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Tuesday, January 23, 2018

FDA Discretionary Enforcement under FSMA


 The FDA announced in  early January that the agency would be using its discretion not to enforce certain of the rules promulgated under the Food Safety Modernization Act the as they apply to specific entities or activities.  The enforcement discretion applies to provisions in the : Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule Foreign Supplier Verification Programs Rule, and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.  The discretion relates to facilities impacted by the confusion under the definition of "Farms;" written assurance provisions in the  rules concerning  the control of identified hazards or microorganisms that could be a risk to public health. Their discretion will also be applied to animal food preventive controls  for certain manufacturing/processing activities performed on human food by-products that are to be used as animal food; and initially as to the verification requirements for importers of food contact substances.

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