The FDA has released its third and final supplemental draft guidance to support compliance with the Intentional Adulteration Rule under FSMA.
This rule is aimed at addressing hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread public harm. Unlike the other FSMA rules that address specific foods or hazards, the rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.
This last installment of the IA rule draft guidance adds to the previously published guidance, with chapters covering food defense corrective actions, food defense verification, reanalysis and recordkeeping. It also includes appendices on FDA’s online Mitigation Strategies Database and how businesses can determine their status as a small or very small businesses.
Food facilities covered by the rule are required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies.