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USDA/FSIS RIN: 0583-AD45 Publication ID: Fall 2013 
Title: Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products 
Abstract: 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 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. 
Agency: Department of Agriculture(USDA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 9 CFR 317.2(e)(3)   
Legal Authority: 21 USC 601 to 695   
Legal Deadline:  None

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.

Action Date FR Cite
NPRM  06/10/2013  78 FR 34589   
NPRM Comment Period End  08/09/2013 
NPRM Comment Period Extended  08/09/2013  78 FR 48631   
Final Action  06/00/2014 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Rosalyn Murphy-Jenkins
Director, Labeling and Program Delivery Staff (LPDS)
Department of Agriculture
Food Safety and Inspection Service
Office of Policy and Program Development, Patriots Plaza 3, 1400 Independence Avenue SW., Room 8-148, Mailstop 5273,
Washington, DC 20250-5273
Phone:301 504-0879
Fax:202 245-4792