With the first of the compliance dates for FSMA’s Intentional Adulteration (IA) Rule only four months away, FDA has released the second of three installments of its draft guidance document for the rule. Interestingly, it is less of a second installment and more of an updated version of the first installment which was issued in June 2018 and discussed in TAG’s Insights article that month. While this makes the guidance easier to use in the long run, it makes it a bit cumbersome to review, as it not only adds new chapters and appendices, it makes updates to the first installment. However, FDA does indicate all new or updated items – which are primarily found in chapters 2 and 8 and appendices 1 and 4 – with brackets: [New March 2019] or [Updated March 2019]. So, if you are already familiar with the first installment, an easy way to quickly sort through and find the changes is to do a search (“Find”/ctrl F) for “March 2019]”, which brings up 14 results: New Sections Chapter 2 F. Evaluating the Three Fundamental Elements G. Identifying Significant Vulnerabilities and Actionable Process Steps Using the Three Fundamental Elements H. Identifying Actionable Process Steps Using the Hybrid Approach: Combining the Key Activity Types and the Three Fundamental Elements Chapter 8: Education, Training, or Experience Appendix 1: Worksheet1-D Appendix 4: Vulnerability Assessment Examples Appendix 4: Vulnerability Assessment Examples Updated Sections III. C. Table of Abbreviations Used in This Guidance (This includes CCTV: Closed-circuit television, HFCS: High fructose corn syrup, LD: Lethal Dose) Appendix 1, Food Defense Plan Worksheets D. Food Defense Plan Vulnerability Assessment (This adds the distinction that vulnerability assessments are conducted “to identify significant vulnerabilities and actionable process steps by using Key Activity Types, by evaluating the three fundamental elements, or a hybrid of both.”) D. 1. (4) Vulnerability Assessment Method: (This explains how to indicate your use of the three fundamental elements or the hybrid approach, which were newly added to the guidance, on the worksheet.) Coming Soon The following chapters and appendices are listed as coming soon in the draft guidance, apparently intended for publication in the third installment. Chapter 5: Mitigation Strategies Management Components: Food Defense Corrective Actions Chapter 6: Mitigation Strategies Management Components: Food Defense Verification Chapter 7: Reanalysis Chapter 9: Records Appendix 2: Mitigation Strategies in the Food Defense Mitigation Strategies Database Appendix 3: Calculating Small Business and Very Small Business Sizes In relation to Appendix 3, while I do understand the amount of work that goes into writing such guidance, so appreciate FDA’s publishing of installments rather than waiting to publish until the entire draft is completed, it does seem that calculating small and very small business sizes should be provided much sooner, since that determines whether or not certain business will need to be in compliance by July 26, 2019. In short, the additions and updates focus on: The components of, and worksheets for, the food defense plan. Conducting vulnerability assessments using the four key activity types method, evaluation of the three fundamental elements, or a hybrid of the two – with examples. Identification and implementation of mitigation strategies. Food defense monitoring requirements. Education, training, and experience. What it means to you Food facilities covered by the rule are required to develop and implement a Food Defense Plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities – then ensure that the mitigation strategies are working. So, if nothing else, the issuance of this second draft guidance installment should spur anyone who has not been working on their Food Defense Plan and its verification to do so, particularly those needing to be in compliance in July. Four months may not seem to be just around the corner, but, as we all know, time can fly much faster than we expect, and that will be particularly true if you realize your mitigation strategies don’t work after all. For those who have developed their Food Defense Plan(FDP) and verified its mitigation strategies, I would use this new guidance to double check your work to ensure you understood the rule’s provisions in the same way that FDA intended. The new elements of the guidance also provide some new tools that may be helpful in further simplifying aspects of your plan and/or enable more comprehensive vulnerability assessments. While there are areas for which FDA has not yet provided guidance – not the least of which is recordkeeping – the elements that have been added in this second installment should provide both those who have already developed a solid FDP and foundation of IA prevention – and those who haven’t – with some good information and support, not just for compliance, but for the protection of your products, consumers, and brand. As with all draft guidance, there is a comment period. In this case, FDA is allowing comment on both the first and second installments during the 120-day period. The agency also plans to hold a public meeting on the draft guidance. If you need help to better understand how to approach compliance with the Intentional Adulteration Rule or develop a Food Defense Program. please don’t hesitate to reach out to TAG and explore our services at www.AchesonGroup.com. 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
