FDA releases guidance on FSMA 'enforcement discretion'

The US Food and Drug Administration (FDA) released guidance detailing four provisions of the Food Safety Modernization Act (FSMA) the agency won’t enforce. In a statement, FDA Commissioner Scott Gottlieb explained that the agency intends to exercise “enforcement discretion” in four FSMA rules while the agency addresses issues that have made implementation of the food safety law problematic for industry stakeholders. The enforcement discretion includes entities or activities covered by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal food rules (PC Human Food and PC Animal Food or CGMP & PC rules), Foreign Supplier Verification Programs rule (FSVP), and the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety rule).