CHAPTER IV - ANNOUNCING THE RECALL

I. ACTION BY FIRM

    A. FSIS outlines in the guidance document "Product Recall Guidelines for Firms" the actions a firm can take to ensure that it recovers the maximum amount of product in the shortest amount of time. This guidance includes information on complying with recordkeeping requirements and a model letter that a firm may use to communicate with its consignees.

    B. If the firm decides not to accept the Agency's recommendation and chooses not to conduct a recall, FSIS personnel are to follow the instructions in FSIS Directive 8410.1, Detention and Seizure, to detain any product found in commerce that would have been subject to a recall and petition the Department of Justice to seize these products on behalf of FSIS. CPAS is to issue a Press Release informing the public that adulterated or misbranded product has been shipped by the responsible firm, that the firm has declined to recall the product, and that the Agency is detaining product in commerce. If a firm is already adequately recovering adulterated or misbranded product from commerce (e.g., firm proactively notified customers to return, destroy product, etc.) but declines to accept the Agency identifying their action as a recall, FSIS may still issue a recall release as described below on the basis that the voluntary actions already initiated by the firm constitute , by definition in this Directive, a recall.

II. RECALL RELEASE

    A. Following approval of the recall by the OFO AA or designee, RMTAD notifies CPAS to issue a Recall Release and upload a copy of the Recall Release to the ARA case. CPAS is to distribute the Recall Release for Class I and Class II recalls to media wire services, media outlets in areas that received recalled products, the FSIS email subscription service for recalls, and FSIS-affiliated social media outlets. FSIS will not distribute a
Class III Recall Release to the media. CPAS will also post all Recall Releases on the FSIS website.

    B. The Recall Release will:

        1. Identify the firm that produced the product;

        2. Clearly describe the product involved, along with any identifying marks or codes;

        3. Explain the reason for the recall, including the reason the product is adulterated or misbranded and how the problem was discovered, and describe the risks involved in consuming the product;

        4. When possible, and without slowing the public notification of the recall, FSIS will post an electronic picture of the product label that clearly describes the product to the public;

        5. Instruct the public on how to properly handle the product if consumers have it in their possession, including specific recommendations for affected consumers when the product contains an allergen;

        6. Provide the name and telephone number of a company contact for consumers and media to call with any questions; and

        7. Provide general information about the product's known destination. For example, "Ham and turkey products were distributed to retail stores and institutions in the States of...."

    C. For Class I recalls related to human illness, an Incident Report (IR) will be posted on the FSIS FIMS by OPACE if one has not already been created. The Recall Release will be attached to the IR. Program areas are to update the IR, as appropriate, until the recall is complete. RMTAD will enter the IR case link in the ARA case.

    D. CPAS is to email a draft copy of the Recall Release to the recalling firm prior to its release. At this time, CPAS is to inform the firm that it may review the Recall Release to verify that the product description, the company contact information, and available product distribution information are accurate. CPAS is to inform the firm that if it does not respond to CPAS within 30 minutes of receiving the Recall Release, FSIS will proceed to issue the Recall Release. If the firm notifies CPAS of any typographical or other inadvertent errors, CPAS is to correct them before issuing the Recall Release.

III. PUBLIC NOTIFICATION OF RECALLED STATE-INSPECTED OR FOREIGN PRODUCT

    A. When adulterated or misbranded product produced by an establishment under a State's Meat and Poultry Inspection (MPI) program enters intrastate commerce, FSIS will expect the State's MPI program to take the lead on mitigating these issues and notifying the public, when necessary, as part of its agreement with FSIS to administer an MPI program at least equal to that of FSIS.

    B. When FSIS is informed by a foreign government's food inspection agency or a company under its jurisdiction that the foreign government or the company is recalling product that may be available to U.S. consumers, FSIS is to issue a PHA or Press Release that provides information similar to FSIS Recall Releases. For example, FSIS may issue a PHA or Press Release that contains information about a Canadian recall if that product was exported to the United States. FSIS may also conduct ad hoc effectiveness checks whenever a foreign government or a company under the jurisdiction of the foreign government recalls product available in the United States, unless, on review, the Agency determines that effectiveness checks are not necessary in a specific situation. FSIS may issue a PHA or Press Release to notify the public and identify any downstream products included in the scope of the recall (e.g., product further processed and repackaged without sufficient mitigation of public health hazards).

    C. When FSIS becomes aware that meat, poultry, or egg products are implicated in a recall of source material or ingredients used in such products, FSIS will verify that firms that have received these ingredients are following the instructions received from their suppliers. FSIS may conduct ad hoc effectiveness checks if deemed necessary and may issue a PHA or Press Release to notify the public and identify such products that are not referenced by the source material or ingredient recall release.

IV. PUBLIC HEALTH ALERTS

    A. FSIS may issue a PHA instead of or in addition to recommending a recall. PHAs inform the public of specific public health risks posed by products in commerce or in the possession of end consumers when there is no product recall (See Chapter III.II.F) or when available product has already been recovered from commerce and controlled prior to FSIS notification or engagement but may still pose a risk to consumers at their homes. FSIS also issues PHAs when firms decline to initiate a recall upon FSIS recommendation.

        1. There may be situations in which the Event Assessment Committee determines that one or more products that have entered commerce may pose a public health risk, but the Committee cannot recommend a recall (See Chapter III.II.F).

        2. The committee is to consider whether the known information that could be communicated in a PHA would be meaningful to the public and end consumers (e.g., how would consumers identify the potentially adulterated products in their possession) and if this information adds to any public messaging previously made by other partners (e.g., does the known information only repeat what has already been communicated).

        3. If OPHS personnel have reason to believe that a meat, poultry, or egg product may be associated with human illnesses, but there is not sufficient information available for RMTAD to convene an Event Assessment Committee (e.g. during the initial phases of an outbreak investigation where the Agency is still working to identify a specific product or specific lot or lots of product that FSIS could recommend be recalled or otherwise identified to the public), OPHS personnel are to report the incident through supervisory channels. FSIS typically becomes aware of these situations from the findings of a foodborne illness investigation conducted by, or reported to, OPHS's Applied Epidemiology Staff (AES). If appropriate, the OPHS AA or designee is to notify SIPRS and request activation of the Emergency Management Committee (EMC), as provided in FSIS Directive 5500.2, Significant Incidence Response. If the situation is considered by the EMC, the EMC is to decide whether FSIS should issue a PHA. OPHS is to communicate the EMC recommendation for a PHA to RMTAD, which will document this event in APM.

    B. When the Event Assessment Committee recommends a PHA, RMTAD is to submit a PHA recommendation in the form of a memo for approval by the OFO AA or designee. The recommendation is to contain:

        1. The reason for the PHA, including why there is a reason to believe that the product is adulterated or misbranded and why a PHA is appropriate;

        2. An explanation of how, when, and by whom the problem was discovered; and

        3. The estimated amount of adulterated or misbranded product in distribution, when available.

    C. If the OFO AA or designee approves the PHA recommendation and the firm responsible for the adulterated or misbranded product is known, RMTAD is to contact the firm and inform them of the Agency's decision to issue a PHA. CPAS is to confirm the information necessary for the PHA. The OPACE AA may request that other AAs review the draft PHA before it is issued.

    D. If the OFO AA or designee does not approve the PHA recommendation, the OFO AA is to convene the AAs to discuss and resolve whether to issue a PHA. Each AA is to discuss the potential PHA with their Office's Event Assessment Committee representative.

    E. If FSIS issues a PHA, the alert will, to the extent possible:

        1. Identify the firm that produced the product;

        2. Clearly describe the product involved, along with any identifying marks or codes;

        3. Explain the reason the product is adulterated or misbranded and describe the risks involved in consuming the product;

        4. Provide an electronic picture of the product label, if one is available, that clearly describes the product to the public;

        5. Instruct consumers on how to properly handle the product if they have it in their possession, including specific recommendations for affected consumers when the product contains an allergen; and

        6. If available, provide the name and telephone number of a company contact for consumers and media to call with any questions.

    F. When the firm responsible for the adulterated or misbranded product is known, CPAS is to email a draft copy of the PHA to the firm prior to its release. At this time, CPAS is to inform the firm that it may review the PHA to verify that the product description, the company contact information, and product distribution information are accurate. CPAS is to inform the firm that if it does not respond to CPAS within 30 minutes of receiving the PHA, FSIS will proceed to issue the PHA. If the firm notifies CPAS of any typographical or other inadvertent errors, CPAS is to correct them before issuing the PHA.

    G. FSIS notifies the public about PHAs through press releases.

V. RETAIL CONSIGNEE LISTS

    A. For every Class I recall, the RO, or designee, develops a list of retail consignees that may have, or may have had, the recalled products in their possession. The RO gathers the retail consignee information by first contacting the recalling firm's directly affected consignees. Then, all subsequent consignees to whom the recalling firm's direct consignees distributed the recalled product are contacted. The RO asks all consignees if they have the recalled products in their possession. The RO also collects retail consignee information while conducting effectiveness checks. If the recalled product is not distributed to the retail level, the RO does not develop a list of retail consignees.

    B. The RO, or designee, is to use the PHIS-reporting feature to generate the retail consignee list, including the name, street address, city, and state of each retail consignee in a spreadsheet matching the standard Agency format as soon as the initial list of retail locations can be prepared. The RO, or designee, is to submit the list to RMTAD. RMTAD is then to review and send the list of retail consignees to the OPACE Digital and Executive Communications Staff (DECS) for posting on the FSIS website. FSIS will aim to post an initial list within approximately 10 days of the date of the recall. Developing the retail consignees list may take longer than this if the recalling firm also sells the recalled product to distributors. The RO is to periodically re-run the PHIS report for retail recall consignees when new retail locations are added to the Master Consignee List (MCL) and provide the update to RMTAD.

    C. DECS is to post to the list periodic updates from the list to RMTAD as additional retail consignee information becomes available. After the initial posting, updates may be frequent for the first several days, and then less often, as new information becomes less available.