On May 18, 2015, the Food Safety and Inspection Service (FSIS) published its final rule on “Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products” (http://1.usa.gov/1HsoLwN).

The final rule adopts, with minor modifications, the requirements proposed in the June 10, 2013, Federal Register. Under the final rule, the label of raw or partially cooked beef products that have been mechanically tenderized must bear a descriptor and validated cooking instructions. The rule will be effective in about one year: May 17, 2016.

Regulatory requirements

Product Name
The final rule provides establishments options as to the prescribed descriptor. An establishment can use the phrase “mechanically tenderized” on all products or use the phrase “needle tenderized” on needle tenderized products or “blade tenderized” on blade tenderized products.

Although the rule specifies that the descriptor be part of the total product name, the descriptive designation is not considered part of the common or usual name of the product (i.e., name of the beef component). Therefore, the descriptor:

• Can appear above, below, or next to the name of the beef component as long as there is no intervening text or graphics,
• Can appear in upper and lower case letters, and
• Can be of a different font size than the name of the beef component, provided the smallest letter in any part of the total product name is not smaller than 1/3 the size of the largest letter.

Validated Cooking Instructions
In addition to the mandatory descriptor, the label must bear validated cooking instructions that inform consumers on how to cook the product. An establishment can place the validated cooking instructions anywhere on the label. Beyond informing purchasers that these products need to be cooked, the instructions shall, at a minimum:

1. Specify the method of cooking,
2. Specify the validated minimum internal temperature,
3. Specify whether the products need to be held at that minimum internal temperature for a specified time before consumption, i.e., dwell time or rest time, and
4. Indicate that the internal temperature is to be determined through use of a thermometer.

Validation guideline

FSIS also announced the availability of its revised Compliance Guideline (http://1.usa.gov/1PTZ1sl) on validating cooking instructions. The guideline provides examples of cooking instructions and a list of peer-reviewed articles on lethality. If the establishment uses the examples from the Guideline, no additional scientific support is necessary. Once the scientific support is selected, the establishment needs to ensure that the cut of beef, method of tenderization, and thickness of product matches the product in the selected support.

As to variation in thickness, FSIS stated that the establishment should validate the cooking using a worst case scenario, i.e., the thickest product. In determining the worst case scenario, the establishment should select and measure product from three lots.

If an establishment choses not to follow the guidance, the guideline outlines the procedures an establishment should follow in validating its own cooking instructions.

Products excluded

The requirements do not apply to:

• Products where tenderization is obvious, e.g., cubed steak.
• Products that have been tumble marinated or otherwise marinated without injection.
• Products treated with an enzyme.
• Products that have been received a full lethality, includes products treated with high pressure pasteurization (HPP) if the HPP achieves lethality.

Implementation issues

FSIS will:

• Require mechanically tenderized product repackaged by an official establishment or a retailer to bear a label with all the information required above unless the product has been fully cooked.
• Permit establishments and retail stores to add the descriptor to existing label designs or to apply a sticker with the required information to existing labels.
• Deem labels revised to comport with the rule to be generically approved.
• Conduct consumer education and outreach on mechanically tenderized products.
• When effective, instruct inspection program personnel (IPP) to verify that the production process is accurately stated on the label; non-compliance could result in misbranded product and label rescission.
• Share the issue of menu labeling with the Food and Drug Administration (FSIS is not requiring the labeling on restaurant menus).
• Permit an establishment producing intact product to declare that fact on the labels of such products; this change would be deemed generically approved.

This has been a controversial proposal, since many have questioned whether it will advance public health. FSIS has resolved that issue, now it is time for implementation.