The FDA has issued its second installment of how companies should take measures and mitigation strategies to protect themselves against intentional adulteration (IA rule), which is a requirement of the recent Food Safety Modernization Act (FSMA). The draft document is out for consultation, which closes on 5 July 2019. The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the USA. There are some exceptions including farms, except farms producing milk. Companies are required to develop/implement a food defence plan identifying vulnerabilities, and how to deal with them, and ensure they are working. The FSMA covers attacks intended to cause wide scale public health harm to humans including acts of terrorism focused on the food supply, and these are ranked as the highest risk. There is also intentional adulteration for economic gain with or without any safety implications; acts of disgruntled employees, consumers, or competitors. The IA rule is focused on addressing only acts causing wide scale public health harm, and not acts of disgruntled employees, consumers, or competitors, or acts of economic gain without public health implications.
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