FSIS Directive 8080.1 Recall of Meat and Poultry Products - Chapter 1 General

CHAPTER 1 - GENERAL

I. PURPOSE

This directive provides the terminology, responsibilities, and public notification procedures regarding the voluntary recall of FSIS inspected meat and poultry products.

II. CANCELLATION

FSIS Directive 8080.1, Revision 6, Recall of Meat and Poultry Products dated 10/26/10

III. REASON FOR REISSUANCE

This directive is being reissued in its entirety to provide guidance regarding recall plans and to incorporate new regulations that address the following:

    1. Official establishments are required to notify their local FSIS District Office (DO) personnel within 24 hours when they learn or determine that adulterated or misbranded product has entered commerce.

    2. If an official establishment notifies FSIS personnel other than the DO that adulterated or misbranded product has entered commerce, those personnel are to contact the DO promptly, through supervisory channels. They are also to notify the establishment that it is still required to contact the DO directly.

IV. BACKGROUND

    A. A recall is a firm's action to remove product from commerce to protect the public from consuming adulterated or misbranded products. Although it is a firm's decision to recall product, FSIS coordinates with the firm to ensure it has properly identified and removed recalled product from commerce by verifying the effectiveness of the firm's recall activities. FSIS also notifies the public about product recalls.

    B. A recall may be an alternative to FSIS detention or seizure of adulterated or misbranded products. However, a recall does not preclude FSIS from taking other appropriate actions, such as issuing Public Health Alerts or performing product detentions and seizures, to mitigate the risk to the public when firms have inadequately removed recalled product from commerce. The Agency will investigate 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 retail establishments, the appropriate State agency 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 request that the importer of record recall the product. The importer of record would be responsible for recovering the product involved and properly disposing of the affected product.

V. TERMINOLOGY

Recall: A firm's removal of distributed meat or poultry products from commerce when there is reason to believe that such products are adulterated or misbranded under the provisions of the FMIA or the PPIA. "Recall" does not include a market withdrawal or a stock recovery.

Market Withdrawal: A firm's removal or correction, on its own initiative, of a distributed product that involves a minor company quality program or regulatory program infraction that would not result in the product being adulterated or misbranded. For example, product does not meet company quality standards because of discoloration.

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.

Recall 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 the presence of pathogens in ready-to-eat meat or poultry products, or the presence of E. coli O157:H7 or non-O157 Shiga toxin-producing E. coli (STECs) in raw ground beef.

    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 because of the presence in a product of very small amounts of undeclared allergens typically associated with milder human reactions, e.g., wheat.

    3. Class III: This is a situation where the use of the product will not cause adverse health consequences. 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.

Depth of Recall: The level of product distribution to which the recall is to extend:

    1. Wholesale level: The product has been distributed to a warehouse or distribution center where it is not under the direct control of the producing company. This is the distribution level between the manufacturer and the retailer. This level may not be encountered in every recall situation (i.e., the recalling firm may sell directly to the retail or consumer level.)

    2. Retail level: The product has been received by retailers for sale to household consumers.

    3. HRI level: The product has been received by hotels, restaurants, and other institutional customers.

    4. Consumer level: The product has been sold directly to household consumers.

Scope: This defines the amount and type of product in question. Several factors are used in determining the scope of a recall, such as the plant's processing and sanitation procedures, the definition of a lot, or specific grouping, and whether there is any finished product reincorporated into fresh product (rework). The findings of epidemiological investigations that link certain lots of product with known cases of foodborne illnesses may also affect the scope of a recall.

Disposition: This is the firm's action with respect to the recalled product to correct the situation leading to the recall, such as relabeling, cooking, reworking, or destroying product.

Health Hazard Evaluation Board (HHEB): The HHEB is the primary group in FSIS that reviews the public health significance of any human health hazard about which a regulatory decision needs to be made. If the risk to the public health presented by a given product appears to be unique or in some way unusual, the Recall Committee may consult the Office of Public Health Science's (OPHS) HHEB. (See FSIS Directive 8091.1, Procedures for the FSIS Health Hazard Evaluation Board.)

Recall Committee: A committee of representatives from various FSIS offices and staffs assembled to respond to potential or real health hazard incidents reported to the Recall Management and Technical Analysis Staff (RMTAS).
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