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FSMA Intentional Adulteration Rule inspections to begin in March 2021


Once inspections for small businesses begin in March 2021, the FDA will perform “quick checks” during regularly scheduled food safety inspections to identify potential breaches of the Intentional Adulteration rule.

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.

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