What do quick checks, a plan builder, and the FBI have in common? They are integrated components of defending the U.S. food supply from intentional adulteration.
Protecting food from intentional contamination has been an essential focus of the FDA since 2001, evolving from the facility registration and one-forward/one-back tracking mandates of the Bioterrorism Act to the Food Defense Plan requirements and inspections of FSMA’s Intentional Adulteration Rule. But if an event occurs, FDA does not have to go it alone, rather the FBI gets involved as well.
In fact, the FBI has been involved even longer. When the Federal Anti-Tampering Act of 1983 made it a federal offense to tamper with consumer products, tampering became a crime handled by the FBI with other federal authorities. As noted in a session of the October Food Safety Consortium, the FBI is not a regulatory agency, rather it focuses on law enforcement and prevention through “countermeasures and trip wires.” Because the FBI has different authorities and expertise than FDA, facilities should contact their local law enforcement agency and local FBI field office if intentional adulteration is suspected or discovered. Potential threats require both criminal and epidemiological investigation, and the FBI can follow the criminal investigation across the nation.
The focus on food defense has also increased for the FDA, with the agency beginning to conduct comprehensive food defense inspections in August. Although having only five initial members of the FDA’s food defense inspection team has enabled 10 inspections thus far, this does not mean facilities are off the hook for compliance with the IA Rule. As explained by Capt. Jon Woody, Director, Division of Preparedness & Emergency Programs (DPEP), inspectors will continue conducting food defense quick checks with food safety inspections with “no projected end date” for these.
While these do not involve a full inspection of the facility’s food defense program, the purpose is to verify that the facility has satisfied the basic requirements of the IA Rule, has a written Food Defense Plan, and can answer some general vulnerability assessment questions. The comprehensive inspection, on the other hand, is more of a deep dive into the Food Defense Plan, the vulnerability assessment used, actionable process steps, mitigation strategies, and the related record keep provisions that are required.
One reason the quick checks are paired with food safety inspections is because the agency would not want an inspector to just conduct a quick check in a facility, then have a food safety issue in that same facility a day or week later. Woody also cautioned that while the FDA Food Defense Plan Builder tool will help a facility develop its plan, using the software does not mean a facility is completely compliant. Nor are facilities required to use the software to develop their plan.
Additionally, while the only IA Rule required training is that of food defense awareness for individuals assigned to work at actionable process steps, and their immediate supervisors, each facility must have a food defense qualified individual (QI) to perform the key activities required by the regulation. Specific training is not required, but is highly recommended, and the FDA sees the FSPCA training to be the most complete training. Some providers use other trainings, but Woody said that these don’t always provide fully comprehensive training or even the right information. Additionally, not all food safety consultants are knowledgeable in food defense, so be sure to work with those that are.
With four FSPCA Intentional Adulteration Vulnerability Assessment (IAVA) Lead Instructors on our roster who have taught hundreds of courses, TAG has proven its expertise in food defense and in training. Give us a call to help develop your Food Defense Plan, train your QIs, perform a mock FDA Food Defense inspection, or lead your worker awareness training.
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