A recent gap analysis of FSSC 22000 and FSMA Final Preventive Controls (PC) Rule for Human Food found no discrepancies between the requirements of FSSC 22000 certification and the final PC rule.
Based on existing ISO standards, FSSC 22000 (Food Safety System Certification) provides a framework for effectively managing an organization’s food safety responsibilities and demonstrates that a robust food safety management system is in place.
The comparison study, commissioned by The Foundation FSSC 22000 and conducted by independent consultancy The Acheson Group (TAG), can be found here.
The Comparison of FSSC 22000 against the Preventive Controls for Human Food (Final Rule) suggests that “FSSC 22000 as the owner of the scheme should be very proud of how it compares with the PC rule” and “where FSSC 22000 is not exceeding, the scheme requirements are in very large measure comparable to those of the Final Rule.”
The report, which provides evidence of the alignment between FSSC 22000 and the PC rule, is the first of many studies intended to help FSSC 22000 certified food manufacturers and processors meet the requirements of FSMA and support the FDA as they focus their implementation efforts on gaining voluntary FDA Food Safety Modernization Act (FSMA) compliance.
As background, FSMA was signed into law in 2011 and enables the FDA to focus its food safety efforts on preventing problems, rather than reacting to problems after they have occurred.
Since 2013, the FDA has proposed seven risk-based, foundational rules to implement FSMA and has now finalized six of these, including the Preventive Controls for Human Food.
The TAG report pinpoints the major points of alignment between FSSC 22000 and the PC Rule, including that both share a common philosophy of a “risk based and system based approach” and the overarching policy requirement for staff and management commitment to food safety. However, some discrepancies in terminology were identified.
In the absence of the identification of discrepancies between FSSC 22000 and the PC Rule, FSSC 22000 will continue to document and monitor this alignment in practice and will conduct similar analyses on the remaining published rules. The report is anticipated to be used as supporting evidence of the alignment between FSSC 22000 and FSMA so that companies achieving FSSC 22000 certification can be confident that they meet the requirements of the forthcoming legislation.