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Statement of Need: FSIS has concluded that without proper labeling, raw or partially cooked mechanically tenderized beef products could be mistakenly perceived by consumers to be whole, intact muscle cuts. The fact that a cut of beef has been needle or blade tenderized is a characterizing feature of the product and, as such, a material fact that is likely to affect consumers' purchase decisions and that should affect their preparation of the product. FSIS has also concluded that the addition of validated cooking instruction is necessary to ensure that potential pathogens throughout the product are destroyed. Without thorough cooking, pathogens that may have been introduced to the interior of the product during the tenderization process may remain in the product.

Summary of the Legal Basis: 21 U.S.C. 601 to 695.

Alternatives: The Agency considered two options: Option 1, extend labeling requirements to include vacuum tumbled beef products and enzyme-formed beef products; and Option 2, extend the proposed labeling requirements to all needle- or blade-tenderized meat and poultry products.

Anticipated Costs and Benefits: The proposed rule estimated the one-time cost to produce labels for mechanically tenderized beef at $1.05 million or $2.62 million, if this rule is in effect before the added solutions rule. The annualized cost is $140,000 for 10 years at a 7 percent discount rate or $349,000 over 10 years at a 7 percent discount rate, if this rule is in effect before the added solutions rule. The proposed rule estimated the expected number of E. coli O157:H7 illnesses prevented would be 453 per year, with a range of 133 to 1,497, if the predicted percentages of beef steaks and roasts are cooked to an internal temperature of 160⁰ F (or 145⁰ F and 3 minutes of dwell time). These prevented illnesses amount to $1,486,000 per year in benefits with a range of $436,000 to $4,912,000. Therefore, the expected annualized net benefits are $296,000 to $4,772,000 with a primary estimate of $1,346,000. If, however, this rule is in effect before the added solutions rule, the expected annualized net benefits are then $1,137,000, with a range of $87,000 to $4,563,000, plus the unquantifiable benefits of increased consumer information and market efficiency, minus an unquantified consumer surplus loss and an unquantified cost associated with food service establishments changing their standard operating procedures.

Risks: FSIS estimates that approximately 1,965 illnesses annually is attributed to mechanically tenderized beef, either with or without added solutions. If all the servings are cooked to a minimum of 160° F then the number of illnesses drops to 78. This number of illness is due to a data set for all STEC and not just O157 data. From the risk assessment, 1,887 out of 1,965 illnesses were estimated to be prevented annually if mechanically tenderized meat were cooked to 160 degrees.