CHAPTER II - DETERMINING NEED FOR RECALL
I. BECOMING AWARE OF POTENTIAL NEED FOR A RECALL
A. When official establishments learn or determine that adulterated or misbranded product has entered commerce, they are required to notify FSIS DO personnel within 24 hours (9 CFR 418.2). If an official establishment notifies FSIS personnel other than the DO that adulterated or misbranded product has entered commerce, those personnel are to contact the DO promptly, through supervisory channels. They are also to notify the establishment that it is still required to contact the DO directly.
B. FSIS has informed other firms, including importers of record, that when they learn or determine that adulterated or misbranded product has entered commerce or decide to recall product on their own initiative, they are to immediately notify RMTAS or other FSIS personnel. However, if the firm contacts other FSIS personnel, those employees are to promptly contact RMTAS through supervisory channels.
C. FSIS may become aware of misbranded or adulterated 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 inspection program personnel (IPP) in the course of their routine duties or investigations;
4. Consumer complaints reported through the FSIS Consumer Complaint Monitoring System (CCMS);
5. Epidemiological or laboratory data submitted by State or local public health departments, other USDA agencies, and other Federal agencies such as the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), or the Department of Defense; or
6. 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 FSIS learns that there is reason to believe that adulterated or misbranded product is in commerce, FSIS will conduct a preliminary inquiry. The Recall Officer (RO) is assigned to direct the activities of IPP. FSIS personnel are to begin the preliminary inquiry by gathering product information, contact information, and any additional relevant information. They are to forward the following to RMTAS:
1. Contact Information for an Official Establishment:
a. Establishment number, name, and address;
b. Company Recall Coordinator (name, title, and telephone number);
c. Company Media Contact (name, title, and telephone number); and
d. Company Consumer Contact (name, title, and telephone number).
2. Contact Information for Imported Products:
a. Import establishment (number, name, address, and telephone number);
b. Foreign establishment (number, name, address, and telephone number);
c. Importer of Record (name, address, and telephone number);
d. Importer of Record Company?s Recall Coordinator (name, title, and telephone number);
e. Importer of Record Media Contact (name, title, and telephone number); and
f. Importer of Record Consumer Contact (name, title, and telephone number).
3. Product Information: For all products, including imported products, FSIS personnel are to gather the following product information:
a. Reason for recall;
b. Brand names;
c. Product names;
d. Packaging (Type & Size (pounds));
e. Package codes (Use by/Sell by);
f. Packaging dates;
g. Photos of label or package;
h. Case codes;
j. Production dates;
k. Distribution areas;
l. School lunch (yes/no);
m. Department of Defense (yes/no); and
n. Internet or catalog sales (yes/no).
4. Additional Product Information for Official Establishments:
a. Amount produced (pounds);
b. Amount held at establishment;
c. Amount distributed (pounds/cases); and
d. Distribution level (depth of the recall, if known).
5. Additional information for Imported Product:
a. Amount imported (pounds/cases);
b. Amount held at import establishment;
c. Amount distributed (pounds/cases);
d. Distribution level (depth of the recall, if known); and
e. Foreign country notified (yes/no).
6. When appropriate:
a. Violation reported to Import/Export Coordination and Policy Development Staff (yes/no);
b. Health Hazard Evaluation Board (HHEB) convened (yes/no); and
c. Emergency Coordination Staff (ECS) notified (yes/no).
B. During the preliminary inquiry, FSIS personnel are to gather additional information by taking the following steps, as necessary:
1. Collecting and verifying information about suspect product;
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 suspect product;
6. Collecting and submitting product samples for analysis;
7. Contacting other agencies, State and local health departments, or foreign governments;
8. Analyzing any available epidemiological data;
9. Reviewing supporting documentation and evidence (e.g., sanitation standard operating procedures, or HACCP and production records).
C. RMTAS is to collect all of the information gathered during the preliminary inquiry and forward the relevant materials to the Recall Committee. Firms are encouraged to submit product label information electronically, whenever possible, to minimize transcription errors and enable consignees and consumers to readily identify recalled product if FSIS must issue a Recall Release.