Contains Nonbinding Recommendations 
Temporary Policy Regarding 
Accredited Third-Party Certification 
Program Onsite Observation and 
Certificate Duration Requirements 
Due to COVID-19  
Guidance for Industry 
Comments may be submitted at any time for Agency consideration. Submit written comments to 
the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. 
All comments should be identified with the docket number FDA-2023-D-2827. 
For questions about this document, contact FDA at FDAthirdpartyprogram@fda.hhs.gov. 
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 2020 
Updated July 2023  
Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction ................................................................................................................................... 1 
II.  Background ................................................................................................................................... 2 
III.  Discussion ..................................................................................................................................... 3 
 
 
   
 
   
Contains Nonbinding Recommendations 
Temporary Policy Regarding 
Accredited Third-Party Certification 
Program Onsite Observation and 
Certificate Duration Requirements 
Due to COVID-19  
 
Guidance for Industry 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) 
on this topic. It does not establish any rights for any person and is not binding on FDA or the public. 
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this 
guidance as listed on the title page. 
I.  Introduction 
The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the 
United States from threats such as emerging infectious diseases, including the Coronavirus Disease 
2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response 
efforts to this pandemic. 
 
The Accredited Third-Party Certification Program regulation (21 CFR part 1, subpart M) establishes a 
voluntary program for the recognition of accreditation bodies (ABs) that accredit third-party 
certification bodies (CBs) to conduct food safety audits and issue food or facility certifications to 
eligible foreign entities for the purposes specified in sections 801(q) and 806 of the Federal Food, 
Drug, and Cosmetic (FD&C) Act (21 U.S.C. 381 and 384b).1 The regulation requires that 
recognized ABs and accredited CBs perform certain onsite observations and examinations. 
 
Due to the ongoing, international impact of COVID-19, FDA is issuing this guidance to 
temporarily provide the Accredited Third-Party Certification Programs currently-recognized ABs 
and accredited CBs flexibility, in certain circumstances, regarding the following requirements: 
 
  The requirement for recognized ABs to monitor the performance of CBs they have 
accredited under the program by conducting onsite observations of a representative sample 
 
1 For information on Part 1, Subpart M, see https://www.fda.gov/food/importing-food-products-united-states/accredited- 
third-party-certification-program and https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule- 
accredited-third-party-certification. 
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Contains Nonbinding Recommendations 
of regulatory audits performed by the CBs they accredited and to visit the CBs 
headquarters (or other location, as needed) no later than 1 year after the initial date of 
accreditation of the CB and every 2 years thereafter. 
  The requirement that certificates be issued for a term only up to 12 months for already- 
issued certifications issued under the Accredited Third-Party Certification Program. 
 
This guidance (originally titled Temporary Policy Regarding Accredited Third-Party Certification 
Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public 
Health Emergency) was initially implemented without prior public comment on April 22, 2020, 
because FDA had determined that prior public participation was not feasible or appropriate (21 CFR 
10.115(g)(2)) given the exigent circumstances related to the COVID-19 public health emergency. For 
the reasons discussed in Section II.A., and to clarify that the policies continue to reflect our current 
thinking, FDA is now reissuing this guidance in accordance with 21 CFR 10.115(c) and 10.115(g)(4). 
The policies are unchanged from the April 2020 guidance. 
 
In general, FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The 
use of the word should in Agency guidance means that something is suggested or recommended, but 
not required. 
 
II.  Background 
A.  Coronavirus  
 
Since December 2019, governments around the world have instituted various responses to outbreaks 
of the respiratory disease COVID-19 caused by the virus SARS-CoV-2. Some of these responses 
have included travel restrictions and advisories that are designed to curb the spread of COVID-19. 
Since the first COVID-19 cases were reported, it has become clear that SARS-CoV-2 is constantly 
evolving, with the public health impact  and consequent travel restrictions and advisories  
fluctuating.  As a result of these fluctuations, FDA expects that the recognized ABs and accredited 
CBs currently participating in the Accredited Third-Party Certification Program may, from time to 
time, have difficulties meeting the requirements to conduct onsite observations and examinations. 
FDA is issuing this guidance to address these circumstances. 
  
B.  Requirements for Recognized ABs Monitoring Accredited CBs 
 
After accrediting a CB, recognized ABs must monitor the performance of the CB(s) they accredited 
(21 CFR 1.621). The monitoring requirements include activities that can be conducted remotely (21 
CFR 1.621(a)), and also activities that must be conducted onsite (21 CFR 1.621(b)). The monitoring 
activities that recognized ABs may conduct remotely are an annual comprehensive assessment of the 
performance of each CB they accredited by reviewing the CBs self-assessments, the regulatory audit 
reports and notifications submitted to FDA under 21 CFR 1.656, and any other information 
reasonably available to the recognized AB regarding the compliance history of eligible entities that 
the accredited CB certified or that is otherwise relevant to determining whether the accredited CB is 
in compliance with the regulation (21 CFR 1.621(a)). 
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Contains Nonbinding Recommendations 
 
The monitoring activities that recognized ABs must conduct onsite are observations of a 
representative sample of regulatory audits performed by the accredited CB (or its audit agents) and a 
visit to the accredited CBs headquarters (or other location that manages audit agents under this 
program), no later than one year after the initial date of accreditation of the CB and every 2 years 
thereafter for the duration of the CBs accreditation (21 CFR 1.621(b)). 
 
C.  Requirement that Certificates be for a Term of Up to 12 Months 
 
The basis for the issuance of certifications under the Accredited Third-Party Certification Program 
is that an accredited CB must complete a regulatory audit that meets the requirements of 21 CFR 
1.651 and any other activities that may be necessary to determine an eligible entitys compliance 
with the applicable food safety requirements of the FD&C Act and FDA regulations (21 CFR 
1.653(a)(1)). The regulatory audit must include, among other activities, an unannounced onsite 
examination (21 CFR 1.651(c)(1)-(2)). The regulatory 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, and whether the eligible entity, given 
its food safety system and practices, would be likely to remain in compliance with the applicable 
food safety requirements of the FD&C Act and FDA regulations for the duration of any certification 
issued under the Accredited Third-Party Certification Program (21 CFR 1.651(c)(3)). 
 
The certificates may only be for a term of up to 12 months (see 21 CFR 1.653(b)(1); section 808(d) 
of the FD&C Act). When the certification for an eligible entity expires, the accredited CB must 
conduct a new regulatory audit (including an unannounced onsite examination) in order to issue a 
new certification (21 CFR 1.653(a)). 
 
After issuing a certificate, if an accredited CB has reason to believe that an eligible entity to which it 
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 such 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 because it 
determines that the entity is no longer in compliance with the applicable food safety requirements of 
the FD&C Act and FDA regulations. See 21 CFR 1.654. 
 
Section 808(c)(2)(B) of the FD&C Act specifies two uses for the certifications issued by accredited 
CBs under this program: for participation in the Voluntary Qualified Importer Program (VQIP) 
under section 806 of the FD&C Act and for import certification under section 801(q) of the FD&C 
Act. 
 
III.  Discussion 
 
To help address the difficulties caused by COVID-19 with conducting onsite observations and 
examinations, we are providing temporary flexibility so that ABs can maintain the accreditations of 
CBs and so that already-issued certifications need not lapse.  
 
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Contains Nonbinding Recommendations 
FDA does not intend to enforce certain onsite observation and certificate term requirements in the 
following circumstances: 
 
For recognized ABs monitoring their accredited CBs, FDA does not intend to enforce the 
requirements in 21 CFR 1.621(b) that, within 1 year after the initial date of accreditation and every 2 
years thereafter, the recognized AB conduct onsite observations of a representative sample of 
regulatory audits performed by the accredited CB (or its audit agents) and that the recognized AB 
visit the CBs headquarters (or other location that manages audit agents conducting food safety audits 
under the regulation), when: 
 
  A recognized AB determines that it is impracticable to conduct onsite observations of 
regulatory audits or visit an accredited CBs headquarters (or other location) due to 
government travel restrictions or advisories related to COVID-19; and 
  The recognized AB conducts the annual comprehensive assessment of the performance of a 
CB it has accredited in accordance with 21 CFR 1.621(a) to determine whether the 
accredited CB is in compliance with the regulation.2  
 
Recognized ABs should resume onsite observations and visits within a reasonable period of time 
after it becomes practicable to do so. 
 
For already-issued certificates, FDA does not intend to enforce the requirement that the accredited 
CBs issue the certificates for a term only up to 12 months (21 CFR 1.653(b)(1)), when: 
 
  The accredited CB determines that it is impracticable to conduct a regulatory audit due to 
government travel restrictions or advisories related to COVID-19; 
  The regulatory audit would ordinarily be needed to support the issuance of a new certificate 
under 21 CFR 1.653(a)(1); 
  The accredited CB has already issued a food or facility certificates to the eligible entity 
under 21 CFR 1.653 that is due to expire;3  
  The food or facility certificate has not been suspended or withdrawn by the accredited CB; 
and 
  The accredited CB continues to adhere to the requirements of 21 CFR 1.654 regarding 
monitoring eligible entities to which they have issued certificates. 
 
An accredited CB that has issued a certificate with an upcoming expiration date can contact FDA at 
FDAthirdpartyprogram@fda.hhs.gov to discuss the term of the current certificates. Accredited CBs 
should resume conducting regulatory audits to determine if the eligible entities should be issued new 
certificates within a reasonable period after it becomes practicable to conduct the onsite 
examinations required for regulatory audits. 
 
FDA intends to provide timely notice about the withdrawal of this policy. 
 
2 This policy only applies when a recognized AB has already accredited CBs under the Accredited Third-Party Certification 
Program regulation. The policy does not apply to the evaluations that an AB conducts for CBs that are seeking accreditation 
or for accredited CBs seeking scope expansion. 
3 This policy only applies to already-issued certificates under the Accredited Third-Party Certification Program. 
 
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