The question is not new: "I am GFSI certified, so does that mean I am FSMA compliant?" It's a question with which industry has been wrestling since the Food Safety Modernization Act was signed into law in 2011.
FDA has even referenced the Global Food Safety Initiative at various times, such as then-Deputy Commissioner for Foods Michael Taylor's comments at the 2012 Global Food Safety Conference, at which he stated, "As we build our new import system, we want to work closely with GFSI and build on the foundation you have established for effective and credible certification programs." And the more recent report compiled from 2016 FDA public meetings on the implementation of import safety programs under FSMA, showing that questions of GFSI/FSMA comparison still abound, e.g., "Most participants expressed interest in seeing or participating in the creation of comparative analyses of existing programs, plans, and schemes (such as GFSI) to provide industry with a better understanding of what, specifically, they need to do in order to comply with FSMA and FSVP requirements."
So, if the question has continued to be a source of industry angst, you may be asking "What exactly is new?" (or more succinctly – "Why are you writing about it now, David?")
What's new is that FDA is now asking for your input on initiatives on which it should focus "as it develops, expands, and refines partnership activities related to imported foods" that align with and support FSMA implementation. In the announcement of the February 14-15 public hearing, FDA noted that it will include a focus on obtaining information on the role of partnerships "to enhance risk-based decision making through the consideration of private standards, the recognition of commodity-specific export programs, and the implementation of the existing systems recognition program."
While FDA did not specifically call it out, to me the talk of partnerships, consideration of standards and implementation of existing programs to align with FSMA all point a pretty definite finger at GFSI. And, even though the public hearing focuses specifically on imported foods, any alignment with GFSI should cross over to all the rules. As FDA states in the meeting announcement, FSMA "has provided FDA with new authorities to help ensure that imported foods meet the same safety standards as foods produced domestically. While the FSMA regulations are not the subject of this public hearing, the initiatives that will be discussed align with and support FSMA implementation." So, if the safety standards are to be the same, then my deduction would be that consideration or recognition of a standard (i.e., GFSI) for an imported food would mean consideration or recognition of the standard for a food produced in the U.S.
A couple months ago, I spoke at a GFSI Briefing in Washington D.C. on this very topic. Based on the results of a comparative analysis of the GFSI Benchmarking Requirements V7 and FSMA's Preventive Controls Rule for Human Foods, I stated that GFSI generally meets or exceeds all the requirements in the FSMA preventive controls rule – with GFSI actually exceeding FSMA in some cases where it has requirements not reflected in FSMA.
GFSI Chair Mike Robach also spoke at the meeting. Citing The Reciprocity Advantage by Bob Johansen and Karl Ronn, he said, “GFSI is an example of partnering to do something that no single company could do alone. It is massive reciprocity on a global scale.” It seems to me that that is exactly what FDA is – or should be – seeking, and exactly what will enable FSMA to be accepted around the world, rather than seen as a trade barrier, as some have contended it could be.
While we've never had an FDA official come out and say GFSI certification equals FSMA compliance – and we're not likely to, as the two do have some distinct differences – I, as a former FDA official, am here to say that (1) Having a GFSI certification will put you in a good place for FSMA compliance; and (2) The bottom line is that, when properly implemented, both GFSI and FSMA will protect the food supply to the same extent.
Both FSMA and GFSI are, in essence, a set of standards. What is key with both for success is to make sure that you not only meet those standards at the time of your audit or FDA inspection, but that you maintain those standards during every other day of operation.
FDA is a risk-based Agency which puts resources in areas of greatest risk – as they should. As FDA is looking at plants and operations that have a GFSI certification, I would urge the Agency to take that into consideration as part of the risk analysis when it comes to determining the priority of a food company for a regulatory visit. Being GFSI certified should not be viewed as an excuse to ignore FSMA compliance, but rather be used as a strong indicant to FDA that a GFSI-certified plant is very likely to be doing a good job with food safety and is likely to be in compliance with the FSMA preventive controls rule.
So … What does it mean to be GFSI certified in a FSMA environment? I believe it is a meaning that is being furthered defined and solidified and becomes more beneficial every day. If you are GFSI certified, you are definitely in a good place. If you're not, you may want to think about looking into it, as it could certainly move you further down the road of compliance than waiting for FDA to publish the rest of its guidance. But that, as they say, is a whole 'nother newsletter!
This post was written and contributed by:
CEO and Founder of The Acheson Group and former Associate Commissioner for Foods at the U.S. Food and Drug Administration
Republished with permission from the TAG blog