As part of the US Food Safety Modernization Act (FSMA), the US Food and Drug Administration (FDA) has issued several rules to further clarify the requirements of the regulations. This rule’s intent is to prevent deliberate adulteration of foods intended to cause widespread harm, including acts of terrorism. Although it is not specifically called a “Threat Assessment Critical Control Point (TACCP) rule, this final rule has essentially the same function.
In developing the provisions of this rule, the FDA consulted the intelligence community, as well as the food industry, to identify vulnerabilities.
Who is Covered?
The rule applies to both foreign and domestic companies whose products reach many people. At the time the FDA published the rule, 3,400 companies operating 9,800 foreign and domestic food facilities were identified as falling within the provisions. Exemptions are noted below.