The Food and Drug Administration (FDA) recently published its final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (hereinafter, the “IA” rule). This regulation is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Rather than targeting specific foods or hazards, the rule applies to all domestic and foreign facilities that are required to register with FDA, with several broad exemptions. The rule is designed to primarily cover large companies whose products reach many people, and thus the regulation exempts very small businesses and sets a higher dollar threshold for the definition of very small business than under the other FSMA final rules.
The compliance date for companies with 500 or more full-time equivalent employees is July 26, 2019.
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