For example, if your 
approved supplier ceases operations and you intend to continue to use a temporary supplier, you 
should promptly evaluate the new supplier and revise your supply-chain program accordingly.  If 
you are considering multiple new suppliers to replace your approved supplier, you may need 
some additional time to evaluate and approve the additional suppliers.  As another example, it 
could be the case that you expect to be able to obtain the raw material or other ingredient from 
the approved supplier in a few weeks, but you subsequently determine that it may take several 
months or an indefinite period of time before you can obtain the raw material or other ingredient 
from the approved supplier because of an equipment breakdown or a weather-related incident.  
In that circumstance, you may determine that you want to use your temporary supplier or another 
supplier on a more permanent basis.  If that occurs, you should promptly evaluate and approve 
the new supplier and revise your supply-chain program to reflect this.  Having multiple suppliers 
approved for each raw material or ingredient you receive can reduce the use of temporary 
suppliers when one supplier experiences an emergency. 
 
How you document use of the written procedures for receiving raw materials and other 
ingredients depends on what your procedures are and how you implement them.  For example, if 
you use a checklist, or put a check mark on the receiving document if the supplier is an approved 
supplier, then the checklist or receiving document would be your documentation.  If you use a 
computerized system, you can generate records such as a list of approved suppliers and a list of 
approved raw materials and other ingredients received from those suppliers on an as needed 
basis.  If you receive documentation from another entity that has documented the receipt of raw 
materials or other ingredients from suppliers you have approved, you would review that 
documentation to verify that it is correct and document your assessment (e.g., with a notation on 
the documentation you received or in a computerized receiving log). 
 
If you receive raw materials or other ingredients on a temporary basis from an unapproved 
supplier, remember that subpart E requires you to subject raw materials or other ingredients from 
that unapproved supplier to adequate verification activities before you accept the raw materials 
or other ingredients for use.  See 21 CFR 507.120(b)(2).  You should document the verification 
activities that you conducted before accepting raw materials or other ingredients from a 
temporary supplier. 
 
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IX.  Determining Appropriate Supplier Verification Activities (Including Determining the 
Frequency of Conducting the Activity) (21 CFR 507.125) 
 
Section 21 CFR 507.125 requires that appropriate supplier verification activities (including the 
frequency of conducting the activity) be determined in accordance with the requirements of 21 
CFR 507.110(d).  Section 21 CFR 507.110(d) specifies the considerations in approving suppliers 
and determining the appropriate supplier verification activities and the frequency with which 
they are conducted.  For details about the requirements of 21 CFR 507.110(d) and our 
recommendations for complying with those requirements, see section VI.D. 
 
X.  Conducting Supplier Verification Activities for Raw Materials and Other Ingredients 
(21 CFR 507.130) 
 
Section 21 CFR 507.130 specifies requirements to conduct one or more of the supplier 
verification activities specified in 21 CFR 507.110(b), provides for alternative supplier 
verification activities in certain circumstances, and prohibits certain financial conflicts of 
interest.  We discuss these provisions in sections X.A through X.F. 
 
A.  Requirement to Conduct Supplier Verification Activities 
 
With some exceptions, 21 CFR 507.130(a) requires that one or more supplier verification 
activities (i.e., onsite audit, sampling and testing, review of food safety records, and other 
supplier verification activities)5 must be conducted for each supplier before using the raw 
material or other ingredient from that supplier and periodically thereafter.  The exceptions to this 
requirement are specified in 21 CFR 507.130(c), (d), and (e).  See the discussion of the 
exceptions to this requirement in sections X.C through X.E. 
 
A successful supplier program includes supplier verification activities both before the use of the 
raw material or other ingredient and periodically thereafter to evaluate ongoing compliance 
(Refs. 5, 8, and 9).  Periodic verification provides routine feedback on the suppliers 
performance, rather than only when a problem arises (Ref. 5). 
 
Subpart E includes specific requirements for conducting onsite audits (21 CFR 507.135) and for 
documenting the conduct of supplier verification activities (21 CFR 507.175).  See sections X.B 
and XI for discussions of conducting an onsite audit as a supplier verification activity.  See 
section XII for a discussion of documenting of supplier verification activities. 
   
                                                 
5 The list of appropriate supplier verification activities is specified in 21 CFR 507.110(b).  The receiving facility 
determines which activity to conduct in accordance with 21 CFR 507.110(d).  See the discussion of the appropriate 
supplier verification activities in section VI.B. See the discussion of determining appropriate supplier verification 
activities in section VI.D. 
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B.  Specific Requirements When the Hazard Requiring a Preventive Control is a 
SAHCODHA Hazard 
 
1.  Requirement for an onsite audit when the hazard requiring a preventive 
control is a SAHCODHA hazard 
 
With one exception (see section X.B), 21 CFR 507.130(b)(1) requires that when a hazard in a 
raw material or other ingredient will be controlled by the supplier and is one for which there is a 
reasonable probability that exposure to the hazard will result in serious adverse health 
consequences or death to humans or animals (i.e., SAHCODHA hazard): 
 
  The appropriate supplier verification activity is an onsite audit of the supplier (21 CFR 
507.130(b)(1)(i)); and 
 
  The audit must be conducted before using the raw material or other ingredient from the 
supplier and at least annually thereafter (21 CFR 507.130(b)(1)(ii)). 
 
SAHCODHA hazards are those for which a recall of a violative product posing such a hazard is 
designated as Class 1 under 21 CFR 7.3(m)(1) (i.e., a situation in which there is a reasonable 
probability that the use of, or exposure to, a violative product will cause serious adverse health 
consequences or death).  Examples of such hazards that, in some circumstances, have resulted in 
serious adverse health consequences or death to humans or animals include pathogens (e.g., 
Salmonella in pet food) and nutrient deficiencies and toxicities (e.g., copper toxicity in food for 
sheep).  Animal food containing a SAHCODHA hazard is considered reportable food, subject to 
the Reportable Food Registry requirements prescribed by the Food and Drug Administration 
Amendments Act of 2007.  See our Guidance for Industry: Questions and Answers Regarding 
the Reportable Food Registry as Established by the Food and Drug Administration Amendments 
Act of 2007 and the annual reports of the Reportable Food Registry for examples of animal 
food that we have considered to contain SAHCODHA hazards (Refs. 10, 11, and 12). 
 
Onsite audits provide the opportunity to review the food safety plan and written procedures and 
to observe the implementation of food safety procedures, as well as to review the records related 
to the past application of control measures, including laboratory test results.  Audits also provide 
the opportunity to interview employees to assess their understanding of the food safety measures 
for which they are responsible. 
 
The goal of conducting an audit at least annually thereafter is to receive the results of an audit 
with sufficient frequency to provide assurance that a hazard requiring a supply-chain-applied 
control has been significantly minimized or prevented.  We realize there could be practical 
reasons which preclude meeting this timeframe, e.g., if a third-party auditor needs to delay a 
previously scheduled audit.  We do not intend to take action if the timeframe between annual 
audits is reasonably close to one year (e.g., within 13-14 months). 
 
For specific requirements that apply to an onsite audit, see 21 CFR 507.135 and section XI.  For 
a discussion of documentation associated with an onsite audit, see section XII. 
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2.  Exception to the requirement for an onsite audit when the hazard requiring a 
preventive control is a SAHCODHA hazard 
 
The exception to the requirement to conduct an annual onsite audit when the hazard requiring a 
preventive control is a SAHCODHA hazard is when there is a written determination that other 
verification activities and/or less frequent onsite auditing of the supplier provide adequate 
assurance that the hazards are controlled.  See 21 CFR 507.130(b)(2).  The written determination 
is part of your food safety plan and, thus, must be prepared by (or under the oversight of) your 
PCQI (see the discussion in section V.E). 
 
As an example of using an alternative approach to an annual onsite audit, consider the situation 
in which you are part of a larger corporation, are making dog food, and obtain meat meal from a 
supplier that is a subsidiary of the corporation and is operating under the same food safety 
system as you.  You could determine that the food safety requirements established by the parent 
company and applied at the subsidiary provide the needed assurance that Salmonella in meat 
meal is adequately controlled.  You could support your decision by documenting this 
determination, including the suppliers procedures and the corporations activities to verify that 
the subsidiary operates in accordance with corporate food safety policies to ensure that hazards 
are adequately controlled.  See also the discussion in section V.B of a circumstance where an 
individual at the corporate level is the PCQI for the purposes of the supply-chain program. 
 
However, if a SAHCODHA hazard is identified for the animal food and you conclude that 
annual onsite auditing is not required, we recommend that your supplier verification activities 
generally include some frequency of onsite auditing, such as every 2 or 3 years for most 
suppliers not in your same corporate structure.  For example, consider the situation in which you 
have many years of experience with the same supplier.  You could document the history of the 
suppliers compliance with control of the hazard (including summarizing test results, audit 
findings and other information) to support your decision that an annual onsite audit is not 
needed.  You would identify appropriate supplier verification activities and document these in 
your supply-chain program, e.g., you could determine and describe in your written program that 
you will require an audit every two years and sample and test for the hazard each quarter in the 
intervening year. 
 
C.  Alternative Supplier Verification Activity If the Supplier Is a Qualified Facility 
 
Section 21 CFR 507.130(c) provides for an alternative supplier verification activity if a supplier 
is a qualified facility as defined by 21 CFR 507.3.  If this is the case, you do not need to comply 
with the requirements to conduct one of the supplier verification activities specified in 21 CFR 
507.110(b) (i.e., onsite audit, sampling and testing, review of the suppliers relevant food safety 
records, or other appropriate supplier verification activity), or conduct an annual onsite audit if 
the hazard requiring a preventive control is a SAHCODHA hazard, if you: 
   
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  Obtain written assurance that the supplier is a qualified facility as defined by  507.3: 
 
  Before first approving the supplier for an applicable calendar year (21 CFR 
o
507.130(c)(1)(i)); and 
 
  On an annual basis thereafter, by December 31 of each calendar year, for the 
o
following calendar year (21 CFR 507.130(c)(1)(ii)); and 
 
  Obtain written assurance, at least every 2 years, that the supplier is producing the raw 
material or other ingredient in compliance with applicable FDA food safety regulations (or, 
when applicable, relevant laws and regulations of a country whose food safety system 
FDA has officially recognized as comparable or has determined to be equivalent to that of 
the United States).  The written assurance must include either: 
 
  A brief description of the preventive controls that the supplier is implementing to 
o
control the applicable hazard in the animal food (21 CFR 507.130(c)(2)(i)); or 
 
  A statement that the facility is in compliance with State, local, county, tribal, or 
o
other applicable non-Federal food safety law, including relevant laws and 
regulations of foreign countries (21 CFR 507.130(c)(2)(ii)). 
 
A facility is a qualified facility if it is a very small business as that term is defined in part 507.  
See the definitions for qualified facility and very small business in 21 CFR 507.3 and in the 
Glossary in Appendix A.  A qualified facility is not subject to the PCAF requirements for hazard 
analysis and risk-based preventive controls, including the supply-chain program.  The supplier is 
responsible for determining whether it is a qualified facility; you are responsible for obtaining 
written assurance from the supplier that it is a qualified facility. 
 
By specifying by December 31 for the annual written assurance that the supplier is a qualified 
facility, the provision provides some flexibility for you to work with each applicable supplier to 
determine the specific date within a calendar year for that supplier to annually notify you about 
its status.  You and your suppliers have some flexibility to approach the potential for the status of 
a facility to shift between qualified facility and not a qualified facility (or vice versa) in a 
way that works best for your specific business relationship. 
 
The biennial written assurance aligns with the responsibilities of a qualified facility to submit an 
attestation to FDA every two years.6  See 21 CFR 507.7(a).  In its attestation, the qualified 
facility attests that: (1) it meets the definition of a qualified facility; and (2) either it has 
established and is following certain food safety practices, or it is in compliance with State, local, 
county, tribal, or other applicable non-Federal food safety law, including relevant laws and 
regulations of foreign countries.  See section VI.D.3 for a discussion of the applicability of 
                                                 
6 For a facility that begins manufacturing, processing, packing or holding food before September 17, 2019, the 
facility must make its first submission by December 16, 2019.  For a facility that begins manufacturing, processing, 
packing or holding food after September 17, 2019, the facility must make its first submission before beginning 
operations.  See 21 CFR 507.7(c)(2). 
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relevant laws and regulations of a country whose food safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of the United States. 
 
A qualified facility submits its attestation to FDA on Form FDA 3942b.  A supplier that is a 
qualified facility could provide a copy of that form to its customers to help them comply with 21 
CFR 507.130(c)(1).  (A qualified facility that submits the attestation electronically could print a 
copy for this purpose).  Subpart E also requires that a receiving facility obtain a written 
assurance that includes a brief written description of the preventive controls that the qualified 
facility is implementing to control the applicable hazard in the animal food, or a statement that 
the qualified facility is in compliance with an applicable non-Federal food safety law (see 21 
CFR 507.130(c)(2)).  For example, a qualified facility that supplies a flavor enhancer could 
include in its written assurance:  (1) a brief written description of its preventive controls to 
control Salmonella in the flavor enhancer (e.g., heat treatment at a specified temperature for a 
specified time period), or (2) a statement that it complies with the food safety laws of the state in 
which it is located. 
 
D.  Alternative Supplier Verification Activity If the Supplier is a Certain Type of 
Produce Farm 
 
Section 21 CFR 507.130(d) provides for an alternative supplier verification activity if a supplier 
is a farm that grows produce and is not a covered farm under the produce safety regulation in 21 
CFR part 112 in accordance with 21 CFR 112.4(a), or in accordance with 21 CFR 112.4(b) and 
112.5.  If this is the case, you do not need to comply with the requirements to conduct one of the 
supplier verification activities specified in 21 CFR 507.110(b) or conduct an annual onsite audit 
if the hazard requiring a preventive control is a SAHCODHA hazard, for produce that the 
receiving facility receives from the farm as a raw material or other ingredient if you: 
 
  Obtain written assurance that the raw material or other ingredient provided by the supplier 
is not subject to the produce safety regulation in 21 CFR part 112 in accordance with 21 
CFR 112.4(a), or in accordance with 21 CFR 112.4(b) and 112.5: 
 
  Before first approving the supplier for an applicable calendar year; and 
o
 
  On an annual basis thereafter, by December 31 of each calendar year, for the 
o
following calendar year; and 
 
  Obtain written assurance, at least every 2 years, that the farm acknowledges that its food is 
subject to section 402 of the FD&C Act (or, when applicable, that its food is subject to 
relevant laws and regulations of a country whose food safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of the United States). 
 
Under 21 CFR 112.4(a), a farm or farm mixed-type facility that has less than $25,000 in annual 
sales averaged over the previous 3-year period is not a covered farm under the produce safety 
regulation.  Under 21 CFR 112.4(b) and 112.5, a farm is not a covered farm if the farm is eligible 
for a qualified exemption and associated modified requirements based on average monetary 
value of all food sold and the relative value of food sold directly to qualified end users as 
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compared to all other buyers,7 and FDA has not withdrawn the farms exemption.  The supplier 
is responsible for determining whether it is not subject to the produce safety regulation; you are 
responsible for obtaining written assurance from the supplier that it is not subject to the produce 
safety regulation. 
 
By specifying by December 31 for the annual written assurance that the supplier is a farm that 
grows produce and is not a covered farm under the produce safety regulation, the provision 
provides some flexibility for you to work with each applicable supplier to determine the specific 
date within a calendar year for that supplier to annually notify you about its status.  You and your 
suppliers have some flexibility to approach the potential for the status of a farm to shift between 
not a covered farm and covered farm (or vice versa) in a way that works best for your 
specific business relationship. 
 
See section VI.D.3 for a discussion of the applicability of relevant laws and regulations of a 
country whose food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States. 
 
E.  Alternative Supplier Verification Activity If the Supplier Is a Shell Egg Producer 
That Is Not Subject to the Requirements of 21 CFR Part 118 
 
Section 21 CFR 507.130(e) provides for an alternative supplier verification activity if a supplier 
is a shell egg producer that is not subject to the requirements of 21 CFR part 118 for the 
production, storage, and transportation of shell eggs because it has less than 3,000 laying hens.  
If this is the case, you do not need to comply with the requirements to conduct one of the 
supplier verification activities specified in 21 CFR 507.110(b), or conduct an annual onsite audit 
if the hazard requiring a preventive control is a SAHCODHA hazard, if you: 
 
  Obtain written assurance that the shell eggs produced by the supplier are not subject to 21 
CFR part 118 because the shell egg producer has less than 3,000 laying hens: 
 
  Before first approving the supplier for an applicable calendar year; and 
o
 
  On an annual basis thereafter, by December 31 of each calendar year, for the 
o
following calendar year; and 
 
  Obtain written assurance, at least every 2 years, that the shell egg producer acknowledges 
that its food is subject to section 402 of the FD&C Act (or, when applicable, that its food is 
subject to relevant laws and regulations of a country whose food safety system FDA has 
officially recognized as comparable or has determined to be equivalent to that of the 
United States). 
 
A shell egg producer is not subject to the requirements for the production, storage, and 
transportation of shell eggs if it has less than 3,000 laying hens.  The supplier is responsible for 
determining whether it not subject to the requirements for the production, storage, and 
                                                 
7 See 21 CFR 112.5(a) for the requirements of the qualified exemption and 21 CFR 112.3 for the definition of 
qualified end users. 
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transportation of shell eggs; you are responsible for obtaining written assurance from the supplier 
that it is not subject to those requirements. 
 
By specifying by December 31 for the annual written assurance that the supplier is a shell egg 
producer that is not subject to 21 CFR part 118, the provision provides some flexibility for you to 
work with each applicable supplier to determine the specific date within a calendar year for that 
supplier to annually notify the receiving facility about its status.  You and your suppliers have 
some flexibility to approach the potential for the status of a shell egg producer to shift between 
not subject to 21 CFR part 118 and subject to 21 CFR part 118 (or vice versa) in a way that 
works best for your specific business relationship. 
 
See section VI.D.3 for a discussion of the applicability of relevant laws and regulations of a 
country whose food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States. 
 
F.  Financial Conflict of Interest 
 
Section 21 CFR 507.130(f) specifies that there must not be any financial conflicts of interests 
that influence the results of the verification activities listed in 21 CFR 507.110(b).  For example, 
if a qualified individual has a financial conflict of interest that influences the results of supplier 
verification activities, the qualified individual would be precluded from being able to 
independently conduct supplier verification activities.  You can avoid this possibility when 
conducting supplier verification activities by only using individuals or firms that do not have 
conflicts of interest. 
 
In addition, 21 CFR 507.130(f) specifies that payment must not be related to the results of the 
activity.  For example, you may not give a qualified auditor who conducts an onsite audit, or a 
qualified individual who reviews supplier food safety records, greater compensation for 
determining that a supplier is in compliance with applicable FDA requirements.  Also, you may 
not reduce the compensation of a qualified auditor or qualified individual or assess financial 
penalties because the qualified auditor or qualified individual identified areas of supplier non-
compliance.  Similarly, a supplier may not make such payments. 
 
The requirements of 21 CFR 507.130(f) do not prohibit employees of a supplier from performing 
the functions specified in 21 CFR 507.115 in accordance with 21 CFR 507.115.  See the 
discussion of functions that a supplier can perform in accordance with 21 CFR 507.115(a)(4) in 
section VII.B.2.  For example, this provision would not prohibit an employee of a supplier from 
conducting sampling and testing so that the supplier could provide the results in documentation 
provided to the receiving facility; it is common for suppliers to include COAs for tests conducted 
on specific lots of product along with the shipment to the receiving facility.  The requirements of 
21 CFR 507.130(f) also do not prohibit you from relying on an audit provided by your supplier 
when the audit of the supplier was conducted by a third-party qualified auditor.  See the 
discussion of 21 CFR 507.115(c) in section VII.D. 
   
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XI.  Onsite Audit (21 CFR 507.135) 
 
Section 21 CFR 507.135 specifies requirements applicable to onsite audits, including who must 
conduct an onsite audit; consideration of applicable food safety regulations; and when the written 
results of an inspection can be substituted for an audit.  We discuss these provisions in sections 
XI.A through XI.C. 
 
A.  Who Conducts an Onsite Audit? 
 
Section 21 CFR 507.135(a) requires that an onsite audit of a supplier be performed by a qualified 
auditor (see also 21 CFR 507.53(b)).  Section 21 CFR 507.3 defines qualified auditor as a 
person who is a qualified individual as defined in part 507 and has technical expertise obtained 
through education, training, or experience (or a combination thereof) necessary to perform the 
auditing function.  Examples of potential qualified auditors include: 
 
  A government employee, including a foreign government employee; and 
 
  An audit agent of a certification body that is accredited in accordance with the accredited 
third-party certification regulation in 21 CFR part 1, subpart M. 
 
Part 507 defines qualified individual as a person who has the education, training, or experience 
(or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe 
animal food as appropriate to the individuals assigned duties.  A qualified individual may be, 
but is not required to be, an employee of the establishment. 
 
See the definitions of qualified auditor and qualified individual in 21 CFR 507.3 and in the 
Glossary in Appendix A.  The requirements applicable to a qualified auditor are set forth in 21 
CFR 507.53(c)(2), which specifies that to be a qualified auditor, a qualified individual must have 
technical expertise obtained through education, training, or experience (or a combination thereof) 
necessary to perform the auditing function.  A qualified auditor may be, but is not required to be, 
an employee of the receiving facility. 
 
We have not established specific courses, programs, or certifications, or defined the type of 
experiences that would be required to satisfy the requirements applicable to a qualified auditor as 
defined in part 507.  However, consistent with the requirements for competent audit agents in 21 
CFR 1.650 and the guidance entitled Third-Party Certification Body Accreditation for Food 
Safety Audits: Model Accreditation Standards: Guidance for Industry and FDA Staff (Guidance 
on Accredited Third-Party Certification) (Ref. 13), a qualified auditor should have education, 
training, or experience that provides the person with knowledge and skills necessary to evaluate 
whether the equipment, processes, and procedures in a food facility or on a farm ensure that the 
hazards associated with the animal food have been controlled.  For example, an individual who 
has previously conducted food safety inspections for a food safety authority may be a qualified 
auditor, provided that the individual has the knowledge and experience to assess compliance with 
the applicable provisions of the FD&C Act.  A person should have at least some actual 
experience in auditing (including assisting in audits or observing audits) to meet the definition of 
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a qualified auditor, because the necessary technical expertise likely cannot be obtained solely 
through education and/or training that does not involve assisting or observing others in the 
performance of an audit. 
 
The example of an audit agent of a certification body that has been accredited in accordance with 
regulations in our accredited third-party certification regulation (21 CFR part 1, subpart M) adds 
context about the standard for such individuals.  The requirements in 21 CFR 1.650 address how 
an accredited third-party certification body must ensure its audit agents are competent and 
objective.  Although an onsite audit that is solely conducted to meet the requirements of part 507 
by an audit agent of a certification body that is accredited in accordance with regulations in part 
1, subpart M, is not subject to the requirements in those regulations (see section XI.D), the 
requirements for audit agents and the Guidance on Accredited Third-Party Certification with 
respect to competency are useful in determining appropriate education, training, or experience 
for a qualified auditor (Ref. 13).  For example, competency requirements for audit agents in the 
accredited third-party certification regulation include that they: 
 
  Have relevant knowledge and experience that provides an adequate basis for the audit 
agent to evaluate compliance with applicable food safety requirements of the FD&C Act 
and FDA regulations; 
 
  Be competent to conduct food safety audits; and 
 
  Have completed annual food safety training. 
 
See 21 CFR 1.650(a). 
 
The Guidance on Accredited Third-Party Certification further recommends education and/or 
experience for entry level auditors (audit agents) and lead auditors, as well as auditor skills such 
as observational, reasoning, analytical, and communication skills (Ref. 13).  For purposes of the 
third-party certification program, auditors should be trained to understand and properly apply 
FDAs food safety requirements under the FD&C Act and FDA regulations for purposes of 
auditing.  Technical training may vary depending on the processes and products being audited.  
Training methods may include classroom training, annual food safety training, and joint audits 
with a qualified trainer to help the audit agent apply classroom learning (Ref. 13). 
 
The Global Food Safety Initiative (GFSI) provisions for auditor competency in GFSI Food 
Safety Auditor Competencies are also useful in determining the knowledge, experience, and 
skills for a qualified auditor (Ref. 14).  The GFSIs auditor competency model lists three main 
components for auditor competencies: (1) auditing skills and knowledge; (2) technical skills and 
knowledge; and (3) behavior and systems thinking.  Within each main component, GFSI 
provides details of specific tasks and the required auditor knowledge and skills to perform the 
specific tasks. 
 
You or one of your employees may conduct the audit as long as you are or your employee is a 
qualified auditor, based on education, training, or experience, or a combination thereof. 
 
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B.  Consideration of Food Safety Regulations 
 
Section 21 CFR 507.135(b) requires that if the raw material or other ingredient at the supplier is 
subject to one or more FDA food safety regulations, an onsite audit must consider such 
regulations and include a review of the supplier's written plan (e.g., food safety plan), if any, and 
its implementation, for the hazard being controlled (or, when applicable, an onsite audit may 
consider relevant laws and regulations of a country whose food safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of the United States). 
 
The qualified auditor who audits your supplier may be your own employee (second-party 
audit) or an independent third party (i.e., a qualified auditor who is neither your employee nor 
an employee or the supplier) (third-party audit).  Both second-party audits and third-party audits 
allow first-hand review of the critical food safety programs in place at a suppliers establishment 
and can help you to obtain a sense of how effective programs are by diligently reviewing 
program records, observing activities, and interviewing workers. 
 
Because FDA food safety regulations vary in scope and detail, the parameters and key 
components of an onsite audit conducted under section 21 CFR 507.135(a) would vary 
depending on what regulations apply to the supplier. 
 
A supplier that is subject to the PCAF requirements must have a food safety plan (see 21 CFR 
507.31).  If your supplier is subject to the PCAF requirements, the onsite audit would focus on 
the suppliers food safety plan and assess the implementation of the preventive controls applied 
by the supplier to address the known or reasonably foreseeable hazards that you have determined 
to require a supply-chain-applied control.  For example, before you obtain mineral premix for 
which you had identified copper toxicity as a hazard from a supplier subject to the PCAF 
requirements, you would audit the supplier (or obtain documentation of an audit performed by a 
third party) to determine whether the suppliers manufacturing process adequately controlled the 
level of copper in the mineral premix.  Because the supplier was subject to the PCAF 
requirements, the onsite audit should include a review of the suppliers food safety plan.  The 
auditor should review whether the manufacturing process had been validated to significantly 
minimize excess levels of copper in the mineral premix and should examine whether the supplier 
had implemented the manufacturing procedures in accordance with its food safety plan (e.g., 
through observing the establishments procedures and reviewing records). 
 
An onsite audit of your supplier should include both records review and observation of practices 
to obtain a complete picture of the safety of your suppliers operations.  Comprehensive systems 
audits that include records reviews are more likely to reflect conditions throughout the year than 
an audit focused only on the state of the facility at the time of the audit.  An onsite audit of a 
manufacturing/processing facility subject to the PCAF requirements should address process, 
sanitation, and supply-chain applied controls (if any), as well as CGMPs (if applicable) and the 
specific hazards identified in your hazard analysis of the animal food. 
 
There are several national and international auditing schemes used to assess food safety practices 
in manufacturing facilities and on farms.  You could rely on the results of audits conducted in 
accordance with such schemes provided that the audits evaluate the farm or facilitys compliance 
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with applicable FDA regulations, review the suppliers food safety plan (if any) and its 
implementation, and otherwise meet the requirements for onsite audits in 21 CFR 507.135.  
Before relying on the results of a third-party onsite audit, you should determine whether the 
auditing scheme used can help you to conclude whether the supplier uses processes and 
procedures that comply with applicable regulations.  Audit schemes that consider FDA food 
safety regulations and include a review of the suppliers written food safety plan, if any, and its 
implementation, with respect to the hazard being controlled, are likely to satisfy the requirements 
for an onsite audit. 
 
C.  Substitution of an Inspection for an Audit 
 
Section 21 CFR 507.135(c) allows for the following inspections to substitute for an onsite audit, 
provided that the inspection was conducted within 1 year of the date that the onsite audit would 
have been required to be conducted: 
 
  The written results of an appropriate inspection of the supplier for compliance with 
applicable FDA food safety regulations by FDA, by representatives of other Federal 
Agencies (such as the United States Department of Agriculture (USDA)), or by 
representatives of State, local, tribal, or territorial agencies (21 CFR 507.135(c)(1)(i)); or 
 
  For a foreign supplier, the written results of an inspection by FDA or the food safety 
authority of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United States.  See 21 CFR 
507.135(c)(1)(ii).  For inspections conducted by the food safety authority of a country 
whose food safety system FDA has officially recognized as comparable or determined to 
be equivalent, the animal food that is the subject of the onsite audit must be within the 
scope of the official recognition or equivalence determination, and the foreign supplier 
must be in, and under the regulatory oversight of, such country (see 21 CFR 
507.135(c)(2)). 
 
For an inspection conducted by FDA, other Federal Agencies, or State, local, tribal, or territorial 
agencies, an appropriate inspection conducted for compliance with applicable FDA regulations 
means that the inspection was sufficiently relevant to compliance with applicable FDA food 
safety regulations to credibly substitute for an onsite audit.  For example, inspection by a State 
agency to determine whether a facility satisfies the requirements of the BSE regulations (see 21 
CFR part 589) could constitute an appropriate inspection that could substitute for an audit if the 
hazard being controlled is BSE, but an inspection by a State agency to determine whether a 
facility meets the BSE regulation could not substitute for an inspection if the hazard being 
controlled by the supplier is a nutrient deficiency or toxicity hazard. 
 
In the case of a foreign supplier, a country whose food safety system FDA has officially 
recognized as comparable to that of the United States would be one for which there is a signed 
systems recognition arrangement or other agreement between FDA and the country establishing 
official recognition of the foreign food safety system.  See section VI.D.3 for information on 
countries for which we have a Food Safety Systems Recognition Arrangement or other 
cooperative arrangement with a foreign country. 
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Some countries issue certifications or recognitions to facilities for compliance with certain 
requirements such as for hazard analysis and critical control points (HACCP) systems.  We 
would not accept a HACCP certificate issued by a foreign government as a substitute for an 
onsite audit because HACCP requirements are not identical to the PCAF requirements and it 
would not be clear as to what basis was used to issue a HACCP certificate.  However, a receiving 
facility could consider whether such a certificate could be part of its justification for conducting 
another supplier verification activity in lieu of an annual onsite audit, or for conducting an onsite 
audit on a less frequent basis than annually (see section X.B.2). 
 
D.  Audits Conducted to Meet the Requirements of Subpart E Do Not Have to 
Comply with the Requirements of the Accredited Third-Party Regulation 
 
Section 21 CFR 507.135(d) specifies that if an onsite audit is solely conducted to meet the 
requirements of part 507 by an audit agent of a certification body that is accredited in accordance 
with regulations in part 1, subpart M, the audit is not subject to the requirements in those 
regulations. 
 
Audits conducted under the accredited third-party certification regulation are done for specific 
purposes, e.g., for compliance with the requirements of the Voluntary Qualified Importer 
Program.  Audits conducted to meet the requirements of 21 CFR 507.135 may be conducted by a 
person who had been accredited under part 1, subpart M; however, the requirements for audits 
conducted under the accredited third-party certification regulation (e.g., specific information that 
must be included in an audit and submission of regulatory audit reports to FDA under 21 CFR 
1.652) would not apply to an audit even when the auditor is accredited to do such audits unless 
they are also conducted for purposes under the accredited third-party certification regulation. 
 
XII.  Records Documenting the Supply-Chain Program 
 
Section 21 CFR 507.175 specifies that the records documenting the supply-chain program are 
subject to the requirements of subpart F of part 507.  See 21 CFR 507.175(a).  Subpart F sets 
forth general requirements applicable to all records, such as the use of either paper or electronic 
records and the need for records to be accurate, indelible, and legible.  Subpart F also sets forth 
requirements for record retention and official review.  Section 507.212 in subpart F explains how 
you can use existing records to satisfy the recordkeeping requirements of part 507. 
 
Section 21 CFR 507.175 requires that you must review the records of the supply-chain program 
in accordance with 21 CFR 507.49(a)(4).  See 21 CFR 507.175(b).  Under 21 CFR 
507.49(a)(4)(ii)), records of the supply-chain program must be reviewed by (or under the 
oversight of) a PCQI within a reasonable time after the records are made to ensure that the 
records are complete, the activities reflected in the records occurred in accordance with the food 
safety plan, the preventive controls are effective, and appropriate decisions were made about 
corrective actions. 
 
   
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Table 2 lists the records required for the supply-chain program.  See 21 CFR 507.175(c). 
 
Table 2.  List of Records Required for the Supply-Chain Program 
 
Section  Description  Discussion 
507.175(c)(1)  The written supply-chain program  There is no standardized or required 
format for the written supply-chain 
program or its records.  You can use 
whatever format works best for your 
facility, provided that the records 
include all the required information.  
Also, the written supply-chain 
program is part of the food safety 
plan, which must be signed and 
dated by the owner, operator, or 
agent in charge of the facility upon 
initial completion and upon any 
modification.  See 21 CFR 507.206. 
507.175(c)(2)  If you are an importer, documentation  If you are an importer, and you have 
that you are in compliance with the  records documenting the supplier 
FSVP requirements under part 1,  verification activities you conducted 
subpart L, including documentation of  to comply with the FSVP regulation, 
verification activities conducted under  you can rely on those records as 
 1.506(e)  documentation of verification 
activities to comply with the supply-
chain program requirements of 
subpart E. 
507.175(c)(3)  Documentation of the approval of a  Your written determination of the 
supplier  basis for approving the supplier.  
You could include a paper list of 
approved suppliers or an electronic 
system that can generate a list of 
approved suppliers as needed. 
507.175(c)(4)  Written procedures for receiving raw  Examples are a paper checklist and a 
materials and other ingredients  computer system that manages the 
procurement, receipt, and usage of 
raw materials and other ingredients. 
507.175(c)(5)  Documentation demonstrating use of  Examples are a paper checklist that 
the written procedures for receiving  was marked to demonstrate receipt 
raw materials and other ingredients  and electronic records produced by a 
computer system that manages the 
procurement, receipt, and usage of 
raw materials and other ingredients. 
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Section  Description  Discussion 
507.175(c)(6)  Documentation of the determination of  Your written determination should 
the appropriate supplier verification  explain why you chose your 
activities for raw materials and other  particular supplier verification 
ingredients  activities.  See the discussion in 
section VI.D. 
507.175(c)(7)  Documentation of the conduct of an  Examples of documentation of audit 
onsite audit, including (i) The name of  procedures include the process(es) 
the supplier subject to the onsite audit;  and animal food observed, types of 
(ii) Documentation of audit procedures;  records reviewed, and whether the 
(iii) The dates the audit was conducted;  audit included interviews or 
(iv) The conclusions of the audit; (v)  laboratory testing.  Examples of the 
Corrective actions taken in response to  conclusions of an audit include 
significant deficiencies identified  whether the audit did, or did not, 
during the audit; and (vi)  identify any significant deficiencies. 
Documentation that the audit was   
conducted by a qualified auditor.  You have some flexibility to work 
with the qualified auditor, or with a 
supplier who arranges for a third-
party audit, on appropriate 
documentation that the auditor has 
technical expertise obtained through 
education, training, or experience (or 
a combination thereof) necessary to 
perform the auditing function.  
Examples of such documentation are 
a list of applicable training and 
examples of relevant audits 
conducted by the auditor. 
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Section  Description  Discussion 
507.175(c)(8)  Documentation of sampling and testing  You have some flexibility in the 
conducted as a supplier verification  format of appropriate documentation 
activity.  This documentation must  of sampling and testing, such as on a 
include: (i) Identification of the raw  COA.  Documentation of corrective 
material or other ingredient tested  actions would apply to the steps you 
(including lot number, as appropriate)  take when you (or a third party 
and the number of samples tested; (ii)  acting on your behalf) detect the 
Identification of the test(s) conducted,  hazard in raw materials or other 
including the analytical method(s)  ingredients that you received, 
used; (iii) The date(s) on which the  including what you do with the raw 
test(s) were conducted and the date of  material or other ingredient and the 
the report; (iv) The results of the  steps you take to address the 
testing; (v) Corrective actions taken in  problem with the supplier. 
response to detection of hazards; and 
(vi) Information identifying the 
laboratory conducting the testing. 
507.175(c)(9)  Documentation of the review of the  Records of the supply-chain 
supplier's relevant food safety records.   program must be reviewed by (or 
This documentation must include: (i)  under the oversight of) a PCQI 
The name of the supplier whose  within a reasonable time after the 
records were reviewed; (ii) The date(s)  records are made to ensure that the 
of review; (iii) The general nature of  records are complete, the activities 
the records reviewed; (iv) The  reflected in the records occurred in 
conclusions of the review; and (v)  accordance with the food safety 
Corrective actions taken in response to  plan, the suppliers preventive 
significant deficiencies identified  controls are effective, and 
during the review.  appropriate decisions were made 
about corrective actions.  See 21 
CFR 507.49(a)(4). 
507.175(c)(10)  Documentation of other appropriate  Your documentation of other 
supplier verification activities based on  appropriate supplier verification 
the supplier performance and the risk  activities would depend on the 
associated with the raw material or  nature of the activity.  For example, 
other ingredient  if you use a fact-specific 
questionnaire you should have a 
record of the questionnaire applied 
to a particular supplier.  If you 
considered information applicable to 
a suppliers certification to a specific 
audit scheme, you should have a 
record of the information you 
considered. 
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Section  Description  Discussion 
507.175(c)(11)  Documentation of any determination  Because your written supply-chain 
that verification activities other than an  program is part of your food safety 
onsite audit, and/or less frequent onsite  plan, the written determination must 
auditing of a supplier, provide adequate  be prepared by (or under the 
assurance that the hazards are  oversight of) your PCQI.  See 21 
controlled when a hazard in a raw  CFR 507.31.  See the discussion in 
material or other ingredient will be  section X.B.2 for examples of what 
controlled by the supplier and is one for  such a written determination could 
which there is a reasonable probability  address. 
that exposure to the hazard will result 
in serious adverse health consequences 
or death to humans or animals. 
507.175(c)(12)  The following documentation of an  You and your suppliers have some 
alternative verification activity for a  flexibility to determine the 
supplier that is a qualified facility: (i)  appropriate documentation in a way 
The written assurance that the supplier  that works best for your specific 
is a qualified facility as defined by   business relationship.  For example, 
507.3; and (ii) The written assurance  for documentation of its status, a 
that the supplier is producing the raw  qualified facility could provide you 
material or other ingredient in  with documentation of its 
compliance with applicable FDA food  submission of the qualified facilities 
safety regulations (or, when applicable,  form (Form FDA 3942b).  For the 
relevant laws and regulations of a  other assurance, you and your 
country whose food safety system FDA  supplier can choose which of two 
has officially recognized as comparable  options to use, based on the specific 
or has determined to be equivalent to  circumstances of the supplier.  See 
that of the United States).  the discussion in section X.C of the 
two different types of attestation. 
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Section  Description  Discussion 
507.175(c)(13)  The following documentation of an  You and your suppliers have some 
alternative verification activity for a  flexibility to determine the 
supplier that is a farm that supplies a  appropriate documentation in a way 
raw material or other ingredient and is  that works best for your specific 
not a covered farm under part 112 of  business relationship. 
this chapter: (i) The written assurance 
that the supplier is not a covered farm 
under part 112 of this chapter in 
accordance with  112.4(a), or in 
accordance with  112.4(b) and 112.5; 
and (ii) The written assurance that the 
farm acknowledges that its food is 
subject to section 402 of the FD&C Act 
(or, when applicable, that its food is 
subject to relevant laws and regulations 
of a country whose food safety system 
FDA has officially recognized as 
comparable or has determined to be 
equivalent to that of the United States). 
507.175(c)(14)  The following documentation of an  You and your suppliers have some 
alternative verification activity for a  flexibility to determine the 
supplier that is a shell egg producer that  appropriate documentation in a way 
is not subject to the requirements  that works best for your specific 
established in part 118 of this chapter  business relationship. 
because it has less than 3,000 laying 
hens:  (i) The written assurance that the 
shell eggs provided by the supplier are 
not subject to part 118 of this chapter 
because the supplier has less than 3,000 
laying hens; and (ii) The written 
assurance that the shell egg producer 
acknowledges that its food is subject to 
section 402 of the FD&C Act (or, when 
applicable, that its food is subject to 
relevant laws and regulations of a 
country whose safety system FDA has 
officially recognized as comparable or 
has determined to be equivalent to that 
of the United States). 
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Section  Description  Discussion 
507.175(c)(15)  The written results of an appropriate  The written results of an appropriate 
inspection of the supplier for  inspection would depend on the 
compliance with applicable FDA food  inspection and how the entity 
safety regulations by FDA, by  conducting the inspection reports its 
representatives of other Federal  results. 
Agencies (such as the U.S. Department 
of Agriculture), or by representatives 
from State, local, tribal, or territorial 
agencies, or the food safety authority of 
another country when the results of 
such an inspection is substituted for an 
onsite audit. 
507.175(c)(16)  Documentation of actions taken with  Your documentation of actions taken 
respect to supplier nonconformance.  with respect to supplier 
nonconformance would depend on 
the nature of the nonconformance.  
See the examples of potential 
supplier nonconformance in section 
VI.E. 
507.175(c)(17)  Documentation of verification of a  If you obtain the documentation of 
supply-chain-applied control applied by  the verification activity from another 
an entity other than the receiving  entity, the documentation you 
facility's supplier.  receive from the other entity should 
be similar to the documentation you 
would have if you had conducted the 
activity yourself. 
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Section  Description  Discussion 
507.175(c)(18)  When applicable, documentation of the  You have some flexibility for how to 
receiving facility's review and  appropriately document that you 
assessment of: (i) Applicable  reviewed and assessed the 
documentation from an entity other  documentation from another entity.  
than the receiving facility that written  For example, appropriate staff in 
procedures for receiving raw materials  your facility could date and sign the 
and other ingredients are being  documentation received from the 
followed; (ii) Applicable  other entity, or you could attach a 
documentation, from an entity other  signed, dated statement, from 
than the receiving facility, of the  appropriate staff in your facility, 
determination of the appropriate  specifying that the documentation 
supplier verification activities for raw  had been reviewed and assessed.   
materials and other ingredients; (iii) 
Applicable documentation, from an 
entity other than the receiving facility, 
of conducting the appropriate supplier 
verification activities for raw materials 
and other ingredients; (iv) Applicable 
documentation, from its supplier, of: 
(A) The results of sampling and testing 
conducted by the supplier; or (B) The 
results of an audit conducted by a third-
party qualified auditor in accordance 
with  507.130(f) and 507.135; and 
(v) Applicable documentation, from an 
entity other than the receiving facility, 
of verification activities when a supply-
chain-applied control is applied by an 
entity other than the receiving facility's 
supplier. 
 
XIII. Compliance Dates 
 
In the preamble of the final rule establishing part 507, we provided compliance dates for the 
requirements of the supply-chain program in subpart E.  See Table 33 in the final rule, 80 FR 
56170 at 56329.  The compliance dates for implementing your supply-chain program apply with 
respect to each of your suppliers, not to your supply-chain program as a whole because the 
compliance dates depend on whether your suppliers will be subject to the CGMP or PCAF 
requirements (or both) of part 507.  For those suppliers subject to part 507, you are not required 
to conduct supplier verification activities until after your suppliers compliance date is reached. 
 
   
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For your convenience, Table 3 provides the information from Table 33 in the preamble of the 
final rule establishing part 507. 
 
Table 3.  Compliance Dates for the Requirements of the Supply-Chain Program 
 
Situation  Compliance date: 
You are a small business and your supplier  6 months after your supplier of that raw 
will be subject to the CGMPs, but not the  material or other ingredient is required to 
preventive control requirements, of part 507.  comply with the CGMP requirements of part 
507. 
You are a small business and your supplier is  The later of: September 17, 2018 or 6 months 
subject to the CGMP and PCAF requirements  after your supplier of that raw material or 
of part 507.  other ingredient is required to comply with 
part 507. 
You are not a small business or a very small  6 months after your supplier of that raw 
business and your supplier will be subject to  material or other ingredient is required to 
CGMPs, but not the preventive control  comply with the CGMP requirements of part 
requirements, of part 507.  507. 
You are not a small business or a very small  The later of: September 18, 2017 or 6 months 
business and your supplier will be subject to  after your supplier of that raw material or 
the CGMP and preventive control  other ingredient is required to comply with 
requirements of part 507.  part 507. 
 
   
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XIV. References 
 
1.  FDA. 2018. Draft Guidance for Industry: Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals. 
(https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio
n/ucm593060.htm).  Last accessed 3/9/18. 
 
2.  FDA. 2018. Draft Guidance #245  Hazard Analysis and Risk-Based Preventive Controls 
for Food for Animals. 
(https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guid
anceforIndustry/UCM592870.pdf).  Last accessed 3/9/18. 
 
3.  FDA. 2016. Supplier Evaluation Resources. 
(https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm516330.htm).  Last accessed 
3/9/18. 
 
4.  FDA. 2018. Animal and Veterinary Website. 
(https://www.fda.gov/AnimalVeterinary/default.htm).  Last accessed 3/9/18. 
 
5.  Zaura, D., 2005. Effective Supplier Program. Food Quality Magazine, December/January, 
86-88. (http://www.foodqualityandsafety.com/article/effective-supplier-programs/2/).  Last 
accessed 3-23-18. 
 
6.  International Featured Standards (IFS). 2014. IFS Food: Standard for auditing quality and 
food safety of food products, Version 6. (https://www.ifs-
certification.com/images/standards/ifs_food6/documents/standards/IFS_Food_V6_en.pdf).  
Last accessed 3-23-18. 
 
7.  Safe Quality Food Institute (SQFI). 2014. SQF Code 7.2. A HACCP-Based Supplier 
Assurance Code for the Food Industry. (http://www.sqfi.com/wp-content/uploads/SQF-
Code_Ed-7.2-July.pdf).  Last accessed 3-23-18. 
 
8.  Eldridge, B., 2012. Supplier Management: Six Steps to Selecting the Right Supplier. Food 
Safety Magazine, 18 (4): 30-31. (https://www.foodsafetymagazine.com/magazine-
archive1/augustseptember-2012/supplier-management-six-steps-to-selecting-the-right-
supplier/.)  Last accessed 3-26-18. 
 
9.  Eastern Research Group, Inc. (ERG). 2004. Good Manufacturing Practices (GMPs) for the 
21st Century - Food Processing. Section Four. Common Food Safety Problems in the U.S. 
Food Processing Industry: A Delphi Study. 
(https://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110914.htm.)  Last accessed 
3.12.18. 
   
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10.  FDA. 2009. Guidance for Industry: Questions and Answers Regarding the Reportable Food 
Registry as Established by the Food and Drug Administration Amendments Act of 2007. 
(https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio
n/RFR/ucm180761.htm.)  Last accessed 3-26-18. 
 
11.  FDA. 2010. Draft Guidance for Industry: Questions and Answers Regarding the Reportable 
Food Registry as Established by the Food and Drug Administration Amendments Act of 
2007 (Edition 2). 
(https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM213214.pdf.)  Last 
accessed 3-26-18. 
 
12.  FDA. 2016. The Reportable Food Registry: A Five-Year Overview of Targeting Inspection 
Resources and Identifying Patterns of Adulteration, September 8, 2009  September 7, 
2014. (https://www.fda.gov/downloads/food/complianceenforcement/rfr/ucm502117.pdf)  
Last accessed 3-26-18. 
 
13.  FDA. 2016. Third-Party Certification Body Accreditation for Food Safety Audits: Model 
Accreditation Standards: Guidance for Industry and FDA Staff.  
(https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatory
Information/UCM455331.pdf.)  Last accessed 3.9.18. 
 
14.  Global Food Safety Initiative & The Consumer Goods Forum 2013. GFSI Food Safety 
Auditor Competencies, Edition 1. 
   
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Appendix A  Glossary of Terms 
 
Definitions Established in 21 CFR 507.3 
 
Adequate means that which is needed to accomplish the intended purpose in keeping with good 
public (human and animal) health practice. 
 
Animal food means food for animals other than man and includes pet food, animal feed, and raw 
materials and ingredients. 
 
Audit means the systematic, independent, and documented examination (through observation, 
investigation, records review, discussions with employees of the audited entity, and, as 
appropriate, sampling and laboratory analysis) to assess an audited entitys food safety processes 
and procedures. 
 
Environmental pathogen means a pathogen capable of surviving and persisting within the 
manufacturing, processing, packing, or holding environment such that food for animals may be 
contaminated and may result in foodborne illness if that animal food is not treated to 
significantly minimize or prevent the environmental pathogen.  Examples of environmental 
pathogens for the purposes of this part include Listeria monocytogenes and Salmonella spp. but 
do not include the spores of pathogenic sporeforming bacteria. 
 
Facility means a domestic facility or a foreign facility that is required to register under section 
415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of 21 
CFR part 1, subpart H. 
 
Farm means farm as defined in 21 CFR 1.227. 
 
Food-contact surfaces are those surfaces that contact animal food and those surfaces from which 
drainage, or other transfer, onto the animal food or onto surfaces that contact the animal food 
ordinarily occurs during the normal course of operations.  Food-contact surfaces includes 
utensils and animal food-contact surfaces of equipment. 
 
Hazard means any biological, chemical (including radiological), or physical agent that has the 
potential to cause illness or injury in humans or animals. 
 
Hazard requiring a preventive control means a known or reasonably foreseeable hazard for 
which a person knowledgeable about the safe manufacturing, processing, packing, or holding of 
animal food would, based on the outcome of a hazard analysis (which includes an assessment of 
the severity of the illness or injury to humans or animals if the hazard were to occur and the 
probability that the hazard will occur in the absence of preventive controls), establish one or 
more preventive controls to significantly minimize or prevent the hazard in an animal food and 
components to manage those controls (such as monitoring, corrections or corrective actions, 
verification, and records) as appropriate to the animal food, the facility, and the nature of the 
preventive control and its role in the facilitys food safety system. 
 
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Holding means storage of animal food and also includes activities performed incidental to 
storage of an animal food (e.g., activities performed for the safe or effective storage of that 
animal food, such as fumigating animal food during storage, and drying/dehydrating raw 
agricultural commodities when the drying/dehydrating does not create a distinct commodity 
(such as drying/dehydrating hay or alfalfa)).  Holding also includes activities performed as a 
practical necessity for the distribution of that animal food (such as blending of the same raw 
agricultural commodity and breaking down pallets), but does not include activities that transform 
a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal 
Food, Drug, and Cosmetic Act.  Holding facilities could include warehouses, cold storage 
facilities, storage silos, grain elevators, and liquid-storage tanks. 
 
Known or reasonably foreseeable hazard means a biological, chemical (including radiological), 
or physical hazard that is known to be, or has the potential to be, associated with the facility or 
the animal food. 
 
Lot means the animal food produced during a period of time and identified by an establishments 
specific code. 
 
Manufacturing/ processing means making animal food from one or more ingredients, or 
synthesizing, preparing, treating, modifying or manipulating animal food, including food crops 
or ingredients.  Examples of manufacturing/processing activities include: Baking, boiling, 
bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural 
commodities to create a distinct commodity (such as drying/dehydrating grapes to produce 
raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, 
homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere 
packaging), pasteurizing, peeling, pelleting, rendering, treating to manipulate ripening, trimming, 
washing, or waxing.  For farms and farm mixed-type facilities, manufacturing/processing does 
not include activities that are part of harvesting, packing, or holding. 
 
Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and 
includes species that are pathogens.  The term undesirable microorganisms includes those 
microorganisms that are pathogens, that subject animal food to decomposition, that indicate that 
animal food is contaminated with filth, or that otherwise may cause animal food to be 
adulterated. 
 
Mixed-type facility means an establishment that engages in both activities that are exempt from 
registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that 
require the establishment to be registered.  An example of such a facility is a farm mixed-type 
facility, which is an establishment that is a farm, but also conducts activities outside the farm 
definition that require the establishment to be registered. 
 
Monitor means to conduct a planned sequence of observations or measurements to assess 
whether control measures are operating as intended. 
 
   
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Packing means placing animal food into a container other than packaging the animal food and 
also includes repacking and activities performed incidental to packing or repacking an animal 
food (e.g., activities performed for the safe or effective packing or repacking of that animal food 
(such as sorting, culling, grading, and weighing or conveying incidental to packing or 
repacking)), but does not include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. 
 
Pathogen means a microorganism of public (human or animal) health significance. 
 
Preventive controls means those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, processing, packing, or 
holding of animal food would employ to significantly minimize or prevent the hazards identified 
under the hazard analysis that are consistent with the current scientific understanding of safe 
food manufacturing, processing, packing, or holding at the time of the analysis. 
 
Preventive controls qualified individual means a qualified individual who has successfully 
completed training in the development and application of risk-based preventive controls at least 
equivalent to that received under a standardized curriculum recognized as adequate by FDA, or 
is otherwise qualified through job experience to develop and apply a food safety system. 
 
Qualified auditor means a person who is a qualified individual as defined in part 507 and has 
technical expertise obtained through education, training, or experience (or a combination thereof) 
necessary to perform the auditing function.  Examples of potential qualified auditors include: (1) 
A government employee, including a foreign government employee; and (2) An audit agent of a 
certification body that is accredited in accordance with regulations in part 1, subpart M.  
(Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue 
Certifications). 
 
Qualified facility means a facility (when including the sales by any subsidiary; affiliate; or 
subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or 
affiliate) that is a very small business as defined in part 507, or a facility to which both of the 
following apply: (1) During the 3-year period preceding the applicable calendar year, the average 
annual monetary value of the food manufactured, processed, packed or held at such facility that 
is sold directly to qualified end-users (as defined in part 507) during such period exceeded the 
average annual monetary value of the food sold by such facility to all other purchasers; and (2) 
The average annual monetary value of all food sold during the 3-year period preceding the 
applicable calendar year was less than $500,000, adjusted for inflation. 
 
Qualified individual means a person who has the education, training, or experience (or a 
combination thereof) necessary to manufacture, process, pack, or hold safe animal food as 
appropriate to the individuals assigned duties.  A qualified individual may be, but is not required 
to be, an employee of the establishment. 
 
   
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Raw agricultural commodity (RAC) has the meaning given in section 201(r)of the Federal Food, 
Drug, and Cosmetic Act (any food in its raw or natural state, including all fruits that are washed, 
colored, or otherwise treated in their unpeeled natural form prior to marketing). 
 
Receiving facility means a facility that is subject to subparts C and E of part 507 and that 
manufactures/processes a raw material or other ingredient that it receives from a supplier. 
 
Significantly minimize means to reduce to an acceptable level, including to eliminate. 
 
Supplier means the establishment that manufactures/processes the animal food, raises the animal, 
or grows the food that is provided to a receiving facility without further 
manufacturing/processing by another establishment, except for further manufacturing/processing 
that consists solely of the addition of labeling or similar activity of a de minimis nature. 
 
Supply-chain-applied control means a preventive control for a hazard in a raw material or other 
ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. 
 
Verification means the application of methods, procedures, tests and other evaluations, in 
addition to monitoring, to determine whether a control measure or combination of control 
measures is or has been operating as intended and to establish the validity of the food safety plan. 
 
Very small business means a business (including any subsidiaries and affiliates) averaging less 
than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the 
applicable calendar year in sales of animal food plus the market value of animal food 
manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm 
without sale). 
 
Written procedures for receiving raw materials and other ingredients means written procedures 
to ensure that raw materials and other ingredients are received only from suppliers approved by 
the receiving facility (or, when necessary and appropriate, on a temporary basis from unapproved 
suppliers whose raw materials or other ingredients are subjected to adequate verification 
activities before acceptance for use). 
 
Other Terms Used in This Guidance 
 
Approved supplier: A supplier that has met the criteria of the receiving facilitys supply-chain 
program, is controlling the identified hazard, and has been approved by the receiving facility. 
 
Customer: An entity that receives a product, raw material, or ingredient from a receiving 
facility. 
 
Identified hazard: A known or reasonably foreseeable hazard identified by the receiving facility 
as requiring a supply-chain-applied control. 
 
Second-party audit: An audit conducted by an employee of a receiving facility. 
 
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SAHCODHA hazard: A hazard for which there is a reasonable probability that exposure to the 
hazard will result in serious adverse health consequences or death to humans or animals. 
 
Third-party audit: An audit conducted by a qualified auditor that is not an employee of either 
the receiving facility or the supplier. 
   
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Appendix B  Table of Abbreviations and Acronyms Used in This Guidance 
 
Abbreviation 
What It Means 
or Acronym 
BSE  Bovine Spongiform Encephalopathy 
CFR  Code of Federal Regulations 
CGMP  current good manufacturing practice 
COA  Certificate of Analysis 
FDA  U.S. Food and Drug Administration 
FD&C Act  Federal Food, Drug, and Cosmetic Act 
GFSI  Global Food Safety Initiative 
HACCP  Hazard Analysis and Critical Control Point 
L. monocytogenes  Listeria monocytogenes 
PCAF  Preventive Control for Animal Food (requirements in 21 CFR 
part 507 for hazard analysis and risk-based preventive controls 
for animal food in accordance with 418 of the FD&C Act) 
PCQI  preventive controls qualified individual 
SAHCODHA  Serious Adverse Health Consequences or Death to Humans or 
Animals 
USDA  U.S. Department of Agriculture 
 
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