The U.S. Food and Drug Administration (FDA) has finalized a new food safety rule under the agency’s Food Safety Modernization Act (FSMA). While acts of intentional adulteration comes in many forms--including acts of disgruntled employees or economically motivated adulteration--this rule will help to prevent wide-scale public health harm by requiring U.S. and international companies to take steps to prevent intentional adulteration of the food supply. FDA says that such acts are “unlikely to occur”, but the new rule advances mitigation strategies to further protect the food supply.

This precedent-setting new rule for both domestic and foreign food facilities requires them to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Under the new rule, facilities have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.

For more specific information about the rule, FDA will host a FSMA webinar next month to present key pieces of the final rule.