U.S – The U.S. Food and Drug Administration (FDA) has released the findings of its voluntary pilot program, unveiling the alignment of private third-party food safety audit standards with the stringent requirements set forth in the Preventive Controls for Human Foods Rule (PCHF) and the Produce Safety Rule (PSR). 

These two vital rules were implemented by the FDA as part of the monumental Food Safety Modernization Act (FSMA) – a historic overhaul of food safety practices in the United States.

Throughout the food supply chain, buyers and stakeholders place immense trust in third-party audits to assess the quality and safety of food products. 

Under FSMA regulations, third-party audits are recognized as a legitimate means of supplier verification, bolstering confidence in the industry’s ability to uphold strict FDA food safety requirements.

By conducting an in-depth evaluation of the extent to which third-party audit standards align with FSMA regulations, the FDA aims to provide importers and receiving facilities with the assurance that supplier audit standards adequately address crucial food safety requirements set forth by the FDA. 

This essential information can also play a pivotal role in helping the FDA determine risk prioritization and allocate resources effectively.

The FDA meticulously selected and assessed several prominent third-party food safety standards for alignment with the PCHF and PSR. 

While the specific elements of these standards and FSMA-implementing regulations may not be identical, the alignment signifies that the critical technical components of the PCHF and PSR are being effectively addressed.

The FDA reviewed the BRC Global Standard Food Safety and the Global Standard Food Safety, Issue 9, Interpretation Guideline; FSSC 22000 Scheme 5.1 for Food Manufacturing and the FSSC 22000 V5.1 FSMA PCHF Report Addendum; and SQF Food Safety Code: Food Manufacturing, Edition 9 and the SQF Addendum for the Preventive Controls for Human Food.

The agency found all three third-party standards to be in alignment with PCHF.

It also found GLOBALG.A.P. Integrated Farm Assurance—All Farm Base-Crops Base—Fruit and Vegetables Checklist Version 5.4-GFS and the GLOBALG.A.P. Food Safety Modernization Act Produce Safety Rule Add-On Module Version 1.2 to be in alignment with PSR.

Emphasizing technical alignment, not quality assessment

The FDA emphasizes that its reviews were focused solely on assessing third-party food safety standards’ alignment with FSMA regulations and not on evaluating the overall quality of the audit programs or the qualifications of auditors. 

These findings are not an endorsement of any specific food safety audit standard, nor do they constitute an endorsement of audits conducted under such standards.

The FDA recognizes the immense value of third-party food safety audit standards in facilitating the industry’s implementation of FSMA and their potential to inform risk prioritization. 

However, the agency currently faces resource constraints, leading to the conclusion that further review and evaluation of third-party food safety standards beyond the pilot are not feasible at present.

The groundbreaking findings of this pilot program have far-reaching implications not only for the United States but also the global food industry. 

With the alignment of prominent third-party food safety standards with FSMA regulations, consumers worldwide can be assured that their food is produced and distributed with the highest level of safety and compliance.

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