The U.S. Food and Drug Administration (“FDA”) recently released Chapter 14 of its Draft Guidance for Industry, “Hazard Analysis and Risk-Based Preventive Controls for Human Food” (“Draft Guidance”). Entitled “Recall Plans,” the chapter explains how food facilities subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (“PCHF Rule”) can establish and implement a written recall plan. This memorandum provides a brief overview of the Draft Guidance. Comments on the Draft Guidance should be submitted by February 4, 2020.
Facilities covered by the PCHF Rule are required to have a written recall plan if they have any foods with a “hazard requiring a preventive control,” as determined based on their hazard analysis. The regulations require the recall plan to include procedures that describe the steps to be taken, and assign responsibility for taking those steps, for the following actions, as appropriate to the facility:
- Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;
- Notify the public about any hazard presented by the food when appropriate to protect public health;
- Conduct effectiveness checks to verify that the recall is carried out; and
- Appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.