CHAPTER VI - EFFECTIVENESS CHECKS

I. GENERAL

    A. Each official establishment is required to develop written procedures to specify how they will decide whether and how to conduct a recall, should they decide that one is necessary (9 CFR 418.3). Establishments and recalling firms are responsible for notifying all consignees of the need to remove recalled product from commerce. FSIS personnel are to conduct effectiveness checks to verify that the recalling firm has been diligent and successful in notifying and advising the consignees of the need to retrieve and control recalled product and that the consignees have responded accordingly. FSIS will conduct effectiveness checks throughout the distribution chain. Effectiveness checks are risk-based and dependent on the class of the recall (which is based on the hazard and any available epidemiological data), the number of consignees, and other relevant factors.

    B. Depending on the availability of Agency personnel and the type of firm conducting the recall, Enforcement Investigations and Analysis Officers (EIAOs) or CID Investigators are to conduct effectiveness checks. Generally, if the recalling firm is an official establishment, the RO is to coordinate and direct OFO personnel to conduct effectiveness checks. If the recalling firm is an importer or otherwise not an FSIS-inspected establishment, the RO is to coordinate and direct OIEA personnel to conduct the checks and contact the CID RD to obtain assistance from CID investigators to conduct checks. Assigned personnel are to contact the recalling firm's distribution consignees to collect customer information and provide it to the RO. The RO is to compile an MCL by uploading consignees to APM. Personnel assigned to contact distribution consignees are to verify the same information gathered as part of an effectiveness check, including interviewing the consignees to ens ure they were notified of the recall and that they communicated appropriate instructions to their customers. If at any time during the effectiveness checks FSIS personnel discover that a firm did not contact the consignees promptly with recall instructions or that the consignees are not handling product in the manner requested by the firm, FSIS personnel are to detain any product found in commerce as set out in FSIS Directive 8410.1. FSIS personnel are to notify the RO immediately when the recalled product remains available to the consumer and when the recalling firm has not properly implemented its recall strategy. The RO is to notify RMTAD and take immediate action to address identified concerns including, but not limited to, conducting follow-up with distributor consignees and notifying the recalling firm of insufficiencies or ineffectiveness of its recall, and ensuring the recalling firm takes appropriate measures to correct any insufficiencies that may lead to an ineffective recal l when necessary. The recalling firm is ultimately responsible for all aspects of the recall.

II. FIELD RECALL RESPONSIBILITIES UPON NOTICE OF A RECALL

    A. The RO is to:

        1. Serve as the primary point of contact for the recalling firm;

        2. Immediately request that the recalling firm provide information regarding product distribution, including the names, addresses, and phone numbers of its consignees (Attachment 1);

        3. Obtain a copy of any notice of recall issued by the firm to its consignees or to the public for accuracy of product information, risk, and clarity (e.g., verify that the firm discloses the reason for the recall and describes the product defect or adulterant), and verify that the recall notice does not contain promotional or company information that obscures the risk of the product. Upload a copy of the written recall notice to the APM Recall case. If the recall notice is incomplete or inaccurate, the RO is to immediately call the firm and explain the reasons why the notification or instructions are inadequate and follow up the call with a letter to the firm and a courtesy copy to RMTAD;

        4. Inquire how the firm plans to control recovered product; and

        5. Inquire how the firm plans to handle product disposition.

    B. If the firm's recall strategy includes destroying product on site, the RO may assign FSIS personnel to witness destruction of the product in accordance with 9 CFR part 329, part 381, Subpart U, or 590.422. FSIS personnel are to document this on the Report of Effectiveness Check in APM as product disposition verification.

III. RO RESPONSIBILITIES FOR COORDINATING FSIS PERSONNEL ACTIVITIES DURING EFFECTIVENESS CHECKS

The RO is to:

        1. Coordinate effectiveness checks and direct the activities of FSIS personnel;

        2. Determine product distribution and request assistance from Assisting Offices (AOs) in Districts/Regions where product was distributed. The Deputy District Managers (DDMs)/RDs of the AOs are to determine whether additional consignees need to be added to the distribution list. When contacting all primary, secondary, and tertiary distributors to compile the MCL, the RO and AOs are to treat these interactions in the same way as an effectiveness check and interview the subject firm as outlined in Chapter VI, Section IV, A directly below;

        3. The RO will eliminate duplicate consignee listings and upload the list of consignees into APM;

        4. The RO will determine the appropriate table in Attachment 1 to assign a total number of effectiveness checks in APM that will be performed by on-site verification and by telephone. If there is sufficient information, the RO may decide to group effectiveness checks by special consignee categories (e.g., schools, day care centers, hospital cafeterias, or retirement homes). If the RO decides to group effectiveness checks by special categories, the RO is to apply the appropriate table in Attachment 1 to each consignee category in APM, as provided in Section G of this attachment; and

        5. Select a sub-set of consignees for effectiveness checks using the appropriate selection criteria (Attachment 1).

    B. The RO is to add any additional consignees identified after FSIS has started conducting effectiveness checks to the MCL in the APM. These consignees will be randomly selected for recall effectiveness checks until the number of required effectiveness checks as defined by Tables 2-5 (Attachment 1) below are met. If additional consignees are identified and added to the MCL after the required number of effectiveness checks is met, the RO will review the outcome of the conducted checks to determine whether additional biased checks should be selected from the newly identified consignees.

IV. FSIS PERSONNEL RESPONSIBILITIES FOR CONDUCTING EFFECTIVENESS CHECKS

    A. For a recall to be deemed effective, the number of consignees checked that are found to have the product available to the public must be less than or equal to the critical number applied to the effectiveness check plan (Attachment 1). Using the selections generated by the RO in the APM Recall case, FSIS personnel are to:

        1. Contact or visit the consignees to determine whether they were notified of the recall and have removed the recalled product from commerce (e.g., located, segregated, and appropriately controlled affected product pending disposition);

        2. Verify that the consignees are handling the product in accordance with regulatory requirements and the instructions of the recalling firm by reviewing records and observing or verifying product disposition, when necessary;

        3. Determine whether any recalled product remains available to consumers (e.g., by checking store shelves, storage areas, or freezers during on-site visits). Take appropriate action to detain any recalled product found available for sale or use in accordance with FSIS Directive 8410.1;and

        4. Record the effectiveness checks on the Report of Effectiveness Check in APM and submit the completed reports to the appropriate District or Regional office. Supervisors are to review and approve the completed checks, including determining whether any follow-up actions are needed for ineligible checks or locations that did not receive a recall notification.

    B. FSIS may verify the disposition of the recalled product during an effectiveness check. In cases where product disposition is still pending during the on-site effectiveness check, FSIS personnel may request that the location provide documentation, when it becomes available, sufficient to demonstrate that the product was handled in accordance with the recalling firm's instructions and regulatory requirements and document this on the Report of Effectiveness Check in APM as a follow-up.

    C. If, when conducting effectiveness checks, FSIS finds recalled product offered for sale or use in commerce, the Agency will consider whether the recalling establishment clearly communicated the recall notification to its consignees and whether those consignees adequately relayed the notification down through the distribution chain. When a trend is identified, the RO may assign additional effectiveness checks by biased selection.

    D. The RO is to issue a letter to the violating firm describing the circumstances of any prohibited acts and the potential enforcement or criminal action the Agency may pursue. In this scenario, the violating firm may be a recalling firm or consignee that failed to adequately notify downstream consignees, or it may be a consignee that received adequate notification but failed to follow the recalling firm's instructions to remove product from sale or use. FSIS may find that the recalling firm effectively communicated the recall, but that the recalling firm's consignees failed to ensure that the recalled product was removed from commerce. As necessary, FSIS personnel are to follow FSIS Directive 8410.1 and notify the consignee of any prohibited activity. FSIS personnel are to notify the recalling firm immediately of any instances involving recalled product found available for sale or use. When the prohibited activity is a result of a failure to provide adequate re call notification to consignees, in addition to issuing notification of the prohibited act, FSIS personnel are to contact the firm that failed to notify consignees and request information on how the firm will ensure all consignees are notified of the recall. The RO is to refer all instances of prohibited activity to OIEA/CID for investigation and enforcement.

V. RO RESPONSIBILITIES FOR REVIEWING EFFECTIVENESS CHECKS AND CONFIRMING THE FIRM'S CONTROL AND DISPOSITION OF THE PRODUCT

The RO is to:

    1. Continually monitor recall effectiveness reports from all AOs in APM;

    2. Analyze the information that is submitted by FSIS personnel on the Report of Effectiveness Check in APM and review any instances in which recalled product was found in commerce or consignees did not receive recall notification. The RO is to immediately contact RMTAD and the recalling firm regarding any pattern or trend that may suggest certain consignees were not contacted or any other issues that may result in an ineffective recall (see VI below); and

    3. Maintain contact with the recalling firm and verify that the firm:

        a. Completed execution of the recall as planned;

        b. Controlled, recovered, or confirmed disposition of the product as planned; and

        c. Considers the recall closed.

    4. Obtain the recalling firm's request to close the recall either verbally or in writing.

    NOTE: RMTAD and the RO are not to leave a recall case open pending disposition of recovered product. Control and disposition of recovered product will be monitored by FSIS in the same manner that it would have had the adulterated or misbranded product not entered commerce.

VI. THE RO DETERMINATION ON THE EFFECTIVENESS OF THE RECALL

    A. The outcome of the recall is deemed effective or ineffective based on the number of locations where products were found to be available for sale (see Attachment 1).

    B. In consultation with RMTAD, the RO may determine that the recall action is ineffective based on their review of the effectiveness checks because of the firm's failure to control and dispose of the product. The RO is to make this determination as early as possible, even if effectiveness checks are ongoing. The RO is to notify the recalling firm immediately upon determining an active recall may be ineffective, follow up in writing, and provide a courtesy copy of the notification to RMTAD, explaining why the recall action is deemed to be ineffective. The RO is to ask how the recalling firm intends to address the situation. If the recalling firm is unwilling or unable to correct its recall strategy, the RO is to recommend that the Agency take further action to mitigate the risk to the public, if necessary. The recommended actions may include public warnings, product detentions and seizures, or other appropriate actions.

    C. FSIS personnel conducting effectiveness checks should continue with all assigned checks even though a recall has been determined ineffective.

VII. RMTAD REVIEW OF ACTIVE RECALL DATA

RMTAD is to perform periodic review of active recall data in APM to assess recall case progress and ongoing issues identified during recall effectiveness checks.