By Rolando Gonzalez and Christopher Snabes With the first of the compliance dates for the FSMA final rule on intentional adulteration (IA Rule) less than three months away, FDA has issued two of the three installments of its draft guidance and held a public meeting in April covering these, along with
discussion of and a Q&A on topics such as industry readiness and inspection plans. The IA Rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. The rule requires the food industry to implement risk-reducing strategies for processes (rather than specific foods or hazards) in food facilities that are significantly vulnerable to intentional adulteration. It applies to both domestic facilities and foreign facilities that import into the U.S., as well as to FDA-regulated food and beverage facilities not currently covered by the Human PC Rule, such as dietary supplements and foods covered by Seafood HACCP, Low-Acid Canned Food HACCP, Juice HACCP, etc. Food facilities covered by the rule will be required to develop and implement a Food Defense Plan (FDP) that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date arrives on July 26, 2019. At the public meeting, FDA addressed the first and second installments of the draft guidance, which include chapters on topics such as: Components of the FDP. Conducting vulnerability assessments (VA) using the four Key Activity Types (KAT) method, evaluation of the Three Fundamental Elements, or a hybrid of the two. Identifying and implementing mitigation strategies. Food defense monitoring requirements. Education, training, and experience. FDA stated that the third and last installment of the draft guidance is in the works and will address food defense corrective actions, food defense verification, reanalysis, records, appendices. Additionally, just as the Preventive Controls (PC) Rule requires a preventive controls qualified individual (PCQI), so, too, does the IA rule require a food defense qualified individual (FDQI). An FDQI is to perform the IA Rule activities that require the most food defense expertise, including: Preparation of the FDP. Conducting the VAs. Identification and explanation of mitigation strategies. Performance of the reanalysis. To become an FDQI, an individual must complete training for their specific function that is at least equivalent to that received under a standardized curriculum recognized by FDA (or be qualified through job experience or a combination of education, training and experience). Online training is available for conducting VAs using the KAT method, identifying and explaining mitigation strategies, and preparing and reanalyzing the FDP, but training for conducting VAs using the Three Fundamental Elements approach will be available only as a one-day course taught by lead instructors trained by the Food Safety Preventive Controls Alliance (FSPCA). Having heard from stakeholders that there is a need for additional time to develop a fully compliant food defense plan – given that food defense is an area that the industry is still becoming familiar with – FDA stated that it is “working hard to provide resources, including the final portion of draft guidance, which may be helpful to industry. To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020.” Compliance dates have not changed. The updated version (2.0) of FDA’s Food Defense Plan Builder also was introduced and briefly demonstrated during the meeting. It is aligned with the requirements of the IA rule and will be released soon, according to the agency. Additional information about the upcoming compliance date, the recently released draft guidance, and other topics related to the IA rule were provided by FDA food defense experts Ryan Newkirk and Jon Woody and are available at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm587803.htm Through a collaboration with the Food Protection and Defense Institute (FPDI), TAG has published an Intentional Adulteration and Food Defense Industry Preparedness Report. Keep an eye out for our coverage of the report in an upcoming newsletter! 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
