The U.S. Food and Drug Administration (FDA) has issued its final regulation under the Food Safety and Modernization Act (FSMA) this week. The Mitigation Strategies to Protect Food Against Intentional Adulteration is designed to prevent wide-scale harm to public health from food supply adulteration.

Specifically, the rule focuses on mitigation strategies in registered food facilities, both domestic and foreign facilities. This is the first time that a foreign facilities are required to complete a food defense plan. According to the FDA: “Facilities now 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.”

The rule clearly emphasizes intent to prevent wide-scale adulteration—not small-scale. This means that smaller food operations are exempt from these requirements, at least for the first few years.

Exemptions

1. A business and subsidiaries averaging less than $10 million annually in a three-year period preceding the sale of food, plus the market value of the food handled, stored or processed without sale. These businesses would have to comply with modified requirements within five years of the publication of this rule.
2. The holding of food except the holding of food in liquid storage tanks.
3. Packing, re-packing, labeling or re-labeling of food where the container remains intact.
4. Activities defined as ‘farm.’
5. Manufacturing, processing, packing or holding food for animals.
6. Alcoholic beverages under certain conditions.
7. On-farm manufacturing/processing.

Download this FDA diagram to find out if you are exempt from the final rule on intentional adulteration.

A webinar is planned for June 21, 2016 to present key pieces of the final rule including a vulnerability assessment and mitigation strategies and management components.