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FDA to verify Intentional Adulteration rule compliance in 2021

Now is the time to help food facility clients prepare for the FDA's impending food defense plan 'quick checks.'

By David Fiske and Lori Hunter | September 25, 2020 at 05:30 AM
The FSMA’s Intentional Adulteration (IA) rule was created to address intentional acts whose objective is to cause widespread harm to public health. (Courtesy photo) The FSMA’s Intentional Adulteration (IA) rule was created to address intentional acts whose objective is to cause widespread harm to public health. (Courtesy photo)

In 2019, the U.S. Food and Drug Administration (FDA) announced that inspections of large businesses under the Intentional Adulteration (IA) rule would begin in March 2020 following a compliance date of July 2019. However, the COVID-19 pandemic required the FDA to postpone most routine inspections. As a result, the FDA announced they would halt all routine on-site surveillance inspections in the U.S. until March 2021. This was in an effort to verify a facility’s compliance with the FDA Food Safety Modernization Act’s IA rule.

According to the FDA, routine inspections for facilities covered by the IA rule will consist of a food defense plan “quick checks” during regularly scheduled food safety inspections. These quick checks will consist of 10-minute conversations that will allow the FDA to verify the facility has satisfied the basic requirements of the IA rule. This will also provide an opportunity to educate facilities. During the quick check, the FDA inspector will begin by asking the facility owner or operator a series of questions that may include whether the facility has a food defense plan in place. The inspector may also ask questions based on the IA compliance rule.

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