Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification ProgramSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program
					
		
		April 2022


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
	Share
    Post
    Linkedin

    Email
    PrintDocket Number:
		    FDA-2022-D-0370
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Center for Food Safety and Applied Nutrition


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 bodies 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).

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.

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.

Download the Draft Guidance

Related Resources

Accredited Third-Party Certification Program
	Apply to become an Accreditation Body
	Select "Create New Account" and then select the appropriate box under FSMA
	Accreditation Body Electronic Portal User Instructions (PDF: 6MB)
	Certification Body Electronic Portal User Instructions (PDF: 6.48MB)
	Key Facts About the Program (PDF: 79KB)
	Public Registry of Recognized Accreditation Bodies
	Public Registry of Accredited Third-Party Certification Bodies
	User FeesSubmit Comments
	   		  			    		Submit Comments Online
					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-2022-D-0370.

                                                                                  Content current as of:
      04/28/2022
         
                  
Regulated Product(s)
		 Food & BeveragesTopic(s)
			  ImportLaw(s) & Regulation(s)
			  Food Safety Modernization ActSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop