The Accredited Third-Party Certification 
Program: Questions and Answers: 
Guidance for Industry  
 
Draft Guidance
  
This guidance is being distributed for comment purposes only. 
 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that FDA considers your comment on this draft guidance before we begin work on the 
final version of the guidance, submit either electronic or written comments on the draft 
guidance within 90 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance. Submit electronic comments to 
http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket number FDA-
2022-D-0370 listed in the notice of availability that publishes in the Federal Register.  
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
Office of Regulatory Affairs 
 
April 2022 
    Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Table of Contents 
 
 
 
 
I. Introduction ........................................................................................ 3
 
II. Background ....................................................................................... 5
 
III. Questions and Answers ................................................................... 6
 
A. Definitions Applying to the Third-Party Program ......................................................................... 6 
B. Circumstances Requiring Certification Under the Third-Party Program ................................... 7 
C. Requirements for Accreditation Bodies Seeking Recognition Under the  
     Third-Party Program ........................................................................................................................ 8 
D. Requirements for Recognized Accreditation Bodies Under the Third-Party Program ............ 11 
E. Requirements for Certification Bodies Seeking Accreditation from Recognized Accreditation  
     Bodies Under the Third-Party Program ....................................................................................... 15 
F. Requirements for Accredited Certification Bodies Under the Third-Party Program ............... 23 
G. Requirements for Eligible Entities Under the Third-Party Program ......................................... 33 
H. General Requirements for the Third-Party Program .................................................................. 34 
 
 
 
 
   
2 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
The Accredited Third-Party Certification 
Program: Questions and Answers: 
Guidance for Industry1 
 
  
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration's (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 FDAs Technical Assistance Network by submitting the form available at 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-
network-tan. 
 
 
I. Introduction  
 
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) added section 808 to the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d), which directs the U.S. 
Food and Drug Administration (FDA or Agency) to establish a program for accreditation of third-
party certification bodies2 to conduct food safety audits and to certify that eligible foreign food 
entities (including registered foreign food facilities) and food produced by such entities meet 
applicable FDA requirements for purposes of sections 801(q) (21 U.S.C. 381(q)) and 806 (21 
U.S.C. 384b) of the FD&C Act. On November 27, 2015, FDA issued the final rule, Accreditation 
of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications 
(also referred to as the TPP regulation) (80 FR 74569; 21 CFR Part 1, Subpart M).3   
 
This guidance answers frequently asked questions relating to the requirements of the Accredited 
Third-Party Certification Program (also referred to as the Third-Party Program or TPP) 
established in 21 CFR Part 1, Subpart M (21 CFR 1.600-1.695, 21 CFR 1.700-1.725). This 
guidance intends to assist the accreditation bodies, third-party certification bodies, and eligible 
entities understanding of the TPP regulation and program requirements. 
 
 
1 This guidance has been prepared by the Center for Food Safety and Applied Nutrition, Office of Compliance, in 
collaboration with the Office of Regulatory Affairs and Center for Veterinary Medicine at the U.S. Food and Drug 
Administration.   
2 As defined in 21 CFR 1.600(c), a third-party certification body has the same meaning as third-party auditor as 
that term is defined in section 808(a)(3) of the FD&C Act. For consistency with the implementing regulations in 21 
CFR Parts 1, 11, and 16, the TPP final rule uses the term certification body. 
3 For the requirements in 21 CFR Part 1, Subpart M, see https://www.ecfr.gov/cgi-bin/text-
idx?SID=829f8115c895b28fef2cb6234b603a05&mc=true&node=sp21.1.1.m&rgn=div6.  
3 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
In this guidance, the pronouns you and your are used to refer to the accreditation bodies, 
certification bodies, or eligible entities, as applicable, applying to, or participating in the Third-
Party Program. The pronouns we and our are used to refer to the FDA. 
 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDA guidance 
documents, including this guidance, should be viewed only as recommendations, unless specific 
regulatory or statutory requirements are cited. The use of the word should in FDA guidances 
means that something is suggested or recommended, but not required. 
 
Table 1 lists abbreviations and acronyms used in this guidance.  
 
Table 1  Abbreviations and Acronyms Used in This Guidance 
 
Reference  Abbreviation/Acronym 
Accreditation Body  AB 
Accredited Third-Party Certification Program   Third-Party Program or TPP 
Accreditation of Third-Party Certification Bodies to  TPP regulation 
Conduct Food Safety Audits and to Issue 
Certifications  
Acidified Foods   AF 
Current Good Manufacturing Practices   CGMPs 
FDA Food Safety Modernization Act  FSMA 
FDAs Unified Registration and Listing System   FURLS 
Federal Food, Drug, and Cosmetic Act  FD&C Act 
Foreign Supplier Verification Program   FSVP 
Guidance for Industry: FDAs Voluntary Qualified  VQIP Guidance 
Importer Program 
Juice Hazard Analysis and Critical Control Points   Juice HACCP 
Low-Acid Canned Foods   LACF 
Preventive Controls for Animal Food   PCAF 
Preventive Controls for Human Food  PCHF 
Raw Agricultural Commodity  RAC 
Regulatory Audit Report   RAR 
Seafood Hazard Analysis and Critical Control Points   Seafood HACCP 
Third-Party Certification Body  CB 
U.S. Food and Drug Administration  FDA 
Voluntary Qualified Importer Program  VQIP 
4 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
II. Background  
 
The TPP regulation implements section 808 of the FD&C Act by establishing the framework, 
procedures, and requirements for the accreditation of third-party certification bodies (CBs) to 
conduct food safety audits and issue food or facility certifications to eligible entities. 
Accreditation bodies (ABs) apply to FDA to be recognized under TPP. Once recognized by 
FDA, an AB may begin assessing CBs for accreditation and accrediting CBs that meet our 
program requirements. In turn, the accredited CBs under TPP conduct consultative and/or 
regulatory food safety audits of eligible entities that produce food for humans or animals. An 
eligible entity is a foreign entity in the import supply chain of food for consumption in the 
United States that chooses to be subject to a food safety audit conducted by an accredited CB 
under TPP (21 CFR 1.600(c) (definition of eligible entity)).  
 
The certifications issued under TPP are based on a determination of whether the food or facility 
meets the food safety requirements of the FD&C Act and FDA regulations. Audits and 
certifications issued under TPP provide the Agency with useful information regarding the 
operations of an eligible entity. They do not preclude the Agency from performing inspections of 
eligible entities that fall under our jurisdiction. The TPP regulation also provides that FDA may 
refuse to accept any certification for purposes of section 801(q) or 806 of the FD&C Act if the 
agency determines that the certification is not valid or reliable (21 CFR 1.653(b)(3)). For 
example, if a certification was issued without reliable demonstration regarding the basis for 
issuance, we may determine that the certification is not valid or reliable (21 CFR 
1.653(b)(3)(iii)).4 
 
Section 808(c)(2)(B) of the FD&C Act specifies two uses for the certifications issued by 
accredited CBs under this program. First, a facility certification will be used by importers to 
establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which 
allows for expedited review and entry of foods from importers in the program under section 806 
of the FD&C Act (21 U.S.C. 384b). One condition of participation in VQIP is importation of 
food from facilities audited and certified by accredited CBs under TPP. The second use of a 
certification issued under TPP is for the purposes of section 801(q) of the FD&C Act (21 U.S.C. 
381(q)) where FDA can require, in specific circumstances, that a food offered for import be 
accompanied by certification or other assurances that the food complies with applicable FD&C 
Act requirements, as provided under section 801(q) of the FD&C Act.  
 
The TPP regulation is part of FSMAs paradigm shift toward a modern, preventive, and risk-
based approach to food safety. The TPP regulation establishes requirements for the competence 
and independence of CBs who are accredited to conduct foreign food safety audits to examine 
compliance with the applicable food safety requirements of the FD&C Act and FDA regulations. 
The program requirements help ensure the integrity of the TPP certificates that are used for the 
purposes of VQIP under section 806 of the FD&C Act and the safety of imported food subject to 
import certification under section 801(q) of the FD&C Act. FDA maintains oversight and 
management of TPP through routine monitoring and periodic assessments of the participating 
 
4 See also 21 CFR 1.664(f); 21 CFR 1.665(c). 
5 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
ABs and CBs, with the main focus of our regulatory oversight on the ABs, who are responsible 
for overseeing the accredited CBs and ensuring that they are in compliance with the TPP 
requirements.   
 
III. Questions and Answers 
 
A. Definitions Applying to the Third-Party Program 
 
A.1 What are consultative audits and regulatory audits? 
 
Consultative audits and regulatory audits are the two types of food safety audits that are 
conducted under TPP to determine compliance with the applicable food safety requirements of 
the FD&C Act and FDA regulations.  
 
Consultative audits are conducted by accredited CBs to determine if the eligible entity 
complies with applicable food safety requirements of the FD&C Act, FDA regulations, and 
industry standards and practices (21 CFR 1.600(c) (definition of consultative audit)). The 
audits are conducted to help eligible entities prepare for a regulatory audit. Consultative audit 
reports do not have to be submitted to FDA, but CBs must maintain records of the consultative 
audit. The consultative audit records must also be made available to FDA in accordance with 
FDAs records access authority under section 414 of the FD&C Act (21 U.S.C. 350c) (21 CFR 
1.658(b)).  
 
Regulatory audits are conducted to determine if the eligible entity is in compliance with the 
applicable food safety requirements under the FD&C Act and FDA regulations. Only the 
results of a regulatory audit can determine eligibility for issuing food or facility certification 
under sections 801(q) or 806 of the FD&C Act (21 CFR 1.600(c) (definition of regulatory 
audit)). An accredited CB must, no later than 45 days after completing a regulatory audit, 
prepare and submit electronically, in English, to FDA and to its recognized AB, a report of 
such regulatory audit (see 21 CFR 1.652(b) and Responses F.2.3-F.2.6).  
 
A.2 What is an audit agent?  
 
An audit agent is defined as an individual who is an employee or other agent of an accredited 
CB who, although not individually accredited, is qualified to conduct food safety audits on 
behalf of an accredited CB. An audit agent includes a contractor of the accredited CB but 
excludes subcontractors, or other agents under outsourcing arrangements for conducting food 
safety audits without direct control by the accredited CB (21 CFR 1.600(c) (definition of audit 
agent)). 
 
It is the responsibility of the accredited CB that uses audit agents to conduct food safety audits 
to ensure that each audit agent has the required qualifications (see 21 CFR 1.650(a)). The 
accredited CB exercises adequate oversight of its audit agents under TPP, such that the CB 
accepts the result of the audit agents as its own (80 FR 74569 at 74580) and exercises adequate 
6 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
control and oversight over a contractor that is used as an audit agent such that the accredited 
CB accepts the result of the contractors audit as its own (80 FR 74569 at 74581). 
 
A.3 How are days defined in the Third-Party Program regulation? 
 
The TPP regulation uses both the terms days and business days. Unless specified as 
business days, FDA interprets days in 21 CFR Part 1, Subpart M as calendar days.  
 
B. Circumstances Requiring Certification Under the Third-Party Program 
 
B.1 Is certification under the Third-Party Program mandatory for all FDA-regulated 
products offered for import into the United States? 
 
No. There is no general requirement for foreign firms to obtain a certification by an accredited 
CB under TPP. Food or facility certification under TPP is only required under specific 
circumstances:  
 
(1) to establish eligibility for participation of importers in VQIP, which offers expedited 
review and entry of food from a facility that has been certified by an accredited CB 
(section 806 of the FD&C Act) and;  
 
(2) in specific circumstances, where FDA can require that a food offered for import be 
accompanied by a certification issued by a CB accredited under this program (or by a 
representative of a foreign government, if designated by FDA to issue such certifications) 
that the food meets applicable requirements of the FD&C Act to prevent potentially 
harmful food from reaching U.S. consumers. (For a complete explanation of the 
circumstances under which FDA may require such certifications, see section 801(q) of 
the FD&C Act).  
 
Under section 806(d) of the FD&C Act, an entity seeking VQIP benefits needs to have a 
facility certification issued consistent with TPP for each foreign suppliers facility.5 Additional 
information on the eligibility criteria for participation in VQIP is available in the FDA 
Guidance for Industry: FDAs Voluntary Qualified Importer Program (VQIP Guidance).6  
 
Additional information on how audits under TPP can be used to meet the supplier verification 
requirements of other FDA regulations is available in Response H.2.2.   
 
 
5 Although participation in VQIP allows for expedited review and entry of foods from importers in the program, a 
VQIP food may nevertheless be subject to for cause examination when FDA determines the food is or may be 
associated with a risk to public health. VQIP food may, at times, also be subject to microbiological sampling related 
to specific risk-based surveillance assignments.  For additional information on circumstances under which FDA may 
examine or sample a VQIP food, see https://www.fda.gov/media/92196/download.  
6 See U.S. Food and Drug Administration, Guidance for Industry: FDAs Voluntary Qualified Importer Program, 
Final Guidance, November 2016, (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-fdas-voluntary-qualified-importer-program). 
7 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
C. Requirements for Accreditation Bodies Seeking Recognition Under the Third-Party 
Program  
 
C.1 Who is eligible to be a recognized accreditation body under the Third-Party 
Program? 
 
Interested parties, such as private third-parties, foreign governments, or foreign agencies, may 
apply to FDA to become recognized ABs under TPP. Such parties must meet the requirements 
established in the regulation for the legal authority, competency, capacity, conflict of interest 
safeguards, quality assurance, and records procedures that ABs must demonstrate to be eligible 
for recognition (see 21 CFR 1.610-1.615).  
 
C.2 Where and how can you apply for recognition?  
 
An AB can apply for recognition through FDAs electronic portal dedicated to TPP within the 
FDAs Unified Registration and Listing System (FURLS) page. In addition, you can use this 
portal to manage the ABs account and submit reports and notifications to FDA.  
 
Users must first create an online account at the FURLS page to gain access. Only those 
organizations seeking recognition by FDA as an AB may submit an application. Users may 
access detailed application instructions in a document titled U.S. Food and Drug 
Administration, Accredited Third-Party Certification Program Portal, Step-by-Step Instructions 
for an Accreditation Body to Apply for and Manage Recognition Status in the Program, 
available at https://www.fda.gov/media/119119/download. This instruction guide can also be 
accessed from FDAs Accredited Third-Party Certification Program Web site at 
https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-
certification-program.  
 
C.3 What are the scopes of recognition under the Third-Party Program? 
 
FDA has implemented 11 scopes of food or process categories for which the Agency will 
recognize ABs under TPP. Each scope represents a set of overarching food safety requirements 
of the FD&C Act and FDA regulations for the respective food or process category. We refer to 
the 11 scopes as scopes of recognition for ABs and scopes of accreditation for CBs (see 
Response E.4 for more detail about how the scopes of accreditation correspond to the facility, 
process(es), or food to be audited). 
 
The 11 scopes include the following: 
  Acidified Foods (AF) scope 
  Dietary Supplements scope 
  Infant Formula scope 
  Juice Hazard Analysis and Critical Control Points (Juice HACCP) scope 
  Low-Acid Canned Foods (LACF) scope 
  Medicated Feed Current Good Manufacturing Practices (Medicated Feed CGMPs) 
scope 
8 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
  Preventive Controls for Animal Food (PCAF) scope 
  Preventive Controls for Human Food (PCHF) scope 
  Produce Safety scope 
  Seafood Hazard Analysis and Critical Control Points (Seafood HACCP) scope 
  Shell Eggs scope 
 
ABs select the scope(s) of recognition for which they are seeking recognition during the 
application process in FURLS. As part of the application review, FDA evaluates the 
competency and capacity of the operations of the AB for each scope selected in the application 
(21 CFR 1.600(c) (definition of assessment)). FDA may recognize an applicant and 
recognize all scopes in the application, some of the scopes, or may deny the application in 
whole. 
 
A recognized AB can only accredit a CB for the scope(s) for which FDA has recognized them. 
That means, for example, that an AB recognized for the Juice HACCP and PCHF scopes can 
accredit a CB for the Juice HACCP scope, the PCHF scope, or both scopes but cannot accredit 
a CB for the other nine scopes.  
 
We also note that recognized ABs may have additional restrictions in place for the scopes as 
part of their management of accredited CBs within the program and may make CB 
accreditation decisions based on FDAs TPP requirements and their own restrictions.  
 
Additional information about the scopes is available in Responses C.4, E.3, and E.4.  
 
C.4 How do the scopes of recognition correspond with the food safety requirements of the 
FD&C Act and FDA regulations? 
 
As discussed in Response C.3, the scopes of recognition and accreditation represent sets of the 
overarching food safety requirements under the FD&C Act and FDA regulations.  
 
The titles of the scopes correspond with specific FDA regulations, but the TPP regulation 
requires that food safety audits examine compliance with all applicable food safety 
requirements of the FD&C Act and FDA regulations. Therefore, additional FDA food safety 
requirements may also apply to the audit that are not in the specific regulation that corresponds 
with the title of the scope. For example, for processors of acidified foods that are subject to the 
Acidified Foods regulation (21 CFR Part 114), the processors are also subject to the 
requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk Based 
Preventive Controls for Human Food regulation (21 CFR Part 117). So, a food safety audit of 
an acidified food would be conducted under the AF scope and would consider the FDA 
regulations that are specific to acidified foods, i.e., the food safety requirements in 21 CFR Part 
114, Emergency Permit Control (21 CFR Part 108), as well as the food safety requirements in 
21 CFR Part 117.   
 
9 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
The applicable food safety requirements from the FD&C Act and FDA regulations would 
depend on the type of eligible entity and the specific facility, process, or food being audited.7 
Even when an audit is conducted under a single scope (for example, the LACF scope), the food 
safety audit may need to examine compliance with multiple different applicable food safety 
requirements of the FD&C Act and FDA regulations. For example, consider a food safety audit 
of a low-acid canned food that would be conducted under the LACF scope (see Response E.4 
for more detail about how to determine the appropriate scope for an audit). Manufacturers of 
low-acid canned foods, while exempt from the requirements of subparts C and G of 21 CFR 
Part 117 for biological hazards controlled under 21 CFR Part 113,8 still must meet all the other 
applicable requirements of Part 117.9 Therefore, in addition to considering the FDA 
regulations that are specific to low-acid canned foods --- i.e., the Low-Acid Foods Packaged in 
Hermetically Sealed Containers regulation (21 CFR Part 113) and 21 CFR Part 108 --- an audit 
conducted under the LACF scope would also consider the applicable requirements of 21 CFR 
Part 117. In addition, these audits may need to also consider additional applicable food safety 
requirements of the FD&C Act and FDA regulations. For example, food additive 
requirements,10 which are generally not addressed in 21 CFR Parts 113 and 117, may be 
applicable to the low-acid canned food being audited under the LACF scope.    
 
As another example, a medicated animal food audit would be conducted under the Medicated 
Feed CGMPs scope. Audits conducted under that scope would consider the applicable food 
safety requirements in the Current Good Manufacturing Practice for Medicated Feeds 
regulation (21 CFR Part 225) and in the Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Food for Animals regulation (21 CFR Part 
507), along with the food safety requirements of any additional applicable FDA regulations 
and the FD&C Act.  
 
Additionally, even when a general scope such as the PCHF scope is the appropriate scope, 
audits may still need to consider product-specific food safety requirements. For example, a 
bottled water product would be audited under the PCHF scope. Such an audit would need to 
assess compliance with the applicable food safety requirements under the Processing and 
Bottling of Bottled Drinking Water regulation (21 CFR Part 129) in addition to 21 CFR Part 
117, as well as other applicable food safety requirements of the FD&C Act and FDA 
regulations.  
 
In addition, sometimes the title of the most appropriate scope may refer to a regulation to 
 
7 The descriptions of the scopes of recognition and accreditation are listed in Response E.4 to assist CBs in 
identifying the appropriate scope for an audit of a specific type of facility, process, or food. 
8 See 21 CFR 117.5(d), which exempts the processing activities of processors of low-acid canned foods from the 
requirements of 21 CFR Part 117 subpart C, Hazard Analysis and Risk-Based Preventive Controls, and subpart G, 
Supply Chain Program, for biological hazards and their controls, if the processor of low-acid canned foods is in 
compliance with 21 CFR Part 113. 
9 For a more complete discussion of how the FSMA requirements apply to processors of low-acid canned foods, see 
Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety 
Modernization Act: Guidance for Industry, available at https://www.fda.gov/media/106721/download.  
10 Food additive requirements are set forth in section 409 of the FD&C Act (21 U.S.C. 348). See also 21 CFR Parts 
170-189.    
10 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
which the particular food is not subject. For example, the most appropriate scope for produce 
that FDA has determined to be rarely consumed raw is the Produce Safety scope, even 
though such rarely consumed raw produce is not subject to FDAs Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation 
(21 CFR Part 112) in accordance with 21 CFR 112.2(a)(1). (See 21 CFR 112.2(a)(1) for 
identifying the specific produce items that are exempt from the requirements in 21 CFR Part 
112 because they are rarely consumed raw).11   
 
FDA developed templates that ABs may voluntarily choose to use to help develop evaluation 
criteria for food safety requirements of certain FDA regulations to ensure that accredited CBs 
conduct food safety audits that adequately evaluate the applicable FDA food safety 
requirements (see Response D.1). Additional food safety requirements beyond those for which 
FDA has developed templates may need to be considered, as appropriate. 
 
Additional information about the scopes is available in Responses C.3, E.3, and E.4.  
 
D. Requirements for Recognized Accreditation Bodies Under the Third-Party Program 
 
D.1 Is there information available to assist accreditation bodies in developing criteria for 
evaluating the food safety audits?  
 
FDA developed templates that ABs may voluntarily use to help develop evaluation criteria for 
food safety requirements of certain FDA regulations to ensure that accredited CBs conduct 
food safety audits that adequately evaluate the FDA food safety requirements. The audit 
templates present certain food safety requirements in a table format, which can be used to more 
easily compare third-party food safety audit standards to these FDA food safety requirements. 
ABs are not required to use the FDA templates. ABs and CBs may use other means to 
determine that audits meet the requirements of TPP. 
 
Food safety audits must consider all applicable FDA food safety requirements, such that CBs 
may need to consider additional food safety requirements beyond those for which FDA has 
developed templates, as appropriate. The templates are available at 
https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-
certification-program-voluntary-audit-templates and at FDAs Accredited Third-Party 
Certification Program Web site (https://www.fda.gov/food/importing-food-products-united-
states/accredited-third-party-certification-program).   
 
D.2 What factors should be considered when a recognized accreditation body determines 
the appropriate number of onsite audits to observe prior to accrediting a certification 
body?  
 
11 Because audits need only consider the applicable food safety requirements of the FD&C Act and FDA 
regulations, an audit for produce that FDA has determined to be rarely consumed raw would not assess 
compliance with the Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 
regulation in 21 CFR Part 112. In this example, the audit would consider the applicable food safety requirements of 
the FD&C Act. 
11 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
In accordance with 21 CFR 1.620(a)(3), a recognized AB evaluating a CB seeking 
accreditation must observe a representative sample of onsite audits examining compliance with 
applicable food safety requirements of the FD&C Act and FDA regulations conducted by the 
applicant CB or its agents. The recognized AB should use these observations as part of its 
evaluation to determine whether the CB meets the requirements for accreditation under TPP.  
  
The size of the representative sample will vary on a case-by-case basis and will depend on a 
number of factors including the scope(s) of accreditation sought by the CB, whether the CB is 
an individual who will conduct audits and make certification decisions, or whether the CB uses 
agents to conduct audits and, if so, whether such agents are centrally managed, conducting 
similar types of audits, under a single set of operating procedures or whether the agents are 
managed from various locations, perform different types of audits, or follow different 
procedures such that these various locations, activities, or practices must be observed to ensure 
that the sample is sufficiently representative.  
 
For example, to ensure that the CB adequately demonstrates its qualifications to conduct food 
safety audits, a recognized AB may need to conduct more onsite audits to evaluate 
accreditation for the PCHF scope as compared to the accreditation for the Juice HACCP scope 
because of the diverse types of facilities and foods subject to the PCHF scope as compared to 
that of the Juice HACCP scope.  
 
Additionally, a CB seeking accreditation with audit agents managed from three different 
locations may require more onsite audits than a CB with audit agents managed from one 
central location in order to ensure a representative review. The recognized AB should consider 
how many locations the CB manages and whether the sample includes audit agents from each 
location.  
 
D.3 What reports and notifications must a recognized accreditation body submit to FDA? 
 
A recognized AB must electronically submit the following information to FDA: 
  Assessments of an accredited CBs performance. The recognized AB must submit to 
FDA electronically, in English, a report of the results of any assessment conducted 
under 21 CFR 1.621, no later than 45 days after completing such assessment. The 
report must include an up-to-date list of any audit agents used by the accredited CB to 
conduct food safety audits under TPP (see 21 CFR 1.623(a)). 
 
  Self-assessments. An AB must electronically submit to FDA, in English, reports of the 
recognized ABs self-assessments. Specifically, the reports must be of the annual self-
assessment required under 21 CFR 1.622, and must be sent to FDA no later than 45 
days after completing such self-assessment (see 21 CFR 1.623(b)(1)). For a recognized 
AB subject to 21 CFR 1.664(g)(1) because FDA withdraws the accreditation of a CB 
that the AB accredited, the AB must submit a report of a self-assessment under 21 CFR 
1.622 no later than 60 days after the CBs withdrawal. A recognized AB may use a 
12 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
report prepared for conformance to ISO/IEC 17011:2004, supplemented as necessary, 
in meeting the requirement related to self-assessment reports (see 21 CFR 1.623(b)). 
 
  Immediate notification to FDA. The AB must immediately submit electronic 
notifications to FDA, in English, upon accrediting a CB, expanding the scope of 
accreditation of a CB, withdrawing, suspending, or reducing the scope of an 
accreditation, determining that an accredited CB failed to comply with 21 CFR 1.653 
when issuing a certificate, when denying accreditation, or when making significant 
changes that would affect the manner in which the recognized AB complies with the 
TPP requirements (21 CFR 1.623(c)). See 21 CFR 1.623(c) for the specific information 
that must be provided.  
 
A recognized AB should submit the information required in 21 CFR 1.623 through FDAs 
electronic portal dedicated to TPP in FURLS. This portal in FURLS is the primary system for 
managing the ABs account and submitting reports and notifications to FDA (see Response 
C.2). Within this portal, there are tabs for Supplemental Documentation and a Reports and 
Notification Directory where the various reports and notifications required in 21 CFR 1.623 
should be electronically submitted to FDA through the data or text entry fields or as 
attachments, as applicable. Note that the information required in 21 CFR 1.623 must be 
submitted in English. Users may access instructions for submitting the reports and notifications 
at https://www.fda.gov/media/119119/download. 
 
D.4 Can a recognized accreditation body apply to FDA for recognition of additional 
scopes of recognition?  
 
Yes. There are 11 scopes of recognition under TPP. A recognized AB may apply for any scope 
of recognition that they are not currently recognized for under TPP. The request for additional 
scopes would be submitted in FURLS as a report and notification and would include the 
additional scope(s) of recognition being sought along with the information necessary to 
demonstrate the recognized ABs qualifications for the new scope(s). Specifically, the 
recognized AB would submit information supporting the competency, capacity, and quality 
assurance requirements under TPP for the requested scope(s).  
 
D.5 When may an accreditation body accept payment from a certification body for 
accreditation services? 
 
A recognized AB may accept the payment of fees for accreditation services and the 
reimbursement of direct costs associated with assessment of a CB only after the date on which 
the report of such assessment was completed or the date on which the accreditation was issued, 
whichever comes later (21 CFR 1.624(b)). Such payment is not considered a conflict of interest 
for purposes of 21 CFR 1.624(a).  
 
If a recognized AB determines that a CB should not be accredited, the recognized AB may 
accept fees for accreditation services and reimbursement of direct costs when the recognized 
13 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
AB completes its assessment report documenting the decision that the CB will not be 
accredited. 
 
If the CB withdraws from the application process, the recognized AB may accept fees for 
accreditation services and reimbursement of direct costs when the CB withdraws from the 
application process.   
 
D.6 Can an employee of a recognized accreditation body serve as an audit agent for a 
certification body that the recognized accreditation body has accredited under the Third-
Party Program? 
 
A recognized AB must implement a written program to protect against conflict of interest 
between the recognized AB and any CBs seeking accreditation from, or accredited by, such 
recognized AB (21 CFR 1.624(a)). This includes prohibiting officers, employees, or other 
agents involved in accreditation activities under the program from accepting any money, gift, 
gratuity, or item of value from a CB seeking accreditation from, or accredited by, the 
recognized AB (21 CFR 1.624(a)(2)). 
 
An employee of a recognized AB that serves as an audit agent for a CB that the AB has 
accredited would likely receive compensation from the CB and therefore would be in receipt of 
money or an item of value from the CB.  If the employee is involved in TPP-related 
accreditation activities of the accredited CB, such a relationship would therefore be prohibited.     
 
If an officer, employee, or other agent that is not involved in any TPP-related accreditation 
activities, with respect to the ABs accreditation of CBs, serves as an audit agent for an 
accredited CB, the recognized AB should document how it is maintaining the required conflict 
of interest protections such that the employees activities remain separate from TPP-related 
accreditation activities.     
 
D.7 Do the financial interests of the spouses and children of a recognized accreditation 
bodys officers, employees, and agents involved in accreditation activities need to be 
considered in the written program to protect against conflicts of interest?  
 
Yes. The financial interests of the spouses and children younger than 18 years of age of a 
recognized ABs officers, employees, and other agents involved in accreditation activities will 
be considered the financial interests of such officers, employees, and other agents involved in 
accreditation activities (21 CFR 1.624(c)). Therefore, the written program under 21 CFR 
1.624(a) to protect against conflicts of interest between the recognized AB and any CB seeking 
accreditation from, or accredited by, the recognized AB must protect against conflicts of 
interest related to the financial interests of their spouses and children younger than 18. 
 
D.8 What types of records should be maintained to meet the requirements in 21 CFR 
1.625(a)(8) regarding records for fee payments and reimbursement of direct costs?      
 
14 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
An AB must maintain records related to fee payments and reimbursement of direct costs to 
demonstrate compliance with this program (21 CFR 1.625(a)(8)).   
 
The records needed to demonstrate compliance include the amount paid and the date(s) on 
which the accredited CB paid any fees or reimbursements of direct costs. The records could 
also include any fee schedules or standard operating procedures to describe what costs are 
considered and how the fee payments and reimbursement of direct costs are determined. 
Recognized ABs are required to electronically maintain the records of fee payments and 
reimbursement of direct costs for five years (21 CFR 1.625(a)).  
 
The records that the recognized AB maintains in accordance with 21 CFR 1.625(a)(8) may also 
be used to document the ABs compliance with 21 CFR 1.624(b) (regarding when a recognized 
AB may accept the payment of fees for accreditation services) and 21 CFR 1.624(d) (regarding 
the requirement to maintain a Web site with an up-to-date list of accredited CBs and the date(s) 
on which the accredited CB paid any fee or reimbursement associated with the accreditation).  
 
D.9 Is the recognized accreditation body notified of FDAs response when a certification 
body they accredited requests a waiver for the 13-month limit for audit agents conducting 
regulatory audits? 
 
Yes. An accredited CB cannot use an audit agent to conduct a regulatory audit at an eligible 
entity if such audit agent conducted a consultative audit or regulatory audit for the same 
eligible entity in the preceding 13 months, except that such limitation may be waived if the 
accredited CB demonstrates to FDA, under 21 CFR 1.663, there is insufficient access to audit 
agents in the country or region where the eligible entity is located. Once the Agency makes a 
determination for the waiver or waiver extension request in accordance with 21 CFR 1.663, the 
point of contact from the recognized AB would be copied on the FURLS automatic system 
notification that is sent to the point of contact from the accredited CB. See Response F.1.1 for 
additional information about the FDA waiver for the 13-month limit. 
 
E. Requirements for Certification Bodies Seeking Accreditation from Recognized 
Accreditation Bodies Under the Third-Party Program 
 
E.1 Who is eligible to be an accredited certification body under the Third-Party 
Program? 
 
A CB can be a foreign government, agency of a foreign government, foreign cooperative, or 
any other third-party (foreign or domestic) that is eligible to be considered for accreditation to 
conduct food safety audits and to certify that eligible entities meet the applicable food safety 
requirements of the FD&C Act and FDA regulations. An individual may also be accredited as 
a CB (21 CFR 1.640). All such entities and individuals will only be accredited if they can meet 
the requirements of 21 CFR 1.641 through 1.645. Additional information for CBs seeking 
15 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
accreditation under TPP is available in FDAs guidance entitled Third-Party Certification 
Body Accreditation for Food Safety Audits: Model Accreditation Standards.12 
 
E.2 Where and how can you apply to be an accredited certification body?  
 
Interested CBs can seek accreditation from an AB recognized under TPP. FDA maintains a 
public registry of recognized ABs along with their Web site and contact information (as 
discussed in Response H.1.1).  
 
CBs will not be able to transmit any information to FDA until they have been accredited by a 
recognized AB. FURLS is the primary system for managing the CBs account, issuing food 
safety certifications, and submitting reports and notifications to FDA. Users may access 
detailed instructions on creating and managing an account in FURLS from a document titled 
U.S. Food and Drug Administration, Accredited Third-Party Certification Program Portal, 
Instructions for a Certification Body to Manage Accreditation Status in the Program, available 
at https://www.fda.gov/media/143888/download. This instruction guide can also be accessed 
from the FDAs Accredited Third-Party Certification Program Web site at 
https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-
certification-program.  
 
E.3 What are the scopes of accreditation under the Third-Party Program? 
 
As discussed in Responses C.3 and C.4, FDA implemented 11 scopes of food or process 
categories for which the CBs will be accredited under TPP: 
  Acidified Foods (AF) scope 
  Dietary Supplements scope 
  Infant Formula scope 
  Juice Hazard Analysis and Critical Control Points (Juice HACCP) scope 
  Low-Acid Canned Foods (LACF) scope 
  Medicated Feed Current Good Manufacturing Practices (Medicated Feed CGMPs) 
scope 
  Preventive Controls for Animal Food (PCAF) scope 
  Preventive Controls for Human Food (PCHF) scope 
  Produce Safety scope 
  Seafood Hazard Analysis and Critical Control Points (Seafood HACCP) scope 
  Shell Eggs scope 
 
The scopes represent sets of overarching food safety requirements of the FD&C Act and FDA 
regulations for respective food or process categories. We refer to the 11 scopes as scopes of 
recognition for ABs and scopes of accreditation for CBs. 
 
12 See U.S. Food and Drug Administration, Guidance for Industry and FDA Staff: Model Accreditation Standards 
for Third-Party Certification Body Accreditation for Food Safety Audits, Final Guidance, December 2016, 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-
model-accreditation-standards-third-party-certification-body). 
16 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
As part of the assessment to evaluate a CB seeking accreditation, a recognized AB evaluates 
the competency and capacity of the CB for the specific scope(s) of accreditation being sought 
under TPP that correspond to the specific scopes for which the AB is recognized. An AB can 
only accredit a CB for scopes for which the AB has been recognized (see Response C.3). Once 
a recognized AB accredits a CB, the AB also conducts annual comprehensive assessments of 
the accredited CB for each scope of accreditation (21 CFR 1.621).  
 
Additional information about the scopes is available in Responses C.3, C.4, and E.4.  
 
E.4 How do the scopes of accreditation correspond to the facility, process(es), or food to 
be audited under the Third-Party Program? 
 
As discussed in Response E.3, a recognized AB evaluates the competency and capacity of the 
CB for the specific scope(s) of accreditation being sought under TPP (that correspond to the 
specific scopes for which the AB is recognized). During the evaluation of a CB seeking 
accreditation, the recognized AB observes a representative sample of onsite audits examining 
compliance with the applicable food safety requirements of the FD&C Act and FDA 
regulations as conducted by the CB or its agents (21 CFR 1.620(a)(3)). The recognized AB 
must use these observations as part of its evaluation to determine whether the CB meets the 
requirements for accreditation under TPP (21 CFR 1.620(a)(3)). 
 
Table 2 describes the 11 scopes of recognition and accreditation. We are providing this 
description to assist CBs in identifying the appropriate scope for an audit of a specific type of 
facility, process, or food. Recognized ABs and CBs seeking accreditation should consider this 
information when identifying appropriate audits for the ABs to observe while evaluating a 
CBs accreditation request. In addition, accredited CBs should consider this list in determining 
the appropriate scope of food safety audits to conduct under TPP. 
 
Table 2  Description of the Scopes of Recognition and Accreditation 
 
Scope of Recognition and  Description of the Scopes of Recognition and 
Accreditation  Accreditation 
Acidified Foods (AF)  The scope applies to acidified foods packaged in 
hermetically sealed containers. Acidified food means 
low-acid food to which acid(s) or acid food(s) are added 
and that have a finished equilibrium pH of 4.6 or below 
and a water activity greater than 0.85. (See 21 CFR 
114.3 for the complete definition of acidified foods) 
Dietary Supplements  The scope applies to dietary supplements as defined in 
section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)). 
The term dietary supplement means a product (other than 
tobacco) intended to supplement the diet that bears or 
contains one or more of the following dietary 
ingredients: a vitamin, mineral, herb or other botanical, 
17 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Scope of Recognition and  Description of the Scopes of Recognition and 
Accreditation  Accreditation 
amino acid, a dietary substance to supplement the diet by 
increasing the total dietary intake, or a concentrate, 
metabolite, constituent, extract, or combination of any 
ingredients listed above. (See section 201(ff) of the 
FD&C Act for the complete definition of dietary 
supplements) 
Infant Formula  The scope applies to infant formula as defined in section 
201(z) of the FD&C Act (21 U.S.C. 321(z)). Infant 
formula means a food which purports to be or is 
represented for special dietary use solely as a food for 
infants by reason of simulation of human milk or its 
suitability as a complete or partial substitute for human 
milk. (See section 201(z) of the FD&C Act)  
Juice Hazard Analysis and Critical  The scope applies to juice, as defined in 21 CFR 
Control Points (Juice HACCP)  120.1(a). Juice means the aqueous liquid expressed or 
extracted from one or more fruits or vegetables, purees 
of the edible portions of one or more fruits or 
vegetables, or any concentrates of such liquid or puree. 
(See 21 CFR 120.1(a) for a complete description of the 
applicability of the juice HACCP requirements) 
Low-Acid Canned Foods (LACF)  The scope applies to thermally processed low-acid foods 
packaged in hermetically sealed containers. Low-acid 
food means foods (other than alcoholic beverages) with 
a finished equilibrium pH greater than 4.6 and a water 
activity greater than 0.85. (See 21 CFR 113.3 for the 
complete definition of low-acid foods) 
Medicated Feed Current Good  The scope applies to all types of facilities and equipment 
Manufacturing Practices (Medicated  used in the production (i.e., manufacturing, processing, 
Feed CGMPs)  packing, and holding) of medicated feeds for 
consumption in the United States, and also applies to 
instances in which failure to adhere to the regulations 
has caused nonmedicated feeds that are manufactured, 
processed, packed, or held to be adulterated (21 CFR 
225.1(b)(1)). The scope applies to facilities 
manufacturing one or more medicated feeds for which 
an approved medicated feed mill license is required 
where the requirements in 21 CFR 225.10-225.115 
would apply. The scope also applies to facilities 
manufacturing solely medicated feeds for which an 
approved license is not required where the requirements 
in 21 CFR 225.120-225.202 would apply (21 CFR 
225(b)(2)). (See 21 CFR Part 225) 
Medicated feed production is also subject to the Current 
Good Manufacturing Practice, Hazard Analysis, and 
18 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Scope of Recognition and  Description of the Scopes of Recognition and 
Accreditation  Accreditation 
Risk-Based Preventive Controls for Food for Animals 
regulation (21 CFR 507.1(c)). An audit conducted under 
the Medicated Feed CGMPs scope should assess 
compliance with the applicable food safety requirements 
of 21 CFR Part 225 and 21 CFR Part 507 (along with 
any other applicable requirements of the FD&C Act and 
FDA regulations). 
Preventive Controls for Animal  The scope generally applies to the manufacturing, 
Food (PCAF)  processing, packing, or holding of animal food. The 
Current Good Manufacturing Practice, Hazard Analysis 
and Risk-Based Preventive Controls for Food for 
Animals regulation applies to facilities that are required 
to register with the FDA under section 415 of the FD&C 
Act because they manufacture, process, pack, or hold 
animal food for consumption in the United States (21 
CFR 507.5(a)), unless an exemption applies (see 21 
CFR 507.5 for exemptions). (See 21 CFR Part 507) 
Preventive Controls for Human  The scope generally applies to the manufacturing, 
Food (PCHF)  processing, packing, or holding of human food (unless 
there is a product-specific scope that is more 
appropriate). Subparts A, B, and F of 21 CFR Part 117 
(the Current Good Manufacturing Practice, Hazard 
Analysis and Risk-Based Preventive Controls for 
Human Food regulation) include requirements for 
manufacturing, packing, or holding human food.  
Subparts A, C, D, E, F, and G of Part 117 include 
requirements for food facilities that are required to 
register under section 415 of the FD&C Act because 
they manufacture, process, pack, or hold human food for 
consumption in the United States. (See 21 CFR Part 
117) 
The scope does not apply when the food being assessed 
is more appropriately assessed under the LACF, AF, 
Produce Safety, Dietary Supplement, Juice HACCP, 
Infant Formula, or Seafood HACCP scopes.  
Produce Safety  The scope applies to produce as defined in 21 CFR 
112.3. Produce means any fruit or vegetable (including 
mixes of intact fruit and vegetables) and includesbut 
is not limited tomushrooms, sprouts, peanuts, tree 
nuts, and herbs.  The scope only applies to produce that 
is a raw agricultural commodity (RAC) as defined in 
section 201(r) of the FD&C Act (21 U.S.C. 321(r)), 
which means any food in its raw or natural state. The 
scope may apply to produce that is not subject to the 
19 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Scope of Recognition and  Description of the Scopes of Recognition and 
Accreditation  Accreditation 
Standards for Growing, Harvesting, Packing, and 
Holding of Produce for Human Consumption regulation 
(21 CFR Part 112), such as RAC produce that has been 
designated as rarely consumed raw in accordance with 
21 CFR 112.2(a)(1). (See 21 CFR 112.3 for the 
complete definition of produce and section 201(r) of the 
FD&C Act for the complete definition of RAC) 
Seafood Hazard Analysis and  The scope applies to fish or fishery products as defined 
Critical Control Points (Seafood  in 21 CFR 123.3, where fish means fresh or saltwater 
HACCP)  finfish, crustaceans, other forms of aquatic animal life 
other than birds or mammals, and all mollusks, where 
such animal life is intended for human consumption and 
fishery products means any human food product in 
which fish is a characterizing ingredient. (See 21 CFR 
123.3(d) and (e) for the complete definitions of fish and 
fishery products) 
Shell Eggs  The scope applies to shell eggs as defined in 21 CFR 
118.3, which means the egg of a domesticated chicken. 
(See 21 CFR 118.3) 
 
The descriptions of the scopes in Table 2 are to assist CBs in determining the appropriate scope 
for an audit of a specific type of facility, process, or food. The scopes apply to the 
manufacturing, processing, growing, or other related activities pertaining to the food subject to 
the applicable scope. Along with determining the appropriate scope for a specific audit, the CB 
is also responsible for determining the applicable food safety requirements of the FD&C Act 
and FDA regulations that should be assessed. An audit conducted under a single scope may 
need to examine compliance with food safety requirements from more than one food safety 
regulation (see Response C.4). 
 
Identifying the specific facility, process(es), or food to be audited is important in determining 
the appropriate scope of accreditation for the audit (see Response F.1.5 for information on how 
to determine what should be assessed as part of a food safety audit). The appropriate scope for 
an audit may depend not just on the product being audited, but also on the specific activity or 
process being examined during the audit. For example, a food safety audit of the packing of 
avocados that are RACs would be conducted under the Produce Safety scope, while a food 
safety audit of the processing of avocado oil would be conducted under the PCHF scope.   
 
Further, there may be multiple appropriate scopes of accreditation in the case of a facility that 
manufactures multiple types of products at one location. For example, suppose the following 
conditions exist: an eligible entity that manufactures an acidified food that meets the definition 
of 21 CFR 114.3(b) and manufactures a dietary supplement that meets the definition of section 
201(ff) of the FD&C Act requests a regulatory audit from an accredited CB. The CB is 
accredited for the AF and Dietary Supplement scopes under TPP and during the audit planning, 
the CB determines that the dietary supplement product is not an acidified food. In the case 
20 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
where the request was for a regulatory audit focusing on only the production of the acidified 
food product, the appropriate scope of accreditation would be the AF scope. In the case where 
the request was for a regulatory audit focusing on only the production of the dietary 
supplement product, the appropriate scope of accreditation would be the Dietary Supplement 
scope.  
 
However, if the request was for a regulatory audit focusing on the production of both the 
acidified food and the dietary supplement products, the regulatory audit would be conducted 
under both the AF and Dietary Supplement scopes of accreditation. In this regulatory audit, the 
physical locations, activities, and processes related to the production of the acidified food 
would be assessed for compliance with the FDA food safety requirements that apply to 
acidified foods (e.g., 21 CFR Parts 114, 108, and 117). In addition, the physical locations, 
activities, and processes related to the production of the dietary supplement would be assessed 
for compliance with the FDA food safety requirements that apply to dietary supplements (e.g., 
21 CFR Parts 111 and 117).  
 
There are also foods where the descriptions of two of the scopes may apply. For example, 
suppose the following conditions exist: a CB accredited for both the AF and Juice HACCP 
scopes conducts a regulatory audit at an eligible entity that manufactures an acidified juice and 
the CB issues a certificate to the eligible entity as a result of the audit. The regulatory audit for 
an acidified juice would have considered the food safety requirements in the FDA regulations 
applicable to both acidified foods in 21 CFR Part 114 and juice in 21 CFR Part 120. When 
submitting the RAR and certificate information to FDA through FURLS, the CB would need to 
identify either the AF or Juice HACCP scopes, because FURLS is designed so that the 
accredited CB selects a single scope of accreditation (and then submits the product codes for 
the products observed during the regulatory audit). In this example, we recommend that the 
accredited CB identify the Juice HACCP scope, because juice is the more specific category of 
food, and the acidification describes the processing method of the juice product. See Response 
F.2.7 for more information about the use of the FDA product codes in FURLS under TPP.   
 
The eligible entity seeking a food safety audit should work with the CB to ensure that they 
have identified the appropriate scope and purpose of the food safety audit, including the 
facility, process(es), or food to be audited by the accredited CB. The CB, in turn, should 
determine whether the requested audit is within its scope of accreditation during the audit 
planning (21 CFR 1.651(a)).     
 
Additional information about the scopes is available in Responses C.3, C.4, and E.3.   
 
E.5 Where can certification bodies locate the audit criteria to evaluate eligible entities? 
 
The TPP regulation establishes the framework, procedures, and applicable procedural 
requirements for accredited CBs participating in the program, including requirements regarding 
how accredited CBs must conduct food safety audits of eligible entities (see 21 CFR 1.651). 
Audits must be focused on determining whether the facility, its process(es), and food are in 
compliance with the applicable food safety requirements of the FD&C Act and FDA 
21 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
regulations, and, for consultative audits, also includes conformance with applicable industry 
standards and practices that are within the scope of the audit (21 CFR 1.651(c)(1)). The criteria 
that accredited CBs will use in auditing eligible entities for compliance with the applicable 
FDA food safety requirements appear in the FD&C Act and applicable FDA regulations.  
 
As discussed in Response D.1, FDA has provided templates that recognized ABs and 
accredited CBs may voluntarily use to help ensure that CBs conduct audits to adequately 
evaluate the food safety requirements in certain FDA regulations.   
 
CBs may need to consider additional food safety requirements beyond those for which FDA 
has developed templates, as appropriate. The templates are provided as a tool as a starting point 
for developing evaluation criteria and are not required to be used. The voluntary audit 
templates are available at https://www.fda.gov/food/importing-food-products-united-
states/accredited-third-party-certification-program-voluntary-audit-templates and at FDAs 
Accredited Third-Party Certification Program Web site (https://www.fda.gov/food/importing-
food-products-united-states/accredited-third-party-certification-program).  
 
We note that recognized ABs under TPP may have their own audit criteria requirements 
beyond the TPP requirements as part of their management systems and processes.  
 
E.6 How could a certification body demonstrate capability to meet the requirements for 
accreditation if the certification body has not previously issued certifications based on 
food safety programs? 
 
A CB is not required to have previously issued certificates based on food safety programs to 
become accredited under TPP.   
 
A CB seeking accreditation under TPP must establish its eligibility by demonstrating it has the 
legal authority, competency, capacity, quality assurance procedures, records procedures, and 
conflict of interest protections to meet the TPP requirements (see 21 CFR 1.641-1.645). A CB 
may use documentation of its conformance with ISO/IEC 17021:2011 or ISO/IEC 17065:2012, 
supplemented as necessary, to demonstrate that it meets the requirements under the program 
(21 CFR 1.640(a)). Conformance with other standards may be used, but are not required, to 
support some of the requirements.  
 
E.7 Can the onsite audits that a recognized accreditation body observes before 
accrediting a certification body serve as a basis for issuing a food or facility certification 
to an eligible entity?  
 
As discussed in Response D.2, prior to accrediting a CB, a recognized AB evaluating a CB 
seeking accreditation must observe the CB or its agents conduct a representative sample of 
onsite audits examining compliance with applicable food safety requirements of the FD&C Act 
and FDA regulations (21 CFR 1.620(a)(3)). The onsite audits that the AB observes as part of 
the evaluation process are conducted prior to the recognized AB accrediting the CB. As a 
result, the TPP requirements for accredited CBs conducting food safety audits in 21 CFR 1.651 
22 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
do not apply. Because the basis for food and facility certifications is a regulatory audit that 
meets the requirements of 21 CFR 1.651, and section 1.651 only applies to accredited CBs, 
onsite audits conducted prior to the CBs accreditation cannot serve as the basis for issuing a 
food or facility certification (see 21 CFR 1.653(a); 21 CFR 1.651).  
 
F. Requirements for Accredited Certification Bodies Under the Third-Party Program 
 
F.1 Accredited Certification Bodies Conducting Observed Onsite Audits and Food Safety 
Audits  
 
F.1.1 Can the same certification body conduct both consultative audits and regulatory 
audits for an eligible entity? 
 
Yes, an accredited CB may conduct both regulatory audits for certification purposes and 
consultative audits for internal purposes of the same eligible entity.  
 
There are restrictions on an accredited CBs ability to use an audit agent to conduct a 
regulatory audit of an eligible entity if the same agent conducted a consultative or regulatory 
audit of the same eligible entity in the preceding 13 months, unless FDA waives the limitation 
(see 21 CFR 1.650(c)).  
 
An accredited CB can request an FDA waiver or waiver extension for the 13-month limit for 
audit agents conducting regulatory audits. The accredited CB seeking the FDA waiver must 
demonstrate that there is insufficient access to audit agents in the country or region where the 
eligible entity is located (21 CFR 1.663(a)). Accredited CBs that are comprised of an 
individual may also request the FDA waiver under 21 CFR 1.663.  
 
F.1.2 For a regulatory audit, can advanced notice be given to the eligible entitys key food 
safety employees if they are based in another site that is several hours away? 
 
Before beginning to conduct a food safety audit under TPP, an accredited CB must engage in 
audit planning that requires the eligible entity seeking certification to identify the scope and 
purpose of the food safety audit and provide a 30-day operating schedule with information 
relevant to the scope and purpose (21 CFR 1.651(a)(1)). The availability of the key employees 
could be discussed during the audit planning, but with the exception of records review, which 
may be scheduled, the audit must be conducted without announcement during the 30-day 
timeframe identified (21 CFR 1.651(c)(1)-(2); section 808(c)(5)(C)(i) of the FD&C Act).  
   
F.1.3 Are there any restrictions that prohibit accredited certification bodies from 
auditing and certifying eligible entities outside the countries of the certification bodies? 
 
The TPP regulation does not set geographic limitations regarding where an accredited CB 
could audit and certify eligible entities. However, accredited CBs must have the authority, 
whether contractual or otherwise, to perform such audits at the location of the eligible entity in 
accordance with the requirements of TPP (21 CFR 1.651(b)). We are aware that some 
23 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
recognized ABs may include geographic restrictions in their contracts with their accredited 
CBs, but any such restrictions are beyond the TPP requirements.  
 
F.1.4 Who issues food or facility certificates to eligible entities and makes the 
determination of whether to issue such certificates?   
 
Under TPP, accredited CBs issue food or facility certificates after conducting a regulatory 
audit and any other activities necessary to establish whether a food or facility complies with the 
applicable food safety requirements of the FD&C Act and FDA regulations (see, e.g., 21 CFR 
1.600(c) (definitions of accredited third-party certification body and regulatory audit)). 
Where a CB uses an audit agent to conduct a regulatory audit of an eligible entity, the CB, not 
the audit agent, must make the determination of whether to issue certification based on the 
results of the regulatory audit (21 CFR 1.653(a)(5)). In the circumstance where the accredited 
CB is an individual, the same individual would conduct the food safety audit and determine 
whether to issue certification.  
 
F.1.5 How should an accredited certification body determine what should be assessed as 
part of a food safety audit?  
 
Prior to issuing a food or facility certification to an eligible entity, an accredited CB (or, where 
applicable, audit agent(s) on its behalf) must complete a regulatory audit that meets the 
requirements of 21 CFR 1.651 and any other activities that may be necessary to determine 
compliance with the applicable food safety requirements of the FD&C Act and FDA 
regulations (21 CFR 1.653(a)). The audit must be sufficiently rigorous to allow the accredited 
CB to determine whether the eligible entity is in compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations. A regulatory audit must also be sufficient 
to determine whether the eligible entity, given its food safety system and practices, would be 
likely to remain in compliance with the applicable FDA food safety requirements of the FD&C 
Act and FDA regulations for the duration of any certification issued under TPP (21 CFR 
1.651(c)(3)).  
 
The eligible entity identifies the scope and purpose of the audit, including the facility, 
process(es), or food to be audited and the type of certification(s) being sought for a regulatory 
audit during the audit planning (21 CFR 1.651(a)). When the accredited CB conducts the 
resulting audit, the CB should ensure that the audit covers the appropriate physical locations, 
activities, and processes to be audited, and information collected during the audit must be 
relevant to the purpose and criteria, including information related to interfaces between 
functions, activities, and processes of the food safety system (80 FR 74569 at 74610).  
 
For example, suppose the following conditions exist: an eligible entity requests a regulatory 
audit for a processed food product (that is within the accredited CBs scope of accreditation) 
for the purposes of seeking a facility certification. The eligible entity had requested the 
regulatory audit because they are working with an importer that is trying to establish eligibility 
for VQIP. The eligible entity only identifies one building that should be audited. The 
accredited CB conducts a record review prior to the onsite examination of the facility and 
24 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
determines that the handling and processing of the raw materials, filling, and packaging of the 
food product occur at the eligible entity in different buildings. In this scenario, the accredited 
CB should ensure that its record review and the onsite examination for the regulatory audit 
includes an evaluation of all of the buildings, activities, and processes involved in the 
manufacturing and production of the processed food product.  
 
We encourage eligible entities, importers, and accredited CBs to consult the VQIP guidance for 
information about the program, eligibility criteria for VQIP applicants, and the use of the 
facility certificates in VQIP.13  
 
F.1.6 Can a certification be issued for a food that was not directly observed during the 
onsite examination of the regulatory audit?   
 
In some circumstances, yes. An accredited CB may issue a certification that covers food for 
which the CB did not directly observe the manufacturing/processing if the operations that the 
CB did observe are applicable to that food.    
 
For example, suppose the following conditions exist: an eligible entity contacts an accredited 
CB requesting a regulatory audit of the processing of frozen vacuum-packed tilapia and salmon 
fillets. The accredited CB determines that the regulatory audit is within its scope of 
accreditation, Seafood HACCP in this case. For the regulatory audit, the accredited CB reviews 
the records pertaining to the processed frozen vacuum-packed tilapia and salmon fillets. During 
the onsite examination, only the frozen vacuum-packed tilapia fillets are being processed.  
 
In this example, the accredited CB could consider issuing a certificate for the frozen vacuum-
packed salmon fillets along with the frozen vacuum-packed tilapia fillets based on their 
assessment during the records review, onsite observations, and visual examination of the 
processing of the frozen vacuum-packed tilapia fillets. For a regulatory audit of both the frozen 
vacuum-packed tilapia and salmon fillets, the records review would include records related to 
the processing of both types of fish fillets to assess compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations. The onsite examination would also cover 
the appropriate physical locations, activities, and processes for both the frozen vacuum-packed 
tilapia and salmon fillets, even if only the tilapia fillets are in production at the time of the 
onsite examination. After the onsite examination, the accredited CB would need to consider the 
results of the records review, onsite observations, and visual examination to determine if the 
food or facility certificate should be issued to the eligible entity in accordance with 21 CFR 
1.653(a)(3), and if so, which products should be included in the certificate.   
 
F.1.7 Can the onsite audits that a recognized accreditation body observes to evaluate an 
accredited certification body seeking accreditation for a new scope serve as a basis for 
issuing a food or facility certification to an eligible entity? 
 
 
13 See U.S. Food and Drug Administration, Guidance for Industry: FDAs Voluntary Qualified Importer Program, 
Final Guidance, November 2016, (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-fdas-voluntary-qualified-importer-program). 
25 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Since the basis for food and facility certifications is a regulatory audit that meets the 
requirements of 21 CFR 1.651, and audits conducted under section 1.651 must be within the 
scope of a CBs accreditation, an accredited CB cannot provide a food or facility certification 
for a scope that is not part of the CBs accreditation (See 21 CFR 1.653(a); 21 CFR 1.651; and 
Response E.7). Therefore, when a recognized AB is observing audits pertaining to an 
accredited CBs request for a new scope, the onsite audits that the AB observes as part of the 
evaluation process for the new scope cannot be a basis for issuing a food or facility 
certification.  
 
F.1.8 Can an accredited certification body be evaluated for a new scope while their 
recognized accreditation body is onsite conducting monitoring activities for an already-
accredited scope? 
 
Yes, provided that all of the requirements of TPP are met. As discussed in Response C.3, the 
AB would need to be recognized for both the scope which the CB is already accredited and the 
scope for which it is seeking accreditation. The recognized AB must also observe a 
representative sample of onsite audits for both the scope for which the CB is already accredited 
and for which it is seeking accreditation (21 CFR 1.620(a)(3); 21 CFR 1.621(b)).   
 
For example, consider a scenario where a CB accredited for the PCHF scope is seeking 
accreditation for the PCAF scope. The accredited CB has previously issued a facility certificate 
to an eligible entity for the production of a dry vegetable soup mix. The eligible entity is 
seeking recertification, and the accredited CB plans to conduct a regulatory audit of the 
vegetable soup mix operations under the PCHF scope to support the recertification. The 
recognized AB plans to conduct onsite observations of the CBs regulatory audit in accordance 
with its obligation under 21 CFR 1.621(b) to conduct onsite observations of a representative 
sample of regulatory audits performed by the accredited CB. In an adjacent building of the 
same facility, the eligible entity also manufactures a baked pet treat subject to the Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals regulation (21 CFR Part 507). The recognized AB also plans to observe the CB 
conduct an onsite audit of the baked pet treat operations under the PCAF scope for which the 
CB is seeking accreditation. 
 
In this scenario, the recognized AB could observe the accredited CBs food safety audit of the 
vegetable soup mix operations under the PCHF scope in conjunction with also observing the 
CBs audit of the baked pet treat operations under the PCAF scope. The AB would observe the 
food safety audit under the PCHF scope to meet its obligations under 21 CFR 1.621(b) to 
conduct onsite observations of a representative sample of regulatory audits conducted by the 
CBs it has accredited. The AB would observe the audit under the PCAF scope as part of its 
obligation when evaluating a CB seeking accreditation to observe the CB or its agents conduct 
a representative sample of onsite audits examining compliance with applicable food safety 
requirements of the FD&C Act and FDA regulations under 21 CFR 1.620(a)(3).    
 
The accredited CB would consider the results of the regulatory audit under the PCHF scope to 
determine if the eligible entity would be issued a new facility certificate for the production of 
26 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
the dry vegetable soup mix under the PCHF scope of accreditation. As discussed in Response 
F.1.7, the CB could not use that audit as a basis for issuing a food or facility certification for 
the pet treat operations because the audit of the eligible entitys pet treat operations was 
conducted prior to the CB being accredited for the PCAF scope of accreditation. In addition, 
the regulatory audit report requirements for CBs under 21 CFR 1.651 would not apply to the 
audit of the baked pet treats conducted under the PCAF scope, because those requirements only 
apply to accredited CBs and the CB was not accredited for the PCAF scope at the time of the 
audit. The recognized AB would consider its observations from the CBs audit of the baked pet 
treat operations in determining whether to grant the CBs request to be accredited for the PCAF 
scope. 
 
F.2 Reports and Notifications Accredited Certification Bodies Submit to FDA 
 
F.2.1 What reports and notifications must an accredited certification body submit to 
FDA? 
 
An accredited CB must electronically submit the following information to FDA: 
  Regulatory audit reports (RARs). The accredited CB must submit an RAR 
electronically, in English, to FDA to report the results of a regulatory audit no later than 
45 days after completing such audit (21 CFR 1.656(a); see Responses F.2.3 and F.2.6 
for additional information about the RARs). The RAR should be submitted to FDA via 
FURLS. 
 
  Self-assessments. If the accredited CB is subject to an FDA request for cause, or as 
required in 21 CFR 1.631(f)(1)(i) (after FDA's issuance of the notice of the denial of 
recognition renewal to any CB accredited by the AB whose renewal application FDA 
denied), 21 CFR 1.634(d)(1)(i) (after FDA's issuance of the notice of revocation of the 
AB that has accredited the CB), or 21 CFR 1.635(c)(1)(i) (after the date of 
relinquishment or the date of expiration of the recognition of the AB that has accredited 
the CB), the accredited CB must submit the report of its self-assessment to FDA, 
electronically, in English. The report of its self-assessment must be submitted to FDA 
within 60 days of the FDA request, denial of renewal, revocation, or relinquishment of 
recognition of the AB that granted its accreditation (21 CFR 1.656(b)). The self-
assessment should be submitted to FDA via FURLS. 
 
  Serious risk to public health. The accredited CB must immediately notify FDA 
electronically, in English, if during a regulatory or consultative audit, any of its audit 
agents or the accredited CB itself discovers a condition that could cause or contribute to 
a serious risk to the public health (21 CFR 1.656(c)). The notification should be 
submitted to FDA via FURLS. 
 
  Withdrawing or suspending a food or facility certification. The accredited CB must 
immediately notify FDA electronically, in English, when withdrawing or suspending 
any food or facility certification of an eligible entity and the basis for such action (21 
CFR 1.656(d)). The notification should be submitted to FDA via FURLS. 
27 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
There are additional requirements in 21 CFR 1.656 for when accredited CBs must provide 
reports or notifications to their recognized AB or eligible entities.   
 
FDA has an electronic portal dedicated to TPP in FURLS. FURLS is the primary system for 
managing the CBs account, issuing food safety certifications, and submitting reports and 
notifications to FDA (see Response E.2). Within the portal dedicated to TPP in FURLS, there 
are tabs for Supplemental Documentation and a Reports and Notification Directory where the 
various reports and notifications required under 21 CFR 1.656 are electronically submitted to 
FDA through the data or text entry fields or as attachments, as applicable. Note that the 
information required in 21 CFR 1.656 must be submitted in English. Instructions for 
submitting information in FURLS are available at 
https://www.fda.gov/media/143888/download (see a related response in D.3 applicable to ABs 
submission of information to FDA). 
 
F.2.2 Can a company name be used in place of the audit agent(s) name(s) in the food or 
facility certificate information submitted to FDA?  
 
No. The name(s) of the audit agent(s) who conducted the regulatory audit is required to be 
included in the certifications that the accredited CB issues and submits to FDA (21 CFR 
1.653(b)(2)(v)). An audit agent is an individual, not a company or other corporate entity (see 
21 CFR 1.600(c) (definition of audit agent)). Therefore, the submission of the accredited 
CBs company name instead of the name(s) of the individual audit agent(s) that conducted the 
regulatory audit is not permissible. (However, in the case where an individual is accredited as a 
CB, the audit agent name may match the company name because the individual audit agent is 
the accredited CB.)     
 
During the certification submission process in FURLS, the accredited CB selects the name(s) 
of the audit agent(s) that conducted the regulatory audit from a drop-down list. It is critical that 
the selected name(s) of the audit agent(s) are correct since the FURLS portal uses this 
information to monitor adherence with the TPP requirements, including the 13-month limit for 
audit agent(s) conducting a regulatory audit at the eligible entity (see Responses D.9 and 
F.1.1). Instructions for adding a certificate and managing audit agent information in FURLS 
are available at https://www.fda.gov/media/143888/download. This instruction guide can also 
be accessed from the FDAs Accredited Third-Party Certification Program Web site at 
https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-
certification-program.  
 
F.2.3 When must an accredited certification body submit a regulatory audit report to 
FDA and when does FDA consider a regulatory audit to be complete? 
 
An accredited CB must electronically submit a RAR to FDA, in English, no later than 45 days 
after completing a regulatory audit (21 CFR 1.656(a)). The RAR must be submitted regardless 
of whether the CB issued a food or facility certification to the eligible entity (21 CFR 
1.652(c)).  
28 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
We consider a regulatory audit to be complete when the accredited CB has completed all 
activities required under 21 CFR 1.651. Specifically, the accredited CB must consider all 
information from the regulatory audit and other activities conducted under 21 CFR 1.651, 
including each observation to determine whether the entity was in compliance with the 
applicable food safety requirements of the FD&C Act and FDA regulations at the time of the 
audit. The activities also include reviewing information that may take place after the onsite 
audit, such as the verification of effectiveness of corrective actions, and any discussions 
regarding whether to issue the food or facility certificate.  
 
The 45-day timeframe for submitting the RAR begins once all the pertinent data and 
information have been considered by the CB.   
 
F.2.4 What must an accredited certification body include in a regulatory audit report? 
 
An RAR must contain all of the data elements required under 21 CFR 1.652(b). RARs are used 
in TPP for the accredited CBs to provide FDA with a robust executive summary of the 
regulatory audits and findings that support the decision of whether the eligible entity was 
issued a food or facility certificate.  
 
The data elements required in the regulatory audit reports under 21 CFR 1.652(b) are: 
 
(1) The identity of the site or location where the regulatory audit was conducted, including:  
(i) The name, address, and FDA Establishment Identifier of the facility subject to the 
regulatory audit and a unique facility identifier, if designated by FDA; and  
(ii) Where applicable, the FDA registration number assigned to the facility under 21 CFR 
Part 1, Subpart H;  
 
(2) The identity of the eligible entity, if different from the facility, including the name, address, 
FDA Establishment Identifier, and unique facility identifier, if designated by FDA, and, where 
applicable, registration number under 21 CFR Part 1, Subpart H;  
 
(3) The dates and scope of the regulatory audit;  
 
(4) The process(es) and food(s) observed during such regulatory audit;  
 
(5) The name(s) and telephone number(s) of the person(s) responsible for the facilitys 
compliance with the applicable food safety requirements of the FD&C Act and FDA 
regulations;  
 
(6) Any deficiencies observed during the regulatory audit that present a reasonable probability 
that the use of or exposure to a violative product:  
(i) Will cause serious adverse health consequences or death to humans and animals; or  
29 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
(ii) May cause temporary or medically reversible adverse health consequences or where 
the probability of serious adverse health consequences or death to humans or animals is 
remote;  
 
(7) The corrective action plan for addressing each deficiency identified, unless corrective 
action was implemented immediately and verified onsite by the accredited CB (or its audit 
agent, where applicable);  
 
(8) Whether any sampling and laboratory analysis (e.g., under a microbiological sampling 
plan) is performed in or used by the facility; and  
 
(9) Whether the eligible entity has made significant changes to the facility, its process(es), or 
food products during the two years preceding the regulatory audit. 
 
All the information in the RAR is important in supporting the decision of whether the eligible 
entity was issued a certificate and it provides FDA with a robust executive summary of the 
regulatory audits. For example, the identity or location of the regulatory audit and identity of 
the eligible entity helps ensure that we have comprehensive, accurate, and up-to-date 
information on eligible entities and audited facilities that chose to participate in the program 
(additional information discussed in Response F.2.5). The dates and scope of the regulatory 
audit and process(es) and food(s) observed during the regulatory audit may help us determine 
whether the certification matches the scope of the audit and whether the stated scope of audit 
matches the CBs scope of accreditation (additional information discussed in Response F.2.6). 
Observed deficiencies and corrective action plan for addressing each deficiency, as well as the 
facilitys use of sampling and laboratory analysis and any significant changes to the facility, its 
process(es), or food products during the previous two years are important because the elements 
are related to or influential to a determination of compliance with the applicable food safety 
standards of the FD&C Act and FDA regulations. 
 
F.2.5 If an eligible entity registered with FDA with one address but the local authority 
recently changed that address, what address should be submitted in the regulatory audit 
report? 
 
The accredited CB should use the eligible entitys most current address in the RAR. In 
accordance with 21 CFR 1.234(a), facilities that are required to register with FDA must update 
a facility's registration within 60 calendar days of any change to any of the information 
previously submitted under 21 CFR 1.232, including the address of the facility. Information 
about updating the registration is available in the Food Facility Registration User Guide on 
FDAs Web site.14  
 
F.2.6 What information about the observed processes and foods should be included in the 
regulatory audit report?   
 
 
14 The Food Facility Registration User Guidance for updating registration information is available at 
https://www.fda.gov/food/online-registration-food-facilities/food-facility-registration-user-guide-update-registration. 
30 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
As discussed in Response F.2.4, an RAR must document the process(es) and food(s) observed 
during the regulatory audit (21 CFR 1.652(b)(4)). The description of the observed process(es) 
and food(s) in the RAR should contain enough information about the specific process(es) and 
food(s) that were observed during the audit for FDA and the recognized AB to be able to 
determine that the certification matches the scope of the audit.   
 
For example, suppose the following conditions exist: an accredited CB completes a regulatory 
audit of processed mixed vegetables. The description should include details about the 
process(es) and food such that FDA or the recognized AB can determine the processing steps 
that were assessed during the records review and onsite examination of the regulatory audit and 
understand key details about the food that may affect the appropriate scope (e.g., if it was 
thermally processed and hermetically sealed, frozen, etc.). For example, if the RAR stated only 
that the CB observed food manufacturing of processed mixed vegetables, FDA or the 
recognized AB would not be able to determine the appropriate scope of the audit since any 
heat-treatments or whether the product is frozen or shelf stable could affect the appropriate 
scope for the audit (e.g., PCHF scope for a bag of frozen mixed vegetables vs LACF scope for 
heat-treated product of mixed vegetables that is in a hermetically sealed container, such as 
canned mixed vegetables). Without detailed descriptions, it is difficult for FDA or the 
recognized AB to understand what was assessed as part of the regulatory audit.  
 
F.2.7 What is the role of the FDA product codes that accredited certification bodies 
provide FDA in the certification information in FDAs Unified Registration and Listing 
System?  
 
Once an accredited CB issues a food or facility certificate to an eligible entity, the CB must 
electronically submit information to FDA (21 CFR 1.653(b)). When submitting the certificate 
information through FURLS, the accredited CB selects the FDA product codes to describe the 
products covered under the certificate. The FDA product codes are used to describe a specific 
product and contain a combination of five to seven numbers and letters. The product code 
should match the actual product name and/or invoice description of the product.15  
 
It is important for the accredited CB to include the FDA product codes for all products that are 
covered under the certificate when filling out the information in FURLS. For example, suppose 
the following conditions exist: an accredited CB completes a regulatory audit of frozen, 
shredded coconut and dried, shredded coconut at an eligible entity. The eligible entity had 
requested the regulatory audit because they are working with an importer that is trying to 
establish eligibility for VQIP. The accredited CB decides to issue a facility certificate for both 
the frozen and dried shredded coconut products based on the results of the regulatory audit. In 
order to inform FDA through FURLS that the facility certificate covers both products, the 
accredited CB would need to include the two FDA products codes for the frozen, shredded 
 
15 Additional information on FDA product codes and a product code builder are available at 
https://www.fda.gov/industry/import-program-resources/product-codes-and-product-code-builder.  
31 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
coconut and the dried, shredded coconut in FURLS.16 The importer could then include the 
issued facility certificate for the frozen, shredded coconut and the dried, shredded coconut in 
their application for VQIP.17 
 
The accredited CB may need to coordinate with the eligible entity and the importer interested 
in applying for VQIP to identify the product codes that should be documented in FURLS for 
the TPP facility certificate. The FDA product codes in the facility certificates issued by the 
accredited CB should correspond to the product codes for the products that would be included 
in the importers VQIP application so that VQIP benefits can be applied to those products. 
 
F.2.8 Is an accredited certification body required to notify FDA if a condition that could 
potentially cause or contribute to a serious risk to public health is identified during a 
non-Third-Party Program audit? 
 
An accredited CB must immediately notify FDA if, during a regulatory or consultative audit, 
any of its audit agents or the accredited CB itself discovers a condition that could cause or 
contribute to a serious risk to the public health (21 CFR 1.656(c); see Response F.2.1). This 
requirement only applies to audits that are conducted as part of TPP. Accredited CBs may 
conduct audits and issue certificates outside of TPP. Audits that fall outside TPP are not 
subject to the TPP requirements, including the reporting and notification requirements under 21 
CFR 1.656(c) regarding a condition identified during a regulatory or consultative audit that 
could cause or contribute to a serious risk to public health.  
 
However, under 21 CFR 1.654, if an accredited CB has reason to believe that an eligible entity 
to which it has already issued a food or facility certification may no longer be in compliance 
with the applicable food safety requirements of the FD&C Act and FDA regulations, the 
accredited CB must conduct any monitoring (including an onsite audit) of the eligible entity 
necessary to determine whether the entity is in compliance with such requirements. The 
accredited CB must immediately notify FDA, under 21 CFR 1.656(d), if it withdraws or 
suspends a food or facility certification and the basis for such action. The accredited CB must 
also maintain records of any monitoring it conducted of an eligible entity to which the CB 
issued a food or facility certification (21 CFR 1.658(a)(6)).   
 
Please see Response G.2 regarding the eligible entitys responsibility to report to FDA 
regarding a food that could cause serious adverse health consequences or death to humans or 
animals. 
 
F.3 Conflict of Interest Requirements for Accredited Certification Bodies 
 
16 Instructions for submitting FDA product codes in FURLS are available at 
https://www.fda.gov/media/143888/download and additional information on FDA product codes and a product code 
builder are available at https://www.fda.gov/industry/import-program-resources/product-codes-and-product-code-
builder.  
17 See U.S. Food and Drug Administration, Guidance for Industry: FDAs Voluntary Qualified Importer Program, 
Final Guidance, November 2016, (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-fdas-voluntary-qualified-importer-program). 
32 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
F.3.1 Do the financial interests of the spouses and children of an accredited certification 
bodys officers, employees, and agents involved in auditing and certification activities 
need to be considered in the written program to protect against conflicts of interest?  
 
Yes. The financial interests of the spouses and children younger than 18 years of age of 
accredited CBs officers, employees, and other agents involved in auditing and certification 
activities are considered the financial interests of such officers, employees, and other agents 
(21 CFR 1.657(c); see related response in D.7 applicable to ABs officers, employees, and 
agents). Therefore, the written program under 21 CFR 1.657(a)(1) to protect against conflicts 
of interest between the accredited CB and an eligible entity must protect against conflicts of 
interests related to the financial interests of their spouses and children younger than 18.  
 
G. Requirements for Eligible Entities Under the Third-Party Program 
 
G.1 Can an eligible entity that is not required to register as a food facility with FDA be 
issued a certification under the Third-Party Program? 
 
Yes. Eligible entity means a foreign entity in the import supply chain of food for consumption 
in the United States that chooses to be subject to a food safety audit conducted by an accredited 
CB under TPP. Eligible entities include foreign facilities required to be registered under 
section 415 of the FD&C Act (21 U.S.C. 350d), but for the purposes of section 808 of the 
FD&C Act, eligible entities are not limited to registered facilities (see 21 CFR 1.600(c) 
(definition of eligible entity)).  
 
For example, farms that are not required to register as a food facility under section 415 of the 
FD&C Act may be eligible entities that could seek certification under TPP. Additionally, a 
foreign firm that manufactures/processes food that undergoes further manufacturing/processing 
by another facility outside the United States would not be required to register under section 415 
of the FD&C Act (see 21 CFR 1.226(a)) but could seek certification under TPP.  
 
G.2 Should an accredited certification body consider whether an eligible entity is in 
compliance with FDA registration requirements in determining whether to issue a food 
or facility certificate? 
 
Yes. When issuing a food or facility certificate, an accredited CB must determine whether an 
eligible entity is in compliance with the applicable food safety requirements of the FD&C Act 
and FDA regulations (21 CFR 1.653(a)(3)). We consider FDA registration requirements, such 
as food facility registration requirements under section 415 of the FD&C Act, to be food safety 
requirements. Therefore, the accredited CB should assess an eligible entitys compliance with 
applicable FDA registration requirements. Accredited CBs should not issue certifications to 
eligible entities that are not in compliance with applicable registration requirements.   
 
33 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
The reportable food requirements under section 417 of the FD&C Act (21 U.S.C. 350(f)) also 
apply to facilities that are required to register with FDA.18   
 
H. General Requirements for the Third-Party Program 
 
H.1 General 
 
H.1.1 Where can you locate a list of the recognized accreditation bodies and accredited 
certification bodies under the Third-Party Program? 
 
The Agency maintains public registries of the recognized ABs and accredited CBs under TPP. 
The public registries include a list of the names and contact information for the recognized 
ABs and accredited CBs along with other information. The public registries of recognized ABs 
and accredited CBs are available on the FDA Data Dashboard at 
https://datadashboard.fda.gov/ora/fd/tpp.htm. The information is also available at FDAs 
Accredited Third-Party Certification Program Web site (https://www.fda.gov/food/importing-
food-products-united-states/accredited-third-party-certification-program).  
 
H.1.2 Are there user fees to participate in the Third-Party Program? 
 
Yes. Section 808(c)(8) of the FD&C Act directs FDA to establish by regulation a 
reimbursement (user fee) program to assess fees and requires reimbursement for the work 
performed to establish and administer TPP. The user fee program for TPP was established by 
the final rule entitled, Amendments to Accreditation of Third- Party Certification Bodies To 
Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program 
(81 FR 90186). The user fees include application, renewal, and annual fees in accordance with 
21 CFR 1.700 and 1.705.  
 
A fee notice is published annually in the Federal Register, prior to each fiscal year, to reflect 
the user fee rates for the upcoming fiscal year and information on how the fees must be paid. 
The TPP user fee information is available at https://www.fda.gov/industry/fda-user-fee-
programs/accredited-third-party-certification-program-user-fees and at FDAs Accredited 
Third-Party Certification Program Web site (https://www.fda.gov/food/importing-food-
products-united-states/accredited-third-party-certification-program).    
 
H.1.3 Once certification bodies are accredited, can logos or markings be included in their 
mark of conformity to demonstrate participation in the Third-Party Program? 
 
The TPP regulation does not require the use of a logo or mark of conformity as part of the 
program. We understand that marks of conformity are included in some industry certification 
programs.  
 
18 See U.S. Food and Drug Administration, Guidance for Industry: Questions and Answers Regarding the 
Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007, Final 
Guidance, September 2009, (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-
industry-questions-and-answers-regarding-reportable-food-registry-established-food-and-drug). 
34 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
The official FDA logo may not be used by the private sector (see FDA Logo Policy at 
https://www.fda.gov/about-fda/website-policies/fda-logo-policy). However, FDAs Logo 
Policy does not apply to the use of non-FDA logos and we do not have a policy against the use 
of non-FDA logos or markings. In addition, FDA does not approve or endorse private firms 
logos or marks of conformity. 
 
We would have concerns with the use of FDAs name in an ABs or CBs promotional 
materials if such use would likely cause confusion as to the origin or approval of the services 
of an AB or CB.  For example, an accredited CB should not falsely suggest that their food 
safety audits under TPP are conducted by current FDA employees. 
 
H.2 Third-Party Program and Other FSMA Requirements 
 
H.2.1 What is the relationship between the Voluntary Qualified Importer Program and 
the Third-Party Program?  
 
Although FDAs TPP and VQIP are two separate programs, FSMA established a link between 
them. Facility certifications under TPP are used by importers that want to establish eligibility 
for VQIP.   
 
Section 806(d) of the FD&C Act requires VQIP importers to have a facility certification issued 
in accordance with TPP for each foreign suppliers facility from which the importer wants to 
import a food under VQIP. Therefore, foreign establishments may be asked by their importers 
to obtain a facility certification under TPP for the products they wish to import into the United 
States under VQIP. Either the importer or the foreign supplier may request the regulatory audit 
required for facility certification. 
 
We encourage TPP participants and importers interested in VQIP to consult the VQIP guidance 
for information about the eligibility criteria for VQIP applicants and the use of the facility 
certificates in VQIP.19  
 
H.2.2 Can audits conducted by accredited certification bodies be used to meet the 
supplier verification requirements of the Foreign Supplier Verification Program and 
Preventive Controls regulations? 
 
Yes. There are three FSMA regulations that provide for onsite audits of food suppliers in 
certain circumstances.20 The three regulations are Current Good Manufacturing Practice, 
 
19 See U.S. Food and Drug Administration, Guidance for Industry: FDAs Voluntary Qualified Importer Program, 
Final Guidance, November 2016, (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-fdas-voluntary-qualified-importer-program). 
20 See https://www.fda.gov/media/136142/download for the Temporary Policy Regarding Preventive Controls and 
FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: 
Guidance for Industry. 
35 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Hazard Analysis, and Risk Based Preventive Controls for Human Food (21 CFR Part 117),21 
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls 
for Food for Animals (21 CFR Part 507),22 and Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals (21 CFR Part 1 Subpart L) (FSVP regulation).23 
 
In circumstances where an onsite audit is an appropriate supplier verification activity under one 
of those three regulations, receiving facilities and importers are not required to use onsite 
audits conducted by a CB accredited under TPP, but they may choose to do so. The onsite 
audits used to meet the supplier verification requirements under the three regulations must 
meet the applicable requirements of the specific regulations.  
 
We note that audits conducted by an audit agent of an accredited CB to solely meet the 
requirements of 21 CFR Part 117, 21 CFR Part 507, or the FSVP regulation would not be 
subject to the requirements of the TPP regulation, including the reporting and notification 
requirements. However, if a receiving facility subject to 21 CFR Part 117 or Part 507 or an  
importer subject to the FSVP regulation would like to use a single audit to meet obligations 
under one of those regulations and to apply for participation in VQIP, then the audit would be 
subject to the requirements of the TPP regulation (because the audit would be used for 
 
21 Among other things, subpart G in 21 CFR Part 117 requires the receiving facility to establish and implement a 
written supply chain-program (21 CFR 117.405(a)-(b)) and approve suppliers for those raw materials and other 
ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control (21 CFR 
117.415(a)(1)). The receiving facility (or a designee) also must determine and conduct appropriate supplier 
verification activities (21 CFR 117.425, 21 CFR 117.415(a)(3)(iii)). With some exceptions, one or more supplier 
verification activities (e.g., onsite audit, sampling and testing, review of food safety records) must be conducted for 
each supplier before using the raw material or other ingredient from that supplier and periodically thereafter (21 
CFR 117.430(a)). Generally, 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, the appropriate supplier verification activity is an onsite audit of the supplier, and it must be 
conducted before using the food and at least annually thereafter (21 CFR 117.430(b)(1)). For more information on 
21 CFR Part 117, including links to guidance that discusses the requirements mentioned in this document, see 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food. 
22 Subpart E of Part 507 contains supply-chain program requirements for animal food receiving facilities that are 
comparable to those for human food facilities. For more information on 21 CFR Part 507, including links to 
guidance that discusses the requirements mentioned in this document, see https://www.fda.gov/food/food-safety-
modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food. 
23 The FSVP regulation requires importers to conduct a hazard analysis to determine whether there are any hazards 
that require a control (21 CFR 1.504) and, based on the hazard determine the appropriate type of verification activity 
as well as the frequency of conducting the activity. The foreign supplier verification activities must provide 
assurance that the hazards requiring a control in the imported food have been significantly minimized or prevented 
(21 CFR 1.506(c)). Importers must establish and follow written procedures to ensure they import food only from 
suppliers they have approved (21 CFR 1.506(a)(1)). Appropriate supplier verification activities may include onsite 
audits, sampling and testing of a food, and review of the foreign suppliers relevant food safety records (21 CFR 
1.506(d)(1)(ii)). When a hazard in a food is controlled by the foreign supplier and 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, the default verification activity is to conduct an annual onsite audit before initially importing the 
food from the supplier and at least annually thereafter (21 CFR 1.506(d)(2)).  For more information on the FSVP 
regulation, including links to guidance that discusses the requirements mentioned in this document, see 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-
programs-fsvp-importers-food-humans-and-animals. 
36 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
purposes of VQIP eligibility). In those circumstances, the audit would need to be conducted as 
a regulatory audit in accordance with TPP requirements (21 CFR 1.651).  
 
We also emphasize that receiving facilities and importers subject to 21 CFR Part 117, Part 507, 
or the FSVP regulation are not required to use accredited CBs under TPP to meet their supplier 
verification requirements under 21 CFR Part 117, Part 507, or the FSVP regulation. Audits 
under those regulations must be conducted by qualified auditors as defined in 21 CFR 117.3, 
21 CFR 507.3, and 21 CFR 1.500, respectively.24 An example of a potential qualified auditor 
under those regulations includes, but is not limited to, an audit agent of a CB that has been 
accredited under TPP.  
 
H.2.3 What are the requirements for conflict of interest if an FDA-recognized 
accreditation body is also a Foreign Supplier Verification Program importer? 
 
In accordance with 21 CFR 1.624(a), a recognized AB must implement a written program to 
protect against conflicts of interest between the recognized AB (and its officers, employees, 
and other agents involved in accreditation activities) and any CB (and its officers, employees, 
and other agents involved in auditing and certification activities) seeking accreditation from, or 
accredited by, such recognized AB, including the following:  
 
(1) Ensuring that the recognized AB (and its officers, employees, or other agents 
involved in accreditation activities) does not own or have a financial interest in, manage, 
or otherwise control the CB (or any affiliate, parent, or subsidiary); and  
 
(2) Prohibiting officers, employees, or other agents involved in accreditation activities of 
the recognized AB from accepting any money, gift, gratuity, or item of value from the 
CB.  
 
For purposes of FSVP, importer means the U.S. owner or consignee of an article of food that 
is being offered for import into the United States. If there is no U.S. owner or consignee of an 
article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the 
foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent 
to serve as the importer under the FSVP regulation. The term U.S. owner or consignee 
means the person in the United States who, at the time of U.S. entry, either owns the food, has 
purchased the food, or has agreed in writing to purchase the food (21 CFR 1.500 (definition of 
U.S. owner or consignee)). The term person includes an individual, partnership, 
corporation, and association (21 U.S.C. 321(e)).  
 
 
24 Additional information on the qualified auditor requirements is available in the draft FSVP guidance at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-
supplier-verification-programs-importers-food-humans-and-animals, draft guidance on Hazard Analysis and Risk-
Based Preventive Controls for Human Food (Chapter 15) at https://www.fda.gov/media/110443/download, and draft 
guidance on Hazard Analysis and Risk Based Preventive Controls for Food and Animals: Supply-Chain Program at 
https://www.fda.gov/files/animal%20&%20veterinary/published/CVM-GFI--246-Hazard-Analysis-and-Risk-Based-
Preventive-Controls-for-Food-for-Animals--Supply-Chain-Program.pdf. 
37 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
If a recognized AB under TPP is an importer for purposes of FSVP, then the AB must follow 
the conflict of interest rules that apply to recognized AB and FSVP importers, as applicable. 
According to 21 CFR 1.506(b), importers must establish and follow adequate written 
procedures for ensuring that appropriate foreign supplier verification activities are conducted 
with respect to the foods they import. As required by 21 CFR 1.506(e)(4), there must not be 
any financial conflicts of interests that influence the results of the verification activities set 
forth in paragraph (e)(1) of 21 CFR 1.506, and payment must not be related to the results of the 
activity.  
 
An example of a FSVP verification activity under 21 CFR 1.506(e)(1) is an onsite audit of the 
foreign supplier by a qualified auditor where the audit agent is affiliated with a CB that is 
accredited under TPP. Therefore, if a recognized AB that is also an FSVP importer chooses to 
use an audit as a verification activity, they would need to abide by the conflict of interest 
requirements of 21 CFR 1.506(e) and 1.624(a).  
 
38