The subject of this final rule is to, consistent with the statute, protect food from intentional adulteration when the intent is to cause wide scale public health harm. The final rule takes a HACCP-type approach to intentional adulteration, similar to the approach used in the preventive controls rule, as the most effective means of ensuring that mitigation strategies are consistently applied to areas of highest vulnerability in food production. The rule requires facilities to write and implement a food defense plan, train certain employees, and includes records requirements.