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USDA/FSIS RIN: 0583-AD45 Publication ID: 2012 
Title: Descriptive Designation for Needle or Blade Tenderized (Mechanically Tenderized) Beef Products 
Abstract: FSIS is proposing 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. FSIS is proposing that the product name for such beef products include the descriptive designation "mechanically tenderized" and accurate description of the beef component. FSIS is also proposing 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, FSIS is proposing to 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 that inform consumers 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: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 9 CFR 317.8    9 CFR 381.129   
Legal Authority: 21 USC 453 and 21 USC 601   
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 required 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; 21 U.S.C. 451 to 470

Alternatives: As an alternative to the proposed requirements, FSIS considered not proposing new requirements for needle or blade tenderized beef products. A second alternative was for the Agency to propose to amend the labeling regulations to include a new requirement for labeling all mechanically tenderized meat and poultry products.

Anticipated Costs and Benefits: Benefits: Benefits are both qualitative and quantifiable. The proposed new labeling requirements will improve public awareness of product identities, meaning that it will provide truthful and accurate labeling of beef products to clearly differentiate the non-intact, mechanically tenderized beef products from intact products. Since needle or blade tenderized beef products are not readily distinguishable from non-tenderized beef products, the descriptive designation of "mechanically tenderized" on the labels of these products will inform the consumers of the true nature of the product when deciding whether to purchase the products. Additionally, the knowledge of knowing that these products are mechanically tenderized will help consumers, official establishments, and retail establishments become aware that they need to cook these products differently from intact products before they can be safely consumed. Costs: FSIS estimated that 32,130 labels are for beef product. Assuming 10.5 percent of the 32,130 labels are for products that are mechanically tenderized, then 3,374 labels will be required to add "mechanically tenderized" to their labels in accordance with this proposed rule. If we include the labels that are for beef product that are mechanically tenderized and contain added solutions, then we would assume that an additional, 5,077 labels will be required to add "mechanically tenderized" to their labels. From the 2011 Model to Estimate Costs of Using Labeling as a Risk Reduction Strategy for Consumer Products Regulated by the Food and Drug Administration, a minor labeling change was defined as one in which only one color is affected and the label does not need to be redesigned. FSIS concluded that the change that is required by this propose rule is minor. The mid-point label design modification costs for a minor coordinated label change are an estimated $310 per label. In the case of a coordinated label change, only administrative and recordkeeping costs are attributed to the regulation, and all other costs are not. FSIS estimates the cost to be $1.05 million (3,374 labels x $310) for mechanically tenderized only. For all products that are mechanically tenderized and contain added solutions, the cost is estimated to be $2.6 million. Establishments would also incur minimal costs to validate the required cooking instructions for raw and partially cooked needle or blade tenderized beef products. These costs would be incurred to ensure that the cooking instructions are adequate to destroy any potential pathogens that may remain in the beef product after being tenderized.

Risks: In 2011, FSIS conducted a Comparative Risk Assessment for Intact and Non-intact Beef. The comparative risk assessment was conducted to determine the difference in risk between different types of steak products and to examine the effect of different cooking practices on reducing human illness. This comparative risk assessment informed this rule. The risk assessment looked at the comparative effects of cooking at 140, 150, 160, and 165 degrees Fahrenheit. In its risk assessment, FSIS estimated the annual E. coli O157:H7 illnesses prevented from achieving various internal temperatures. From the risk assessment it was estimated that between 191 and 239 illnesses would be prevented annually, if mechanically tenderized meat were cooked to 160 degrees. Using the FSIS average cost per case for E. coli O157:H7 of $3,281, the propose rule would save approximately $627,000 to - $784,000.

Action Date FR Cite
NPRM  12/00/2012 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
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

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