[Federal Register Volume 59, Number 99 (Tuesday, May 24, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-12557] [[Page Unknown]] [Federal Register: May 24, 1994] _______________________________________________________________________ Part VII Department of Agriculture _______________________________________________________________________ Food Safety and Inspection Service _______________________________________________________________________ 9 CFR Part 317 Nutrition Labeling of Ground Beef and Hamburger; Proposed Rule DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 317 [Docket No. 93-030P] RIN 0583-AB74 Nutrition Labeling of Ground Beef and Hamburger AGENCY: Food Safety and Inspection Service, USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations by permitting percentage labeling for lean and fat on ground beef and hamburger, provided such product labeling contains nutrition information. This proposed rule would provide increased flexibility in the labeling of ground beef and hamburger, and would also allow consumers to readily identify and differentiate between the varying lean/fat percentages of these products. FSIS is taking this action in response to comments received after publication of the final nutrition labeling regulations and a petition submitted by Western States Meat Association, Oakland, CA, and encourages comments on all aspects of the proposed rule including nutrition information. DATES: Comments must be received on or before July 8, 1994. ADDRESSES: Written comments to: Policy Office, ATTN: Diane Moore, FSIS Hearing Clerk, room 3171, South Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, (202) 254-2565. SUPPLEMENTARY INFORMATION: Executive Order 12866 FSIS has determined that this proposed rule is significant for purposes of Executive Order 12866. FSIS has assessed the impacts of its proposed rule that would permit percentage labeling for lean and fat on ground beef and hamburger. This rule would provide an incentive to maintain or reduce fat in ground beef and hamburger which represent over 45 percent of the domestic beef supply. About 41 percent of the ground beef is sold through retail outlets. Benefits of the Proposed Rule Without this rule, processors and retailers of raw ground beef and hamburger would be essentially prohibited from making any lean or extra lean claims. Some producers of hamburger have made substantial strides in reducing the fat content which has been communicated as ``____ percent lean.'' The provisions of the proposed rule allow for presentation of objective and truthful information that would enable consumers to distinguish among products that range anywhere from 10 to 30 percent fat by weight. Consumers would obtain health benefits by seeing terms with which they are familiar and have used since 1973 to select leaner versions of these ground products. The labeling flexibility should provide manufacturers and retailers an incentive to maintain or reduce fat content in ground beef and hamburger. By requiring nutrition labeling and ``____ percent fat,'' whenever a product displays the ``____ percent lean'' content, industry is given a greater incentive to market and promote reduced fat ground beef products with higher lean contents than would occur under the final nutrition labeling regulations to take effect on July 6, 1994. FSIS believes that this nutrition information helps consumers make better food choices and provides incentives to continue producing nutritionally-improved products which contribute substantially to the health benefits associated with nutrition labeling. FSIS believes that this exemption is properly limited to ground beef products due to the past labeling practices of using lean and extra lean terms primarily on ground beef products. If there is sufficient interest to extend this flexibility to other ground product, the final analysis will assess the benefits and costs. Costs of the Proposed Rule The cost of the proposed regulations for nutrition labeling of ground beef and hamburger consists of presenting complete nutrition information obtained from existing databases on the labeling of the product or in the form of point-of-purchase materials when percentage labeling for lean and fat is used. The products on which FSIS is proposing to permit the percentage labeling are single-ingredient, raw ground beef products that fall under the voluntary nutrition labeling program if they do not contain added seasoning. FSIS believes that the costs associated with this proposed rule will be negligible and indistinguishable from the costs associated with the voluntary nutrition labeling program because the same point-of- purchase materials can serve both needs. FSIS's final regulation on nutrition labeling specifies that retail stores voluntarily provide quantitative nutrition information for these products, and that the nutrition information may be supplied by point-of-purchase material. Also, FSIS will survey retailers to ascertain whether there is significant participation in the program. If FSIS determines that significant participation does not exist, it will initiate rulemaking to determine whether it would be beneficial to require nutrition labeling on these products. FSIS has not assessed whether multiple uses of the term ``percent lean'' on USDA-regulated foods might result in any misunderstanding among consumers, or whether any such misunderstanding might limit informed consumer choice. Executive Order 12778 This proposed rule has been reviewed under Executive Order 12778, Civil Justice Reform. States and local jurisdictions are preempted under the Federal Meat Inspection Act (FMIA) from imposing any marking, labeling, packaging, or ingredient requirements on federally inspected meat products that are in addition to, or different than, those imposed under the FMIA. States and local jurisdictions may, however, exercise concurrent jurisdiction over meat products that are outside official establishments for the purpose of preventing the distribution of meat products that are misbranded or adulterated under the FMIA, or, in the case of imported articles, which are not at such an establishment, after their entry into the United States. Under the FMIA, States that maintain meat inspection programs must impose requirements that are at least equal to those required under the FMIA. The States may, however, impose more stringent requirements on such State inspected products and establishments. No retroactive effect will be given to this rule. The administrative procedures specified in 9 CFR 306.5 must be exhausted prior to any judicial challenge of the application of the provisions of this rule, if the challenge involves any decision of an inspector relating to inspection services provided under the FMIA. The administrative procedures specified in 9 CFR part 335 must be exhausted prior to any judicial challenge of the application of the provisions of this rule with respect to labeling decisions. Effect on Small Entities The Administrator has determined that this proposed rule would not have a significant effect on small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). The Agency finds that this proposed rule would result in positive net benefits because it would allow for increased flexibility in labeling rules. Small meat establishments are exempt from nutrition labeling, provided the labeling of their products bears no nutrition claims or nutrition information. Therefore, most small establishments would not be affected by this proposed rule. Comments Interested persons are invited to submit written comments concerning this proposed rule. Written comments should be sent to the Policy Office at the address shown above and should refer to Docket Number 93-030P. All comments submitted in response to this proposal will be available for public inspection in the Policy Office from 9 a.m. to 12:30 p.m. and from 1:30 p.m. to 4 p.m., Monday through Friday. Background FSIS published a final rule entitled ``Nutrition Labeling of Meat and Poultry Products'' in the Federal Register on January 6, 1993 (58 FR 632) (corrected at 58 FR 43787, August 18, 1993, and amended at 58 FR 47624, September 10, 1993). The final rule amends the Federal meat and poultry products inspection regulations by permitting voluntary nutrition labeling on single-ingredient, raw meat and poultry products and by establishing mandatory nutrition labeling for all other meat and poultry products, with certain exceptions. It provides definitions at 9 CFR 317.362 and 381.462 for specific nutrient content claims, including the terms ``lean'' and ``extra lean.'' The definitions include fat, saturated fat, and cholesterol criteria that take into consideration the inherent presence of these nutrients in meat and poultry products. The use of the terms ``lean'' and ``extra lean'' provide meat and poultry products with unique descriptive terms that allow consumers to readily identify and compare products with distinctive levels of fat, saturated fat, and cholesterol within the meat and poultry product category. Under the final nutrition labeling regulations, ground beef and hamburger may be labeled ``lean'' if they contain less than 10 grams of fat, 4.5 or less grams of saturated fat, and less than 95 milligrams of cholesterol, per 100 grams and Reference Amount Customarily Consumed (RACC) for individual foods. Ground beef and hamburger may be labeled ``extra lean'' if they contain less than 5 grams of fat, less than 2 grams of saturated fat, and less than 95 milligrams of cholesterol, per 100 grams and RACC for individual foods. Ground beef and hamburger, however, seldom meet these criteria, and are virtually precluded from using these terms. FSIS's correction to the final nutrition labeling regulations (58 FR 43788) at 9 CFR 317.362(a)(2) and 381.462(a)(2) defined the term ``____ percent lean'' as a synonym for the term ``____ percent fat free.'' To qualify for a ``____ percent lean'' claim, the product must meet the definition for ``low fat.'' The ``low fat'' definition allows 3 grams or less fat per RACC for individual foods. Since the final nutrition labeling regulations did not provide an exemption for ground beef and hamburger, these products must meet the definition of ``low fat'' to be labeled with a lean percentage. This restriction virtually precludes the use of ``____ percent lean'' labeling on ground beef and hamburger. Following the publication of the final nutrition labeling regulations, trade associations representing both manufacturers and retailers asked FSIS to make an exception for ground beef and hamburger to allow the use of ``____ percent lean'' on package labels. They contend that a lean descriptor standard, such as ``ground beef, not less than (X)% lean,'' has been in use for 20 years and became a legal requirement in some States. Industry believes that such labeling assists consumers in selecting leaner versions of these products and provides industry with incentives to market products lower in fat than the 30 percent permitted under 9 CFR 319.15. Western States Meat Association, Oakland, CA, submitted a petition to FSIS, dated October 15, 1993, to permit the use of a ``____ percent lean''/``____ percent fat'' statement following the product name for ground beef and hamburger. The petitioner states that, for many years, consumers have been receiving truthful and useful information from the ``____ percent lean''/``____ percent fat'' labeling. The petitioner argues that the statement is widely used by both wholesalers and retailers in the marketplace and the final nutrition labeling regulations will take this information away. Additionally, the petitioner states that this information will accomplish the objective of the new nutrition labeling rules of bringing more meaningful and more useful information to consumers. The petitioner urges FSIS to amend the nutrient content claims provision of the nutrition labeling regulations (9 CFR 317.362(c)) to provide for the use of the statement ``____ percent lean''/``____ percent fat'' following the product name for ground beef and hamburger. FSIS has reviewed the information provided by the petitioner and the comments received, and has determined that, with the preclusion of ground beef and hamburger from the use of the terms ``lean,'' ``extra lean,'' and ``____ percent lean,'' these products should be labeled to permit consumers to readily identify and differentiate between the varying lean to fat ratios in such products. Identification of fat content by means of percentage labeling of lean and fat on ground beef and hamburger would allow consumers to recognize products at the retail level that are now frequently marketed with terms such as ``regular,'' ``lean,'' and ``extra lean,'' or with lean percentages. Allowing such labeling would also assist consumers in selecting leaner versions of these products and provide incentives for manufacturers to market products lower in fat. FSIS also recognizes that the practice of labeling ground beef and hamburger with lean percentages has been in use since 1973, following the development of the Uniform Retail Meat Identity Standards by representatives from the meat industry, the Council of Better Business Bureau, the White House Office of Consumer Affairs, and the U.S. Department of Agriculture. The standards recommend that nomenclature and specifications for retail ground beef be decided by the lean-to-fat content and shown on the label as ``ground beef, not less than (X)% lean.''1 --------------------------------------------------------------------------- \1\These standards for retail ground beef are available for public inspection in the office of the FSIS Hearing Clerk. --------------------------------------------------------------------------- However, FSIS believes that a percentage lean and a percentage fat labeling statement on the product would be potentially misleading unless appropriate nutrition information for the product is available to the consumer. Requiring the percentage lean and percentage fat labeling statement to be accompanied by nutrition information would ensure that consumers do not misinterpret the percentage lean portion of the identifying statement. The Proposal FSIS is proposing to amend the Federal meat inspection regulations by permitting percentage labeling for lean and fat on ground beef and hamburger. Such labeling may be used only when the product is accompanied by nutrition information which characterizes the nutrition profile of the product. Consistent with guidelines for voluntary nutrition labeling of single-ingredient, raw meat products, FSIS is proposing that this nutrition information may be presented on the labeling of the product or in the form of point-of-purchase materials, such as signs, notebooks or leaflets, in close proximity to the product and readily available to the consumer. Guidelines for point-of-purchase materials, as stated in 9 CFR 317.345 for supplying nutrition information in the absence of a nutrition claim, would apply to these products. FSIS is also proposing that the percentage lean statement and the percentage fat statement be contiguous and in lettering of the same size, type, and on the same color background. FSIS is proposing to allow the use of percentage labeling for lean and fat on ground beef and hamburger only. FSIS will consider expanding the proposed percentage labeling for lean and fat to ground meat from other species and/or ground poultry, if information submitted during the comment period demonstrates the need and consumer acceptability of these terms for such products or that differential treatment of ground beef relative to other ground products would inappropriately restrict informed consumer choice. The final nutrition labeling regulations promulgated by FSIS on January 6, 1993, in most instances, did not permit ground beef and hamburger to be labeled based on a percentage of ``lean.'' As a result of the regulations, manufacturers and retailers would be prohibited from using the terms ``lean'' and ``extra lean'' in labeling ground beef and hamburger, unless such products meet the definitions of these terms, as set forth in 9 CFR 317.362 and 381.462. The practice of labeling ground beef and hamburger based on lean percentages has been allowed by FSIS under the Uniform Retail Meat Identity Standards since 1973. Under the final FSIS nutrition labeling regulations, which become effective on July 6, 1994, this longstanding practice would become prohibited. FSIS has reexamined this unintended consequence, and has concluded that consumers and the goals of nutrition labeling will best be served if the practice of labeling ground beef and hamburger based on lean percentages is allowed to continue, with certain restrictions as outlined in this proposed rule. Consumers are widely familiar with the percentage of lean information. FSIS believes that continuation of the practice will help consumers to select leaner ground beef and hamburger products. In order to avoid an unintended lapse in the allowed use of lean percentages for ground beef and hamburger, it is imperative that regulations pertaining to this issue become effective simultaneously with the overall July 6, 1994, effective date of the FSIS nutrition labeling regulations. The Agency has already reviewed comments received on the November 27, 1991, proposed rule concerning the continued use of lean percentages. The issue has been the subject of considerable public discussion. Therefore, FSIS believes that a 45-day comment period is sufficiently adequate to allow interested parties a meaningful opportunity to comment. List of Subjects in 9 CFR Part 317 Food labeling, Food packaging, Meat inspection. Proposed Rule For the reasons discussed in the preamble, FSIS is proposing to amend 9 CFR part 317 of the Federal meat inspection regulations as follows: PART 317--LABELING, MARKING DEVICES, AND CONTAINERS 1. The authority citation for part 317 would continue to read as follows: Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55. 2. Section 317.362 would be amended by adding and reserving paragraphs (d) through (f) and adding a new paragraph (g) to read as follows: Sec. 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content of meat products. * * * * * (g) A statement of the lean percentage may be used on the labeling of ground beef and hamburger when the product does not meet the criteria for ``low fat'' as defined in Sec. 317.362(a)(2): Provided, (1) That a statement of the fat percentage is contiguous to and in lettering of the same size, type, and on the same color background as the statement of the lean percentage; and (2) That nutrition information for the product is supplied in accordance with Sec. 317.345. Done at Washington, DC, on May 18, 1994. Patricia Jensen, Acting Assistant Secretary, Marketing and Inspection Services. [FR Doc. 94-12578 Filed 5-23-94; 8:45 am] BILLING CODE 3410-DM-P _______________________________________________________________________ Part VIII Department of the Interior Bureau of Indian Affairs Department of Health and Human Services Indian Health Services _______________________________________________________________________ 25 CFR Part 900 Indian Self-Determination and Education Assistance Act Amendments; Proposed Rule DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service 25 CFR Part 900 RINs 0905-AC98; 1076-AC20 Indian Self-Determination and Education Assistance Act Amendments AGENCIES: Departments of the Interior (DOI) and Health and Human Services (DHHS). ACTION: Proposed rule; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The DOI and the DHHS are extending the comment period for the notice of proposed rulemaking for the implementation of the Indian Self-Determination and Education Assistance Act Amendments of 1988 from May 20, 1994 to August 20, 1994, in response to tribal requests for more time to analyze the proposed rule and to prepare their comments. DATE: All comments must be received on or before August 20, 1994. ADDRESSES: Written comments to these proposed rules should be sent to Betty J. Penn, Chief, Regulations Branch, Office of Planning, Evaluation and Legislation, Indian Health Service, 12300 Twinbrook Parkway, suite 450, Rockville, Maryland 20852. All comments will be available for public inspection at this address from 8:30 a.m. to 5 p.m., Monday through Friday. Comments will also be available for public inspection at the (DOI), room 4627, Main Interior Building, 1849 C Street, NW., Washington, DC 20204. Comments will be available at the same time as in Rockville. FOR FURTHER INFORMATION CONTACT: James J. Thomas, Chief, Division of Self-Determination Services, Bureau of Indian Affairs, Department of the Interior, room 4627-MIB, 1849 C Street, NW., Washington, DC 20240, Telephone 202/208-5727 or Mitchell L. Parks, Director, Division of Self-Determination Services, Office of Tribal Activities, Indian Health Service, 5600 Fishers Lane, Parklawn Building, room 6A-05, Rockville, Maryland 20857, Telephone 301/443- 6480/1104/1044. SUPPLEMENTARY INFORMATION: In the Federal Register of January 20, 1994 (59 FR 3166), the DOI and DHHS proposed regulations to implement Public Law 100-472, the Indian Self-Determination and Education Assistance Act Amendments of 1988. Comments received and requests for an extension of the comment period made at regional and national public meetings from American Indian and Alaska Natives indicate that 120 days was not sufficient time to review and submit comments on the proposed rule. The requests ranged from 90 days to 7 months. At the national meeting held in Albuquerque, New Mexico, the Tribal Leaders Caucus considered the requests and determined that an additional 90 days would provide adequate time for a review of the proposed regulations. All comments received during the public comment period will be given full consideration in the development of the final regulations. Dated: May 18, 1994. Ada E. Deer, Assistant Secretary-Indian Affairs-DOI. Dated: May 17, 1994. Michel E. Lincoln, Acting Director, Indian Health Service, DHHS. [FR Doc. 94-12557 Filed 5-23-94; 8:45 am] BILLING CODE 4160-16-M; 4310-02-M