A recent FSMA Fridays webinar, presented by SafetyChain and The Acheson Group, focused on the interesting topic of FSMA and GFSI: Alignment and Gaps. The discussion covered questions such as did FDA reinvent the wheel with FSMA, given GFSI? If you are GFSI certified, will you comply with all FSMA rules? What do you need to do in addition? Will FDA accept GFSI certification in lieu of an inspection?
David Acheson, M.D., and Jennifer McEntire, Ph.D., of The Acheson Group gave their perspective on where the rules and guidance shaping food safety programs in the industry are similar, and how they differ. We present below some excerpts.
Did FDA reinvent the wheel with FSMA, with GFSI already there?
Dr. Acheson: At a very fundamental level, GFSI is global and FSMA is more U.S.-centric, focused on protecting the American consumer. If you look back a few years, to the time when FSMA rules were being put together, there wasn’t clear understanding about the impact of GFSI and what it could accomplish. GFSI has evolved substantially since then, both in terms of the various standards, and in terms of the execution (preparing companies for audits and doing the actual audits). While there is a lot of alignment between FSMA proposed rules and the various GFSI guidance documents, I don’t think FDA reinvented the wheel with FSMA, which is more detailed, more prescriptive and U.S.-centric.
Which proposed rules are most similar to the GFSI guidance document, and which are different?
McEntire: If we consider the seven proposed rules under GFSI so far, and compare it with the different ‘scopes’ under GFSI, you can see within one scope several elements of FSMA rule:
Produce rule: In some areas what FDA is looking for is more prescriptive, more stringent than what GFSI has in their books, and in other areas, GFSI standard is more detailed. We need to remember that these are still ‘proposed’ rules, so it is hard to predict where FDA will land eventually.
Preventive controls: There is fairly strong alignment between this rule and GFSI. There is some minor differences, but the approach is quite similar.
Food defense: With this rule, you can see of the greater differences. Under FSMA, there’s a whole new rule, compared to just a few lines under GFSI for food defense. So FDA is more specific in what they are looking for and will expect food companies to do more work, over the GFSI scheme.
Sanitary transportation: FDA said they wanted to align with industry practices, and GFSI Logistics guidance for this rule. So broadly the requirements are consistent.
Foreign Supplier Verification Program: This is an interesting one, because there’s no GFSI call out for international versus domestic supplier. FDA is taking a more specific approach in what needs to be done to evaluate and verify foreign suppliers. In our mind, GFSI is taking a more appropriate approach, which FDA will need to consider, to include all suppliers, global or domestic.
There are other elements of GFSI that FDA has not issued rules such as traceability, but overall there’s general alignment between the two sets of food safety requirements.
When you look at some key differences, again, GFSI is global. FSMA more US focused. GFSI is more guidance documents and broad scope, while FSMA is actual rules.
When it comes to rule-specific differences, if you consider Preventive Controls, the proposed rule looks at it pretty comprehensively, not just at critical points. So while it’s aligned with HACCP principles, it builds on it, and goes beyond HACCP.
Also, there are some terminology differences: FDA calls the point person a ‘qualified individual.’ Each scheme has their own term for this person. Some standards require a team to evaluate – not just one individual.
Will FDA accept a certificate from one of the GFSI schemes instead of an inspection?
Dr. Acheson: This is a million dollar question and often asked. I feel if it is a full course inspection (based on a compliant, an RFR etc.), then no. FDA will want to do the inspection in order to do their regulatory job, as they are supposed to. Remember, there’s a lot of alignment between GFSI and FSMA, though it’s not a 100 percent. So will they accept a certificate in lieu of an inspection? Right now, no. but there will be a point, where FDA will take a certificate as recognition that a company is certified to a GFSI standard – and factor this in to a certain level, for instance, to determine who will get inspected this week versus next month. As the schemes evolve, and as GFSI becomes more aligned with FDA, keeping in mind that GFSI is intended to be more global than U.S. focused, if a company is certified against a GFSI standard, I think it’s likely that FDA will take it seriously.
McEntire: If a company is certified to a GFSI scheme, and is willing to share information of that certification process with FDA, it will go a long way in establishing credibility of the food safety and quality program. Of course, you need to keep in mind that the certificate is limited to that audit, which at best, is a snap shot of the company’s food safety management program a given time. Also, note that GFSI audits are currently announced, versus FDA inspections which are unannounced, where an inspector show s up at your door.
Broadly, if you are certified to a GFSI standard, you are in a good place to comply with FSMA rules, and in better shape than other companies who are not certified. But you need to read the rules, understand the rules, and see what additional things you need to do to be compliant.
Hear more about FSMA and GFSI – Alignment and Gaps, and what you need to do by clicking here.Next FSMA Fridays, on October 31, will cover Foreign Supplier Verification, Produce, Human and Animal Rules – 2nd Review Cycle – Part 2.