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GUIDANCE DOCUMENT

Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency Guidance for Industry April 2020

Final
Docket Number:
FDA-2020-D-1304
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs

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 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 impact of the public health emergency related to COVID-19, FDA is issuing this guidance to provide the Accredited Third-Party Certification Program’s 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 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 policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services Act (42 U.S.C. 247(d)(a)(2)).

Given this public health emergency, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s 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.

Download the Guidance


[1] For information on Part 1, Subpart M, see Accredited Third-Party Certification Program and FSMA Final Rule on Accredited Third-Party Certification.


Related Information


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1304.