CHAPTER 1 - GENERAL

I. PURPOSE

This directive provides the terminology, responsibilities, and public notification procedures regarding the assessment of adulterated and misbranded meat, poultry, and egg products that may have entered commerce, and the voluntary recall of such products. FSIS is revising this directive in its entirety to include egg products as an FSIS-regulated commodity subject to voluntary recall and to provide instruction regarding large volume recalls and recalls of ingredients regulated by the Food and Drug Administration (FDA). It also includes new definitions for Class III recalls; clarifies when FSIS may publish Public Health Alerts (PHAs); and makes clarifying revisions throughout.

II. CANCELLATION

FSIS Directive 8080.1, Revision 7, Recall of Meat and Poultry Products dated 9/9/13

III. BACKGROUND

    A. A recall is 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.

    B. 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. Additionally, FSIS may investigate and take additional actions if it appears that a firm's recall strategy or execution of that strategy is ineffective. Based on its findings, FSIS may seek enforcement action against the recalling firm or its consignees.

    C. For recalls conducted by State-inspected firms or retailers, the appropriate State or local agency leads, manages, and verifies the recall, in most cases. If requested to do so, FSIS will provide the State agencies with appropriate assistance and information.

NOTE: Recall procedures for meat and poultry products produced in an establishment operating under the Cooperative Interstate Shipment program are addressed in FSIS Directive 5740.1,Cooperative Interstate Shipment Program.

    D. When FSIS finds that imported product should be recalled, the Agency will recommend that the importer recall the product. The importer would be responsible for recovering and properly disposing of the affected product. The importer may include: the consignee, the importer of record, the actual owner of the merchandise, or the transferee of the merchandise.

IV. TERMINOLOGY

    A. Recall: A firm's voluntary removal of distributed meat, poultry, or egg products from commerce when there is reason to believe that such products are adulterated or misbranded under the provisions of the Federal Meat Inspection Act (FMIA, 21 U.S.C. 601 et seq.), Poultry Products Inspection Act (PPIA, 21 U.S.C. 451 et seq.), or Egg Products Inspection Act (EPIA, 21 U.S.C. 1031 et seq.) and that such product remains available in commerce, free to move to consignees or consumers. A recall is not a market withdrawal or a stock recovery.

    B. Market Withdrawal: A firm's removal or correction, on its own initiative, of product that is in commerce, for any reason that would not ordinarily lead the Agency to pursue detention and seizure. This includes deviations from a company quality program or minor regulatory infractions. For example, a firm may conduct a market withdrawal of product that does not meet its quality standards because of discoloration. An example of a minor regulatory infraction could be when the product fails to bear an official inspection mark but otherwise includes the establishment number and information allowing traceability to the producing establishment. A company can remove product from commerce or have product returned from a customer at any time for any reason. This does not necessarily make that action a recall.
Stock Recovery: A firm's removal or correction of product that has not been marketed or that has not left the direct control of the firm. For example, product is located on the premises owned by the producing firm or under its control.

    C. Stock Recovery: A firm's removal or correction of product that has not left the direct control of the firm. For example, product is located on the premises owned by the producing firm or stored offsite under its control at a consignee or third-party warehouse.

    D. Hazard Classifications: FSIS assesses the public health concern or hazard presented by a product being recalled, or considered for recall, whether firm-initiated or requested by FSIS, and classifies the concern as one of the following:

        1. Class I: This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death. Examples of a Class I recall include recalls of ready-to-eat (RTE) meat, poultry, or egg products that contain pathogens or recalls of raw, ground beef that contains Shiga toxin-producing E. coli (STEC) or product that contains an allergen likely to elicit an adverse human health reaction, such as milk or soybeans, that is not declared on the product label.

        2. Class II: This is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product. An example of a Class II recall is a recall of product that contains a highly refined/denatured allergen not likely to elicit an adverse human health reaction, such as hydrolyzed soy protein, that is not declared on the product label.

        3. Class III: This is 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, non-allergenic substances, such as excess water in meat or poultry products, which provide an unfair economic advantage to the producer.

    E. Scope: This defines the amount and type of product in question. Several factors are used in determining the scope of product that is potentially adulterated or misbranded (product scope), as well as the scope of product meeting that determination and available in commerce (recall scope). Scope consideration includes multiple factors, such as processing and sanitation procedures, the definition of a lot or specific grouping of products, related records or lack thereof, and whether there is any affected finished product reincorporated into an earlier step of the process (rework). The findings of epidemiological investigations that link certain lots of product with known cases of foodborne illnesses may also affect the scope of product considered adulterated and product included in a recall.

    F. Disposition: This is the firm's action with respect to adulterated or misbranded product to correct the applicable concern, such as relabeling, cooking, reworking, or destroying product.

    G. Event Assessment Committee: A committee comprised of representatives from various FSIS program areas assembled to determine the best response to potential health hazard incidents escalated for analysis to the Recall Management and Technical Analysis Division (RMTAD).

    H. Health Hazard Evaluation Board (HHEB): The HHEB addresses situations involving potential human health hazards (physical, biological, or chemical) when the Agency is uncertain about the nature or severity of the human health risk and needs additional information to inform its response. The HHEB reviews available scientific information to assess the public health risk associated with potential hazards and draws conclusions to inform Agency decisions. The HHEB does not decide what action the Agency should take in response to a potential hazard. If an Event Assessment Committee is unable to determine the public health risk associated with a novel event, it may convene the HHEB to assess the matter. (See FSIS Directive 8091.1, Procedures for the FSIS Health Hazard Evaluation Board.)