Section 103 of the Food Safety Modernization Act (FSMA) requires certain regulated food facilities to assume a more proactive role in preventing food-borne illness. This provision requires regulated facilities to conduct an extensive hazard analysis of their operations, implement and monitor preventive controls that will reduce identified risks, maintain records of the effectiveness of these controls, and adjust the controls as necessary to protect the food supply. The facilities are also required to create a written plan that documents and describes how they will address these requirements. However, there are several types of facilities that are exempt from these requirements or subject to modified safety measures.
While Section 103 applies to both human and animal food, this primer provides information on the impact of Section 103 on facilities that produce human food.