FSMA Intentional Adulteration Rule inspections to begin in March 2021

The US Food and Drug Administration (FDA) has announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will begin in March 2021.

The FSMA IA rule 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. Food facilities covered by the rule are required to develop and implement a food defence plan that identifies vulnerabilities and puts in place mitigation strategies to address those vulnerabilities. The rule was finalised in 2016 and compliance dates are being phased in depending on business size.

Last year the FDA announced that inspections of large businesses under the FSMA IA rule would begin in March 2020 following a compliance date of July 2019 for those businesses. In the time since that announcement, COVID-19 has required the FDA to postpone most routine inspections, including those of large businesses under the IA rule, because travel restrictions, social distancing and other public health measures have made them temporarily impractical to conduct.

The compliance date for small businesses (those with fewer than 500 employees) is 27 July 2020 and FDA intends to begin routine inspections of small businesses under the IA rule in March 2021. This approach aims to help facilitate industry’s continuing efforts to put in place measures that will protect public health while allowing the FDA additional time to conduct outreach to stakeholders.

When routine inspections begin for facilities covered by the FSMA IA rule they will consist of food defence plan “quick checks” during regularly scheduled food safety inspections. These quick checks aim to allow FDA to verify that the facility has satisfied the basic requirements of the rule while also providing an opportunity to “educate while we regulate.”

During the quick check, FDA investigators will ask the owner or operator of the facility a series of questions and may provide some educational materials relating to compliance and prevention.