[Federal Register Volume 59, Number 51 (Wednesday, March 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6012]


[[Page Unknown]]

[Federal Register: March 16, 1994]


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Part IV





Department of Agriculture





_______________________________________________________________________



Food Safety and Inspection Service



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9 CFR Parts 317 and 381




Nutrition Labeling of Meat and Poultry Products; Technical Amendments; 
Proposed Rule
DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 93-022P]

 
Nutrition Labeling of Meat and Poultry Products; Technical 
Amendments

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend its final nutrition labeling regulations, which permit voluntary 
nutrition labeling on single-ingredient, raw meat and poultry products 
and establish mandatory nutrition labeling for all other meat and 
poultry products, with certain exceptions. FSIS is taking this action 
to address inconsistencies in the regulations, improve their accuracy, 
and correct unintended technical consequences of the regulations, in 
order to provide consumers with the most informative labeling system 
possible. Most of the changes FSIS is proposing are designed to 
parallel technical amendments the Food and Drug Administration (FDA) 
made to its regulations that require nutrition labeling on most foods 
under its jurisdiction.

DATES: Comments must be received on or before May 16, 1994.

ADDRESSES: Written comments to: Policy Office, ATTN: Diane Moore, FSIS 
Hearing Clerk, room 3171, South Building, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250. Oral 
comments as provided by the Poultry Products Inspection Act should be 
directed to Mr. Charles Edwards at (202) 254-2565. (See also 
``Comments'' under Supplementary Information.)

FOR FURTHER INFORMATION CONTACT: Charles Edwards, Director, Product 
Assessment Division, Regulatory Programs, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250, (202) 
254-2565.

SUPPLEMENTARY INFORMATION: 

Executive Order 12866

    This proposed rule has been reviewed under Executive Order 12866.

Executive Order 12778

    This proposed rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. States and local jurisdictions are preempted 
under the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) from imposing any marking, labeling, packaging, 
or ingredient requirements on federally inspected meat and poultry 
products that are in addition to, or different than, those imposed 
under the FMIA or PPIA. States and local jurisdictions may, however, 
exercise concurrent jurisdiction over meat and poultry products that 
are outside official establishments for the purpose of preventing the 
distribution of meat and poultry products that are misbranded or 
adulterated under the FMIA or PPIA, or, in the case of imported 
articles, which are not at such an establishment, after their entry in 
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 proposed 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 proposed 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 proposed rule 
with respect to labeling decisions.

Effect on Small Entities

    The Administrator, FSIS, has determined that this proposed rule 
will not have a significant effect on small entities, as defined by the 
Regulatory Flexibility Act (5 U.S.C. 601). The proposed rule would 
clarify and improve understanding of certain provisions of the 
nutrition labeling regulations. The Administrator finds that this 
proposed rule would result in positive benefits because it would enable 
official establishments to more easily comprehend the regulations and 
facilitate their implementation. The proposal would 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 would not be affected by this proposed rule.

Comments

    Interested persons are invited to submit comments concerning this 
proposed rule. Written comments should be sent to the Policy Office and 
refer to Docket No. 93-022P. Any person desiring an opportunity for an 
oral presentation of views, as provided by the Poultry Products 
Inspection Act, should make such a request to Mr. Charles Edwards, so 
that arrangements can be made for such views to be presented. A record 
will be made of all views orally presented. All comments submitted in 
response to this proposed rule will be available for public inspection 
at the Policy Office from 9 a.m. to 12:30 p.m. and from 1:30 p.m. to 4 
p.m., Monday through Friday.

Background

    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 proposing to amend 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 proposing to 
correct the terminology for extra lean ground beef in a provision of 
the final nutrition labeling regulations and to correct an oversight in 
the Federal poultry products inspection regulations related to product 
analyses.

Elements of Proposed Rule

Serving Sizes

    FSIS acknowledges that the variety of specifications for products 
in discrete units which is contained in a single paragraph at 9 CFR 
317.309(a)(3) and 381.409(a)(3) may be confusing. For this reason, FSIS 
is proposing 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), reorder some of the information, and 
make minor editorial changes to improve clarity. For example, the 
proposed revisions at 9 CFR 317.309(a)(3)(ii) and 381.409(a)(3)(ii) 
make it explicit that for products in discrete units that contain 
between 50 and 67 percent of the reference amount, the manufacturer may 
declare the serving size as either one or two units.
    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 ``complete'' products, such as chow mein components in multiple 
cans and pizza mix with a prepared crust, and mixes and kits with 
separate packets that require the addition of water or other 
ingredients, such as soups and stir-fry kits. Also included are 
products that are distinct and separate foods packaged together in the 
same container and intended to be consumed together; e.g., chicken 
wings with a dipping sauce, turkey with gravy packet, and ham with 
glaze packet.
    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.'' 
An example of the ``reference amount for the combined product'' 
calculated for a package of six chicken nuggets weighing 170 grams (g) 
and barbecue sauce weighing 100 grams is 135 grams; i.e., 85 grams for 
nuggets and 50 grams for sauce. The serving size for the composite 
product could be expressed as ``3 chicken nuggets with sauce (135g),'' 
and the serving size for each component could be expressed as ``3 
nuggets (85g)'' and either ``barbecue sauce for 3 nuggets (50g)'' or 
``3 tbsp sauce (50g),'' if 50 grams of sauce makes 3 tablespoons. The 
number of servings for this package would be two. FSIS is proposing 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 is proposing 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). The option to specifically allow 
proportioning of minor ingredients to the major ingredients appears at 
9 CFR 317.309(a)(6)(vi) and 381.409(a)(6)(vi). Also, FSIS is proposing 
to delete reference to the term ``portion'' at 9 CFR 317.309(a)(1), 
381.409(a)(1), 317.312(a), and 381.412(a) because it is no longer 
defined in the nutrition labeling regulations.
    At 9 CFR 317.309(a) and 381.409(a), FSIS cross-referenced 
provisions pertaining to serving sizes at 21 CFR 101.9(b) (1) and (2) 
except (2)(i), and 21 CFR 101.9(b) (5) through (9) except (b)(5)(iii). 
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. This provision applies 
to products that are ``packaged and sold individually.'' Similar 
provisions at 9 CFR 317.309(a)(3) and 381.409(a)(3) for products within 
multi-serving packages were inadvertently omitted. This unintended 
inconsistency would allow individual units packaged and sold separately 
to be labeled as one or two servings while not permitting the same 
label declaration on the same product when sold as part of a multi-
serving package. To correct this oversight FSIS is proposing 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.
    FSIS also realizes that 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. For example, if 
labeled and sold individually, mini pizzas weighing 50 grams could be 
considered single-serving packages, and the serving size would be one 
mini pizza. However, if several mini pizzas were packaged within a 
multi-serving package, the serving size, when determined in accordance 
with 9 CFR 317.309(a)(3) and 381.409(a)(3), is the number of whole 
units that most closely approximates the reference amount for the 
product category, which is 140 grams. Therefore, the serving size for a 
multi-serving package would be three mini pizzas, and a box containing 
15 mini pizzas would be labeled with five servings per container. If 
each of the mini pizzas in the multi-serving package is labeled as a 
single serving, the outer and inner labeling would have inconsistent 
nutrient values on a per serving basis. To prevent this ambiguity, FSIS 
is proposing 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. All of these provisions require that 
each of the individual units bears all required labeling information, 
including nutrition labeling.
    FSIS and FDA also determined that for 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, the most appropriate 
household measure for the serving size is the fraction of the box that 
makes the ``reference amount for the unprepared product.'' The 
provision at 21 CFR 101.9(b)(2)(ii) has been amended to incorporate 
this change. FSIS is proposing to cross-reference this provision, as 
amended. FSIS is also proposing 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 acknowledges that allowing for only whole numbers of 
tablespoons poses a significant problem for concentrated products that 
require further preparation, especially those reconstituted with water. 
Consideration of the 1 to 2 tablespoon range was inadvertently omitted 
in the final rule and FSIS is correcting this omission. FSIS is 
proposing 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 is proposing 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. These provisions would alleviate any ambiguity 
between 9 CFR 317.309(a)(3) and 381.409(a)(3) and 9 CFR 317.309(a)(6) 
and 381.409(a)(6), and add requirements that were inadvertently omitted 
from the final rule.

Equivalent Metric Quantity

    FSIS noted in its final rule that two different values for the gram 
equivalent weight of a product could appear on labels of single-serving 
containers and meal-type products when the net quantity of contents 
statement bearing the metric equivalent and the serving size refer to 
the same amount of product in the containers. For example, the net 
quantity of contents for a 5-ounce burrito would be 142 grams, which is 
obtained by multiplying 28.35 grams by 5, while the serving size 
declaration for the same burrito would be expressed as ``1 burrito 
(140g),'' which is obtained by multiplying 28 grams by 5. If a 
manufacturer chose to declare the metric equivalent weight for this 
single serving of burrito, the two discrepant values could potentially 
cause consumer confusion. 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, but 
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 is proposing to adopt this new provision.
    To achieve greater consistency with FDA provisions, FSIS is 
proposing 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 proposal would require that, when it is necessary to round the 
parenthetical milliliter equivalent of the household measure, 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 agrees with the 
changes made at 21 CFR 101.9(b)(7) and is proposing to cross-reference 
21 CFR 101.9(b)(7), except the new provision at (b)(7)(v) which 
pertains to additional descriptive information.

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 agrees with these changes and is proposing 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. For example, if a 
bulk package of sausage contains three inner packages, each of which 
makes 5.2 servings, each inner package label would have to declare the 
servings per container as ``about 5.'' That declaration implies the 
total package contains 15 servings (5 times 3). However, if the amount 
of sausage in all three packages were counted, the total package 
actually contains 15.6 servings (5.2 times 3), and its label would 
declare the servings per container as ``about 16.''
    To correct this problem and avoid consumer confusion, FSIS is 
proposing to cross-reference a new provision at 21 CFR 101.9(b)(8)(v) 
which 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. In the sausage example, the serving size would be 
approximately 1/5 of an individual unit, and each unit would carry a 
servings-per-container statement of ``about 5.'' The number of servings 
in the entire package would be ``about 15'' (3 packages times ``about 
5'' servings per package).

Nutrient Declarations

    At 9 CFR 317.309(b) and 381.409(b), FSIS cross-referenced 
provisions pertaining to nutrient declarations at 21 CFR 101.9(c)(1) 
through (c)(9), except (c)(1)(i)(E), bomb calorimetry, and (c)(7)(ii), 
use of nitrogen conversion factors other than 6.25. At 21 CFR 
101.9(c)(1), requirements were included for calorie content 
calculations using general or specific factors without specifying 
whether only the final calorie determination should be rounded, or 
whether the actual quantitative values for protein, total carbohydrate, 
total fat, and ingredients with specific food factors should be rounded 
before the calculation is performed. FSIS and FDA concluded that 
calorie declaration should be calculated with as much precision as 
possible up to the point of final rounding. 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 is proposing to cross-reference this provision, 
as amended.
    Both FSIS and FDA received comments concerning the definition of 
``lean'' that convinced them to change the saturated fat criterion in 
the definition of this term to a maximum of 4.5 grams or less of 
saturated fat. FSIS included this change in its interim rule on 
technical amendments published on September 10, 1993, and FDA included 
the same change in its rule on August 18, 1993. As a consequence of the 
change, both agencies believe it is necessary to require that levels of 
fat, saturated fat, and poly- and monounsaturated fat below 5 grams per 
serving be declared in half-gram increments rather than below 3 grams. 
This action would prevent consumer confusion because the declared 
values on labels would be consistent with the definitions of nutrient 
content claims. 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 the four nutrients. FSIS is proposing to cross-reference 
these provisions, as amended. In addition, FSIS is proposing to amend 9 
CFR 317.309(d) and 381.409(d) to provide the same consistency in 
declared values for stearic acid, a component of saturated fat. The 
proposal would require that stearic acid content below 5 grams per 
serving be declared in half-gram increments.
    FSIS believes that the required disclosure of poly- and 
monounsaturated fat in the nutrition labeling of a ``fat free'' food 
serves no useful purpose because no additional information would be 
provided to consumers. 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 is proposing 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 believes this change will provide more precise 
information about beta-carotene contents, and compatible declaration of 
vitamin A and beta-carotene would assist consumers to understand the 
nutrition labeling. FSIS is proposing to cross-reference this 
provision, as amended.
    Inadvertently, this provision failed to provide expressly how the 
declaration of beta-carotene is to be presented. FSIS and FDA believe 
it is necessary to require that information on beta-carotene be 
formatted to convey to the consumer that it is a subcomponent of 
vitamin A. FDA has amended 21 CFR 101.9(c)(8)(vi) to include this 
requirement. FSIS is proposing to cross-reference this provision, 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

    At 9 CFR 317.309(e) and 381.409(e), FSIS cross-referenced format 
elements as provided at 21 CFR 101.9(d). 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, which was intended to apply to all 
type systems. However, there is no single numeric kerning value 
applicable to all type systems. For this reason FDA has replaced the 
requirement to state instead that ``Letters should never touch.'' FSIS 
is proposing to cross-reference this provision, as amended.
    Type size specifications at 21 CFR 101.9(d)(1)(iii) did not address 
several statements that may be declared within the display of nutrition 
information, such as the declaration of percent of vitamin A present as 
beta-carotene and the statement ``Not a significant source of 
____________.'' In apparent conflict, the last sentence of 21 CFR 
101.9(c)(8)(iii), which pertained to vitamin and mineral declarations, 
required that the ``Not a significant source of ____________.'' 
Statement be in the same type size as nutrients that are indented; 
i.e., in 8-point type, while FDA's sample labels showed the statement 
in 6-point type. The provision at 21 CFR 101.9(d)(1)(iii) has been 
amended to correct this technical error. The corrected provision 
specifies 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 is proposing to cross-reference this provision, as amended. 
FSIS is also proposing to adopt the change made to 21 CFR 
101.9(c)(8)(iii) that removes the conflicting sentence.
    FSIS agrees with FDA that 21 CFR 101.9(d)(7) needed to be corrected 
to be inclusive of 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.'' FSIS is proposing to 
cross-reference the provision, as amended, which clarifies that the 
listing of some nutrients is required, and the listing of others is 
voluntary by inserting the word ``as'' before ``specified.''
    FSIS and FDA received comments concerning inconsistences between 
quantitative amounts and percent Daily Values (DV) caused by dividing 
the actual amount of a nutrient before rounding, as required, by the 
Daily Reference Value (DRV) for the nutrient. For example, saturated 
fat in an amount of 0.4 gram would be declared as 0 gram, but its 
percent DV would be declared as 2 percent. FSIS acknowledges this 
apparent discrepancy while recognizing there are legitimate advantages 
and disadvantages for using either rounded or unrounded values. FSIS is 
proposing to adopt 21 CFR 101.9(d)(7)(ii) which has been amended to 
correct this technical inconsistency. FSIS would require that the 
percent 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 DRV for 
that nutrient. Manufacturers should use whichever value will provide 
the greatest consistency on the product labeling. Where quantitative 
amounts must be declared as zero, the rounded values should be used to 
calculate percent DV. When unrounded values support the basis for 
nutrient content claims, they should be used.
    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. 
Although FSIS believes the public can benefit from having the caloric 
conversion factors, the Agency is convinced that there is no real need 
to make the information mandatory because consumers do not have to 
calculate calories. The regulations require that declarations of 
calories and calories from fat be stated on the labeling. 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. For consistency, FSIS is proposing to 
cross-reference these provisions, as amended, and adopt changes to 21 
CFR 101.9(d)(11)(ii) which allow for the presentation of the 
information described above. FSIS is also proposing to amend 9 CFR 
317.309(f)(3) and 381.409(f)(3) to delete reference to the footnote as 
required information.
    In response to many requests for greater flexibility in presenting 
required nutrition information, especially for the display on packages 
that have more than 40 square inches of space available to bear 
labeling but do not have sufficient space to place the full vertical 
format, 21 CFR 101.9(d)(11) has been modified as follows. The provision 
has been redesignated as 21 CFR 101.9(d)(11)(i) and a new provision has 
been added 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 is proposing to 
adopt these changes and cross-reference the amended provisions 
discussed above.
    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 is proposing 
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). This aggregate display is the same as 
that shown by FDA at 21 CFR 101.9(d)(13)(ii). A new provision has been 
added at 21 CFR 101.9(d)(14) to provide for the inclusion and display 
of two languages under a single ``Nutrition Facts'' heading. FSIS 
agrees with the change and is proposing to adopt the new provision.

Modified Format

    Both FSIS and FDA allowed format modifications for products in 
packages that have a surface area available to bear labeling of 40 or 
less square inches to include tabular and linear displays of 
information. At 9 CFR 317.309(f)(1) and and 381.409(f)(1), FSIS 
permitted nutrition information to be given in a linear fashion only 
when the tabular display could not be accommodated. FSIS inadvertently 
used the term ``label'' as the basis for determining whether the 
accommodation could be made. FSIS intended for package shape or size to 
be the determining factor. Therefore, FSIS is proposing to amend these 
provisions to clarify this fact and to maintain consistency with FDA's 
requirements for use of a linear display. The proposal would add new 
paragraphs at 9 CFR 317.309(f)(1)(ii) and 381.409(f)(1)(ii) to define 
the linear display and would remove the former direction that any 
subcomponents declared may be listed parenthetically after principal 
components. Many commenters requested that FSIS and FDA provide 
examples of linear displays. Both agencies worked together to develop 
such examples.
    In its final rule, FSIS provided for abbreviations for mandatory 
nutrients whose name exceeds 10 characters. FSIS believes it should 
also allow abbreviations for voluntary nutrients because they become 
mandatory if claims are made. FSIS is proposing 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. This action parallels an identical FDA 
allowance.

Reference Amounts

    In its final rule, FSIS cross-referenced 21 CFR 101.12(c) 
pertaining to reference amounts for products requiring further 
preparation. FDA changed the terms used in this section to improve 
clarity and require manufacturers to use reference amounts for 
unprepared forms of products, if those reference amounts are contained 
in the tables at 21 CFR 101.12(b). The FSIS tables of reference amounts 
are contained at 9 CFR 317.312(b) and 381.412(b). These sections 
contain reference amounts for ready-to-cook forms of bacon-type 
products, sausages, and raw cuts of meat and poultry. FSIS never 
intended to limit manufacturers to those amounts and allows them to use 
product-specific yields, such as their own or the extensive listings in 
USDA's Agriculture Handbook No. 8, when determining the ``reference 
amount for the unprepared product.'' Therefore, FSIS is proposing 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.
    At 9 CFR 317.312(b) and 381.412(b), Table 2.--Reference Amounts 
Customarily Consumed--General Food Supply, FSIS erred by listing bagel 
dogs and poultry bagel dogs as examples under the product category of 
entrees without sauce, and at 9 CFR 317.312(b), erred by listing freeze 
dry, dehydrated, concentrated soup mixes as an example under the 
product category of seasoning mixes dry. FSIS is proposing to remove 
these examples because the products are not deemed amenable to FSIS 
inspection.
    FSIS found that, when products are used to make foods that are 
consumed in small discrete units, the prescribed approach to 
determining a ``reference amount for the unprepared product'' results 
in discrepancies between the number of servings declared per package, 
e.g., ``about 5,'' and the number of discrete units prepared in 
accordance with package directions, e.g., ``makes 8 patties.'' Also, 
for products that prepare large discrete units, discrepancies can occur 
between the number of servings declared per package, e.g., ``about 9,'' 
and the declaration of a fraction of a large discrete unit, e.g., ``\1/
8\ pizza,'' for use in an optional second column for the prepared form 
of the product.
    When a product, such as a pizza kit, is used to prepare a large 
discrete unit, FSIS determined that the discrepancies can be remedied 
by providing for a reference amount for the 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, 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. FSIS is proposing to cross-reference a new provision at 21 
CFR 101.12(c)(2) that allows for this approach.
    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 is proposing 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 would 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 noted that a procedure for determining reference amounts for 
products packaged and presented to be consumed together and for which 
there is no established reference amount was not adequately provided 
for in the final rule. FSIS is proposing to amend 9 CFR 317.312(c) and 
381.412(c) to provide for this procedure. This modification affects 
only 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 is proposing 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.'' This approach 
has been selected because amounts that are provided as volume measures 
can easily be expressed as weights and summed. However, the opposite is 
not the case because weights cannot be readily expressed as volumes.

Nutrient Content Claims; General Principles

    At 9 CFR 317.313(b) and 381.413(b), FSIS cross-referenced 21 CFR 
101.13(b) in its final rule. Both FSIS and FDA later determined that 
reasonable alternate spellings of various descriptive terms defined by 
regulations are reasonable and may be used. This allowance, however, 
was not incorporated into 21 CFR 101.13(b). The provision at 21 CFR 
101.13(b) has been amended 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 is proposing to cross-reference 21 CFR 101.13(b), as 
amended.
    In its final rule, FSIS provided that a nutrient content claim be 
in type size and style no larger than two times that of the statement 
of identity in 9 CFR 317.313(b) and 381.413(b) by cross-referencing 21 
CFR 101.13(f). FDA clarified these provisions in 21 CFR 101.13(f) to 
require that a nutrient content claim 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. FSIS is proposing to 
cross-reference 21 CFR 101.13(f), as amended.
    In its final rule, FSIS prescribed minimum type size requirements 
for nutrient content claims at 9 CFR 317.313 and 381.413 by cross-
referencing various provisions in 21 CFR 101.13 that included these 
requirements. However, minimum type sizes were not specified for all 
the accompanying information for relative claims; e.g., in cross-
referenced provisions at 21 CFR 101.13(j)(2)(iv). To correct this 
oversight, FDA amended 21 CFR 101.2(b) to include the nutrient content 
claims sections in its scope 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 is proposing 
to amend 9 CFR 317.313 and 381.413 by adding a new paragraph (g) to 
include the same requirement in its regulations.
    As discussed in this document under the section on nutrient 
declarations, FSIS determined that when unrounded values support the 
basis for nutrient content claims, they should be used in labeling. 
Requirements for comparative claims other than ``light'' are contained 
at 9 CFR 317.313(j) and 381.413(j) that cross-references 21 CFR 
101.13(j), except comparison to product of another manufacturer at 21 
CFR 101.13(j)(1)(ii)(B). The cross-referenced section states that when 
comparing a single manufacturer's product to the labeled product, the 
nutrient value for the single manufacturer's product shall be the value 
declared in the nutrition labeling of the product. The provision at 21 
CFR 101.13(j) has been amended 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. FSIS is proposing 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). FSIS is also clarifying that its restriction 
on comparison to the product of another manufacturer is to the use of 
the name of the competitor as opposed to a complete restriction on 
comparison to product of another manufacturer.

Extra Lean Ground Beef

    FSIS identified 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. 
The cuts included extra lean ground beef, which, according to USDA's 
Agriculture Handbook No. 8, is a product averaging approximately 17 
percent fat by weight on an uncooked basis as it is currently marketed. 
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. 
Effective July 6, 1994, the term ``extra lean'' will no longer be 
applicable to the product listed at 9 CFR 317.344. For this reason, 
FSIS is proposing to amend this section by changing the name ``ground 
beef extra lean without added seasoning'' to ``ground beef about 17% 
fat without added seasoning.''

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-references 21 CFR 101.60 for the 
requirements, and for sodium and salt at 9 CFR 317.361 and 381.461, 
which cross-references 21 CFR 101.61 for the requirements. The 
requirement that sugars and salt defined in these sections meet the 
general requirements for nutrient content claims was inadvertently 
omitted from 21 CFR 101.61 and 101.62. FDA has 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 
agrees with these modifications and is proposing to cross-reference 21 
CFR 101.60 and 101.61, as amended.

Criteria for Free Claims

    The FSIS provisions on nutrient content claims contained in its 
final nutrition labeling regulations at 9 CFR 317.360, 317.361, 
317.362, 381.460, 381.461, and 381.462 cross-reference the following 
provisions for the definition of ``free'': 21 CFR 101.60 for calories 
and sugars; 21 CFR 101.61 for sodium; and 21 CFR 101.62 for fat, fatty 
acids, and cholesterol. The criterion for ``free'' claims was based on 
the amount of nutrient per reference amount customarily consumed. FDA 
amended this criterion to include a per-labeled-serving basis. This 
amendment avoids the confusion that may be created should products bear 
``free'' claims when the nutrition labeling could contain a nutrient 
value other than zero, which is the amount considered to be 
nutritionally trivial and is the basis for the term ``free.'' 
Provisions at 21 CFR 101.60, 101.61, and 101.62 have been amended to 
restrict the amount of nutrient per labeled serving, as well as per 
reference amount customarily consumed. The specific modifications 
appear at 21 CFR 101.60 (b)(1)(i) and (c)(1)(i); 101.61(b)(1)(i); and 
101.62 (b)(1)(i), (c)(1)(i), (d)(1)(i)(A), and (d)(1)(ii)(A). FSIS 
agrees with these changes and is proposing to cross-reference 21 CFR 
101.60, 101.61, and 101.62, as amended, for the definition of ``free'' 
for calories, sugars, sodium, fat, fatty acids, and cholesterol.

Criterion for Saturated Fat Free Claims

    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). A criterion for the definition of the 
term is that the level of trans fatty acids in the product not exceed 1 
percent of the total fat. 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, because this is an amount that can be analyzed and 
is consistent with the definition of ``free'' for fat and saturated 
fat. FSIS agrees with this change and is proposing to cross-reference 
21 CFR 101.62(c), as amended.

Nutrient Content Claims for Rehydrated Products

    The nutrient content claim requirements in FSIS's final nutrition 
labeling regulations specify that for products that have a reference 
amount customarily consumed of 30 grams or less or 2 tablespoons or 
less, the criteria for claims are based on 50 grams of product, as well 
as per reference amount. 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. The specific FDA provisions which have been amended 
to this effect are the following: 21 CFR 101.60(b)(2)(i)(B); 101.61(b) 
(2)(i)(B) and (4)(i)(B); and 101.62 (b)(2)(i)(B) and (d)(2)(ii)(A). 
FSIS is proposing 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 is 
proposing 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. The percent Daily 
Values for protein, vitamins, and minerals are to be declared in 
accordance with the applicable cross-referenced provisions of 21 CFR 
101.9(c). FSIS is proposing additional format specifications in the 
amended provisions. These changes are consistent with FDA's amendments 
to its provision governing nutrition labeling of products intended for 
these age groups.

Packages With Less Than 12 Square Inches of Space

    In its interim final rule published on September 10, 1993, FSIS 
added provisions at 9 CFR 317.400(d) and 381.500(d) to permit product 
manufacturers of packages that have a total surface area available to 
bear labeling of less than 12 square inches to provide an address or 
telephone number for consumers to write or call for nutrition 
information, provided that the labeling for these products bear no 
nutrition claims or information. FSIS and FDA concluded that a greater 
selection of type sizes for use on these packages is warranted. Such 
options would benefit consumers by allowing nutrition information to be 
presented on more packages and would provide manufacturers flexibility 
when provision of nutrition information becomes mandatory. FSIS is 
proposing 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.

Product Analyses

    FSIS is proposing to remove 9 CFR 381.133(b) of the poultry 
products inspection regulations to correct an oversight relating to 
product analyses. Generally, 9 CFR 381.133(b) provides 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. Under the nutrition 
labeling regulations, companies are required to maintain records that 
support nutrient information. Companies may base nutrient information 
on data bases and on recipe analysis using data bases, as well as on 
laboratory analyses. FSIS will, in turn, use specific methods to 
analyze samples for enforcement purposes. Thus, 9 CFR 381.133(b) should 
have been removed as part of the nutrition labeling rulemaking. There 
is no similar provision in the Federal meat inspection regulations.

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.

Proposed Rule

    For the reasons discussed in the preamble, FSIS is proposing to 
amend 9 CFR parts 317 and 381 of the Federal meat and poultry products 
inspection regulations to read as follows:

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

    1. The authority citation for part 317 would continue to read as 
follows:

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

    2. Section 317.309 would be amended by revising paragraphs (a) (1), 
(3), (6), (d), (e), and (f) (1), (2), and (3) 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).
    (2) * * *
    (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 
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., 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.''
* * * * *
    3. Section 317.312 would be amended by revising paragraphs (a) and 
(c) 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).
    (b) * * *
    (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 or 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).


Sec. 317.312  [Amended]

    4. Table 2 in Sec. 317.312(b) would be 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 would be 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 would be amended by removing the words ``ground 
beef extra lean without added seasoning'' and adding the words ``ground 
beef about 17% fat without added seasoning.''
    7. Section 317.400 would be amended by revising paragraph (c), 
redesignating paragraph (d) as (d)(1) and by revising the newly 
designated paragraph (d)(1) and adding paragraph (d)(2) 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

    8. The authority citation for part 381 would continue to read as 
follows:

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


Sec. 381.133  [Amended]

    9. Section 381.133 would be 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).
    10. Section 381.409 would be amended by revising paragraphs (a), 
(d), (e), and (f) 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).
    (2) * * *
    (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 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 quantitive 
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.''
* * * * *
    11. Section 381.412 would be amended by revising paragraphs (a) and 
(c) 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).
    (b) * * *
    (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 or 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).


Sec. 381.412  [Amended]

    12. Table 2 in Sec. 381.412(b) would be amended by removing the 
words ``poultry bagel dogs'' from the Product Category ``Entrees 
without sauce.''
    13. Section 381.413 would be 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.
* * * * *
    14. Section 381.500 would be amended by revising paragraph (c), 
redesignating paragraph (d) as (d)(1) and by revising the newly 
designated paragraph (d)(1) and adding paragraph (d)(2) 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 labels 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 March 9, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing & Inspection Services.
[FR Doc. 94-6012 Filed 3-15-94; 8:45 am]
BILLING CODE 3410-DM-M