assertion that grouping foods in such a manner violates the FD&C Act.
We followed the methodology used for all products categories when
determining the RACC for the ``Measurable with cup, e.g., casseroles,
hash, macaroni and cheese, pot pies, spaghetti with sauce, stews,
etc.'' product category under the ``Mixed Dishes'' general category.
Products with a larger sample size in the product category did not show
a significant amount of change; therefore, we did not update the RACC
for pasta with sauce.
    (Comment 58) We received a comment requesting us to clarify if
plant-based beverages with added ingredients are included in the
proposed product category for ``Milk, milk-substitute beverages, milk-
based drinks, e.g., instant breakfast, meal replacement, cocoa, soy
beverage.'' The comment stated that the proposed rule does not discuss
the appropriate RACC for plant-based beverages with added ingredients,
such as protein, fiber, or fruit, including those that may be
positioned as a plant-based ``smoothie.'' The comment argued that
plant-based beverages with added ingredients should be included within
the RACC for milk and milk-substitute beverages because plant-based
beverages with added ingredients are more nutrient dense than a
carbonated or non-carbonated beverage like a soda or water, and
typically contain higher levels of protein, vitamins, and minerals.
    (Response 58) We did not intend plant-based beverages with added
ingredients to be included in the proposed product category for ``Milk,
milk-substitute beverages, milk-based drinks, e.g., instant breakfast,
meal replacement, cocoa, soy beverage,'' and we disagree that plant-
based beverages with added ingredients should be included in this
product category. Whether or not plant-based beverages with added
ingredients are more nutrient dense than a carbonated or non-carbonated
beverage like a soda or water depends on the contents of a specific
product; however, we do agree that plant-based beverages do not belong
in the same product category as carbonated and non-carbonated
beverages. A plant-based beverage such as a smoothie is a beverage that
is made by blending fruit with yogurt, milk, or ice cream until it is
thick and smooth (Ref. 26). Plant-based beverages with added
ingredients are otherwise more similar to other items in the product
category ``Shakes and shake substitute, e.g., dairy shake mixes, fruit
frost mixes'' than to products in the category ``Milk, milk-substitute
beverages, milk-based drinks, e.g., instant breakfast, meal
replacement, cocoa, soy beverage.'' The comment's description of a
plant-based mix includes products with fruit or cocoa as added
ingredients. Fruit and cocoa are commonly added ingredients in
milkshakes (Ref. 26). Regardless of the distinction between product
categories, we note that the RACC for the milk and milk substitute
product category is the same as the RACC for the milkshake product
category.
    (Comment 59) Powdered candies and liquid candies--We received one
comment in support of our proposals to add ``powdered candies'' and
``liquid candies'' to the product category currently designated as
``Hard candies, others'' and to establish an RACC of 15 mL for liquid
candies and 15 g for powdered candies and all other hard candies. The
comment noted that the proposed RACCs are consistent with ``suggested
RACCs'' provided in FDA guidance and are consistent with current
industry practices. The comment also supported our proposal to rename
this product category ``Hard candies, others; powdered candies, liquid
candies'' to indicate that

powdered and liquid candies would now be included in this product
category.
    (Response 59) We agree with this comment. Powdered candies may be
dispensed from straws, and liquid candy can be dispensed from small
bottles or waxy containers. This final rule establishes an RACC of 15 g
for powdered candies and an RACC of 15 mL for liquid candies and
includes both in the product category ``Hard candies, others; powdered
candies, liquid candies.'' Additionally, the label statement for this
category in table 2 of Sec.  101.12(b) will include label statements
for powdered candies (``____straw(s) (____g) for powdered candies'')
and liquid candies (`` ____wax bottle(s) (____mL) for liquid
candies'').
    (Comment 60) Powdered coffee creamer--Some comments requested that
we increase the RACC for powdered coffee creamer from the current RACC
of 2 g, which is equal to 1 teaspoon (tsp). The comments stated that
the NHANES data show that the median consumption of powdered coffee
creamer has doubled to 4 g, or 2 tsps. One comment stated that
consumers use much more than 2 g or 4 g and suggested that we use 6 g,
or 1 tbsp, as the RACC. The comment stated that we should increase the
RACC for powdered creamers to 1 tbsp so that it can be the same serving
size as is used for liquid creamers.
    (Response) The current 1993 RACC for ``Cream or cream substitutes,
powder'' is 2 g (or 1 tsp). Although the median 2003-2008 NHANES
consumption is 4 g, the data available in 2003-2008 NHANES were
insufficient to provide adequate information on which to base a change
from the 1993 RACC (Ref. 31). The data available did not meet the
criteria to update the RACC from the 1993 RACC of 2 g because there was
not an adequate sample size to provide a reliable median intake
estimate. Therefore, we did not propose to change the RACC for powdered
creamers.
    With respect to the comment that suggested we use the same RACC for
both liquid and powdered creamers, we disagree. Powdered creamer and
liquid creamer have different product characteristics (e.g., powder vs.
liquid), and the household measurement for the two types of products is
different. A weight measurement is used for powdered creamer, and a
volume measurement is used for liquid creamer. Additionally, the
consumption amounts for powdered and liquid creamers are not similar.
The current RACC for ``Cream or cream substitute, liquid'' did not show
a significant increase from the current RACC of 15 mL (or 1 tbsp);
therefore, we did not propose to change it.
    (Comment 61) Soup--Several comments addressed the ``All varieties''
product category under the ``Soups'' general category. Most comments
requested that we update the RACC for canned soup. The comments stated
that the current RACC for soups is too small and that many consumers
can eat an entire can of soup in one sitting. Some comments referred to
a single serving container of soup that is typically 15 oz and lists
the serving size as 2 servings.
    (Response 61) While we understand the concern that some canned
soups that appear to be single-serving containers are being labeled as
having more than one serving, consumption data for this product
category has not significantly increased. However, we note that under
the new requirements for single-serving containers finalized in this
rulemaking, products that are packaged and sold individually and that
contain less than 200 percent of the RACC will be labeled as single-
serving containers. Additionally, under the new dual-column labeling
requirements finalized in this rulemaking, products containing at least
200 percent but less than 300 percent of the RACC will be required to
provide nutrition information for the full container. Pursuant to this
rule, canned soups that are currently labeled as containing ``about 2
servings'' will be required to provide nutrition information for the
entire container, either using a single-serving container label or
using a voluntary or mandatory dual-column label format.
    (Comment 62) Sugar--One comment opposed updating the RACC for
sugar. The comment stated that a change in consumption data is not
enough to justify a change in the RACC. The comment noted that
consumption data used in the 1991 proposed rule also showed that sugar
should have an RACC of 8 g, but we nonetheless chose to finalize the
RACC at 4 g in 1993. The comment stated that consumption data for sugar
is limited and that we should, therefore, take into account other
sources of information when determining the RACC. The comment stated
that consumers typically add sugar to foods 1 tsp at a time and that
the proposed 8 g RACC (2 tsp serving size) is cumbersome for most
consumers who do not measure out sugar 2 tsp at a time. The comment
also stated that if we update the RACC for sugar, consumers will
believe that 2 tsp is the recommended serving size.
    (Response 62) The decision to update the RACC for sugar is based on
consumption data. The methodology used in the decisionmaking process
for updating the RACC for sugar is the same methodology used to
determine when to update the RACC for all product categories. While the
current RACC for sugar has been used for more than two decades, RACCs
are based primarily on the amount that is customarily consumed.
Consumption data shows that the amount of sugar that is customarily
consumed is 8 g, which is 2 tsp. We further disagree that the amount of
consumption data available for sugar was ``limited,'' as the sample
size of data available met the criteria set forth in our methodology
memo (Ref. 31). Therefore, we are finalizing the RACC for sugar as
proposed.
    We acknowledge that determining nutrition values on the label when
measuring an odd number of teaspoons of sugar (such as 3 tsp, which
equals 1\1/2\ servings) might be cumbersome for some consumers. Given
the data showing a significant increase in consumption, however, we
determined it was important for the RACC to reflect current consumption
amounts.
    The comment is correct in noting that we received no comments in
favor of our changes to the RACC for sugar. We do not consider this
relevant to our decision, however, as the consumption data is clear
with respect to this product category.
    To address the statement that updating the RACC for sugar would
cause consumers to view the larger serving size as a recommended amount
to eat, as discussed in comment 2, we intend to conduct nutrition
education to help clarify that the meaning of ``serving size'' is not a
recommended amount, but rather is based on an amount customarily
consumed.
    (Comment 63) Raisins--One comment requested that we add a separate
product category for raisins with an RACC of 28/30 g (1 oz). The
comment stated that the existing RACC does not represent the quantity
of raisins contained in individual packages typically purchased by
consumers and, therefore, is not representative of the actual amount
customarily consumed per eating occasion. The comment stated that mini
raisins boxes are packaged in \1/2\ oz (14.2 g) boxes and sold in bags
of various quantities, primarily 12 or 14 minis per bag. The comment
also stated that the larger individual snack size products are
currently packaged in boxes that are 1 oz (28.3 g) and are sold in
packages of six. The comment asserted that the two different individual
unit sizes of 14.2 g and 28.3 g are both widely consumed and represent
the predominant proportion of industry retail raisin sales

to consumers for out-of-hand snacking. The comment requested a separate
RACC for raisins that is in line with the amount of raisins that is in
an individual package of raisins. The comment stated that multiple-
serving raisin packages are a different category from other dried
fruits and are consumed in different ways by different consumers.
    (Response 63) We decline to establish a new product category for
raisins. Raisins are currently under the product category ``Dried''
under the ``Fruits and Fruit Juices'' general category with an RACC of
40 g. We group together like products with similar dietary usage so
consumers can easily compare nutrient information between similar
products. Raisins are comparable to other dried fruits such as
cranberries and are used in similar ways (e.g., as an ingredient in
cookies); other dried fruits, such as cranberries are also consumed as
snacks (Ref. 26). It would not be helpful for a consumer if there was a
different RACC for raisins than there was for similar products on the
market.
    RACCs are determined primarily using consumption data, and other
factors we consider in grouping products include similarities in
dietary usage and product characteristics. Package size, which is not
consistent and can change over time, is not a factor we considered in
determining RACCs (see Sec.  101.12(a)).
    (Comment 64) Spray type fats and oils--Several comments requested
that we amend the RACC for the product category ``spray types'' in the
general category ``Fats and Oils.'' The comments noted that the current
RACC for this product category is 0.25 g. The comments stated that
cooking sprays have tiny serving sizes which allow them to make certain
claims such as ``zero calorie'' or ``fat free,'' even though they are
essentially pure oil. One comment recognized that no intake data were
available from NHANES at the time of the proposed rule, but referred to
a survey of 15 people that found that consumers spray a pan for 1.6
seconds on average, with the range being 1 to 3 seconds, compared to
the one second spray that is found on the label of a common brand of
cooking spray oil (Ref). The comments requested that we increase the
RACC for spray cooking oils to a 2-second spray so consumers have a
better understanding of the calories and fat they are consuming.
    (Response 64) We decline to make a change to the RACC for spray
oils. There are no data available in NHANES that can be used to update
the RACC for cooking spray oils. We also have not identified any other
information on consumption of cooking spray oils that we can use as a
basis for determining a different RACC. Although one comment referred
to a study that it conducted, the comment provided no information about
the methodology used and included a small sample size of only 15
people; therefore, this information provides an insufficient basis on
which to update the RACC. Additionally, we note that serving size is
based on the amount an individual consumes. Spray oils are often used
to prepare food for multiple individuals, so even if the typical spray
is longer than one second, the amount consumed by each individual may
be significantly less.
    (Comment 65) Yogurt--Several comments supported the proposed
changes to the RACC for yogurt. Some comments asked us to clarify that
the proposed 170 g (6 oz) RACC for yogurt applies to all forms of
``yogurt'' (e.g., cup, drinkable, squeezable) that comply with our
standard of identity for yogurt. The comments specifically wanted
clarification that drinkable yogurts would be subject to the proposed
170 g (6 fl oz) yogurt RACC versus the 240 mL (8 fl oz) RACC for the
``Milk, milk substitutes, and fruit based drink mixers (without
alcohol) (e.g., drink mixers, fruit flavored powdered drink mixes,
sweetened cocoa powder)'' product category. One comment stated that a
product labeled as ``drinkable yogurt'' is ``yogurt'' and must, like
cup yogurt, meet one of our standards of identity for yogurt. The
comment stated that drinkable yogurts are produced, marketed, and used
by consumers as food (not as beverages) and are fundamentally different
in both form and use from fluid milk, milk-substitute beverages, and
other milk-based drinks.
    (Response 65) We agree that drinkable yogurt is more similar to
other forms of yogurt than to milk beverages. Drinkable yogurt is a
product that is consistent with the standard of identity for yogurt
under 21 CFR 131.200 but that is more fluid than other forms of yogurt.
Therefore, we are clarifying that the new yogurt RACC applies to all
forms of yogurt including drinkable yogurt.

E. Impact of Changes in RACCs on the Eligibility To Make Nutrient
Content Claims and Health Claims

    We stated in the proposed rule that we were aware that individual
foods that currently meet the requirements for certain claims based on
existing RACCs may potentially become ineligible to continue to bear
such claims if their RACCs change. Also, we recognized that other
regulatory requirements for nutrient content claims and health claims
are considered on a per-RACC basis, and changes to the RACCs could
affect the ability of foods to meet these requirements. We noted that
changes in the eligibility to bear claims may be appropriate in light
of the changes in the amounts of food being customarily consumed but
that it would be difficult to fully understand any potential impacts of
changes to the RACCs on the eligibility to bear claims until the rules
for both serving sizes and updating the Nutrition Facts label are
finalized. We invited comment on any concerns related to changes to
current claims used on specific foods that will be affected if the
serving size rule is finalized as proposed (79 FR 11989 at 12015 to
12016).
    (Comment 66) We received a number of comments in response to our
discussion on claim eligibility in the proposed rule agreeing with us
that foods could potentially become ineligible to bear a claim based on
changes to the RACCs. A number of these comments suggested that we
consider potential impacts on claim eligibility and evaluate if
resulting changes in eligibility assists consumers in constructing
healthful diets. Some comments stated that any changes that will be
needed to regulations for nutrient content claims (NCCs) and health
claims should be coordinated with the changes to the Nutrition Facts
label and serving sizes. A few comments cited examples of specific
issues that could affect the foods that the commenters produce. One
such example indicated that foods with the terms ``Healthy'' or
``Lean'' in their brand name may become ineligible to bear such claims
and could be considered misbranded if the products would continue to
bear such claims. Another example discussed the changes to the RACCs
that make the RACCs different between bulk and novelty ice cream
products and noted that such changes could make identical food
products, but of different sizes, unable to bear the same claims. One
example discussed changes to the RACC of confections and noted that
because of the smaller proposed RACC, some confections would become
subject to the NCC criteria for foods with small RACCs and become
ineligible to bear some claims.
    (Response 66) As we discussed in the proposed rule, we anticipate
that there may be changes needed with regard to claims based on the new
and updated regulations for Nutrition Facts and serving sizes. We agree
with the comments that suggested that we evaluate claim regulations and
any change to eligibility for claims. Changes to nutrition labeling is
a step-wise

process, and all changes to Nutrition Facts and serving sizes need to
become final before we can determine any and all necessary changes to
claim regulations. Because it is prudent for us to be fully aware of
all final and official changes to the RACCs (and to the information in
Nutrition Facts) before determining the scope of all of the changes
needed to claim regulations, we are not publishing rules updating claim
regulations simultaneously with the publication of the rules for
serving sizes and Nutrition Facts. With the publication of this final
rule (and the publication of the Nutrition Facts final rule, we can
assess the impacts of all of the updates on claim eligibility.
    We intend to consider in a future rulemaking issues such as whether
any changes in eligibility for claims would assist consumers in
constructing healthy diets and whether the criteria for claims remain
appropriate. However, as we noted in the proposed rule, changes in the
eligibility to bear claims may be appropriate for some foods (79 FR
11989 at 12016). Reformulation of some foods in line with current
dietary recommendations may be expected in order to continue to bear
claims. Manufacturers will have some time to make necessary changes
before the compliance dates for the final rules on serving size and
Nutrition Facts. This time will allow manufacturers to update food
labels to come into compliance with the new regulations for serving
size and Nutrition Facts, and it also allows time to discontinue use of
individual voluntary claims that the labeling of certain products may
no longer be eligible to make. The time will also allow us to evaluate
the existing claim regulations and publish, in a separate rulemaking,
any amendments to those claim regulations.
    (Comment 67) One comment regarding the changes in the definition of
a single-serving container and a product's ability to qualify for
``free'' claims stated that beverages that are routinely sold in
single-serving containers for which the labeled serving is less than
the RACC may no longer be able to make a calorie ``free'' or other
``free'' claims, even though the caloric or other nutrient content may
be trivial in those particular single-serving packages. The comment
said this outcome may occur because ``free'' claims are based on the
nutrient content for both the labeled serving and the RACC. The comment
gave the example of certain energy drink products that are commonly
sold in 8 oz, single-serving containers. The comment asserted that the
caloric content of these below-RACC, single-serving beverages is
insignificant, which supports a calorie-free claim. However, 12 ozs of
the product would contain just enough calories to preclude a calorie-
free claim. Consequently, even though the single-serving product would
not contain any more calories than before the RACCs would be updated,
the small, single-serving beverage would be precluded from bearing a
calorie-free claim because of the combined effect of the proposed RACC
and the requirement that calorie-free claims must be based on both per-
labeled-serving and per-RACC nutrient content.
    (Response 67) When we established ``free'' claims, we decided to
make the basis of the claim on a per-RACC and per-labeled-serving basis
(56 FR 60421 and 58 FR 2302). When we developed our general principles
on nutrient content claims, we concluded that it would be misleading to
allow certain claims to be based only on the RACC, particularly with
single-serving containers, since the consumer would be expected to
consume the entire labeled serving size. Likewise, we concluded that it
would be misleading to allow claims based only on the labeled serving
size. This decision was made to prevent potentially misleading claims
and to provide a level field for industry. Since that time, consumption
patterns have changed so that the RACC for some beverages has increased
from 8 oz to 12 oz. Because the consumption amount has increased for
certain beverages, such products for which the RACC has increased may
appropriately no longer be able to make ``free'' claims. As noted
previously, we intend to consider in a future rulemaking issues such as
whether any changes in eligibility for claims would assist consumers in
constructing healthy diets and whether the criteria for claims remain
appropriate.

F. Establishing a New Serving Size for Breath Mints

    In the serving size proposed rule, we proposed to establish a new
serving size of ``1 unit'' for breath mints while maintaining the
current reference amount of 2 g for the product category ``Hard
candies, breath mints.'' We proposed this action in response to a
petition that suggested the appropriate serving size for small breath
mints should be ``one mint'' instead of the number of pieces that is
closest to the 2 g RACC. The petitioner had also requested that a
separate product category, having an RACC of 0.5 g, should be
established for small breath mints weighing 0.5 g or less.
    We received one comment that supported a ``1-unit'' serving size
for breath mints and no comments that addressed changing the RACC for
breath mints. As mentioned in the serving size proposed rule (79 FR
11989 at 12016), we have determined through our analysis of two large
commercial databases that 2 g remains an appropriate RACC for the
product category ``Hard candies, breath mints.'' Further, because only
a limited number of small breath mint products are commercially
available, establishing a separate product category for small breath
mints weighing 0.5 g or less, as the petitioner requested, is not
warranted. Therefore, we will keep 2 g as the single reference amount
for the ``Hard candies, breath mints'' product category, which includes
breath mints of all sizes. However, we will now require that the label
statement for the serving size of all breath mints be 1 unit, rather
than declaring the serving size in terms of the number of mints closest
to the 2 g RACC. We have indicated this in table 2 of Sec.  101.12(b)
by changing footnote 8 (formerly footnote 9) to state, in part, ``Label
serving size of ice cream cones, eggs, and breath mints of all sizes
will be 1 unit.''

G. Technical Amendments

1. Rounding Rules for Products That Have More Than Five Servings and
the Number of Servings Falls Exactly Between Two Values
    In the serving size proposed rule (79 FR 11989) we proposed to add
the following to Sec.  101.9(b)(8)(i): ``For containers that contain
greater than 5 servings, if the number of servings determined from the
procedures provided in this section falls exactly halfway between two
allowable declarations, the manufacturer must round the number of
servings up to the nearest incremental size.'' We made this proposal to
provide information to manufacturers who have products that contain
five or more servings to round the number of servings up when the
number of servings falls exactly between two values.
    We received no comments on this topic but are not finalizing the
amendment as proposed. Standard rounding rules require numbers that
fall exactly half way between two declarations to be rounded up to the
nearest incremental size. This rule applies to all provisions where
rounding is required and is not unique to rounding required for
containers that contain greater than 5 servings. Because this proposed
addition to Sec.  101.9(b)(8)(i) is unnecessary, we are not finalizing
the proposed amendment.

2. Options for When the Number of Servings per Container Varies
    In the serving size proposed rule (79 FR 11989) we proposed to
amend Sec.  101.9(b)(8)(iii) by: (1) Defining ``random-weight
products'' and (2) eliminating the wording that specifies that the
nutrition information is based on the reference amount expressed in
ounces. The proposed rule would define random-weight products as
``foods such as cheeses that are sold as random weights that vary in
size, such that the net contents for different containers would vary.''
    We received no comments on this topic, and will finalize the
amendment as proposed. We are also amending the final sentence of this
paragraph to read ``in parentheses'' rather than ``in parenthesis.''
3. Minor Corrections to General and Product Category Names
    In the serving size proposed rule (79 FR 11989) we proposed to make
minor changes to the names of certain general categories and product
categories to clarify the products contained in the category, and to
correct minor errors in these categories.
    We received no comments on this topic, and will make these
corrections in table 2 in Sec.  101.12(b).
4. Minor Changes to Footnotes
    In the serving size proposed rule (79 FR 11989) we proposed to
remove footnote 4 from table 1 in Sec.  101.12(b) to provide clearer
guidance on the types of products that can be included in the product
categories listed in the tables. We further proposed to renumber
footnote 5 as footnote 4 and revise it by removing the first sentence
and replacing it with the following: ``The label statements are meant
to provide examples of serving size statements that may be used on the
label, but the specific wording may be changed as appropriate for
individual products.'' In table 2 we proposed to remove footnote 4 and
renumber the remaining footnotes. We further proposed to revise
renumbered footnote 4 by removing the first sentence and replacing it
with the following: ``The label statements are meant to provide
examples of serving size statements that may be used on the label, but
the specific wording may be changed as appropriate for individual
products.'' We also proposed to revise renumbered footnote 5 to include
the sentence, ``The serving size for fruitcake is 1\1/2\ ounces''; to
add renumbered footnote 10 as a superscript to the word ``pimento'' in
the ``Vegetables, primarily used for garnish or flavor, e.g., pimento,
parsley, fresh or dried)'' product category; and to revise renumbered
footnote 12 to state, ``For raw fruit, vegetables, and fish,
manufacturers should follow the label statement for the serving size
specified in Appendices C and D to part 101 (21 CFR 101) Code of
Federal Regulations.''
    We received no comments to these minor technical amendments and
will make the changes in tables 1 and 2 in Sec.  101.12(b).
    In addition to the changes to various footnotes proposed in the
proposed rule, we are making several additional technical amendments to
table 2 by adding language to footnote 1 explaining that the values
have been updated with data from various NHANES surveys, adding
renumbered footnote 10 to the product category ``Fruits for garnish or
flavor, e.g., maraschino cherries,'' removing the ``(b)'' from the Code
of Federal Regulations citation ``101.9(b)(j)(11)'' in renumbered
footnote 11, and revising renumbered footnote 12 to state, ``For raw
fruit, vegetables, and fish, manufacturers should follow the label
statement for the serving size specified in Appendices C and D to part
101 (21 CFR 101) Code of Federal Regulations.''
5. Minor Changes to Table 1 in Sec.  101.12(b)
    In the serving size proposed rule (79 FR 11989) we proposed to
change the title of table 1 from ``Reference Amounts Customarily
Consumed Per Eating Occasion: Infant and Toddler Foods'' to ``Reference
Amounts Customarily Consumed Per Eating Occasion: Foods for Infants and
Young Children 1 through 3 years of age.'' We also proposed to make
other conforming changes in the product category names, by changing the
product category name ``Dinners, stews or soups for toddlers, ready-to-
serve'' to ``Dinners, stews or soups for young children, ready-to-
serve,'' the product category name ``Fruits for toddlers, ready-to-
serve'' to ``Fruits for young children, ready-to-serve,'' and the
product category name ``Vegetables for toddlers, ready-to-serve'' to
``Vegetables for young children, ready-to-serve.''
    We received no comments to these minor technical amendments and
will make the changes in table 1 in Sec.  101.12(b).
6. Minor Changes to Table 2 in Sec.  101.12(b)
    In the serving size proposed rule (79 FR 11989) we proposed to make
some editorial changes to the product category names.
    We received no comments to these minor technical amendments and
will make the changes in table 2 in Sec.  101.12(b).
7. Reference Amounts for Products That Require Further Preparation
    In the serving size proposed rule (79 FR 11989), we proposed to
amend Sec.  101.12(c) to change the definition of the reference amount
for products that require further preparation in which the entire
contents of the package are used to prepare one large discrete unit
usually divided for consumption.
    We received no comments on this topic, and will finalize this
amendment as proposed.
8. Reference Amount for Combined Products Consisting of Two or More
Separate Foods That Are Packaged Together and Are Intended To Be Eaten
Together and That Have No Reference Amount for the Combined Product
    Section 101.12(f) establishes the approach for determining the
reference amount for combined products consisting of two or more
separate foods, packaged together and intended to be eaten together,
that have no established reference amount in the tables for the
combined product. In the serving size proposed rule (79 FR 11989) we
proposed to amend Sec.  101.9(f)(1) and (2) to change the definition of
the RACC for these products consisting of two or more separate foods,
packaged together and intended to be eaten together, so that it will
not affect the serving size declaration on the label.
    We received no comments on this topic, and will finalize the
amendment as proposed.
9. Reference Amounts for Varieties or Assortments of Foods in Gift
Packages That Have No Appropriate Reference Amount
    Section 101.9(h)(3)(ii) establishes the procedure for determining
the serving size for varieties or assortments of foods in gift packages
when there is no appropriate reference amount. The current language in
Sec.  101.9(h)(3)(ii) states that 8 fl ozs may be used as the standard
serving size for beverage varieties or assortments in gift packages.
Because we are amending the RACCs for some beverages, we proposed
conforming amendments to this section to state that 12 fl oz should be
used as the standard serving size for beverages, except that the
standard serving size for milk, fruit juices, nectars, and fruit drinks
will be based on 8 fl ozs.
    We received no comments on this topic, and will finalize the
amendment

as proposed, with minor edits for clarity.

IV. Effective and Compliance Dates

    In the preamble of the proposed rule (79 FR 11989 at 12019), we
proposed that any final rule resulting from this rulemaking, as well as
any final rule resulting from the proposed rule entitled ``Food
Labeling: Revision of the Nutrition and Supplement Facts Labels'' (the
Nutrition Facts proposed rule), would become effective 60 days after
the date of the final rule's publication in the Federal Register. We
also proposed that any final rule that resulted would have a compliance
date that would be 2 years after the effective date (79 FR 11989 at
12019). We explained that industry might need some time to analyze
products for which there may be new mandatory nutrient declarations,
make any required changes to the Nutrition Facts label (which may be
coordinated with other planned label changes), review and update
records of product labels, and print new labels.
    After considering comments submitted to the docket for the
Nutrition Facts proposed rule regarding the effective and compliance
dates, we have maintained the compliance date of 2 years after the
effective date, except that for manufacturers with less than $10
million in annual food sales, we are providing a compliance date of 3
years after the effective date. Comments to the Nutrition Facts
proposed rule emphasized the rule's potential impact on small
businesses. We agree that the impacts to smaller businesses may be more
substantial than those on larger businesses; thus, for manufacturers
with less than $10 million in annual food sales, the compliance date
will be July 26, 2019. Using Nielsen data, we estimate that
manufacturers with less than $10 million in annual food sales
constitute approximately 95 percent of all food manufacturers and
market 48 percent of food UPCs.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(i) and (k) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
are publishing two final rules on nutrition labeling in the Federal
Register. We have developed a comprehensive Regulatory Impact Analysis
(RIA) that assesses the impacts of the two final nutrition labeling
rules taken together. We believe that the final rules on nutrition
labeling, taken as a whole, are an economically significant regulatory
action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Additional costs per entity from the final rules are small,
but not negligible, and as a result we find that the final rules on
nutrition labeling, taken as a whole, will have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. We have determined that the final rules on
nutrition labeling, taken as a whole, would result in an expenditure in
any year that meets or exceeds this amount.
    The full analysis of economic impacts for the final rules on
nutrition labeling is available in the docket for this final rule (Ref.
35) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

VII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these provisions is given in this section with an
estimate of the annual third-party disclosure burden. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
    Title: Third-Party Disclosure Requirements for Serving Sizes of
Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-
Column Labeling; Updating, Modifying and Establishing Certain RACCs;
Serving Size for Breath Mints; and Technical Amendments
    Description of Respondents: The respondents to this information
collection are manufacturers of retail food products marketed in the
United States.
    Description: In major part, this final rule revises Sec. Sec.
101.9 and 101.12 to: (1) Amend the definition of a single serving, (2)
require a second column of nutrition information per package for
products that contain at least 200 and up to and including 300 percent
of the applicable RACCs, as well as per unit for discrete units in
multiserving packages in which each unit contains at least 200 percent
and up to and including 300 percent of the applicable RACCs, (3)
update, modify, and establish RACCs for certain food products, (4) make
several technical amendments to the regulations for serving sizes, and
(5) change the label serving size for breath mints to ``1 unit.'' These
revisions, in many instances, will require changes to the nutrition
information that is presented on the Nutrition Facts label of retail
food products. Preexisting Sec. Sec.  101.9 and 101.12 are approved by
OMB in accordance with the PRA under OMB control number 0910-0381. This
final rule will modify the information collection associated with
preexisting Sec. Sec.  101.9 and 101.12 by adding to the burden
associated with the collection by requiring the following manufacturers
to make changes to their product labels: Those whose retail food
products are labeled with a serving size that is inconsistent with the
provisions of the final rule, and those whose retail food products
would be required to use dual-column labeling.\2\ The nutrient
information disclosed on labels of retail food products is necessary to
inform purchasers of the nutritional value of the food.
---------------------------------------------------------------------------

    \2\ Included in this burden are the labeling costs that result
from changes in the eligibility to bear nutrient content claims or
health claims (e.g., the cost of removing a claim from labeling or
adding a required disclaimer).
---------------------------------------------------------------------------

    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total capital
                                                            Number of       Number of      Total annual   Average burden                     costs (in
                     21 CFR Section                        respondents   disclosures per    disclosures   per disclosure    Total hours     billions of
                                                                            respondent                                                        2014$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.9 and 101.12.......................................          13,452               25         336,300               2         672,600           $1.00
    Total Initial Hours and Capital Costs..............                                                                          672,600           $1.00
New Products...........................................             500                1             500               2           1,000           $0.01
    Total Recurring Hours and Capital Costs............                                                                            1,000           $0.01
    Total Burden Hours and Capital Costs...............                                                                          673,600           $1.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    Under Sec. Sec.  101.9 and 101.12, some manufacturers of retail
food products would need to make a labeling change to modify the
serving sizes and other nutrition information based on changes to what
products may be or are required to be labeled as a single serving or
based on updated, modified, or established RACCs. Additionally, some
manufacturers would need to change their product labels to add a second
column of nutrition information per package or per discrete unit as
part of the Nutrition Facts label. The third-party disclosure burden
consists of the setup time required to design a revised label and
incorporate it into the manufacturing process. The third-party
disclosure burden for this final rule is estimated in table 1.
    Based upon our knowledge of food labeling, we estimate that the
affected manufacturers would require 2 hours per product to modify the
label's Nutrition Facts panel. We estimate that it would take an
affected manufacturer 1 hour to review a label to assess how to bring
it into compliance with the requirements of this final rule. Each label
redesign would require an estimated 1 additional hour per UPC, for a
total of 2 hours per UPC.
    We estimate that about 13,452 manufacturers would initially be
affected by this final rule and that about 336,300 products would
initially be required to be relabeled, for an average of 25 (336,300/
13,452) products per respondent. The total initial third-party
disclosure burden of 672,600 hours is reported in table 1. The final
column of table 1 gives the estimated initial capital cost of the
relabeling associated with this final rule. Based on the RIA, we
estimate the initial capital cost to be approximately $1 billion
(2014$).
    This final rule generates recurring burdens related to the
requirement that some manufacturers undertake an extensive label change
due to the effect of the changed definition of a single-serving
container on the permissibility of certain health and nutrient content
claims and also to the requirement that some manufacturers undertake a
major redesign of their labels to include a Nutrition Facts Panel that
had not previously been required.\3\ We estimate that about 500 new
products would be affected by these requirements each year, and that
the required third party disclosure burden would be 2 hours per
product, for an annual recurring third party disclosure burden of 1,000
hours. Based on the RIA, we estimate the annual recurring capital cost
to be approximately $0.01 billion (2014$).
---------------------------------------------------------------------------

    \3\ This final rule does not otherwise generate any recurring
burdens because establishments must already print packaging for food
products as part of normal business practices and must disclose
required nutrition and serving size information under NLEA.
---------------------------------------------------------------------------

    Adding the recurring burden from new products to the initial burden
for existing products results in a total of 673,600 third party
disclosure burden hours and $1.01 billion (2014$) in capital costs as
reported in table 1.
    The information collection provisions in this final rule and the
Nutrition Facts Label final rule have been submitted to OMB for review
as required by section 3507(d) of the PRA of 1995.
    Before the effective date of this final rule, we will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.

VIII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive Order
requires agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.''
    Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a) of the FD&C Act provides that ``.
. . no State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect as to
any food in interstate commerce. . . (4) any requirement for nutrition
labeling of food that is not identical to the requirement of section
403(q) [of the FD&C Act]. . . .''
    The express preemption provision of section 403A(a) of the FD&C Act
does not preempt any State or local requirement respecting a statement
in the labeling of food that provides for a warning concerning the
safety of the food or component of the food (section 6(c)(2) of the
NLEA).
    This final rule will create requirements that fall within the scope
of section 403A(a) of the FD&C Act.

IX. References

    The following references are on display in FDA's Division of
Dockets Management (see ADDRESSES) and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

    1. Report of the Working Group on Obesity, ``Calories Count,''
March 12, 2004.
    2. Dallas, S. K., P. J. Liu, P. A. Ubel, ``Potential Problems
with Increasing Serving Sizes on the Nutrition Facts
Label,'''Appetite, 95:577-84, 2015.
    3. Zhang, Y., M. A. Kantor, W. Juan, ``Usage and Understanding
of Serving Size Information on Food Labels in the United States,''
American Journal of Health Promotion, 30:181-7, 2016.
    4. Chung-Tung, Lin., Memorandum to file: ``2014 Health and Diet
Survey,'' May 6, 2016.

    5. FDA, Resources for You, August 10, 2015: http://www.fda.gov/Food/ResourcesForYou/default.htm.
    6. CDC, National Center for Health Statistics (NCHS), ``National
Health and Nutrition Examination Survey Data 2007-2008''. http://wwwn.cdc.gov/nchs/nhanes/search/nhanes07_08.aspx.
    7. CDC, NCHS, ``National Health and Nutrition Examination Survey
Data 2005-2006.''
    8. CDC, NCHS, ``National Health and Nutrition Examination Survey
Data 2003-2004.'' http://www.cdc.gov/nchs/nhanes/nhanes2003-2004/nhanes03_04.htm.
    9. Juan, W., Memorandum to File: ``Technical Support for
Documentation on Examining the Association Between the Consumption
Variability and the Reference Amounts Customarily Consumed (RACCs)
per Eating Occasion for All Products in Each Product Category,''
February 11, 2014.
    10. Wansink, B., J. Kim. ``Bad Popcorn in Big Buckets: Portion
Size Can Influence Intake as Much as Taste,'' Journal of Nutrition
Education and Behavior, 37:242-5, 2005.
    11. Rolls, B. J., L. S. Roe, J. Meengs, D. Wall, ``Increasing
the Portion Size of A Sandwich Increases Energy Intake,'' Journal of
the American Dietetic Association, 104:367-72, 2004.
    12. Lando, A. M., J. Labiner-Wolfe, ``Helping Consumers Make
More Healthful Food Choices: Consumer Views on Modifying Food Labels
and Providing Point-of-Purchase Nutrition Information at Quick-
Service Restaurants,'' Journal of Nutrition Education and Behavior,
39:157-63, 2007.
    13. Geier, A., P. Rozin, G. Doros, ``Unit Bias. A New Heuristic
That Helps Explain the Effect of Portion Size on Food Intake,''
Psychological Science, 17:521-5, 2006.
    14. Antonuk, B., L. Block, ``The Effect of Single Serving Versus
Entire Package Nutritional Information on Consumption Norms and
Actual Consumption of a Snack Food,'' Journal of Nutrition Education
and Behavior, 38:365-70, 2006.
    15. Lando, A. M., S. C. Lo, ``Single-Larger-Portion-Size and
Dual-Column Nutrition Labeling May Help Consumers Make More
Healthful Food Choices,'' Journal of the Academy of Nutrition and
Dietetics, 113:241-50, 2013.
    16. Juan, W., Memorandum to File: ``Comparison Between the Foods
Consumed in the United States from NHANES 2003-2008 at the 90th
Percentile and Reference Amounts Customarily Consumed (RACCs) Per
Eating Occasion by General Category and Product Category,'' February
11, 2014.
    17. FDA, ``Preliminary Regulatory Impact Analysis (PRIA) for the
Food Labeling: Revision of the Nutrition and Supplement Facts Labels
Proposed Rule (Docket No. FDA-2012-N-1210) and Food Labeling:
Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating
Occasion; Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily Consumed; Serving
Size for Breath Mints; and Technical Amendments Proposed Rule
(Docket No. FDA-2004-N-0258),'' 2014.
    18. Chung-Tung, Lin., Memorandum to File: ``Eye-Tracking
Experimental Study on Consumer Responses to Modifications to the
Nutrition Facts Label Outlined in the Food and Drug Administration's
Proposed Rulemaking,'' June 30, 2015.
    19. Lando, A., Liu, S., Lo, S., and Yu, K., Memorandum to File:
``Experimental Study of Proposed Changes to the Nutrition Facts
Label Formats'' June 30, 2015.
    20. O'Neil, C. E., T. A. Nicklas, G. C. Rampersaud, and V. L.
Fulgoni III, ``100% Orange juice Consumption is Associated with
Better Diet Quality, Improved Nutrient Adequacy, Decreased Risk for
obesity, and Improved Biomarkers of Health in Adults: National
Health and Nutrition Examination Survey, 2003-2006,'' Nutrition
Journal, 11:107-16, 2012.
    21. O'Neil, C. E., T. A. Nicklas, G. C. Rampersaud, and V. L.
Fulgoni III, ``One Hundred Percent Orange Juice Consumption is
Associated with Better Diet Quality, Improved Nutrient Adequacy, and
no Increased Risk for Overweight/Obesity in Children,'' Nutrition
Research, 31:673-82, 2011.
    22. Juan, W., Memorandum to File: ``Evaluation of Consumption
Amounts of Food Consumed in the United States for Which 2003-2008
Consumption at the 90th Percentile Exceeds 300% of the 1993
Reference Amounts Customarily Consumed (RACCs) per Eating Occasion;
Comparison of 2003-2008 Food Consumption Amounts to the Proposed
RACCs'' April 7, 2016.
    23. Cowburn, G. and L. Stockley, ``Consumer Understanding and
Use of Nutrition Labelling: A Systematic Review,'' Public Health
Nutrition, 8:21-8, 2005.
    24. Rothman, R., R. Housam, H. Weiss, D. Davis, R. Gregory, T.
Gebretsadik, et al., ``Patient Understanding of Food Labels: The
Role of Literacy and Numeracy,'' American Journal of Preventive
Medicine, 31:391-8, 2006.
    25. Agricultural Research Service, Food Surveys Research Group,
``U.S. Department of Agriculture, Food and Nutrient Database for
Dietary Studies, 4.1'' Beltsville, MD, 2010.
    26. Herbst, S.T. and R. Herbst, ``The New Food Lover's
Companion,'' Fourth Edition. Barron's Educational Series, Inc, 2007.
    27. USDA, Food Safety and Inspection Service, ``A Guide to
Federal Food Labeling Requirements for Meats and Poultry Products,''
2007. http://www.fsis.usda.gov/wps/wcm/connect/f4af7c74-2b9f-4484-bb16-fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES.
    28. Allrecipes. Allrecipes, December 6, 2012. http://www.allrecipes.com.
    29. Park, Y., Memorandum to File: ``Documentation for
Determining Reference Amounts Customarily Consumed per Eating
Occasion,'' October 30, 1991.
    30. ``Council of Better Business Bureaus. Children's Food and
Beverage Advertising Initiative. 2014 Cereals Snapshot. March
2014.'' Available online: http://www.bbb.org/globalassets/shared/media/cfbai/cereal-fact-sheet-march-2014.pdf.
    31. Juan, W., Memorandum to File: ``Methodology used to
Determine Whether to Propose to Update, Modify, or Establish the
Reference Amounts Customarily Consumed (RACCs) per Eating
Occasion,'' February 11, 2014.
    32. Juan, W., Memorandum to File: ``Rationale Used to Amend
Reference Amounts Customarily Consumed (RACCs) per Eating Occasion
for Specific Product Categories,'' April 7, 2016.
    33. Henderson, C., Memorandum to File, ``Sample of Ice Cream
Scoops Available to Consumers from National Retailers'' May 16,
2016.
    34. Park, Y., Memorandum to the file, List of products for each
product category, October 8, 1992.
    35. FDA, ``Regulatory Impact Analysis for Final Rules on Food
Labeling: Revision of the Nutrition and Supplement Facts Labels
(Docket No. FDA-2012-N-1210 and Food Labeling: Serving Sizes of
Foods That Can Reasonably Be Consumed At One Easting Occsion; Dual-
Column Labeling; Updating, Modifying and Establishing Certain RACCs;
Serving Size for Breath Mints; and Technical Amendments (Docket No.
FDA-2004-N-0258 (formerly Docket No. 2004N-0456),'' 2016.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and record keeping
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for part 101 continues to read as follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. In Sec.  101.9:
0
a. Revise paragraph (b)(2)(i)(D);
0
b. Remove paragraph (b)(2)(i)(E) and redesignate paragraphs
(b)(2)(i)(F) through (I) as paragraphs (b)(2)(i)(E) through (H)
respectively;
0
c. Revise paragraphs (b)(6), (b)(8)(iii), and (b)(10)(ii);
0
d. Add paragraph (b)(12); and
0
e. Revise paragraph (h)(3)(ii).
    The revisions and addition read as follows:

Sec.  101.9  Nutrition labeling of food.

* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (D) If a unit weighs at least 200 percent and up to and including
300 percent of the applicable reference amount, the serving size shall
be the amount that approximates the reference amount. In addition to
providing a column within the Nutrition Facts label that lists the
quantitative amounts and percent Daily Values per serving size, the
manufacturer shall provide a column within the Nutrition Facts label
that lists the quantitative amounts and

percent Daily Values per individual unit. The first column would be
based on the serving size for the product and the second column would
be based on the individual unit. The exemptions in paragraphs
(b)(12)(i)(A), (B), and (C) of this section apply to this provision.
* * * * *
    (6) A product that is packaged and sold individually that contains
less than 200 percent of the applicable reference amount must be
considered to be a single-serving container, and the entire content of
the product must be labeled as one serving. In addition to providing a
column within the Nutrition Facts label that lists the quantitative
amounts and percent Daily Values per serving, for a product that is
packaged and sold individually that contains more than 150 percent and
less than 200 percent of the applicable reference amount, the Nutrition
Facts label may voluntarily provide, to the left of the column that
provides nutrition information per container (i.e., per serving), an
additional column that lists the quantitative amounts and percent Daily
Values per common household measure that most closely approximates the
reference amount.
* * * * *
    (8) * * *
    (iii) For random weight products, manufacturers may declare
``varied'' for the number of servings per container provided the
nutrition information is based on the reference amount expressed in the
appropriate household measure based on the hierarchy described in
paragraph (b)(5) of this section. Random weight products are foods such
as cheeses that are sold as random weights that vary in size, such that
the net contents for different containers would vary. The manufacturer
may provide the typical number of servings in parentheses following the
``varied'' statement.
* * * * *
    (10) * * *
    (ii) Per one unit if the serving size of a product in discrete
units is more than 1 unit.
* * * * *
    (12)(i) Products that are packaged and sold individually and that
contain at least 200 percent and up to and including 300 percent of the
applicable reference amount must provide an additional column within
the Nutrition Facts label that lists the quantitative amounts and
percent Daily Values for the entire package, as well as a column
listing the quantitative amounts and percent Daily Values for a serving
that is less than the entire package (i.e., the serving size derived
from the reference amount). The first column would be based on the
serving size for the product and the second column would be based on
the entire contents of the package.
    (A) This provision does not apply to products that meet the
requirements to use the tabular format in paragraph (j)(13)(ii)(A)(1)
of this section or to products that meet the requirements to use the
linear format in paragraph (j)(13)(ii)(A)(2) of this section.
    (B) This provision does not apply to raw fruits, vegetables, and
seafood for which voluntary nutrition labeling is provided in the
product labeling or advertising or when claims are made about the
product.
    (C) This provision does not apply to products that require further
preparation and provide an additional column of nutrition information
under paragraph (e) of this section, to products that are commonly
consumed in combination with another food and provide an additional
column of nutrition information under paragraph (e) of this section, to
products that provide an additional column of nutrition information for
two or more groups for which RDIs are established (e.g., both infants
and children less than 4 years of age), to popcorn products that
provide an additional column of nutrition information per 1 cup popped
popcorn, or to varied-weight products covered under paragraph
(b)(8)(iii) of this section.
    (ii) When a nutrient content claim or health claim is made on the
label of a product that uses a dual column as required in paragraph
(b)(2)(i)(D) or (b)(12)(i) of this section, the claim must be followed
by a statement that sets forth the basis on which the claim is made,
except that the statement is not required for products when the
nutrient that is the subject of the claim meets the criteria for the
claim based on the reference amount for the product and the entire
container or the unit amount. When a nutrient content claim is made,
the statement must express that the claim refers to the amount of the
nutrient per serving (e.g., ``good source of calcium per serving'' or
``per X [insert unit]_serving'') or per reference amount (e.g., ``good
source of calcium per [insert reference amount (e.g., per 8 ounces)]),
as required based on Sec.  101.12(g). When a health claim is made, the
statement shall be ``A serving of _ounces of this product conforms to
such a diet.''
* * * * *
    (h) * * *
    (3) * * *
    (ii) In the absence of a reference amount customarily consumed in
Sec.  101.12(b) that is appropriate for the variety or assortment of
foods in a gift package, the following may be used as the standard
serving size for purposes of nutrition labeling of foods subject to
this paragraph: 1 ounce for solid foods; 2 fluid ounces for nonbeverage
liquids (e.g., syrups); 8 ounces for beverages that consist of milk and
fruit juices, nectars and fruit drinks; and 12 fluid ounces for other
beverages. However, the reference amounts customarily consumed in Sec.
101.12(b) shall be used for purposes of evaluating whether individual
foods in a gift package qualify for nutrient content claims or health
claims.
* * * * *

0
3. In Sec.  101.12:
0
a. In paragraph (b), revise tables 1 and 2;
0
b. Revise paragraphs (c) and (f)(1);
0
c. Remove paragraph (f)(2) and redesignate paragraph (f)(3) as
paragraph (f)(2); and
0
d. Revise newly redesignated paragraph (f)(2).
    The revisions read as follows:

Sec.  101.12  Reference amounts customarily consumed per eating
occasion.

* * * * *
    (b) * * *

  Table 1--Reference Amounts Customarily Consumed per Eating Occasion:
  Foods for Infants and Young Children 1 Through 3 Years of Age \1\ \2\
                                   \3\
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference amount           \4\
------------------------------------------------------------------------
Cereals, dry instant............  15 g..............  _ cup (_ g)
Cereals, prepared, ready-to-      110 g.............  _ cup(s) (_ g)
 serve.
Other cereal and grain products,  7 g for infants     _ cup(s) (_ g) for
 dry ready-to-eat, e.g., ready-    and 20 g for        ready-to-eat
 to-eat cereals, cookies,          young children (1   cereals; piece(s)
 teething biscuits, and toasts.    through 3 years     (_ g) for others
                                   of age) for ready-
                                   to-eat cereals; 7
                                   g for all others.
Dinners, deserts, fruits,         15 g..............  _ tbsp(s) (_ g); _
 vegetables or soups, dry mix.                         cup(s) (_ g)

Dinners, desserts, fruits,        110 g.............  _ cup(s) (_ g);
 vegetables or soups, ready-to-                        cup(s) (_ mL)
 serve, junior type.
Dinners, desserts, fruits,        110 g.............  _ cup(s) (_ g);
 vegetables or soups, ready-to-                        cup(s) (_ mL)
 serve, strained type.
Dinners, stews or soups for       170 g.............  _ cup(s) (_ g);
 young children, ready-to-serve.                       cup(s) (_ mL)
Fruits for young children, ready- 125 g.............  _ cup(s) (_ g)
 to-serve.
Vegetables for young children,    70 g..............  _ cup(s) (_ g)
 ready-to-serve.
Eggs/egg yolks, ready-to serve..  55 g..............  _ cup(s) (_ g)
Juices all varieties............  120 mL............  4 fl oz (120 mL)
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were primarily derived from the 1977-1978 and the
  1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture. We further considered data from the
  National Health and Nutrition Examination Survey, 2003-2004, 2005-
  2006, and 2007-2008 conducted by the Centers for Disease Control and
  Prevention, in the U.S. Department of Health and Human Services.
\2\ Unless otherwise noted in the reference amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (e.g., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  mixes, concentrates, dough, batter, fresh and frozen pasta) is the
  amount required to make the reference amount of the prepared form.
  Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures in 21 CFR 101.9(b).
\4\ The label statements are meant to provide examples of serving size
  statements that may be used on the label, but the specific wording may
  be changed as appropriate for individual products. The term ``piece''
  is used as a generic description of a discrete unit. Manufacturers
  should use the description of a unit that is most appropriate for the
  specific product (e.g., sandwich for sandwiches, cookie for cookies,
  and bar for frozen novelties).

  Table 2--Reference Amounts Customarily Consumed Per Eating Occasion:
                     General Food Supply \1\ \2\ \3\
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference amount           \4\
------------------------------------------------------------------------
Bakery Products:
    Bagels, toaster pastries,     110 g.............  _ piece(s) (_ g)
     muffins (excluding English
     muffins).
    Biscuits, croissants,         55 g..............  _ piece(s) (_ g)
     tortillas, soft bread
     sticks, soft pretzels, corn
     bread, hush puppies,
     scones, crumpets, English
     muffins.
    Breads (excluding sweet       50 g..............  _ piece(s) (_ g)
     quick type), rolls.                               for sliced bread
                                                       and distinct
                                                       pieces (e.g.,
                                                       rolls); 2 oz (56
                                                       g/_ inch slice)
                                                       for unsliced
                                                       bread
    Bread sticks--see crackers..
    Toaster pastries--see
     bagels, toaster pastries,
     muffins (excluding English
     muffins).
    Brownies....................  40 g..............  _ piece(s) (_ g)
                                                       for distinct
                                                       pieces;
                                                       fractional slice
                                                       (_ g) for bulk
    Cakes, heavyweight (cheese    125 g.............  _ piece(s) (_ g)
     cake; pineapple upside-down                       for distinct
     cake; fruit, nut, and                             pieces (e.g.,
     vegetable cakes with more                         sliced or
     than or equal to 35 percent                       individually
     of the finished weight as                         packaged
     fruit, nuts, or vegetables                        products); _
     or any of these                                   fractional slice
     combinations) \ 5\.                               (_ g) for large
                                                       discrete units
    Cakes, mediumweight           80 g..............  _ piece(s) (_ g)
     (chemically leavened cake                         for distinct
     with or without icing or                          pieces (e.g.,
     filling except those                              cupcake); _
     classified as light weight                        fractional slice
     cake; fruit, nut, and                             (_ g) for large
     vegetable cake with less                          discrete units
     than 35 percent of the
     finished weight as fruit,
     nuts, or vegetables or any
     of these combinations;
     light weight cake with
     icing; Boston cream pie;
     cupcake; eclair; cream
     puff) \6\.
    Cakes, lightweight (angel     55 g..............  _ piece(s) (_ g)
     food, chiffon, or sponge                          for distinct
     cake without icing or                             pieces (e.g.,
     filling) \7\.                                     sliced or
                                                       individually
                                                       packaged
                                                       products); _
                                                       fractional slice
                                                       (_ g) for large
                                                       discrete units
    Coffee cakes, crumb cakes,    55 g..............  _ piece(s) (_ g)
     doughnuts, Danish, sweet                          for sliced bread
     rolls, sweet quick type                           and distinct
     breads.                                           pieces (e.g.,
                                                       doughnut); 2 oz
                                                       (56 g/visual unit
                                                       of measure) for
                                                       bulk products
                                                       (e.g., unsliced
                                                       bread)
    Cookies.....................  30 g..............  _ piece(s) (_ g)
    Crackers that are usually     15 g..............  _ piece(s) (_ g)
     not used as snack, melba
     toast, hard bread sticks,
     ice cream cones \8\.
    Crackers that are usually     30 g..............  _ piece(s) (_ g)
     used as snacks.
    Croutons....................  7 g...............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g); _
                                                       piece(s) (_ g)
                                                       for large pieces
    Eggroll, dumpling, wonton,    20 g..............  _ sheet (_ g);
     or potsticker wrappers.                           wrapper (_ g)
    French toast, crepes,         110 g prepaed for   _ piece(s) (_ g);
     pancakes, variety mixes.      French toast,       _ cup(s) (_ g)
                                   crepes, and         for dry mix
                                   pancakes; 40 g
                                   dry mix for
                                   variety mixes.

    Grain-based bars with or      40 g..............  _ piece(s) (_ g)
     without filling or coating,
     e.g., breakfast bars,
     granola bars, rice cereal
     bars.
    Ice cream cones--see
     crackers.
    Pies, cobblers, fruit         125 g.............  _ piece(s) (_ g)
     crisps, turnovers, other                          for distinct
     pastries.                                         pieces; _
                                                       fractional slice
                                                       (_ g) for large
                                                       discrete units
    Pie crust, pie shells,        the allowable       _ fractional
     pastry sheets, (e.g.,         declaration         slice(s) (_ g)
     phyllo, puff pastry sheets).  closest to an 8     for large
                                   square inch         discrete units; _
                                   surface area.       shells (_ g); _
                                                       fractional _
                                                       sheet(s) (_ g)
                                                       for distinct
                                                       pieces (e.g.,
                                                       Pastry sheet).
    Pizza crust.................  55 g..............  _ fractional slice
                                                       (_ g)
    Taco shells, hard...........  30 g..............  _ shell(s) (_ g)
    Waffles.....................  85 g..............  _ piece(s) (_ g)
Beverages:
    Carbonated and noncarbonated  360 mL............  12 fl oz (360 mL)
     beverages, wine coolers,
     water.
    Coffee or tea, flavored and   360 mL prepared...  12 fl oz (360 mL)
     sweetened.
Cereals and Other Grain
 Products:
    Breakfast cereals (hot        1 cup prepared; 40  _ cup(s) (_ g)
     cereal type), hominy grits.   g plain dry
                                   cereal; 55 g
                                   flavored,
                                   sweetened cereal.
    Breakfast cereals, ready-to-  15 g..............  _ cup(s) (_ g)
     eat, weighing less than 20
     g per cup, e.g., plain
     puffed cereal grains.
    Breakfast cereals, ready-to-  40 g..............  _ cup(s) (_ g)
     eat, weighing 20 g or more
     but less than 43 g per cup;
     high fiber cereals
     containing 28 g or more of
     fiber per 100 g.
    Breakfast cereals, ready-to-  60 g..............  _ piece(s) (_ g)
     eat, weighing 43 g or more                        for large
     per cup; biscuit types.                           distinct pieces
                                                       (e.g., biscuit
                                                       type); _ cup(s)
                                                       (_ g) for all
                                                       others
    Bran or wheat germ..........  15 g..............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g)
    Flours or cornmeal..........  30 g..............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g)
    Grains, e.g., rice, barley,   140 g prepared; 45  _ cup(s) (_ g)
     plain.                        g dry.
    Pastas, plain...............  140 g prepared; 55  _ cup(s) (_ g); _
                                   g dry.              piece(s) (_ g)
                                                       for large pieces
                                                       (e.g., large
                                                       shells or lasagna
                                                       noodles) or 2 oz
                                                       (56 g/visual unit
                                                       of measure) for
                                                       dry bulk products
                                                       (e.g., spaghetti)
    Pastas, dry, ready-to-eat,    25 g..............  _ cup(s) (_ g)
     e.g., fried canned chow
     mein noodles.
    Starches, e.g., cornstarch,   10 g..............  _ tbsp (_ g)
     potato starch, tapioca, etc.
    Stuffing....................  100 g.............  _ cup(s) (_ g)
Dairy Products and Substitutes:
    Cheese, cottage.............  110 g.............  _ cup (_ g)
    Cheese used primarily as      55 g..............  _ cup (_ g)
     ingredients, e.g., dry
     cottage cheese, ricotta
     cheese.
    Cheese, grated hard, e.g.,    5 g...............  _ tbsp (_ g)
     Parmesan, Romano.
    Cheese, all others except     30 g..............  _ piece(s) (_ g)
     those listed as separate                          for distinct
     categories--includes cream                        pieces; _ tbsp(s)
     cheese and cheese spread.                         (_ g) for cream
                                                       cheese and cheese
                                                       spread; 1 oz (28
                                                       g/visual unit of
                                                       measure) for bulk
    Cheese sauce--see sauce
     category.
    Cream or cream substitutes,   15 mL.............  1 tbsp (15 mL)
     fluid.
    Cream or cream substitutes,   2 g...............  _ tsp (_ g)
     powder.
    Cream, half & half..........  30 mL.............  2 tbsp (30 mL)
    Eggnog......................  120 mL............  \1/2\ cup (120
                                                       mL); 4 fl oz (120
                                                       mL)
    Milk, condensed, undiluted..  30 mL.............  2 tbsp (30 mL)
    Milk, evaporated, undiluted.  30 mL.............  2 tbsp (30 mL)
    Milk, milk-substitute         240 mL............  1 cup (240 mL); 8
     beverages, milk-based                             fl oz (240 mL)
     drinks, e.g., instant
     breakfast, meal
     replacement, cocoa, soy
     beverage.
    Shakes or shake substitutes,  240 mL............  1 cup (240 mL); 8
     e.g., dairy shake mixes,                          fl oz (240 mL)
     fruit frost mixes.
    Sour cream..................  30 g..............  _ tbsp (_ g)
    Yogurt......................  170 g.............  _ cup (_ g)
Desserts:
    Ice cream, frozen yogurt,     \2/3\ cup--         \2/3\ cup (_ g), _
     sherbet, frozen flavored      includes the        piece(s) (_ g)
     and sweetened ice and pops,   volume for          for individually
     frozen fruit juices: all      coatings and        wrapped or
     types bulk and novelties      wafers.             packaged products
     (e.g., bars, sandwiches,
     cones, cups).
    Sundae......................  1 cup.............  1 cup (_ g)
    Custards, gelatin, or         \1/2\ cup           _ piece(s) (_ g)
     pudding.                      prepared; amount    for distinct unit
                                   to make \1/2\ cup   (e.g.,
                                   prepared when dry.  individually
                                                       packaged
                                                       products); \1/2\
                                                       cup (_ g) for
                                                       bulk
Dessert Toppings and Fillings:
    Cake frostings or icings....  2 tbsp............  _ tbsp(s) (_ g)
    Other dessert toppings,       2 tbsp............  2 tbsp (_ g); 2
     e.g., fruits, syrups,                             tbsp (30 mL)
     spreads, marshmallow cream,
     nuts, dairy and non-dairy
     whipped toppings.

    Pie fillings................  85 g..............  _ cup(s) (_ g)
Egg and Egg Substitutes:
    Egg mixtures, e.g., egg foo   110 g.............  _ piece(s) (_ g)
     young, scrambled eggs,                            for discrete
     omelets.                                          pieces; _ cup(s)
                                                       (_ g)
    Eggs (all sizes) \8\........  50 g..............  1 large, medium,
                                                       etc. (_ g)
    Egg whites, sugared eggs,     An amount to make   _ cup(s) (_ g); _
     sugared egg yolks, and egg    1 large (50 g)      cup(s) (_ mL)
     substitutes (fresh, frozen,   egg.
     dried).
Fats and Oils:
    Butter, margarine, oil,       1 tbsp............  1 tbsp (_ g); 1
     shortening.                                       tbsp (15 mL)
    Butter replacement, powder..  2 g...............  _ tsp(s) (_ g)
    Dressings for salads........  30 g..............  _ tbsp (_ g); _
                                                       tbsp (_ mL)
    Mayonnaise, sandwich          15 g..............  _ tbsp (_ g)
     spreads, mayonnaise-type
     dressings.
    Spray types.................  0.25 g............  About _ seconds
                                                       spray (_ g)
Fish, Shellfish, Game Meats,\9\
 and Meat or Poultry
 Substitutes:
    Bacon substitutes, canned     15 g..............  _ piece(s) (_ g)
     anchovies,\10\ anchovy                            for discrete
     pastes, caviar.                                   pieces; _ tbsp(s)
                                                       (_ g) for others
    Dried, e.g., jerky..........  30 g..............  _ piece(s) (_ g)
    Entrees with sauce, e.g.,     140 g cooked......  _ cup(s) (_ g); 5
     fish with cream sauce,                            oz (140 g/visual
     shrimp with lobster sauce.                        unit of measure)
                                                       if not measurable
                                                       by cup
    Entrees without sauce, e.g.,  85 g cooked; 110 g  _ piece(s) (_ g)
     plain or fried fish and       uncooked \11\.      for discrete
     shellfish, fish and                               pieces; _ cup(s)
     shellfish cake.                                   (_ g); _ oz (_ g/
                                                       visual unit of
                                                       measure) if not
                                                       measurable by cup
                                                       \12\
    Fish, shellfish, or game      85 g..............  _ piece(s) (_ g)
     meat \9\, canned \10\.                            for discrete
                                                       pieces; _ cup(s)
                                                       (_ g); 3 oz (85 g/
                                                       _ cup) for
                                                       products that are
                                                       difficult to
                                                       measure the g
                                                       weight of cup
                                                       measure (e.g.,
                                                       tuna); 3 oz (85 g/
                                                       _ pieces) for
                                                       products that
                                                       naturally vary in
                                                       size (e.g.,
                                                       sardines)
    Substitute for luncheon       55 g..............  _ piece(s) (_ g)
     meat, meat spreads,                               for distinct
     Canadian bacon, sausages,                         pieces (e.g.,
     frankfurters, and seafood.                        slices, links); _
                                                       cup(s) (_ g); 2
                                                       oz (56 g/visual
                                                       unit of measure)
                                                       for nondiscrete
                                                       bulk product
    Smoked or pickled fish,\10\   55 g..............  _ piece(s) (_ g)
     shellfish, or game meat                           for distinct
     \9\; fish or shellfish                            pieces (e.g.,
     spread.                                           slices, links) or
                                                       _ cup(s) (_ g); 2
                                                       oz (56 g/visual
                                                       unit of measure)
                                                       for nondiscrete
                                                       bulk product
    Substitutes for bacon bits--
     see Miscellaneous.
Fruits and Fruit Juices:
    Candied or pickled \10\.....  30 g..............  _ piece(s) (_ g)
    Dehydrated fruits--see snack
     category.
    Dried.......................  40 g..............  _ piece(s) (_ g)
                                                       for large pieces
                                                       (e.g., dates,
                                                       figs, prunes); _
                                                       cup(s) (_ g) for
                                                       small pieces
                                                       (e.g., raisins)
    Fruits for garnish or         4 g...............  1 cherry (_ g); _
     flavor, e.g., maraschino                          piece(s) (_ g)
     cherries \10\.
    Fruit relishes, e.g.,         70 g..............  _ cup(s) (_ g)
     cranberry sauce, cranberry
     relish.
    Fruits used primarily as      50 g..............  See footnote \12\
     ingredients, avocado.
    Fruits used primarily as      50 g..............  _ piece(s) (_ g)
     ingredients, others                               for large fruits;
     (cranberries, lemon, lime).                       _ cup(s) (_ g)
                                                       for small fruits
                                                       measurable by
                                                       cup\12\
    Watermelon..................  280 g.............  See footnote \12\
    All other fruits (except      140 g.............  _ piece(s) (_ g)
     those listed as separate                          for large pieces
     categories), fresh, canned                        (e.g.,
     or frozen.                                        strawberries,
                                                       prunes, apricots,
                                                       etc.); _ cup(s)
                                                       (_ g) for small
                                                       pieces (e.g.,
                                                       blueberries,
                                                       raspberries,
                                                       etc.) \12\
    Juices, nectars, fruit        240 mL............  8 fl oz (240 mL)
     drinks.
    Juices used as ingredients,   5 mL..............  1 tsp (5 mL)
     e.g., lemon juice, lime
     juice.
Legumes:
    Tofu,\10\ tempeh............  85 g..............  _ piece(s) (_ g)
                                                       for discrete
                                                       pieces; 3 oz (84
                                                       g/visual unit of
                                                       measure) for bulk
                                                       products
    Beans, plain or in sauce....  130 g for beans in  _ cup (_ g)
                                   sauce or canned
                                   in liquid and
                                   refried beans
                                   prepared; 90 g
                                   for others
                                   prepared; 35 g
                                   dry.
Miscellaneous:
    Baking powder, baking soda,   0.6 g.............  _ tsp (_ g)
     pectin.
    Baking decorations, e.g.,     1 tsp or 4 g if     _ piece(s) (_ g)
     colored sugars and            not measurable by   for discrete
     sprinkles for cookies, cake   teaspoon.           pieces; 1 tsp (_
     decorations.                                      g)
    Batter mixes, bread crumbs..  30 g..............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g)
    Chewing gum \8\.............  3 g...............  _ piece(s) (_ g)
    Cocoa powder, carob powder,   1 tbsp............  1 tbsp (_ g)
     unsweetened.
    Cooking wine................  30 mL.............  2 tbsp (30 mL)

    Dietary supplements.........  The maximum amount  _ tablet(s), _
                                   recommended, as     capsules(s), _
                                   appropriate, on     packet(s), _
                                   the label for       tsp(s) (_ g),
                                   consumption per     etc.
                                   eating occasion
                                   or, in the
                                   absence of
                                   recommendations,
                                   1 unit, e.g.,
                                   tablet, capsule,
                                   packet,
                                   teaspoonful, etc.
    Meat, poultry, and fish       Amount to make one  _ tsp(s) (_ g); _
     coating mixes, dry;           reference amount    tbsp(s) (_ g)
     seasoning mixes, dry, e.g.,   of final dish.
     chili seasoning mixes,
     pasta salad seasoning mixes.
    Milk, milk substitute, and    Amount to make 240  _ fl oz (_ mL); _
     fruit juice concentrates      mL drink (without   tsp (_  g); tbsp
     (without alcohol) (e.g.,      ice).               (_ g)
     drink mixers, frozen fruit
     juice concentrate,
     sweetened cocoa powder).
    Drink mixes (without          Amount to make 360  _ fl oz (_ mL); _
     alcohol): All other types     mL drink (without   tsp (_ g); _ tbsp
     (e.g., flavored syrups and    ice).               (_ g)
     powdered drink mixes).
    Salad and potato toppers,     7 g...............  _ tbsp(s) (_ g)
     e.g., salad crunchies,
     salad crispins, substitutes
     for bacon bits.
    Salt, salt substitutes,       \1/4\ tsp.........  \1/4\ tsp (_ g); _
     seasoning salts (e.g.,                            piece(s) (_ g)
     garlic salt).                                     for discrete
                                                       pieces (e.g.,
                                                       individually
                                                       packaged
                                                       products)
    Seasoning oils and seasoning  1 tbsp............  1 tbsp (_ g)
     sauces (e.g., coconut
     concentrate, sesame oil,
     almond oil, chili oil,
     coconut oil, walnut oil).
    Seasoning pastes (e.g.,       1 tsp.............  1 tsp (_ g)
     garlic paste, ginger paste,
     curry paste, chili paste,
     miso paste), fresh or
     frozen.
    Spices, herbs (other than     \1/4\ tsp or 0.5 g  \1/4\ tsp (_ g); _
     dietary supplements).         if not measurable   piece(s) (_ g) if
                                   by teaspoon.        not measurable by
                                                       teaspoons (e.g.,
                                                       bay leaf)
Mixed Dishes:
    Appetizers, hors d'oeuvres,   85 g, add 35 g for  _ piece(s) (_ g)
     mini mixed dishes, e.g.,      products with
     mini bagel pizzas, breaded    gravy or sauce
     mozzarella sticks, egg        topping.
     rolls, dumplings,
     potstickers, wontons, mini
     quesadillas, mini quiches,
     mini sandwiches, mini pizza
     rolls, potato skins.
    Measurable with cup, e.g.,    1 cup.............  1 cup (_ g)
     casseroles, hash, macaroni
     and cheese, pot pies,
     spaghetti with sauce,
     stews, etc.
    Not measurable with cup,      140 g, add 55 g     _ piece(s) (_ g)
     e.g., burritos, enchiladas,   for products with   for discrete
     pizza, pizza rolls, quiche,   gravy or sauce      pieces; _
     all types of sandwiches.      topping, e.g.,      fractional slice
                                   enchilada with      (_ g) for large
                                   cheese sauce,       discrete units
                                   crepe with white
                                   sauce \13\.
Nuts and Seeds:
    Nuts, seeds and mixtures,     30 g..............  _ piece(s) (_ g)
     all types: Sliced, chopped,                       for large pieces
     slivered, and whole.                              (e.g., unshelled
                                                       nuts); _ tbsp(s)
                                                       (_ g); _ cup(s)
                                                       (_ g) for small
                                                       pieces (e.g.,
                                                       peanuts,
                                                       sunflower seeds)
    Nut and seed butters,         2 tbsp............  2 tbsp (_ g)
     pastes, or creams.
    Coconut, nut and seed flours  15 g..............  _ tbsp(s) (_ g); _
                                                       cup (_ g)
Potatoes and Sweet Potatoes/
 Yams:
    French fries, hash browns,    70 g prepared; 85   _ piece(s) (_ g)
     skins, or pancakes.           g for frozen        for large
                                   unprepared French   distinct pieces
                                   fries.              (e.g., patties,
                                                       skins); 2.5 oz
                                                       (70 g/_ pieces)
                                                       for prepared
                                                       fries; 3 oz (84 g/
                                                       _ pieces) for
                                                       unprepared fries
    Mashed, candied, stuffed or   140 g.............  _ piece(s) (_ g)
     with sauce.                                       for discrete
                                                       pieces (e.g.,
                                                       stuffed potato);
                                                       _ cup(s) (_ g)
    Plain, fresh, canned, or      110 g for fresh or  _ piece(s) (_ g)
     frozen.                       frozen; 125 g for   for discrete
                                   vacuum packed;      pieces; _ cup(s)
                                   160 g for canned    (_ g) for sliced
                                   in liquid.          or chopped
                                                       products
Salads:
    Gelatin salad...............  120 g.............  _ cup (_ g)
    Pasta or potato salad.......  140 g.............  _ cup(s) (_ g)
    All other salads, e.g., egg,  100 g.............  _ cup(s) (_ g)
     fish, shellfish, bean,
     fruit, or vegetable salads.
Sauces, Dips, Gravies, and
 Condiments:
    Barbecue sauce, hollandaise   2 tbsp............  2 tbsp (_ g); 2
     sauce, tartar sauce, tomato                       tbsp (30 mL)
     chili sauce, other sauces
     for dipping (e.g., mustard
     sauce, sweet and sour
     sauce), all dips (e.g.,
     bean dips, dairy-based
     dips, salsa).
    Major main entree sauces,     125 g.............  _ cup (_ g); _ cup
     e.g., spaghetti sauce.                            (_ mL)
    Minor main entree sauces      \1/4\ cup.........  \1/4\ cup (_ g);
     (e.g., pizza sauce, pesto                         \1/4\ cup (60 mL)
     sauce, Alfredo sauce),
     other sauces used as
     toppings (e.g., gravy,
     white sauce, cheese sauce),
     cocktail sauce.

    Major condiments, e.g.,       1 tbsp............  1 tbsp (_ g); 1
     catsup, steak sauce, soy                          tbsp (15 mL)
     sauce, vinegar, teriyaki
     sauce, marinades.
    Minor condiments, e.g.,       1 tsp.............  1 tsp (_ g); 1 tsp
     horseradish, hot sauces,                          (5 mL)
     mustards, Worcestershire
     sauce.
Snacks:
    All varieties, chips,         30 g..............  _ cup (_ g) for
     pretzels, popcorn, extruded                       small pieces
     snacks, fruit and vegetable-                      (e.g., popcorn);
     based snacks (e.g., fruit                         _ piece(s) (_ g)
     chips), grain-based snack                         for large pieces
     mixes.                                            (e.g., large
                                                       pretzels; pressed
                                                       dried fruit
                                                       sheet); 1 oz (28g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products (e.g.,
                                                       potato chips)
Soups:
    All varieties...............  245 g.............  _ cup (_ g); _ cup
                                                       (_ mL)
    Dry soup mixes, bouillon....  Amount to make 245  _ cup (_ g); _ cup
                                   g.                  (_ mL)
Sugars and Sweets:
    Baking candies (e.g., chips)  15 g..............  _ piece(s) (_ g)
                                                       for large pieces;
                                                       _ tbsp(s) (_ g)
                                                       for small pieces;
                                                       \1/2\ oz (14 g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products
    After-dinner confectioneries  10 g..............  _ piece(s) (_ g)
    Hard candies, breath mints    2 g...............  _ piece(s) (_ g)
     \8\.
    Hard candies, roll-type,      5 g...............  _ piece(s) (_ g)
     mini-size in dispenser
     packages.
    Hard candies, others;         15 mL for liquid    _ piece(s) (_ g)
     powdered candies, liquid      candies; 15 g for   for large pieces;
     candies.                      all others.         _ tbsp(s) (_ g)
                                                       for ``mini-size''
                                                       candies
                                                       measurable by
                                                       tablespoon; _
                                                       straw(s) (_ g)
                                                       for powdered
                                                       candies; _ wax
                                                       bottle(s) (_ mL)
                                                       for liquid
                                                       candies; \1/2\ oz
                                                       (14 g/visual unit
                                                       of measure) for
                                                       bulk products
    All other candies...........  30 g..............  _ piece(s) (_ g);
                                                       1 oz (30 g/visual
                                                       unit of measure)
                                                       for bulk products
    Confectioner's sugar........  30 g..............  _ cup (_ g)
    Honey, jams, jellies, fruit   1 tbsp............  1 tbsp (_ g); 1
     butter, molasses, fruit                           tbsp (15 mL)
     pastes, fruit chutneys.
    Marshmallows................  30 g..............  _ cup(s) (_ g) for
                                                       small pieces; _
                                                       piece(s) (_ g)
                                                       for large pieces
    Sugar.......................  8 g...............  _ tsp (_ g); _
                                                       piece(s) (_ g)
                                                       for discrete
                                                       pieces (e.g.,
                                                       sugar cubes,
                                                       individually
                                                       packaged
                                                       products)
    Sugar substitutes...........  An amount           _ tsp(s) (_ g) for
                                   equivalent to one   solids; _ drop(s)
                                   reference amount    (_ g) for liquid;
                                   for sugar in        _ piece(s) (_ g)
                                   sweetness.          (e.g.,
                                                       individually
                                                       packaged
                                                       products)
    Syrups......................  30 mL for all       2 tbsp (30 mL)
                                   syrups.
Vegetables:
    Dried vegetables, dried       5 g, add 5 g for    _ piece(s); \1/3\
     tomatoes, sun-dried           products packaged   cup (_ g)
     tomatoes, dried mushrooms,    in oil.
     dried seaweed.
    Dried seaweed sheets........  3 g...............  _ piece(s) (_ g);
                                                       _ cup(s) (_ g)
    Vegetables primarily used     4 g...............  _ piece(s) (_ g);
     for garnish or flavor                             _ tbsp(s) (_ g)
     (e.g., pimento,\10\                               for chopped
     parsley, fresh or dried).                         products
    Fresh or canned chili         30 g..............  _ piece(s) (_ g)
     peppers, jalapeno peppers,                        \12\; _ tbsp(s)
     other hot peppers, green                          (_ g); _ cup(s)
     onion.                                            (_ g) for sliced
                                                       or chopped
                                                       products
    All other vegetables without  85 g for fresh or   _ piece(s) (_ g)
     sauce: Fresh, canned, or      frozen; 95 g for    for large pieces
     frozen.                       vacuum packed;      (e.g., Brussels
                                   130 g for canned    sprouts); _
                                   in liquid, cream-   cup(s) (_ g) for
                                   style corn,         small pieces
                                   canned or stewed    (e.g., cut corn,
                                   tomatoes,           green peas); 3 oz
                                   pumpkin, or         (84 g/visual unit
                                   winter squash.      of measure) if
                                                       not measurable by
                                                       cup
    All other vegetables with     110 g.............  _ piece(s) (_ g)
     sauce: Fresh, canned, or                          for large pieces
     frozen.                                           (e.g., Brussels
                                                       sprouts); _
                                                       cup(s) (_ g) for
                                                       small pieces
                                                       (e.g., cut corn,
                                                       green peas); 4 oz
                                                       (112 g/visual
                                                       unit of measure)
                                                       if not measurable
                                                       by cup
    Vegetable juice.............  240 mL............  8 fl oz (240 mL)
    Olives \10\.................  15 g..............  _ piece(s) (_ g);
                                                       _ tbsp(s) (_ g)
                                                       for sliced
                                                       products
    Pickles and pickled           30 g..............  1 oz (28 g/visual
     vegetables, all types \10\.                       unit of measure)
    Pickle relishes.............  15 g..............  _ tbsp (_ g)
    Sprouts, all types: Fresh or  1/4 cup...........  \1/4\ cup (_ g)
     canned.
    Vegetable pastes, e.g.,       30 g..............  _ tbsp (_ g)
     tomato paste.
    Vegetable sauces or purees,   60 g..............  _ cup (_ g); _ cup
     e.g., tomato sauce, tomato                        (_ mL)
     puree.
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
  customarily consumed per eating occasion and were primarily derived
  from the 1977-1978 and the 1987-1988 Nationwide Food Consumption
  Surveys conducted by the U.S. Department of Agriculture and updated
  with data from the National Health and Nutrition Examination Survey,
  2003-2004, 2005-2006 and 2007-2008 conducted by the Centers for
  Diseases Control and Prevention, in the Department of Health and Human
  Services.
\2\ Unless otherwise noted in the Reference Amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (e.g., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  mixes, concentrates, dough, batter, fresh and frozen pasta) is the
  amount required to make the reference amount of the prepared form.
  Prepared means prepared for consumption (e.g., cooked).

\3\ Manufacturers are required to convert the reference amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures in 21 CFR 101.9(b).
\4\ The label statements are meant to provide examples of serving size
  statements that may be used on the label, but the specific wording may
  be changed as appropriate for individual products. The term ``piece''
  is used as a generic description of a discrete unit. Manufacturers
  should use the description of a unit that is most appropriate for the
  specific product (e.g., sandwich for sandwiches, cookie for cookies,
  and bar for ice cream bars). The guidance provided is for the label
  statement of products in ready-to-serve or almost ready-to-serve form.
  The guidance does not apply to the products which require further
  preparation for consumption (e.g., dry mixes, concentrates) unless
  specifically stated in the product category, reference amount, or
  label statement column that it is for these forms of the product. For
  products that require further preparation, manufacturers must
  determine the label statement following the rules in Sec.   101.9(b)
  using the reference amount determined according to Sec.   101.12(c).
\5\ Includes cakes that weigh 10 g or more per cubic inch. The serving
  size for fruitcake is 1 \1/2\ ounces.
\6\ Includes cakes that weigh 4 g or more per cubic inch but less than
  10 g per cubic inch.
\7\ Includes cakes that weigh less than 4 g per cubic inch.
\8\ Label serving size for ice cream cones, eggs, and breath mints of
  all sizes will be 1 unit. Label serving size of all chewing gums that
  weigh more than the reference amount that can reasonably be consumed
  at a single-eating occasion will be 1 unit.
\9\ Animal products not covered under the Federal Meat Inspection Act or
  the Poultry Products Inspection Act, such as flesh products from deer,
  bison, rabbit, quail, wild turkey, geese, ostrich, etc.
\10\ If packed or canned in liquid, the reference amount is for the
  drained solids, except for products in which both the solids and
  liquids are customarily consumed (e.g., canned chopped clam in juice).
\11\ The reference amount for the uncooked form does not apply to raw
  fish in Sec.   101.45 or to single-ingredient products that consist of
  fish or game meat as provided for in Sec.   101.9(j)(11).
\12\ For raw fruit, vegetables, and fish, manufacturers should follow
  the label statement for the serving size specified in Appendices C and
  D to part 101 (21 CFR part 101) Code of Federal Regulations.
\13\ Pizza sauce is part of the pizza and is not considered to be sauce
  topping.

    (c) If a product requires further preparation, e.g., cooking or the
addition of water or other ingredients, and if paragraph (b) of this
section provides a reference amount for the product in the prepared
form, but not the unprepared form, then the reference amount for the
unprepared product must be the amount of the unprepared product
required to make the reference amount for the prepared product as
established in paragraph (b) of this section.
* * * * *
    (f) * * *
    (1) The reference amount for the combined product must be the
reference amount, as established in paragraph (b) of this section, for
the ingredient that is represented as the main ingredient (e.g., peanut
butter, pancakes, cake) plus proportioned amounts of all minor
ingredients.
    (2) If the reference amounts are in compatible units, the weights
or volumes must be summed (e.g., the reference amount for equal volumes
of peanut butter and jelly for which peanut butter is represented as
the main ingredient would be 4 tablespoons (tbsp) (2 tbsp peanut butter
plus 2 tbsp jelly)). If the reference amounts are in incompatible
units, all amounts must be converted to weights and summed, e.g., the
reference amount for pancakes and syrup would be 110 g (the reference
amount for pancakes) plus the weight of the proportioned amount of
syrup.
* * * * *

    Dated: May 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11865 Filed 5-20-16; 8:45 am]
 BILLING CODE 4164-01-P