The processed food industry has evolved over the past several decades to keep pace with food safety advances, including the development of HACCP and, more recently, the implementation of GFSI-benchmarked food safety management programs. The implementation of FSMA is yet another revolutionary change that will have tremendous impact on the industry. Why? Because the food safety programs within facilities are no longer voluntary. They will be evaluated by FDA and require documentation and justification in a format that will be accepted by an FDA inspector, which is not necessarily the approach of a food manufacturer today. “Because we’ve always done it this way” won’t necessarily hold up with an FDA inspector in this new era.

To show they are in compliance with the preventive controls rules, companies will need to think hard about the rationale supporting their HACCP plans, especially their hazard analysis. Have you thoroughly considered possible hazards? Are the hazards clearly identified and independently evaluated? Moving forward, companies will have to spend more time deliberating and documenting their analyses than they have in the past in order to remain in compliance with the new regulations. This leads to the next big question: How are significant hazards controlled? Historically there were critical control points (CCPs) and prerequisite programs (PRPs). Now, with the finalization of the preventive controls rules, we have “preventive controls” (PCs) in addition to CCPs and PRPs. The distinction between a PRP and a PC is much fuzzier than the distinction between a CCP and a PRP. Prior to the rule, the default was that if a hazard couldn’t be controlled by a CCP, it was controlled by a PRP. Now that’s not necessarily the case. If the PRP is necessary for the control of a significant hazard, it’s no longer a PRP. It now falls under the definition of a PC. For example, if you’re relying on your supplier to control a hazard, that’s not a PRP, it’s a PC. The same could be true of the need to assure adequate sanitation to remove residual allergens; allergen control and sanitation might have previously been considered PRPs, but may now be considered PCs as part of the new rules. Once a company reconsiders if PRPs should be re-designated as preventive controls under the new rules, these programs and processes that are part of the PCs need to be implemented, monitored, and documented with the same rigor that has always been associated with a CCP. Obviously, the nature of the documentation and monitoring is different between a CCP and other PCs, but the importance of PCs, and the emphasis that a facility places on them, needs to be high. This will represent a major shift for some companies. Even if PRPs, CCPs, and other PCs are in place today and are well implemented, companies may lack the necessary documentation to prove it. At the end of the day, a regulatory inspection will not be limited to what the inspector sees happening on the plant floor that day; it will include an evaluation of how the facility has been operating for the past several weeks or months. Records provide that history, and facilities will need to make sure that they not only exist, but are legible and accessible. In the eyes of FDA, if it isn’t documented, it didn’t occur. As the rules change, resulting in increases in the need for record-keeping, manufacturers will need to convey this to their staff throughout the company, including those on the production lines, at receiving, in sanitation, etc. Every employee will need to understand the critical role they play in the production of safe food and the necessity of following written procedures — and documenting that they have done so. While documentation and record-keeping around historical PRPs is taking on new importance, in the pre-rule days, progressive companies realized that the “HACCP system” encompasses PRPs and care and attention was paid to them. One GFSI-benchmarked scheme goes so far as to call out operational PRPs that are required for the assurance of safety. That said, there may be instances where a regulator observes a process that they might consider a CCP only to find that the facility considers it a PRP. This will most commonly occur when a product is cooked to quality, far surpassing safety. In other words, in order to produce an edible product, the process by definition exceeds the conditions required for safety. An example could be cooked, ready-to-eat pasta. Another FSMA-related issue companies need to be aware of is managing the inspection process. As FDA transitions to a mentality where they are looking at the totality of food safety that results from a comprehensive approach to food safety, we can anticipate there will be times when a company and a regulator do not see eye to eye. This is part of the reason that being able to demonstrate thoughtful consideration of the programs and policies in place is imperative. We anticipate that FDA will release guidance documents to illustrate implementation options to firms. However, since many companies already implement, in one form or another, several of the programs that are now required by regulation, they may have approaches that differ from what is stated in the FDA guidance. We are hopeful that FDA will develop an escalation and appeals process so a company has an opportunity to share its justification of a specific decision or process with subject matter experts at the agency in order to gain recognition and acceptance of valid approaches that may stray from provisions specified in FDA guidance. Members of the food industry can take several steps now to begin preparing for compliance and the changed inspections:

• Review food safety plans and ensure that they include CCPs, preventive controls such as supplier verification and recall plans, and PRPs.
• Ensure sufficient documentation exists for every aspect of the decision-making process that identifies what is a CCP, PC, and PRP.
• Conduct a mock inspection of your facility to gauge preparedness and assess whether staff knows where and how to access relevant information in a timely manner.

FDA has indicated that it will be developing multiple guidance documents to aid the industry in FSMA implementation. In addition, several other groups, such as university Extension offices, consultants, and associations such as the Grocery Manufacturers Association, are launching comprehensive education and training programs as a resource to assist companies in filling the gaps that might be identified.

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