FDA to begin intentional adulteration inspections in March 2020

By Dave Fairfield, Senior Vice President of Feed Services

The U.S. Food and Drug Administration (FDA) announced during an April 17 public meeting that routine inspections to verify compliance with its Food Safety Modernization Act (FSMA)-related final rule for Mitigation Strategies to Protect Food Against Intentional Adulteration will begin in March 2020.

The final rule on intentional adulteration is designed to address hazards that may be introduced intentionally into human foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. The rule requires covered human food facilities to implement risk-reducing strategies for processes that are significantly vulnerable to intentional adulteration. Affected facilities are required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities.

Importantly, the final rule exempts from the intentional adulteration requirements facilities that solely manufacture, process, pack or hold animal feed and pet food. In addition, the final rule exempts facilities, such as grain elevators, that solely store food (e.g., grain) that may be destined for human consumption, except the holding of food in liquid storage tanks. However, the rule also expressly exempts from requirements the storage of mineral oil in liquid storage tanks and its application to raw, whole grains or oilseeds. Significantly, the rule does stipulate that facilities that store and apply mineral oil on other food products, such as baked goods, condiments, spices or confectionary products, evaluate mineral oil storage and use when conducting vulnerability assessments required under the regulations.

As established by the final rule, the first compliance date is July 26, 2019 for human food facilities defined as “large” businesses – those with 500 or more full-time equivalent employees and with $10,000,000 or more in average annual human food sales plus the market value of human food not sold. However, FDA stated in the public meeting that because of the novel nature of the rule and its requirements, the agency believes more time is needed by industry to develop fully compliant food defense plans. In addition, FDA still is working to issue the last portion of draft guidance on the rule, which may be helpful to industry for compliance purposes. To allow industry time with the forthcoming materials, tools and trainings, and because the intentional adulteration rule represents a new type of regulation, FDA said it will delay the start of routine intentional adulteration rule inspections until March 2020.