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Have you marked your calendar for September 17, 2016? Would you be ready if FDA were to knock on your door for an inspection on the first day of mandated compliance for FSMA’s Preventive Controls rule? Does even the thought of that cause stress and panic? If so, my key message of this newsletter is: Keep calm, FDA won’t bite. With only two months to go for many food facilities (small facilities have an extra year), it is likely that some of you aren’t quite ready – which is understandable, given the new mandates and the complexity of some aspects of the rule – and the fact that we still have seen no guidance on any of the rules, let alone the PC rule which has been out for nearly a year. However, while a lack of absolute compliance may be understandable, you’d better be prepared to show FDA what you do have, explain exactly what you don’t have, why you don’t have it, and what you are doing to have it ASAP. Some of the key areas of compliance I would see as being a challenge for some food facilities and what you will need to be able to show FDA are: HARPC – Can you speak HARPC? You will need to be able to talk the talk of the Hazard Analysis Risk-Based Preventive Controls (HARPC), demonstrate that you understand what it means and requires, explain where you are in its implementation, and show what you have been doing and will be doing. I also suggest you be able to discuss how your current HACCP plan fits in with HARPC. Preventive Controls Qualified Individual (PCQI)/Food Safety Plan – It may have taken a while to get your PCQI selected and trained to lead the writing and implementation of the Food Safety Plan. But you will need to show that you do have a PCQI in place and you were continuing to move forward; that you know what is required; that you are well on the way to having a complete written plan – even if some sections are still a bit iffy; and that you have a strategy for its completion. The Written Food Safety Plan – With the written Food Safety Plan as the foundation of the PC rule – which is, essentially, the foundation of FSMA, I see it as critical to reiterate this point. It is likely to be the first thing that FDA asks to see. So be ready! How will you respond when the inspector says, “Show me your Food Safety Plan?” Even if the inspector finds some holes that you may not have realized existed, if you show that you understand HARPC, you have put preventive controls in place – with verification, and environmental monitoring (which brings up a whole new set of challenges), FDA is likely to understand, knowing that we are all facing a learning curve – or at least I am hoping they will. Lack of Guidance. This is definitely creating a challenge for food facilities, particularly smaller to medium-sized companies who don’t have the internal expertise or resources or budget for expert consultation. Even if the guidance were to come out tomorrow, there would be little time left to read, review, understand, and implement it, so it is likely to be of little help in the short-term for September compliance. Supply Chain Program. Remember – you have an extra six months on this, so while you definitely need to be working on it, you may want to put your primary focus, for the next two months, on reviewing the rest of the rule and doing everything you can to be in compliance with that which is due. But don’t let your supply-chain work drop. One aspect we have been seeing as proving to be very difficult is determining who in the supply chain is controlling risk – and getting that verification. For example, if you produce a non-ready-to-eat product for further processing where the risk is to be controlled downstream (e.g., you produce raw flour which your customer cooks), you need a written statement (letter of assurance) from that customer that they are controlling the risk. If you have thousands, or even hundreds – or, in some cases, even a few – customers, it can be very difficult and time-consuming to get letters from them all (particularly if any are hesitant about putting the onus on themselves). Even with all the challenges, however, it is critical that you remember that the compliance date is the date by which compliance is required. So I am not suggesting that you sit back and relax, thinking partial compliance is good enough and FDA is unlikely to show up at your facility right away anyway. FDA will be at someone’s door September 17. While I hope the inspectors will exert a lot of enforcement discretion, and realize we are all in a learning curve and are in this together, you need to ensure you know the mandates of the rule and exactly what applies to you; be in compliance as much as viably possible, knowing where your gaps are and what you will do to fill them; and build a strategy for what you will say if FDA selects your facility for inspection in September – or anytime thereafter. But don’t panic; don’t let the stress bog you down. Just … Keep Calm and Carry On. 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.


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