While FSMA sections on the Produce Safety Rule and Hazard Analysis and Risk-Based Preventive Controls for Human Food Rule have garnered the lion’s share of the news in the last few months, the Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration is out for comment until the end of March. Though no large-scale events have occurred, a few small ones have affected small groups of people for various, unrelated reasons.
The intentional adulteration rule actually consists of three major sections. Section 103 allows FDA to issue regulations establishing requirements for facilities that manufacture, process or hold food and requires them to consider hazards that may be intentionally introduced, including acts of terrorism. Section 106 requires FDA to issue regulations to protect food for which there is a high risk of intentional contamination that could cause serious adverse health consequences or death to humans or animals. Section 105 directs FDA to issue science-based, minimum standards for the safe production and harvesting of produce, and requires the final rule to consider hazards that may be intentionally introduced, including by acts of terrorism.