Food Safety and Quality Assurance

“At core of the Food Safety Modernization Act is the requirement to control hazards through preventive means. However, who or where in the supply chain those controls are implemented can have substantial implications, especially on distributors, that even FDA hadn’t anticipated. I’m referring to 21 C.F.R. 117.136, a section of FDA’s Hazard Analysis and Preventive Controls rule that provides a manufacturer the ability to rely on their customers, such as distributors, to obtain and maintain certain records regarding preventive controls not implemented by the manufacturer.”