[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
