FSMA versus FSSC 22000 Gap Analysis


A recent comparison of FSSC 22000 against the FSMA Final Preventive Controls (PC) Rule for Human Food was commissioned by The Foundation FSSC 22000 and conducted by The Acheson Group (TAG), an independent consultancy with expertise in food safety legislation. Although it was intended as a gap analysis, the comparison showed that there are no gaps in the elements required for FSSC 22000 certification when compared with the requirements of the final PC rule.

The analysis which is published as 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” TAG: April 2016. The report which provides evidence of the alignment between FSSC 22000 and the PC rule, is the first of many that will be produced 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 FSMA compliance.


The FDA Food Safety Modernization Act (FSMA), signed into law in 2011, enables the FDA to focus its food safety efforts on preventing problems rather than relying primarily on reacting to problems after they occur. Since January 2013, the FDA has proposed seven risk-based, foundational rules to implement FSMA and has now finalized six of the seven FSMA rules including the Preventive Controls for Human Food.
Throughout the process of developing the new rules the FDA conducted extensive outreach to industry, academia, consumer groups, tribal governments and the agency’s counterparts at the international, federal, state and local levels, and received thousands of comments. On many occasion the FDA has been questioned about their view of the role of the existing network of “GFSI benchmarked certification schemes” and where they stand with regard to compliance. The FDA has even been questioned as to why they should seek to develop yet another food safety standard, when industry has been working to harmonize the requirements and practices.
Responses to these questions are provided in the extensive preamble to the published legislation and while the FDA have always acknowledged the existence of the GFSI schemes and their contribution to maintaining safety standards, the agency has until now considered them inadequate to provide the rigor of food safety control sought by the new FSMA rule.
They do however offer: 

“where systems mirror the requirements, existing records can be used to provide evidence of compliance” (Comment 8) 

And acknowledge that systems could be used to provide 

“…. evidence of compliance with the appropriate supplements” (Comment 382) 

Prior to this report, the FDA believed it premature to accept the schemes, but that once evidence of alignment was provided it is suggested that systems could be used as; 

.…evidence of validation (Comment 496), 
…. verification of supplier (Comment 673), 
And …. to meet the requirements of the annual audit required for FSVP (Comment 683)

The TAG report pinpoints the major points of alignment between FSSC 22000 and the PC Rule. 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. Discrepancies in terminology were identified in the comparison which should be noted, but these remain a global problem and could be solved by an international glossary.
In the absence of the identification of any gaps 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. It is anticipated that this report may 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 are meeting the requirements of the forthcoming legislation. (Source: http://www.fssc22000.com/)