[Federal Register Volume 59, Number 89 (Tuesday, May 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11140]


[[Page Unknown]]

[Federal Register: May 10, 1994]


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Part II





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Part 317 et al.




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

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 91-006F-HLTH]
RIN 0583-AB34

 
Nutrition Labeling; Use of ``Healthy'' and Similar Terms on Meat 
and Poultry Product Labeling

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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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.
    (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. 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 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. 381.409 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. 381.413(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. 381.413(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.

    Done at Washington, DC, on: May 4, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-11140 Filed 5-5-94; 10:27 am]
BILLING CODE 3410-DM-M