A recent Directive revision by the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA’s FSIS) now includes egg products, a commodity subject to recall under the Directive, and outlines instructions for large-scale recalls and recalls of ingredients regulated by the U.S. Food and Drug Administration (FDA). The revision—FSIS Directive 8080.1, “Managing Adulterated or Misbranded Meat, Poultry, and Egg Products,” Revision 8—also includes new definitions for Class III recalls, clarifies when FSIS may publish Public Health Alerts (PHAs), and makes clarifying revisions throughout.

The Directive defines a recall as a firm's voluntary action to remove adulterated or misbranded products from commerce. Although it is a firm's decision to recall product, either at the firm's initiative or the Agency's recommendation, FSIS will coordinate with the firm to ensure it has properly identified and removed recalled product from commerce. FSIS also notifies the public about Class I and Class II recalls through press releases.

A recall may be an alternative to the detention or seizure of adulterated or misbranded products in commerce by FSIS. However, a recall does not preclude FSIS from ultimately detaining or seizing adulterated or misbranded products or from taking other appropriate actions, such as issuing PHAs, to mitigate public health risks.

The decision of whether to issue a PHA is made by an Event Assessment Committee. If the committee has evidence that the product in question is adulterated or misbranded, or that the product in question remains in commerce, or available for sale or use, then a PHA should be recommended.

Class III recalls involve a situation where the use of the product will not cause adverse health consequences or the risk is negligible. An example of a Class III recall is the presence of undeclared, generally recognized as safe (GRAS), non-allergenic substances, such as excess water in meat or poultry products, which provide an unfair economic advantage to the producer.

The Directive outlines more information about PHAs and classes of recalls, as well as determining a need for a recall, Event Assessment Committees, recall announcements, special considerations for large-volume recalls, and effectiveness checks.