Intentional Adulteration Compliance Deadline for Small Businesses Passed: FDA will Begin Inspections March 2021

July 27, 2020 marked the compliance deadline for small food businesses to comply with the U.S. Food and Drug Administration’s (FDA) Intentional Adulteration Rule. Under the Intentional Adulteration rule, registered food facilities that averaged more than $10 million in sales in the previous three years must prepare and implement a food defense plan. Small businesses are defined by this rule as employing fewer than 500 full-time equivalent employees.

According to a recent announcement, FDA will begin conducting routine inspections of small businesses for compliance with this rule in March 2021. FDA began inspecting large food businesses for compliance with the rule in March 2020.

What does this mean for small food businesses?

FDA states the Intentional Adulteration Rule of the Food Safety Modernization Act (FSMA) “is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide scale public health harm.”

The Rule requires covered food facilities to develop and implement a Food Defense Plan. This Food Defense Plan must include a vulnerability assessment of areas within a facility and processing steps where food could be intentionally contaminated as well as mitigation strategies for identified vulnerabilities. For example, a room containing liquid storage tanks may be vulnerable to intentional adulteration. Mitigation strategies for this vulnerability may include locking the storage tanks, restricting access to the room, and monitoring security cameras.

Facilities are also required to have written procedures in place for food defense monitoring and verification that mitigation strategies are properly implemented. FDA requires businesses to maintain records of their Food Defense Plan for at least two years.

FDA states that inspections will consist of quick checks of facilities’ Food Defense plans to verify that they are satisfying basic requirements of the Intentional Adulteration Rule, while also looking into the facilities’ compliance with other areas of FSMA.

Get help with a Food Defense Plan

Registrar Corp’s trained food safety professionals can create a Food Defense plan for your facility or review your existing plan and documentation for compliance to assure you are prepared in the case of an FDA inspection. Registrar Corp also offers 100% online employee training on the Food Defense Rule.

For assistance, email info@registrarcorp.com or call +1-7573046744. You can also chat online with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat