[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]


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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.

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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
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    \1\These standards for retail ground beef are available for 
public inspection in the office of the FSIS Hearing Clerk.
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    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
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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.

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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