As the first of the compliance dates for the rules of the Food Safety Modernization Act became effective, FDA’s mantra was “Educate before we regulate.” The agency understood that many in the industry had a lot of work to do not only to come into compliance but to understand all the intricacies of the provision. It also admitted that there was a learning curve for its own inspectors. As time passed the refrain evolved to “Educate before and while we regulate.” Facilities were still given some leeway in the execution of specifics of the provisions, but it was being expected that the general preventive thinking and application of overarching rules would be apparent. Today, a further evolution has taken place, with FDA citing its role as being to “Educate while we regulate.” While the agency understands that there will continue to be a need for some education, it expects that food facilities will have implemented all the applicable provisions and be in the maintenance phase. That is, there may be some things that they would like to see implemented differently; you may have overlooked something in your Food Safety Plan (FSP) they see as needed; or you may even have implemented a provision that was unnecessary for your product and processes. But you do have an FSP, you have attempted the pro per implementation – and too much food safety is always better than not enough. FDA’s inspections also have evolved per Congressional mandates on frequency. As stated on FDA’s Inspection & Compliance page, FSMA established a mandated inspection frequency, based on risk, for food facilities, requiring regular increase in the frequency of inspection. The specifics are that, effective upon enactment, all high-risk domestic facilities were to be inspected within five years and no less than every three years thereafter; all non-high-risk facilities within seven years and every five years thereafter. Additionally, within one year of enactment, FDA was to inspect at least 600 foreign facilities and double those inspections every year for the next five years. Although FDA has had “challenges” in meeting these numbers, as we discussed in the October 2017 newsletter, “FDA Blasted Again by the Office of the Inspector General,” it is facing mandates to do so, and a desire to avoid another OIG “blasting” – on both the number of inspections conducted and a lack of action when uncovering significant inspection violations could compel it to do even less education and more regulation. However, FDA appears to have done a pretty good job of meeting the domestic inspection requirements; where the Agency falls short is the foreign inspections which is entirely a result of lack of resources. So what does all this mean? It means that with the continuing evolution of FDA’s approach to FSMA and its preventive controls inspection, you, too, need to be evolving. You should no longer be in an implementation phase, but should be executing and maintaining the FSMA-related practices and processes you put in place. And, you need to be able to show an FDA inspector exactly how you are doing so. When the FSMA rules were first enacted, the agency’s approach was often a matter of reviewing records and documentation, looking over your Food Safety Plan, talking with your PCQI, and ensuring things were in place relevant to FSMA (along with conducting its now-infamous swabathons). But today’s inspections have shifted that focus to: “Don’t just show me your plan, show me how you’re using it.” Writing the Food Safety Plan likely took a great deal of time and effort – even if it was more a matter of reworking or rewording previous plans to fit FDA’s requirements. But with that task completed, are you applying all the procedures, and preventive controls listed in the plan? Are you regularly reviewing your processes and practices against the plan? Have you educated and trained your employees to ensure their understanding and application? And – has there been any turnover requiring training of a new PCQI? In today’s world of tracking, traceability and related accountability, documentation is critical. But it doesn’t stand alone. To cite a cluster of clichés: If you aren’t “practicing what you preach”; if you aren’t “walking the talk”; if you are “pencil whipping” records … you need to “bite the bullet” and align your actions with your words. As evidenced by FDA’s mandatory recall order of kratom-containing food products in April, the Agency is taking its FSMA-given authorities seriously, and its increasing focus on regulation vs. education during inspections is also proving that out. One of the greatest challenges we have seen over the last 12 months as food companies move from the Food Safety Plan “build” to the Food Safety Plan “maintenance” is that the C suite questions why resources are still needed for FSMA. If you are reading this and feeling that pain, don’t hesitate to reach out to TAG. We have worked with many companies to help get the message right for the C suite to help them recognize what needs to be done to stay out in front of both FSMA requirements and brand protection. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
