The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.
Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.
The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.
In developing the rule, FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.
While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration is addressed in the final preventive controls rules for human and animal foods.