FSIS Directive 8080.1 Recall of Meat and Poultry Products - Chapter 4 Announcing the Recall

CHAPTER IV - ANNOUNCING THE RECALL

I. ACTION BY FIRM

    A. FSIS outlines in ?Product Recall Guidelines for Firms? (Attachment 3) 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 detain any product found in commerce that would have been subject to a recall as set out in FSIS Directive 8410.1, Detention and Seizure. CPAO is to issue a Press Release informing the public that product that appears to be adulterated or misbranded has been shipped by the responsible firm and that the Agency is detaining product in commerce.

II. PUBLIC NOTIFICATION

    A. Following approval of the recall by the OFO AA, RMTAS notifies CPAO to issue a Recall Release. CPAO is to distribute the Recall Release to media wire services, media outlets in areas that received recalled products, the FSIS e-mail subscription service, and the @USDAfoodsafety Twitter Feed. CPAO will also post it on the FSIS website. Generally, FSIS will issue a Recall Release for Class I and Class II recalls. However, if the recalled product has not been distributed beyond the wholesale level and has only been sent to warehouses or distribution centers where it is not likely to be sold directly to consumers, a Recall Release would not be necessary, even for Class I or Class II recalls. Instead, the Agency would issue an RNR (see section III below). FSIS will typically not issue a Recall Release for Class III recalls unless there are overriding public welfare reasons, such as a case of egregious economic adulteration.

    B. The Recall Release will:

        1. Clearly describe what product the firm is recalling, along with any identifying marks or codes, explain the reason for the recall, and describe the risks involved in consuming the product;

        2. Instruct the public on how to properly handle the product if consumers have it in their possession;

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

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

    C. 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 on the FSIS website.

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

    E. For Class I recalls related to human illness, an Incident Report (IR) will be posted on the FSIS Incident Management System (FIMS) by OPACE. The Recall Release will be attached to the IR. Program areas will update the IR, as appropriate, until the recall is complete.

III. RECALL NOTIFICATION REPORT (RNR)

    A. RMTAS coordinates with CPAO to issue an RNR for Class III recalls or for Class I or Class II recalls in situations where FSIS does not issue a Recall Release. Unlike a Recall Release, an RNR is not distributed to media wire services or media outlets in areas that received recalled products. However, RNRs are posted on the FSIS website and are distributed to FSIS e-mail subscribers and the @USDAfoodsafety Twitter Feed. CPAO is to develop the RNR and post it to the FSIS website. RNRs are posted and distributed during normal business hours. If a draft RNR is not completed by close of business, it can be done so the next business day.

    B. The RNR will:

        1. Clearly describe what product the firm is recalling, along with any identifying marks or codes, and explain the reason for the recall;

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

        3. Provide general information about the product?s destination. For example, ?Ham and turkey products were distributed to a warehouse in the State of?.?

    C. When possible, FSIS will post an electronic picture of the product label that clearly describes the product to the public on the FSIS website.

    D. CPAO is to fax or e-mail a draft copy of the RNR to the recalling firm 30 minutes before it is posted to the FSIS website. At this time, CPAO is to inform the firm that it may review the RNR to verify that the product description, the company contact information, and the product distribution information are accurate. CPAO is to inform the firm that if it does not respond to CPAO within 30 minutes of receiving the RNR, FSIS will proceed to post the RNR on the FSIS website. CPAO is to inform the firm that if it notifies CPAO of typographical or other inadvertent errors, CPAO is to correct them before posting the RNR.

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

    A. When a recall is conducted by a retail establishment under a State?s inspection program, FSIS may issue a Press Release announcing the intrastate recall to provide factual information, including identification of the State that is verifying the recall and a description of the affected product. A Press Release provides general public notification through the general news media, either national or local, as appropriate.

    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 United States (U.S.) consumers, FSIS is to issue a Press Release that provides information similar to FSIS Recall Releases or RNRs. For example, FSIS may issue a Press Release that contains information about a Canadian recall if U.S. consumers could have purchased the product in Canada and then brought it into the U.S. FSIS will also conduct effectiveness checks whenever a foreign government or a company under the jurisdiction of the foreign government recalls product available in the U.S., unless, on review, the Agency determines that effectiveness checks are not necessary in a specific situation. FSIS will follow the same procedure in similar cases when the information is received from other foreign government officials that product is adulterated or misbranded.

V. PUBLIC HEALTH ALERTS

    A. If FSIS personnel have reason to believe that a meat or poultry product may be associated with human illnesses, but they cannot identify a specific product that FSIS could recommend be recalled, they should 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. If appropriate, the situation should be referred to the ECS, as provided in
FSIS Directive 5500.2. If the situation is referred to the ECS, the ECS will decide whether FSIS should issue a Public Health Alert.

    B. There may be situations in which the Recall Committee determines that a specific product may present a risk to human health, but the Committee cannot recommend a recall. In these circumstances, the RMTAS Director is to notify the OFO AA, and the other Recall Committee members are to notify their AAs. The OFO AA is to convene a meeting of the AAs and advise the Administrator that he/she is convening this meeting. The AAs will decide whether to issue a Public Health Alert or to take no action on the incident. If the AAs cannot resolve the matter, they are to report the situation as a potential significant incident to be resolved by the ECS, as provided in FSIS Directive 5500.2.

    C. If FSIS issues a Public Health Alert 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. Identify whether the product presents any health risk;

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

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

        6. Instruct consumers on how to properly handle the product if, by some remote chance, they have it in their possession; and

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

VI. RETAIL CONSIGNEE LISTS

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

    B. FSIS personnel enter the name, street address, city, and state of each retail consignee into an electronic database. As soon as an initial list of retail locations can be prepared from this information, RMTAS does so. RMTAS then sends the list of retail consignees to the FSIS Web Services Staff for posting on the FSIS website. The initial list is posted within approximately 3 to 10 days of the date of the recall.

    C. The FSIS Web Services Staff posts to the list periodic updates from RMTAS 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.

VII. SPECIAL CONSIDERATIONS FOR WHOLESALE LEVEL RECALLS

    A. There may be instances in which adulterated or misbranded product that is implicated in a recall is not available to consumers because, although the product is in commerce, it has been distributed only to consignees at the wholesale level (i.e., to warehouses or distribution centers) and the producing company was able to regain control over the product before it could be further distributed to the retail, hotels, restaurants and similar institutions (HRI), or consumer level. In this situation, issuing a Recall Release to inform the public of the recall would not be useful to consumers. FSIS will not issue a Recall Release or conduct effectiveness checks beyond the wholesale level for recalls in which a company is able to regain control over adulterated or misbranded product distributed solely to the wholesale level. Instead, the following public notification and recall verification procedures will apply:

        1. Public Notification: If the distribution of adulterated or misbranded product is limited to the wholesale level, and the company is able to account for and regain control over all recalled product, FSIS will issue an RNR instead of a Recall Release. The Agency will follow the procedures for issuing an RNR in Chapter IV, section III, above. The Agency will issue an RNR instead of a Recall Release even if the if the recall is classified as Class I or II.

        2. Recall Verification: If the distribution of adulterated or misbranded product is limited to the wholesale level, and the company is able to account for and regain control over all recalled product, FSIS personnel are to verify that the recalling company conducted proper disposition of the product in question. FSIS personnel are to report their findings to RMTAS through supervisory channels. If during their verification checks, FSIS personnel determine that the recalling firm does not have control over all recalled product, and that product may have been distributed to the retail, HRI, or consumer level, they are to notify RMTAS and the RO.

NOTE: Upon the determination that a recall will involve the issuance of an RNR, but not a Recall Release, RMTAS will typically complete the recall during normal business hours.
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