FDA releases guidance on FSMA 'enforcement discretion'

by Erica Shaffer
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WASHINGTON – 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).

Scott Gottlieb
Scott Gottlieb, Ph.D., FDA commissioner

“This action will help reduce the burdens on both industry and government and provide the agency the ability to consider the most effective and efficient way forward,” Gottlieb said.

For example, FDA will not enforce a provision of FSMA related to written assurances from a manufacturer’s customers that the food will be processed to control for hazards before the food reaches consumers. The FDA decided to exercise enforcement discretion in this instance based on feedback from industry that certain distribution chains would require “…vastly more written assurances and resources to comply than was anticipated by FDA during the rulemaking process.” FDA intends to consider rulemaking that accounts for the complexity of supply chain networks and the resources required to meet the current requirements of these rules.

FDA added that the agency will protect public health by requiring manufacturers, processors, importers, and farmers to disclose relevant hazards that haven’t been controlled.
Additional information about the FSMA provisions affected by this recent decision can be found on the FDA website.

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