[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
