CHAPTER III - EVENT ASSESSMENT COMMITTEE

I. EVENT ASSESSMENT COMMITTEE MEMBERS

    A. All members of the Event Assessment Committee are to be knowledgeable about the issues raised by an escalated event and are to be empowered to represent their respective AA's views. Committee members are to make every effort to achieve consensus on whether to recommend a recall, formally consider recovery actions already planned or initiated by a firm to be a recall necessitating public notification and FSIS verification, issue a PHA, or consider recommending other appropriate actions. The primary members of the Committee and their roles are described below:


        1. RMTAD, OFO - (chair) - Gathers and analyzes information regarding escalated events. Calls a committee meeting, when necessary, and distributes information about the escalated event to committee members. RMTAD invites other FSIS program areas to assist as necessary.

        2. Office of Policy and Program Development (OPPD) - Provides the statutory basis for each action recommended by the Committee and addresses any policy questions relevant to the event being assessed.

        3. OPHS - Addresses microbiological, epidemiological (including CCMS queries), and other scientific issues associated with the event. OPHS also assesses the public health impact of the event. If the Committee recommends a recall, OPHS proposes the classification.

        4. Office of Public Affairs and Consumer Education (OPACE), Congressional and Public Affairs Staff (CPAS) - Gathers information and generates a Recall Release or Recall Notification Report if there is a recall. When appropriate, OPACE generates a PHA in situations where a recall action is not warranted, or the firm does not accept the Agency's recommendation for a recall. OPACE ensures that information contained in the Recall Release, PHA, or Press Release is accurate.

        5. OIEA, CID: - Assists OFO upon request. OIEA may lead preliminary inquiries when an escalated event involves products in commerce that did not originate from an official establishment or involves imported products. OIEA also conducts investigations of alleged criminal violations, such as those involving the sale, transport, or receipt of adulterated or misbranded product associated with the event.

        6. Reporting Office (OFO or OIEA) - Clarifies and explains to the Committee the information collected during the preliminary inquiry.

    B. The Committee may also consist of representatives from the following program areas in a supporting role at RMTAD's request and in accordance with any existing Memorandum of Understanding:

        1. Significant Incident Preparedness and Response Staff (SIPRS) - A representative from SIPRS is invited to all Event Assessment Committee meetings. If a recall involves illness or injury, the SIPRS representative records the information from the recall so that it may be entered into the FSIS Incident Management System (FIMS).

        2. Other Federal or State agencies, as appropriate: (e.g., FDA, Food and Nutrition Service, CDC, Agricultural Marketing Service, Office of the General Counsel, State departments of public health).

        3. OIC: A representative from the OIC is invited to all Event Assessment Committee meetings to participate as a non-voting member when the event involved imported product. OIC notifies foreign governments when FSIS becomes aware that domestically produced recalled product was exported from the United States to a foreign country.

II. DELIBERATIONS OF THE EVENT ASSESSMENT COMMITTEE

    A. The Event Assessment Committee meets when an adulteration or misbranding event requires the committee's consideration. To convene the Event Assessment Committee, RMTAD is to contact the Committee members via the Agency's messaging application to inform them of the event and arrange a meeting to discuss. RMTAD is to make every effort to ensure that the six (6) primary members of the Recall Committee are available to participate in the Committee meeting.

    B. The Event Assessment Committee is to discuss the details of the escalated event, including the applicable statutory requirements to determine the Agency's best approach for addressing the event. This may include the reasons that a particular product may need to be removed from commerce and whether there is a statutory basis to recommend a recall. If the Event Assessment Committee decides to recommend a recall, it is to also determine the appropriate recall classification.

    C. When determining whether to recommend a product recall, the Event Assessment Committee is to seek the answers to the following questions:

        1. Does FSIS have evidence to demonstrate that the product in question is adulterated or misbranded under the FMIA, PPIA, or EPIA? For example:

            a. If the results of a laboratory analysis show that raw ground beef or beef manufacturing trimmings contain E. coli O157:H7 or non-O157 STEC, or that an RTE product contains Listeria monocytogenes or Salmonella spp., the product is adulterated because it is likely to be injurious to health;

            b. Situations in which laboratory results are not available or are inconclusive, but FSIS believes, on the basis of epidemiological and traceback evidence, that a specific meat, poultry, or egg product is associated with human illnesses. Under these circumstances, the Event Assessment Committee is to consider the strength of the epidemiological and traceback evidence to determine whether there is evidence to conclude that a specific lot or lots of product contain the pathogen causing illness or is otherwise unhealthful and, therefore, adulterated.

        2. Does any of the product in question remain in commerce, available for sale or use?

            a. Domestic product is considered "in commerce" if it has been shipped from an establishment without Agency or establishment controls or restrictions and is free to be moved to any consignee or to consumers. This does not include product that is only in the possession of end consumers at their personal residences.

            b. Imported product is considered "in commerce" when it has been released by CBP and is offloaded at a location other than the official import inspection establishment or the official establishment designated on the import inspection application. Imported product held offsite pending laboratory results or otherwise is not considered "in-commerce," provided the importer maintains product control over the entire lot as identified on the foreign inspection certificate.

            c. The Event Assessment Committee and program employees are to consider all available information to determine whether product remains in commerce, and whether any product that has been distributed in commerce remains available to consumers at retail facilities, restaurants, etc.

    D. To properly assess whether any of the product remains available for sale to consignees or consumers, the Event Assessment Committee is to seek responses to the following questions:

        1. Is the product readily identifiable and able to be differentiated from similar unaffected product?

        2. When was the product produced?

        3. To whom has the product been distributed?

        4. What type of product is involved (e.g., RTE, fresh-packed, canned, frozen)?

        5. What is the typical, usable shelf life of the product?

        6. What are the typical consumer or user practices concerning handling and storage of the product in question (e.g., is the product typically prepared for immediate consumption and likely is not stored or frozen for later use/consumption)?

        7. Is the Agency able to verify that the product previously distributed in commerce is no longer free to move to consignees or otherwise available to consumers at retail facilities, restaurants, or other institutions? To verify whether product remains free to move to consignees or consumers, the Committee may consider records provided by the establishment or its consignees.

    E. If the answers to questions C.1. and C.2. are both "yes," the Committee should recommend a recall. The Committee should not recommend a recall under the following circumstances:

        1. FSIS does not have sufficient evidence to support that product is adulterated or misbranded according to the Acts.

        2. Adulterated or misbranded product is no longer available for sale or use in commerce.

        3. FSIS is unable to identify the responsible party.

        4. FSIS is unable to readily identify the scope of product that may be adulterated or misbranded.

        5. The product in question is already recovered or under control.

        6. The product in question is long past its usable shelf life.

        7. FSIS identifies an ineligible foreign product imported by multiple importers or through nefarious means.

        8. FSIS identifies FSIS-regulated products that contain ingredients already subject to recall.

        9. FSIS, working with its Federal and State partners, determines that a meat, poultry, or egg product may be associated with human illnesses, but it cannot identify a specific product (e.g., lot or lots) that it could recommend be recalled.

    F. If the Committee determines the answer to C.1 and C.2. are "yes," but the Committee is unable to identify the responsible party for the product or cannot readily identify the scope of the issue, the Committee should recommend a PHA. See Chapter IV for information regarding PHAs.

    G. If the Event Assessment Committee finds that the establishment has recovered or controlled all products from commerce that would have been subject to recall, the Committee should not recommend a recall, as no product should remain available for sale or use in commerce. Instead, FSIS personnel are to verify that the product is under control and that the firm conducts proper disposition of the affected products. If a portion of such product had been previously sold to consumers, the Committee should consider whether typical consumer or user practices concerning handling and storage indicate that product may remain in the possession of end consumers at their private residences (e.g., stored or frozen for later consumption). In these circumstances, the Committee should consider recommending a PHA.

    H. If one or more Committee members do not agree with the action that a majority of the committee has decided to recommend, all members of the Committee are to immediately discuss the issue with their respective AAs and report back to the Committee. If the Event Assessment Committee is unable to come to consensus, the RMTAD representative is to notify the OFO AA or designee, who is to discuss the issue with the dissenting AA(s). The OFO AA may decide to convene a meeting of the AAs and advise the FSIS Administrator that they are convening the meeting. Each AA is to discuss the potential recall with their Office's Event Assessment Committee representative or their designee. If the AAs are unable to resolve the matter, they are to report the situation to the Administrator to make a final decision.

    I. If the Event Assessment Committee agrees that a recall is not recommended, RMTAD is to document the results of the preliminary inquiry in a memorandum and upload it to the ARA.

    J. If the Event Assessment Committee agrees to recommend a recall, the OPHS representative is to recommend a classification for consideration by the Committee, which is to reach consensus on the classification. The classification is to consider the human health hazard presented by the specific product subject to recall, as well as any precedents for determining the significance of the health hazard presented by an adulterated product and the classification of the hazard. The Event Assessment Committee generally is to be guided by these precedents in classifying recalls. However, if the Event Assessment Committee has questions about hazards or conditions that have not been previously encountered by the Agency, the OPHS representative may request OPHS to convene the HHEB, which is to consider, at a minimum, the following factors:

        1. The nature of the problem (i.e., what is the problem with the product and what health hazards does the problem create);

        2. The occurrence of any illnesses or injuries;

        3. The likelihood that illnesses or injuries may result; and

        4. The types of illnesses or injuries that may result.

    K. The Committee may also refer to the guidance document "Factors That Are Considered by the FSIS Event Assessment Committee in Evaluating the Public Health Significance of an Undeclared Ingredient in a Meat, Poultry, or Egg Product" when considering the classification of a recall that involves a meat, poultry, or egg product that contains an ingredient that is not declared on the product labeling.

    L. After the Committee members have discussed the issues described in the above paragraphs and agreed to recommend a recall, RMTAD is to contact the firm to allow its representatives to join the Event Assessment Committee discussion. RMTAD is to present the Committee's recommendation to the firm. During the discussion, the Event Assessment Committee is to provide the recalling firm with an opportunity to present information about the hazard or concern associated with the affected product. Based on the merits of this information, RMTAD may decide to clarify the Committee's position or to temporarily adjourn and re-engage Committee deliberations. FSIS expects the firm to have its recall strategy available upon request, including how it intends to notify and instruct its consignees to retrieve or dispose of the recalled product.

III. RECALL RECOMMENDATION

    A. When the Event Assessment Committee recommends a recall, RMTAD is to submit a Recall 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 recall, including why there is a reason to believe that the product is adulterated or misbranded and the applicable statutory citations;

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

        3. The recall classification (i.e., Class I, Class II, or Class III);

        4. The ability of distributors, consumers, or users of the product to identify the products covered by the recall;

        5.How the scope of the recall was determined; and

        6. The estimated amount of recalled product in distribution (the amount of product subject to recall that was distributed). In some cases, not all product in distribution will be recalled because some of it will be beyond the sell by/use by dates or codes at the time of recall. In these cases, the Event Assessment Committee is to determine whether consumers might still have the product, and, if so, whether they would possibly consume it.

    B. The Event Assessment Committee generally determines much of the above information from the recalling firm through written documents or telephone conference calls. Before deciding on a recommendation, RMTAD may request that FSIS inspection or enforcement personnel verify the information provided by the firm. RMTAD is to strongly encourage firms to digitally provide the information involved in the recall to facilitate the speed and accuracy of the information transfer.

    C. If the OFO AA or designee approves the Recall Recommendation, RMTAD is to follow up in writing with an email to the firm memorializing its discussion with the Committee. If the OFO AA or designee does not approve the Recall Recommendation, the OFO AA is to convene the AAs to discuss and resolve whether to recommend a recall. Each AA is to discuss the potential recall with their Office's Event Assessment Committee representative. If the decision is made to recommend a recall, CPAS is to confirm the information necessary for a Recall Release. The OPACE AA may request that other AAs review the draft Recall Release before it is issued. The applicable District or Regional Office is to assign a Recall Officer (RO) to begin coordinating effectiveness checks (see Chapter VI), consistent with the class of the recall, and is responsible for directing the activities of FSIS field personnel.

    D. If product subject to recall has been exported to a foreign country, RMTAD is to notify the relevant FSIS personnel in OIC, who will inform the foreign country of the recall.