In 2015, the Food and Drug Administration (FDA) promulgated the Preventive Controls Rule to control known or reasonably foreseeable biological, chemical, radiological and physical hazards in human food. This rule was the centerpiece of a series of rules mandated by the FDA’s Food Safety Modernization Act of 2011 (FSMA).
The driving force for the rules and the law has been reducing pathogenic contamination in food. However, the Preventive Controls Rule defines a hazard to include any chemical, whether a contaminant or an additive, that “has the potential to cause illness or injury.”