[Federal Register Volume 59, Number 169 (Thursday, September 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21577]


[[Page Unknown]]

[Federal Register: September 1, 1994]


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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 93-022F]

 

Nutrition Labeling of Meat and Poultry Products; Technical 
Amendments

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its 
final nutrition labeling regulations, which were published in the 
Federal Register on January 6, 1993. FSIS is taking this action to 
address inconsistencies in the regulations, improve their accuracy, and 
correct unintended technical consequences of the regulations. Most of 
the changes are designed to parallel technical amendments the Food and 
Drug Administration (FDA) made to its final nutrition labeling 
regulations.

EFFECTIVE DATE: September 1, 1994.

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:

Background

    On January 6, 1993, FSIS published in the Federal Register final 
regulations on nutrition labeling for meat and poultry products (58 FR 
632). FSIS's nutrition labeling regulations are designed to parallel, 
to the extent possible, FDA's final regulations on nutrition labeling. 
FDA's regulations were published in the Federal Register simultaneously 
with FSIS's publication.
    Following publication of its final regulations, FSIS received 
comments from various interested parties contending that portions of 
its regulations were unclear, contained technical unintended 
consequences in a specific provision, or were not parallel to FDA's 
nutrition labeling regulations. After considering these comments and 
conducting an in-depth review of FDA's final nutrition labeling 
regulations, FSIS issued technical amendments to its final regulations 
in an interim final rule published on September 10, 1993 (58 FR 47624).
    On August 18, 1993, FDA published corrections and technical 
amendments (58 FR 44020, 44039, and 44063) to its final regulations in 
response to comments received on its final rule. Many of the provisions 
amended in the August 18, 1993, publication were cross-referenced by 
FSIS in its final nutrition labeling regulations. The provisions 
related to nutrient declarations, label format, serving sizes, 
equivalent metric quantity, servings per container, reference amounts, 
nutrient content claims, saturated fat free claims, foods for infants 
and children under 4 years of age, and packages with less than 12 
square inches of space. FSIS conducted a thorough review of FDA's 
amendments and comments received and concluded that additional 
amendments to the FSIS nutrition labeling regulations were necessary to 
provide greater clarity, accuracy, and consistency with FDA's 
regulations, and to satisfy concerns of commenters.
    Accordingly, FSIS is amending its final nutrition labeling 
regulations by adopting certain changes made by FDA in cross-referenced 
provisions and amending certain of its own provisions to be consistent 
with those changes. In addition, FSIS is correcting the terminology for 
extra lean ground beef in a provision of the final nutrition labeling 
regulations and correcting an oversight in the Federal poultry products 
inspection regulations related to product analyses.

Proposed Rule

    On March 16, 1994, FSIS published in the Federal Register a 
proposed rule (59 FR 12472) to amend its final nutrition labeling 
regulations (58 FR 632). A summary of the proposed technical amendments 
follows.

Serving Sizes

    FSIS acknowledged in its proposed rule (59 FR 12472) that the 
variety of specifications for products in discrete units, contained in 
a single paragraph at 9 CFR 317.309(a)(3) and 381.409(a)(3), may be 
confusing. FSIS proposed to subdivide the single paragraphs of 9 CFR 
317.309(a)(3) and 381.409(a)(3) into 9 CFR 317.309(a)(3)(i) through 
(iv) and 381.409(a)(3)(i) through (iv), reordering some of the 
information, and making minor editorial changes for clarity.
    In its final nutrition labeling rule, FSIS inadvertently omitted 
provisions on how to declare serving sizes for products made up of 
distinct and separate foods packaged together in the same container and 
intended to be consumed together when the manufacturer chooses to list 
the nutrition information separately for each component. These products 
include mixes and kits and cuts of meat or poultry packaged with sauce 
or gravy packets.
    For a number of these products, the serving size can be expressed 
as the amount of the main ingredient plus proportioned minor 
ingredients based on the ``reference amount for the combined product.'' 
FSIS proposed to add new paragraphs at 9 CFR 317.309(a)(3)(vi) and 
381.409(a)(3)(vi) to provide the option described above for serving 
sizes for products that consist of two or more foods that are packaged 
and presented to be consumed together. FDA amended provisions at 21 CFR 
101.9(b)(2)(ii) and (iii) to provide the same option for products in 
large discrete units usually divided for consumption and nondiscrete 
bulk products, respectively. In order to accommodate this option in 21 
CFR 101.9(b)(5), as well as other changes, FDA revised the section 
considerably. For clarity, FSIS proposed to delete its cross-reference 
to 21 CFR 101.9(b)(5) at 9 CFR 317.309(a)(1) and 381.409(a)(1) and 
incorporate the pertinent provisions into 9 CFR 317.309(a)(6) and 
381.409(a)(6). Also, FSIS proposed to delete reference to the term 
``portion'' at 9 CFR 317.309(a)(1), 317.312(a), 381.409(a)(1), and 
381.412(a) because it is no longer defined in the nutrition labeling 
regulations.
    By cross-referencing 21 CFR 101.9(b)(6), FSIS provided that single-
serving containers of products with large reference amounts, i.e., 
equal to or greater than 100 grams or milliliters, may declare one or 
two servings per container if they contain more than 150 percent but 
less than 200 percent of the reference amount. Similar provisions at 9 
CFR 317.309(a)(3) and 381.409(a)(3) for products within multi-serving 
packages were inadvertently omitted. To correct this oversight, FSIS 
proposed to add a new paragraph at 9 CFR 317.309(a)(3)(v) and 
381.409(a)(3)(v) to permit products within multi-serving packages to be 
declared as one or two servings if they meet the criteria described 
above.
    The provisions for single-serving containers at 21 CFR 101.9(b)(6) 
and the provisions for individually packaged products within multi-
serving containers at 9 CFR 317.309(a)(3) and 381.409(a)(3) could 
produce inconsistent labeling on the inner and outer packaging of these 
products. To prevent this inconsistency, FSIS proposed to add a new 
paragraph at 9 CFR 317.309(a)(3)(vii) and 381.409(a)(3)(vii) to provide 
for a serving size declaration of one unit for products containing 
several individual single-serving containers that are fully labeled, 
and to adopt the change to 21 CFR 101.9(b)(8)(iv) on the number of 
servings when a product contains such individually labeled containers.
    FSIS proposed to cross-reference 21 CFR 101.9(b)(2)(ii), which was 
amended to allow products requiring further preparation, where the 
entire contents of the package, e.g., a pizza kit, are used to prepare 
a large discrete unit usually divided into fractional slices for 
consumption, e.g., a pizza, to use a household measure for the serving 
size that is the fraction of the box that makes the ``reference amount 
for the unprepared product.'' FSIS also proposed to add new paragraphs 
at 9 CFR 317.309(a)(6)(v) and 381.409(a)(6)(v) to provide that, in 
these circumstances, the fraction of the package is to be used to 
express the serving size.
    FSIS proposed to amend 9 CFR 317.309(a)(6) and 381.409(a)(6) to 
allow use of the fractions 1/3, 1/2, and 2/3 tablespoons between 1 and 
2 tablespoons. This action is consistent with an FDA amendment to make 
the same allowance.
    FSIS proposed to add new paragraphs at 9 CFR 317.309(a)(6)(iv) and 
381.409(a)(6)(iv), which state that household units for serving sizes 
of single-serving containers, meal-type products, and individually 
packaged products within multi-serving containers must be stated using 
a description of the container, e.g., can, box, package, meal, or 
dinner, and that the serving sizes of other discrete units must be 
stated using a description of the individual unit; e.g., wing, slice, 
link, or patty.

Equivalent Metric Quantity

    A manufacturer is not required to declare the metric equivalent 
weight on single-serving containers and meal-type products if it 
appears in the net quantity of contents statement. However, FSIS has 
determined that if a manufacturer optionally declares the metric 
equivalent, the serving size declaration should agree with the net 
contents declaration. FDA created a new provision at 21 CFR 
101.9(b)(7)(i) that ensures agreement between serving size and net 
quantity values. FSIS proposed to adopt this new provision.
    To achieve greater consistency with FDA provisions, FSIS proposed 
to adopt the change made at 21 CFR 101.9(b)(7)(ii), to correct for the 
omission of rounding rules for milliliters for liquids. The equivalent 
should be rounded to the nearest whole number, except for quantities 
that are less than 5 milliliters. Milliliter amounts between 2 and 5 
should be rounded to the nearest 0.5 milliliter, and amounts less than 
2 should be expressed in 0.1-milliliter increments.
    Also, FDA divided 21 CFR 101.9(b)(7) into subparagraphs and made 
minor editorial changes to improve clarity. FSIS agreed with the 
changes and proposed to cross-reference 21 CFR 101.9(b)(7), except the 
new provision at 21 CFR 101.9(b)(7)(v).

Servings Per Container

    To improve the clarity of the provisions on servings per container, 
FDA divided 21 CFR 101.9(b)(8) into subparagraphs and made minor 
editorial changes. FSIS agreed with these changes and proposed to 
cross-reference this section, as amended.
    FSIS noted a problem in the provisions of its final regulations for 
declaring the number of servings per container for some individually 
packaged products containing at least 200 percent of the reference 
amount and packaged within multi-serving packages. To correct this 
problem, FSIS proposed to cross-reference a new provision at 21 CFR 
101.9(b)(8)(v) that provides that the number of servings be determined 
by multiplying the number of servings per individual inner unit by the 
total number of inner units.

Nutrient Declarations

    In order to ensure that calorie declarations are calculated with as 
much precision as possible, FDA amended 21 CFR 101.9(c)(1) to state 
that where specific or general food factors are used, the factors 
should be applied to the unrounded amounts of the food components. FSIS 
proposed to cross-reference this provision, as amended.
    Because the saturated fat criterion in the definition of ``lean'' 
is a maximum of 4.5 grams or less, provisions at 21 CFR 101.9(c)(2)(i), 
(ii), and (iii) have been amended to require half-gram reporting 
increments below 5 grams for fat, saturated fat, and poly- and 
monounsaturated fat so that declared values on labels are consistent 
with the definitions of nutrient content claims. FSIS proposed to 
cross-reference these provisions, as amended. In addition, FSIS 
proposed to amend 9 CFR 317.309(d) and 381.409(d) to provide the same 
consistency in declared values for stearic acid.
    FDA has revised 21 CFR 101.9(c)(2)(ii) and (iii), to remove the 
required disclosure of poly- and monounsaturated fat when fatty acid or 
cholesterol claims are made on products that meet the criteria for a 
``fat free'' claim. FSIS proposed to cross-reference these provisions, 
as amended.
    To provide consistency with the incremental rounding at 2-, 5-, and 
10-percent increments required for vitamins and minerals, 21 CFR 
101.9(c)(8)(vi) has been revised to require that the vitamin A that is 
present as beta-carotene is to be declared in the same increments as 
provided for vitamins and minerals instead of to the nearest 10-percent 
increment. FSIS proposed to cross-reference this provision, as amended.
    FSIS also proposed to cross-reference 21 CFR 101.9(c)(8)(vi), as 
amended, to require that, when vitamins and minerals are arranged in a 
single column, the information on beta-carotene is to be indented under 
the information on vitamin A, and, when vitamins and minerals are 
arrayed horizontally, the declaration of beta-carotene is to be placed 
in parenthesis after the declaration of vitamin A.

Format

    Section 101.9(d)(1)(ii)(D) of FDA's regulations limited the 
proximity of one letter to another with a numeric kerning value of -4 
setting. However, there is no single numeric kerning value applicable 
to all type systems, and FDA has replaced the requirement to state 
instead that ``Letters should never touch.'' FSIS proposed to cross-
reference this provision, as amended.
    FDA corrected the provision at 21 CFR 101.9(d)(1)(iii) to specify 
that 6-point type shall be used for all information contained within 
the nutrition information display, except for the heading ``Nutrition 
Facts'' which must be set in a type that is larger than all other print 
in the display, and for the information required at 21 CFR 101.9(d)(3), 
(5), (7), and (8), which must be no smaller than 8-point type. FSIS 
proposed to cross-reference this provision, as amended. FSIS also 
proposed to adopt a change made to 21 CFR 101.9(c)(8)(iii) that removes 
a conflicting sentence.
    FSIS proposed to cross-reference the provision at 21 CFR 
101.9(d)(7), as amended, to include all nutrients that can be declared 
in the nutrition information display, not only those that are required. 
The wording of the provision has been changed from ``nutrients required 
by paragraph (c) of this section'' to ``nutrient information for both 
mandatory and any voluntary nutrients listed in paragraph (c) of this 
section that are to be declared in the nutrition label.'' The provision 
clarifies that the listing of some nutrients is required, and the 
listing of others is voluntary by inserting the word ``as'' before 
``specified.''
    FSIS proposed to adopt 21 CFR 101.9(d)(7)(ii) which was amended to 
require that the percent Daily Value (DV) for all nutrients, other than 
protein, be calculated by dividing either the rounded amount of the 
nutrient declared on the label or the actual, unrounded amount of the 
nutrient by the Daily Reference Value (DRV) for that nutrient. 
Manufacturers should use whichever value will provide for the greatest 
consistency on the product labeling.
    FSIS believes the footnote required by 21 CFR 101.9(d)(10) stating 
that fat, carbohydrate, and protein furnish 9, 4, and 4 calories per 
gram, respectively, can create consumer confusion because the 
regulations allow for different methods of calculating calorie content. 
The provision at 21 CFR 101.9(d)(10) has been amended to make use of 
the footnote voluntary and 21 CFR 101.9(d)(1)(iii) and (11)(i) has been 
amended to delete the reference to the footnote with caloric conversion 
information as a requirement. FSIS proposed to cross-reference these 
provisions, as amended, and adopt changes to 21 CFR 101.9(d)(11)(ii) to 
allow for the presentation of the information described above. FSIS 
also proposed to amend 9 CFR 317.309(f)(3) and 381.409(f)(3) to delete 
reference to the footnote as required information.
    FDA redesignated the provision at 21 CFR 101.9(d)(11) as 21 CFR 
101.9(d)(11)(i) and added a new provision at 21 CFR 101.9(d)(11)(iii) 
to state that when there is insufficient continuous vertical label 
space, i.e., approximately 3 inches, to accommodate the required 
components of the nutrition information up to and including the 
mandatory declaration of iron, the nutrition information may be 
presented in a tabular display. In this display, the footnote listing 
DRV's for 2,000 and 2,500 calorie diets is given to the far right of 
the display, and additional vitamins and minerals beyond vitamin A, 
vitamin C, calcium, and iron are arrayed horizontally following the 
required vitamin and mineral declarations. A new provision has been 
added at 21 CFR 101.9(d)(11)(ii) that provides for an additional break 
to allow the continuation of the list of vitamins and minerals beyond 
the declaration of iron to be moved to the right, just above the 
footnote listing the DRV's. FSIS proposed to adopt these changes and 
cross-reference the amended provisions.
    Because the format requirements in its final rule did not provide 
for listing of nutrition information within a single nutrition display 
for packages containing more than one food product, FSIS proposed to 
correct this oversight by providing for the use of an aggregate display 
of nutrition information in new provisions at 9 CFR 317.309(e)(2) and 
381.409(e)(2). FSIS also proposed to adopt a new provision at 21 CFR 
101.9(d)(14) to provide for the inclusion and display of two languages 
under a single ``Nutrition Facts'' heading.

Modified Format

    FSIS proposed to amend 9 CFR 317.309(f)(1) and 381.409(f)(1) to 
clarify that package shape or size is the determining factor whether 
nutrition information may be given in a linear fashion when the tabular 
display cannot be accommodated. FSIS proposed to add new paragraphs at 
9 CFR 317.309(f)(1)(ii) and 381.409(f)(1)(ii) to define the linear 
display and direct that any subcomponents declared may be listed 
parenthetically after principal components.
    FSIS proposed to amend 9 CFR 317.309(f)(2) and 381.409(f)(2) to 
include new abbreviations as follows: Calories from saturated fat--Sat 
fat cal; Monounsaturated fat--Monounsat fat; Polyunsaturated fat--
Polyunsat fat; Soluble fiber--Sol fiber; Insoluble fiber--Insol fiber; 
Sugar alcohol--Sugar alc; and Other carbohydrate-- Other carb.

Reference Amounts

    FSIS proposed to cross-reference 21 CFR 101.12(c), as amended, to 
improve clarity, except for the words ``but not the unprepared'' 
referring to the form of a reference amount. FSIS does not require 
manufacturers to use reference amounts for unprepared forms of products 
when those reference amounts are contained in the tables at CFR 
317.312(b) and 381.412(b).
    At 9 CFR 317.312(b) and 381.412(b), Table 2.-Reference Amounts 
Customarily Consumed-General Food Supply, FSIS proposed to remove bagel 
dogs and poultry bagel dogs as examples under the product category of 
entrees without sauce, and at 9 CFR 317.312(b), to remove ``freeze dry, 
dehydrated, and concentrated soup mixes'' as examples under the product 
category of ``Seasoning mixes dry'' because the products are not deemed 
amenable to FSIS inspection.
    FSIS proposed to cross-reference a new provision at 21 CFR 
101.12(c)(2) that provides for a reference amount for an unprepared 
product that reflects the fraction of the prepared product closest to 
the reference amount for the prepared product for the specific product 
category. For example, when a product, such as a pizza kit, is used to 
prepare a large discrete unit, the reference amount for the unprepared 
product would be the amount of the pizza kit needed to make 1/8 pizza, 
the optional second column could provide nutrition information for 1/8 
pizza, and the number of servings would be listed as 8. This approach 
is consistent with that for arriving at the serving size for ready-to-
serve products; that is, the fraction of a large discrete unit that 
comes closest to the reference amount for the prepared product for the 
specific product category.
    To ensure that the serving size declaration will not be improperly 
influenced by minor dense ingredients, and that the number of servings 
will be consistent for all ingredients, FSIS proposed to amend 9 CFR 
317.312(c) and 381.412(c) by adding new paragraphs at (c)(1) and (c)(2) 
for bulk products and discrete units, respectively. The proposed 
paragraphs clarify that a ``reference amount for the combined product'' 
that consists of two or more distinct foods packaged separately within 
the same container, intended to be consumed together, and without 
established reference amounts, be derived based on the reference amount 
of the ingredient that is represented as the main ingredient. Other 
ingredients within the container are proportioned to fit the serving 
size of the main ingredient.
    FSIS proposed to amend 9 CFR 317.312(c) and 381.412(c) to provide a 
procedure for determining reference amounts for products intended to be 
combined and consumed together and for which the combination is not 
listed as a reference amount at 9 CFR 317.312(b) and 381.412(b). For 
products with reference amounts in compatible units, the units can be 
directly summed. For products with incompatible units that cannot be 
directly summed, i.e., grams and milliliters, FSIS proposed to add a 
new paragraph at 9 CFR 317.312(c)(3) and 381.412(c)(3) to incorporate 
the approach of summing the weights of the relevant amounts of the 
foods that are combined to make the ``reference amount for the combined 
product.''

Nutrient Content Claims; General Principles

    FDA amended the provision at 21 CFR 101.13(b) to include a new 
paragraph at (b)(4), which states that the use of reasonable variations 
in the spelling of the various descriptive terms and their synonyms, 
such as ``hi'' and ``lo,'' are permitted provided that these variations 
are not misleading. FSIS proposed to cross-reference 21 CFR 101.13(b), 
as amended.
    FSIS proposed to cross-reference 21 CFR 101.13(f), as amended, 
which clarifies that a nutrient content claim is required to be in type 
size no larger than two times the statement of identity and not be 
unduly prominent in type style compared to the statement of identity.
    In its final rule, FSIS did not prescribe minimum type sizes for 
all the accompanying information for relative claims. FSIS proposed to 
amend 9 CFR 317.313 and 381.413 by adding a new paragraph (g) so that 
all information appearing on the principal display panel or the 
information panel will appear in letters and/or numbers not less than 
1/16-inch minimum height unless otherwise specified in the nutrient 
content claims regulations.
    FSIS proposed to cross-reference 21 CFR 101.13(j)(1)(ii)(B), as 
amended, except comparison to product of another manufacturer at 21 CFR 
101.13(j)(1)(ii)(B) to permit comparisons to a single manufacturer's 
product using either the values declared in the nutrition labeling or 
the actual nutrient values, provided that the values stated in the 
nutrition information, the nutrient values in the accompanying 
information, and the declaration of the percentage of nutrient by which 
the product has been modified are consistent and will not cause 
confusion when compared, and that the actual modification is at least 
equal to the percentage specified in the definition of the claim.

Extra Lean Ground Beef

    FSIS identified extra lean ground beef as one of 35 major cuts of 
meat products at 9 CFR 317.344 that would be used in evaluating 
significant participation for voluntary nutrition labeling of single-
ingredient, raw meat products. FSIS proposed to amend this section by 
changing the name ``ground beef extra lean without added seasoning'' to 
``ground beef about 17% fat'' because the term ``extra lean'' will no 
longer be applicable to the product listed at 9 CFR 317.344 after July 
6, 1994. While the final rule allows the term ``extra lean'' to be used 
on individual food products containing, among other criteria, less than 
5 grams of fat per reference amount customarily consumed and per 100 
grams, ground beef and hamburger seldom contain this level of fat. 
Also, the phrase ``without added seasoning'' is unnecessary because 
ground beef containing a seasoning is not a single-ingredient product.

Nutrient Content Claims About Sugars and Salt

    In its final nutrition labeling regulations, FSIS specified 
requirements for nutrient content claims for calories and sugars at 9 
CFR 317.360 and 381.460, which cross-reference 21 CFR 101.60 for the 
requirements, and for sodium and salt at 9 CFR 317.361 and 381.461, 
which cross-reference 21 CFR 101.61 for the requirements. FDA added 
explicit mention of sugars at 21 CFR 101.60(a) and salt at 21 CFR 
101.61(a) to clarify that the general requirements also apply to sugars 
and salt. FSIS proposed to cross-reference 21 CFR 101.60 and 101.61, as 
amended.

Criteria for Free Claims

    FSIS proposed to cross-reference 21 CFR 101.60, 101.61, and 101.62, 
as amended, to restrict the amount of nutrient per labeled serving, as 
well as per reference amount customarily consumed, for ``free'' claims 
for calories, sugars, sodium, fat, fatty acids, and cholesterol.
    In its final nutrition labeling regulations, FSIS defined the term 
``saturated fat free'' at 9 CFR 317.362 and 381.462 by cross-
referencing 21 CFR 101.62(c)(1). FDA changed the criterion at 21 CFR 
101.62(c)(1) to require that the product contain less than 0.5 grams 
trans fatty acids. FSIS agreed with this change and proposed to cross-
reference 21 CFR 101.62(c), as amended.

Nutrient Content Claims for Rehydrated Products

    For dehydrated products that typically must be rehydrated with 
water before consumption, FSIS at 9 CFR 317.360, 317.361, 317.362, 
381.460, 381.461, and 381.462 provides that the 50-gram criterion be 
based on the ``as prepared'' form by cross-referencing applicable 
provisions in 21 CFR 101.60, 101.61, and 101.62. FDA amended its 
regulations to extend to rehydration with diluents, such as vinegar, 
that have insignificant amounts of all nutrients per reference amount. 
FSIS proposed to cross-reference 21 CFR 101.60, 101.61, and 101.62, as 
amended.

Foods for Infants and Children Under 4 Years of Age

    To address a conflict in nutrition labeling rules for foods 
intended for infants and children less than 4 years of age, FSIS 
proposed to amend 9 CFR 317.400(c) and 381.500(c) to state that foods 
represented or purported to be specifically for infants and children 
less than 4 years of age shall not include declarations of percent 
Daily Value for total fat, saturated fat, cholesterol, sodium, 
potassium, total carbohydrate, and dietary fiber. FSIS proposed 
additional format specifications in the amended provisions.

Packages With Less Than 12 Square Inches of Space

    FSIS proposed to redesignate 9 CFR 317.400(d) and 381.500(d) as 9 
CFR 317.400(d)(1) and 381.500(d)(1), respectively, and add new 
paragraphs at 9 CFR 317.400(d)(2) and 381.500(d)(2) to provide for the 
optional use of 6-point type or all uppercase type of \1/16\-inch 
minimum height for packages with less than 12 square inches available 
to bear labeling and to permit a type size of \1/32\-inch minimum 
height when packages have a total surface area to bear labeling of 3 
square inches or less. Such options allow nutrition information to be 
presented on more packages and provides manufacturers flexibility when 
provision of nutrition information becomes mandatory.

Product Analyses

    FSIS proposed to remove 9 CFR 381.133(b) of the poultry products 
inspection regulations to correct an oversight relating to product 
analyses. This section specifies that when labels for poultry products 
bear a chemical analysis, such products must be analyzed on a lot basis 
by an impartial laboratory to determine whether the products conform to 
the analysis shown. The section is now obsolete because, under the 
nutrition labeling regulations, companies are required to maintain 
records that support nutrient information and may base nutrient 
information on data bases and on recipe analysis using data bases, as 
well as on laboratory analyses. FSIS will use specific methods to 
analyze samples for enforcement purposes. Section 381.133(b) (9 CFR 
381.133(b)) should have been removed as part of the nutrition labeling 
rulemaking. As noted in the proposed rule, there is no similar 
provision in the Federal meat inspection regulations.

Discussion of Comments

    FSIS received two comments in response to the March 16, 1994, 
proposed technical amendments rule (59 FR 12472). Both comments were 
from trade associations and supported the proposed technical 
amendments. Two suggestions were made relating to technical issues that 
were not raised for comment in the proposed amendments.
    One commenter requested that FSIS amend Table 2 at 9 CFR 317.312(b) 
and 381.412(b) to include FDA's product category of major condiments 
with a reference amount of ``1 tablespoon'' for use with meat hotdog 
sauce or for chili products promoted for use as a hotdog condiment. The 
commenter noted that FDA included hotdog chili sauce as an example of 
products in the category of major condiments, but did not provide 
information showing that nonmeat and meat hotdog chili sauces are the 
same type of products or are used in similar amounts.
    Because no information was submitted upon which FSIS could make a 
determination that the USDA-regulated products should be classified as 
major condiments, it will not take action to modify Table 2 at this 
time. To the extent that manufacturers believe their products are not 
properly categorized, they should avail themselves of the process 
established in the regulations to seek to establish or amend a product 
category and/or reference amount.
    One commenter stated that the requirements for nutrient content 
claims about sodium at 9 CFR 317.361 and 381.461, which cross-reference 
21 CFR 101.61 for the requirements, are redundant in certain 
circumstances when claims are made about salt. The provisions require 
that when references to salt content such as ``unsalted,'' ``without 
added salt,'' or ``no salt added'' are made on the labeling of a 
product which is not sodium free, the statement ``not a sodium free 
food'' or ``not for control of sodium in the diet'' must appear on the 
information panel. The commenter contended that when labeling bears a 
reference to salt content, and also bears a ``low,'' ``very low,'' or 
``reduced'' sodium content claim on the same panel, it is clear to 
consumers that the product is not sodium free.
    While FSIS finds merit with this observation, it did not provide an 
opportunity for interested parties to comment on the issue in its 
proposed rule. Therefore, in order to ensure full public consideration 
of this comment, FSIS will consider taking action on the matter in 
future rulemaking.
    After careful consideration of the comments received in response to 
the proposed rule, FSIS is adopting the provisions as published in the 
Federal Register on March 16, 1994 (59 FR 12472).

Paperwork Requirements

    At the time FSIS published its final regulations on nutrition 
labeling, the Agency advised the public that the paperwork requirements 
contained in the final rule had been submitted to the Office of 
Management and Budget (OMB) for approval. FSIS is advising the public 
that OMB has approved the paperwork requirements under control number 
0583-0088.
    The OMB control number must be included as part of the regulatory 
language of each section that contains a paperwork requirement. 
Therefore, a statement identifying the OMB control number that 
signifies approval of the paperwork requirements has been added to the 
end of 9 CFR 317.309, 317.312, 317.369, 381.409, 381.412, and 381.469.

Executive Order 12866

    This final rule has been determined to be significant and was 
reviewed by the Office of Management and Budget under Executive Order 
12866.

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 requirement 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 effect on small entities, as defined by the Regulatory 
Flexibility Act (5 U.S.C. 601). The final rule clarifies and improves 
understanding of certain provisions of the nutrition labeling 
regulations. The Administrator finds that this final rule will result 
in positive benefits because it will enable official establishments to 
more easily comprehend the regulations and facilitate their 
implementation. The final rule will not impose any new requirements on 
the affected establishments. Small meat and poultry establishments are 
exempt from nutrition labeling, provided the labels of their products 
bear no nutrition claims or information. Therefore, most small 
establishments will not be affected by this final rule.

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 317.309 is amended by revising paragraphs (a)(1), 
(a)(3), (a)(6), (d), (e), (f)(1), (f)(2), and (f)(3), and by adding the 
OMB control number for paperwork requirements at the end of the section 
to read as follows:


Sec. 317.309  Nutrition label content.

    (a)(1) All nutrient and product component quantities shall be 
declared in relation to a serving as defined at 21 CFR 101.9(b)(1) and 
(2), except (b)(2)(i), and 21 CFR 101.9(b)(6) through (9), except 
(b)(7)(v).
* * * * *
    (3) For products in discrete units (e.g., hot dogs, and 
individually packaged products within a multi-serving package), and for 
products which consist of two or more foods packaged and presented to 
be consumed together where the ingredient represented as the main 
ingredient is in discrete units (e.g., beef fritters and barbecue 
sauce), the serving size shall be declared as follows:
    (i) If a unit weighs 50 percent or less of the Reference Amount, 
the serving size shall be the number of whole units that most closely 
approximates the Reference Amount for the product category.
    (ii) If a unit weighs more than 50 percent but less than 67 percent 
of the Reference Amount, the manufacturer may declare one unit or two 
units as the serving size.
    (iii) If a unit weighs 67 percent or more but less than 200 percent 
of the Reference Amount, the serving size shall be one unit.
    (iv) If a unit weighs 200 percent or more of the Reference Amount, 
the manufacturer may declare one unit as the serving size if the whole 
unit can reasonably be consumed at a single eating occasion.
    (v) For products that have Reference Amounts of 100 grams (or 
milliliters) or larger and are individual units within a multi-serving 
package, if a unit contains more than 150 percent but less than 200 
percent of the Reference Amount, the manufacturer may decide whether to 
declare the individual unit as 1 or 2 servings.
    (vi) For products which consist of two or more foods packaged and 
presented to be consumed together where the ingredient represented as 
the main ingredient is in discrete units (e.g., beef fritters and 
barbecue sauce), the serving size may be the number of discrete units 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount for the combined product as 
determined in Sec. 317.312(c).
    (vii) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in Sec. 317.309 (that is, are 
labeled appropriately for individual sale as single-serving 
containers), the serving size shall be 1 unit.
* * * * *
    (6) For labeling purposes, the term ``common household unit'' means 
cup, tablespoon, teaspoon, piece, slice, fraction (e.g., \1/4\ pizza), 
ounce (oz), or other common household equipment used to package food 
products (e.g., jar or tray). In expressing serving size in household 
measures, except as specified in paragraphs (a)(6)(iv), (v), and (vi) 
of this section, the following rules shall be used:
    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup 
increments, tablespoons in whole number of tablespoons for quantities 
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp), 
1, 1\1/3\, 1\1/2\, or 1\2/3\ tbsp for quantities less than 2 tbsp but 
greater than or equal to 1 tbsp, and teaspoons in whole number of 
teaspoons for quantities less than 1 tbsp but greater than or equal to 
1 teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 
1 tsp.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If cups, tablespoons and teaspoons, or units such as piece, 
slice, tray, jar, or fraction are not applicable, ounces may be used. 
Ounce measurements shall be expressed in 0.5-ounce increments most 
closely approximating the Reference Amount with rounding indicated by 
the use of the term ``about'' (e.g., about 2.5 ounces).
    (iv) A description of the individual container or package shall be 
used for single-serving containers and meal-type products and for 
individually packaged products within multi-serving containers (e.g., 
can, box, package, meal, or dinner). A description of the individual 
unit shall be used for other products in discrete units (e.g., chop, 
slice, link, or patty).
    (v) For unprepared products where the entire contents of the 
package is used to prepare large discrete units that are usually 
divided for consumption (e.g., pizza kit), the fraction or portion of 
the package may be used.
    (vi) As provided for in Sec. 317.309(c)(1), for products that 
consist of two or more distinct ingredients or components packaged and 
presented to be consumed together (e.g., ham with a glaze packet), the 
nutrition information may be declared for each component or as a 
composite. The serving size may be provided in accordance with the 
provisions of paragraph (a)(3) of this section and 21 CFR 
101.9(b)(2)(ii) and (iii).
    (vii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 
oz in weight means 28 g.
    (viii) When a serving size, determined from the Reference Amount in 
Sec. 317.312(b) and the procedures described in this section, falls 
exactly half way between two serving sizes (e.g., 2.5 tbsp), 
manufacturers shall round the serving up to the next incremental size.
* * * * *
    (d) ``Stearic Acid'' (VOLUNTARY): A statement of the number of 
grams of stearic acid may be declared voluntarily, except that when a 
claim is made about stearic acid, label declaration shall be required. 
Stearic acid content shall be indented under saturated fat and 
expressed to the nearest 0.5 (1/2) gram increment below 5 grams and to 
the nearest gram increment above 5 grams. If the serving contains less 
than 0.5 gram, the content shall be expressed as zero.
    (e)(1) Formats for nutrition labeling shall be in accordance with 
21 CFR 101.9(d) and (e), except for (d)(13) and references to (f), 
(j)(5), and (j)(13), or in accordance with paragraph (g)(1) of this 
section.
    (2)(i) Nutrition labeling on the outer labeling of packages of meat 
products that contain two or more meat products in the same package 
(e.g., variety packs) or of packages that are used interchangeably for 
the same type of food (e.g., meat salad containers) may use an 
aggregate display.
    (ii) Aggregate displays shall comply with format requirements of 
paragraph (e)(1) of this section to the maximum extent possible, except 
that the identity of each food shall be specified immediately under the 
``Nutrition Facts'' title, and both the quantitative amount by weight 
(i.e., g/mg amounts) and the percent Daily Value for each nutrient 
shall be listed in separate columns under the name of each food.
    (f) * * *
    (1)(i) Presenting the required nutrition information in a tabular 
or linear (i.e., string) fashion, rather than in vertical columns, if 
the product has a total surface area available to bear labeling of less 
than 12 square inches, or if the product has a total surface area 
available to bear labeling of 40 or less square inches and the package 
shape or size cannot accommodate a standard vertical column or tabular 
display on any label panel. Nutrition information may be given in a 
linear fashion only if the package shape or size will not accommodate a 
tabular display.
    (ii) When nutrition information is given in a linear display, the 
nutrition information shall be set off in a box by the use of a 
hairline. The percent Daily Value is separated from the quantitative 
amount declaration by the use of parenthesis, and all nutrients, both 
principal components and subcomponents, are treated similarly. Bolding 
is required only on the title ``Nutrition Facts'' and is allowed for 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
    (2) Using any of the following abbreviations: 

Serving size.........................  Serv size                        
Servings per container...............  Servings                         
Calories from fat....................  Fat cal                          
Calories from saturated fat..........  Sat fat cal                      
Saturated fat........................  Sat fat                          
Monounsaturated fat..................  Monounsat fat                    
Polyunsaturated fat..................  Polyunsat fat                    
Cholesterol..........................  Cholest                          
Total carbohydrate...................  Total carb                       
Dietary fiber........................  Fiber                            
Soluble fiber........................  Sol fiber                        
Insoluble fiber......................  Insol fiber                      
Sugar alcohol........................  Sugar alc                        
Other carbohydrate...................  Other carb                       
                                                                        

    (3) Omitting the footnote required in 21 CFR 101.9(d)(9) and 
placing another asterisk at the bottom of the label followed by the 
statement ``Percent Daily Values are based on a 2,000 calorie diet'' 
and, if the term ``Daily Value'' is not spelled out in the heading, a 
statement that ``DV'' represents ``Daily Value.''
* * * * *
(Paperwork requirements were approved by the Office of Management 
and Budget under control number 0583-0088)

    3. Section 317.312 is amended by revising paragraphs (a) and (c), 
and by adding the OMB control number for paperwork requirements at the 
end of the section to read as follows:


Sec. 317.312  Reference amounts customarily consumed per eating 
occasion.

    (a) The general principles followed in arriving at the Reference 
Amounts for serving sizes set forth in paragraph (b) of this section 
are found in 21 CFR 101.12 (a), (c), except for reference to the 
unprepared form in the first paragraph, (d), and (g).
* * * * *
    (c) For products that have no Reference Amount listed in paragraph 
(b) of this section for the unprepared or the prepared form of the 
product and that consist of two or more foods packaged and presented to 
be consumed together (e.g., lunch meat with cheese and crackers), the 
Reference Amount for the combined product shall be determined using the 
following rules:
    (1) For bulk products, the Reference Amount for the combined 
product shall be the Reference Amount, as established in paragraph (b) 
of this section, for the ingredient that is represented as the main 
ingredient plus proportioned amounts of all minor ingredients.
    (2) For products where the ingredient represented as the main 
ingredient is one or more discrete units, the Reference Amount for the 
combined product shall be either the number of small discrete units or 
the fraction of the large discrete unit that is represented as the main 
ingredient that is closest to the Reference Amount for that ingredient 
as established in paragraph (b) of this section plus proportioned 
amounts of all minor ingredients.
    (3) If the Reference Amounts are in compatible units, they shall be 
summed (e.g., ingredients in equal volumes such as tablespoons). If the 
Reference Amounts are in incompatible units, the weights of the 
appropriate volumes should be used (e.g., grams of one ingredient plus 
gram weight of tablespoons of a second ingredient).
* * * * *
(Paperwork requirements were approved by the Office of Management 
and Budget under control number 0583-0088)

    4. Table 2 in Sec. 317.312(b) is amended by removing the words 
``bagel dog'' from the Product Category ``Entrees without sauce'' and 
by removing the words ``freeze dry, dehydrated, and concentrated soup 
mixes'' from the Product Category ``Seasoning mixes dry.''
    5. Section 317.313 is amended by adding paragraph (g) to read as 
follows:


Sec. 317.313  Nutrient content claims; general principles.

* * * * *
    (g) Labeling information required in Secs. 317.313, 317.354, 
317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is not 
otherwise specified, is required to be in letters and/or numbers no 
less than \1/16\ inch in height.
* * * * *


Sec. 317.344  [Amended]

    6. Section 317.344 is amended by replacing the words ``ground beef 
extra lean without added seasoning'' with the words ``ground beef about 
17% fat.''
    7. Section 317.369 is amended by adding the OMB control number for 
paperwork requirements at the end of the section to read as follows:


Sec. 317.369  Labeling applications for nutrient content claims.

* * * * *
(Paperwork requirements were approved by the Office of Management 
and Budget under control number 0583-0088)

    8. Section 317.400 is amended by revising paragraphs (c) and (d) to 
read as follows:


Sec. 317.400  Exemption from nutrition labeling.

* * * * *
    (c)(1) Foods represented to be specifically for infants and 
children less than 2 years of age shall bear nutrition labeling as 
provided in paragraph (c)(2) of this section, except such labeling 
shall not include calories from fat, calories from saturated fat, 
saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat, 
and cholesterol.
    (2) Foods represented or purported to be specifically for infants 
and children less than 4 years of age shall bear nutrition labeling 
except that:
    (i) Such labeling shall not include declarations of percent of 
Daily Value for total fat, saturated fat, cholesterol, sodium, 
potassium, total carbohydrate, and dietary fiber;
    (ii) Nutrient names and quantitative amounts by weight shall be 
presented in two separate columns;
    (iii) The heading ``Percent Daily Value'' required in 
Sec. 317.309(e) shall be placed immediately below the quantitative 
information by weight for protein;
    (iv) The percent of the Daily Value for protein, vitamins, and 
minerals shall be listed immediately below the heading ``Percent Daily 
Value''; and
    (v) Such labeling shall not include the footnote specified at 21 
CFR 101.9(d)(9).
    (d)(1) Products in packages that have a total surface area 
available to bear labeling of less than 12 square inches are exempt 
from nutrition labeling, provided that the labeling for these products 
bear no nutrition claims or other nutrition information. The 
manufacturer, packer, or distributor shall provide, on the label of 
packages that qualify for and use this exemption, an address or 
telephone number that a consumer can use to obtain the required 
nutrition information (e.g., ``For nutrition information call 1-800-
123-4567'').
    (2) When such products bear nutrition labeling, either voluntarily 
or because nutrition claims or other nutrition information is provided, 
all required information shall be in a type size no smaller than 6 
point or all upper case type of \1/16\-inch minimum height, except that 
individual serving-size packages of meat products that have a total 
area available to bear labeling of 3 square inches or less may provide 
all required information in a type size no smaller than \1/32\-inch 
minimum height.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    9. The authority citation for part 381 continues to read as 
follows:

    Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR 
2.17, 2.55.


Sec. 381.133  [Amended]

    10. Section 381.133 is amended by revising the section title to 
read ``Requirement of formulas,'' by removing the paragraph (a) 
designation of the first paragraph, and by removing paragraph (b).
    11. Section 381.409 is amended by revising paragraphs (a)(1), 
(a)(3), (a)(6), (d), (e), (f)(1), (f)(2), and (f)(3), and adding the 
OMB control number for paperwork requirements at the end of the section 
to read as follows:


Sec. 381.409  Nutrition label content.

    (a)(1) All nutrient and product component quantities shall be 
declared in relation to a serving as defined at 21 CFR 101.9(b)(1) and 
(2), except (b)(2)(i), and 21 CFR 101.9(b)(6) through (9), except 
(b)(7)(v).
* * * * *
    (3) For products in discrete units (e.g., chicken wings, and 
individually packaged products within a multi-serving package), and for 
products which consist of two or more foods packaged and presented to 
be consumed together where the ingredient represented as the main 
ingredient is in discrete units (e.g., chicken wings and barbecue 
sauce), the serving size shall be declared as follows:
    (i) If a unit weighs 50 percent or less of the Reference Amount, 
the serving size shall be the number of whole units that most closely 
approximates the Reference Amount for the product category;
    (ii) If a unit weighs more than 50 percent but less than 67 percent 
of the Reference Amount, the manufacturer may declare one unit or two 
units as the serving size;
    (iii) If a unit weighs 67 percent or more but less than 200 percent 
of the Reference Amount, the serving size shall be one unit;
    (iv) If a unit weighs 200 percent or more of the Reference Amount, 
the manufacturer may declare one unit as the serving size if the whole 
unit can reasonably be consumed at a single eating occasion.
    (v) For products that have Reference Amounts of 100 grams (or 
milliliter) or larger and are individual units within a multi-serving 
package, if a unit contains more than 150 percent but less than 200 
percent of the Reference Amount, the manufacturer may decide whether to 
declare the individual unit as 1 or 2 servings.
    (vi) For products which consist of two or more foods packaged and 
presented to be consumed together where the ingredient represented as 
the main ingredient is in discrete units (e.g., chicken wings and 
barbecue sauce), the serving size may be the number of discrete units 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount for the combined product as 
determined in Sec. 381.412(c).
    (vii) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in Sec. 381.409 (that is, are 
labeled appropriately for individual sale as single-serving 
containers), the serving size shall be 1 unit.
* * * * *
    (6) For labeling purposes, the term ``common household unit'' means 
cup, tablespoon, teaspoon, piece, slice, fraction (e.g., \1/4\ pizza), 
ounce (oz), or other common household equipment used to package food 
products (e.g., jar or tray). In expressing serving size in household 
measures, except as specified in paragraphs (a)(6)(iv), (v), and (vi) 
of this section, the following rules shall be used:
    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup 
increments, tablespoons in whole number of tablespoons for quantities 
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp), 
1, 1\1/3\, 1\1/2\, or 1\2/3\ tbsp for quantities less than 2 tbsp but 
greater than or equal to 1 tbsp, and teaspoons in whole number of 
teaspoons for quantities less than 1 tbsp but greater than or equal to 
1 teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 
1 tsp.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If cups, tablespoons and teaspoons, or units such as piece, 
slice, tray, jar, or fraction are not applicable, ounces may be used. 
Ounce measurements shall be expressed in 0.5-ounce increments most 
closely approximating the Reference Amount with rounding indicated by 
the use of the term ``about'' (e.g., about 2.5 ounces).
    (iv) A description of the individual container or package shall be 
used for single-serving containers and meal-type products and for 
individually packaged products within multi-serving containers (e.g., 
can, box, package, meal, or dinner). A description of the individual 
unit shall be used for other products in discrete units (e.g., wing, 
slice, link, or patty).
    (v) For unprepared products where the entire contents of the 
package is used to prepare large discrete units that are usually 
divided for consumption (e.g., pizza kit), the fraction or portion of 
the package may be used.
    (vi) As provided for in Sec. 381.409(c)(1), for products that 
consist of two or more distinct ingredients or components packaged and 
presented to be consumed together (e.g., chicken wings and barbecue 
sauce), the nutrition information may be declared for each component or 
as a composite. The serving size may be provided in accordance with the 
provisions of paragraph (a)(3) of this section and 21 CFR 101.9(b)(2) 
(ii) and (iii).
    (vii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 
oz in weight means 28 g.
    (viii) When a serving size, determined from the Reference Amount in 
Sec. 381.412(b) and the procedures described in this section, falls 
exactly half way between two serving sizes (e.g., 2.5 tbsp), 
manufacturers shall round the serving up to the next incremental size.
* * * * *
    (d) ``Stearic Acid'' (VOLUNTARY): A statement of the number of 
grams of stearic acid may be declared voluntarily, except that when a 
claim is made about stearic acid, label declaration shall be required. 
Stearic acid content shall be indented under saturated fat and 
expressed to the nearest 0.5 (1/2) gram increment below 5 grams and to 
the nearest gram increment above 5 grams. If the serving contains less 
than 0.5 gram, the content shall be expressed as zero.
    (e)(1) Formats for nutrition labeling shall be in accordance with 
21 CFR 101.9(d) and (e), except for (d)(13) and references to (f), 
(j)(5), and (j)(13), or in accordance with paragraph (g)(1) of this 
section.
    (2)(i) Nutrition labeling on the outer labeling of packages of 
poultry products that contain two or more poultry products in the same 
package (e.g., variety packs) or of packages that are used 
interchangeably for the same type of food (e.g., poultry salad 
containers) may use an aggregate display.
    (ii) Aggregate displays shall comply with format requirements of 
paragraph (e)(1) of this section to the maximum extent possible, except 
that the identity of each food shall be specified immediately under the 
``Nutrition Facts'' title, and both the quantitative amount by weight 
(i.e., g/mg amounts) and the percent Daily Value for each nutrient 
shall be listed in separate columns under the name of each food.
    (f) * * *
    (1)(i) Presenting the required nutrition information in a tabular 
or linear (i.e., string) fashion, rather than in vertical columns, if 
the product has a total surface area available to bear labeling of less 
than 12 square inches, or if the product has a total surface area 
available to bear labeling of 40 or less square inches and the package 
shape or size cannot accommodate a standard vertical column or tabular 
display on any label panel. Nutrition information may be given in a 
linear fashion only if the package shape or size will not accommodate a 
tabular display.
    (ii) When nutrition information is given in a linear display, the 
nutrition information shall be set off in a box by the use of a 
hairline. The percent Daily Value is separated from the quantitative 
amount declaration by the use of parenthesis, and all nutrients, both 
principal components and subcomponents, are treated similarly. Bolding 
is required only on the title ``Nutrition Facts'' and is allowed for 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
    (2) Using any of the following abbreviations: 

Serving size.........................  Serv size                        
Servings per container...............   Servings                        
Calories from fat....................  Fat cal                          
Calories from saturated fat..........  Sat fat cal                      
Saturated fat........................  Sat fat                          
Monounsaturated fat..................  Monounsat fat                    
Polyunsaturated fat..................  Polyunsat fat                    
Cholesterol..........................  Cholest                          
Total carbohydrate...................  Total carb                       
Dietary fiber........................  Fiber                            
Soluble fiber........................  Sol fiber                        
Insoluble fiber......................  Insol fiber                      
Sugar alcohol........................  Sugar alc                        
Other carbohydrate...................  Other carb                       
                                                                        

    (3) Omitting the footnote required in 21 CFR 101.9(d)(9) and 
placing another asterisk at the bottom of the label followed by the 
statement ``Percent Daily Values are based on a 2,000 calorie diet'' 
and, if the term ``Daily Value'' is not spelled out in the heading, a 
statement that ``DV'' represents ``Daily Value.''
* * * * *
(Paperwork requirements were approved by the Office of Management 
and Budget under control number 0583-0088.)

    12. Section 381.412 is amended by revising paragraphs (a) and (c), 
and by adding the OMB control number for paperwork requirements at the 
end of the section to read as follows:


Sec. 381.412  Reference amounts customarily consumed per eating 
occasion.

    (a) The general principles followed in arriving at the Reference 
Amounts for serving sizes set forth in paragraph (b) of this section 
are found in 21 CFR 101.12 (a), (c), except for reference to the 
unprepared form in the first paragraph, (d), and (g).
* * * * *
    (c) For products that have no Reference Amount listed in paragraph 
(b) of this section for the unprepared or the prepared form of the 
product and that consist of two or more foods packaged and presented to 
be consumed together (e.g., poultry lunch meat with cheese and 
crackers), the Reference Amount for the combined product shall be 
determined using the following rules:
    (1) For bulk products, the Reference Amount for the combined 
product shall be the Reference Amount, as established in paragraph (b) 
of this section, for the ingredient that is represented as the main 
ingredient plus proportioned amounts of all minor ingredients.
    (2) For products where the ingredient represented as the main 
ingredient is one or more discrete units, the Reference Amount for the 
combined product shall be either the number of small discrete units or 
the fraction of the large discrete unit that is represented as the main 
ingredient that is closest to the Reference Amount for that ingredient 
as established in paragraph (b) of this section plus proportioned 
amounts of all minor ingredients.
    (3) If the Reference Amounts are in compatible units, they shall be 
summed (e.g., ingredients in equal volumes such as tablespoons). If the 
Reference Amounts are in incompatible units, the weights of the 
appropriate volumes should be used (e.g., grams of one ingredient plus 
gram weight of tablespoons of a second ingredient).
* * * * *
(Paperwork requirements were approved by the Office of Management 
and Budget under control number 0583-0088.)

    13. Table 2 in Sec. 381.412(b) is amended by removing the words 
``poultry bagel dogs'' from the Product Category ``Entrees without 
sauce.''
    14. Section 381.413 is amended by adding paragraph (g) to read as 
follows:


Sec. 381.413  Nutrient content claims; general principles.

* * * * *
    (g) Labeling information required in Secs. 381.413, 381.454, 
381.456, 381.460, 381.461, 381.462, and 381.480, whose type size is not 
otherwise specified, is required to be in letters and/or numbers no 
less than 1/16 inch in height.
* * * * *
    15. Section 381.469 is amended by adding the OMB control number for 
paperwork requirements at the end of the section to read as follows:


Sec. 381.469  Labeling applications for nutrient content claims.

* * * * *
(Paperwork requirements were approved by the Office of Management 
and Budget under control number 0583-0088.)

    16. Section 381.500 is amended by revising paragraphs (c) and (d) 
to read as follows:


Sec. 381.500  Exemption from nutrition labeling.

* * * * *
    (c)(1) Foods represented to be specifically for infants and 
children less than 2 years of age shall bear nutrition labeling as 
provided in paragraph (c)(2) of this section, except such labeling 
shall not include calories from fat, calories from saturated fat, 
saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat, 
and cholesterol.
    (2) Foods represented or purported to be specifically for infants 
and children less than 4 years of age shall bear nutrition labeling 
except that:
    (i) Such labeling shall not include declarations of percent of 
Daily Value for total fat, saturated fat, cholesterol, sodium, 
potassium, total carbohydrate, and dietary fiber;
    (ii) Nutrient names and quantitative amounts by weight shall be 
presented in two separate columns;
    (iii) The heading ``Percent Daily Value'' required in 
Sec. 381.409(e) shall be placed immediately below the quantitative 
information by weight for protein;
    (iv) The percent of the Daily Value for protein, vitamins, and 
minerals shall be listed immediately below the heading ``Percent Daily 
Value''; and
    (v) Such labeling shall not include the footnote specified at 21 
CFR 101.9(d)(9).
    (d)(1) Products in packages that have a total surface area 
available to bear labeling of less than 12 square inches are exempt 
from nutrition labeling, provided that the labeling for these products 
bear no nutrition claims or other nutrition information. The 
manufacturer, packer, or distributor shall provide, on the label of 
packages that qualify for and use this exemption, an address or 
telephone number that a consumer can use to obtain the required 
nutrition information (e.g., ``For nutrition information call 1-800-
123-4567'').
    (2) When such products bear nutrition labeling, either voluntarily 
or because nutrition claims or other nutrition information is provided, 
all required information shall be in a type size no smaller than 6 
point or all upper case type of \1\/16-inch minimum height, except 
that individual serving-size packages of poultry products that have a 
total area available to bear labeling of 3 square inches or less may 
provide all required information in a type size no smaller than \1\/
32-inch minimum height.

    Done at Washington, DC, on: August 25, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-21577 Filed 8-31-94; 8:45 am]
BILLING CODE 3410-DM-P