Nutrition Labeling; Use of ``Healthy'' and Similar Terms on Meat and Poultry Product Labeling; Final Rule DEPARTMENT OF AGRICULTURE

Federal RegisterMay 10, 1994

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the

Federal meat and poultry products inspection regulations to permit the

use of the term ``healthy'' or any other derivative of the term

``health,'' such as ``healthful'' or ``healthier,'' on the labeling of

meat and poultry products. FSIS is taking this action to provide

consumers with accurate, informative labeling on meat and poultry

products that conforms with such labeling on other foods. This final

rule provides a definition for the implied nutrient content claim

``healthy'' for individual foods and meal-type products, and is

designed to parallel the definition issued by the Food and Drug

Administration (FDA) for other foods.

EFFECTIVE DATE: November 10, 1995.

FOR FURTHER INFORMATION CONTACT:

Charles 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 examined the economic implications of its final rule on

use of the term ``healthy'' and any other derivative of the term

``health'' on the labeling of meat and poultry products, as required by

Executive Order 12866. FSIS has determined that this final rule is

economically significant for purposes of Executive Order 12866.

Regulatory Options

1. No Definition. FSIS could choose not to define the term

``healthy.'' However, in its nutrition labeling final rule issued on

January 6, 1993, FSIS determined that the term ``healthy'' is an

implied nutrient content claim. If FSIS does not define the term

``healthy,'' its use on labeling, except on those products using the

claim in their brand name prior to November 27, 1991, or in a non-

nutritional context, would misbrand the food. This option would result

in large costs, including labeling costs, and a valuable signal used by

consumers to alert them to foods that may assist them in meeting

dietary goals would be lost.

FSIS could alternatively decide to propose to reverse its previous

determination that use of the term ``healthy'' is an implied nutrient

content claim. However, FSIS could only make such an amendment if it

were persuaded that its original determinations were in error. FSIS did

not receive any information that would support such a conclusion.

Furthermore, such an action would require separate rulemaking, and

would not take effect until well after the effective date of the

nutrition labeling regulations. Therefore, until FSIS published a final

rule, this alternative would have the same impact as not defining the

term ``healthy.''

2. Different Definition Than Proposed. FSIS could determine that an

alternative definition for the term ``healthy'' would be more

appropriate that that which was proposed. FSIS and FDA simultaneously

published proposals that would define the term ``healthy.'' However,

the definitions were different. FSIS proposed to link the definition of

the term ``healthy'' to the definition for the nutrient content claim

``lean'' with an added sodium restriction. Consequently, there would be

limits for fat, saturated fat, cholesterol, and sodium. FDA proposed a

definition that linked the term ``healthy'' to definitions for the

nutrient content claims ``low fat'' and ``low saturated fat'' with

restrictions on cholesterol and sodium.

There was overwhelming agreement among commenters that if

``healthy'' is defined, both FSIS and FDA should adopt uniform criteria

so as not to undermine the benefits consumers will ultimately realize

through application of the same definition.

Costs of the Final Regulations

FSIS has identified 27 uses of ``healthy'' or derivatives of the

term ``health'' in brand names, trade names, product lines, or

prominent displays on labeling of meat and poultry products. This

information was obtained by a search of the FSIS files from its prior

label approval system. The manufacturers of these products include five

large companies with annual sales of over $50 million and an estimated

20 medium-size companies with annual sales between $5 million and $50

million. FSIS has not identified usage of ``healthy'' on labeling by

small companies with annual sales of less than $5 million. However,

based on the percentage of medium-size companies using the term, FSIS

estimates that possibly 38 small companies might use ``healthy'' or

derivatives of the term ``health'' on product labeling. FSIS's Final

Regulatory Impact Analysis (FRIA) for nutrition labeling estimates that

large companies average 250 labels per company and 2.3 average labels

per product; medium companies average 80 labels per company and 2

average labels per product; and small companies average 30 labels per

company and 1.5 average labels per product. Based on this information,

FSIS found that at most a total of 3,990 labels and 2,100 products

could be affected by the final rule. However, FSIS expects that a much

lower number of labels will be influenced.

Manufacturers of products not meeting the definition of ``healthy''

have three options to bring their products into compliance with the

regulations: Reformulate, cease marketing, or relabel. Of these three

options, complete reformulation would be the most expensive. Assuming,

as an upper bound for total costs to the industry, all the estimated

2,100 products that might be affected had to be completely

reformulated, the total costs to companies based on initial analytical,

administrative, printing, and inventory costs for an 18-month

implementation period presented in the FRIA would be $33.1 million for

large companies, $18.9 million for medium companies, and $3.6 million

for small companies. Not all labeling will be affected and some

products could be reformulated with minimal cost.

FSIS examined data for 61 meals from a leading brand name producer.

These meals weighed between 7 and 13.5 ounces. Of these, 49 (80

percent) are FSIS-regulated products, and 12 are regulated by FDA.

Nutrient values were compared to criteria for maximum fat, saturated

fat, and cholesterol levels that meet the ``healthy'' definition for

meals. Only three meals failed to meet the lipid cutoff levels. The

three meals--meat loaf, chicken enchilada, and an FDA-regulated

manicotti--failed by exceeding the saturated fat cutoff level. Meal

sodium contents ranged from 220 to 580 milligrams in the 61 meals so

that all could meet the 1994 maximum level of 600 milligrams per

serving. When compared to the 1997 phase-in criterion of 480

milligrams, 17 meals (28 percent) failed the sodium test. On the other

hand, 72 percent did meet the level.

FSIS staff went to grocery stores to record current label values

for other FSIS meal products labeled ``healthy'' and obtained

information on 16 additional meals beyond those of the leading brand.

When these 16 meals were compared to the cutoff level for fat

components, four failed by only small amounts. The majority did not

meet the 1994 sodium limit of 600 milligrams.

Based on the data reviewed, FSIS believes many meals can easily

meet the ``healthy'' definition for fat, saturated fat, and cholesterol

levels. FSIS also believes all meals can be formulated to meet the 1994

sodium criterion of 600 milligrams per serving. Regarding the 1997

phase-in criterion of 480 milligrams, 72 percent of the leading brand

meals meet that criterion now. This indicates that it is

technologically feasible to formulate products acceptable to current

consumer taste.

Individual processed meat and poultry products, such as luncheon

meats and frankfurters, will have more difficulty meeting the criteria.

Generally, individual processed meat and poultry products can meet the

fat, saturated fat, and cholesterol levels when the reference amounts

are less than 2 ounces or if they do not contain too much meat or

poultry when the reference amounts are over 8 ounces.

Of about 100 individual food product types for which minimum meat

and/or poultry contents are established by FSIS's ``Standards and

Labeling Policy Book,'' FSIS estimates that approximately one-half

could not be labeled as ``healthy'' if made with lean meat or poultry

to meet the minimum meat or poultry content. However, this still leaves

many individual food product types with the potential to be labeled

``healthy.'' Furthermore, more foods could be so labeled if made with

extra-lean meat or made as nonstandardized versions with less meat or

poultry content.

FSIS also examined current labeling values for individual food

products now carrying the term ``healthy'' in the brand name. All

luncheon meats met the fat criteria; most did not meet the 1994 sodium

criterion of 480 milligrams per reference amount and labeled serving,

although they were not far off. None of the products were close to the

360 milligram criterion for 1997. Most soups met the fat criteria, but

would need some reformulation to meet the current sodium standard, and

would require major reformulation to meet the 1997 sodium criterion of

360 milligrams. Overall, the sodium level will cause the most problem

for this food category. Nonetheless, FSIS believes that the market can

reach the 480 milligrams and 360 milligrams levels within the

timeframes allowed as consumer sodium tastes continue to change.

Under the extra-lean criterion for raw, unprocessed meat and

poultry cuts, a limited number of raw meat and poultry cuts will be

able to meet the cutoff level for fat, saturated fat, and cholesterol.

FSIS is not aware that any of the cuts of meat and poultry that can

meet the definition currently are labeled ``healthy'' in brand names.

FSIS believes that the use of the extra-lean criteria for these foods

and the resulting healthy status of the very leanest of these products

enforce the fact that these foods can be part of a healthy diet. FSIS

also notes that the lean meats can be trimmed, prepared, and

incorporated into meals so that the resulting meal can be labeled

``healthy.'' Since all single-ingredient muscle meats and poultry are

low in sodium, at less than 100 milligrams per 100 grams on both a raw

and cooked basis, a maximum sodium restriction is unnecessary.

In conclusion, FSIS recognizes that the above information is not a

strict representation of the marketplace, but believes that it gives

some expectation of the reformulation problems that will be faced by

the industry. Many products, especially meals, will not face major

changes.

Some manufacturers might not be able to reformulate their products

or may determine that the costs of reformulation are prohibitive. The

manufacturers may choose to market their products under a different

brand name. New resources must also be expended in marketing the

product and in informing consumers that the product has a new name. A

brand name is an intangible asset representing capital just as a

tangible asset is capital. Brand names act as signals that help

consumers identify quality differences and shop more efficiently.

Manufacturers invest real resources in developing and maintaining their

brand identities.

FSIS acknowledges that it could be a cost to the individual

manufacturers of products currently branded ``healthy'' if the brand

names were, in fact, removed from the market. The loss of a brand name

could be a societal loss, as is the loss of any productive asset. The

price consumers are willing to pay for the product may have been due to

consumer misperception about the nutritional profile of the product

bearing the term ``healthy.'' Although most of these products are

nutritionally labeled, some consumers use the term ``healthy'' as a

signal to buy the product and do not read the information on the

nutrition panel on the back of the product.

Manufacturers of those products that make ``healthy'' claims on

products that are not sold under ``healthy'' brand names may choose to

relabel products without the claim when reformulation is either too

costly or not technologically feasible. In its FRIA for the nutrition

labeling regulations, FSIS determined that average costs of redesigning

and printing new labels and inventory losses fell significantly as the

compliance period increased. Costs approach zero when the compliance

period is long enough so that mandated changes can be accomplished in

conjunction with planned labeling changes. FSIS has no information

regarding the number of products that make ``healthy'' claims but do

not use the term in the brand name, but assumes this number is not very

large for meat and poultry products.

Benefits of the Final Rule

In its cost-benefit analysis for the nutrition labeling

regulations, FSIS noted many significant benefits of improved nutrition

labeling, including decreased rates of three types of cancer and

coronary heart disease. The Agency concluded that, as consumers are

given more informative labeling, uncertainty concerning the nutritional

value of the foods they eat will decrease, and many consumers will

select more nutritious, healthier foods. The improved health status of

Americans expected to result from the nutrition labeling rule

pertaining to meat and poultry products was estimated to be about $1.6

billion over a period of 20 years.

It is possible that some products that are currently marketed as

``healthy'' but do not fit the definition may be misleading consumers.

Removal of these products from the marketplace may actually increase

health benefits to consumers. It is also possible that a small number

of products that could assist some consumers in reducing their

consumption of fat, saturated fat, cholesterol, or sodium will be

unable to bear the claim ``healthy,'' thus potentially reducing

benefits. Some products may be reformulated to meet the requirements

for the claim, but may lose sales from lack of consumer taste

satisfaction. It is expected, however, given the selling power of the

term ``healthy'' and the technological advances present in the food

industry, that this rule will increase the number of products bearing

the term ``healthy.''

Executive Order 12778

This final rule has been reviewed under Executive Order 12778,

Civil Justice Reform. States and local jurisdictions are preempted

under the Federal Meat Inspection Act (FMIA) and the Poultry Products

Inspection Act (PPIA) from imposing any marking, labeling, packaging,

or ingredient requirements on federally inspected meat and poultry

products that are in addition to, or different than, those imposed

under the FMIA or PPIA. States and local jurisdictions may, however,

exercise concurrent jurisdiction over meat and poultry products that

are outside official establishments for the purpose of preventing the

distribution of meat and poultry products that are misbranded or

adulterated under the FMIA or PPIA, or, in the case of imported

articles, which are not at such an establishment, after their entry

into the United States. Under the FMIA and PPIA, States that maintain

meat and poultry inspection programs must impose requirements that are

at least equal to those required under the FMIA and PPIA. The States

may, however, impose more stringent requirements on such State

inspected products and establishments.

No retroactive effect will be given to this final rule. The

administrative procedures specified in 9 CFR 306.5 and 381.35 must be

exhausted prior to any judicial challenge of the application of the

provisions of this final rule, if the challenge involves any decision

of an inspector relating to inspection services provided under the FMIA

or PPIA. The administrative procedures specified in 9 CFR parts 335 and

381, subpart W, must be exhausted prior to any judicial challenge of

the application of the provisions of this final rule with respect to

labeling decisions.

Effect on Small Entities

The Administrator has determined that this final rule will not have

a significant economic impact on a substantial number of small

entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).

The final rule provides a definition for the implied nutrient content

claim ``healthy'' and its derivatives and provides for its use on the

labeling of meat and poultry products. Small meat and poultry

establishments are exempt from nutrition labeling, provided the

labeling of their products bears no nutrition claims or nutrition

information.

However, small entities with products that currently bear labeling

that FSIS is regulating as a defined implied nutrient content claim,

i.e., labeling bearing the term ``healthy'' or its derivatives that is

an implied nutrient content claim under FSIS's regulatory definition of

an implied nutrient content claim, may be impacted by this regulation.

If such products do not conform to the regulatory definition of

``healthy,'' the labeling would need to be changed so as not to

misbrand the product, or the product would need to be reformulated to

meet the criteria for the definition. While the term ``healthy'' has

been widely used on labeling, FSIS believes that the number of small

entities with products bearing such labeling is not substantial because

most of the firms using such labeling are large.

Small manufacturers opting to use the term ``healthy'' or its

derivatives as an implied claim on their labeling, as defined by these

regulations, would be required to comply with the nutrition labeling

requirements, thereby, incurring the costs associated with such

compliance. However, the use of the defined implied nutrient content

claim on the labeling would be voluntary. Decisions by individual

manufacturers on whether to use the claim on their product labeling

would be based on their conclusions that the benefits would outweigh

the costs of including such a claim on the labeling. To minimize the

impact on firms with products that do not conform to the regulations,

FSIS is allowing an 18-month implementation period, with an additional

24 months to achieve a further reduction in sodium levels.

Paperwork Requirements

The final rule specifies the regulations permitting the use of the

term ``healthy,'' or any other derivative of the term ``health'' on the

labeling of meat and poultry products. The final rule requires those

manufacturers opting to use the term ``healthy'' or its derivatives as

an implied claim on their labeling, as defined by this regulation, to

revise their labeling and submit such labeling to FSIS for approval.

The paperwork requirements contained in this final rule have been

submitted to the Office of Management and Budget for review.

Background

On January 6, 1993, FSIS published in the Federal Register (58 FR

632) final regulations on nutrition labeling for meat and poultry

products. These regulations contain, in part, provisions governing use

of implied nutrient content claims on product labeling. At 9 CFR

317.313(b) and 381.413(b), FSIS cross-referenced provisions pertaining

to nutrient content claims at 21 CFR 101.13(b) to define an implied

nutrient content claim as one that either describes a food or

ingredient in a manner suggesting a nutrient is absent or present in a

certain amount, or suggests the food, because of its nutrient content,

may be useful in maintaining healthy dietary practices and is made in

association with an explicit claim or statement about a nutrient. FSIS

did not provide a regulatory provision covering the use of the term

``healthy'' in its final nutrition labeling regulations.

In that same issue of the Federal Register (58 FR 688), FSIS

published a proposed rule to solicit comments from the public on

regulatory provisions for the definition and use of the term

``healthy'' or any other derivative of the term ``health.'' FSIS

proposed that the implied nutrient content claim ``healthy'' or any

other derivative of the term ``health'' be permitted on the labeling of

meat and poultry products that meet the following criteria: Contain

less than 10 grams (g) of fat, less than 4 g of saturated fatty acids,

less than 95 milligrams (mg) of cholesterol, and less than 480 mg of

sodium per 100 g and Reference Amount Customarily Consumed for

individual foods, and per 100 g and labeled serving for meal-type

products, as defined in 9 CFR 317.313(l) and 381.413(l). FSIS stated

that the proposed rule would apply the criteria for ``healthy'' to any

term used anywhere on the label that includes the term ``health.'' FSIS

proposed to include the ``healthy'' provisions contained in the

proposed rule (58 FR 688) in 9 CFR 317.309(j) and 381.409(j). FSIS now

believes that the proposed ``healthy'' provisions were inappropriately

placed in a section of the regulations that do not relate to general or

specific requirements for nutrient content claims. Therefore, FSIS is

correcting that oversight in this final rule by promulgating those

provisions at 9 CFR 317.363 and 381.463, which are reserved for

nutrient content claim requirements.

On January 6, 1993, FDA also published a proposal (58 FR 2944) that

would establish a definition for the implied nutrient content claim

``healthy'' for foods under its jurisdiction. FDA proposed to permit

the term ``healthy'' to be used on foods that meet regulatory

definitions for ``low fat'' and ``low saturated fat,'' and that do not

exceed disclosure levels for cholesterol and sodium. In their final

nutrition labeling regulations, FSIS and FDA adopted identical

definitions for the express nutrient content claims of ``low fat'' and

``low saturated fat.'' As defined in 9 CFR 317.362 and 381.462, ``low

fat'' claims may only be made on products containing 3 g or less total

fat per reference amount when they are individual foods and per 100 g

when they are meal-type products. ``Low saturated fat'' claims may only

be made on products containing 1 g or less saturated fat per reference

amount when they are individual foods and per 100 grams when they are

meal-type products. As defined in 21 CFR 101.13(h), FDA's disclosure

levels for cholesterol are 60 mg per reference amount and labeled

serving for individual foods, 90 mg per labeled serving for main

dishes, and 120 mg per labeled serving for meal products. Sodium

disclosure levels are 480 mg per reference amount and labeled serving

for individual foods, 720 mg per labeled serving for main dishes, and

960 mg per labeled serving for meal products.

Discussion of Comments and Final Rule

FSIS received 47 comments in response to the January 6, 1993,

proposed rule (58 FR 688). The majority of the comments (31) were

submitted by food manufacturers, while 5 were received from consumer

groups; 3 from academia; 2 from professional organizations; 2 from

trade associations; 1 from a foreign government; 1 from a State

government; 1 from a food retailer; and 1 from a consumer. All comments

submitted with respect to the proposed rule were given due

consideration. A summary of the comments and FSIS's responses follow.

Use of the Term ``Healthy''

Some commenters questioned FSIS's authority to regulate use of the

word ``healthy.'' These commenters argued that the term is an adjective

which does not characterize the quantity of nutrients in food products.

Other commenters wanted use of ``health'' banned altogether because the

term offers shoppers no substantial information on which to base food

choices, and is only a marketing tool. A foreign government stated that

any differences in nutrition labeling requirements between the U.S. and

other countries will create significant trade barriers. A few

commenters contended that if ``healthy'' is not defined, it should not

be grandfathered, i.e., used as an implied nutrient content claim as

part of brand names in use prior to November 27, 1991, as long as such

use is not false or otherwise misleading, but it should be available

for use by all companies.

The majority of responses supported defining the term because of

current inconsistent usage in the marketplace that serves to confuse

and mislead consumers. Several commenters cited the 1992 National

Consumers League opinion poll, and another cited internal market

research to show that consumers often expect products labeled as

``healthy'' to be low in nutrients of public health concern, such as

fat and sodium. A few manufacturers or products with brand names, trade

names, or product lines now containing the term ``healthy'' advised

that their products were specially formulated to be ``good for you''

and/or control nutrients that health authorities recommend be consumed

at decreased dietary levels in order to lessen the risk of diet-related

diseases or health conditions. There was overwhelming agreement among

commenters that if ``healthy'' is defined, both FSIS and FDA should

adopt uniform criteria so as not to undermine the benefits consumers

will ultimately realize through application of the same definition.

FSIS has authority to require nutrition labeling and to regulate

the labeling of meat and poultry products based upon the statutory

provisions concerning misbranding in the FMIA (21 U.S.C. 601(n)(1)) and

the PPIA (21 U.S.C. 453(h)(1)). Under these statutory provisions, an

article is misbranded if it is false or misleading in any particular.

FSIS agrees with the many commenters who concluded that use of the term

``healthy'' on the labeling of meat and poultry products conveys a

powerful message to consumers about the nutritional attributes of those

products. FSIS believes that in the absence of a regulatory definition

for the term, its use on product labeling has great potential to be

false or misleading to consumers. Accordingly, FSIS is establishing

regulatory provisions governing use of the term ``healthy'' as an

implied nutrient content claim. FSIS's intent is not to hamper free

trade by this action, but, rather, to eliminate misleading the American

consumer through inconsistent use of implied nutrient content claims.

The grandfathering provisions contained in 9 CFR 317.313(q)(1) and

381.413(q)(1) do not exempt defined implied nutrient content claims.

Therefore, upon the effective date of this final rule, the term

``healthy'' or any other derivative of the term ``health'' may no

longer appear as an implied nutrient content claims in brand names of

products that were initially marketed prior to November 27, 1991,

unless the product meets the regulatory requirements covering use of

nutrient content claims.

FSIS and FDA carefully reviewed and assessed their respective

comments regarding the need for a uniform definition for ``healthy.''

Both agencies agree with the comments that requested consistency in the

FSIS and FDA definition of ``healthy,'' and recognize that having

different definitions for the same nutrient content claim could likely

lead to consumer confusion and undermine the usefulness and credibility

of the claim. FSIS and FDA have jointly reached a decision to establish

a uniform definition of the term ``healthy'' as it applies to all foods

regulated by both agencies.

Derivatives and Synonyms

Commenters who addressed applying the criteria for ``healthy'' to

any term that includes the term ``health'' agreed with FSIS's proposed

position to include derivatives of ``health'' in the definition because

they are viewed by consumers as having the same general meaning.

Derivatives of ``health'' include, but are not limited to, the

following terms: Healthful, healthfully, healthfulness, healthier,

healthiest, healthily, and healthiness.

Several commenters asserted that products with labeling bearing

synonymous terms or phrases such as ``nutritious,'' ``wholesome,''

``smart choice,'' and ``foods for today's diets,'' all of which relay a

``good for you'' message, should be defined or required to meet the

``healthy'' definition. FSIS believes that such terms and phrases can

be implied nutrient content claims depending on the context in which

they are used. However, FSIS does not have sufficient information to

establish definitions for such terms or to determine that they are

synonyms for ``healthy.'' Therefore, such synonymous terms or phrases

are not included in this final rule.

Nutritional Context

Some commenters supported FSIS's proposed approach to treat the

term ``healthy'' as an implied nutrient content claim when it is used

in a brand name or elsewhere on the labeling of a product, except as it

pertains to general dietary guidance language. For example, one

commenter stated that when the term is used without context, either in

a brand name or standing alone, or when it is used on labeling that

bears other nutrient content claims, it should be presumed, based on

scores of examples on the market today, that consumers will believe the

term is used in reference to the nutritional properties of the labeled

food. Without context, the possible meaning is ambiguous, at a minimum,

which should be construed against the manufacturer, who has the

opportunity to provide clarifying language if a different meaning is

intended.

Other commenters urged FSIS to consider the textual use of the term

in determining whether it constitutes an implied nutrient claim,

contending that there will be circumstances where the term ``healthy''

neither explicitly nor implicitly characterizes the level of nutrients

in a food. Many were concerned that the vast bulk of published,

authoritative guidance material would be prohibited from use with any

USDA-regulated product under FSIS's proposed approach.

After careful review of all comments, FSIS has reconsidered usage

of ``healthy'' on labeling, and concludes that it would not be in the

best interest of consumers to preclude use of dietary guidance

statements, which frequently include the term ``healthy,'' on the

labeling of meat and poultry products. Also, FSIS recognizes that there

may be circumstances where the term ``healthy'' neither explicitly or

implicitly characterizes the level of a nutrient in a product, and

where it can be placed in proper context, for example, in advertising

copy on product labeling. FSIS is now convinced that it should evaluate

the term within the context of the entire labeling to determine if it

is used as an implied nutrient content claim as provided for in 9 CFR

317.313(b) and 381.413(b).

However, comments strongly suggest that use of the term ``healthy''

or any other derivative of the term ``health'' in the brand name of a

product or standing alone, including in a phrase, as in a banner or

flagged statement, and either with or without other nutrient content

claims, might lead consumers reasonably to believe that the labeled

product is useful in achieving a total diet conforming to dietary

guidelines by virtue of the nutritional attributes of the specific

product. While clarifying language might be used to identify non-

nutritional meaning, FSIS does not believe that such statements

standing alone, which might take the form of ``healthy, a big portion''

or ``healthy, no chemical preservatives,'' would necessarily negate a

nutritional meaning, and consumers might assume reasonably that

``healthy'' has a double meaning in those situations.

While FSIS agrees that use of the term ``healthy'' or any other

derivative of the term ``health'' in the brand name of a product or

standing alone is not inherently misleading, FSIS believes that such

use may be placed in a nutritional context in the absence of other

explicit or implied nutrient content claims on the labeling of the

product. Products bearing ``healthy'' in the brand name or standing

alone often are advertised and promoted to highlight the fact that they

are specially formulated to contain nutrients at levels that will

assist consumers to maintain healthy dietary practices. The product

lines frequently cover a wide variety of products, and the names are

recognized as characterizing products that can help consumers to meet

dietary recommendations.

FSIS believes that a nutritional context for a term may be

established by written statements, symbols, or vignettes on a product's

labeling, and by advertising, promotional materials, or other relevant

action. Therefore, FSIS views use of the term ``healthy'' or any other

derivative of the term ``health'' in a brand name or standing alone to

be in a nutritional context, even in the absence of other nutrient

claims, when such appearance implies that the product is useful in

maintaining healthy dietary practices. A nutritional context would not

be established when the term appears in a name listed only as part of

the identification of the manufacturer, packer, or distributor as

required in 9 CFR 317.2(c)(3) and 381.122 for meat and poultry

products, respectively, because associations would be to a company as

opposed to a specific product.

Individual Foods

Some commenters requested that FSIS restrict use of the term

``healthy'' to meal-type products. They argued that the term should be

limited to complete meals containing proper proportions of foods from

different food groups because the Food Guide Pyramid and other

traditional approaches to sound nutrition recommend certain numbers of

a variety of foods from several food groups for the average person.

Other commenters agreed with FSIS that the definition should not be

limited solely to meal-type products because many individual foods have

special nutritional attributes that contribute to a healthy diet. FSIS

is not persuaded that the definition should be confined to meal-type

products, and believes that both individual foods and meal-type

products can be used with a variety of foods to assist consumers to

achieve a total diet conforming to dietary guidelines.

Uniform Definition

FSIS received numerous comments that suggested definitions for use

of the term ``healthy'' on food labeling. As mentioned previously,

there was overwhelming agreement that FSIS and FDA adopt a uniform

definition. Both agencies conclude that because of the term's

widespread appeal and its potential usefulness in denoting foods than

can assist consumers in maintaining healthy dietary practices, the

definition should be reasonable and practical. The following discussion

addresses fat and saturated fat, cholesterol, sodium, and nutritive

value in turn.

1. Fat and Saturated Fat. Most commenters who maintained that the

term ``healthy'' should be defined by regulation supported limitations

on amounts of fat and saturated fat as prerequisites to use the term on

the labeling of meat and poultry products. Some agreed with the

proposed criteria of parallel levels for fat and saturated fat, as

required for use of the term ``lean'' without providing further grounds

for support other than those presented by FSIS in the preamble to its

proposal. The majority of commenters opposed the proposed criteria for

fat and saturated fat, on the basis that the levels were too high under

most conditions. Other commenters urged FSIS not to apply the same

criteria to individual foods as to meal-type products because the

latter generally contribute a larger fraction of total daily nutrients

and energy than most individual foods.

Some commenters who objected to the proposed definition voiced

concern that it might mislead consumers who purchase a product labeled

as ``healthy'' in an effort to minimize their intake of fat and

saturated fat. They argued that linking the definition of ``healthy''

to the definition of ``lean'' was not appropriate because foods labeled

as ``healthy'' are more than merely foods that can be incorporated into

a healthy diet. They asserted that the term ``healthy,'' as understood

by consumers and used by manufacturers, should be reserved for those

products that are the very best in helping consumers to limit their

intake of nutrients of public health concern, such as fat, cholesterol,

and sodium.

FSIS has carefully considered these comments, and concludes that

the criteria established for use of the term ``healthy'' on the

labeling of meat and poultry products should minimize intakes of fat

and saturated fat. FSIS is convinced that products low in fat and

saturated fat meet this goal. Accordingly, FSIS has modified the

proposed criteria of less than 10 g of fat and less that 4 g of

saturated fat to require that products meet the regulatory definitions

for ``low fat'' and ``low saturated fat.'' These new restrictions

recognize that a significant characteristic of the American diet is an

excess of fat and saturated fat, and will assure consumers that foods

labeled ``healthy'' are among the lowest in fat and saturated fat on

the market. Selection of ``low fat'' and ``low saturated fat'' criteria

for use of the term ``healthy'' is also responsive to the assertion

that individual foods and meal-type products should not be treated

uniformly because the latter, by definition, make a substantial

contribution to the diet.

One commenter suggested that the fat and saturated fat content of

meal-type products be capped at 10 g and 4 g per labeled serving,

respectively, to ensure that products labeled as ``healthy'' are lower

in these nutrients than meal-type products bearing competing claims

such as ``low fat'' and ``lean.'' FSIS rejects this suggestion because

the ``low'' criteria are designed to help consumers construct a diet

that is consistent with dietary guidelines, and FSIS believes they are

adequate to minimize fat intake.

A manufacturer of a line of meal-type products bearing the term

``healthy'' and exceeding the limit of 12 ounces per serving

(container) prescribed at 9 CFR 317.313(l) and 281.413(l) for meal-type

products for the purposes of making nutrient content claims requested

that limits on fat and saturated fat be indexed up for single-serving

meals that exceed 12 ounces in weight. In response, FSIS notes that the

``low fat'' and ``low saturated fat'' criteria are indexed on the per-

100-g basis. Therefore, FSIS does not perceive a need to evaluate meal-

type products that weigh more than 12 ounces on a case-by-case basis

for use of the implied nutrient content claim ``healthy.'' Accordingly,

FSIS is including meals that weigh more than 12 ounces in the

definition of a meal-type product for purposes of using the term

``healthy'' on the labeling of these products.

2. Cholesterol. Most of the commenters who supported limitations on

fat and saturated fat also supported limitations on cholesterol so that

products labeled as ``healthy'' would assist consumers to minimize

their intake of cholesterol. While some commenters argued for a strict

``low cholesterol'' criterion, a number agreed that the proposed levels

were appropriate because they were not overly restrictive and were

consistent with the cholesterol content of muscle meat.

Regarding comments favoring a ``low cholesterol'' criterion, FSIS

is not persuaded that a definition for ``healthy'' that requires a

product to be low in cholesterol is warranted. Such a definition would

virtually preclude use of the term on a large majority of food products

for the general public that are in the marketplace today--an outcome

that would be a disservice to both consumers and manufacturers alike.

Dietary guidelines advise consumers to eat a variety of foods, choosing

different foods from five major food groups that include vegetables;

fruits; grain products; dairy products; and meat, poultry, fish, dry

beans, eggs, and nuts. FSIS believes that the ``healthy'' definition

should encompass appropriate foods from all of these food groups in

order to be useful to consumers in selecting foods that can be used to

construct a healthy diet. Cholesterol is not ubiquitous in the food

supply but only found in foods of animal origin. Cholesterol is not

present in a number of foods, such as fruits and vegetables, that are

included in healthy diets, and dietary reductions in both total fat and

saturated fat facilitate reduction in dietary cholesterol. Because FSIS

is adopting in this final rule ``low fat'' and ``low saturated fat''

criteria for the definition of ``healthy,'' it concludes that a need to

require a ``low cholesterol'' criterion is not justified.

In view of concerns expressed by commenters that criteria for

``healthy'' should minimize intake of cholesterol, as well as fat and

saturated fat, FSIS has reconsidered its proposed criteria for

cholesterol. FSIS had proposed a limit of no more than 95 mg per 100 g

and per labeled serving (container) for meal-type products. Because

these products must weigh at least 6 ounces as defined in 9 CFR

317.313(l) and 381.413(l), they are restricted to less than 95 mg of

cholesterol in an entire serving. A commenter observed that it is

reasonable to expect meal-type products to contain no more than this

level. Even if meal-type products provided a third of a day's food

intake, their cholesterol content would have to fall under 100 mg for

an individual to consume less than the 300-mg recommended daily intake.

FSIS examined the disclosure level for cholesterol defined by FDA

at 21 CFR 101.13(h)(3) for a main dish product, as defined in 21 CFR

101.13(m) and that weighs at least 6 ounces. This level is 90 mg of

cholesterol per labeled serving and represents the lowest cholesterol

disclosure level for meal-type products of all weights. Because low fat

foods generally help individuals in reducing their intake of saturated

fat and cholesterol, and FSIS is adopting ``low fat'' and ``low

saturated fat'' criteria for use of the term ``healthy,'' FSIS

concludes that it is reasonable to apply a limitation of 90 mg of

cholesterol per labeled serving for use of the term ``healthy'' on

meal-type products. FSIS believes the 90 mg of cholesterol limit used

in conjunction with ``low fat'' and ``low saturated fat'' criteria

combine to set technologically feasible parameters that should

encourage manufacturers to design a broad range of these food products.

When cholesterol-containing foods such as meat, poultry, fish, eggs, or

cheese are components of meal-type products, manufacturers should be

able to meet the 90 mg of cholesterol limit by decreasing the amount of

cholesterol-containing foods in the products.

Commenters noted that most individual foods play a smaller role in

the daily diet than meal-type products so that it is anomalous to apply

the same disqualifying levels to both types of products. They stated

further that, as it was appropriate for FSIS to develop different

nutrient content claim criteria for individual foods and for meal-type

products, it is likewise appropriate that this same rationale be

applied in defining ``healthy.'' FSIS is now convinced that the

cholesterol criterion for individual foods should be lower than the

proposed 95-mg limit. FSIS believes that the limit of 60 mg of

cholesterol per reference amount customarily consumed and per labeled

serving size proposed by FDA for individual foods is a reasonable and

appropriate limit to minimize cholesterol intake from these products

when considering that the products must also meet ``low fat'' and ``low

saturated fat'' criteria. Accordingly, FSIS is adopting in this final

rule FDA's cholesterol criterion for the definition of ``healthy'' as

applied to individual food products.

3. Sodium. While a few commenters suggested that a limit on sodium

for a healthy food is unnecessary, most agreed that a limit is

appropriate, noting it is widely recognized that the average daily

sodium intake of Americans is higher than optimal under the Dietary

Guidelines for Americans, and that it is worth striving for the control

of sodium in food products. Although some commenters urged FSIS to

adopt FDA's proposed limits on sodium, the majority expressed the

opinion that FDA's sodium restrictions for meal products, main dishes,

and individual foods are too high. They further stated that while

FSIS's proposed limits may be reasonable for meal-type products, they

are too low for individual food products, in some cases, because they

must qualify on the per-100-g basis, as well as per reference amount. A

few commenters urged FSIS to adopt ``low sodium'' criteria for

individual foods and meal-type products. One commenter suggested a cap

of 480 mg of sodium per labeled serving for meal-type products if ``low

sodium'' criteria are adopted for this category of products.

After review and evaluation of the comments, FSIS concludes that

the concept of using disclosure levels as limits on the sodium content

in foods labeled as ``healthy'' does not minimize sodium intake from

such products. FSIS believes that a level above 480 mg of sodium per

labeled serving in meal-type products may not be helpful to consumers

who might choose products labeled as ``healthy'' as a means to achieve

the recommended daily intake of 2,400 mg of sodium per day. However,

FSIS maintains that ``low sodium'' criteria are overly restrictive

because a diet limited to ``low sodium'' products is not required to

meet dietary recommendations. FSIS is not persuaded by the comments to

change its proposed sodium criterion for meal-type products. FSIS is

convinced that a level of 480 mg of sodium per labeled serving is both

appropriate and technologically feasible. FSIS is deleting the per-100-

g basis on the sodium criterion for meal-type products because it is

superfluous for products that, by definition, weigh over 100 g.

Evidence supplied by commenters shows that many meal-type products

currently bearing the term ``healthy,'' or similar terms, on their

labeling average well below FDA's proposed cutoff levels of 720 mg of

sodium per labeled serving for main dishes and 960 mg for meal

products. While a number of the products are at or slightly below the

limit of 480 mg of sodium per labeled serving proposed by FSIS, there

are a number that exceed this level. A commenter suggested that a

sodium limit of 600 mg per labeled serving might be a reasonable level

for meal-type products that would provide room for consumption of

beverages and snacks throughout the day. Other commenters stressed that

it would be counterproductive to establish restrictions on sodium that

would diminish consumer acceptance of otherwise healthy products and

damage their marketability.

Based on information about the sodium content of meal-type products

on the market, FSIS believes that additional time should be afforded

manufacturers to reformulate products to meet the level FSIS is

adopting. This action minimizes compliance costs, ensures that products

will continue to meet consumer expectations, and is consistent with

FDA's approach. Accordingly, with regard to use of the term ``healthy''

on meat and poultry products, FSIS is establishing an interim criterion

of 600 mg of sodium per labeled serving for meal-type products.

Although this criterion must be met by the effective date of the

regulations, FSIS is allowing an additional 24 months for affected

parties to comply with the sodium criterion of 480 mg per labeled

serving.

Regarding individual foods, several commenters objected to FSIS's

proposed criterion of 480 mg of sodium per 100 g as too low in some

cases, contending that salt is a necessary addition to processed meats,

not a discretionary addition as with other processed food products. One

commenter stated that sodium is required for the production, shelf life

and safety of processed meats at some minimal level which exceeds 480

mg per 100 g. The commenter further argued that even though potassium

salt has been able to replace sodium salt to some degree (up to 40

percent), a level of 700 mg of sodium per 100 g of product could be

reached at best. A commenter also suggested that products reflecting a

meaningful reduction in a nutrient from a previous recipe should be

allowed to qualify for use of the term ``healthy.''

Based on information received in the comments and discussions with

FDA, FSIS concludes that, in order for the definition of ``healthy'' as

it applies to individual foods to be useful in assisting consumers to

achieve dietary goals, the amount of sodium permitted should be

significantly less than 20 percent of the recommended daily level of

2,400 mg per day, i.e., less than 480 mg per reference amount and

labeled serving. A significant reduction in a nutrient, as provided for

in 9 CFR 317.313(j) and 381.413(j) for relative claims, is at least 25

percent. However, for the definition of ``healthy,'' the reduction

cannot be applied to a particular food because the term ``healthy'' is

not defined as a relative claim, but as an implied nutrient content

claim. By applying the significant reduction principle to FDA's sodium

disclosure level for individual foods, FSIS arrives at a level of 360

mg (75 percent of 480 mg) per reference amount and labeled serving.

Accordingly, FSIS is establishing the sodium criterion for the

``healthy'' definition as it applies to individual foods at 360 mg per

reference amount and labeled serving.

For the same reasons discussed for meal-type products, FSIS

believes that additional time should be afforded manufacturers for

product reformulation to comply with the criterion of 360 mg of sodium

for the ``healthy'' definition as it applies to individual foods. As

with meal-type products, such action minimizes compliance costs,

ensures continued product acceptability, and is consistent with the

approach FDA is adopting. Accordingly, with regard to use of the term

``healthy'' on meat and poultry products, FSIS is establishing an

interim criterion of 480 mg of sodium per reference amount and labeled

serving for products that are individual foods. Although this criterion

must be met by the effective date of the regulations, FSIS is allowing

an additional 24 months for affected parties to comply with the sodium

criterion of 360 mg per reference amount and labeled serving.

Based on the comments submitted and other data it reviewed, FSIS is

aware that many meat and poultry products, which are individual foods,

exceed the 360 mg of sodium limit. Only a few products meet the limit

at this time, while somewhat more meet the interim limit of 480 mg of

sodium. Considering the 3\1/2\-year phase-in period allowed and the

information reviewed, FSIS believes the 360-mg level is a reasonable

and practical limit that both minimizes sodium intake and encourages

production of improved products. Furthermore, manufacturers have

options other than ``healthy'' to choose other claims such as ``light''

and ``reduced'' to describe products that fit into a healthy diet,

should their products fail to meet the sodium qualification for the

``healthy'' definition.

To ensure full compatibility with FDA's sodium criterion for

individual foods, FSIS is providing identical allowances for foods with

reference amounts of 30 g or less or 2 tablespoons or less, and for

dehydrated products that must be reconstituted with water or diluents

containing insignificant amounts of nutrients.

4. Nutritive Value. In its proposal on use of the term ``healthy,''

FSIS stated that it had solicited comments on use of the term in its

proposed rule entitled ``Nutrition Labeling of Meat and Poultry

Products'' published in the Federal Register on November 27, 1991 (56

FR 60302). Although FSIS did not propose requirements for essential

nutrients in its proposal on ``healthy'' issued on January 6, 1993,

FSIS noted that a few comments were received in response to the

November 27, 1991, proposal. Some commenters stated that the term

should not only be equated with controlled amounts of fat, saturated

fatty acids, cholesterol, and sodium, but that use of the term should

also meet the ``high'' definition for a certain number of

micronutrients.

In response to FSIS's proposal on ``healthy,'' some commenters

opposed additional definition requirements that a food labeled as

``healthy'' contain certain specified amounts of essential vitamins,

minerals, or other nutrients, on the basis that many nutritious foods

might fail to qualify, or that such a requirement might limit a

manufacturer's ability to formulate improved products. However, others

stated it would be absurd if foods without nutritional value could be

labeled as ``healthy'' while nutrient-dense lean meat products might

fail to qualify because of the inherent fat content of muscle tissue.

Most commenters favored an essential nutrient requirement because foods

labeled as ``healthy'' should make a nutritional contribution to the

diet, in addition to minimizing intake of nutrients of public health

concern. One commenter cited a recent survey by the American

Association of Retired Persons showing that 63 percent of respondents

said they expect a product labeled as ``healthy'' to be a good source

of some important vitamins and minerals.

Commenters suggested that requirements for six essential nutrients

for which labeling disclosure is mandatory, i.e., vitamin A, vitamin C,

calcium, iron, protein, and dietary fiber, be established at 10 percent

of the Reference Daily Intake or Daily Reference Value, i.e., an amount

consistent with the definition for good source of a nutrient, based on

the weight of the food product as follows: Meal products should provide

at least three of the six nutrients; main dishes should provide at

least two of the six nutrients; and individual foods should be a good

source of at least one of the six nutrients. Commenters also

recommended that requirements for essential nutrients be met prior to

nutrient addition to food products, so as to preclude addition solely

for the purpose of meeting the criteria for the claim ``healthy.''

FSIS has carefully considered these comments and suggested

requirements, and agrees that products labeled as ``healthy'' should

provide essential nutrients in the amounts recommended by commenters

prior to nutrient addition. Accordingly, FSIS is adopting the suggested

requirements of meal products, main dishes, and individual foods prior

to nutrient addition. To provide consistency with FDA's meal categories

on a weight basis, FSIS is applying the requirements per labeled

serving suggested for FDA's main dish products to FSIS-regulated meal

products weighing at least 6 ounces, but less than 10 ounces, and the

requirements per labeled serving suggested for FDA's meal products to

FSIS-regulated meal products weighing 10 ounces or more, including

those weighing more than 12 ounces.

FSIS interprets nutrient addition as an addition of nutrients

specifically to meet the requirements for ``healthy.'' For example, the

requirement does not preclude claims on products where a nutrient is

added to meet a standard of identity; a nutrient is added for

technological purposes, e.g., L-ascorbic acid (vitamin C) in curing

meats; a non-meat or non-poultry ingredient fortified in accordance

with FDA requirements and policy is used; or an ingredient is used that

is a source of a nutrient, such as textured vegetable protein.

Single-Ingredient, Raw Products

Several commenters suggested that FSIS establish a separate

category for muscle cuts of meat and poultry based on criteria for

``extra lean,'' which might also be appropriate for fish and game meats

under FDA jurisdiction. Based on information submitted by commenters

and otherwise available, FSIS believes that a number of meat and

poultry products that are individual foods comprised of more than one

ingredient readily can be formulated to meet the criteria for fat,

saturated fat, and cholesterol that FSIS is adopting. For example, many

soups that contain lesser amounts of meat or poultry and certain

luncheon products with added water or non-meat ingredients and that

have 55-g reference amounts currently meet the criteria.

However, FSIS realizes that single-ingredient, raw meat and poultry

products are severely impacted by the restrictions on fat, saturated

fat, and cholesterol. Information reported in USDA's Agriculture

Handbook No. 8 shows that no single cut of beef, pork, lamb, veal, or

chicken could meet all three requirements, and only skinless light meat

cuts of turkey could qualify to use the term.

A number of commenters stressed that ``healthy'' should be defined

in such a way that it is consistent with dietary guidelines. They

mentioned that many recommendations from public health organizations

and the Dietary Guidelines for Americans advise choosing lean meats,

fish, and poultry without skin as a means of achieving nutritious diets

low in fat, saturated fat, and cholesterol. They further stated that if

lean meats cannot be labeled as ``healthy'' because of the inherent fat

content of muscle tissue, there is little incentive for industry to

further its research and production of leaner red meat.

FSIS believes that products failing to meet the definition for

``healthy'' can also have a place in a healthy diet. Choosing lean

versus fattier cuts of meats makes it easier for Americans to meet

dietary guidelines. FSIS is fully aware that lean cuts of meat and

poultry, which of themselves do not meet definitions for ``low fat''

and ``low saturated fat,'' and do not contain 60 mg or less of

cholesterol per reference amount and labeled serving, can be

incorporated readily into meal-type products and individual food

mixtures that do meet the ``healthy'' definition. As stated in the

preamble to its proposal, FSIS believes that the criteria for

``healthy'' should not interfere with dietary guidance messages of

encouraging consumption of a variety of foods and increased use of lean

meats and poultry products.

FSIS is convinced that products labeled as ``healthy'' should both

assist consumers in meeting dietary guidelines, as well as minimize

intake of nutrients of public health concern. FSIS finds merit in those

comments suggesting that criteria for ``extra lean'' be considered for

use of the term ``healthy'' in connection with cuts of meat and

poultry. Accordingly, FSIS is providing in this final rule that single-

ingredient, raw meat and poultry products that meet the requirements

for ``extra lean'' may qualify to use the term ``healthy'' on the

labeling, provided they meet all other requirements to bear the claim.

Products qualify for the ``extra lean'' claim when they contain less

than 5 g of fat, less than 2 g of saturated fat, and less than 95 mg of

cholesterol per 100 g and per reference amount customarily consumed.

Single-ingredient, raw meat and poultry products may meet the ``extra

lean'' requirements in lieu of meeting definitions for ``low fat'' and

``low saturated fat'' and the limitation of

60 mg or less of cholesterol per reference amount and labeled serving.

Although ``extra lean'' criteria as applied to single-ingredient, raw

products are slightly less stringent than the criteria adopted for

processed, multi-ingredient individual food products, they both

recognize the inherent nutrient profile of muscle tissue and identify

the very leanest of meat and poultry products available to consumers in

the marketplace. Thus, ``extra lean'' criteria meet the goal of

minimizing fat intake from this important category of products that are

staples in the American diet.

FSIS is not specifying a sodium criterion for single-ingredient,

raw meat and poultry products because these products are inherently low

in sodium, containing amounts well below the limit established for

individual foods.

Implementation Date

In its proposed rule on use of the term ``healthy,'' FSIS advised

that it intended to make any final rule that derived from the

rulemaking effective the same effective date as the final rule entitled

``Nutrition Labeling of Meat and Poultry Products,'' which is July 6,

1994. FSIS further stated that, if, for some reason, a final rule on

``healthy'' and similar terms is not issued in time to meet the same

effective date as FSIS's final rule on nutrition labeling, the use of

``healthy'' and similar terms would be subject to the nutrient content

claim provisions set forth in the final rule on nutrition labeling.

In response to comments on the proposed rule, the provisions of

this final rule differ from the provisions contained in the proposed

rule. The differences are of a magnitude that will require the

relabeling, reformulation, and/or reanalysis of some products currently

on the market, i.e., those with labeling currently bearing the term

``healthy'' or any other derivative of ``health,'' and which do not

meet the requirements set forth in this final rule.

Therefore, FSIS has decided that sufficient time should be allotted

to make any changes necessary for manufacturers to comply with this

rule. FSIS has determined that this final rule will be implemented 18

months from the date of its promulgation, with an additional 24 months

to achieve further reductions in sodium levels. This 18-month period is

the same period as allowed for the nutrition labeling regulations based

on comments received from the public on issues related to its

implementation date. This timeframe is also consistent with FDA's

enforcement strategy as discussed in its companion rulemaking on use of

the term ``healthy.''

List of Subjects

9 CFR Part 317

Food labeling, Food packaging, Meat inspection.

9 CFR Part 381

Food labeling, Poultry and poultry products, Poultry inspection.

Final Rule

For the reasons discussed in the preamble, FSIS is amending 9 CFR

parts 317 and 381 of the Federal meat and poultry products inspection

regulations as follows:

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

1. The authority citation for part 317 continues to read as

follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

2. Section 317.363 is added to read as follows:

Sec. 317.363 Nutrient content claims for ``healthy.''

(a) The term ``healthy,'' or any other derivative of the term

``health,'' may be used on the labeling of any meat or meat food

product, provided that the product is labeled in accordance with

Sec. 317.309 and Sec. 317.313.

(b)(1) The product shall meet the requirements for ``low fat'' and

``low saturated fat,'' as defined in Sec. 317.362, except that single-

ingredient, raw products may meet the total fat and saturated fat

criteria for ``extra lean'' in Sec. 317.362.

(2) The product shall not contain more than 60 milligrams (mg) of

cholesterol per reference amount customarily consumed, per labeled

serving size, and, only for foods with reference amounts customarily

consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per

50 g, and, for dehydrated products that must be reconstituted with

water or a diluent containing an insignificant amount, as defined in

Sec. 317.309(g)(1), of all nutrients, the per-50-g criterion refers to

the prepared form, except that:

(i) A meal-type product, as defined in Sec. 317.313(l), and

including meal-type products that weigh more than 12 ounces (oz) per

serving (container), shall not contain more than 90 mg of cholesterol

per labeled serving size; and

(ii) Single-ingredient, raw products may meet the cholesterol

criterion for ``extra lean''in Sec. 317.362.

(3) The product shall not contain more than 360 mg of sodium,

except that it shall not contain more than 480 mg of sodium during the

first 24 months of implementation, per reference amount customarily

consumed, per labeled serving size, and, only for foods with reference

amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50

g, and, for dehydrated products that must be reconstituted with water

or a diluent containing an insignificant amount, as defined in

Sec. 317.309(g)(1), of all nutrients, the per-50-g criterion refers to

the prepared form, except that:

(i) A meal-type product, as defined in Sec. 317.313(l), and

including meal-type products that weigh more than 12 oz per serving

(container), shall not contain more than 480 mg of sodium, except that

it shall not contain more than 600 mg of sodium during the first 24

months of implementation, per labeled serving size; and

(ii) The requirements of this paragraph (b)(3) do not apply to

single-ingredient, raw products.

(4) The product shall contain 10 percent or more of the Reference

Daily Intake or Daily Reference Value as defined in Sec. 317.309 for

vitamin A, vitamin C, iron, calcium, protein, or fiber per reference

amount customarily consumed prior to any nutrient addition, except

that:

(i) A meal-type product, as defined in Sec. 317.313(l), and

including meal-type products that weigh at least 6 oz but less than 10

oz per serving (container), shall meet the level for two of the

nutrients per labeled serving size; and

(ii) A meal-type product, as defined in Sec. 317.313(l), and

including meal-type products that weigh 10 oz or more per serving

(container), shall meet the level for three of the nutrients per

labeled serving size.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

3. The authority citation for part 381 continues to read as

follows:

Authority: 7 U.S.C. 450, 21 U.S.C. 451-470; 7 CFR 2.17, 2.55.

4. Section 381.463 is added to read as follows:

Sec. 381.463 Nutrient content claims for ``healthy.''

(a) The term ``healthy,'' or any other derivative of the term

``health,'' may be used on the labeling of any poultry product,

provided that the product is labeled in accordance with Sec. 381.409

and Sec. 381.413.

(b)(1) The product shall meet the requirements for ``low fat'' and

``low saturated fat,'' as defined in Sec. 381.462, except that single-

ingredient, raw products may meet the total fat and saturated fat

criteria for ``extra lean'' in Sec. 381.462.

(2) The product shall not contain more than 60 milligrams (mg) of

cholesterol per reference amount customarily consumed, per labeled

serving size, and, only for foods with reference amounts customarily

consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per

50 g, and, for dehydrated products that must be reconstituted with

water or a diluent containing an insignificant amount, as defined in

Sec. 381.409(g)(1), of all nutrients, the per-50-g criterion refers to

the prepared form, except that:

(i) A meal-type product, as defined in Sec. 381.413(l), and

including meal-type products that weigh more than 12 ounces (oz) per

serving (container), shall not contain more than 90 mg of cholesterol

per labeled serving size; and

(ii) Single-ingredient, raw products may meet the cholesterol

criterion for ``extra lean'' in Sec. 381.462.