I. PURPOSE

This directive provides instructions for Office of Investigation, Enforcement and Audit (OIEA) Compliance and Investigations Division (CID) Investigators on how to verify whether retail stores are meeting the labeling requirements for raw or partially cooked needle- or blade-tenderized beef at 9 CFR 317.2(e)(3), as instructed in FSIS Directive 8010.1, Methodology for Conducting In-Commerce Surveillance Activities, Section IV. Previously, FSIS issued the instructions in this directive in FSIS Notice 33-17, Verifying Labeling of 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. Validated cooking instructions must include, at a minimum:

1. The cooking method (e.g., grill or 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: The validated cooking instructions may appear anywhere on the label. An example of an instruction that contains these minimum elements is "Grill until product reaches 145°F, as measured by a food thermometer, and hold the product at or above that temperature for 3 minutes.”

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

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

B. 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.

C. Any beef product that has been fully cooked.

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

When retail stores produce and package raw or partially cooked needle- or blade-tenderized raw beef products, the retail label must comply with 9 CFR 317.2(e)(3) except for products wrapped in butcher paper or placed in a carry-out container at a retail store upon a consumer’s request.

VI. OIEA COMPLIANCE INVESTIGATOR (CI) RESPONSIBILITIES IN A RETAIL STORE THAT PRODUCES AND PACKAGES OR REPACKAGES MECHANICALLY TENDERIZED RAW BEEF

A. If a retail store packages or repackages raw or partially cooked needle- or blade-tenderized raw beef product that was produced at an official establishment or imported, the CI is to verify that the descriptive designation and validated cooking instructions from the incoming product label appear on the retail label and comply with 9 CFR 317.2(e)(3).

B. If a retail store produces and packages raw or partially cooked needle- or blade-tenderized, the CI is to verify that the retail store is complying with the requirements in 9 CFR 317.2(e)(3), including verification that the retail store has the appropriate supporting documentation to validate the cooking instructions provided on the label.

NOTE: If the CI has questions regarding the adequacy of the support, they are to seek guidance from their immediate supervisor or submit a question via askFSIS.

C. CIs are to be aware that retail stores may wish to include additional information within the validated cooking instructions that will make the labels more useful to consumers; however, FSIS does not require additional information on the product labels. For example, retail stores 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 thickest part of the product, etc.

D. When a CI observes labeling that does not meet the requirements in 9 CFR 317.2(e)(3), he or she is to document the violation in accordance with FSIS Directive 8010.4, Report of Investigation, recommending issuance of a Notice of Warning.

VII. QUESTIONS

Refer labeling questions to the Office of Policy and Program Development (OPPD) through askFSIS. OPPD can also be reached by telephone at 1-800-233-3935. 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 8150.1.
• 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.

See full PDF for Attachments 

• EXAMPLES OF LABELS ON BEEF PRODUCTS PRODUCED AND PACKAGED OR RE-PACKAGED AT A RETAIL STORE.