The U.S. Food and Drug Administration 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.
Last year the FDA announced that inspections of large businesses under the IA rule would begin in March 2020 following a compliance date of July 2019 for those businesses. At that time we felt that it was important to provide additional time for industry to benefit from certain guidance, training and other tools that FDA issued last year. 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.
Recognizing the unique situation COVID-19 has created for both industry and regulators, the FDA intends to begin routine inspections of small businesses under the IA rule in March 2021. This approach, consistent with our approach regarding IA inspections of larger businesses, will 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 IA rule they will consist of food defense plan “quick checks” during regularly scheduled food safety inspections. These “quick checks” allow FDA to verify that the facility has satisfied the basic requirements of the rule while also providing us with 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 such as “do you have a food defense plan?” and may provide some educational materials.
For More Information
- Protecting the Food Supply from Intentional Adulteration, Such as Acts of Terrorism
- Constituent Update: FDA Publishes Second Installment of Intentional Adulteration Draft Guidance
- Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
- FSMA Final Rule on Intentional Adulteration
- Food Defense Plan Builder
(Source: FDA website)
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