[Federal Register: October 1, 2004 (Volume 69, Number 190)]
[Rules and Regulations]               
[Page 58799-58803]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc04-1]                         


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Rules and Regulations
                                                Federal Register
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[[Page 58799]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 00-046F]
RIN 0583-AD07

 
Nutrition Labeling: Nutrient Content Claims on Multi-Serve, Meal-
Type Meat and Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its 
nutrition labeling regulations to change the definition of ``meal-
type'' products to allow for nutrient content claims on multiple-serve 
food containers, to adopt the definition of ``main dish'' used by the 
Food and Drug Administration (FDA), and to define how meal-type 
products and main dishes should be nutrition labeled. The change in the 
definition of meal-type products will allow nutrient content claims on 
qualifying products to be based on 100 grams of product rather than on 
the serving size, which is based on the Reference Amounts Customarily 
Consumed (RACCs) for the food components. These actions are in response 
to a petition filed by ConAgra, Inc. (the petitioner). The changes will 
help to ensure that FSIS' nutrition labeling regulations are parallel, 
to the maximum extent possible, to the nutrition labeling regulations 
of FDA, which were promulgated under the Nutrition Labeling and 
Education Act (NLEA) of 1990.

EFFECTIVE DATE: Effective on November 30, 2004.

FOR FURTHER INFORMATION CONTACT: Robert C. Post, Ph.D., Director, 
Labeling and Consumer Protection Staff, Office of Policy, Program and 
Employee Development, FSIS, at (202) 205-0279 or by fax at (202) 205-
3625.

SUPPLEMENTARY INFORMATION:

Background

    The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the 
Poultry Products Inspection Act (21 U.S.C. 451 et seq.) authorize the 
Secretary of Agriculture to establish and maintain inspection programs 
designed to assure consumers that meat and poultry products distributed 
in commerce are wholesome, not adulterated, and properly marked, 
labeled, and packaged. FSIS regulates the labeling of meat and poultry 
products, and FDA has responsibility for all other food labeling.
    In January of 1993, FSIS and FDA published their final rules on 
nutrition labeling. Both agencies amended their respective regulations 
to (1) Require either mandatory or voluntary nutrition labeling on most 
of the food products they regulate; (2) revise the list of required 
nutrients and food components; (3) specify a new format for declaring 
the nutrients and food components in nutrition labeling; (4) permit 
specific products to be exempt from nutrition labeling; (5) establish 
RACCs specific for food categories; and (6) prescribe a simplified form 
of nutrition labeling and the conditions under which such labeling may 
be used.
    In order for persons to use the nutrition information to construct 
healthy diets that include products from across the food supply, the 
two agencies recognized that the regulations need to be as consistent 
as possible. There was overwhelming support for FSIS to proceed with 
the adoption of FDA-defined nutrient content claims, including adopting 
a constant value of 100 grams for comparison of nutrient content claims 
on meal-type products. As a result, both agencies issued regulations 
establishing, as nearly uniform as possible, definitions for nutrient 
content claims to allow consumers to make valid comparisons among food 
product categories.
    In addition, the agencies participated in the Interagency Committee 
on Serving Sizes to jointly establish the RACCs for foods and the 
criteria for converting RACCs to serving sizes in common household 
measures. The final FSIS rule, among other things, established RACCs 
for 23 meat (9 CFR 317.312(b)) and 22 poultry product categories (9 CFR 
381.412(b)). These RACCs were calculated to reflect the amount of food, 
including snacks, dinners, and condiments, that persons four years of 
age and older customarily consume. These calculations were based on 
consumption survey data and on data used by food manufacturers and 
grocers. RACCs are designed to be used by food companies as the basis 
for determining the serving sizes for nutrition labeling of their 
products.
    Nutrient content claims for both FDA and FSIS are composed of two 
defined parts: The amount (weight) of the nutrient and the amount 
(generally a serving) of food in which the nutrient is found. If the 
food is considered to be an individual food, the amount of food (a 
serving) is represented as the RACC for the food category. If the food 
is a meal-type product, the amount of food is measured by weight, i.e., 
100 grams. If a ``low-fat'' or ``healthy'' claim is used, the amount of 
fat is limited to a maximum of 3 grams per RACC for individual foods 
and 3 grams per 100 grams of product for meal-type products.
    However, FSIS and FDA have established different criteria for what 
constitutes a meal. FSIS defined a ``meal-type'' product (9 CFR 
317.313(l) and 381.413(l)) as a product for consumption by one person 
on one eating occasion that constitutes the major portion of a meal. 
For purposes of making a nutrition claim, a meal-type product must (1) 
make a significant contribution to the diet by weighing at least 6 
ounces, but no more than 12 ounces per serving (container); (2) contain 
ingredients from two or more food groups, depending on the weight of 
the product; and (3) represent, or be in a form commonly understood to 
be, a meal (breakfast, dinner, etc). In addition, the serving size for 
meal-type products is defined as the entire content (edible portion 
only) of the package, i.e., single-serve container.
    FDA defined a ``meal-type'' product (21 CFR 101.13(l)) for the 
purpose of making a claim as a product that makes a major contribution 
to the total diet by (1) weighing at least 10 ounces per labeled 
serving; (2) containing not less than three 40-gram portions of food or 
combinations of foods from two or more of the four food groups; and (3) 
representing, or being in a form commonly understood to be, a meal

[[Page 58800]]

(breakfast, dinner, etc). FDA's regulations do not restrict the use of 
the meal-type product claims to single-serve containers.
    FDA also defined a ``main-dish'' product (21 CFR 101.13(m)) for the 
purpose of making a claim as a food that makes a major contribution to 
the meal by (1) weighing at least 6 ounces per labeled serving; (2) 
containing not less than 40 grams of food, or combinations of foods 
from at least two of four food groups; and (3) representing, or being 
in the form commonly understood to be, a main dish (i.e., not a 
beverage or dessert). FSIS regulations do not define a ``main-dish'' 
product.
    FSIS' and FDA's rationale for allowing different criteria to serve 
as the basis for evaluating nutrient content claims on meal-type 
products versus other types of foods is that meal-type products have 
potentially large variations in amounts customarily consumed, and the 
average serving size would not be an appropriate basis for comparison 
of nutrients. Rather, a constant value of 100 grams was determined to 
be an appropriate basis. FSIS further reasoned that restricting this 
category to a single-serving criterion and requiring that products 
within the category be represented as a meal would adequately 
distinguish these products from other similarly formulated products.

ConAgra's Petition

    In September 1998, ConAgra petitioned FSIS to amend the definition 
of ``meal-type'' products in its regulations to allow nutrient content 
claims on multi-serve food containers based on the same criteria as for 
meals that are sold in single-serving containers. Specifically, the 
petitioner sought an amendment of the definition of ``meal'' (9 CFR 
317.313(l)) to include product in multiple-serving containers in the 
general principles (9 CFR 317.313) and the ``healthy'' regulations (9 
CFR 317.363). FSIS' initial response was that the few changes requested 
by the petitioner would not be sufficient to address all of the issues 
and amend the regulations so that manufacturers can make consistent 
nutrition content claims on multi-serve containers. FSIS requested that 
the petitioner provide additional data to justify the changes it was 
seeking and clearly state the need for consistent definitions for main-
dish and meal-type products that do not compromise the established 
RACCs for food products and that are consistent with the intent of the 
NLEA.
    In 2001, FSIS concluded that more conclusive data submitted by the 
petitioner indicated that there was a market for multi-serve meals that 
did not exist in 1993 when the nutrition labeling regulations were 
issued. Because of the increasing popularity of multi-serve meals and 
evidence that a significant number of consumers were purchasing such 
meals, FSIS said it was prepared to consider changing the regulatory 
definition of ``meal-type'' products and allowing nutrient content 
claims based on a 100 gram criterion as long as there are no 
established RACCs for the food product category in question. It also 
said that consistency in nutrient content claims and criteria for RACCs 
for all meat and poultry products must be maintained in accordance with 
the regulations. The Agency noted that if Federal regulations regarding 
the basis on which nutrient content claims are made are modified for 
consistency, FSIS and FDA need identical definitions for what 
constitutes a meal and a main-dish product. FSIS granted the petition 
in September 2001. The petition and supporting documentation are 
available in the FSIS Docket Room (see ADDRESSES) and on the FSIS Web 
site at http://www.fsis.usda.gov.

Response to Comments
    The proposed rule was published in the Federal Register on April 
16, 2003 (68 FR 18560-65). The public comment period of the proposed 
rule closed on June 16, 2003. Four comments were received. All of the 
respondents supported the proposal because it increased the regulatory 
consistency between FSIS and FDA on nutrient content claims, and it 
would benefit consumers by permitting them to choose from more healthy 
food options.
    Several respondents commented that, with this change, FSIS has 
positioned meat and poultry meals as being as nutritious as similar 
products regulated by FDA. The commenters further stated that the FSIS 
regulations will no longer promote the idea of good versus bad foods, 
and that the change will eliminate nutrient content claims based on the 
packaging format instead of the product formulation.
    While it is true that some consumers tend to infer that multi-serve 
and other products are nutritionally inferior if they lack the claims 
that other products have, FSIS has never promoted a good food/bad food 
policy.
    The commenters asserted that the change will be an incentive for 
manufacturers to provide more low-fat or healthy meal options. FSIS 
agrees. In addition, the consistency in the nutrient claim criteria 
will benefit consumers by providing them with additional tools and 
guidance for adhering to a low-fat diet at a more favorable cost.
    We are adopting the proposed rule as final but are making some 
minor editorial changes to conform the existing regulations with this 
final rule. In addition, although discussed in the preamble of the 
proposed rule, the definition of ``main-dish'' was inadvertently 
omitted in the regulatory changes of the proposed rule to Part 317 of 
the meat regulations (but was included in Part 381 of the proposed 
rule's regulatory changes to the poultry regulations). In the final 
rule, paragraph (m) of section 317.383 of the meat regulations contains 
the definition of main-dish.

Costs and Benefits Associated With the Rule

    No significant cost impact is seen as a result of this final rule. 
All costs would be borne by industry, which petitioned for the change. 
The only labels that would be affected would be those of multi-serve, 
meal-type products above 6 ounces that would be able to bear nutrient 
content claims. The Agency believes that no more than 300 products 
currently on the market will be affected by the change. Therefore, the 
expected additional labeling costs would be nominal for the industry.
    A more consistent format across similar food products will be of 
benefit to consumers, who will be able to make more informed choices in 
their food purchases. Consumers report that they are experiencing some 
confusion about how some food products are labeled, and why some 
packages bear claims specifying the nutrient content of the product and 
others do not.

The Final Rule

    The final rule will provide consumers of meat and poultry products 
with consistency in nutrition labeling with FDA's requirements by 
amending Sec.  317.309 and the parallel poultry regulations at Sec.  
381.409 to provide for the nutrition labeling of multi-serve meal-type 
products and of main-dish products. The final rule also will amend 
Sec.  317.313(l) and Sec.  317.313(m) and the parallel poultry 
regulations at Sec.  381.413(l) and Sec.  381.413(m) by revising the 
definitions of a ``meal-type'' product and adding a ``main-dish'' 
product for the purpose of making a claim on the packaging of the food 
products. In addition, this rule will amend the individual nutrient 
content claim regulations for both meat and poultry products at 9 CFR 
317.313(l) and (m) and 9 CFR Sec. Sec.  381.413 (l) and (m).

[[Page 58801]]

    FSIS' paramount objectives in considering this modification of its 
nutrition labeling regulations were that the changes not undermine the 
basic principles or intent of the misbranding provisions of the Federal 
Meat Inspection Act and the Poultry Products Inspection Act, and that 
such modifications would result in labels that would not mislead 
consumers or create unfair marketing advantages for any segment of the 
food industry. The Agency also was concerned about extending the use of 
the 100-gram criterion for nutrient content claims to include products 
not in single-serve containers. Although useful, the 100-gram criterion 
does not provide nutrient information to consumers that is as 
definitive as the amount of nutrient per RACC.
    However, in the interests of maintaining consistency between FSIS 
and FDA and of providing incentives to industry to develop more less-
caloric yet economical meals and main dish products in multi-serve 
containers that would qualify for nutrient content claims, FSIS is 
making changes in its nutrition labeling regulations. The Agency 
believes that consumers will benefit from the information on the 
containers of products that were formulated to qualify to bear such 
claims.

Executive Order 12866 and the Regulatory Flexibility Act

    This final rule has been determined to be not economically 
significant for the purposes of Executive Order 12866 and, therefore, 
has not been reviewed by the Office of Management and Budget. FSIS is 
responding to an industry petition for a labeling change affecting 
approximately 300 food products.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. When this rule becomes final: (1) All State and 
local laws and regulations that are inconsistent with this rule will be 
preempted; (2) no retroactive effect will be given to this rule; and 
(3) administrative proceedings will not be required before parties may 
file suit in court challenging this rule.

Effect on Small Entities

    The Administrator, FSIS, has made a determination that this final 
rule will not have a significant economic impact on a substantial 
number of small entities. This rule will change the definition of 
``meal-type'' products to allow for nutrient content claims based on 
100 grams of product on multi-serve food containers and adopt FDA's 
definition of ``main-dish'' products; however, it will not require 
anyone to change their labeling.

Paperwork Requirements

    This rule has been reviewed under the Paperwork Reduction Act and 
imposes no new paperwork or recordkeeping requirements.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that the 
public and in particular minorities, women, and persons with 
disabilities, are aware of this final rule, FSIS will announce it on-
line through the FSIS Web page located at http://www.fsis.usda.gov.

    The Regulations.gov website is the central online rulemaking portal 
of the United States government. It is being offered as a public 
service to increase participation in the Federal government's 
regulatory activities. FSIS participates in Regulations.gov and will 
accept comments on documents published on the site. The site allows 
visitors to search by keyword or Department or Agency for rulemakings 
that allow for public comment. Each entry provides a quick link to a 
comment form so that visitors can type in their comments and submit 
them to FSIS. The Web site is located at http://www.regulations.gov.

    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS web page. Through 
Listserv and the web page, FSIS is able to provide information to a 
much broader, more diverse audience.

List of Subjects

9 CFR Part 317

    Food labeling, Food packaging, Meat inspection, Nutrition.

9 CFR Part 381

    Food labeling, Food packaging, Nutrition, Poultry and poultry 
products

The Final Rule

0
For the reasons discussed in the preamble, FSIS is amending 9 CFR, 
Parts 317 and 381, as follows:

PART 317--LABELING, MARKING DEVICES AND CONTAINERS

0
1. The authority citation for 9 CFR part 317 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

0
2. Section 317.309 is amended as follows:
0
a. By removing the phrase ``and meal type products'' in paragraph 
(b)(7)(iv).
0
b. By revising paragraph (b)(12) to read as follows:


Sec.  317.309  Nutrition label content.

* * * * *
    (b) * * *
    (12) The serving size for meal-type products and main-dish products 
as defined in Sec.  317.313(l) and Sec.  317.313(m) in single-serving 
containers will be the entire edible content of the package. Serving 
size for meal-type products and main-dish products in multi-serve 
containers will be based on the reference amount applicable to the 
product in Sec.  317.312(b) if the product is listed in Sec.  
317.312(b). Serving size for meal-type products and main-dish products 
in multi-serve containers that are not listed in Sec.  317.312(b) will 
be based on the reference amount according to Sec.  317.312(c), (d), 
and (e).
* * * * *

0
3. Section 317.313 is amended by revising paragraph (l) and by adding 
paragraph (m) to read as follows:


Sec.  317.313  Nutrient content claims; general principles.

* * * * *
    (l) For purposes of making a claim, a ``meal-type'' product will be 
defined as a product that:
    (1) Makes a major contribution to the diet by:
    (i) Weighing at least 10 ounces per labeled serving; and
    (ii) Containing not less than three 40 gram portions of food, or 
combinations of foods, from two or more of the following four food 
groups, except as noted in paragraph (l)(1)(ii)(E) of this section:
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (l)(1)(ii)(A) through (D) of this section, 
that are in the sauces),

[[Page 58802]]

gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, 
breadings, or garnishes; and
    (2) Is represented as, or is in the form commonly understood to be, 
a breakfast, lunch, dinner, meal, or entre. Such representations may be 
made by statements, photographs, or vignettes.
    (m) For purposes of making a claim, a main-dish product will be 
defined as a food that:
    (1) Makes a major contribution to the meal by:
    (i) Weighing at least 6 ounces per labeled serving; and
    (ii) Containing not less than 40 grams of food, or combinations of 
foods, from two or more of the following four food groups, except as 
noted in paragraph (m)(1)(ii)(E) of this section.
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (m)(l)(ii)(A) through (D) of this section, 
that are in the sauces), gravies, condiments, relishes, pickles, 
olives, jams, jellies, syrups, breadings, or garnishes; and
    (3) Is represented as, or is in a form commonly understood to be, a 
main dish (e.g., not a beverage or dessert). Such representations may 
be made by statements, photographs, or vignettes.
* * * * *


Sec.  317.354  [Amended]

0
4. Section 317.354 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
317.313(m)'' after the phrase ``meal-type products as defined in Sec.  
317.313(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(1), (e)(1) and (e)(2).
0
b. By adding the phrase ``and main-dish products as defined in Sec.  
317.313(m)'' after the phrase ``meal-type products as described in 
Sec.  317.313(l)'' in the introductory text of paragraph (c)(1).
0
c. By adding the phrase ``and main-dish product as defined in Sec.  
317.313(m)'' after the phrase ``meal-type product as defined in Sec.  
317.313(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(2) and (c)(2).
0
(d) By adding the phrase ``or a main-dish product'' after the phrase 
``meal-type product'' in paragraphs (d)(1) and (e)(2)(ii)(B).


Sec.  317.356  [Amended]

0
5. Section 317.356 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
317.313(m)'' after the phrase ``meal-type products as defined in Sec.  
317.313(l)'', whenever it occurs in paragraph (b) introductory text and 
paragraph (c)(3).
0
b. By adding the phrase ``and main-dish product as defined in Sec.  
317.313(m)'' after the phrase ``meal-type product as defined in Sec.  
317.313(l)'', whenever it occurs in paragraph (d)(1) introductory text 
and paragraph (d)(2)(i).


Sec.  317.360  [Amended]

0
6. Section 317.360 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
317.313(m)'' after the phrase ``meal-type products as defined in Sec.  
317.313(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(2), (b)(4), and (c)(4).
0
b. By adding the phrase ``and main-dish product as defined in Sec.  
317.313(m)'' after the phrase ``meal-type product as defined in Sec.  
317.313(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(3), (b)(5), and (c)(5).
0
c. By adding the phrase ``or a main-dish product'' after the phrase ``a 
meal-type product'' in paragraph (c)(1)(i).


Sec.  317.361  [Amended]

0
7. Section 317.361 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
317.313(m),'' after the phrase ``meal-type products as defined in Sec.  
317.313(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(2), (b)(4), and (b)(6).
0
b. By adding the phrase ``and main-dish product as defined in Sec.  
317.313(m)'' after the phrase ``meal-type product as defined in Sec.  
317.313(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(3), (b)(5), and (b)(7).
0
c. By adding the phrase ``or a main-dish product'' after the phrase ``a 
meal-type product'' in paragraph (b)(1)(i).


Sec.  317.362  [Amended]

0
8. Section 317.362 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
317.313(m)'' after the phrase ``meal-type products as defined in Sec.  
317.313(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(2), (b)(4), (c)(2), (c)(4), (d)(2), (d)(4), (e)(1), and (e)(2).
0
b. By adding the phrase ``and main-dish product as defined in Sec.  
317.313(m)'' after the phrase ``meal-type product as defined in Sec.  
317.313(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(3), (b)(5), (c)(3), (c)(5), (d)(1)(i), (d)(1)(iii), (d)(3), and 
(d)(5).
0
c. By adding the phrase ``or a main-dish product'' after the phrase ``a 
meal-type product'', in paragraphs (b)(1)(i) and (c)(1)(i).


Sec.  317.363  [Amended]

0
9. Section 317.363 is amended as follows:
0
a. By adding the phrase ``main-dish product, as defined in Sec.  
317.313(m), and before the phrase ``a meal-type product, as defined in 
Sec.  317.313(l)'' in the introductory text of paragraph (b)(2)(i) and 
(b)(3)(i).
0
b. By removing the phrase ``meal-type product, as defined in Sec.  
317.313(l),'' and adding the phrase ``main-dish product, as defined in 
Sec.  317.313(m),'' in its place in paragraph (b)(4)(i) and by removing 
the phrase ``meal-type products that weigh at least 6 oz. but'' and 
adding the phrase ``main-dish products that weigh'' in its place in 
paragraph (b)(4)(i).
0
c. By removing the phrase ``and including meal-type products that weigh 
10 oz. or more per serving (container),'' in paragraph (b)(4)(ii).

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
10. The authority citation for Part 381 continues to read as follows:

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18, 
2.53.
0
11. Section 381.409 is amended as follows:
0
a. By removing the phrase ``and meal-type products'' in paragraph 
(b)(7)(iv).
0
b. By revising paragraph (b)(12) to read as follows:


Sec.  381.409  Nutrition label content.

* * * * *
    (b) * * *
    (12) The serving size for meal-type products and main-dish products 
as defined in Sec.  381.413(l) and Sec.  381.413 (m) in single-serve 
containers will be the entire edible content of the package. Serving 
size for meal-type products and main-dish products in multi-serve 
containers will be based on the reference amount applicable to the 
product in Sec.  381.412(b) if the product is listed in Sec.  
381.412(b). Serving size for meal-type products and main-dish products 
in multi-serve containers that are not listed in Sec.  381.412(b) will 
be based on the reference amount according to Sec.  381.412(c), (d), 
and (e).
* * * * *

0
12. Section 381.413 is amended by revising paragraph (1) and by adding 
paragraph (m) to read as follows:

[[Page 58803]]

Sec.  381.413  Nutrient content claims; general principles.

* * * * *
    (1) For purposes of making a claim, a ``meal-type'' product will be 
defined as a product that:
    (1) Makes a major contribution to the diet by:
    (i) Weighing at least 10 ounces per labeled serving; and
    (ii) Containing not less than three 40 gram portions of food, or 
combinations of foods, from two or more of the following four food 
groups, except as noted in paragraph (l)(1)(ii)(E) of this section:
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (l)(1)(ii)(A) through (D) of this section, 
that are in the sauces), gravies, condiments, relishes, pickles, 
olives, jams, jellies, syrups, breadings, or garnishes; and
    (2) Is represented as, or is in the form commonly understood to be, 
a breakfast, lunch, dinner, meal, or entr[egrave]e. Such 
representations may be made by statements, photographs, or vignettes.
    (m) For purposes of making a claim, a ``main-dish'' product will be 
defined as a food that:
    (1) Makes a major contribution to the meal by:
    (i) Weighing at least 6 ounces per labeled serving; and
    (ii) Containing not less than 40 grams of food, or combinations of 
foods, from two or more of the following four food groups, except as 
noted in paragraph (m)(1)Iii)(E) of this section.
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (m)(1)(ii)(A) through (D) of this section, 
that are in the sauces), gravies, condiments, relishes, pickles, 
olives, jams, jellies, syrups, breadings, or garnishes; and
    (2) Is represented as, or is in a form commonly understood to be, a 
main dish (e.g., not a beverage or a dessert). Such representations may 
be made by statements, photographs, or vignettes.
* * * * *


Sec.  381.454  [Amended]

0
13. Section 381.454 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
381.413(m)'' after the phrase ``meal-type products as defined in Sec.  
381.413(l)'', wherever it occurs in the introductory text of paragraphs 
(b)(1), (e)(1), and (e)(2).
0
b. By adding the phrase ``and main-dish products as defined in Sec.  
317.313(m)'' after the phrase ``meal-type products as described in 
Sec.  317.413(l)'', of paragraph (c)(1).
0
c. By adding the phrase ``and main-dish product as defined in Sec.  
381.413(m)'' after the phrase ``meal-type product as defined in Sec.  
381.413(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(2) and (c)(2).
0
d. By adding the phrase ``or in a main-dish product'' after the phrase 
``meal-type product'' in paragraphs (d)(1) and (e)(2)(ii)(B).


Sec.  381.456  [Amended]

0
14. Section 381.456 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
381.413(m)'' after the phrase ``meal-type products as defined in Sec.  
318.413(l)'', whenever it occurs in paragraph (b) introductory text and 
paragraph (c)(3).
0
b. By adding the phrase ``and main-dish product as defined in Sec.  
381.413(m)'' after the phrase ``meal-type product as defined in Sec.  
381.413(l)'', whenever it occurs in paragraph (d)(1) introductory text 
and paragraph (d)(2)(i).


Sec.  381.460  [Amended]

0
15. Section 381.460 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
318.413(m)'' after the phrase ``meal-type products as defined in Sec.  
381.413(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(2), (b)(4), and (c)(4).
0
b. By adding the phrase ``and main-dish product as defined in Sec.  
381.413(m)'' after the phrase ``meal-type product as defined in Sec.  
381.413(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(3), (b)(5), and (c)(5).
0
c. By adding the phrase ``or a main-dish product'' after the phrase ``a 
meal-type product'' in paragraph (c)(1)(i).


Sec.  381.461  [Amended]

0
16. Section 381.461 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
381.413(m),'' after the phrase ``meal-type products as defined in Sec.  
381.413(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(2), (b)(4), and (b)(6).
0
b. By adding the phrase ``and main-dish product as defined in Sec.  
381.413(m)'' after the phrase ``meal-type product as defined in Sec.  
381.413(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(3), (b)(5), and (b)(7).
0
c. By adding the phrase ``or a main-dish product'' after the phrase ``a 
meal-type product'' in paragraph (b)(1)(i).


Sec.  381.462  [Amended]

0
17. Section 381.462 is amended as follows:
0
a. By adding the phrase ``and main-dish products as defined in Sec.  
381.413(m)'' after the phrase ``meal-type products as defined in Sec.  
381.413(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(2), (b)(4), (c)(2), (c)(4), (d)(2), (d)(4), (e)(1) and (e)(2).
0
b. By adding the phrase ``and main-dish product as defined in Sec.  
381.413(m)'' after the phrase ``meal-type product as defined in Sec.  
381.413(l)'', whenever it occurs in the introductory text of paragraphs 
(b)(3), (b)(5), (c)(3), (c)(5), (d)(1)(i), (d)(1)(iii), (d)(3), and 
(d)(5).
0
c. By adding the phrase ``or a main-dish product'' after the phrase ``a 
meal-type product'', in paragraphs (b)(1)(i) and (c)(1)(i).


Sec.  381.463  [Amended]

0
18. Section 381.463 is amended as follows:
0
a. By adding the phrase ``main-dish product, as defined in Sec.  
381.413(m), and'' before the phrase ``meal-type product, as defined in 
Sec.  381.413(l)'' in the introductory text of paragraph (b)(2)(i) and 
(b)(3)(i).
0
b. By removing the phrase ``meal-type product, as defined in Sec.  
381.413(l),'' and adding the phrase ``main-dish product, as defined in 
Sec.  381.413(m),'' in its place in paragraph (b)(4)(i) and by removing 
the phrase ``meal-type products that weigh at least 6 oz. but'' and 
adding the phrase ``meal-type products that weigh'' in its place in 
paragraph (b)(4)(i).
0
c. By removing the phrase ``and including meal-type products that weigh 
10 oz. or more per serving container.'' in paragraph (b)(4)(ii).

    Done at Washington, DC, on: September 27, 2004.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 04-22028 Filed 9-30-04; 8:45 am]