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.
However, 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.
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Inspections of Small Businesses under the FSMA Intentional Adulteration (IA) Rule
FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (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. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.
Food facilities covered by the rule are required to develop and implement a food defense plan that identifies vulnerabilities and puts in place mitigation strategies to address those vulnerabilities. Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented.
Food defense plans (FDPs) may include sensitive information and it is the facility’s responsibility to ensure files are saved and stored in a secure location.
Food Defense Plan Builder
The Food Defense Plan Builder (FDPB) is a user-friendly tool, standalone desktop application, designed to help owners and operators of food companies in the development of a food defense plan that is specific to their facilities, and guides the user through the following sections:
The holding of food, except the holding of food in liquid storage tanks
The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact
Activities that fall within the definition of “farm”
Manufacturing, processing, packing, or holding of food for animals
Alcoholic beverages under certain conditions
On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the rule. These foods include certain types of eggs, and certain types of game meats.