CHAPTER II - DETERMINING NEED FOR RECALL


I. BECOMING AWARE OF POTENTIAL NEED FOR A RECALL

    A. When FSIS official establishments learn or determine that adulterated or misbranded meat or poultry products have entered commerce, they are required to notify FSIS OFO District Office (DO) personnel within 24 hours (9 CFR 418.2). This notification can be made through traditional methods (phone call, text message, or email) or can be made by the establishment through the Public Health Information System (PHIS). When official establishments notify FSIS personnel that adulterated or misbranded product has entered commerce, those FSIS personnel are to refer to FSIS Directive 8140.1, Notice of Receipt or Distribution of Adulterated or Misbranded Product, for actions to take in response to a report of adulterated or misbranded products.

    B. If other firms responsible for products, such as importers or retailers, determine that adulterated or misbranded product have entered commerce or decide to recover product from commerce on their own initiative, they may notify RMTAD (formtad@usda.gov) or other FSIS personnel. If the firm contacts other FSIS personnel, those employees are to promptly contact RMTAD through supervisory channels.

    C. FSIS may become aware of adulterated or misbranded product in commerce through its own resources and personnel activities or through other sources outside of FSIS. For example, FSIS may receive information from:

        1. The company that manufactures, distributes, or receives the product;

        2. Test results from FSIS sampling programs;

        3. Observations or information gathered by FSIS personnel in the course of their routine duties or investigations;

        4. Consumer complaints reported through the FSIS Consumer Complaint Monitoring System (CCMS);

        5. Complaints reported to FSIS through sources other than CCMS;

        6. Epidemiological or laboratory data submitted by State or local public health departments or authorities, other USDA agencies, and other Federal agencies such as the FDA, the Centers for Disease Control and Prevention (CDC), or the Department of Defense; or

        7. Information from other agencies, such as the Department of Homeland Security, Customs and Border Protection, the Animal and Plant Health Inspection Service, or foreign inspection officials.


II. PRELIMINARY INQUIRY

    A. When there is reason to believe that adulterated or misbranded product is in commerce, FSIS will conduct a preliminary inquiry. The applicable FSIS OFO District Manager (DM) or Office of Investigations, Enforcement and Audit (OIEA) Regional Director (RD) is to assign personnel to lead this effort. FSIS personnel are to begin the preliminary inquiry by gathering relevant information about the products in question, contact information for the firms involved in production and distribution, and any information that might affect the scope of involved product or mitigate the need for a recall. If the applicable DM or RD determine the event should be escalated for further RMTAD analysis, the personnel assigned to lead this effort are to work with the firm to complete and forward a copy of FSIS Form 5020-3, Preliminary Inquiry Worksheet, to RMTAD for assessment and escalate the event by creating an Agency Report of Adulteration (ARA) in PHIS. Firms may complete FSIS Form 5020-3. If the firm elects to complete this form the information should be verified by District or Regional Office personnel before submission to RMTAD.

    NOTE: Information about creating and escalating cases in PHIS Adulterated Product Monitoring (APM) can be found in FSIS Directive 8140.1.

    B. FSIS personnel are to gather product label information, including photographs or digital scans of labels, and submit to RMTAD via email whenever possible, to minimize transcription errors and enable consignees and consumers to readily identify affected product if FSIS issues public notification.

    C. While investigating and assessing potential adulteration and misbranding events, OFO or OIEA personnel may coordinate with other program areas to perform some of the following activities, as necessary, to gain a full understanding of the event being investigated or assessed. This list is not exhaustive:

        1. Collecting and verifying information about suspect products and ingredients;

        2. Documenting a chronology of events;

        3. Contacting the company that manufactures or distributes the product for additional information;

        4. Communicating with FSIS field inspection and FSIS enforcement personnel;

        5. Interviewing any consumer who allegedly became ill or was injured from eating regulated product;

        6. Collecting and submitting product samples for analysis;

        7. Contacting other agencies, State and local health departments, or coordinating with the Office of International Coordination (OIC) to contact foreign governments;

        8. Coordinating with OPHS during the analysis of any available epidemiological data; and

        9. Reviewing supporting documentation and evidence (e.g., Sanitation Standard Operating Procedures, Hazard Analysis and Critical Control Point (HACCP) and production records, risk assessments, etc.).

D. RMTAD is to assess all information gathered during the preliminary inquiry.

        1. If RMTAD determines that the Event Assessment Committee should be engaged, RMTAD is to provide the relevant materials to committee members. To facilitate committee deliberations and ensure the appropriate disposition of products, RMTAD is to ensure that firms have an opportunity to submit any mitigating information that the Committee will consider.

        2. RMTAD may determine that further recall consideration is unnecessary.

                a. RMTAD may determine that the product in question is not, in fact, adulterated or misbranded. In such cases, engagement of the Event Assessment Committee is unnecessary.

                b. RMTAD may determine that adulterated or misbranded product had been in commerce but is unlikely to be either still available for sale or still in the possession of end consumers, e.g., RMTAD may learn that fresh, perishable meat or poultry product entered U.S. commerce but is well past its use by date and highly unlikely to be stored by consumers.

                c. If RMTAD determines that further recall consideration is unnecessary per D.2.a or D.2.b above, RMTAD is to document the result of the assessment in the ARA in PHIS.

                d. RMTAD may determine that adulterated or misbranded products entered commerce, are no longer for sale, but are likely in the possession of consumers and may present a public health risk. In such cases, RMTAD is to engage the Event Assessment Committee to discuss whether a PHA may be necessary.

                e. If RMTAD determines that product in commerce is adulterated or misbranded because it contains an ingredient subject to an FDA recall, RMTAD is to engage the Event Assessment Committee to discuss whether a PHA may be necessary.