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TAG June 13, 2019 0 Comments

FSMA’s Intentional Adulteration (IA) Rule takes effect for the largest food and beverage facilities in just over a month. Are you in compliance? Have you read and applied the “voluntary” recommendations of the draft guidance documents (the two installments of the intended three that have been published, that is)? Are your employees trained? And, most importantly, do you have a written Food Defense Plan? Large facility compliance is due July 26, 2019. It is important to realize that businesses subject to the IA Rule include domestic and overseas food and beverage manufacturers not previously impacted by FSMA, such as dietary supplements, bottled water, low-acid canned food, and those subject to seafood and juice HACCP. But like the requirements of the Preventive Controls (PC) rule for a written Food Safety Plan, the IA Rule requires a written Food Defense Plan (FDP), which is the foundation of compliance. Although FDA declined industry requests to push back the IA Rule compliance date to allow more time for implementation, the agency did state that it would hold off on FDA IA inspections until March 2020. At that time, inspectors would focus on “educate while we regulate” – conducting an FDP “quick check” during scheduled food safety inspections. That quick check would essentially be asking the question: “Do you have a Food Defense Plan?” then providing education materials if deemed needed. This is not to say, however, that facilities should consider that time to be an extension of the rule. Rather, companies that have not yet written their FDP are very much behind the eight ball and need to quickly get on the ball instead. FDA is expecting you to have one in place by the original deadline even though the requirement is not being enforced until March 2020. Those that do have written plans – take this time to review your FDP against the latest guidance documents for relevance to ensure they fully meet the intent of the rule. TAG/FPDI Research. We see this review as being very significant, due to the results of a survey conducted by TAG in partnership with the Food Protection and Defense Institute (FPDI). As detailed in the 2018 Intentional Adulteration and Food Defense Industry Preparedness Report, 91% of the food facility respondents said they had a Food Defense Plan, but 81% of them had had their plan prior to implementation of the IA Rule. Only half had either updated their plan or created a new plan after implementation of the rule, and even fewer (48%) had tested their plan. Thus, it is likely that many of these are not fully meeting the provisions of the rule. In fact, only 78% of those covered by the rule were aware of draft guidance after the publication of the first installment. Further, only 62% of those aware of it had reviewed or commented on it. It is important that the industry review guidance documents as they offer valuable insights for the application of the rule. Additionally, draft publications provide the opportunity for industry to comment on, and possibly shape, FDA thinking before it is finalized. With the third, and last, installment of the guidance due by late summer or early fall, along with version 2.0 of the Food Defense Plan Builder and the last installment of FSPCA training by FSPCA on Food Defense Plan Writing and Reanalysis, we would highly recommend that all stakeholders keep an eye out for these and review them as soon as feasible. Another key aspect of the rule is that of training. While the TAG/FPDI report showed that a majority of food facilities had implemented employee training, most (78%) were internal awareness training, with only about half using online resources (54%) or having an employee(s) attend FDP training (52%). Thus, there is a distinct opportunity for companies to improve their food defense strategy through expert training and consultation. For the full TAG/FPDI Report, visit While we generally avoid “marketing” TAG in these newsletters, there are times that we see discussion of TAG expertise as being highly beneficial to our readers. This is one of those times, as we are very proud to announce that Christopher Snabes, TAG Senior Manager of Food Safety, has completed specialized training to become a lead instructor to teach the “Intentional Adulteration Vulnerability Assessment Utilizing the Three Elements” approach, which allows companies to fulfill the IA Rule requirement for a Food Defense Qualified Individual (FDQI). Currently, Christopher is one of only 32 people in the world trained by the FDA and FSPCA to teach that course, which is only available in person. With this additional credential and service offering, TAG continues to bring to its clients exceptional insight, value, and practical solutions in food defense specifically, and FSMA as a whole. So, no matter where you are in your IA Rule compliance, TAG can assist in the development or review of your Food Defense Plan, and/or specific facets of the plan, such as the process flow map, key activity types determination, actionable process steps, and full vulnerability assessment. Contact TAG today! 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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