Program Delivery Staff, accompanied by FSIS Form 7234‐1, Application for Approval of Labels, Marking, and Devices, and approved by such staff, except for generically approved labels authorized for use in § 412.2.”
3.10.2 “Generic” Approvals (Labels Without Prior Approval)
Since 1996, the USDA FSIS regulations have allowed food establishments more flexibility for changing meat and poultry labels without prior FSIS approval. The regulations permit certain labels (categories that are not likely to present significant policy issues that have health or economic significance) to be “generically approved.” Once a generic label is approved by FSIS, the regulations provide for changes in the label in certain circumstances without further authorization from FSIS.92
In 2013, FSIS expanded generic approval so that the only four types of labels need to be submitted to FSIS for evaluation and approval as follows:
1 Labels for religious exempt products. Labels for poultry slaughtered under Buddhist, Confucian, Halal, or Kosher religious exemptions that do not bear the mark of inspection must be approved by FSIS.93
2 Labels for export with deviations from domestic labeling requirements.94
3 Labels with special statements and claims. Special statements and claims are claims, logos, trademarks, and other symbols on labels that are generally not defined in FSIS regulations or the Food Standards and Labeling Policy Book, such as geographical landmarks, heart logos, negative claims (e.g., gluten free), health claims, and processing method and ingredient claims.95
4 Labels for temporary approval. These temporary approvals are for minor deviations from the labeling regulations that do not pose any health, safety, or dietary problems to consumers. For example, if a supplier changed ingredients and failed to inform the establishment, the establishment might apply for a temporary approval to use the existing label, even though it does not have the correct ingredients statement.96
FSIS also evaluates labels for egg products and for exotic species under voluntary USDA inspection. Under generic approvals, it is the establishment’s responsibility to prepare final labeling in accordance with applicable regulations and to create and maintain records of final labeling.
3.10.3 Safe Food Handling Instructions Raw Meat and Poultry
The USDA requires safe handling and cooking instructions on raw meat and poultry products. 97 These instructions must state the following:
Safe Handling Instructions
This product was prepared from inspected and passed meat and/or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.
Keep refrigerated or frozen. Thaw in refrigerator or microwave.
Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry.
Cook thoroughly.
Keep hot foods hot. Refrigerate leftovers.
Mechanically Tenderized Beef Labeling Requirements 98
Tenderizing meat with a needle or blade can transfer pathogenic bacteria from the exterior of the meat to the interior. While intact muscle cuts, such as steaks, can be safe when cooked rare or medium rare because the outside is seared, the mechanically tenderized cuts must be cooked all the way through, like ground beef products, to kill pathogens inside the meat. CDC outbreak data from 2010 to 2014 indicates that consumers and food service facilities sometimes do not cook mechanically tenderized raw beef products to a temperature and for a time sufficient to destroy harmful bacteria that may have been transferred to the tenderized interior of the product.99
However, not all mechanically tenderized products are readily distinguishable from nontenderized products. For this reason, FSIS requires labeling to state that a beef product has been mechanically tenderized along with validated cooking instructions to provide consumers and food service workers the essential information to safely prepare the product.100
The name of raw or partially cooked mechanically tenderized beef must clearly indicate that the product has been mechanically tenderized. The terms “needle tenderized” or “mechanically tenderized” may be used as the descriptive designation for needle tenderized beef and the terms “mechanically tenderized” or “blade tenderized” may be used as the descriptive designation for blade tenderized beef. There are also type size, clarity, and prominence requirements in the labeling rule.101
The labels must also include validated cooking instructions, including the minimum internal temperatures and any hold times, so that consumers know how to safely prepare the products. FSIS released an updated guidance for the use of federally inspected establishments in developing validated cooking instructions for mechanically tenderized products. FSIS predicts that the changes resulting from the new rule will prevent hundreds of illnesses per year.
The new rule applies only to mechanically tenderized beef, and not to tenderized poultry or other nonbeef products. Although FSIS considered this option, the agency concluded that there are insufficient data on the production practices and risks of consuming those products.
3.10.4 Additional Information Required
The official inspection legend.
The establishment’s inspection number.
Other applicable warning statements, such as “Keep refrigerated” and “Keep frozen.”
3.10.5 Recordkeeping
FSIS also sets forth requirements for label recordkeeping in regulations 9 C.F.R. sections 320.1(b)(11) and 381.175(b)(6).
Notes
1 1 Letter from Mark Twain to George Bainton (Oct. 15, 1888), in THE ART OF AUTHORSHIP: LITERARY REMINISCENCES, METHODS OF WORK, AND ADVICE TO YOUNG BEGINNERS 87–8 (George Bainton ed., New York, D. Appleton 1891), http://www.bartleby.com/73/540.html (last visited Sept. 27, 2005).
2 2 335 U.S. 355 (1948).
