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).
3 3 Id.
4 4 FDA COMPLIANCE POLICY GUIDE NO. 7153.13 (Dec. 1, 1982). The revised version of this compliance policy guide is http://www.fda.gov/ora/compliance:ref/cpg/cpggenl/cpg140‐100.html.
5 5 52 Stat. 111, 114 (1938), later incorporated into 15 U.S.C. 52658.
6 6 PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW 43 (2d ed. 1991).
7 7 21 C.F.R. § 101.15(c)(2). In addition, the Tariff Act of 1930, 19 U.S.C. 1304, requires all imported articles to be marked with the English name of the country of origin.
8 8 FD&C Act § 403(f).
9 9 21 C.F.R. § 101.1.
10 10 Id.
11 11 21 C.F.R. §§ 101.3(a) and 101.105(a).
12 12 21 C.F.R. § 101.2(b) and (d).
13 13 21 C.F.R. § 101.2.
14 14 21 C.F.R. § 101.3.
15 15 FD&C Act § 403(f).
16 16 21 C.F.R. 101.3(d).
17 17 21 C.F.R. 101.3(d).
18 18 FD&C Act § 403(g) and 21 C.F.R. § 101.3.
19 19 21 C.F.R. 155.13.
20 20 21 C.F.R. 101.3(b).
21 21 21 C.F.R. § 101.3(b).
22 22 21 C.F.R. § 101.3(c).
23 23 21 C.F.R. § 101.3(b)(3).
24 24 YING HE & JOSEPH G. SEBRANEK, FINELY TEXTURED LEAN BEEF AS AN INGREDIENT FOR PROCESSED MEATS (Beef Research Report, 1996. Paper 39, Iowa State University) (1997).
25 25 Complaint and Jury Demand, Beef Products, Inc. v. American Broadcasting Companies, Inc., No. CIV12292, 2012 WL 4017340 (S.D. Cir. Sept. 13, 2012).
26 26 Id.
27 27 USDA, FSIS, FOOD STANDARDS AND LABELING POLICY BOOK (2005) http://www.fsis.usda.gov/OPPDE/larc/Policies/Labeling_Policy_Book_082005.pdf (last visited Mar. 28, 2015).
28 28 Specifically, ABC evening news broadcast a segment on March 7, 2012.
29 29 Rita‐Marie Cain Reid, You Say “Lean Finely Textured Beef,” I Say “Pink Slime,” 69 FOOD & DRUG L. J. 625, 626 (2014).
30 30 Id.
31 31 For more detailed information, refer to 21 C.F.R. § 101.3(d) and 21 C.F.R. § 101.22.
32 32 21 C.F.R. § 101.3(e)(1).
33 33 21 CFR § 101.30.
34 34 Elizabeth Campbell was then the director of the programs and enforcement policy division in the Office of Food Labeling of FDA's Center for Food Safety and Applied Nutrition.
35 35 21 C.F.R. § 101.105.
36 36 15 U.S.C. § 1453(a)(2).
37 37 15 U.S.C. § 1453(a)(3)(A)(ii).