Director, Labeling and Program Delivery Staff (LPDS)

0583-AD45 201410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0583 Food Safety and Inspection Service FSIS 0500 Department of Agriculture USDA Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products

FSIS has proposed regulations to require the use of the descriptive designation "mechanically tenderized" on the labels of raw or partially cooked needle- or blade-tenderized beef products, including beef products injected with marinade or solution, unless such products are destined to be fully cooked at an official establishment. Beef products that have been needle- or blade-tenderized are referred to as "mechanically tenderized" products. This rule would require that the product name for such beef products include the descriptive designation "mechanically tenderized," and an accurate description of the beef component. The rule would also require that the print for all words in the descriptive designation as the product name appear in the same style, color, and size, and on a single-color contrasting background. In addition, this rule would require that labels of raw and partially-cooked needle- or blade-tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions include validated cooking instructions stating that these products need to be cooked to a specified minimum internal temperature, and whether they need to be held at that minimum internal temperature for a specified time before consumption, i.e., dwell time or rest time, to ensure that they are thoroughly cooked.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 9 CFR 317.2(e)(3) 21 USC 601 to 695 Yes

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.

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21 U.S.C. 601 to 695.

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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.

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The proposed rule estimated the one-time cost to produce labels for mechanically tenderized beef at $1.05 million. The annualized cost is $140,000 at 7 percent for 10 years ($120,000 and when annualized at 3 percent for 10 years). The proposed rule estimated an additional one-time total cost to produce labels for mechanically tenderized beef at $1.57 million or $209,000 when annualized at 7 percent for 10 years ($179,000 when annualized at 3 percent for 10 years), if this proposed rule becomes final before the added-solution rule is finalized. 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.

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

]]> NPRM 06/10/2013 78 FR 34589 NPRM Comment Period End 08/09/2013 NPRM Comment Period Extended 08/09/2013 78 FR 48631 NPRM Comment Period Reopened 12/03/2013 78 FR 72597 Final Action 12/00/2014 No None No No No No Rosalyn Murphy-Jenkins Director, Labeling and Program Delivery Staff (LPDS) 0583 Food Safety and Inspection Service FSIS 301 504-0879 202 245-4792 rosalyn.murphy-jenkins@fsis.usda.gov Office of Policy and Program Development, Patriots Plaza 3, 1400 Independence Avenue SW., Room 8-148, Mailstop 5273, Washington DC 20250-5273