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Statement of Need: Under the authority of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and its implementing regulations, FSIS investigates complaints and reports of consumer foodborne illness possibly associated with FSIS-regulated meat products. Many such investigations into consumer foodborne illnesses involve those caused by the consumption of raw beef ground by official establishments or retail stores. FSIS investigators and public health officials frequently use records kept by all levels of the food distribution chain, including the retail level, to identify and trace back product that is the source of the illness to the suppliers that produced the source material for the product. The Agency, however, has often been thwarted in its effort to trace back ground beef products, some associated with consumer illness, to the suppliers that provided source materials for the products. In some situations, official establishments and retail stores have not kept records necessary to allow traceback and traceforward activities to occur. Without such necessary records, FSIS's ability to conduct timely and effective consumer foodborne illness investigations and other public health activities throughout the stream of commerce is also affected, thereby placing the consuming public at risk. Therefore, for FSIS to be able to conduct traceback and traceforward investigations, foodborne illnesses investigations, or to monitor product recalls, the records kept by official establishments and retail stores that grind raw beef products must disclose the identity of the supplier and the names of the sources of all materials that they use in the preparation of each lot of raw ground beef product.

Summary of the Legal Basis: Under 21 U.S.C. 642, official establishments and retail stores that grind raw beef products for sale in commerce are persons, firms, or corporations that must keep such records as will fully and correctly disclose all transactions involved in their businesses subject to the Act. This is because they engage in the business of preparing products of an amenable species for use as human food and they engage in the business of buying or selling (as meat brokers, wholesalers or otherwise) in commerce products of carcasses of an amenable species. These businesses must also provide access to, and inspection of, these records by FSIS personnel. Further, under 9 CFR 320.1(a), every person, firm, or corporation required by section 642 of the FMIA to keep records must keep those records that will fully and correctly disclose all transactions involved in his or its business subject to the Act. Records specifically required to be kept under section 320.1(b) include, but are not limited to, bills of sale; invoices; bills of lading; and receiving and shipping papers. With respect to each transaction, the records must provide the name or description of the livestock or article; the net weight of the livestock or article; the number of outside containers; the name and address of the buyer or seller of the livestock or animal; and the date and method of shipment.

Alternatives: FSIS considered two alternatives to the proposed requirements: the status quo and a voluntary recordkeeping program.

Anticipated Costs and Benefits: Costs occur because about 76,093 retail stores and official establishments will need to develop and maintain records, and make those records available for the Agency's review. Using the best available data, FSIS believes that industry recordkeeping costs would be approximately $1.46 million. Agency costs of approximately $0.01 million would result from record reviews at official establishments and retail stores, as well as travel time to and from retail stores. Annual benefits from this rule come from estimated averted Shiga toxin-producing E.coli illnesses of $1.06 million and $0.58 million due to averted cases of Salmonellosis. Total benefits from this rule are estimated to be $1.64 million, with a net annual benefit of $0.13 million. Non-monetized benefits under this rule include, for the raw ground beef processing industry: 1) an increase in consumers' confidence and greater acceptance of products because mandatory grinding logs will result in a more efficient traceability system, recalls of reduced volume, and reduced negative press; 2) smaller volume recalls will result in higher confidence and acceptability of products including the disposition of product once recovered; 3) improved productivity, which improves profit opportunities. Avoiding loss of business reputation is an indirect benefit. By identifying and defining the responsible party, FSIS will be able to get to the suspect faster and execute a better targeted recall, meaning that a recall will involve a smaller amount of product. This lower volume per recall will decrease costs for the recalls and the disposition of product. In addition, the Agency expects consumers to benefit from improved traceability and, thus, a reduced incidence of STECs in ground raw beef products due to the rapid removal of those products from commerce. The Agency believes that by having official meat establishments and retail stores that engage in the business of grinding raw beef products keep records, traceability of ground raw beef in the U.S. food supply will be greatly enhanced.

Risks: FSIS estimates that the annual costs of STEC and salmonellosis illnesses that will continue to be incurred without this rule is $1.64 million, which comes from an estimated $1.06 million due to illnesses associated with STECs and an estimated $0.58 million due to cases of salmonellosis.