Nutrition Labeling of Ground Beef and Hamburger; Proposed Rule DEPARTMENT OF AGRICULTURE

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]

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