By Charles Breen, Independent Advisor for FSMA
With the recent issuance of a Warning Letter citing violations of Part 117 subpart C (preventive controls), implementation of FDA’s Preventive Controls rule takes its next step – FDA will cite food facilities for preventive control failures. Everyone paying any attention to FSMA knew this would happen, and as long as it happens to someone else, it can be a low pain, high gain learning opportunity.
For example, we now know FDA objects to food facilities that make a ready to eat products, have multiple positive Salmonella results from an environmental sampling program, and yet do not consider Salmonella a hazard in need of one or more controls as part of a food safety plan. Equally, FDA objects to having corrective actions that are not implemented when a problem arises for which the corrective action was planned. And failing to verify that sanitation procedures are properly performed is worthy of citation in a Warning Letter.
No matter how much FDA educates, theoretical agency definitions of unacceptable conditions or practices are no substitute for concrete examples. These first few are obvious, but we can expect more, and more finely detailed, citations in the future.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods and Animal Foods lays out expectations for the prevention of contaminated foods in all areas of processing, packing, holding and transporting. Food facilities must have plans in place that address hazards reasonably likely to occur in the absence of one or more controls.
As noted in the recent Warning Letter, implementation of controls, verification, and monitoring can be lacking. This challenges many companies because writing written procedures is one thing, properly implementing them is another. Practicing accountability from start to completion is often overlooked, leaving many facility managers ill prepared just when and where they need it most. Performing practiced implementation for when things go awry is one critical way of preparing for the inevitable and doing so with measured success.
Firms are busy and time is money. When a production line is down, a product is not being made, customer demand is not met and earnings suffer. In maximizing efficiency, the devil in the details can get lost and we miss steps. Some missed steps may even seem innocuous at the time, after all – we are in a hurry, but they compound each other leading to a failure.
Let’s take the case of the requirement for pathogen swabbing, (shameless plug – EAS is offering a complimentary webinar on swabbing for environmental pathogens September 21). FDA requires that facilities producing foods that have been associated with outbreaks of foodborne illness or pathogen contamination, or produce ready-to-eat foods for that does not include a kill step after packaging, establish environmental sampling programs.
When there is an identified environmental pathogen hazard requiring a preventive control, environmental monitoring is required at regular intervals. At some point, there will be a positive result. If you never find any positives, FDA may suggest your sampling program is not robust enough. As you have read before in this column, no matter how comprehensive your sanitizing procedures, at some point you’ll have a result that requires further assessment, cleaning, evaluation of the previous production, and whether your food safety plan needs revision. When that positive result first comes to light – what next?
This is when copies of Wanting Letters are useful. Comparing what you have to what FDA found inadequate can reassure you, or point to things that need attention.
Another resource that is becoming more useful is FDA’s Technical Assistance Network (TAN). Begun in September 2015, the TAN responds to inquiries related to all FSMA rules. As of May 2018. they have received 9,030 inquiries, indicating at least two things. First, this is an industry that largely wants to do the right thing, and second, it is an industry that needs specific answers to many varied specific questions.
The TAN recently published answers to 172 frequently asked questions (https://www.fda.gov/food/guidanceregulation/fsma/ucm247559.htm). There are insights into FDA thinking to be found among the answers.
Be mindful that a similar question does not mean FDA would give a similar answer. Details matter. Each food facility must tailor its plan to individual facility operations. The expectations behind FSMA and Preventive Controls are laid out in great detail and the Preventive Controls requirements are the hallmark of food safety. Look broadly at first, then focus in. Flow-charts can be helpful with “if-then” scenarios. If a positive result is found, then what? Which zones of the production area should be included in these tests and once the positive result is confirmed, then what? Product recall? Who should the results be reported to? FSMA spells out that these scenarios must be developed and documented so that when disaster strikes a haphazard plan isn’t created in a moment of panic.
Now comes the often overlooked part: Once the plan is made, the real work begins. Practice. It’s easy to spell things out on paper (or digitally) but how practical are the steps? Does everyone understand the process or is there room for interpretation which can lead to confusion and those missteps we spoke of earlier? Much like the requirement for FSMA training which must be in a language that each employee can understand, the same true for PC steps. Make sure all, no matter who is in charge at every step of the process, understands and can perform those activities expected of them.
Lastly, ask for help when needed. Whether it is through the FDA and their TAN, FSMA training videos and fact sheets or through reputable consulting firms such as EAS, your ability to follow PC rules depend on your complete understanding of detailed, documented steps and practicing these steps so that they are seamlessly executed when needed.