increase in serving size on food labels means that more of the food
should be eaten and what additional education efforts should be
provided to consumers to avoid such a conclusion. We also sought
comment on whether we should reconsider the definition of ``serving''
and ``serving size'' or how we interpret ``customarily consumed.''
    Many comments urged us to harmonize label serving sizes and RACCs
with recommended dietary guidance and the Food Guide Pyramid. The
comments indicated that an increase in serving sizes might suggest to
consumers that they should eat larger portions. One comment indicated
that if the serving size was increased to accommodate current
consumption levels, consumers might choose to consume 125 percent of a
new serving size which would result in increased consumption and is
opposite of the intended effect. Some comments indicated that further
science-based research is needed to obtain consumers' perceptions and
reaction to serving sizes.
    In response to the question concerning reconsidering the definition
of serving size, two comments indicated that the terms ``serving'' and
``serving size'' may be confusing to consumers, because they are the
same terms used in dietary guidance, such as the USDA Food Guide and
the Dietary Guidelines for Americans. Other comments indicated that we
should take into account dietary guidance recommendations when defining
``serving'' and ``serving size,'' or how we interpret ``customarily
consumed.'' One comment suggested that ``FDA consider testing terms
such as `suggested serving size,' `reasonable serving size,' or
`sensible serving size' to evaluate consumer usefulness.''
    With regard to the comments that RACCs and serving sizes should be
based on what people should eat rather than what they usually eat, we
acknowledge that there may be benefits to have serving sizes on product
labels that are consistent with the serving sizes in the dietary
guidance documents published by Federal Government Agencies. However,
the FD&C Act specifically defines serving size as an ``amount
customarily consumed,'' rather than a recommended amount people should
eat. In addition, dietary guidance documents published by Federal
Government Agencies usually list approximate amounts of food for the
purpose of providing ``general'' guidance as to what quantity of each
food group a person should consume to maintain good health. Therefore,
the amount that represents a serving is often not well defined. For
example, dietary guidance documents define a serving of bread as 1
slice of bread. However, the weight of a slice of bread varies and
would not be able to be converted into a reference amount without a
specific gram weight. Another example is that the 2010 Dietary
Guidelines for Americans recommended total cups to consume per day of
fruits and vegetables, but does not list specific amounts of particular
types of fruits and vegetables to be consumed per eating occasion (Ref.
7). In addition, not all foods are represented in the dietary
guidelines while all foods would need to be represented in the serving
size RACCs.
    With respect to the comments that indicated that consumers might
think that an increase in serving sizes on the food label suggest that
they should eat larger portions, we agree that some consumers may
misconstrue the meaning of the serving size. We recognize that research
has shown that over half of consumers generally misunderstood the
meaning of serving size on the food label to be a recommended amount
(Ref. 40). Given this confusion among consumers, we will consider
education efforts to help increase consumer understanding of the term
serving size. However, we also note that some consumer comments on the
ANPRM overwhelmingly indicated that current serving sizes in use are
confusing and can be misleading. For example, some indicated that the
RACCs and serving sizes currently in use (e.g., 2 servings on a 16 fl
oz can of soft drink, or an 8 oz pot pie) are confusing because they do
not reflect the amount of food that is currently customarily consumed.
Providing the nutrition composition of the food based on current
consumption amounts informs consumers of the amount of nutrients they
are likely to ingest from a particular food.
    In response to the comment suggesting that we consider testing
terms such as ``suggested serving size,'' ``reasonable serving size,''
or ``sensible serving size'' to evaluate consumer usefulness, as
previously explained, under section 403(q)(1)(A)(i) of the FD&C Act,
serving size is based on the amount of food people customarily consume
and is not a suggested or recommended amount of food to eat. The terms
suggested by the comment are not an accurate indication of the value
that the serving size represents.
b. Methods Used to Update the Existing RACCs
Food Consumption Database
    To update existing RACCs that reflect the amounts of food products
customarily consumed, we analyzed food consumption data from the NHANES
2003-2008 surveys to assess the amount of food reported consumed per
eating occasion. The NHANES collects nutrition and health related
measures among the civilian non-institutionalized U.S. population. The
NHANES oversamples African Americans, Mexican Americans, low-income
whites, adolescents 12 to 19 years of age, and persons 60 years of age
and older. The dietary interview component of NHANES, called ``What We
Eat in America'' (WWEIA), is conducted as a partnership between USDA
and the U.S. Department of Health and Human Services (DHHS) (Ref. 41).
Under this partnership, DHHS' National Center for Health Statistics is
responsible for the sample design and data collection and USDA's Food
Surveys Research Group (FSRG) is responsible for the data collection
methodology and maintaining the food and nutrient database (i.e., the
Food and Nutrient Database for Dietary Studies (FNDDS)) (Ref. 42),
which is used for the survey. The WWEIA provides gram amounts of each
food reported consumed in the past 24-hours (24-hour recall) from each
survey participant. More details of the survey design procedure can be
found in the NHANES Data (Refs. 41 and 43).
    We analyzed the recent consumption by combining data from the
survey years of the NHANES, 2003-2004, 2005-2006, and 2007-2008 (NHANES
2003-2008 surveys) using Statistical Analysis Systems (SAS) and Survey
Data Analysis (SUDAAN) procedures (Refs. 44 and 45) which provide a
current indication of the amount of food being consumed by individuals
(Ref. 46). Food consumption data from the NHANES-WWEIA surveys are
released in 2-year cycles. Since the survey of 2003-2004, there are
two, 24-hour recalls of food intake data (day 1 and day 2) available
for each survey participant and recall of intake data are collected
using the USDA AMPM (Ref. 47). The AMPM is designed to provide an
efficient and accurate way of collecting dietary intake data for a
large-scale national survey (such as NHANES) based on a 5-step probing
technique for extensive compilation of standardized food-specific
questions and possible response

options (Ref. 47). USDA's validation study showed that AMPM provides an
acceptable accuracy of collecting reported intake data by comparing the
estimated calorie intake with total energy expenditure, and estimated
protein intake with urinary nitrogen excretion as measured by the
doubly-labeled water method (Refs. 48 and 49). In our analyses, we used
data to determine the median and mean estimates of consumption (in
grams or in household measurements) for the food products in the 140
product categories for the three population groups: Infants up to 12
months of age, children 1 through 3 years of age, and the general
population of persons 4 years of age or older (Ref. 46). For the bakery
products that were in ``as-consumed'' form (e.g., toasted bread), we
multiplied by a factor of 1.1 or 1.2 to convert the consumption amount
to an ``as-purchased'' form (e.g. untoasted bread) and those foods were
then included in the analysis. The factor is the ratio of the moisture
content between the foods in an ``as-purchased'' to ``as-consumed''
form due to loss of water during the toasting process. The factor was
necessary in order to determine the consumption amount of bakery
products in the form that is listed in table 2 in Sec.  101.12(b).
Steps and Factors Used in Determining the Need to Update the 1993 RACCs
(Ref. 50)
Step I--Evaluate Whether To Consider Updating the 1993 RACCs
    Under Step I, FDA considered two factors. Under this step, if both
of these factors were not met, FDA did not consider updating the 1993
RACC.
    (1) The first factor was to determine whether there was an adequate
sample size from the NHANES 2003-2008 consumption data for each product
in the 140 product categories. The adequate sample size was determined
based on the design effect of the data source for the analyses (Ref.
50). The design effect \5\ is calculated using the ratio of the
variance of the estimate that is based on a sample weighted design to
the variance of the estimate based on a simple random sample by
products within a product category (Ref. 50). This is necessary because
NHANES uses a complex, stratified, probability survey design for data
collection, which is a cost-saving data collection method often used
for population surveys, rather than a simple random sampling method.
---------------------------------------------------------------------------

    \5\ The design effect of the survey is a sample size adjustment
compared to the survey if it would have been completed using a
simple random sampling method. For example, if the design effect of
a survey is 3, this means that the sample variance is 3 times larger
than it would be if the data collection for the survey was based on
a simple random sampling method. In other words, only one-third as
many sample cases would be needed to measure the given statistic if
a simple random sampling method were used instead of the cluster
survey sampling method with a design effect of 3.0.
---------------------------------------------------------------------------

    The data collection for NHANES, which is completed by CDC, is used
to assess intake by the U.S. population; a purpose that differed from
our purpose of updating RACCs. Therefore, sample sizes that CDC
collected were not always adequate for considering updates to the
RACCs. Thus, we retrospectively determined the adequate, minimum
required sample size based on the calculated design effect for each
product within the product categories with a 90 percent confidence
level and 20 percent margin of error. For some products, sample sizes
are not large enough to obtain a reliable estimate of consumption.
Therefore, we have determined that for these products there is no
compelling evidence (due to an insufficient number of samples) to
consider updating the RACCs established in 1993 for those products.
    (2) The second factor was to determine if, for those products with
a sufficient sample size, the median intake estimate from the NHANES
2003-2008 consumption data for the product significantly differed from
the 1993 RACC for that product. Thus, we compared the median intake
estimate from the NHANES 2003-2008 consumption data with the 1993 RACCs
to determine if there was a at least a 25 percent difference (i.e. a
significant difference) from the current RACCs. We used the median
estimate of the intake distribution because it represents the central
tendency of the amount customarily consumed per eating occasion. Also,
the median is less influenced by outliers than the mean. In addition,
we used a statistically conservative approach when considering the
difference between the median intake estimate and the 1993 RACC for a
product, to provide a 90 percent confidence level, with a 20 percent
margin of error, to determine whether significant differences occur
when the 95 percent confidence intervals of the consumption amount from
the NHANES 2003-2008 surveys is outside of the 25 percent range ( 25 percent) of the RACCs established in 1993 (Ref. 50). In other
words, when the consumption amount calculated from NHANES 2003-2008
surveys increased or decreased by at least 25 percent from the RACCs
established in 1993 (i.e., less than 0.75 of the RACC or more than 1.25
of the RACC), we concluded that the current consumption amount is
significantly different than the RACCs established in 1993. We chose
the 25 percent approach based on our analysis of the data and after
evaluating other values for percentage differences (e.g. 5%, 10%), when
applied to the data, to reach a reasonable conservative estimate based
on statistical principles. We further evaluated a product in Step II
below if we found at least a 25 percent difference in consumption from
the product in Step I. For a product for which there was not at least a
25 percent difference in consumption, we did not consider updating the
1993 RACC.
Step II--Determine Whether the 1993 RACCs Need To Be Updated
    When a product had an adequate sample size to provide a reliable
median intake estimate and this amount was significantly different than
the 1993 RACC for the product, we then considered the factors below in
a step-wise process to determine whether to update the 1993 RACCs:
(1) The Skewness of the Intake Distribution
    We compared the median intake estimate from the NHANES 2003-2008
consumption data for the product consumed with the mean intake estimate
from the NHANES 2003-2008 consumption data to determine whether the
distribution of intake was skewed (Ref 48). A skewed intake
distribution suggested that an empirical number of the reported
consumption amounts were inconsistent and therefore, the variability
between the mean and median estimates was considered to be large. The
median intake estimate could not by itself provide sufficient evidence
for the amount customarily consumed of that product by the United
States target population if the intake distribution was skewed.
(2) The Reasonable Consumption Amount
    If the intake distribution was skewed and we could not rely on the
median intake estimate from the NHANES 2003-2008 consumption data as
the sole basis to propose a change in the RACC, we examined the data
from the FNDDS 4.1 (Ref. 42). The data from FNDDS provides the
``reasonable consumption amount,'' which we used to assist in our
decision about whether to propose a change to the RACC. The reasonable
consumption amount is a default consumption amount of food that
researchers have defined and is used by NHANES when survey participants
cannot recall the amount of food that was consumed at one eating
occasion (Ref. 42). If the reasonable consumption

amount for the product was consistent with the median intake estimate,
we considered whether to propose a change to the 1993 RACC on a case-
by-case basis. If the median intake estimate from the NHANES 2003-2008
consumption data was not consistent with the reasonable consumption
amount for the product, we then looked at if there was a significant
difference between the median intake estimates from the NHANES 2003-
2008 consumption data for the product, converted to a common household
measure as applicable, and the 1993 RACC for the product.
(3) The Difference Between the Median Intake Estimates, Converted to
Common Household Measures as Applicable, With the 1993 RACC for the
Products
    If we determined, based on our analysis, that the distribution of
the intake of a product was not skewed, or skewed and not consistent
with the reasonable consumption amount, we next compared the median
intake estimate from the NHANES 2003-2008 consumption data for the
product, converted to a common household measure as applicable, with
the 1993 RACC for the product.
    If the median intake estimate from the NHANES 2003-2008 consumption
data for the product, converted to a common household measure as
applicable, was not significantly different from the 1993 RACC for the
product, we did not propose to update the 1993 RACC. This sometimes
occurred when we converted the median intake estimate from the NHANES
2003-2008 consumption data to determine the common household
measurement. If the converted median intake estimate from the NHANES
2003-2008 consumption data was significantly different from the 1993
RACC for the product, we used other considerations to determine whether
the 1993 RACC should be changed.
(4) Other Considerations When the Median Intake Estimate From the
NHANES 2003-2008 Consumption Data Is Significantly Different From the
1993 RACC for the Product
    If there was no other comparable product with a median intake
estimate from the NHANES 2003-2008 consumption data, we considered
whether the estimated median intake from the NHANES 2003-2008
consumption data for the product was consistent with the reasonable
consumption amount. If the median intake estimate from the NHANES 2003-
2008 consumption data was consistent with the reasonable consumption
amount, we proposed to update the 1993 RACC based on the median intake
estimate from the NHANES 2003-2008 consumption data; otherwise, we
considered each food product case-by-case to determine whether to
change the 1993 RACC.
    If there were comparable products with median intake estimates from
the NHANES 2003-2008 consumption data, we considered these other
comparable products to determine on a case-by-case basis whether to
change the RACC for the product so that comparable products have the
same RACC. In general, if multiple products were represented in a
product category, we attempted to maintain a consistent RACC so that
products with similar dietary usage (e.g., hot breakfast cereals,
hominy, and grits are often used as breakfast items), similar product
characteristics, and similar amounts customarily consumed could be
easily compared. Similarly, we considered it beneficial to generally
use the same RACCs for products that are in different product
categories, when the products have similar amounts customarily
consumed, similar dietary usage, and similar product characteristics
(e.g., the ``All varieties, chips, pretzels, popcorns, extruded snacks,
fruit-based snacks (e.g., fruit chips,) grain-based snack mixes''
product category and the ``Crackers that are usually used as snacks''
product category). Again, this is intended to help consumers to more
easily compare nutrition information on the Nutrition Facts label
across product categories. If the median intake estimate from the
NHANES 2003-2008 consumption data for products in a product category
varied, we gave greater consideration to the product that had the
largest sample size (i.e., was consumed most frequently) in that
product category when proposing a change to the 1993 RACC because there
were more eating occasions reported by consumers for that product.
    While we have taken a conservative approach in the methodology used
to determine which RACCs should be updated, we recognize that there may
be other methods that could be used. We invite comment on our analysis
and rationale, and request data and factual information on alternative
methodologies that we should use for determining which RACCs to update.
c. Proposed Amendments To Update the Existing RACCs
    Using the methods described above, we propose to change the current
RACCs used to determine the serving size for those products where
consumption has changed significantly when compared to the RACCs
established in 1993. These changes, if finalized, will be reflected in
Table 1 ``Reference Amounts Customarily Consumed Per Eating Occasion:
Foods for Infants and Children 1 through 3 years of age'' and Table 2
``Reference Amounts Customarily Consumed Per Eating Occasion: General
Food Supply'' of Sec.  101.12(b).
    Detailed information about how the principles, factors and steps
were applied to change or not change the RACCs for specific food
products is provided in a memorandum (Ref. 50). We analyzed consumption
data for all 129 product categories in Table 2 in Sec.  101.12(b) for
persons 4 years of age or older and for the 11 product categories in
Table 1 (Sec.  101.12(b)), for infants and children 1 through 3 years
of age (Ref. 50). The proposed amendments that follow in this section
are for food products where consumption has increased or decreased by
at least 25 percent when compared to the RACCs established in 1993.
Proposed amendments for food products where consumption has not
increased or decreased by at least 25 percent when compared to the
RACCs established in 1993 are provided in section II.D.3.b.
Changes to Table 1: Reference Amounts Customarily Consumed Per Eating
Occasion: Food for Infants and Children 1 Through 3 Years of Age in
Sec.  101.12(b)
    In the product category ``Dinners, desserts, fruits, vegetables or
soups, ready-to-serve, strained type'' we are proposing to change the
RACC to 110 g from 60 g. The median consumption for desserts, ready-to-
serve, strained type was 103 g and dinners, ready-to-serve, strained
type was 104 g. The median consumption for fruits and vegetables,
ready-to-serve, strained type was about 70 g. Products in this product
category have similar dietary usage and product characteristics to the
products in the ``Dinners, desserts, fruits, vegetables or soups,
ready-to-serve, junior type'' product category. We are proposing to
change the RACC to 110 g, which would allow for consumers to make easy
comparisons of nutrition information.
Changes to Table 2: Reference Amounts Customarily Consumed per Eating
Occasion: General Food Supply in Sec.  101.12(b)
    In the general category of ``Bakery products,'' we propose to
remove ``bagels,'' ``toaster pastries,'' and ``muffins'' from their
current product categories, and to create a new product category for
``Bagels, toaster pastries, muffins (excluding English muffins),'' with
a proposed RACC of 110 g compared to the current RACC of 55 g that was
used for all of those food

products. This change is being proposed because the amounts customarily
consumed in recent consumption data for these products are much higher
than the amounts customarily consumed for the other products in their
current product categories (i.e., the product categories established in
1993). Additionally, bagels, toaster pastries, and muffins (excluding
English muffins) have similar product characteristics and dietary usage
(e.g., they are products that can be used as breakfast products). The
median consumption amounts for bagels, toaster pastries, and muffins
are 104 g, 97 g, and 105 g, respectively. The median consumption
amounts for those products are close to the reasonable consumption
amount of one medium muffin, and the weight in grams of one regular-
sized bagel.
    In the general category of ``Beverages,'' we propose new RACCs of
360 mL and 360 mL for ``Carbonated and noncarbonated beverages, wine
coolers, water'' and ``Coffee or tea flavored and sweetened,''
respectively, compared to the current RACCs of 240 mL and 240 mL
prepared because current median intakes are 360 mL (or 12 fluid ounces)
for these products. We also propose to change the label statements for
these product categories within the general category of ``Beverages''
to 12 fl oz (360 mL) from 8 fl oz (240 mL). The consumption data for
milk, fruit juices and vegetable juices remained unchanged from the
current RACC of 240 mL. In the 1991 proposed serving size rule, we
stated that a uniform RACC for all beverages would help consumers make
nutritional comparisons across beverage categories (56 FR 60394 at
60407). While this is true, we still must base the RACCs on the amounts
customarily consumed, and current data show that consumption amounts of
carbonated and non-carbonated beverages, wine coolers, water, and
coffee or tea flavored and sweetened are much greater than consumption
amounts for milk, fruit juices, and vegetable juices. In addition to
the consumption amounts being dissimilar, the product characteristics
are somewhat different between milk, fruit juice, and vegetable juice
compared to carbonated and non-carbonated beverages, wine coolers,
water, and coffee or tea flavored and sweetened, because they are
inherently nutrient dense (unlike carbonated and non-carbonated
beverages, wine coolers, water, and coffee or tea flavored and
sweetened). For these reasons we are not proposing to change the
current RACC of 240 mL for milk, fruit juices, nectars, fruit drinks,
and vegetable juices.
    In the general category of ``Fish, Shellfish, Game Meats, and Meat
or Poultry Substitutes,'' we propose a new RACC of 85 g for the ``Fish,
shellfish or game meat, canned'' product category, compared to the
current RACC of 55 g because the median intake estimate from the NHANES
2003-2008 consumption data is approximately 85 g.
    In the general category of ``Fruits and Fruit Juices,'' we propose
a new RACC of 50 g for the product category of ``Fruits used primarily
as ingredients, avocado'', compared to the current RACC of 30 g because
the median intake estimate from the NHANES 2003-2008 consumption data
for avocado is 50 g, and avocado is often used as an ingredient (e.g.,
in salads and sandwiches), similar to the product category ``Fruits
used primarily as ingredients, others (cranberries, lemon, line)'' for
which we are also proposing a new RACC of 50 g. Proposing a new RACC of
50 g for the ``Fruits used primarily as ingredients, avocado'' product
category would help consumers easily compare nutrition information
between all fruits used primarily as ingredients.
    In the general category of ``Fruits and Fruit Juices,'' we propose
a new RACC of 50 g for the product category of ``Fruits used primarily
as ingredients, others (cranberries, lemon, lime)'' compared to the
current RACC of 55 g. Because of the large variation between mean and
median intake estimates from the NHANES 2003-2008 consumption data, we
looked at the reasonable consumption amount for the products in the
product category. The reasonable consumption amount for this product
category is 50 g. Products in this product category are comparable to
the product category ``Fruits used primarily as ingredients, avocado,''
which we are proposing a new RACC of 50 g. Proposing a new RACC of 50 g
for the ``Fruits used primarily as ingredients, others (cranberries,
lemon, lime)'' product category would help consumers easily compare
nutrition information between all fruits used primarily as ingredients.
    In the general category of ``Sugars and Sweets,'' we propose a new
RACC of 30 g for the ``All other candies'' product category compared to
the current RACC of 40 g. The median consumption amount for this
product category was 22 g and the mean was 33 g. Because intake
distribution is not considered skewed and there is no comparable
product with a reliable median intake estimate from the NHANES 2003-
2008 consumption data, we looked at data from the FNDDS (Ref. 42) on
the reasonable consumption amounts of candies other than baking
candies; hard candies, breath mints; hard candies, roll-type, mini-size
in dispenser packages and hard candies. The reasonable consumption
amount ranges from 14 to 59 g with the majority of the reasonable
consumption amounts being 28 g. Therefore, given the variance in the
median and mean we rounded the reasonable consumption amount of 28 g up
to 30 g, which can be easily converted to a convenient household
measure of one ounce for the proposed RACC for ``All other candies.''
We are also proposing to change the label statement to ---- pieces (--
-- g); 1 oz (30 g/visual unit of measure) for bulk products.
    In the general category of ``Sugars and Sweets,'' we propose a new
RACC of 8 g for the ``Sugar'' product category compared to the current
RACC of 4 g. The median intake estimate from the NHANES 2003-2008
consumption data for sugar is 8 g.
    In the general category of ``Sugars and Sweets,'' we propose a new
RACC of 30 mL for all syrups in the ``Syrups'' product category,
compared to the RACC of 30 mL for syrups used primarily as an
ingredient (e.g., light or dark corn syrup) and 60 mL for all others
because the median intake estimate from the NHANES 2003-2008
consumption data for all syrups is 2 tablespoons (tbsp), which is close
to 30 mL. We also propose to change the label statement for all Syrups
to 2 tbsp (30 mL) from 2 tbsp (30 mL) for syrups used primarily as an
ingredient; \1/4\ cup (60 mL) for all others.
3. Modifying and Establishing RACCs
    This section discusses changes we are proposing that modify or
establish RACCs. Since the final rule on serving sizes published in
1993, we have received requests from manufacturers to modify RACCs for
products currently listed in the tables in Sec.  101.12(b), establish
RACCs for products not currently listed in the tables in Sec.
101.12(b) and identify appropriate product categories for various food
products (i.e., establish a RACC for that food product). These requests
have come through various forms, including four citizen petitions
referenced in section I.D.3., requests by manufacturers, and public
comments to the ANPRM. In this section, we also propose to modify some
product categories, on our own initiative, so that comparable products
are grouped together. Thus, this proposed rule would establish certain
RACCs for

products not currently listed in the tables in Sec.  101.12(b) (in some
cases by placing a product in a new product category with a new RACC,
and in other cases by placing a product in an existing product
category), and would modify RACCs for some existing products.
a. Methods Used To Modify Existing RACCs and Establish New RACCs
    The products in this category are either new products for which no
RACC is currently established, or products for which RACCs are
currently established, but for which there has not been a significant
increase or decrease in consumption (i.e., an increase or decrease in
consumption representing a 25 percent difference) when compared to the
RACCs established in 1993 (Ref. 50). Some products discussed below are
ingredients of foods or other food products that are not available in
the NHANES database. When determining where to place food products and
what their RACCs should be, we looked first to the NHANES database,
using similar methods to those used to update the 1993 RACCs, as
described previously in this document. We analyzed recent consumption
from the NHANES 2003-2008 surveys, when available, using SAS and SUDAAN
procedures (Refs. 44 and 45). The factors considered when looking at
NHANES 2003-2008 consumption data included: (1) The sample size and the
median intake estimate from the NHANES 2003-2008 consumption data, and
the mean intake estimate from the NHANES 2003-2008 consumption data
(unlike the methods used to update the RACCs, the mean estimate was
used as a guide when the median estimate was not available), (2) the
difference between the NHANES 2003-2008 consumption data, converted to
a common household measure as applicable, and the 1993 RACC for the
product, (3) the reasonable consumption amount, (4) information
received in manufacturers' requests, public comments, and (5) the
NHANES 2003-2008 consumption data for comparable products and the
largest sample size from the NHANES 2003-2008 consumption data within a
product category. Detailed information about how these factors were
applied to individual products is provided in a memorandum to the file
(Ref 48).
    If the food product was not available in the NHANES database, we
looked to the main dietary usage of the product to determine if the
product could fit into an existing product category. For accuracy and
consistency in determining dietary usage, we used a culinary reference
book entitled ``Food Lover's Companion,'' which has been used by
nutrition professionals as a food dictionary reference (Ref. 51), and
internet resources with extensive recipe collections such as, http://www.allrecipes.com, http://www.food.com, and http://www.recipe.com
(Refs. 52, 53 and 54). Market data (e.g., Neilson sales data) were used
to examine the top selling products. Additionally, the Gladson and
Mintel databases, which provide labeling information for products that
are currently available in the market, were used to look at industry
practice (Refs. 55 and 56). For foods that are used as ingredients, the
RACCs are generally determined based on the amount of the ingredient
that is needed to prepare the finished product per eating occasion
(e.g., cocoa powder, unsweetened is used as an ingredient for chocolate
cakes). For all products in this section, we considered additional data
sources, such as data from the gram weight information for various
portion sizes based on the National Nutrient Database for Standard
Reference, release 24 (Ref. 57), recipe information from FNDDS, a
guidance document entitled ``Guidance for Industry: A Food Labeling
Guide'' (Ref. 58), and other federal guidance documents (Ref. 59).
b. Proposed Amendments To Modify Existing RACCs and Establish New RACCs
    In this section we propose to modify RACCs, establish RACCs, and
place products in appropriate product categories in Table 2 in Sec.
101.12(b).
    In the general category of ``Bakery products,'' we propose to:
    1. Add ``scones, crumpets, and English muffins'' to the current
product category ``Biscuits, croissants, bagels, tortillas, soft bread
sticks, soft pretzels, corn bread, hush puppies'' with a RACC of 55 g.
The new name for this product category would be ``Biscuits, croissants,
tortillas, soft bread sticks, soft pretzels, corn bread, hush puppies,
scones, crumpets, and English muffins'' (as discussed in section
II.D.2.c., we also are proposing to move bagels to a new product
category). Currently there is no RACC for scones and crumpets. The
median intake estimate from the NHANES 2003-2008 consumption data for
scones and crumpets is 37 g. The reasonable consumption amount of one
scone with or without fruit is 42 g, and one crumpet weighs 45 g. The
median intake estimate from the NHANES 2003-2008 consumption data for
biscuits and croissants is 51 g and 57 g, respectively. Biscuits and
croissants have a larger sample size compared to scones and crumpets.
Biscuits, croissants, scones, crumpets and English muffins are
comparable to other products in this category and can be used as
breakfast bakery products. Therefore, based on these factors, we
propose to add scones, crumpets, and English muffins to the current
product category ``Biscuits, croissants, bagels, tortillas, soft bread
sticks, soft pretzels, corn bread, hush puppies'' with a RACC of 55 g;
and
    2. Add to proposed footnote 5 that the serving size for fruitcake
is 1\1/2\ oz. Fruitcake belongs in the ``Cakes, heavy weight'' product
category, which has a RACC of 125 g, because it is generally 18 g per
cubic inch, which meets the 10 g or more per cubic inch weight minimum
for this category (see current footnote 6 in table 2 of Sec.
101.12(b)). The NHANES 2003-2008 surveys have limited consumption data
for fruitcake because there are only 24 eating occasions for fruitcake
from NHANES 2003-2008 surveys. The fruitcake petition requested a new
RACC for fruitcake and noted that fruitcake is a specialty item
consumed primarily over the holidays and that the industry has
traditionally, before mandatory nutrition labeling was implemented,
used 1\1/2\ oz as the serving size. We propose to add to proposed
footnote 5 that the serving size for fruitcake is 1\1/2\ oz because:
(1) It is a specialty item consumed primarily over the holidays; and
(2) industry has traditionally used 1\1/2\ oz as a serving size; and
    3. Establish a new product category ``Eggroll, dumpling, wonton, or
potsticker wrappers'' with a RACC of 20 g. The proposed label statement
is ``---- sheet (g)'' or ``---- wrapper (g).'' Wrappers for eggrolls,
dumplings, wontons, or potstickers are generally used as ingredients to
make eggrolls, dumplings, wontons, and potstickers. Eggrolls,
dumplings, wontons, and potstickers are used primarily as appetizers.
Generally about 1 eggroll, 5 wontons, and 3 potstickers will make 1
serving of an appetizer with a RACC of 85 g (as discussed in this
section of the document, we are proposing a new product category for
appetizers with a RACC of 85 g). The amount of wrappers that are needed
to make 1 serving of an appetizer with a RACC of 85 g is about 20 g;
and
    4. Add ``crepes'' to the product category ``French toast, pancakes,
variety mixes,'' with a RACC of 110 g prepared for French toast,
crepes, and pancakes and 40 g dry mix for variety mixes. The new name
for this product category would be ``French toast, crepes, pancakes,
variety mixes.'' The median consumption for crepes is 101 g, and crepes
are comparable products to pancakes and French toast (e.g.,

breakfast bakery products) and are similar to pancakes without the
leavening ingredients that are used in pancakes; and
    5. Add ``pie shell'' and ``pastry sheets'' to the product category
``Pie crust'' and modify the RACC to be ``the allowable declaration
closest to an 8 square inch surface area.'' The new product category
name would be ``Pie crust, pie shell, pastry sheets (e.g., phyllo, puff
pastry sheets).'' We recognize a need to establish additional reference
amounts for crusts to provide a basis for determining serving sizes for
crusts and shells with diameters other than 8 or 9 inches. We also
propose to change the label statement for this product category to ``--
-- fractional slice(s) (---- g) for large discrete units; ---- shells
(---- g); ---- fractional ---- sheet(s) (---- g) for distinct pieces
(e.g., Pastry sheet).'' An example of a label statement for pastry
sheets would be \1/6\ of 1 sheet (---- g). This modified product
category would include, for example, miniature crusts, phyllo pastry
sheets, puff pastry, and pie crusts with a diameter of 10 inches.
Changing the RACC would make the crust and shell category consistent
with the way that pies are treated in this product category, such that
the fraction of the total pie will be equal to the same fraction of the
crust or shell plus filling. In the case of small individual units, the
serving size would be the same number of units whether filled or
unfilled. Pie shells and pastry sheets have similar dietary usage to
pie crusts as an ingredient of dessert products.
    In the ``Dairy Products and Substitutes,'' general category, we are
proposing to:
    1. Change the name of the product category ``Milk, milk-based
drinks, e.g., instant breakfast, meal replacement, cocoa'' to ``Milk,
milk-substitute beverages, milk-based drinks, e.g., instant breakfast,
meal replacement, cocoa, soy beverage'' with a RACC of 240 mL. We are
adding milk-substitute beverages to this product category because milk
and milk-substitute beverages are comparable products and consumers can
make nutrition information comparisons among these products.
Nutritionally equivalent (see Sec.  101.3(e)(2)) soy beverages are an
example of milk-substitute beverages and can be used as a substitute
for milk (Ref. 51).
    2. Change the RACC of the product category ``Yogurt'' to 170 g,
which is approximately 6 oz. The current RACC for yogurt is 225 g or
approximately 8 oz. The NHANES 2003-2008 consumption data show the
median consumption for yogurt is about 6 oz, but did not meet the 25
percent change level we are using in this proposed rule as a factor to
consider whether to update the RACCs. However, comments on the ANPRM
from the yogurt industry and the NYA citizen petition have requested
that we change the RACC for yogurt to reflect what is the most commonly
consumed in the market place. In addition, 2009-2010 AC Nielson sales
data has 6 oz containers of yogurt ranked highest among annual sales
data for yogurt. We have decided to change the RACC for yogurt based on
current consumption data, information in the NYA citizen petition,
information from industry comments on yogurt consumption, and market
trends.
    In the general category of ``Desserts'' we propose to:
    1. Change the name of the product category ``Ice cream, ice milk,
frozen yogurt, sherbet: All types, bulk and novelties (e.g., bars,
sandwiches, cones)'' to ``Ice cream, ice milk, frozen yogurt, sherbet,
frozen flavored and sweetened ice, frozen fruit juices: All types
bulk'' and change the RACC for this product category to 1 cup, as
compared to the current RACC of \1/2\ cup. We also propose to change
the label statement for this product category to ``1 cup (---- g).''
This new product category would not include ice cream novelties because
ice cream novelties are not comparable to the other products in this
product category. Ice cream novelties are often prepackaged and come in
multiple individual units per package. We received comments on the
ANPRM stating that the RACC for ice cream is ``unrealistic and
misleading.'' The comments stated that a \1/2\ cup of ice cream is
smaller than a household ice cream scoop and should be increased to an
amount people normally consume. Current consumption data for bulk ice
cream has increased to 0.875 cup, which is closer to 1 cup as compared
to the current RACC of \1/2\ cup. Bulk ice cream, ice milk, frozen
yogurt, sherbet, frozen flavored and sweetened ice, frozen fruit juices
are all comparable products and are usually all sold in the same area
of the grocery store. We propose to change the RACC to 1 cup although,
based on the calculations from the current consumption data, the
products in the original product category (which included ice cream
novelties) generally did not change by at least 25 percent; and
    2. Change the name of the product category ``Frozen flavored and
sweetened ice and pops, frozen fruit juices: All types, bulk and
novelties (e.g., bars, cups)'' to ``Ice cream, ice milk, frozen yogurt,
sherbet, frozen flavored and sweetened ice and pops, frozen fruit
juices: All types novelties (e.g., bars, sandwiches, cones, cups)'' and
change the RACC for this product category to ``\1/2\ cup--includes the
volume for coatings and wafers,'' as compared to the current RACC of 85
g. We changed the RACC from a weight measurement (grams) to a volume
measurement (cups) because of the difference in density between various
ice creams, frozen flavored and sweetened ice and pops, frozen yogurts,
and sherbets. For example, 1 cup of ice cream generally weighs about
133 g, while 1 cup of frozen yogurt generally weighs 200 g, and 1 cup
of ice pop generally weighs 254 g. However, the median consumption for
all of these products is \1/2\ cup regardless of weight. The new
product category will include ice cream, ice milk, frozen yogurt, and
sherbet novelties. Current consumption for ice cream sandwiches, bars
and cones is 68 g (about \1/2\ cup) and for frozen yogurt cones is 78 g
(about \1/2\ cup), which is similar to the consumption data for frozen
flavored novelties. Ice cream, ice milk, frozen yogurt, and sherbet
novelties are more comparable with frozen flavored novelties than they
are with bulk ice creams, ice milks, frozen yogurts, and sherbets; and
are usually sold in the same area of the grocery store as the other
products listed in this product category; and
    3. Change the RACC for the product category ``Custard, gelatin, or
pudding'' to ``\1/2\ cup prepared; Amount to make \1/2\ cup prepared
when dry.'' The current RACC for this category is ``\1/2\ cup.''
Custard powder, gelatin, and pudding powder are often used to make
custard, gelatin, and pudding desserts. There is currently a RACC for
the prepared version of these products, but not the dry form used in
preparation mixtures.
    In the general category of ``Dessert Toppings and Fillings'' we
propose to:
    1. Change the weight-based RACC for the product category of ``Cake
frostings or icings'' with a RACC of 35 g to a volume-based RACC of 2
tbsp. The RACC of 35 g does not take into account whipped frosting and
icings that may not weigh 35 g. Changing to a volume based reference
amount would allow for consistency in the category and allow comparison
of nutrition information for these products based on the same RACC.
    In the general category of ``Egg and Egg Substitutes'' (proposed to
be renamed as the general category of ``Egg and Egg Substitutes'' as
discussed as follows), we propose to:
    1. Change the name of the product category ``Egg Substitutes''
(which has a RACC of ``An amount to make 1 large

(50 g) egg'') to ``Egg whites, sugared eggs, sugared egg yolks, and egg
substitutes (fresh, frozen, dried).'' The median consumption for egg
white, sugared egg, and sugared egg yolk is 64 g. Egg white, sugared
egg, and sugared egg yolk are comparable products and can be used as a
substitution of a whole egg.
    In the general category of ``Fish, Shellfish, Game Meats, and Meat
or Poultry Substitutes,'' we propose to:
    Add ``seafood'' to the product category ``Substitute for luncheon
meat, meat spreads, Canadian bacon, sausages and frankfurters,'' which
has a RACC of 55 g. The median consumption for seafood substitutes is
60 g. The new name for the product category would be ``Substitute for
luncheon meat, meat spreads, Canadian bacon, sausages, frankfurters,
and seafood.'' Seafood substitutes are comparable products to other
products in this product category.
    In the current general category of ``Miscellaneous Category''
(proposed to be renamed as the general category of ``Miscellaneous'' as
discussed in section II.F.3.), we propose to:
    1. Establish a new product category for ``Cocoa powder, carob
powder, unsweetened'' with a RACC of 1 tbsp. The proposed label
statement is 1 tbsp (---- g). Unsweetened cocoa powder or baking cocoa
is a dry, unsweetened, chocolate-flavored powder that is often used as
an ingredient in various recipes, including cakes, brownies, and
cookies. Because it is an ingredient, there is no direct consumption
data from the NHANES 2003-2008 surveys. Carob powder is used as a
substitution for unsweetened cocoa powder in baking; thus, it has
similar dietary usage to unsweetened cocoa powder (Ref. 51). Examining
a variety of chocolate cake recipes (Ref. 52), the weight of baking
cocoa powder ranges from 3 g to 5 g to make a reference amount of 55 g
for chocolate cake without icing or filling; and
    2. Change the name of the product category ``Drink mixers (without
alcohol)'' to ``Milk, milk substitute, and fruit based drink mixes
(without alcohol): (e.g., drink mixers, fruit flavored powdered drink
mixes, sweetened cocoa powder)'' with a RACC of ``Amount to make 240 mL
drink (without ice).'' The NHANES 2003-2008 consumption data show that
the median intake estimate for milk-substitute beverages is 184 g
(about 6 fl oz). Based on the Gladson database, the majority of
products are using 8 fl oz or 1 cup as the serving size on the label.
This proposed RACC is the same as the RACC for comparable products
(i.e., milk, milk-based drinks, fruit juices, and fruit drinks). This
new product category includes products that were not included in the
1993 serving size final rule. The 1993 serving size final rule includes
prepared versions of the products in this category, but not the dry
forms used to make the prepared beverages. We propose to establish a
label statement for this product category of ``---- fl oz (---- ml), --
-- tsp (---- g), ---- tbsp (---- g)''; and
    3. Establish a new product category ``Drink mixes (without
alcohol): all other types (e.g., flavored syrups and powdered drink
mixes'' with a RACC of ``Amount to make 360 mL drink (without ice).''
This new product category includes products that were not included in
the 1993 serving size final rule. The 1993 serving size final rule
includes prepared versions of these products in the ``Beverages''
general category, but not the dry forms used to make the prepared
beverages. The current RACC for the ``Beverages'' general category is
240 mL. We are proposing to change the RACC for ``Beverages'' to 360
mL. The products in this proposed product category are comparable to
the products in the ``Beverages'' general category. We also propose to
establish a label statement for this product category of ``---- fl oz
(---- mL), ---- tsp (---- g), ---- tbsp (---- g)''; and
    4. Establish a new product category ``Seasoning oils and seasoning
sauces (e.g., coconut concentrate, sesame oil, almond oil, chili oil,
coconut oil, walnut oil)'' with a RACC of 1 tbsp. This product category
includes flavorings, seasonings and spices that are in a liquid form
and are primarily used as ingredients in a product, rather than as
sauces or dips with finished foods. Coconut concentrate is an extract
of the cooked mixture of water and coconut meat, which is often used as
an ingredient of a sauce or dressing (such as curry sauce) (Ref. 51).
The reasonable consumption amount for the flavoring oils (sesame oil,
almond oil, coconut oil, and walnut oil) is 13.6 g (about 1 tbsp) based
on the FNDDS (Ref. 42). We also propose to establish a label statement
for this product category of 1 tbsp (---- g); and
    5. Establish a new product category ``Seasoning pastes (e.g.,
garlic paste, ginger paste, curry paste, chili paste, miso paste, fresh
or frozen)'' with a RACC of 1 teaspoon (tsp). This product category
includes seasonings and spices that are in a paste form and are
primarily used as ingredients (such as miso in making miso soup),
rather than as sauces or dips for finished foods. The current median
intake estimate is 4 g. The reasonable consumption amount for miso
paste, which is an example product in this product category, is 3 g
(about 1 tsp). We also propose to establish a label statement for this
product category of 1 tsp (---- g).
    In the general category of ``Mixed Dishes,'' we propose to:
    1. Change the name of the product category ``Not measurable with
cup, e.g., burritos, egg rolls, enchiladas, pizza, pizza rolls, quiche,
all types of sandwiches'' to ``Not measurable with cup, e.g., burritos,
enchiladas, pizza, pizza rolls, quiche, sandwiches.'' We are proposing
to include smaller sized versions of some of these products in a new
appetizer product category. Smaller versions of these products are
primarily used as appetizers, while products in the mixed dish category
are primarily used as entrees or main dishes. We have updated the
category name to reflect the change; and
    2. Establish a new product category for ``Appetizers, hors
d'oeuvres, mini mixed dishes, e.g., mini bagel pizzas, breaded
mozzarella sticks, egg rolls, dumplings, potstickers, wontons, mini
quesadillas, mini quiches, mini sandwiches, mini pizza rolls, potato
skins,'' with a RACC of 85 g, add 35 g for products with gravy or sauce
topping. The new ``Appetizers, hors d'oeuvres, mini mixed dishes''
product category would contain products that are not included in table
2 of Sec.  101.12(b). The products in this new product category (e.g.,
mini pizza rolls) are similar to those found in a category in USDA's
Guide to Federal Food Labeling Requirements for Meat and Poultry
Products (USDA's Guide) (Ref. 59), which provides a RACC of 85 g for
``Appetizers hors d'oeuvres, mini eggrolls, mini pizza rolls, bagel
pizza with meat or poultry.'' The USDA products are mostly the same as
the products being proposed in our new ``Appetizers, hors d'oeuvres,
mini mixed dishes'' product category, except that the USDA products
always contain meat. The median consumption for mini pizza rolls is 83
g and for egg rolls is between 57 and 59 g. Additionally, all of the
products in this proposed ``Appetizers, hors d'oeuvres, mini mixed
dishes'' product category are comparable in their usage. Therefore, we
propose a RACC of ``85 g add 35 g for products with gravy or sauce
topping'' for this product category, which is consistent with USDA's
RACC for ``Appetizers hors d'oeuvres, mini eggrolls, mini pizza rolls,
bagel pizza with meat or poultry,'' which will allow consumers to
compare nutrition information across food labels for these types of
products. The addition of 35 g sauce is calculated proportionally by
the

weight of the RACC for the product category ``Mixed Dishes not
measurable with cup'' where the addition of 55 g of sauce is used for
the 140 g of RACC. We propose that an individual unit in this new
product category should not weigh more than 85 g, or it would not be
considered an appetizer, hors d'oeuvre, or mini mixed dish. For
example, if an individual eggroll were to weigh more than 85 g, it
would be appropriate to use the RACC from the general category ``Mixed
Dishes'' and the product Category ``Not measurable with cup.'' We also
propose to establish a label statement for this product category of --
-- pieces(s) (---- g).
    In the general category of ``Sauces, Dips, Gravies and
Condiments,'' we propose to:
    1. Add ``Alfredo sauce'' to the product category ``Minor main
entr[eacute]e sauces (e.g., pizza sauce, pesto sauce)'' with a RACC of
\1/4\ cup. The new product category name would be ``Minor main
entr[eacute]e sauces (e.g., pizza sauce, pesto sauce, Alfredo sauce),
other sauces used as toppings (e.g., gravy, white sauce, cheese sauce),
cocktail sauce.'' Alfredo sauce is mixed with and coats a pasta product
(Ref. 51). This dietary usage is similar to that of pesto sauce in the
``Minor main entr[eacute]e sauces'' product category.
    In the general category of ``Soups,'' we propose to:
    1. Establish a product category ``Dry soup mixes, bouillon.'' The
RACC for this category would be the ``Amount to make 245 g.'' Bouillon
and dry soup mixes are often used to make soups and broths (Ref. 51).
There is currently a RACC for the prepared version of these products,
but not the dry form used in preparation mixtures. The RACC for soups
is 245 g. We also propose to establish a label statement for this
product category of ---- cup (---- g); ---- cup (---- mL).
    In the general category of ``Sugars and Sweets,'' we propose to:
    1. Establish a new product category ``After-dinner
confectionaries'' with a RACC of 10 g. We reviewed consumption data
from the NHANES 2003-2008 surveys to determine whether a change in the
RACC for Andes mint wafers and other after-dinner confectionaries, as
requested in the Andes petition, was warranted. These types of candies
are currently included in the ``All other candies'' product category.
Because there are no intake data available from the NHANES 2003-2008
surveys to determine intake estimates for after-dinner confectionaries,
we relied on industry product information available through the Gladson
and Mintel databases (Refs. 55 and 56). These databases are
comprehensive and include label information for products currently on
the market. The databases indicated that products marketed as ``after-
dinner confectionaries'' or comparable candy products ranged in weight
from approximately 2 to 12 g per piece. According to the serving size
information on after-dinner confectionary product labels in the Gladson
and Mintel databases, the weight of an individual piece varies
considerably among the different products in this category. To avoid
having the serving size of the larger size products expressed as a
faction of a piece, we propose that all products marketed as after-
dinner confectionaries (or after-dinner mints) should have the same
RACC of 10 g, which is slightly smaller than the 15 g RACC requested in
the Andes petition. We also propose to establish a label statement for
this product category of ---- piece(s) (---- g);
    2. Add ``powdered candies'' and ``liquid candies'' to the product
category ``Hard candies, others'' with a RACC of 15 mL for liquid
candies and 15 g for all others. We propose to rename the product
category to ``Hard candies, others; powdered candies, liquid candies''
to indicate that powdered and liquid candies would be added to this
product category. After publication of the 1993 serving size final
rule, two manufacturers asked that powdered candies, which are
frequently sold in straws or small packets, be included in the ``Hard
candies, others'' product category with a RACC of 15 g (Refs. 9 and
10). One manufacturer also asked to classify liquid candy (which is
very sweet and frequently sold in wax containers containing syrup or
flavored liquid) in the ``Hard candies, others'' product category with
a RACC of 15 mL. The manufacturers stated that 15 g (or 15 mL) was a
more reasonable RACC than 40 g in the ``All other candies category.''
We suggested that manufacturers use a RACC of 15 g for flavored and
colored powdered candies and 15 mL for syrup-filled wax liquid candies
(Refs. 60 and 61). In ``Guidance for Industry: A Food Labeling Guide''
(Question L62), we listed 15 g as the suggested RACC for powdered,
flavored candy and 15 mL as the suggested RACC for colored, flavored
syrup-filled wax candy (Ref. 58). There are no median intake estimates
for either powdered or liquid candies and the mean intake estimate for
liquid candies is 13 g in the NHANES 2003-2008 surveys. Based on
product label information from the Mintel database, 15 g has been used
for various powdered candy products, and 20 mL has been used for wax
candies. Because powdered and liquid candies are used comparably, we
propose to establish RACCs of 15 g for powdered candies and 15 mL for
liquid candies and to add them to the ``Hard candies, others'' product
category. These are the same RACCs we suggested in 1993 that
manufacturers should use, and which are listed in our ``Guidance for
Industry: A Food Labeling Guide'' (Question L62) (Ref. 58). We also
propose to establish a label statement ---- piece(s) (---- g) for large
pieces; ---- tbsp(s) (g) for ``mini-size'' candies measurable by tbsp;
---- straw(s) (---- g) for powdered candies; ---- wax bottle(s) (----
mL) for liquid candies; and 1/2 oz (14 g/visual unit of measure) for
bulk products; and
    3. Add ``fruit paste and fruit chutney'' to the product category
``Honey, jams, jellies, fruit butter, molasses'' with a RACC of 1 tbsp.
The new product category name would be ``Honey, jams, jellies, fruit
butter, molasses, fruit paste, fruit chutney.'' The current median
consumption for fruit chutney and fruit paste is similar to the 1 tbsp
RACC used for the product category ``Honey, jams, jellies, fruit
butter, molasses.'' Fruit chutneys and fruit pastes have similar
dietary usage to jams, jellies, and fruit pastes, as all can be used to
spread on breads (Ref. 51).
    In the general category of ``Vegetables,'' we propose to:
    1. Change the name of the product category ``Chili pepper, green
onion'' to ``Fresh or canned chili peppers, jalapeno peppers, other hot
peppers, green onion.'' Jalapeno pepper and other hot peppers are
comparable products to chili peppers;
    2. Establish a new product category for ``Dried vegetables, dried
tomatoes, sun-dried tomatoes, dried mushrooms, dried seaweed'' with a
RACC of 5 g, add 5 g for products packaged in oil. We also propose to
establish a label statement for this product category of ``----
piece(s); \1/3\ cup (---- g).'' The median intake estimate from the
NHANES 2003-2008 consumption data for dried vegetables is about 2 g and
6 g for dried tomatoes. One cup of dried seaweed weighs 15 g. Dried
vegetables, dried tomatoes, sun-dried tomatoes, dried mushrooms, and
dried seaweed are comparable products. Sun-dried tomatoes are dried
tomatoes and are often packed in oil (Ref. 51). One tsp of oil weighs
about 5 g;
    3. Establish a new product category ``Dried seaweed sheets'' with a
RACC of 3 g. We also propose to establish a label statement for this
product category of ---- piece(s) (---- g); cup(s) (---- g). Industry
uses 2.5 g to 3 g per sheet, with

one sheet per serving, on the product labels and the current suggested
RACC for dried seaweed sheets is 3 g in our guidance ``Guidance for
Industry: A Food Labeling Guide'' (Ref. 58); and
    4. Establish a new product category ``Sprouts, all types: fresh or
canned'' with a RACC of 10 g. The median intake estimate from the
NHANES 2003-2008 consumption data for all sprouts, is 14 g. However,
because there is a large variation in the density (i.e., the gram
weight per cup) for various types of sprouts, we propose to establish a
RACC of \1/4\ cup for this new product category. We also propose a
label statement for this product category of ``\1/4\ cup (---- g).''
    We also considered modifying the RACCs for burritos, pizza and
sandwiches. We note that burritos, pizza, and sandwiches appear to be
commonly consumed products, as demonstrated by their relatively large
sample sizes in the NHANES 2003-2008 surveys. The intake distributions
for burritos, pizza, and sandwiches are not considered skewed, and
although the median intake estimates from the NHANES 2003-2008
consumption data for burritos, pizza, and sandwiches products are 184
g, 172 g, and 170 g, respectively, they are not significantly different
from the 1993 RACC of 140 g (Refs. 46 and 50). Therefore, we are not
proposing to change to the 1993 RACC. However, the median intake
estimates from the NHANES 2003-2008 surveys are higher for these
products compared to the median intake estimates from the NHANES 2003-
2008 surveys for other comparable products (e.g., Turnovers, 142 g;
other mixed dishes, 149 g) in the same product category ``Mixed dishes
not measureable with cup.'' Therefore, we invite comment on whether the
current RACC for these products should be increased, and if so, by what
amount.
4. Products of Concern Listed in Consumer Comments--Agency Request for
Information
    The majority of consumer comments on the ANPRM stated that the food
labels on the following foods are misleading and recommended that the
serving size be increased: 20 fluid oz bottles of carbonated beverages,
canned soup, snack size packages of potato chips and pretzels (e.g.,
salty snacks), fruit juice, microwave popcorn, canned chili, shelled
nuts, iced tea, TV dinners, energy drinks, canned ravioli, 5-inch
pizzas, dairy beverages, pre-packaged lunches, vending machine items,
breakfast cereals, macaroni and cheese, cookies, crackers, ice cream,
coffee creamer and muffins. Most of these foods did not have a change
in consumption of at least 25 percent, which is a factor we consider in
this rule to update the RACC. Although the proposed rule would not
change the RACC for most of these products, we feel that the comments'
concerns have been addressed with the proposed definition of single-
serving containers and the proposed requirements for dual-column
labeling. The proposed requirements would allow for products that
contain less than 200 percent of the RACC to be labeled as a single-
serving container and for products that contain 200 percent and up to
and including 400 percent of the RACC to be labeled with dual-column
labeling that would provide nutrition information per serving and per
container in the Nutrition Facts label. The majority of the products of
concern listed above would meet either of the proposed requirements for
single-serving containers or dual-column labeling.
    We invite comment on whether we should change the RACC for foods in
these categories due to consumer concern of misleading label
information. If so, which foods should we change? What factor(s) should
we use to determine when these foods should be changed? Are there any
data available to support a change in the RACCs of these foods?
Additionally, to the extent that some comments may be concerned about
misleading package sizes when compared to labeled serving sizes, as
opposed to being concerned with the appropriate serving size for
specific food products within a product category, we invite comment on
whether the proposed requirements for single serving and dual-column
labeling alleviate the comments' concerns.
5. Impact of Changes in RACCs on the Eligibility of Nutrient Content
Claims and Health Claims
    We recognize that changes to the serving size regulations,
especially updating the RACCs, could affect the eligibility of
individual foods to bear nutrient content claims or health claims. The
amount of a nutrient that is the subject of a nutrient content claim or
health claim is typically calculated on a per RACC basis. For example,
for individual foods (i.e., foods that are not meal products or main
dish products) that have RACCs greater than 30 g or greater than 2
tbsp, to be eligible to bear a ``low fat'' nutrient content claim, the
food must meet the criterion of 3 g of total fat or less per RACC
(Sec.  101.62(b)(2)(i)(A)). Using the health claim on intake of sodium
and reduced risk of hypertension as an example, the levels of sodium in
an individual food eligible to bear the claim must meet the criterion
of ``low sodium'' claim under Sec.  101.61(b)(4), which contains
specific requirements respecting maximum amounts of sodium per RACC for
various foods eligible to bear the claim (see Sec.  101.74(c)(2)(ii)).
    We are 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. For example, an individual food with a total fat value of 3 g
of total fat per \1/2\ cup serving may have been eligible for a ``low
fat'' claim with the existing RACC, but if the RACC increases to 1 cup,
the food would have a total fat value of 6 g total fat per RACC and
would no longer be able to be considered ``low fat.'' Additionally, we
are aware that individual foods that are currently ineligible to bear
certain claims may potentially become eligible to bear such claims if
their RACCs change. For example, foods that are currently ineligible
for a ``good source of calcium'' claim (Sec.  101.54(c)) at the current
RACCs may be able to meet the specific criterion in the regulations if
their RACCs increased in size, causing the food to have an accompanying
increase in the calcium levels per RACC. Another example is that
individual foods that are currently ineligible for a ``low sodium
claim'' may be able to meet the specific criterion in the regulations
if their RACCs are decreased in size, causing the food to have an
accompanying decrease in the sodium levels per RACC.
    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 as
well. For example, the levels of total fat, saturated fat, cholesterol,
and sodium that trigger the need for a disclosure statement for
individual foods bearing a nutrient content claim are on a per RACC and
per labeled serving basis (Sec.  101.13(h)). The disclosure levels for
most foods are 13.0 g of total fat, 4.0 g of saturated fat, 60 mg of
cholesterol, and 480 mg of sodium per RACC. Foods that currently bear
nutrient content claims and do not exceed the disclosure values per
RACC would not need to include any disclosure statement; however, if
the RACC for that food were to increase, and values for total fat,
saturated fat, cholesterol, or sodium per RACC were also to increase,
the food may then potentially be required to bear a disclosure
statement. Further, the same levels of total fat, saturated fat,
cholesterol, and sodium per RACC that trigger the need for a disclosure

statement on certain products bearing nutrient content claims, also
disqualify certain foods from making any health claims (Sec.
101.14(a)(4)). Therefore, an increase in a RACC with an accompanying
increase in nutrient value per RACC could potentially disqualify that
food from bearing a health claim. To bear a health claim, foods must
also generally contain a minimum of 10 percent or more of the DV for
one of the following nutrients: Vitamin A, vitamin C, iron, calcium,
protein, or dietary fiber per RACC (Sec.  101.14(e)(6)). Changes to the
RACCs could affect whether a food is able to meet this requirement. An
increase in a RACC could cause a food to be able to meet the minimum
nutrient content requirement, while a decrease in a RACC could cause a
food to have decreased nutrient values per RACC and potentially lose
its' ability to bear a health claim based on minimum nutrient content
requirements.
    Although changes to the existing RACCs have the potential to impact
individual foods' eligibility to bear nutrition claims, changes in the
eligibility to bear claims may be appropriate in light of the changes
in the amounts of food being customarily consumed. It is difficult to
fully understand any potential impacts of changes to the RACCs on the
eligibility to bear claims until such time that rulemaking for both
serving sizes and updating the Nutrition Facts label are finalized. We
are inviting comment on any concerns related to changes to current
claims used on specific foods that will be affected if RACCs are
finalized as proposed.
6. Request To Establish a New 25 g RACC for Candies Weighing 20 g or
Less
    As discussed in section I.D.3.e., two trade associations
representing chocolate and confectionary companies jointly submitted a
citizen petition (the CMA/NCA petition) to FDA. The petitioners
requested that we amend the ``Sugars and Sweets'' general category by
establishing a new 25 g RACC for candies (other than hard candies or
baking candies) weighing 20 g or less per piece.
    Because the national food consumption data (i.e., from the NHANES
2003-2008 surveys) upon which we primarily rely to establish RACCs
generally does not capture data for different sizes of candy products,
we cannot establish a new candy product category with a RACC of 25 g
for candies weighing 20 g or less per piece, as requested in the CMA/
NCA petition. NHANES is designed to provide total intake amounts per
eating occasion for different types of products. If the total
consumption amount of a chocolate candy bar was 100 g, we would not be
able to discern whether this amount was derived from 1 large-size candy
bar weighing 100 g, or from 10 mini-sized bars weighing 10 g each.
Therefore, we do not have data to support basing the RACC on the weight
of individual pieces of candy, as requested in the petition.

E. Establishing a New Serving Size for Breath Mints

    As discussed in section I.D.3.F., we received a petition from a
breath mints manufacturer requesting that we create a separate product
category with a 0.5 g RACC for small breath mints (weighing 0.5 g or
less). The petitioner also specified that the serving size for small
breath mints should be ``one mint.'' In response to this petition, we
published the 1997 breath mints proposed rule (62 FR 67775), which
would require that the label serving size of products included in the
product category ``Hard candies, breath mints'' be one unit. However,
we determined that it would not be appropriate to establish a separate
0.5 g RACC for small breath mints because there was insufficient
evidence for revising the current RACC of 2 g for breath mints. Because
we are addressing issues related to the label serving size for breath
mints, in conjunction with other serving size issues, in this proposed
rule, we are withdrawing the 1997 breath mints proposed rule elsewhere
in this issue of the Federal Register.
    Consumption of breath mints cannot be determined using NHANES 2003-
2008 consumption data, which provide the most recent national food
consumption data available to us. This is because a specific category
for breath mints does not exist in the FNDDS to process and analyze
dietary intake data for the NHANES 2003-2008 surveys. Rather, breath
mints are included as part of the large ``hard candy'' group (food code
91745020), which contains approximately 50 items. However, the
reasonable consumption amount for breath mints in the FNDDS database is
2 g for one-piece breath mints. Further, based on the Mintel and
Gladson databases (large commercial databases containing full product
details on currently available product packages), we determined that
the median estimate of the gram weight distribution of breath mints
from these databases is 3 g and 2 g, respectively (Ref. 62). Therefore,
we have determined that 2 g remains an appropriate RACC for the product
category ``Hard candies, breath mints.''
    Although the 2 g RACC for ``Hard candies, breath mints'' remains
reasonable, we share concerns about the apparent inappropriateness of
the resulting serving sizes on the labels of small and very small
breath mints when the 2 g RACC is used to determine the serving size
(e.g., 5 small breath mints or 15 very small breath mints per serving).
The data submitted to us through the citizen petition suggests that
these products were designed to be consumed singly or in small numbers
and that consumers do, in fact, customarily consume such amounts
(Docket No. FDA-1994-P-0314, formerly Docket No 94P-0168). Requiring
the serving size on the label of all breath mints to be declared as one
mint (or one unit) would more accurately reflect the amount customarily
consumed across a wide variety of breath mint sizes that are
commercially available.
    Therefore, using a label statement of one unit for the serving size
of all breath mints is more appropriate than declaring the serving size
in terms of the number of mints closest to the 2 g RACC, because the
RACC of 2 g for all breath mint products does not specifically
represent the amount customarily consumed per eating occasion for small
breath mints and very small breath mints. This action would allow for
efficient enforcement of the FD&C Act by maintaining one subcategory in
table 2 of Sec.  101.12(b) for all breath mints, while requiring the
label statement for the serving size to accurately reflect the amount
customarily consumed. Thus, we are proposing to amend footnote 9 (which
we are proposing to redesignate as footnote 8 in this rule) of table 2
in Sec.  101.12(b) to state that ``Label serving size for ice cream
cones, eggs, and breath mints of all sizes will be 1 unit . . .'' while
keeping 2 g as the reference amount for the product category ``Hard
candies, breath mints.''

F. Comparison of Calories in Foods of Different Portion Sizes

    As noted in the ``Calories Count'' report (Ref. 1), the Federal
Trade Commission has suggested that we consider ``allowing food
marketers to make truthful, non-misleading label claims comparing foods
of different portion sizes.'' An example of this type of claim would
be: ``This 4 ounce container of yogurt has 25 percent less calories
than our 6 ounce container of yogurt.''
    In the ANPRM, we invited comment on whether it would be confusing
to consumers to have claims made only on the basis of the difference in
the amount

of calories in two different labeled serving sizes (i.e., the serving
size specified in two different Nutrition Facts labels (e.g., an 8 fl
oz can of soda versus a 12 fl oz can of soda) or two different portions
(i.e., amounts specified by the claim, e.g., one 15 g cookie versus two
15 g cookies) of the same food. We also invited comment on other
questions related to this issue, but we received no comments on these
other issues.
    Several comments indicated that we should not allow comparison of
calories to be made among foods of different portion sizes as this
would increase confusion. Some comments suggested that we increase
consumer education on serving sizes instead. Other comments noted that
basing differences in calories on two different label servings or two
different portions would be confusing to consumers and serve no
constructive purpose. One comment noted that calorie claims would
probably be confusing to consumers on bulk-type packages, where
consumers portion out their own serving. However, this comment noted
that if claims were made on single-serving containers, where portion
size is determined by the manufacturer, they could be less confusing
and more helpful to consumers. The comment stated that calorie
differences between choosing an 8 fl oz can of soda versus a 12 fl oz
can of soda could be more apparent to consumers if comparison claims
were allowed.
    We agree with the comments that stated consumer education on
serving sizes should be increased. We consider it appropriate to
provide consumers with education and outreach on serving size issues
and will consider appropriate education methods after publication of
this proposed rule. At this time, we do not see the need to propose
specific regulations for the use of calorie comparison claims, because
our current regulations do not expressly prohibit such claims. In fact,
Sec.  101.13(i) allows for the use of quantitative nutrient content
claims that allow for statements about the amount or percentage of a
nutrient. We also note that under section 403(a) of the FD&C Act, a
food is deemed misbranded if its labeling is deemed false or misleading
in any particular. As such, we would look at any calorie comparison
claims on a case-by-case basis to determine if they were false or
misleading as used in the particular labeling.

G. Technical Amendments

1. Rounding Rules for Products That Have More Than Five Servings and
the Number of Servings Falls Exactly Between Two Values
    Section 101.9(b)(8)(i) does not state how to round the number of
servings for products that contain five or more servings when the
number of servings falls exactly between two values. To provide clarity
to manufacturers whose products have a number of servings that falls
exactly between two values and is greater than five, proposed Sec.
101.9(b)(8)(i) would add that ``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.''
2. Options for When the Number of Servings per Container Varies
    Section 101.9(b)(8)(iii) states that, for random weight products, a
manufacturer may declare ``varied'' for the number of servings per
container provided the nutrition information is based on the reference
amount expressed in ounces. In addition, the manufacturer may provide
the typical number of servings in parenthesis following the ``varied''
statement, e.g., ``varied (about 6 servings).'' We intended that the
term ``random weight product'' refer to products such as certain
cheeses that are sold as random weights that vary in size, such that
the net contents for different packages would vary (56 FR 60394 at
60412). The serving size for this type of product would be declared on
the label as the number of ounces closest to the RACC for the product
category with an accompanying visual unit of measure (Sec.
101.9(b)(5)(iii) (e.g., ``1 oz (28 g/1-inch cube) for bulk cheese)).''
    We have identified several difficulties with Sec.  101.9(b)(8)(iii)
because: (1) There is no clear definition for which specific products
are included in the designation of ``random weight products;'' (2) the
requirement that nutrition information be based on the RACC expressed
in ounces is confusing because, although serving sizes may be declared
in ounces under certain occasions, none of the RACCs are expressed in
ounces; (3) the ounce declaration is the last option in the hierarchy
of household measures for expressing the serving size (Sec.
101.9(b)(5)(i), (b)(5)(ii), and (b)(5)(iii)); and (4) it would not
necessarily be appropriate for all random weight products to list the
serving size in ounces. For example, for a random-weight, multi-serving
package of cooked shrimp or crabs, it would be more appropriate to
declare the serving size as ``---- shrimp (---- g)'' or ``1 crab (----
g),'' and the number of servings would vary depending on the amount of
shrimp or number of crabs in the package.
    To resolve these difficulties, we propose to amend Sec.
101.9(b)(8)(iii) to: (1) Define ``random-weight products;'' and (2)
eliminate 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.''
3. Minor Corrections to General and Product Category Names
    We propose 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. The
proposed rule would:
     Change the name of the general category ``Egg and Egg
Sustitutes'' to ``Egg and Egg Substitutes'' to correct the error in the
current spelling;
     Change the general category name ``Miscellaneous
Category'' to ``Miscellaneous'' to be consistent with the manner in
which the other general category names are titled;
     In the general category of ``Sauces, Dips, Gravies, and
Condiments,'' add ``tomato chili sauce'' to the product category name
``Barbeque sauce, hollandaise sauce, tartar sauce, other sauces for
dipping (e.g., mustard sauce, sweet and sour sauce), all dips (e.g.,
bean dips, dairy-based dips, salsa).'' Tomato chili sauce was included
in the initial data analysis for this category, but was accidentally
omitted from the category name in the codified text of the 1993 serving
size rule. The modified product category would help clarify that
although hot chili sauce belongs with hot sauces in the ``Minor
condiments, e.g., hot sauce . . .'' category, tomato chili belongs in
the ``Barbecue sauce, . . . tomato chili sauce . . .'' category;
     Also in the general category of ``Sauces, Dips, Gravies,
and Condiments,'' correct an error in the product category name ``Minor
condiments, e.g., horseradish, hot sauces, mustards, worcestershire
sauce.'' The new product category name would be ``Minor condiments,
e.g., horseradish, hot sauces, mustards, Worcestershire sauce.''
``Worcestershire'' should be capitalized

in the category name and is currently listed in lower case;
     In the general category of ``Snacks,'' correct three
errors in the product category name ``All varieties, chips, pretzels,
popcorns, extruded snacks, fruit-based snacks (e.g., fruit chips,)
grain-based snack mixes.'' First, there is a comma listed in the
parenthesis as follows ``(fruit chips,)'' that should be listed outside
of the parenthesis as follows ``(fruit chips),''. Second, the product
category name ``Fruit-based snacks'' should be changed to ``fruit and/
or vegetable-based snacks'', since these products can be made from
fruits and/or vegetables. Finally, the word ``popcorns'' should be
corrected to be written as ``popcorn'';
     In the general category of ``Vegetables,'' clarify the
products that are encompassed in the product category ``Pickles, all
types'' by renaming the product category to read as ``Pickles and
pickled vegetables, all types.'' The current product category of
``Pickles, all types'' includes all types of pickled vegetables. This
minor change will clarify this fact and should help manufacturers more
easily locate the appropriate product category for these types of
products;
     Also in the general category of ``Vegetables,'' clarify
that parsley (an example of an herb used for garnish or flavor) can be
in fresh or dried form in the product category ``Vegetables primarily
used for garnish or flavor, e.g., pimento, parsley.'' The new product
category name would be ``Vegetables primarily used for garnish or
flavor, (e.g., pimento, parsley, fresh or dried);'' and
     Change the product category ``Toaster pastries--see coffee
cakes'' to ``Toaster pastries--see bagels, toaster pastries, muffins
(excluding English muffins)'' because we have proposed to move toaster
pastries to a new product category labeled ``Bagels, toaster pastries,
muffins (excluding English muffins).''
4. Minor Changes to Footnotes
    We are aware of several areas of minor confusion in the footnotes
to the RACC tables. Therefore, to reduce misunderstanding, we propose
the following minor changes to the footnotes:
     As discussed in section I.D.2 in this proposed rule, both
the 1991 serving size proposed rule and the 1993 serving size final
rule provided an extensive list of products for each product category
that manufacturers could use to determine the RACC for their specific
product. Because we intend to update the list of products for each
product category and make it available as guidance on our Web site, we
are proposing to remove footnote 4 from both tables in Sec.  101.12(b).
We are also proposing to renumber the footnotes in each table to
reflect the removal of footnote 4.
     Footnote 5 in tables 1 and 2 states that ``[t]he label
statements are meant to provide guidance to manufacturers on the
presentation of serving size information on the label, but they are not
required.'' Several manufacturers have interpreted this language
incorrectly to mean that the label statements are not required. Because
label statements do not necessarily have to use the exact wording
provided, but must contain a presentation of the serving size, the
proposed rule would correct footnote 5 (proposed footnote 4) to state
that label statements are meant to provide examples of serving size
statements that may be used on the label, but that the specific wording
may be changed as appropriate for individual products.
     Footnote 11 in Table 2 refers to products that are packed
or canned in liquid where the RACC refers to the drained solids. The
footnote is included as part of the declaration for ``Fruits for
garnish or flavor, e.g., maraschino cherries.\11\ '' The footnote was
inadvertently omitted from the declaration for the current product
category ``Vegetables primarily used for garnish or flavor, e.g.,
pimento, parsley,'' and the proposed rule would add the footnote
(proposed Footnote 10) as a superscript to the word ``pimento.''
     Footnote 13 in Table 2 refers the reader to a Federal
Register document for label statements for serving sizes for raw fruit,
vegetables, and fish. Because it is more appropriate to direct the
reader to the appendices of the Code of Federal Regulations, we are
proposing to amend footnote 13 (proposed footnote 12) to refer the
reader to the appendices of the Code of Federal Regulations.
5. Minor Changes to Table 1 in 21 CFR 101.12(b)
     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 Children 1 through 3 years of age.''
     Change the product category name ``Dinners, stews or soups
for toddlers, ready-to-serve'' to ``Dinners, stews or soups for young
children, ready-to-serve.''
     Change the product category name ``Fruits for toddlers,
ready-to-serve'' to ``Fruits for young children, ready-to-serve.''
     Change the product category name ``Vegetables for
toddlers, ready-to-serve'' to ``Vegetables for young children, ready-
to-serve.''
6. Minor Changes to Table 2 in 21 CFR 101.12(b)
     Add ``---- pieces (---- g)'' to the label statement for
the ``Fruits for garnish or flavor, e.g., maraschino cherries'' to
provide for other fruits besides cherries that can be used as a garnish
or for flavor.
     Amend the RACC for the ``French fries, hash browns, skins
or pancakes'' product category to: ``70 g prepared; 85 g for frozen
unprepared French fries''. This amendment is necessary to capitalize
the ``f'' in ``french fries.''
     Amend the product category name ``Bean cake (tofu),
tempeh'' to ``Tofu, tempeh.''
7. Reference Amounts for Products That Require Further Preparation
    Section 101.12(c)(2) states that: ``For products where the entire
contents of the package is used to prepare one large discrete unit
usually divided for consumption, the reference amount for the
unprepared product shall be the amount of the unprepared product
required to make the fraction of the large discrete unit closest to the
reference amount for the prepared product as established in paragraph
(b) of this section.''
    This provision allows the RACC to vary based on how the product is
packaged. Although the serving size routinely varies depending upon the
size of the product and how the product is packaged, the RACC, which is
the basis for claims, should not vary. Therefore, the proposed rule
would 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. Proposed Sec.  101.12(c) would state that 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. The serving size would remain the same as
described in Sec.  101.9(b)(2)(ii).

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. For combined products not in discrete units (e.g.,
peanut butter and jelly), the reference amount for the combined product
is the reference amount for the ingredient that is represented as the
main food (e.g., peanut butter) plus a proportioned amount of all minor
ingredients of foods (e.g., jelly) (Sec.  101.12(f)(1)). For combined
products where the main ingredient is in discrete units (e.g., pancakes
and syrup, cake packaged together with frosting), the reference amount
for the combined product is either the number of small discrete units
(e.g., pancakes) or the fraction of the large discrete unit (e.g.,
cake) that is represented as the main ingredient that is closest to the
reference amount for that ingredient plus proportioned amounts of all
minor ingredients (e.g., syrup, frosting) (Sec.  101.12(f)(2)).
    Although the serving size for this type of product varies depending
on the size of the product or how the product is packaged, the RACC,
which is the basis for claims, should not vary. Section 101.12(f)
allows the RACCs to vary based on the size of the discrete units. For
example, for combined products with the main ingredient in discrete
units (e.g., pancakes packaged with syrup where pancakes are the main
ingredient), the current regulation requires that the RACC for the
combined product be based on the weight of the discrete units (e.g.,
the weight of the pancakes) which varies, rather than on the reference
amount for pancakes, which does not vary.
    Therefore, the proposed rule would change the definition of the
RACC for this type of product in proposed Sec.  101.12(f) so that it
will not affect the serving size declaration on the label. The proposed
rule would state that the reference amount for the combined products
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, cakes) plus proportioned amounts of all
minor ingredients. The serving size would remain the number of discrete
units (e.g., pancakes) or the fraction of a large discrete unit (e.g.,
cake) plus the proportioned minor ingredients closest to the RACC of
the combined product.
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
where there is no appropriate reference amount. The current language in
Sec.  101.9(h)(3)(ii) states that 8 fluid ounces may be used as the
standard serving size for beverage varieties or assortments in gift
packages. We are proposing conforming amendments to this section to
state that 12 fluid ounces 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 fluid ounces. This
change is consistent with the changes to the RACCs discussed in section
II.D.2 of this rule. We are proposing to change the RACCs for the
``Carbonated and noncarbonated beverages, wine coolers, water'' and
``Coffee or tea flavored and sweetened'' product categories to 360 mL
(or 12 fluid ounces). We are not proposing to change the RACC for milk,
fruit juices, nectars, fruit drinks, and vegetable juices, which
currently have RACCs of 240 mL or (8 fluid ounces).

III. Proposed Effective and Compliance Dates

    We intend 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''
become effective 60 days after the date of the final rule's publication
in the Federal Register with a compliance date 2 years after the
effective date. We recognize that it may take industry 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 their
records of product labels and print new labels. A compliance date that
is 2 years after the effective date is intended to provide industry
time to revise labeling to come into compliance with the new labeling
requirements. We invite comment on the proposed compliance date.

IV. 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.

V. Analysis of Impacts

    We have examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4), and the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520).
    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 proposed rules on nutrition labeling in the Federal
Register. We have developed one comprehensive Preliminary Regulatory
Impact Analysis (PRIA) (Ref. 63) that presents the benefits and costs
of the two proposed nutrition labeling rules taken together; the PRIA
is available at http://www.regulations.gov (Docket No. FDA-2004-N-
0258). The full economic impact analyses of FDA regulations are no
longer (as of April 2012) published in the Federal Register but are
submitted to the docket and are available on this site. We believe that
the cumulative impact of the proposed rules on nutrition labeling,
taken as a whole, represents a 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 of the proposed rule are small,
but not negligible, and as a result we conclude that the proposed rules
on nutrition labeling, taken as a whole, would have a significant
economic impact. Section 202(a) of the Unfunded Mandates Reform Act of
1995 requires that we prepare a written statement, which includes an
assessment of anticipated costs and benefits, before proposing ``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 $141 million, using the
most current (2012) Implicit Price Deflator for the Gross Domestic
Product. We have determined that the proposed rules on nutrition
labeling, taken as a whole, meet this threshold.
    The analyses that we have performed to examine the impacts of the
proposed rules under Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the PRA (see Section V.) are included
in the PRIA and are available at http://www.regulations.gov (Docket No.
FDA-2004-N-0258). We invite comments on the PRIA.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the PRA. A description of these provisions is given in the PRIA
available at http://www.regulations.gov (Docket No. FDA-2004-N-0258)
with an estimate of the annual third-party disclosure burden. Included
in the burden 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.
    We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the 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 Reference Amounts Customarily Consumed; Serving Size for Breath
Mints; and Technical Amendments.''
    In compliance with the PRA, we have submitted the information
collection provisions of this proposed rule to OMB for review. These
requirements will not be effective until we obtain OMB approval. We
will publish a notice concerning OMB approval of these requirements in
the Federal Register.

VII. Federalism

    We have analyzed this proposed 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) . . . .''
    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
Nutrition Labeling and Education Act of 1990, Public Law 101-535, 104
Stat. 2353, 2364 (1990)).
    If this proposed rule is made final, the final rule would create
requirements that fall within the scope of section 403A(a) of the FD&C
Act.

VIII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IX. References

    We have placed the following references on display in FDA's
Division of Dockets Management (see ADDRESSES). The references may be
seen between 9 a.m. and 4 p.m., Monday through Friday. (We have
verified all the Web site addresses in the References section, but we
are not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register.)

1. Report of the Working Group on Obesity, ``Calories Count,'' March
12, 2004.
2. 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.
3. U.S. Department of Health and Human Services, National Institutes
of Health, National Heart Lung and Blood Institute, ``Portion
Distortion! Do You Know How Food Portions Have Changed in 20
Years?'' http://www.nhlbi.nih.gov/health/public/heart/obesity/wecan/portion/index.htm 2004.
4. Young, L. R., M. Nestle. ``Expanding Portion Sizes in the US
Marketplace: Implications for Nutrition Counseling,'' Journal of the
American Dietetic Association, 103:231-4, 2003.
5. Smiciklas-Wright, H., D. Mitchell, S. Mickle, J. Goldman, A.
Cook. ``Foods Commonly Eaten in the United States, 1989-1991 and
1994-1996: Are Portion Sizes Changing?,'' Journal of the American
Dietetic Association, 103:41-7, 2003.
6. Nielsen, S., B. Popkin. ``Patterns and trends in food portion
sizes, 1977-1998,'' The Journal of the American Medical Association,
289:450-3, 2003.
7. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. Dietary Guidelines for Americans, 2010. 7th Edition,
Washington, DC: U.S. Government Printing Office, December 2010.
http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm.
8. Henderson, C., Memorandum to file, ``Historical documents
requesting a new Reference Amount Customarily Consumed or to modify
an existing Reference Amount Customarily Consumed'' February 11,
2014.
9. Knupfer, D., Letter from W & F Products Inc. to FDA, March 31,
1993.
10. Mercurio, K. C., Letter from Nestle USA Inc. to FDA, May 11,
1993.
11. Park, Y., Memorandum to the file, List of products for each
product category, October 8, 1992.
12. Litner, R. J., Letter from Nutrinfo Corporation to F. E.
Scarbrough, FDA, August 24, 1994.
13. Marcouiller, S. A., Letter from Kraft Foods to F. E. Scarbrough,
FDA, June 28, 1996.
14. Flegal, K. M., M. D. Carroll, C. L. Ogden, L. R. Curtin.
``Prevalence and Trends in

Obesity Among US Adults, 1999-2008,'' The Journal of the American
Medical Association, 303:235-41, 2010.
15. Flegal, K. M., M. D. Carroll, R. J. Kuczmarski, C. L. Johnson.
``Overweight and Obesity in the United States: Prevalence and
Trends, 1960-1994,'' International Journal of Obesity and Related
Metabolic Disorders, 22:39-47, 1998.
16. Center for Disease Control and Prevention, ``Obesity and
Overweight for Professionals: Health Consequences, 2011.'' http://www.cdc.gov/obesity/causes/health.html.
17. Malnick, S. D., H. Knobler. ``The Medical Complications of
Obesity,'' QJM: Monthly Journal of the Association of Physicians,
99:565-79, 2006.
18. Center for Disease Control and Prevention, Chronic Diseases and
Health Promotion, June 8, 2011. http://www.cdc.gov/chronicdisease/overview.
19. Orpana, H. M., J. M. Berthelot, M. S. Kaplan, D. H. Feeny, B.
McFarland, N. A. Ross. ``BMI and Mortality: Results From a National
Longitudinal Study of Canadian Adults,'' Obesity, 18:214-8, 2010.
20. Rolls, B. J., E. L. Morris, L. S. Roe. ``Portion Size of Food
Affects Energy Intake in Normal-Weight and Overweight Men and
Women,'' The American Journal of Clinical Nutrition, 76:1207-13,
2002.
21. Rolls, B. J., L. S. Roe, T. V. Kral, J. Meengs, D. Wall.
``Increasing the Portion Size of a Packaged Snack Increases Energy
Intake in Men and Women,'' Appetite, 42:63-9, 2004.
22. Rolls, B. J., L. S. Roe, J. S. Meengs. ``Reductions in Portion
Size and Energy Density of Foods Are Additive and Lead to Sustained
Decreases in Energy Intake,'' The American Journal of Clinical
Nutrition, 83:11-7, 2006.
23. Kral, T. V., L. S. Roe, B. J. Rolls. ``Combined Effects of
Energy Density and Portion Size on Energy Intake in Women,'' The
American Journal of Clinical Nutrition, 79:962-8, 2004.
24. Rolls, B. J., L. S. Roe, J. Meengs. ``Larger Portion Sizes Lead
to a Sustained Increase in Energy Intake Over 2 Days,'' Journal of
the American Dietetic Association, 106:543-9, 2006.
25. 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.
26. 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.
27. Schwartz, J., C. Byrd-Bredbenner. ``Portion Distortion: Typical
Portion Sizes Selected by Young Adults,'' Journal of the American
Dietetic Association, 106:1412-8, 2006.
28. Cowburn, G., L. Stockley. ``Consumer Understanding and Use of
Nutrition Labelling: A Systematic Review,'' Public Health Nutrition,
8:21-8, 2005.
29. 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.
30. Pelletier, A. L., W. W. Chang, J. E. Delzell, J. W. McCall.
``Patients' Understanding and Use of Snack Food Package Nutrition
Labels,'' The Journal of the American Board of Family Practice,
17:319-23, 2004.
31. 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.
32. 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.
33. 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.
34. Chandon, P., B. Wansink. ``Does Food Marketing Need to Make Us
Fat? A Review and Solutions,'' Nutrition Reviews, 70:571-93, 2012.
35. Mohr, G. S., D. R. Lichtenstein, C. Janiszewski. ``The Effect of
Marketer-Suggested Serving Size on Consumer Responses: The
Unintended Consequences of Consumer Attention to Calorie
Information,'' Journal of Marketing, 76:59-75, 2012.
36. 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.
37. 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.
38. Rolls, B. J. ``The Supersizing of America: Portion Size and the
Obesity Epidemic,'' Nutrition Today, 38:42-53, 2003.
39. Young, L., M. Nestle. ``The Contribution of Expanding Portion
Sizes to the US Obesity Epidemic,'' American Journal of Public
Health, 92:246-9, 2002.
40. Zhang, Y., M. A. Kantor. ``Use and Understanding of Serving Size
Information.''Marketing & Public Policy Conference, Atlanta, GA,
June 8 2012.
41. Center for Disease Control and Prevention. National Center for
Health Statistics (NCHS), ``National Health and Nutrition
Examination Survey Data 2003-2004''. http://www.cdc.gov/nchs/nhanes/nhanes2003-2004/nhanes03_04.htm.
42. Agricultural Research Service, Food Surveys Research Group,
``U.S. Department of Agriculture, Food and Nutrient Database for
Dietary Studies, 4.1'' Beltsville, MD, 2010.
43. Center for Disease Control and Prevention, 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.
44. SAS version 9.2 Cary, NC, 2011 http://www.sas.com/technologies/analytics/statistics/stat/index.html.
45. SUDAAN version 10.1 Research Triangle Park, NC, 2011 http://www.rti.org/sudaan/.
46. Juan, W., Memorandum to file: ``Consumption estimates for foods
for infants and children 1 through 3 years of age and for the
general food supply for individuals ages 4 years and older in the
United States by general category and product category using data
from the National Health and Nutrition Examination Survey, 2003-2008
(NHANES 2003-2008) compared to the 1993 RACCs, and Proposed Changes
to RACCs,'' February 11, 2014.
47. Raper, N., B. Perloff, L. Ingwersen, L. Steinfeldt, J. Anand.
``An Overview of USDA's Dietary Intake Data System,'' Journal of
Food Composition and Analysis, 17:545-55, 2004.
48. Moshfegh, A. J., D. G. Rhodes, D. J. Baer, T. Murayi, J. C.
Clemens, W. V. Rumpler, et al. ``The US Department of Agriculture
Automated Multiple-Pass Method reduces bias in the collection of
energy intakes,'' The American Journal of Clinical Nutrition,
88:324-32, 2008.
49. Rhodes, D. G. ``Accuracy of 24 Hour Dietary Recalls: Preliminary
Results From USDA AMPM Validation Study,'' The FASEB Journal,
18:A111, 2004.
50. 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.
51. Herbst, S.T., R. Herbst, ``The New Food Lover's Companion,''
Fourth Edition. Barron's Educational Series, Inc, 2007.
52. Meredith Corporation. Recipe.com: Serving Up Savings, December
6, 2012. http://www.recipe.com.
53. Scripps Networks, LLC, Food.com: Home of the Home Cook, December
6, 2012. http://www.food.com/.
54. Allrecipes. Allrecipes, December 6, 2012. http://www.allrecipes.com.
55. Gladson Interactive Services, ``Nutrition Database'', http://www.gladson.com/our-services/nutrition-database.
56. Mintel, Global New Products Database, http://www.mintel.com/gnpd.
57. U.S. Department of Agriculture, Agricultural Research Service,
USDA Nutrient Data Laboratory. USDA National Nutrient Database for
Standard Reference, Release 24, 2011. http://www.ars.usda.gov/services/docs.htm?docid=8964.
58. U.S. Department of Health and Human Services, Food and Drug
Administration. ``A Food Labeling Guide: Guidance for Industry'',
January 2013. http://www.fda.gov/FoodLabelingGuide.
59. U.S. Department of Agriculture, 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.
60. Saltsman, J. J., FDA, Letter to Kenneth C. Mercurio, Nestle USA
Inc., August 11, 1993.
61. Saltsman, J. J., FDA, Letter to David Knupfer, W & F Products
Inc., August 26, 1993.
62. Juan, W., Memorandum to File: ``Documentation for determining
the gram weight amount for one individual unit of breath mint''.
February 11, 2014.
63. U.S. Food and Drug Administration. ``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.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

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

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR 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. Section 101.9 is amended as follows:
0
a. Revise paragraph (b)(2)(i)(D);
0
b. Remove paragraph (b)(2)(i)(E) and redesignate paragraphs
(b)(2)(i)(F) through (b)(2)(i)(I), respectively, as paragraphs
(b)(2)(i)(E) through (b)(2)(i)(H), respectively;
0
c. Revise paragraphs (b)(6), (b)(8)(i), and (b)(8)(iii);
0
d. Add paragraph (b)(12).
0
e. Revise paragraph (h)(3)(ii)
    The revisions 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
400 percent of the applicable reference amount, the manufacturer must
provide an additional column within the Nutrition Facts label that
lists the quantitative amounts and percent Daily Values for the
individual unit, as well as the preexisting columns listing the
quantitative amounts and percent Daily Values for a serving that is
less than the unit (i.e., the serving size derived from the Reference
Amount Customarily Consumed (RACC)). 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)(12)(i)(B), and (b)(12)(i)(C) of this section apply to this
provision.
* * * * *
    (6) A product that is packaged and sold individually and 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.
* * * * *
    (8) * * *
    (i) The number of servings must be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
must be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term about (e.g., about 2 servings, about
3.5 servings). 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.
* * * * *
    (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 parenthesis following the
``varied'' statement.
* * * * *
    (12)(i) Products that are packaged and sold individually and
contain at least 200 percent and up to and including 400 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 container, as well as the
preexisting columns listing the quantitative amounts and percent Daily
Values for a serving that is less than the entire container (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 container.
    (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 bulk products that are used
primarily as ingredients (e.g., flour, sweeteners, shortenings, oils),
or bulk products traditionally used for multi-purposes (e.g., eggs,
butter, margarine), and multipurpose baking mixes.
    (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, or products that are commonly
consumed in combination with another food and provide an additional
column of nutrition information under paragraph (e) 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 paragraphs
(b)(12)(i) and (b)(2)(i)(D) of this section, the claim must be followed
by a statement that sets forth the basis on which the claim is made.
The statement must express the amount of the nutrient in a serving
(e.g., ``good source of calcium'' ``a serving of ---- oz of this
product contains ---- mg of calcium'' or for a health claim ``A serving
of ---- ounces of this product conforms to such a diet''). However, if
the serving size declared on the product label differs from the RACC,
and the amount of the nutrient contained in the labeled serving does
not meet the maximum or minimum amount criterion in the definition for
the descriptor for that nutrient, the claim must be followed by the
criteria for the claim as required by Sec.  101.12(g) of this chapter.
This statement is not required for products when the nutrient that is
the subject of the claim meets the criteria based on the entire
container amount or the unit amount, as applicable.
* * * * *
    (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, 1 ounce for solid foods, 2 fluid ounces for
nonbeverage liquids (e.g., syrups), and 12 fluid ounces for beverages,
except that milk and fruit juices, nectars and fruit drinks, which will
be based on 8 fluid ounces, may be used as the standard serving size
for purposes of nutrition labeling of foods subject to this paragraph.
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. Section 101.12 is amended as follows:
0
a. In paragraph (b), revise tables 1 and 2.
0
b. Revise paragraphs (c) and (f)(1), remove paragraph (f)(2),
redesignate paragraph (f)(3) as paragraph (f)(2), and 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 Children 1 Through 3 Years of Age 2 3
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference Amount           \4\
------------------------------------------------------------------------
Cereals, dry instant............  15 g..............  ---- cup (---- g).
Cereals, prepared, ready-to-      110 g.............  ---- cup(s) (----
 serve.                                                g).
Other cereal and grain products,  7g for infants and  ---- cup(s) (----
 dry ready-to-eat, e.g., ready-    20 g for young      g) for ready-to-
 to-eat cereals, cookies,          children (1         eat cereals; ----
 teething biscuits, and toasts.    through 3 years     piece(s) (---- g)
                                   of age) for ready-  for others.
                                   to-eat cereals; 7
                                   g for all others.
Dinners, deserts, fruits,         15 g..............  ---- tbsp(s) (----
 vegetables or soups, dry mix.                         g); ---- cup(s)
                                                       (---- g).
Dinners, desserts, fruits,        110 g.............  ---- cup(s) (----
 vegetables or soups, ready-to-                        g); cup(s) (----
 serve, junior type.                                   mL).
Dinners, desserts, fruits,        110 g.............  ---- cup(s) (----
 vegetables or soups, ready-to-                        g); cup(s) (mL).
 serve, strained type.
Dinners, stews or soups for       170g..............  ---- cup(s) (----
 young children, ready-to-serve.                       g); cup(s) (----
                                                       mL).
Fruits for young children, ready- 125 g.............  ---- cup(s) (----
 to-serve.                                             g).
Vegetables for young children,    70 g..............  ---- cup(s) (----
 ready-to-serve.                                       g).
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 derived primarily 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 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 (i.e., 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) (----
     muffins (excluding English                         g).
     muffins).
    Biscuits, croissants,         55 g..............  ---- piece(s) (----
     tortillas, soft bread                              g).
     sticks, soft pretzels, corn
     bread, hush puppies,
     scones, crumpets, English
     muffins.
    Breads (excluding sweet       50 g..............  ---- piece(s) (----
     quick type), rolls.                                g) 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, heavy weight (cheese   125 g.............  ---- piece(s) (----
     cake; pineapple upside-down                        g) for distinct
     cake; fruit, nut and                              pieces (e.g.,