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:

                New Era of Smarter Food Safety

New Era of Smarter Food Safety

                        New Era of Smarter Food Safety Blueprint
          New Era of Smarter Food Safety Activities
          New Era of Smarter Food Safety Frequently Asked Questions
          Tech-Enabled Traceability - Core Element 1 of the New Era of Smarter Food Safety Blueprint
          Smarter Tools and Approaches for Prevention and Outbreak Response - Core Element 2 of the New Era of Smarter Food Safety Blueprint
          New Business Models and Retail Modernization - Core Element 3 of the New Era of Smarter Food Safety Blueprint
          Food Safety Culture - Core Element 4 of the New Era of Smarter Food Safety Blueprint
          New Era of Smarter Food Safety Management Team


                        New Era of Smarter Food Safety TechTalk Podcast Home
          Food
          New Era of Smarter Food Safety
          The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA RulesNew Era of Smarter Food Safety The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintThe Food and Drug Administration (FDA) has concluded the voluntary pilot program to evaluate alignment of private third-party food safety audit standards with applicable FDA regulations. For the pilot, the FDA selected and assessed third-party food safety standards for alignment with the requirements in the Preventive Controls for Human Food or Produce Safety rules. Although the specific elements of the third-party food safety standards and the FSMA implementing regulations may not be identical, a finding of alignment indicates that the relevant technical components of the PC Human Food or Produce Safety rules have been addressed.

The reviews focused on assessing third-party food safety standards and not the overall quality of the audit programs or qualifications of auditors. The FDA’s review and the findings from this pilot do not constitute an endorsement of any one food safety audit standard, or audits conducted under such standards.

The findings from the reviews of aligned standards can be accessed by clicking on the links in each box of the table below.

Results

Third-Party Food Safety Audit Standard and Applicable Addendum
			Scope NameBRC Global Standard Food Safety, Issue 9 plus the Global Standard Food Safety, Issue 9, Module 13: FSMA Requirements
			Preventive Controls for Human Food (PCHF)FSSC 22000 Scheme 5.1 for Food Manufacturing plus the FSSC 22000 Version 3 FSMA PCHF Report Addendum
			Preventive Controls for Human Food (PCHF)SQF Food Safety Code: Food Manufacturing, Edition 9 plus the SQF Addendum for the Preventive Controls for Human Food
			Preventive Controls for Human Food (PCHF)GLOBALG.A.P. Integrated Farm Assurance – All Farm Base-Crops Base – Fruit and Vegetables Checklist. Version 5.4-1-GFS plus the GLOBALG.A.P. Food Safety Modernization Act Produce Safety Rule Add-on Module Version 1.3
			Produce Safety Rule (PSR)
			*Did not include Subpart E, related to Agricultural Water (as applicable to non-sprout produce) or Subpart M, related to sprouts

*Third-party audits under these food safety audit standards and applicable addenda are not a substitute for FDA or state regulatory inspections for compliance with FDA regulations, including the Preventive Controls for Human Food Rule or the Produce Safety Rule. FDA’s statements regarding alignment of the standards referenced in the table above apply only to the specified audit standards and addenda listed.*

How the Pilot was Conducted

The FDA undertook the voluntary pilot to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations issued to implement the FDA Food Safety Modernization Act (FSMA) - the Preventive Controls for Human Food (PC Human Food) and Produce Safety rules. This pilot program was launched to help both FDA and industry gain a better understanding of whether these standards align with FDA regulations, a goal that is consistent with the New Era of Smarter Food Safety Blueprint. The Blueprint, published on July 13, 2020, explains that the Agency is looking to explore how reliable third-party audits can help ensure food safety, including the use of audit data in risk prioritization for FDA regulatory activities.

Buyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product. Buyers, such as importers and receiving facilities, might stipulate an audit as part of a purchase agreement. In addition, three FSMA regulations - the PC Human Food rule, Preventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule – allow for third-party audits to be used as supplier verification activities.

The FDA understands that findings of alignment could create efficiencies for industry and help give importers and receiving facilities confidence that, in general, the third-party standards used to audit their suppliers adequately address applicable FDA food safety requirements. This information, along with results of a firm’s audits also could help inform the FDA in determining risk prioritization and resource allocation.

Throughout this pilot program the FDA monitored the resources required to review and assess third-party standards for alignment, the ability of the pilot participants to provide adequate information to enable FDA to make alignment findings, and whether the FDA audit comparison templates were helpful in developing such findings.

Conclusion

While the FDA sees value in the use of third-party food safety audit standards in facilitating industry's implementation of FSMA, and the potential of these audits to inform risk prioritization, the Agency does not currently have adequate resources to continue to review and evaluate the alignment of third-party food safety standards beyond this pilot. The FDA will continue to assess future opportunities to leverage third party audit standards to help meet the agency’s public health mission.

                                                                                  Content current as of:
      10/30/2023
              
              
Regulated Product(s)
		 Food & BeveragesNew Era of Smarter Food Safety

          
                        New Era of Smarter Food Safety Blueprint
          New Era of Smarter Food Safety Activities
          New Era of Smarter Food Safety Frequently Asked Questions
          Core Element 1: Tech-Enabled Traceability
          Core Element 2: Smarter Prevention and Outbreak Response
          Core Element 3: New Business Models and Retail Modernization
          Core Element 4: Food Safety Culture
          New Era of Smarter Food Safety Management Team


                        New Era of Smarter Food Safety TechTalk Podcast
 SUBSCRIBE
                      Get regular FDA email updates delivered on this topic to your inbox.
    Enter your email address to subscribe:
 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