I. PURPOSE

This directive provides instructions to inspection program personnel (IPP) on how to continue to verify that establishments meet the labeling requirements for raw or partially cooked needle- or blade-tenderized beef as specified in 9 CFR 317.2(e)(3). Previously, FSIS issued the instructions in this directive in FSIS Notice 37-16, Descriptive Designation for Needle- or Blade-Tenderized Raw Beef Products As Required By 9 CFR 317.2(e)(3).

II. BACKGROUND

On May 18, 2015, FSIS published a final rule to establish labeling requirements for raw or partially cooked mechanically tenderized beef products (Descriptive Designation of Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Product (80 FR 28153)). The rule amended the regulations by adding 9 CFR 317.2(e)(3).

III. REQUIREMENTS OF THE FINAL RULE

A. Under 9 CFR 317.2(e)(3) the product name for mechanically tenderized beef must contain a descriptive designation:

1. “Mechanically Tenderized,” or if needle tenderized, the product can be described as “Needle Tenderized,” or if blade tenderized, the product can be described as “”Blade Tenderized.”
2. The product name and the descriptive designation must be printed in a single easy-to-read type style and color and must appear on a single-color contrasting background. The print may appear in upper and lower case letters, with the lower case letters not smaller than one-third (1/3) the size of the largest letter, and with no intervening text between the identity of the meat and the descriptive designation. The descriptive designation may be above, below, or next to the product name without intervening text or graphics on the principal display panel.

• NOTE: See Attachment for label examples.

B. The labels of raw or partially cooked needle- or blade-tenderized raw beef products destined for household consumers, hotels, restaurants, or similar institutions must bear validated cooking instructions.

IV. PRODUCTS NOT SUBJECT TO THE REQUIREMENTS OF THIS FINAL RULE

A. Products that are going to another official establishment to be fully cooked or to receive another full lethality treatment are not required to have the descriptive designation.

B. Non-intact beef products that are clearly non-intact, e.g., ground beef patties, hamburger patties, beef patties.

C. Beef products that are tenderized by other than needle and blade, such as pounding or cubing, which visibly changes the appearance of the product, e.g., cubed beef steak.

D. Any beef product that has been fully cooked and those destined to another Federal establishment to receive a full lethality treatment.

E. Raw or partially cooked products labeled as “Corned Beef” that have been mechanically tenderized (including through injection of a solution).

F. Raw mechanically tenderized beef products that are less than 1/8” thick, such as beef bacon or carne asada, or raw mechanically tenderized beef products that are diced, such as stew meat.

V. IPP RESPONSIBILITIES

A. IPP are to continue to verify whether establishments meet the requirements in 9 CFR 317.2(e)(3) for product subject to this final rule while conducting the General Labeling task in accordance with FSIS Directive 7221.1, Prior Labeling Approval. IPP are to determine whether the establishment produces this type of product by reviewing a copy of the final label that is in use, the product formulation, and the processing procedure for the product.

B. When performing the General Labeling task, IPP are to verify that the required validated cooking instructions contain at a minimum the following information in order to comply with 9 CFR 317.2(e)(3)(iii):

1. The cooking method (e.g., grill, bake);
2. That these products need to be cooked to a specified minimum internal temperature;
3. Whether these products need to be held for a specified time at that temperature or higher before consumption to ensure that potential pathogens are destroyed throughout the product; and
4. A statement that the internal temperature should be measured by a thermometer.

NOTE: These validated cooking instructions may appear anywhere on the immediate container.

C. IPP are to be aware that establishments may wish to include additional information within the descriptive instructions that will make the labels more useful to consumers; however, FSIS will not require additional information on the product labels. For example, establishments may wish to include the temperature setting of the cooking device, time to complete cooking, whether the product needs to be flipped during cooking, the amount of time to cook on each side exposed to the heat source, recommendations to thaw the product, if applicable, or recommendations to measure the temperature in the thickest part of the product, etc.

D. When conducting the Hazard Analysis Verification task as described in FSIS Directive 5000.6, Performance of the Hazard Analysis Verification (HAV) Task for HACCP plans that include mechanically tenderized beef products subject to the Rule, IPP are to verify that the establishment has the appropriate supporting documentation to validate the cooking instructions provided on the label.

NOTE: If IPP have questions regarding the adequacy of the support, they are to seek guidance from their immediate supervisor.

E. IPP are to document the results of their verification, including any noncompliance, in the Public Health Information System (PHIS) in a manner in accordance with Chapter VI of FSIS Directive 7000.1, Verification of Non-Food Safety Consumer Protection Regulatory Requirements.

VI. QUESTIONS Refer labeling questions to the Labeling and Program Delivery Staff (LPDS) through askFSIS. LPDS can also be reached by telephone at 1-301-504-0878. When submitting a question through askFSIS, use the Submit a Question tab, and enter the following information in the fields provided:

• Subject Field: Enter Directive 7150.1.
• Question Field: Enter your question with as much detail as possible.
• Product Field: Select Labeling from the drop-down menu.
• Category Field: Select Labeling Regulations, Policies and Claims from the drop-down menu
• Policy Arena: Select Domestic (U.S.) only from the drop-down menu

When all fields are complete, press Continue and at the next screen press Finish Submitting Question.

NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.